Part E—Miscellaneous Provisions
Editorial Notes
Codification
§1395x. Definitions
For purposes of this subchapter—
(a) Spell of illness
The term "spell of illness" with respect to any individual means a period of consecutive days—
(1) beginning with the first day (not included in a previous spell of illness) (A) on which such individual is furnished inpatient hospital services, inpatient critical access hospital services or extended care services, and (B) which occurs in a month for which he is entitled to benefits under part A, and
(2) ending with the close of the first period of 60 consecutive days thereafter on each of which he is neither an inpatient of a hospital or critical access hospital nor an inpatient of a facility described in
(b) Inpatient hospital services
The term "inpatient hospital services" means the following items and services furnished to an inpatient of a hospital and (except as provided in paragraph (3)) by the hospital—
(1) bed and board;
(2) such nursing services and other related services, such use of hospital facilities, and such medical social services as are ordinarily furnished by the hospital for the care and treatment of inpatients, and such drugs, biologicals, supplies, appliances, and equipment, for use in the hospital, as are ordinarily furnished by such hospital for the care and treatment of inpatients; and
(3) such other diagnostic or therapeutic items or services, furnished by the hospital or by others under arrangements with them made by the hospital, as are ordinarily furnished to inpatients either by such hospital or by others under such arrangements;
excluding, however—
(4) medical or surgical services provided by a physician, resident, or intern, services described by subsection (s)(2)(K), certified nurse-midwife services, qualified psychologist services, and services of a certified registered nurse anesthetist; and
(5) the services of a private-duty nurse or other private-duty attendant.
Paragraph (4) shall not apply to services provided in a hospital by—
(6) an intern or a resident-in-training under a teaching program approved by the Council on Medical Education of the American Medical Association or, in the case of an osteopathic hospital, approved by the Committee on Hospitals of the Bureau of Professional Education of the American Osteopathic Association, or, in the case of services in a hospital or osteopathic hospital by an intern or resident-in-training in the field of dentistry, approved by the Council on Dental Education of the American Dental Association, or in the case of services in a hospital or osteopathic hospital by an intern or resident-in-training in the field of podiatry, approved by the Council on Podiatric Medical Education of the American Podiatric Medical Association; or
(7) a physician where the hospital has a teaching program approved as specified in paragraph (6), if (A) the hospital elects to receive any payment due under this subchapter for reasonable costs of such services, and (B) all physicians in such hospital agree not to bill charges for professional services rendered in such hospital to individuals covered under the insurance program established by this subchapter.
(c) Inpatient psychiatric hospital services
The term "inpatient psychiatric hospital services" means inpatient hospital services furnished to an inpatient of a psychiatric hospital.
(d) Supplier
The term "supplier" means, unless the context otherwise requires, a physician or other practitioner, a facility, or other entity (other than a provider of services) that furnishes items or services under this subchapter.
(e) Hospital
The term "hospital" (except for purposes of
(1) is primarily engaged in providing, by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons;
(2) maintains clinical records on all patients;
(3) has bylaws in effect with respect to its staff of physicians;
(4) has a requirement that every patient with respect to whom payment may be made under this subchapter must be under the care of a physician, except that a patient receiving qualified psychologist services (as defined in subsection (ii)) may be under the care of a clinical psychologist with respect to such services to the extent permitted under State law;
(5) provides 24-hour nursing service rendered or supervised by a registered professional nurse, and has a licensed practical nurse or registered professional nurse on duty at all times; except that until January 1, 1979, the Secretary is authorized to waive the requirement of this paragraph for any one-year period with respect to any institution, insofar as such requirement relates to the provision of twenty-four-hour nursing service rendered or supervised by a registered professional nurse (except that in any event a registered professional nurse must be present on the premises to render or supervise the nursing service provided, during at least the regular daytime shift), where immediately preceding such one-year period he finds that—
(A) such institution is located in a rural area and the supply of hospital services in such area is not sufficient to meet the needs of individuals residing therein,
(B) the failure of such institution to qualify as a hospital would seriously reduce the availability of such services to such individuals, and
(C) such institution has made and continues to make a good faith effort to comply with this paragraph, but such compliance is impeded by the lack of qualified nursing personnel in such area;
(6)(A) has in effect a hospital utilization review plan which meets the requirements of subsection (k) and (B) has in place a discharge planning process that meets the requirements of subsection (ee);
(7) in the case of an institution in any State in which State or applicable local law provides for the licensing of hospitals, (A) is licensed pursuant to such law or (B) is approved, by the agency of such State or locality responsible for licensing hospitals, as meeting the standards established for such licensing;
(8) has in effect an overall plan and budget that meets the requirements of subsection (z); and
(9) meets such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institution.
For purposes of subsection (a)(2), such term includes any institution which meets the requirements of paragraph (1) of this subsection. For purposes of
(A) with respect to the requirements for nursing services applicable after December 31, 1978, such requirements shall provide for temporary waiver of the requirements, for such period as the Secretary deems appropriate, where (i) the facility's failure to fully comply with the requirements is attributable to a temporary shortage of qualified nursing personnel in the area in which the facility is located, (ii) a registered professional nurse is present on the premises to render or supervise the nursing service provided during at least the regular daytime shift, and (iii) the Secretary determines that the employment of such nursing personnel as are available to the facility during such temporary period will not adversely affect the health and safety of patients;
(B) with respect to the health and safety requirements promulgated under paragraph (9), such requirements shall be applied by the Secretary to a facility herein defined in such manner as to assure that personnel requirements take into account the availability of technical personnel and the educational opportunities for technical personnel in the area in which such facility is located, and the scope of services rendered by such facility; and the Secretary, by regulations, shall provide for the continued participation of such a facility where such personnel requirements are not fully met, for such period as the Secretary determines that (i) the facility is making good faith efforts to fully comply with the personnel requirements, (ii) the employment by the facility of such personnel as are available to the facility will not adversely affect the health and safety of patients, and (iii) if the Secretary has determined that because of the facility's waiver under this subparagraph the facility should limit its scope of services in order not to adversely affect the health and safety of the facility's patients, the facility is so limiting the scope of services it provides; and
(C) with respect to the fire and safety requirements promulgated under paragraph (9), the Secretary (i) may waive, for such period as he deems appropriate, specific provisions of such requirements which if rigidly applied would result in unreasonable hardship for such a facility and which, if not applied, would not jeopardize the health and safety of patients, and (ii) may accept a facility's compliance with all applicable State codes relating to fire and safety in lieu of compliance with the fire and safety requirements promulgated under paragraph (9), if he determines that such State has in effect fire and safety codes, imposed by State law, which adequately protect patients.
The term "hospital" does not include, unless the context otherwise requires, a critical access hospital (as defined in subsection (mm)(1)) or a rural emergency hospital (as defined in subsection (kkk)(2)).
(f) Psychiatric hospital
The term "psychiatric hospital" means an institution which—
(1) is primarily engaged in providing, by or under the supervision of a physician, psychiatric services for the diagnosis and treatment of mentally ill persons;
(2) satisfies the requirements of paragraphs (3) through (9) of subsection (e);
(3) maintains clinical records on all patients and maintains such records as the Secretary finds to be necessary to determine the degree and intensity of the treatment provided to individuals entitled to hospital insurance benefits under part A; and
(4) meets such staffing requirements as the Secretary finds necessary for the institution to carry out an active program of treatment for individuals who are furnished services in the institution.
In the case of an institution which satisfies paragraphs (1) and (2) of the preceding sentence and which contains a distinct part which also satisfies paragraphs (3) and (4) of such sentence, such distinct part shall be considered to be a "psychiatric hospital".
(g) Outpatient occupational therapy services
The term "outpatient occupational therapy services" has the meaning given the term "outpatient physical therapy services" in subsection (p), except that "occupational" shall be substituted for "physical" each place it appears therein.
(h) Extended care services
The term "extended care services" means the following items and services furnished to an inpatient of a skilled nursing facility and (except as provided in paragraphs (3), (6), and (7)) by such skilled nursing facility—
(1) nursing care provided by or under the supervision of a registered professional nurse;
(2) bed and board in connection with the furnishing of such nursing care;
(3) physical or occupational therapy or speech-language pathology services furnished by the skilled nursing facility or by others under arrangements with them made by the facility;
(4) medical social services;
(5) such drugs, biologicals, supplies, appliances, and equipment, furnished for use in the skilled nursing facility, as are ordinarily furnished by such facility for the care and treatment of inpatients;
(6) medical services provided by an intern or resident-in-training of a hospital with which the facility has in effect a transfer agreement (meeting the requirements of subsection (l)), under a teaching program of such hospital approved as provided in the last sentence of subsection (b), and other diagnostic or therapeutic services provided by a hospital with which the facility has such an agreement in effect; and
(7) such other services necessary to the health of the patients as are generally provided by skilled nursing facilities, or by others under arrangements with them made by the facility;
excluding, however, any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital.
(i) Post-hospital extended care services
The term "post-hospital extended care services" means extended care services furnished an individual after transfer from a hospital in which he was an inpatient for not less than 3 consecutive days before his discharge from the hospital in connection with such transfer. For purposes of the preceding sentence, items and services shall be deemed to have been furnished to an individual after transfer from a hospital, and he shall be deemed to have been an inpatient in the hospital immediately before transfer therefrom, if he is admitted to the skilled nursing facility (A) within 30 days after discharge from such hospital, or (B) within such time as it would be medically appropriate to begin an active course of treatment, in the case of an individual whose condition is such that skilled nursing facility care would not be medically appropriate within 30 days after discharge from a hospital; and an individual shall be deemed not to have been discharged from a skilled nursing facility if, within 30 days after discharge therefrom, he is admitted to such facility or any other skilled nursing facility.
(j) Skilled nursing facility
The term "skilled nursing facility" has the meaning given such term in
(k) Utilization review
A utilization review plan of a hospital or skilled nursing facility shall be considered sufficient if it is applicable to services furnished by the institution to individuals entitled to insurance benefits under this subchapter and if it provides—
(1) for the review, on a sample or other basis, of admissions to the institution, the duration of stays therein, and the professional services (including drugs and biologicals) furnished, (A) with respect to the medical necessity of the services, and (B) for the purpose of promoting the most efficient use of available health facilities and services;
(2) for such review to be made by either (A) a staff committee of the institution composed of two or more physicians (of which at least two must be physicians described in subsection (r)(1) of this section), with or without participation of other professional personnel, or (B) a group outside the institution which is similarly composed and (i) which is established by the local medical society and some or all of the hospitals and skilled nursing facilities in the locality, or (ii) if (and for as long as) there has not been established such a group which serves such institution, which is established in such other manner as may be approved by the Secretary;
(3) for such review, in each case of inpatient hospital services or extended care services furnished to such an individual during a continuous period of extended duration, as of such days of such period (which may differ for different classes of cases) as may be specified in regulations, with such review to be made as promptly as possible, after each day so specified, and in no event later than one week following such day; and
(4) for prompt notification to the institution, the individual, and his attending physician of any finding (made after opportunity for consultation to such attending physician) by the physician members of such committee or group that any further stay in the institution is not medically necessary.
The review committee must be composed as provided in clause (B) of paragraph (2) rather than as provided in clause (A) of such paragraph in the case of any hospital or skilled nursing facility where, because of the small size of the institution, or (in the case of a skilled nursing facility) because of lack of an organized medical staff, or for such other reason or reasons as may be included in regulations, it is impracticable for the institution to have a properly functioning staff committee for the purposes of this subsection. If the Secretary determines that the utilization review procedures established pursuant to subchapter XIX are superior in their effectiveness to the procedures required under this section, he may, to the extent that he deems it appropriate, require for purposes of this subchapter that the procedures established pursuant to subchapter XIX be utilized instead of the procedures required by this section.
(l) Agreements for transfer between skilled nursing facilities and hospitals
A hospital and a skilled nursing facility shall be considered to have a transfer agreement in effect if, by reason of a written agreement between them or (in case the two institutions are under common control) by reason of a written undertaking by the person or body which controls them, there is reasonable assurance that—
(1) transfer of patients will be effected between the hospital and the skilled nursing facility whenever such transfer is medically appropriate as determined by the attending physician; and
(2) there will be interchange of medical and other information necessary or useful in the care and treatment of individuals transferred between the institutions, or in determining whether such individuals can be adequately cared for otherwise than in either of such institutions.
Any skilled nursing facility which does not have such an agreement in effect, but which is found by a State agency (of the State in which such facility is situated) with which an agreement under
(m) Home health services
The term "home health services" means the following items and services furnished to an individual, who is under the care of a physician, a nurse practitioner or a clinical nurse specialist (as those terms are defined in subsection (aa)(5)), or a physician assistant (as defined in subsection (aa)(5)), by a home health agency or by others under arrangements with them made by such agency, under a plan (for furnishing such items and services to such individual) established and periodically reviewed by a physician, a nurse practitioner, a clinical nurse specialist, or a physician assistant, which items and services are, except as provided in paragraph (7), provided on a visiting basis in a place of residence used as such individual's home—
(1) part-time or intermittent nursing care provided by or under the supervision of a registered professional nurse;
(2) physical or occupational therapy or speech-language pathology services;
(3) medical social services under the direction of a physician, a nurse practitioner, a clinical nurse specialist, or a physician assistant;
(4) to the extent permitted in regulations, part-time or intermittent services of a home health aide who has successfully completed a training program approved by the Secretary;
(5) medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care, and a covered osteoporosis drug (as defined in subsection (kk)), but excluding other drugs and biologicals) and durable medical equipment and applicable disposable devices (as defined in
(6) in the case of a home health agency which is affiliated or under common control with a hospital, medical services provided by an intern or resident-in-training of such hospital, under a teaching program of such hospital approved as provided in the last sentence of subsection (b); and
(7) any of the foregoing items and services which are provided on an outpatient basis, under arrangements made by the home health agency, at a hospital or skilled nursing facility, or at a rehabilitation center which meets such standards as may be prescribed in regulations, and—
(A) the furnishing of which involves the use of equipment of such a nature that the items and services cannot readily be made available to the individual in such place of residence, or
(B) which are furnished at such facility while he is there to receive any such item or service described in clause (A),
but not including transportation of the individual in connection with any such item or service;
excluding, however, any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital and home infusion therapy (as defined in subsection (iii)(i)). For purposes of paragraphs (1) and (4), the term "part-time or intermittent services" means skilled nursing and home health aide services furnished any number of days per week as long as they are furnished (combined) less than 8 hours each day and 28 or fewer hours each week (or, subject to review on a case-by-case basis as to the need for care, less than 8 hours each day and 35 or fewer hours per week). For purposes of
(n) Durable medical equipment
The term "durable medical equipment" includes iron lungs, oxygen tents, hospital beds, and wheelchairs (which may include a power-operated vehicle that may be appropriately used as a wheelchair, but only where the use of such a vehicle is determined to be necessary on the basis of the individual's medical and physical condition and the vehicle meets such safety requirements as the Secretary may prescribe) used in the patient's home (including an institution used as his home other than an institution that meets the requirements of subsection (e)(1) of this section or
(o) Home health agency
The term "home health agency" means a public agency or private organization, or a subdivision of such an agency or organization, which—
(1) is primarily engaged in providing skilled nursing services and other therapeutic services;
(2) has policies, established by a group of professional personnel (associated with the agency or organization), including one or more physicians, nurse practitioners or clinical nurse specialists (as those terms are defined in subsection (aa)(5)), certified nurse-midwives (as defined in subsection (gg)), or physician assistants (as defined in subsection (aa)(5)) and one or more registered professional nurses, to govern the services (referred to in paragraph (1)) which it provides, and provides for supervision of such services by a physician, nurse practitioner, clinical nurse specialist, certified nurse-midwife, physician assistant, or registered professional nurse;
(3) maintains clinical records on all patients;
(4) in the case of an agency or organization in any State in which State or applicable local law provides for the licensing of agencies or organizations of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing agencies or organizations of this nature, as meeting the standards established for such licensing;
(5) has in effect an overall plan and budget that meets the requirements of subsection (z);
(6) meets the conditions of participation specified in
(7) provides the Secretary with a surety bond—
(A) in a form specified by the Secretary and in an amount that is not less than the minimum of $50,000; and
(B) that the Secretary determines is commensurate with the volume of payments to the home health agency; and
(8) meets such additional requirements (including conditions relating to bonding or establishing of escrow accounts as the Secretary finds necessary for the financial security of the program) as the Secretary finds necessary for the effective and efficient operation of the program;
except that for purposes of part A such term shall not include any agency or organization which is primarily for the care and treatment of mental diseases. The Secretary may waive the requirement of a surety bond under paragraph (7) in the case of an agency or organization that provides a comparable surety bond under State law.
(p) Outpatient physical therapy services
The term "outpatient physical therapy services" means physical therapy services furnished by a provider of services, a clinic, rehabilitation agency, or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient—
(1) who is under the care of a physician (as defined in paragraph (1), (3), or (4) of subsection (r)), and
(2) with respect to whom a plan prescribing the type, amount, and duration of physical therapy services that are to be furnished such individual has been established by a physician (as so defined) or by a qualified physical therapist and is periodically reviewed by a physician (as so defined);
excluding, however—
(3) any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital; and
(4) any such service—
(A) if furnished by a clinic or rehabilitation agency, or by others under arrangements with such clinic or agency, unless such clinic or rehabilitation agency—
(i) provides an adequate program of physical therapy services for outpatients and has the facilities and personnel required for such program or required for the supervision of such a program, in accordance with such requirements as the Secretary may specify,
(ii) has policies, established by a group of professional personnel, including one or more physicians (associated with the clinic or rehabilitation agency) and one or more qualified physical therapists, to govern the services (referred to in clause (i)) it provides,
(iii) maintains clinical records on all patients,
(iv) if such clinic or agency is situated in a State in which State or applicable local law provides for the licensing of institutions of this nature, (I) is licensed pursuant to such law, or (II) is approved by the agency of such State or locality responsible for licensing institutions of this nature, as meeting the standards established for such licensing; and
(v) meets such other conditions relating to the health and safety of individuals who are furnished services by such clinic or agency on an outpatient basis, as the Secretary may find necessary, and provides the Secretary on a continuing basis with a surety bond in a form specified by the Secretary and in an amount that is not less than $50,000, or
(B) if furnished by a public health agency, unless such agency meets such other conditions relating to health and safety of individuals who are furnished services by such agency on an outpatient basis, as the Secretary may find necessary.
The term "outpatient physical therapy services" also includes physical therapy services furnished an individual by a physical therapist (in his office or in such individual's home) who meets licensing and other standards prescribed by the Secretary in regulations, otherwise than under an arrangement with and under the supervision of a provider of services, clinic, rehabilitation agency, or public health agency, if the furnishing of such services meets such conditions relating to health and safety as the Secretary may find necessary. In addition, such term includes physical therapy services which meet the requirements of the first sentence of this subsection except that they are furnished to an individual as an inpatient of a hospital or extended care facility. Nothing in this subsection shall be construed as requiring, with respect to outpatients who are not entitled to benefits under this subchapter, a physical therapist to provide outpatient physical therapy services only to outpatients who are under the care of a physician or pursuant to a plan of care established by a physician. The Secretary may waive the requirement of a surety bond under paragraph (4)(A)(v) in the case of a clinic or agency that provides a comparable surety bond under State law.
(q) Physicians' services
The term "physicians' services" means professional services performed by physicians, including surgery, consultation, and home, office, and institutional calls (but not including services described in subsection (b)(6)).
(r) Physician
The term "physician", when used in connection with the performance of any function or action, means (1) a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or action (including a physician within the meaning of
(s) Medical and other health services
The term "medical and other health services" means any of the following items or services:
(1) physicians' services;
(2)(A) services and supplies (including drugs and biologicals which are not usually self-administered by the patient) furnished as an incident to a physician's professional service, of kinds which are commonly furnished in physicians' offices and are commonly either rendered without charge or included in the physicians' bills (or would have been so included but for the application of
(B) hospital services (including drugs and biologicals which are not usually self-administered by the patient) incident to physicians' services rendered to outpatients and partial hospitalization services or intensive outpatient services incident to such services;
(C) diagnostic services which are—
(i) furnished to an individual as an outpatient by a hospital or by others under arrangements with them made by a hospital, and
(ii) ordinarily furnished by such hospital (or by others under such arrangements) to its outpatients for the purpose of diagnostic study;
(D) outpatient physical therapy services, outpatient speech-language pathology services, and outpatient occupational therapy services;
(E) rural health clinic services and Federally qualified health center services;
(F) home dialysis supplies and equipment, self-care home dialysis support services, and institutional dialysis services and supplies, and, for items and services furnished on or after January 1, 2011, renal dialysis services (as defined in
(G) antigens (subject to quantity limitations prescribed in regulations by the Secretary) prepared by a physician, as defined in subsection (r)(1), for a particular patient, including antigens so prepared which are forwarded to another qualified person (including a rural health clinic) for administration to such patient, from time to time, by or under the supervision of another such physician;
(H)(i) services furnished pursuant to a contract under
(ii) services furnished pursuant to a risk-sharing contract under
(I) blood clotting factors, for hemophilia patients competent to use such factors to control bleeding without medical or other supervision, and items related to the administration of such factors, subject to utilization controls deemed necessary by the Secretary for the efficient use of such factors;
(J) prescription drugs used in immunosuppressive therapy furnished, to an individual who receives an organ transplant for which payment is made under this subchapter;
(K)(i) services which would be physicians' services and services described in subsections (ww)(1) and (hhh) if furnished by a physician (as defined in subsection (r)(1)) and which are performed by a physician assistant (as defined in subsection (aa)(5)) under the supervision of a physician (as so defined) and which the physician assistant is legally authorized to perform by the State in which the services are performed, and such services and supplies furnished as incident to such services as would be covered under subparagraph (A) if furnished incident to a physician's professional service, but only if no facility or other provider charges or is paid any amounts with respect to the furnishing of such services,2
(ii) services which would be physicians' services and services described in subsections (ww)(1) and (hhh) if furnished by a physician (as defined in subsection (r)(1)) and which are performed by a nurse practitioner or clinical nurse specialist (as defined in subsection (aa)(5)) working in collaboration (as defined in subsection (aa)(6)) with a physician (as defined in subsection (r)(1)) which the nurse practitioner or clinical nurse specialist is legally authorized to perform by the State in which the services are performed, and such services and supplies furnished as an incident to such services as would be covered under subparagraph (A) if furnished incident to a physician's professional service, but only if no facility or other provider charges or is paid any amounts with respect to the furnishing of such services;
(L) certified nurse-midwife services;
(M) qualified psychologist services;
(N) clinical social worker services (as defined in subsection (hh)(2));
(O) erythropoietin for dialysis patients competent to use such drug without medical or other supervision with respect to the administration of such drug, subject to methods and standards established by the Secretary by regulation for the safe and effective use of such drug, and items related to the administration of such drug;
(P) prostate cancer screening tests (as defined in subsection (oo));
(Q) an oral drug (which is approved by the Federal Food and Drug Administration) prescribed for use as an anticancer chemotherapeutic agent for a given indication, and containing an active ingredient (or ingredients), which is the same indication and active ingredient (or ingredients) as a drug which the carrier determines would be covered pursuant to subparagraph (A) or (B) if the drug could not be self-administered;
(R) colorectal cancer screening tests (as defined in subsection (pp)); and 3
(S) diabetes outpatient self-management training services (as defined in subsection (qq));
(T) an oral drug (which is approved by the Federal Food and Drug Administration) prescribed for use as an acute anti-emetic used as part of an anticancer chemotherapeutic regimen if the drug is administered by a physician (or as prescribed by a physician)—
(i) for use immediately before, at, or within 48 hours after the time of the administration of the anticancer chemotherapeutic agent; and
(ii) as a full replacement for the anti-emetic therapy which would otherwise be administered intravenously;
(U) screening for glaucoma (as defined in subsection (uu)) for individuals determined to be at high risk for glaucoma, individuals with a family history of glaucoma and individuals with diabetes;
(V) medical nutrition therapy services (as defined in subsection (vv)(1)) in the case of a beneficiary with diabetes or a renal disease who—
(i) has not received diabetes outpatient self-management training services within a time period determined by the Secretary;
(ii) is not receiving maintenance dialysis for which payment is made under
(iii) meets such other criteria determined by the Secretary after consideration of protocols established by dietitian or nutrition professional organizations;
(W) an initial preventive physical examination (as defined in subsection (ww));
(X) cardiovascular screening blood tests (as defined in subsection (xx)(1));
(Y) diabetes screening tests (as defined in subsection (yy));
(Z) intravenous immune globulin, and items and services furnished on or after January 1, 2024, related to the administration of intravenous immune globulin, for the treatment of primary immune deficiency diseases in the home (as defined in subsection (zz));
(AA) ultrasound screening for abdominal aortic aneurysm (as defined in subsection (bbb)) for an individual—
(i) who receives a referral for such an ultrasound screening as a result of an initial preventive physical examination (as defined in subsection (ww)(1));
(ii) who has not been previously furnished such an ultrasound screening under this subchapter; and
(iii) who—
(I) has a family history of abdominal aortic aneurysm; or
(II) manifests risk factors included in a beneficiary category recommended for screening by the United States Preventive Services Task Force regarding abdominal aortic aneurysms;
(BB) additional preventive services (described in subsection (ddd)(1));
(CC) items and services furnished under a cardiac rehabilitation program (as defined in subsection (eee)(1)) or under a pulmonary rehabilitation program (as defined in subsection (fff)(1));
(DD) items and services furnished under an intensive cardiac rehabilitation program (as defined in subsection (eee)(4));
(EE) kidney disease education services (as defined in subsection (ggg));
(FF) personalized prevention plan services (as defined in subsection (hhh));
(GG) home infusion therapy (as defined in subsection (iii)(1));
(HH) opioid use disorder treatment services (as defined in subsection (jjj));
(II) marriage and family therapist services (as defined in subsection (lll)(1)) and mental health counselor services (as defined in subsection (lll)(3)); and
(JJ) lymphedema compression treatment items (as defined in subsection (mmm));
(3) diagnostic X-ray tests (including tests under the supervision of a physician, furnished in a place of residence used as the patient's home, if the performance of such tests meets such conditions relating to health and safety as the Secretary may find necessary and including diagnostic mammography if conducted by a facility that has a certificate (or provisional certificate) issued under section 354 of the Public Health Service Act [
(4) X-ray, radium, and radioactive isotope therapy, including materials and services of technicians;
(5) surgical dressings, and splints, casts, and other devices used for reduction of fractures and dislocations;
(6) durable medical equipment;
(7) ambulance service where the use of other methods of transportation is contraindicated by the individual's condition, but, subject to
(8) prosthetic devices (other than dental) which replace all or part of an internal body organ (including colostomy bags and supplies directly related to colostomy care), including replacement of such devices, and including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens;
(9) leg, arm, back, and neck braces, and artificial legs, arms, and eyes, including replacements if required because of a change in the patient's physical condition;
(10)(A) pneumococcal vaccine and its administration and, subject to section 4071(b) of the Omnibus Budget Reconciliation Act of 1987, influenza vaccine and its administration, and COVID–19 vaccine and its administration; and
(B) hepatitis B vaccine and its administration, furnished to an individual who is at high or intermediate risk of contracting hepatitis B (as determined by the Secretary under regulations);
(11) services of a certified registered nurse anesthetist (as defined in subsection (bb));
(12) subject to section 4072(e) of the Omnibus Budget Reconciliation Act of 1987, extra-depth shoes with inserts or custom molded shoes with inserts for an individual with diabetes, if—
(A) the physician who is managing the individual's diabetic condition (i) documents that the individual has peripheral neuropathy with evidence of callus formation, a history of pre-ulcerative calluses, a history of previous ulceration, foot deformity, or previous amputation, or poor circulation, and (ii) certifies that the individual needs such shoes under a comprehensive plan of care related to the individual's diabetic condition;
(B) the particular type of shoes are prescribed by a podiatrist or other qualified physician (as established by the Secretary); and
(C) the shoes are fitted and furnished by a podiatrist or other qualified individual (such as a pedorthist or orthotist, as established by the Secretary) who is not the physician described in subparagraph (A) (unless the Secretary finds that the physician is the only such qualified individual in the area);
(13) screening mammography (as defined in subsection (jj));
(14) screening pap smear and screening pelvic exam; and
(15) bone mass measurement (as defined in subsection (rr)).
No diagnostic tests performed in any laboratory, including a laboratory that is part of a rural health clinic, or a hospital (which, for purposes of this sentence, means an institution considered a hospital for purposes of
(16) if situated in any State in which State or applicable local law provides for licensing of establishments of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing establishments of this nature, as meeting the standards established for such licensing; and
(17)(A) meets the certification requirements under section 353 of the Public Health Service Act [
(B) meets such other conditions relating to the health and safety of individuals with respect to whom such tests are performed as the Secretary may find necessary.
There shall be excluded from the diagnostic services specified in paragraph (2)(C) any item or service (except services referred to in paragraph (1)) which would not be included under subsection (b) if it were furnished to an inpatient of a hospital. None of the items and services referred to in the preceding paragraphs (other than paragraphs (1) and (2)(A)) of this subsection which are furnished to a patient of an institution which meets the definition of a hospital for purposes of
(t) Drugs and biologicals
(1) The term "drugs" and the term "biologicals", except for purposes of subsection (m)(5) of this section and paragraph (2), include only such drugs (including contrast agents) and biologicals, respectively, as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital.
(2)(A) For purposes of paragraph (1), the term "drugs" also includes any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication (as described in subparagraph (B)).
(B) In subparagraph (A), the term "medically accepted indication", with respect to the use of a drug, includes any use which has been approved by the Food and Drug Administration for the drug, and includes another use of the drug if—
(i) the drug has been approved by the Food and Drug Administration; and
(ii)(I) such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information (or its successor publications), and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or
(II) the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this subclause by the Secretary.
The Secretary may revise the list of compendia in clause (ii)(I) as is appropriate for identifying medically accepted indications for drugs. On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has 4 a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.
(u) Provider of services
The term "provider of services" means a hospital, critical access hospital, rural emergency hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, or, for purposes of section 1395f(g) and
(v) Reasonable costs
(1)(A) The reasonable cost of any services shall be the cost actually incurred, excluding therefrom any part of incurred cost found to be unnecessary in the efficient delivery of needed health services, and shall be determined in accordance with regulations establishing the method or methods to be used, and the items to be included, in determining such costs for various types or classes of institutions, agencies, and services; except that in any case to which paragraph (2) or (3) applies, the amount of the payment determined under such paragraph with respect to the services involved shall be considered the reasonable cost of such services. In prescribing the regulations referred to in the preceding sentence, the Secretary shall consider, among other things, the principles generally applied by national organizations or established prepayment organizations (which have developed such principles) in computing the amount of payment, to be made by persons other than the recipients of services, to providers of services on account of services furnished to such recipients by such providers. Such regulations may provide for determination of the costs of services on a per diem, per unit, per capita, or other basis, may provide for using different methods in different circumstances, may provide for the use of estimates of costs of particular items or services, may provide for the establishment of limits on the direct or indirect overall incurred costs or incurred costs of specific items or services or groups of items or services to be recognized as reasonable based on estimates of the costs necessary in the efficient delivery of needed health services to individuals covered by the insurance programs established under this subchapter, and may provide for the use of charges or a percentage of charges where this method reasonably reflects the costs. Such regulations shall (i) take into account both direct and indirect costs of providers of services (excluding therefrom any such costs, including standby costs, which are determined in accordance with regulations to be unnecessary in the efficient delivery of services covered by the insurance programs established under this subchapter) in order that, under the methods of determining costs, the necessary costs of efficiently delivering covered services to individuals covered by the insurance programs established by this subchapter will not be borne by individuals not so covered, and the costs with respect to individuals not so covered will not be borne by such insurance programs, and (ii) provide for the making of suitable retroactive corrective adjustments where, for a provider of services for any fiscal period, the aggregate reimbursement produced by the methods of determining costs proves to be either inadequate or excessive.
(B) In the case of extended care services, the regulations under subparagraph (A) shall not include provision for specific recognition of a return on equity capital.
(C) Where a hospital has an arrangement with a medical school under which the faculty of such school provides services at such hospital, an amount not in excess of the reasonable cost of such services to the medical school shall be included in determining the reasonable cost to the hospital of furnishing services—
(i) for which payment may be made under part A, but only if—
(I) payment for such services as furnished under such arrangement would be made under part A to the hospital had such services been furnished by the hospital, and
(II) such hospital pays to the medical school at least the reasonable cost of such services to the medical school, or
(ii) for which payment may be made under part B, but only if such hospital pays to the medical school at least the reasonable cost of such services to the medical school.
(D) Where (i) physicians furnish services which are either inpatient hospital services (including services in conjunction with the teaching programs of such hospital) by reason of paragraph (7) of subsection (b) or for which entitlement exists by reason of clause (II) of
(E) Such regulations may, in the case of skilled nursing facilities in any State, provide for the use of rates, developed by the State in which such facilities are located, for the payment of the cost of skilled nursing facility services furnished under the State's plan approved under subchapter XIX (and such rates may be increased by the Secretary on a class or size of institution or on a geographical basis by a percentage factor not in excess of 10 percent to take into account determinable items or services or other requirements under this subchapter not otherwise included in the computation of such State rates), if the Secretary finds that such rates are reasonably related to (but not necessarily limited to) analyses undertaken by such State of costs of care in comparable facilities in such State. Notwithstanding the previous sentence, such regulations with respect to skilled nursing facilities shall take into account (in a manner consistent with subparagraph (A) and based on patient-days of services furnished) the costs (including the costs of services required to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident eligible for benefits under this subchapter) of such facilities complying with the requirements of subsections (b), (c), and (d) of
(F) Such regulations shall require each provider of services (other than a fund) to make reports to the Secretary of information described in
(G)(i) In any case in which a hospital provides inpatient services to an individual that would constitute post-hospital extended care services if provided by a skilled nursing facility and a quality improvement organization (or, in the absence of such a qualified organization, the Secretary or such agent as the Secretary may designate) determines that inpatient hospital services for the individual are not medically necessary but post-hospital extended care services for the individual are medically necessary and such extended care services are not otherwise available to the individual (as determined in accordance with criteria established by the Secretary) at the time of such determination, payment for such services provided to the individual shall continue to be made under this subchapter at the payment rate described in clause (ii) during the period in which—
(I) such post-hospital extended care services for the individual are medically necessary and not otherwise available to the individual (as so determined),
(II) inpatient hospital services for the individual are not medically necessary, and
(III) the individual is entitled to have payment made for post-hospital extended care services under this subchapter,
except that if the Secretary determines that there is not an excess of hospital beds in such hospital and (subject to clause (iv)) there is not an excess of hospital beds in the area of such hospital, such payment shall be made (during such period) on the basis of the amount otherwise payable under part A with respect to inpatient hospital services.
(ii)(I) Except as provided in subclause (II), the payment rate referred to in clause (i) is a rate equal to the estimated adjusted State-wide average rate per patient-day paid for services provided in skilled nursing facilities under the State plan approved under subchapter XIX for the State in which such hospital is located, or, if the State in which the hospital is located does not have a State plan approved under subchapter XIX, the estimated adjusted State-wide average allowable costs per patient-day for extended care services under this subchapter in that State.
(II) If a hospital has a unit which is a skilled nursing facility, the payment rate referred to in clause (i) for the hospital is a rate equal to the lesser of the rate described in subclause (I) or the allowable costs in effect under this subchapter for extended care services provided to patients of such unit.
(iii) Any day on which an individual receives inpatient services for which payment is made under this subparagraph shall, for purposes of this chapter (other than this subparagraph), be deemed to be a day on which the individual received inpatient hospital services.
(iv) In determining under clause (i), in the case of a public hospital, whether or not there is an excess of hospital beds in the area of such hospital, such determination shall be made on the basis of only the public hospitals (including the hospital) which are in the area of the hospital and which are under common ownership with that hospital.
(H) In determining such reasonable cost with respect to home health agencies, the Secretary may not include—
(i) any costs incurred in connection with bonding or establishing an escrow account by any such agency as a result of the surety bond requirement described in subsection (o)(7) and the financial security requirement described in subsection (o)(8);
(ii) in the case of home health agencies to which the surety bond requirement described in subsection (o)(7) and the financial security requirement described in subsection (o)(8) apply, any costs attributed to interest charged such an agency in connection with amounts borrowed by the agency to repay overpayments made under this subchapter to the agency, except that such costs may be included in reasonable cost if the Secretary determines that the agency was acting in good faith in borrowing the amounts;
(iii) in the case of contracts entered into by a home health agency after December 5, 1980, for the purpose of having services furnished for or on behalf of such agency, any cost incurred by such agency pursuant to any such contract which is entered into for a period exceeding five years; and
(iv) in the case of contracts entered into by a home health agency before December 5, 1980, for the purpose of having services furnished for or on behalf of such agency, any cost incurred by such agency pursuant to any such contract, which determines the amount payable by the home health agency on the basis of a percentage of the agency's reimbursement or claim for reimbursement for services furnished by the agency, to the extent that such cost exceeds the reasonable value of the services furnished on behalf of such agency.
(I) In determining such reasonable cost, the Secretary may not include any costs incurred by a provider with respect to any services furnished in connection with matters for which payment may be made under this subchapter and furnished pursuant to a contract between the provider and any of its subcontractors which is entered into after December 5, 1980, and the value or cost of which is $10,000 or more over a twelve-month period unless the contract contains a clause to the effect that—
(i) until the expiration of four years after the furnishing of such services pursuant to such contract, the subcontractor shall make available, upon written request by the Secretary, or upon request by the Comptroller General, or any of their duly authorized representatives, the contract, and books, documents and records of such subcontractor that are necessary to certify the nature and extent of such costs, and
(ii) if the subcontractor carries out any of the duties of the contract through a subcontract, with a value or cost of $10,000 or more over a twelve-month period, with a related organization, such subcontract shall contain a clause to the effect that until the expiration of four years after the furnishing of such services pursuant to such subcontract, the related organization shall make available, upon written request by the Secretary, or upon request by the Comptroller General, or any of their duly authorized representatives, the subcontract, and books, documents and records of such organization that are necessary to verify the nature and extent of such costs.
The Secretary shall prescribe in regulation 5 criteria and procedures which the Secretary shall use in obtaining access to books, documents, and records under clauses required in contracts and subcontracts under this subparagraph.
(J) Such regulations may not provide for any inpatient routine salary cost differential as a reimbursable cost for hospitals and skilled nursing facilities.
(K)(i) The Secretary shall issue regulations that provide, to the extent feasible, for the establishment of limitations on the amount of any costs or charges that shall be considered reasonable with respect to services provided on an outpatient basis by hospitals (other than bona fide emergency services as defined in clause (ii)) or clinics (other than rural health clinics), which are reimbursed on a cost basis or on the basis of cost related charges, and by physicians utilizing such outpatient facilities. Such limitations shall be reasonably related to the charges in the same area for similar services provided in physicians' offices. Such regulations shall provide for exceptions to such limitations in cases where similar services are not generally available in physicians' offices in the area to individuals entitled to benefits under this subchapter.
(ii) For purposes of clause (i), the term "bona fide emergency services" means services provided in a hospital emergency room after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in—
(I) placing the patient's health in serious jeopardy;
(II) serious impairment to bodily functions; or
(III) serious dysfunction of any bodily organ or part.
(L)(i) The Secretary, in determining the amount of the payments that may be made under this subchapter with respect to services furnished by home health agencies, may not recognize as reasonable (in the efficient delivery of such services) costs for the provision of such services by an agency to the extent these costs exceed (on the aggregate for the agency) for cost reporting periods beginning on or after—
(I) July 1, 1985, and before July 1, 1986, 120 percent of the mean of the labor-related and nonlabor per visit costs for freestanding home health agencies,
(II) July 1, 1986, and before July 1, 1987, 115 percent of such mean,
(III) July 1, 1987, and before October 1, 1997, 112 percent of such mean,
(IV) October 1, 1997, and before October 1, 1998, 105 percent of the median of the labor-related and nonlabor per visit costs for freestanding home health agencies, or
(V) October 1, 1998, 106 percent of such median.
(ii) Effective for cost reporting periods beginning on or after July 1, 1986, such limitations shall be applied on an aggregate basis for the agency, rather than on a discipline specific basis. The Secretary may provide for such exemptions and exceptions to such limitation as he deems appropriate.
(iii) Not later than July 1, 1991, and annually thereafter (but not for cost reporting periods beginning on or after July 1, 1994, and before July 1, 1996, or on or after July 1, 1997, and before October 1, 1997), the Secretary shall establish limits under this subparagraph for cost reporting periods beginning on or after such date by utilizing the area wage index applicable under
(iv) In establishing limits under this subparagraph for cost reporting periods beginning after September 30, 1997, the Secretary shall not take into account any changes in the home health market basket, as determined by the Secretary, with respect to cost reporting periods which began on or after July 1, 1994, and before July 1, 1996.
(v) For services furnished by home health agencies for cost reporting periods beginning on or after October 1, 1997, subject to clause (viii)(I), the Secretary shall provide for an interim system of limits. Payment shall not exceed the costs determined under the preceding provisions of this subparagraph or, if lower, the product of—
(I) an agency-specific per beneficiary annual limitation calculated based 75 percent on 98 percent of the reasonable costs (including nonroutine medical supplies) for the agency's 12-month cost reporting period ending during fiscal year 1994, and based 25 percent on 98 percent of the standardized regional average of such costs for the agency's census division, as applied to such agency, for cost reporting periods ending during fiscal year 1994, such costs updated by the home health market basket index; and
(II) the agency's unduplicated census count of patients (entitled to benefits under this subchapter) for the cost reporting period subject to the limitation.
(vi) For services furnished by home health agencies for cost reporting periods beginning on or after October 1, 1997, the following rules apply:
(I) For new providers and those providers without a 12-month cost reporting period ending in fiscal year 1994 subject to clauses (viii)(II) and (viii)(III), the per beneficiary limitation shall be equal to the median of these limits (or the Secretary's best estimates thereof) applied to other home health agencies as determined by the Secretary. A home health agency that has altered its corporate structure or name shall not be considered a new provider for this purpose.
(II) For beneficiaries who use services furnished by more than one home health agency, the per beneficiary limitations shall be prorated among the agencies.
(vii)(I) Not later than January 1, 1998, the Secretary shall establish per visit limits applicable for fiscal year 1998, and not later than April 1, 1998, the Secretary shall establish per beneficiary limits under clause (v)(I) for fiscal year 1998.
(II) Not later than August 1 of each year (beginning in 1998) the Secretary shall establish the limits applicable under this subparagraph for services furnished during the fiscal year beginning October 1 of the year.
(viii)(I) In the case of a provider with a 12-month cost reporting period ending in fiscal year 1994, if the limit imposed under clause (v) (determined without regard to this subclause) for a cost reporting period beginning during or after fiscal year 1999 is less than the median described in clause (vi)(I) (but determined as if any reference in clause (v) to "98 percent" were a reference to "100 percent"), the limit otherwise imposed under clause (v) for such provider and period shall be increased by 1/3 of such difference.
(II) Subject to subclause (IV), for new providers and those providers without a 12-month cost reporting period ending in fiscal year 1994, but for which the first cost reporting period begins before fiscal year 1999, for cost reporting periods beginning during or after fiscal year 1999, the per beneficiary limitation described in clause (vi)(I) shall be equal to the median described in such clause (determined as if any reference in clause (v) to "98 percent" were a reference to "100 percent").
(III) Subject to subclause (IV), in the case of a new provider for which the first cost reporting period begins during or after fiscal year 1999, the limitation applied under clause (vi)(I) (but only with respect to such provider) shall be equal to 75 percent of the median described in clause (vi)(I).
(IV) In the case of a new provider or a provider without a 12-month cost reporting period ending in fiscal year 1994, subclause (II) shall apply, instead of subclause (III), to a home health agency which filed an application for home health agency provider status under this subchapter before September 15, 1998, or which was approved as a branch of its parent agency before such date and becomes a subunit of the parent agency or a separate agency on or after such date.
(V) Each of the amounts specified in subclauses (I) through (III) are such amounts as adjusted under clause (iii) to reflect variations in wages among different areas.
(ix) Notwithstanding the per beneficiary limit under clause (viii), if the limit imposed under clause (v) (determined without regard to this clause) for a cost reporting period beginning during or after fiscal year 2000 is less than the median described in clause (vi)(I) (but determined as if any reference in clause (v) to "98 percent" were a reference to "100 percent"), the limit otherwise imposed under clause (v) for such provider and period shall be increased by 2 percent.
(x) Notwithstanding any other provision of this subparagraph, in updating any limit under this subparagraph by a home health market basket index for cost reporting periods beginning during each of fiscal years 2000, 2002, and 2003, the update otherwise provided shall be reduced by 1.1 percentage points. With respect to cost reporting periods beginning during fiscal year 2001, the update to any limit under this subparagraph shall be the home health market basket index.
(M) Such regulations shall provide that costs respecting care provided by a provider of services, pursuant to an assurance under title VI or XVI of the Public Health Service Act [
(N) In determining such reasonable costs, costs incurred for activities directly related to influencing employees respecting unionization may not be included.
(O)(i) In establishing an appropriate allowance for depreciation and for interest on capital indebtedness with respect to an asset of a provider of services which has undergone a change of ownership, such regulations shall provide, except as provided in clause (iii), that the valuation of the asset after such change of ownership shall be the historical cost of the asset, as recognized under this subchapter, less depreciation allowed, to the owner of record as of August 5, 1997 (or, in the case of an asset not in existence as of August 5, 1997, the first owner of record of the asset after August 5, 1997).
(ii) Such regulations shall not recognize, as reasonable in the provision of health care services, costs (including legal fees, accounting and administrative costs, travel costs, and the costs of feasibility studies) attributable to the negotiation or settlement of the sale or purchase of any capital asset (by acquisition or merger) for which any payment has previously been made under this subchapter.
(iii) In the case of the transfer of a hospital from ownership by a State to ownership by a nonprofit corporation without monetary consideration, the basis for capital allowances to the new owner shall be the book value of the hospital to the State at the time of the transfer.
(P) If such regulations provide for the payment for a return on equity capital (other than with respect to costs of inpatient hospital services), the rate of return to be recognized, for determining the reasonable cost of services furnished in a cost reporting period, shall be equal to the average of the rates of interest, for each of the months any part of which is included in the period, on obligations issued for purchase by the Federal Hospital Insurance Trust Fund.
(Q) Except as otherwise explicitly authorized, the Secretary is not authorized to limit the rate of increase on allowable costs of approved medical educational activities.
(R) In determining such reasonable cost, costs incurred by a provider of services representing a beneficiary in an unsuccessful appeal of a determination described in
(S)(i) Such regulations shall not include provision for specific recognition of any return on equity capital with respect to hospital outpatient departments.
(ii)(I) Such regulations shall provide that, in determining the amount of the payments that may be made under this subchapter with respect to all the capital-related costs of outpatient hospital services, the Secretary shall reduce the amounts of such payments otherwise established under this subchapter by 15 percent for payments attributable to portions of cost reporting periods occurring during fiscal year 1990, by 15 percent for payments attributable to portions of cost reporting periods occurring during fiscal year 1991, and by 10 percent for payments attributable to portions of cost reporting periods occurring during fiscal years 1992 through 1999 and until the first date that the prospective payment system under
(II) The Secretary shall reduce the reasonable cost of outpatient hospital services (other than the capital-related costs of such services) otherwise determined pursuant to
(III) Subclauses (I) and (II) shall not apply to payments with respect to the costs of hospital outpatient services provided by any hospital that is a sole community hospital (as defined in
(IV) In applying subclauses (I) and (II) to services for which payment is made on the basis of a blend amount under
(T) In determining such reasonable costs for hospitals, no reduction in copayments under
(i) for cost reporting periods beginning during fiscal year 1998, by 25 percent of such amount otherwise allowable,
(ii) for cost reporting periods beginning during fiscal year 1999, by 40 percent of such amount otherwise allowable,
(iii) for cost reporting periods beginning during fiscal year 2000, by 45 percent of such amount otherwise allowable,
(iv) for cost reporting periods beginning during fiscal years 2001 through 2012, by 30 percent of such amount otherwise allowable, and
(v) for cost reporting periods beginning during fiscal year 2013 or a subsequent fiscal year, by 35 percent of such amount otherwise allowable.
(U) In determining the reasonable cost of ambulance services (as described in subsection (s)(7)) provided during fiscal year 1998, during fiscal year 1999, and during so much of fiscal year 2000 as precedes January 1, 2000, the Secretary shall not recognize the costs per trip in excess of costs recognized as reasonable for ambulance services provided on a per trip basis during the previous fiscal year (after application of this subparagraph), increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the fiscal year involved reduced by 1.0 percentage point. For ambulance services provided after June 30, 1998, the Secretary may provide that claims for such services must include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished.
(V) In determining such reasonable costs for skilled nursing facilities and (beginning with respect to cost reporting periods beginning during fiscal year 2013) for covered skilled nursing services described in
(i) are not described in
(I) for cost reporting periods beginning on or after October 1, 2005, but before fiscal year 2013, 30 percent of such amount otherwise allowable; and
(II) for cost reporting periods beginning during fiscal year 2013 or a subsequent fiscal year, by 7 35 percent of such amount otherwise allowable.
(ii) are described in such section—
(I) for cost reporting periods beginning on or after October 1, 2005, but before fiscal year 2013, shall not be reduced;
(II) for cost reporting periods beginning during fiscal year 2013, shall be reduced by 12 percent of such amount otherwise allowable;
(III) for cost reporting periods beginning during fiscal year 2014, shall be reduced by 24 percent of such amount otherwise allowable; and
(IV) for cost reporting periods beginning during a subsequent fiscal year, shall be reduced by 35 percent of such amount otherwise allowable.
(W)(i) In determining such reasonable costs for providers described in clause (ii), the amount of bad debts otherwise treated as allowable costs which are attributable to deductibles and coinsurance amounts under this subchapter shall be reduced—
(I) for cost reporting periods beginning during fiscal year 2013, by 12 percent of such amount otherwise allowable;
(II) for cost reporting periods beginning during fiscal year 2014, by 24 percent of such amount otherwise allowable; and
(III) for cost reporting periods beginning during a subsequent fiscal year, by 35 percent of such amount otherwise allowable.
(ii) A provider described in this clause is a provider of services not described in subparagraph (T) or (V), a supplier, or any other type of entity that receives payment for bad debts under the authority under subparagraph (A).
(2)(A) If the bed and board furnished as part of inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) or post-hospital extended care services is in accommodations more expensive than semi-private accommodations, the amount taken into account for purposes of payment under this subchapter with respect to such services may not exceed the amount that would be taken into account with respect to such services if furnished in such semi-private accommodations unless the more expensive accommodations were required for medical reasons.
(B) Where a provider of services which has an agreement in effect under this subchapter furnishes to an individual items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under part A or part B, as the case may be, the Secretary shall take into account for purposes of payment to such provider of services only the items or services with respect to which such payment may be made.
(3) If the bed and board furnished as part of inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) or post-hospital extended care services is in accommodations other than, but not more expensive than, semi-private accommodations and the use of such other accommodations rather than semi-private accommodations was neither at the request of the patient nor for a reason which the Secretary determines is consistent with the purposes of this subchapter, the amount of the payment with respect to such bed and board under part A shall be the amount otherwise payable under this subchapter for such bed and board furnished in semi-private accommodations minus the difference between the charge customarily made by the hospital or skilled nursing facility for bed and board in semi-private accommodations and the charge customarily made by it for bed and board in the accommodations furnished.
(4) If a provider of services furnishes items or services to an individual which are in excess of or more expensive than the items or services determined to be necessary in the efficient delivery of needed health services and charges are imposed for such more expensive items or services under the authority granted in section 1395cc(a)(2)(B)(ii) 8 of this title, the amount of payment with respect to such items or services otherwise due such provider in any fiscal period shall be reduced to the extent that such payment plus such charges exceed the cost actually incurred for such items or services in the fiscal period in which such charges are imposed.
(5)(A) Where physical therapy services, occupational therapy services, speech therapy services, or other therapy services or services of other health-related personnel (other than physicians) are furnished under an arrangement with a provider of services or other organization, specified in the first sentence of subsection (p) (including through the operation of subsection (g)) the amount included in any payment to such provider or other organization under this subchapter as the reasonable cost of such services (as furnished under such arrangements) shall not exceed an amount equal to the salary which would reasonably have been paid for such services (together with any additional costs that would have been incurred by the provider or other organization) to the person performing them if they had been performed in an employment relationship with such provider or other organization (rather than under such arrangement) plus the cost of such other expenses (including a reasonable allowance for traveltime and other reasonable types of expense related to any differences in acceptable methods of organization for the provision of such therapy) incurred by such person, as the Secretary may in regulations determine to be appropriate.
(B) Notwithstanding the provisions of subparagraph (A), if a provider of services or other organization specified in the first sentence of subsection (p) requires the services of a therapist on a limited part-time basis, or only to perform intermittent services, the Secretary may make payment on the basis of a reasonable rate per unit of service, even though such rate is greater per unit of time than salary related amounts, where he finds that such greater payment is, in the aggregate, less than the amount that would have been paid if such organization had employed a therapist on a full- or part-time salary basis.
(6) For purposes of this subsection, the term, "semi-private accommodations" means two-bed, three-bed, or four-bed accommodations.
(7)(A) For limitation on Federal participation for capital expenditures which are out of conformity with a comprehensive plan of a State or areawide planning agency, see
(B) For further limitations on reasonable cost and determination of payment amounts for operating costs of inpatient hospital services and waivers for certain States, see
(C) For provisions restricting payment for provider-based physicians' services and for payments under certain percentage arrangements, see
(D) For further limitations on reasonable cost and determination of payment amounts for routine service costs of skilled nursing facilities, see subsections (a) through (c) of
(8)
(i) entertainment, including tickets to sporting and other entertainment events;
(ii) gifts or donations;
(iii) personal use of motor vehicles;
(iv) costs for fines and penalties resulting from violations of Federal, State, or local laws; and
(v) education expenses for spouses or other dependents of providers of services, their employees or contractors.
(w) Arrangements for certain services; payments pursuant to arrangements for utilization review activities
(1) The term "arrangements" is limited to arrangements under which receipt of payment by the hospital, critical access hospital, skilled nursing facility, home health agency, or hospice program (whether in its own right or as agent), with respect to services for which an individual is entitled to have payment made under this subchapter, discharges the liability of such individual or any other person to pay for the services.
(2) Utilization review activities conducted, in accordance with the requirements of the program established under part B of subchapter XI of this chapter with respect to services furnished by a hospital or critical access hospital to patients insured under part A of this subchapter or entitled to have payment made for such services under part B of this subchapter or under a State plan approved under subchapter XIX, by a quality improvement organization designated for the area in which such hospital or critical access hospital is located shall be deemed to have been conducted pursuant to arrangements between such hospital or critical access hospital and such organization under which such hospital or critical access hospital is obligated to pay to such organization, as a condition of receiving payment for hospital or critical access hospital services so furnished under this part or under such a State plan, such amount as is reasonably incurred and requested (as determined under regulations of the Secretary) by such organization in conducting such review activities with respect to services furnished by such hospital or critical access hospital to such patients.
(x) State and United States
The terms "State" and "United States" have the meaning given to them by subsections (h) and (i), respectively, of
(y) Extended care in religious nonmedical health care institutions
(1) The term "skilled nursing facility" also includes a religious nonmedical health care institution (as defined in subsection (ss)(1)), but only (except for purposes of subsection (a)(2)) with respect to items and services ordinarily furnished by such an institution to inpatients, and payment may be made with respect to services provided by or in such an institution only to such extent and under such conditions, limitations, and requirements (in addition to or in lieu of the conditions, limitations, and requirements otherwise applicable) as may be provided in regulations consistent with
(2) Notwithstanding any other provision of this subchapter, payment under part A may not be made for services furnished an individual in a skilled nursing facility to which paragraph (1) applies unless such individual elects, in accordance with regulations, for a spell of illness to have such services treated as post-hospital extended care services for purposes of such part; and payment under part A may not be made for post-hospital extended care services—
(A) furnished an individual during such spell of illness in a skilled nursing facility to which paragraph (1) applies after—
(i) such services have been furnished to him in such a facility for 30 days during such spell, or
(ii) such services have been furnished to him during such spell in a skilled nursing facility to which such paragraph does not apply; or
(B) furnished an individual during such spell of illness in a skilled nursing facility to which paragraph (1) does not apply after such services have been furnished to him during such spell in a skilled nursing facility to which such paragraph applies.
(3) The amount payable under part A for post-hospital extended care services furnished an individual during any spell of illness in a skilled nursing facility to which paragraph (1) applies shall be reduced by a coinsurance amount equal to one-eighth of the inpatient hospital deductible for each day before the 31st day on which he is furnished such services in such a facility during such spell (and the reduction under this paragraph shall be in lieu of any reduction under
(4) For purposes of subsection (i), the determination of whether services furnished by or in an institution described in paragraph (1) constitute post-hospital extended care services shall be made in accordance with and subject to such conditions, limitations, and requirements as may be provided in regulations.
(z) Institutional planning
An overall plan and budget of a hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, or home health agency shall be considered sufficient if it—
(1) provides for an annual operating budget which includes all anticipated income and expenses related to items which would, under generally accepted accounting principles, be considered income and expense items (except that nothing in this paragraph shall require that there be prepared, in connection with any budget, an item-by-item identification of the components of each type of anticipated expenditure or income);
(2)(A) provides for a capital expenditures plan for at least a 3-year period (including the year to which the operating budget described in paragraph (1) is applicable) which includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure in excess of $600,000 (or such lesser amount as may be established by the State under
(B) provides that such plan is submitted to the agency designated under
(3) provides for review and updating at least annually; and
(4) is prepared, under the direction of the governing body of the institution or agency, by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the institution or agency.
(aa) Rural health clinic services and Federally qualified health center services
(1) The term "rural health clinic services" means—
(A) physicians' services and such services and supplies as are covered under subsection (s)(2)(A) if furnished as an incident to a physician's professional service and items and services described in subsection (s)(10),
(B) such services furnished by a physician assistant or a nurse practitioner (as defined in paragraph (5)), by a clinical psychologist (as defined by the Secretary), by a clinical social worker (as defined in subsection (hh)(1)), by a marriage and family therapist (as defined in subsection (lll)(2)), or by a mental health counselor (as defined in subsection (lll)(4)), and such services and supplies furnished as an incident to his service as would otherwise be covered if furnished by a physician or as an incident to a physician's service,
(C) in the case of a rural health clinic located in an area in which there exists a shortage of home health agencies, part-time or intermittent nursing care and related medical supplies (other than drugs and biologicals) furnished by a registered professional nurse or licensed practical nurse to a homebound individual under a written plan of treatment (i) established and periodically reviewed by a physician described in paragraph (2)(B), or (ii) established by a nurse practitioner or physician assistant and periodically reviewed and approved by a physician described in paragraph (2)(B), and
(D) intensive outpatient services (as defined in
when furnished to an individual as an outpatient of a rural health clinic.
(2) The term "rural health clinic" means a facility which—
(A) is primarily engaged in furnishing to outpatients services described in subparagraphs (A) and (B) of paragraph (1);
(B) in the case of a facility which is not a physician-directed clinic, has an arrangement (consistent with the provisions of State and local law relative to the practice, performance, and delivery of health services) with one or more physicians (as defined in subsection (r)(1)) under which provision is made for the periodic review by such physicians of covered services furnished by physician assistants and nurse practitioners, the supervision and guidance by such physicians of physician assistants and nurse practitioners, the preparation by such physicians of such medical orders for care and treatment of clinic patients as may be necessary, and the availability of such physicians for such referral of and consultation for patients as is necessary and for advice and assistance in the management of medical emergencies; and, in the case of a physician-directed clinic, has one or more of its staff physicians perform the activities accomplished through such an arrangement;
(C) maintains clinical records on all patients;
(D) has arrangements with one or more hospitals, having agreements in effect under
(E) has written policies, which are developed with the advice of (and with provision for review of such policies from time to time by) a group of professional personnel, including one or more physicians and one or more physician assistants or nurse practitioners, to govern those services described in paragraph (1) which it furnishes;
(F) has a physician, physician assistant, or nurse practitioner responsible for the execution of policies described in subparagraph (E) and relating to the provision of the clinic's services;
(G) directly provides routine diagnostic services, including clinical laboratory services, as prescribed in regulations by the Secretary, and has prompt access to additional diagnostic services from facilities meeting requirements under this subchapter;
(H) in compliance with State and Federal law, has available for administering to patients of the clinic at least such drugs and biologicals as are determined by the Secretary to be necessary for the treatment of emergency cases (as defined in regulations) and has appropriate procedures or arrangements for storing, administering, and dispensing any drugs and biologicals;
(I) has a quality assessment and performance improvement program, and appropriate procedures for review of utilization of clinic services, as the Secretary may specify;
(J) has a nurse practitioner, a physician assistant, or a certified nurse-midwife (as defined in subsection (gg)) available to furnish patient care services not less than 50 percent of the time the clinic operates; and
(K) meets such other requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are furnished services by the clinic.
For the purposes of this subchapter, such term includes only a facility which (i) is located in an area that is not an urbanized area (as defined by the Bureau of the Census) and in which there are insufficient numbers of needed health care practitioners (as determined by the Secretary), and that, within the previous 4-year period, has been designated by the chief executive officer of the State and certified by the Secretary as an area with a shortage of personal health services or designated by the Secretary either (I) as an area with a shortage of personal health services under section 330(b)(3) or 1302(7) of the Public Health Service Act [
(3) The term "Federally qualified health center services" means—
(A) services of the type described in subparagraphs (A) through (D) of paragraph (1) and preventive services (as defined in subsection (ddd)(3)); and
(B) preventive primary health services that a center is required to provide under section 330 of the Public Health Service Act [
when furnished to an individual as an outpatient of a Federally qualified health center by the center or by a health care professional under contract with the center and, for this purpose, any reference to a rural health clinic or a physician described in paragraph (2)(B) is deemed a reference to a Federally qualified health center or a physician at the center, respectively.
(4) The term "Federally qualified health center" means an entity which—
(A)(i) is receiving a grant under section 330 of the Public Health Service Act [
(ii)(I) is receiving funding from such a grant under a contract with the recipient of such a grant, and (II) meets the requirements to receive a grant under section 330 of such Act [
(B) based on the recommendation of the Health Resources and Services Administration within the Public Health Service, is determined by the Secretary to meet the requirements for receiving such a grant;
(C) was treated by the Secretary, for purposes of part B, as a comprehensive Federally funded health center as of January 1, 1990; or
(D) is an outpatient health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act [
(5)(A) The term "physician assistant" and the term "nurse practitioner" mean, for purposes of this subchapter, a physician assistant or nurse practitioner who performs such services as such individual is legally authorized to perform (in the State in which the individual performs such services) in accordance with State law (or the State regulatory mechanism provided by State law), and who meets such training, education, and experience requirements (or any combination thereof) as the Secretary may prescribe in regulations.
(B) The term "clinical nurse specialist" means, for purposes of this subchapter, an individual who—
(i) is a registered nurse and is licensed to practice nursing in the State in which the clinical nurse specialist services are performed; and
(ii) holds a master's degree in a defined clinical area of nursing from an accredited educational institution.
(6) The term "collaboration" means a process in which a nurse practitioner works with a physician to deliver health care services within the scope of the practitioner's professional expertise, with medical direction and appropriate supervision as provided for in jointly developed guidelines or other mechanisms as defined by the law of the State in which the services are performed.
(7)(A) The Secretary shall waive for a 1-year period the requirements of paragraph (2) that a rural health clinic employ a physician assistant, nurse practitioner or certified nurse midwife or that such clinic require such providers to furnish services at least 50 percent of the time that the clinic operates for any facility that requests such waiver if the facility demonstrates that the facility has been unable, despite reasonable efforts, to hire a physician assistant, nurse practitioner, or certified nurse-midwife in the previous 90-day period.
(B) The Secretary may not grant such a waiver under subparagraph (A) to a facility if the request for the waiver is made less than 6 months after the date of the expiration of any previous such waiver for the facility, or if the facility has not yet been determined to meet the requirements (including subparagraph (J) of the first sentence of paragraph (2)) of a rural health clinic.
(C) A waiver which is requested under this paragraph shall be deemed granted unless such request is denied by the Secretary within 60 days after the date such request is received.
(bb) Services of a certified registered nurse anesthetist
(1) The term "services of a certified registered nurse anesthetist" means anesthesia services and related care furnished by a certified registered nurse anesthetist (as defined in paragraph (2)) which the nurse anesthetist is legally authorized to perform as such by the State in which the services are furnished.
(2) The term "certified registered nurse anesthetist" means a certified registered nurse anesthetist licensed by the State who meets such education, training, and other requirements relating to anesthesia services and related care as the Secretary may prescribe. In prescribing such requirements the Secretary may use the same requirements as those established by a national organization for the certification of nurse anesthetists. Such term also includes, as prescribed by the Secretary, an anesthesiologist assistant.
(cc) Comprehensive outpatient rehabilitation facility services
(1) The term "comprehensive outpatient rehabilitation facility services" means the following items and services furnished by a physician or other qualified professional personnel (as defined in regulations by the Secretary) to an individual who is an outpatient of a comprehensive outpatient rehabilitation facility under a plan (for furnishing such items and services to such individual) established and periodically reviewed by a physician—
(A) physicians' services;
(B) physical therapy, occupational therapy, speech-language pathology services, and respiratory therapy;
(C) prosthetic and orthotic devices, including testing, fitting, or training in the use of prosthetic and orthotic devices;
(D) social and psychological services;
(E) nursing care provided by or under the supervision of a registered professional nurse;
(F) drugs and biologicals which cannot, as determined in accordance with regulations, be self-administered;
(G) supplies and durable medical equipment; and
(H) such other items and services as are medically necessary for the rehabilitation of the patient and are ordinarily furnished by comprehensive outpatient rehabilitation facilities,
excluding, however, any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital. In the case of physical therapy, occupational therapy, and speech pathology services, there shall be no requirement that the item or service be furnished at any single fixed location if the item or service is furnished pursuant to such plan and payments are not otherwise made for the item or service under this subchapter.
(2) The term "comprehensive outpatient rehabilitation facility" means a facility which—
(A) is primarily engaged in providing (by or under the supervision of physicians) diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, disabled, or sick persons;
(B) provides at least the following comprehensive outpatient rehabilitation services: (i) physicians' services (rendered by physicians, as defined in subsection (r)(1), who are available at the facility on a full- or part-time basis); (ii) physical therapy; and (iii) social or psychological services;
(C) maintains clinical records on all patients;
(D) has policies established by a group of professional personnel (associated with the facility), including one or more physicians defined in subsection (r)(1) to govern the comprehensive outpatient rehabilitation services it furnishes, and provides for the carrying out of such policies by a full- or part-time physician referred to in subparagraph (B)(i);
(E) has a requirement that every patient must be under the care of a physician;
(F) in the case of a facility in any State in which State or applicable local law provides for the licensing of facilities of this nature (i) is licensed pursuant to such law, or (ii) is approved by the agency of such State or locality, responsible for licensing facilities of this nature, as meeting the standards established for such licensing;
(G) has in effect a utilization review plan in accordance with regulations prescribed by the Secretary;
(H) has in effect an overall plan and budget that meets the requirements of subsection (z);
(I) provides the Secretary on a continuing basis with a surety bond in a form specified by the Secretary and in an amount that is not less than $50,000; and
(J) meets such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such facility, including conditions concerning qualifications of personnel in these facilities.
The Secretary may waive the requirement of a surety bond under subparagraph (I) in the case of a facility that provides a comparable surety bond under State law.
(dd) Hospice care; hospice program; definitions; certification; waiver by Secretary
(1) The term "hospice care" means the following items and services provided to a terminally ill individual by, or by others under arrangements made by, a hospice program under a written plan (for providing such care to such individual) established and periodically reviewed by the individual's attending physician and by the medical director (and by the interdisciplinary group described in paragraph (2)(B)) of the program—
(A) nursing care provided by or under the supervision of a registered professional nurse,
(B) physical or occupational therapy, or speech-language pathology services,
(C) medical social services under the direction of a physician,
(D)(i) services of a home health aide who has successfully completed a training program approved by the Secretary and (ii) homemaker services,
(E) medical supplies (including drugs and biologicals) and the use of medical appliances, while under such a plan,
(F) physicians' services,
(G) short-term inpatient care (including both respite care and procedures necessary for pain control and acute and chronic symptom management) in an inpatient facility meeting such conditions as the Secretary determines to be appropriate to provide such care, but such respite care may be provided only on an intermittent, nonroutine, and occasional basis and may not be provided consecutively over longer than five days,
(H) counseling (including dietary counseling) with respect to care of the terminally ill individual and adjustment to his death, and
(I) any other item or service which is specified in the plan and for which payment may otherwise be made under this subchapter.
The care and services described in subparagraphs (A) and (D) may be provided on a 24-hour, continuous basis only during periods of crisis (meeting criteria established by the Secretary) and only as necessary to maintain the terminally ill individual at home.
(2) The term "hospice program" means a public agency or private organization (or a subdivision thereof) which—
(A)(i) is primarily engaged in providing the care and services described in paragraph (1) and makes such services available (as needed) on a 24-hour basis and which also provides bereavement counseling for the immediate family of terminally ill individuals and services described in
(ii) provides for such care and services in individuals' homes, on an outpatient basis, and on a short-term inpatient basis, directly or under arrangements made by the agency or organization, except that—
(I) the agency or organization must routinely provide directly substantially all of each of the services described in subparagraphs (A), (C), and (H) of paragraph (1), except as otherwise provided in paragraph (5), and
(II) in the case of other services described in paragraph (1) which are not provided directly by the agency or organization, the agency or organization must maintain professional management responsibility for all such services furnished to an individual, regardless of the location or facility in which such services are furnished; and
(iii) provides assurances satisfactory to the Secretary that the aggregate number of days of inpatient care described in paragraph (1)(G) provided in any 12-month period to individuals who have an election in effect under
(B) has an interdisciplinary group of personnel which—
(i) includes at least—
(I) one physician (as defined in subsection (r)(1)),
(II) one registered professional nurse, and
(III) one social worker, marriage and family therapist, or mental health counselor,
employed by or, in the case of a physician described in subclause (I), under contract with the agency or organization, and also includes at least one pastoral or other counselor,
(ii) provides (or supervises the provision of) the care and services described in paragraph (1), and
(iii) establishes the policies governing the provision of such care and services;
(C) maintains central clinical records on all patients;
(D) does not discontinue the hospice care it provides with respect to a patient because of the inability of the patient to pay for such care;
(E)(i) utilizes volunteers in its provision of care and services in accordance with standards set by the Secretary, which standards shall ensure a continuing level of effort to utilize such volunteers, and (ii) maintains records on the use of these volunteers and the cost savings and expansion of care and services achieved through the use of these volunteers;
(F) in the case of an agency or organization in any State in which State or applicable local law provides for the licensing of agencies or organizations of this nature, is licensed pursuant to such law; and
(G) meets such other requirements as the Secretary may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization.
(3)(A) An individual is considered to be "terminally ill" if the individual has a medical prognosis that the individual's life expectancy is 6 months or less.
(B) The term "attending physician" means, with respect to an individual, the physician (as defined in subsection (r)(1)), the nurse practitioner (as defined in subsection (aa)(5)), or the physician assistant (as defined in such subsection), who may be employed by a hospice program, whom the individual identifies as having the most significant role in the determination and delivery of medical care to the individual at the time the individual makes an election to receive hospice care.
(4)(A) An entity which is certified as a provider of services other than a hospice program shall be considered, for purposes of certification as a hospice program, to have met any requirements under paragraph (2) which are also the same requirements for certification as such other type of provider. The Secretary shall coordinate surveys for determining certification under this subchapter so as to provide, to the extent feasible, for simultaneous surveys of an entity which seeks to be certified as a hospice program and as a provider of services of another type.
(B) Any entity which is certified as a hospice program and as a provider of another type shall have separate provider agreements under
(5)(A) The Secretary may waive the requirements of paragraph (2)(A)(ii)(I) for an agency or organization with respect to all or part of the nursing care described in paragraph (1)(A) if such agency or organization—
(i) is located in an area which is not an urbanized area (as defined by the Bureau of the Census);
(ii) was in operation on or before January 1, 1983; and
(iii) has demonstrated a good faith effort (as determined by the Secretary) to hire a sufficient number of nurses to provide such nursing care directly.
(B) Any waiver, which is in such form and containing such information as the Secretary may require and which is requested by an agency or organization under subparagraph (A) or (C), shall be deemed to be granted unless such request is denied by the Secretary within 60 days after the date such request is received by the Secretary. The granting of a waiver under subparagraph (A) or (C) shall not preclude the granting of any subsequent waiver request should such a waiver again become necessary.
(C) The Secretary may waive the requirements of paragraph (2)(A)(i) and (2)(A)(ii) for an agency or organization with respect to the services described in paragraph (1)(B) and, with respect to dietary counseling, paragraph (1)(H), if such agency or organization—
(i) is located in an area which is not an urbanized area (as defined by the Bureau of Census), and
(ii) demonstrates to the satisfaction of the Secretary that the agency or organization has been unable, despite diligent efforts, to recruit appropriate personnel.
(D) In extraordinary, exigent, or other non-routine circumstances, such as unanticipated periods of high patient loads, staffing shortages due to illness or other events, or temporary travel of a patient outside a hospice program's service area, a hospice program may enter into arrangements with another hospice program for the provision by that other program of services described in paragraph (2)(A)(ii)(I). The provisions of paragraph (2)(A)(ii)(II) shall apply with respect to the services provided under such arrangements.
(E) A hospice program may provide services described in paragraph (1)(A) other than directly by the program if the services are highly specialized services of a registered professional nurse and are provided non-routinely and so infrequently so that the provision of such services directly would be impracticable and prohibitively expensive.
(ee) Discharge planning process
(1) A discharge planning process of a hospital shall be considered sufficient if it is applicable to services furnished by the hospital to individuals entitled to benefits under this subchapter and if it meets the guidelines and standards established by the Secretary under paragraph (2).
(2) The Secretary shall develop guidelines and standards for the discharge planning process in order to ensure a timely and smooth transition to the most appropriate type of and setting for post-hospital or rehabilitative care. The guidelines and standards shall include the following:
(A) The hospital must identify, at an early stage of hospitalization, those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning.
(B) Hospitals must provide a discharge planning evaluation for patients identified under subparagraph (A) and for other patients upon the request of the patient, patient's representative, or patient's physician.
(C) Any discharge planning evaluation must be made on a timely basis to ensure that appropriate arrangements for post-hospital care will be made before discharge and to avoid unnecessary delays in discharge.
(D) A discharge planning evaluation must include an evaluation of a patient's likely need for appropriate post-hospital services, including hospice care and post-hospital extended care services, and the availability of those services, including the availability of home health services through individuals and entities that participate in the program under this subchapter and that serve the area in which the patient resides and that request to be listed by the hospital as available and, in the case of individuals who are likely to need post-hospital extended care services, the availability of such services through facilities that participate in the program under this subchapter and that serve the area in which the patient resides.
(E) The discharge planning evaluation must be included in the patient's medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient's representative).
(F) Upon the request of a patient's physician, the hospital must arrange for the development and initial implementation of a discharge plan for the patient.
(G) Any discharge planning evaluation or discharge plan required under this paragraph must be developed by, or under the supervision of, a registered professional nurse, social worker, or other appropriately qualified personnel.
(H) Consistent with
(i) not specify or otherwise limit the qualified provider which may provide post-hospital home health services, and
(ii) identify (in a form and manner specified by the Secretary) any entity to whom the individual is referred in which the hospital has a disclosable financial interest (as specified by the Secretary consistent with
(3) With respect to a discharge plan for an individual who is enrolled with a Medicare+Choice organization under a Medicare+Choice plan and is furnished inpatient hospital services by a hospital under a contract with the organization—
(A) the discharge planning evaluation under paragraph (2)(D) is not required to include information on the availability of home health services through individuals and entities which do not have a contract with the organization; and
(B) notwithstanding subparagraph (H)(i) 9, the plan may specify or limit the provider (or providers) of post-hospital home health services or other post-hospital services under the plan.
(ff) Partial hospitalization services; intensive outpatient services
(1) The term "partial hospitalization services" means the items and services described in paragraph (2) prescribed by a physician for an individual determined (not less frequently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week and provided under a program described in paragraph (3) under the supervision of a physician pursuant to an individualized, written plan of treatment established and periodically reviewed by a physician (in consultation with appropriate staff participating in such program), which plan sets forth the physician's diagnosis, the type, amount, frequency, and duration of the items and services provided under the plan, and the goals for treatment under the plan.
(2) The items and services described in this paragraph are—
(A) individual and group therapy with physicians or psychologists (or other mental health professionals to the extent authorized under State law),
(B) occupational therapy requiring the skills of a qualified occupational therapist,
(C) services of social workers, trained psychiatric nurses, and other staff trained to work with psychiatric patients,
(D) drugs and biologicals furnished for therapeutic purposes (which cannot, as determined in accordance with regulations, be self-administered),
(E) individualized activity therapies that are not primarily recreational or diversionary,
(F) family counseling (the primary purpose of which is treatment of the individual's condition),
(G) patient training and education (to the extent that training and educational activities are closely and clearly related to individual's care and treatment),
(H) diagnostic services, and
(I) such other items and services as the Secretary may provide (but in no event to include meals and transportation);
that are reasonable and necessary for the diagnosis or active treatment of the individual's condition, reasonably expected to improve or maintain the individual's condition and functional level and to prevent relapse or hospitalization, and furnished pursuant to such guidelines relating to frequency and duration of services as the Secretary shall by regulation establish (taking into account accepted norms of medical practice and the reasonable expectation of patient improvement).
(3)(A) A program described in this paragraph is a program which is furnished by a hospital to its outpatients or by a community mental health center (as defined in subparagraph (B)), and which is a distinct and organized intensive ambulatory treatment service offering less than 24-hour-daily care other than in an individual's home or in an inpatient or residential setting.
(B) For purposes of subparagraph (A), the term "community mental health center" means an entity that—
(i)(I) provides the mental health services described in section 1913(c)(1) of the Public Health Service Act [
(II) in the case of an entity operating in a State that by law precludes the entity from providing itself the service described in subparagraph (E) of such section, provides for such service by contract with an approved organization or entity (as determined by the Secretary);
(ii) meets applicable licensing or certification requirements for community mental health centers in the State in which it is located;
(iii) provides at least 40 percent of its services to individuals who are not eligible for benefits under this subchapter; and
(iv) meets such additional conditions as the Secretary shall specify to ensure (I) the health and safety of individuals being furnished such services, (II) the effective and efficient furnishing of such services, and (III) the compliance of such entity with the criteria described in section 1931(c)(1) of the Public Health Service Act [
(4) The term "intensive outpatient services" has the meaning given the term "partial hospitalization services" in paragraph (1), except that—
(A)
(B) the reference in such paragraph to an individual "determined (not less frequently than monthly) by a physician to have a need for such services for a minimum of 20 hours per week" shall be treated as a reference to an individual "determined (not less frequently than once every other month) by a physician to have a need for such services for a minimum of 9 hours per week"; and
(C) the reference to "a community mental health center (as defined in subparagraph (B))" in paragraph (3) shall be treated as a reference to "a community mental health center (as defined in subparagraph (B)), a Federally qualified health center, or a rural health clinic".
(gg) Certified nurse-midwife services
(1) The term "certified nurse-midwife services" means such services furnished by a certified nurse-midwife (as defined in paragraph (2)) and such services and supplies furnished as an incident to the nurse-midwife's service which the certified nurse-midwife is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) as would otherwise be covered if furnished by a physician or as an incident to a physicians' service.
(2) The term "certified nurse-midwife" means a registered nurse who has successfully completed a program of study and clinical experience meeting guidelines prescribed by the Secretary, or has been certified by an organization recognized by the Secretary.
(hh) Clinical social worker; clinical social worker services
(1) The term "clinical social worker" means an individual who—
(A) possesses a master's or doctor's degree in social work;
(B) after obtaining such degree has performed at least 2 years of supervised clinical social work; and
(C)(i) is licensed or certified as a clinical social worker by the State in which the services are performed, or
(ii) in the case of an individual in a State which does not provide for licensure or certification—
(I) has completed at least 2 years or 3,000 hours of post-master's degree supervised clinical social work practice under the supervision of a master's level social worker in an appropriate setting (as determined by the Secretary), and
(II) meets such other criteria as the Secretary establishes.
(2) The term "clinical social worker services" means services performed by a clinical social worker (as defined in paragraph (1)) for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital and other than services furnished to an inpatient of a skilled nursing facility which the facility is required to provide as a requirement for participation) which the clinical social worker is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) of the State in which such services are performed as would otherwise be covered if furnished by a physician or as an incident to a physician's professional service.
(ii) Qualified psychologist services
The term "qualified psychologist services" means such services and such services and supplies furnished as an incident to his service furnished by a clinical psychologist (as defined by the Secretary) which the psychologist is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) as would otherwise be covered if furnished by a physician or as an incident to a physician's service.
(jj) Screening mammography
The term "screening mammography" means a radiologic procedure provided to a woman for the purpose of early detection of breast cancer and includes a physician's interpretation of the results of the procedure.
(kk) Covered osteoporosis drug
The term "covered osteoporosis drug" means an injectable drug approved for the treatment of post-menopausal osteoporosis provided to an individual by a home health agency if, in accordance with regulations promulgated by the Secretary—
(1) the individual's attending physician, nurse practitioner or clinical nurse specialist (as those terms are defined in subsection (aa)(5)), certified nurse-midwife (as defined in subsection (gg)), or physician assistant (as defined in subsection (aa)(5)) certifies that the individual has suffered a bone fracture related to post-menopausal osteoporosis and that the individual is unable to learn the skills needed to self-administer such drug or is otherwise physically or mentally incapable of self-administering such drug; and
(2) the individual is confined to the individual's home (except when receiving items and services referred to in subsection (m)(7)).
(ll) Speech-language pathology services; audiology services
(1) The term "speech-language pathology services" means such speech, language, and related function assessment and rehabilitation services furnished by a qualified speech-language pathologist as the speech-language pathologist is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) as would otherwise be covered if furnished by a physician.
(2) The term "outpatient speech-language pathology services" has the meaning given the term "outpatient physical therapy services" in subsection (p), except that in applying such subsection—
(A) "speech-language pathology" shall be substituted for "physical therapy" each place it appears; and
(B) "speech-language pathologist" shall be substituted for "physical therapist" each place it appears.
(3) The term "audiology services" means such hearing and balance assessment services furnished by a qualified audiologist as the audiologist is legally authorized to perform under State law (or the State regulatory mechanism provided by State law), as would otherwise be covered if furnished by a physician.
(4) In this subsection:
(A) The term "qualified speech-language pathologist" means an individual with a master's or doctoral degree in speech-language pathology who—
(i) is licensed as a speech-language pathologist by the State in which the individual furnishes such services, or
(ii) in the case of an individual who furnishes services in a State which does not license speech-language pathologists, has successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulating such supervised clinical experience), performed not less than 9 months of supervised full-time speech-language pathology services after obtaining a master's or doctoral degree in speech-language pathology or a related field, and successfully completed a national examination in speech-language pathology approved by the Secretary.
(B) The term "qualified audiologist" means an individual with a master's or doctoral degree in audiology who—
(i) is licensed as an audiologist by the State in which the individual furnishes such services, or
(ii) in the case of an individual who furnishes services in a State which does not license audiologists, has successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulating such supervised clinical experience), performed not less than 9 months of supervised full-time audiology services after obtaining a master's or doctoral degree in audiology or a related field, and successfully completed a national examination in audiology approved by the Secretary.
(mm) Critical access hospital; critical access hospital services
(1) The term "critical access hospital" means a facility certified by the Secretary as a critical access hospital under
(2) The term "inpatient critical access hospital services" means items and services, furnished to an inpatient of a critical access hospital by such facility, that would be inpatient hospital services if furnished to an inpatient of a hospital by a hospital.
(3) The term "outpatient critical access hospital services" means medical and other health services furnished by a critical access hospital on an outpatient basis.
(nn) Screening pap smear; screening pelvic exam
(1) The term "screening pap smear" means a diagnostic laboratory test consisting of a routine exfoliative cytology test (Papanicolaou test) provided to a woman for the purpose of early detection of cervical or vaginal cancer and includes a physician's interpretation of the results of the test, if the individual involved has not had such a test during the preceding 2 years, or during the preceding year in the case of a woman described in paragraph (3).
(2) The term "screening pelvic exam" means a pelvic examination provided to a woman if the woman involved has not had such an examination during the preceding 2 years, or during the preceding year in the case of a woman described in paragraph (3), and includes a clinical breast examination.
(3) A woman described in this paragraph is a woman who—
(A) is of childbearing age and has had a test described in this subsection during any of the preceding 3 years that indicated the presence of cervical or vaginal cancer or other abnormality; or
(B) is at high risk of developing cervical or vaginal cancer (as determined pursuant to factors identified by the Secretary).
(oo) Prostate cancer screening tests
(1) The term "prostate cancer screening test" means a test that consists of any (or all) of the procedures described in paragraph (2) provided for the purpose of early detection of prostate cancer to a man over 50 years of age who has not had such a test during the preceding year.
(2) The procedures described in this paragraph are as follows:
(A) A digital rectal examination.
(B) A prostate-specific antigen blood test.
(C) For years beginning after 2002, such other procedures as the Secretary finds appropriate for the purpose of early detection of prostate cancer, taking into account changes in technology and standards of medical practice, availability, effectiveness, costs, and such other factors as the Secretary considers appropriate.
(pp) Colorectal cancer screening tests
(1) The term "colorectal cancer screening test" means any of the following procedures furnished to an individual for the purpose of early detection of colorectal cancer:
(A) Screening fecal-occult blood test.
(B) Screening flexible sigmoidoscopy.
(C) Screening colonoscopy.
(D) Such other tests or procedures, and modifications to tests and procedures under this subsection, with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations.
(2) An "individual at high risk for colorectal cancer" is an individual who, because of family history, prior experience of cancer or precursor neoplastic polyps, a history of chronic digestive disease condition (including inflammatory bowel disease, Crohn's Disease, or ulcerative colitis), the presence of any appropriate recognized gene markers for colorectal cancer, or other predisposing factors, faces a high risk for colorectal cancer.
(qq) Diabetes outpatient self-management training services
(1) The term "diabetes outpatient self-management training services" means educational and training services furnished (at such times as the Secretary determines appropriate) to an individual with diabetes by a certified provider (as described in paragraph (2)(A)) in an outpatient setting by an individual or entity who meets the quality standards described in paragraph (2)(B), but only if the physician who is managing the individual's diabetic condition certifies that such services are needed under a comprehensive plan of care related to the individual's diabetic condition to ensure therapy compliance or to provide the individual with necessary skills and knowledge (including skills related to the self-administration of injectable drugs) to participate in the management of the individual's condition.
(2) In paragraph (1)—
(A) a "certified provider" is a physician, or other individual or entity designated by the Secretary, that, in addition to providing diabetes outpatient self-management training services, provides other items or services for which payment may be made under this subchapter; and
(B) a physician, or such other individual or entity, meets the quality standards described in this paragraph if the physician, or individual or entity, meets quality standards established by the Secretary, except that the physician or other individual or entity shall be deemed to have met such standards if the physician or other individual or entity meets applicable standards originally established by the National Diabetes Advisory Board and subsequently revised by organizations who participated in the establishment of standards by such Board, or is recognized by an organization that represents individuals (including individuals under this subchapter) with diabetes as meeting standards for furnishing the services.
(rr) Bone mass measurement
(1) The term "bone mass measurement" means a radiologic or radioisotopic procedure or other procedure approved by the Food and Drug Administration performed on a qualified individual (as defined in paragraph (2)) for the purpose of identifying bone mass or detecting bone loss or determining bone quality, and includes a physician's interpretation of the results of the procedure.
(2) For purposes of this subsection, the term "qualified individual" means an individual who is (in accordance with regulations prescribed by the Secretary)—
(A) an estrogen-deficient woman at clinical risk for osteoporosis;
(B) an individual with vertebral abnormalities;
(C) an individual receiving long-term glucocorticoid steroid therapy;
(D) an individual with primary hyperparathyroidism; or
(E) an individual being monitored to assess the response to or efficacy of an approved osteoporosis drug therapy.
(3) The Secretary shall establish such standards regarding the frequency with which a qualified individual shall be eligible to be provided benefits for bone mass measurement under this subchapter.
(ss) Religious nonmedical health care institution
(1) The term "religious nonmedical health care institution" means an institution that—
(A) is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986 and is exempt from taxes under subsection (a) of such section;
(B) is lawfully operated under all applicable Federal, State, and local laws and regulations;
(C) provides only nonmedical nursing items and services exclusively to patients who choose to rely solely upon a religious method of healing and for whom the acceptance of medical health services would be inconsistent with their religious beliefs;
(D) provides such nonmedical items and services exclusively through nonmedical nursing personnel who are experienced in caring for the physical needs of such patients;
(E) provides such nonmedical items and services to inpatients on a 24-hour basis;
(F) on the basis of its religious beliefs, does not provide through its personnel or otherwise medical items and services (including any medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs) for its patients;
(G)(i) is not owned by, under common ownership with, or has an ownership interest in, a provider of medical treatment or services;
(ii) is not affiliated with—
(I) a provider of medical treatment or services, or
(II) an individual who has an ownership interest in a provider of medical treatment or services;
(H) has in effect a utilization review plan which—
(i) provides for the review of admissions to the institution, of the duration of stays therein, of cases of continuous extended duration, and of the items and services furnished by the institution,
(ii) requires that such reviews be made by an appropriate committee of the institution that includes the individuals responsible for overall administration and for supervision of nursing personnel at the institution,
(iii) provides that records be maintained of the meetings, decisions, and actions of such committee, and
(iv) meets such other requirements as the Secretary finds necessary to establish an effective utilization review plan;
(I) provides the Secretary with such information as the Secretary may require to implement
(J) meets such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institution.
(2) To the extent that the Secretary finds that the accreditation of an institution by a State, regional, or national agency or association provides reasonable assurances that any or all of the requirements of paragraph (1) are met or exceeded, the Secretary may treat such institution as meeting the condition or conditions with respect to which the Secretary made such finding.
(3)(A)(i) In administering this subsection and
(ii) Clause (i) shall not be construed as preventing the Secretary from requiring under
(B)(i) In administering this subsection and
(ii) Clause (i) shall not be construed as preventing the Secretary from reviewing items and services billed by the institution to the extent the Secretary determines such review to be necessary to determine whether such items and services were not covered under part A, are excessive, or are fraudulent.
(4)(A) For purposes of paragraph (1)(G)(i), an ownership interest of less than 5 percent shall not be taken into account.
(B) For purposes of paragraph (1)(G)(ii), none of the following shall be considered to create an affiliation:
(i) An individual serving as an uncompensated director, trustee, officer, or other member of the governing body of a religious nonmedical health care institution.
(ii) An individual who is a director, trustee, officer, employee, or staff member of a religious nonmedical health care institution having a family relationship with an individual who is affiliated with (or has an ownership interest in) a provider of medical treatment or services.
(iii) An individual or entity furnishing goods or services as a vendor to both providers of medical treatment or services and religious nonmedical health care institutions.
(tt) Post-institutional home health services; home health spell of illness
(1) The term "post-institutional home health services" means home health services furnished to an individual—
(A) after discharge from a hospital or critical access hospital in which the individual was an inpatient for not less than 3 consecutive days before such discharge if such home health services were initiated within 14 days after the date of such discharge; or
(B) after discharge from a skilled nursing facility in which the individual was provided post-hospital extended care services if such home health services were initiated within 14 days after the date of such discharge.
(2) The term "home health spell of illness" with respect to any individual means a period of consecutive days—
(A) beginning with the first day (not included in a previous home health spell of illness) (i) on which such individual is furnished post-institutional home health services, and (ii) which occurs in a month for which the individual is entitled to benefits under part A, and
(B) ending with the close of the first period of 60 consecutive days thereafter on each of which the individual is neither an inpatient of a hospital or critical access hospital nor an inpatient of a facility described in
(uu) Screening for glaucoma
The term "screening for glaucoma" means a dilated eye examination with an intraocular pressure measurement, and a direct ophthalmoscopy or a slit-lamp biomicroscopic examination for the early detection of glaucoma which is furnished by or under the direct supervision of an optometrist or ophthalmologist who is legally authorized to furnish such services under State law (or the State regulatory mechanism provided by State law) of the State in which the services are furnished, as would otherwise be covered if furnished by a physician or as an incident to a physician's professional service, if the individual involved has not had such an examination in the preceding year.
(vv) Medical nutrition therapy services; registered dietitian or nutrition professional
(1) The term "medical nutrition therapy services" means nutritional diagnostic, therapy, and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional (as defined in paragraph (2)) pursuant to a referral by a physician (as defined in subsection (r)(1)).
(2) Subject to paragraph (3), the term "registered dietitian or nutrition professional" means an individual who—
(A) holds a baccalaureate or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with completion of the academic requirements of a program in nutrition or dietetics, as accredited by an appropriate national accreditation organization recognized by the Secretary for this purpose;
(B) has completed at least 900 hours of supervised dietetics practice under the supervision of a registered dietitian or nutrition professional; and
(C)(i) is licensed or certified as a dietitian or nutrition professional by the State in which the services are performed; or
(ii) in the case of an individual in a State that does not provide for such licensure or certification, meets such other criteria as the Secretary establishes.
(3) Subparagraphs (A) and (B) of paragraph (2) shall not apply in the case of an individual who, as of December 21, 2000, is licensed or certified as a dietitian or nutrition professional by the State in which medical nutrition therapy services are performed.
(ww) Initial preventive physical examination
(1) The term "initial preventive physical examination" means physicians' services consisting of a physical examination (including measurement of height, weight body mass index,,10 and blood pressure) with the goal of health promotion and disease detection and includes education, counseling, and referral with respect to screening and other preventive services described in paragraph (2), end-of-life planning (as defined in paragraph (3)) upon the agreement with the individual, and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)), but does not include clinical laboratory tests.
(2) The screening and other preventive services described in this paragraph include the following:
(A) Pneumococcal, influenza, and hepatitis B vaccine and administration under subsection (s)(10).
(B) Screening mammography as defined in subsection (jj).
(C) Screening pap smear and screening pelvic exam as defined in subsection (nn).
(D) Prostate cancer screening tests as defined in subsection (oo).
(E) Colorectal cancer screening tests as defined in subsection (pp).
(F) Diabetes outpatient self-management training services as defined in subsection (qq)(1).
(G) Bone mass measurement as defined in subsection (rr).
(H) Screening for glaucoma as defined in subsection (uu).
(I) Medical nutrition therapy services as defined in subsection (vv).
(J) Cardiovascular screening blood tests as defined in subsection (xx)(1).
(K) Diabetes screening tests as defined in subsection (yy).
(L) Ultrasound screening for abdominal aortic aneurysm as defined in subsection (bbb).
(M) An electrocardiogram.
(N) Screening for potential substance use disorders.
(O) Additional preventive services (as defined in subsection (ddd)(1)).
(3) For purposes of paragraph (1), the term "end-of-life planning" means verbal or written information regarding—
(A) an individual's ability to prepare an advance directive in the case that an injury or illness causes the individual to be unable to make health care decisions; and
(B) whether or not the physician is willing to follow the individual's wishes as expressed in an advance directive.
(4) For purposes of paragraph (1), the term "a review of any current opioid prescriptions" means, with respect to an individual determined to have a current prescription for opioids—
(A) a review of the potential risk factors to the individual for opioid use disorder;
(B) an evaluation of the individual's severity of pain and current treatment plan;
(C) the provision of information on non-opioid treatment options; and
(D) a referral to a specialist, as appropriate.
(xx) Cardiovascular screening blood test
(1) The term "cardiovascular screening blood test" means a blood test for the early detection of cardiovascular disease (or abnormalities associated with an elevated risk of cardiovascular disease) that tests for the following:
(A) Cholesterol levels and other lipid or triglyceride levels.
(B) Such other indications associated with the presence of, or an elevated risk for, cardiovascular disease as the Secretary may approve for all individuals (or for some individuals determined by the Secretary to be at risk for cardiovascular disease), including indications measured by noninvasive testing.
The Secretary may not approve an indication under subparagraph (B) for any individual unless a blood test for such is recommended by the United States Preventive Services Task Force.
(2) The Secretary shall establish standards, in consultation with appropriate organizations, regarding the frequency for each type of cardiovascular screening blood tests, except that such frequency may not be more often than once every 2 years.
(yy) Diabetes screening tests
(1) The term "diabetes screening tests" means testing furnished to an individual at risk for diabetes (as defined in paragraph (2)) for the purpose of early detection of diabetes, including—
(A) a fasting plasma glucose test; and
(B) such other tests, and modifications to tests, as the Secretary determines appropriate, in consultation with appropriate organizations.
(2) For purposes of paragraph (1), the term "individual at risk for diabetes" means an individual who has any of the following risk factors for diabetes:
(A) Hypertension.
(B) Dyslipidemia.
(C) Obesity, defined as a body mass index greater than or equal to 30 kg/m2.
(D) Previous identification of an elevated impaired fasting glucose.
(E) Previous identification of impaired glucose tolerance.
(F) A risk factor consisting of at least 2 of the following characteristics:
(i) Overweight, defined as a body mass index greater than 25, but less than 30, kg/m2.
(ii) A family history of diabetes.
(iii) A history of gestational diabetes mellitus or delivery of a baby weighing greater than 9 pounds.
(iv) 65 years of age or older.
(3) The Secretary shall establish standards, in consultation with appropriate organizations, regarding the frequency of diabetes screening tests, except that such frequency may not be more often than twice within the 12-month period following the date of the most recent diabetes screening test of that individual.
(zz) Intravenous immune globulin
The term "intravenous immune globulin" means an approved pooled plasma derivative for the treatment in the patient's home of a patient with a diagnosed primary immune deficiency disease, but not including items or services furnished before January 1, 2024, related to the administration of the derivative, if a physician determines administration of the derivative in the patient's home is medically appropriate.
(aaa) Extended care in religious nonmedical health care institutions
(1) The term "home health agency" also includes a religious nonmedical health care institution (as defined in subsection (ss)(1)), but only with respect to items and services ordinarily furnished by such an institution to individuals in their homes, and that are comparable to items and services furnished to individuals by a home health agency that is not religious nonmedical health care institution.
(2)(A) Subject to subparagraphs (B), payment may be made with respect to services provided by such an institution only to such extent and under such conditions, limitations, and requirements (in addition to or in lieu of the conditions, limitations, and requirements otherwise applicable) as may be provided in regulations consistent with
(B) Notwithstanding any other provision of this subchapter, payment may not be made under subparagraph (A)—
(i) in a year insofar as such payments exceed $700,000; and
(ii) after December 31, 2006.
(bbb) Ultrasound screening for abdominal aortic aneurysm
The term "ultrasound screening for abdominal aortic aneurysm" means—
(1) a procedure using sound waves (or such other procedures using alternative technologies, of commensurate accuracy and cost, that the Secretary may specify) provided for the early detection of abdominal aortic aneurysm; and
(2) includes a physician's interpretation of the results of the procedure.
(ccc) Long-term care hospital
The term "long-term care hospital" means a hospital which—
(1) is primarily engaged in providing inpatient services, by or under the supervision of a physician, to Medicare beneficiaries whose medically complex conditions require a long hospital stay and programs of care provided by a long-term care hospital;
(2) has an average inpatient length of stay (as determined by the Secretary) of greater than 25 days, or meets the requirements of clause (II) 8 of
(3) satisfies the requirements of subsection (e); and
(4) meets the following facility criteria:
(A) the institution has a patient review process, documented in the patient medical record, that screens patients prior to admission for appropriateness of admission to a long-term care hospital, validates within 48 hours of admission that patients meet admission criteria for long-term care hospitals, regularly evaluates patients throughout their stay for continuation of care in a long-term care hospital, and assesses the available discharge options when patients no longer meet such continued stay criteria;
(B) the institution has active physician involvement with patients during their treatment through an organized medical staff, physician-directed treatment with physician on-site availability on a daily basis to review patient progress, and consulting physicians on call and capable of being at the patient's side within a moderate period of time, as determined by the Secretary; and
(C) the institution has interdisciplinary team treatment for patients, requiring interdisciplinary teams of health care professionals, including physicians, to prepare and carry out an individualized treatment plan for each patient.
(ddd) Additional preventive services; preventive services
(1) The term "additional preventive services" means services not described in subparagraph (A) or (C) of paragraph (3) that identify medical conditions or risk factors and that the Secretary determines are—
(A) reasonable and necessary for the prevention or early detection of an illness or disability;
(B) recommended with a grade of A or B by the United States Preventive Services Task Force; and
(C) appropriate for individuals entitled to benefits under part A or enrolled under part B.
(2) In making determinations under paragraph (1) regarding the coverage of a new service, the Secretary shall use the process for making national coverage determinations (as defined in
(3) The term "preventive services" means the following:
(A) The screening and preventive services described in subsection (ww)(2) (other than the service described in subparagraph (M) of such subsection).
(B) An initial preventive physical examination (as defined in subsection (ww)).
(C) Personalized prevention plan services (as defined in subsection (hhh)(1)).
(eee) Cardiac rehabilitation program; intensive cardiac rehabilitation program
(1) The term "cardiac rehabilitation program" means a program (as described in paragraph (2)) that furnishes the items and services described in paragraph (3) under the supervision of a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)).
(2) A program described in this paragraph is a program under which—
(A) items and services under the program are delivered—
(i) in a physician's office;
(ii) in a hospital on an outpatient basis; or
(iii) in other settings determined appropriate by the Secretary;
(B) a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)) is immediately available and accessible for medical consultation and medical emergencies at all times items and services are being furnished under the program, except that, in the case of items and services furnished under such a program in a hospital, such availability shall be presumed; and
(C) individualized treatment is furnished under a written plan established, reviewed, and signed by a physician every 30 days that describes—
(i) the individual's diagnosis;
(ii) the type, amount, frequency, and duration of the items and services furnished under the plan; and
(iii) the goals set for the individual under the plan.
(3) The items and services described in this paragraph are—
(A) physician-prescribed exercise;
(B) cardiac risk factor modification, including education, counseling, and behavioral intervention (to the extent such education, counseling, and behavioral intervention is closely related to the individual's care and treatment and is tailored to the individual's needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary may determine, but only if such items and services are—
(i) reasonable and necessary for the diagnosis or active treatment of the individual's condition;
(ii) reasonably expected to improve or maintain the individual's condition and functional level; and
(iii) furnished under such guidelines relating to the frequency and duration of such items and services as the Secretary shall establish, taking into account accepted norms of medical practice and the reasonable expectation of improvement of the individual.
(4)(A) The term "intensive cardiac rehabilitation program" means a program (as described in paragraph (2)) that furnishes the items and services described in paragraph (3) under the supervision of a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)) and has shown, in peer-reviewed published research, that it accomplished—
(i) one or more of the following:
(I) positively affected the progression of coronary heart disease; or
(II) reduced the need for coronary bypass surgery; or
(III) reduced the need for percutaneous coronary interventions; and
(ii) a statistically significant reduction in 5 or more of the following measures from their level before receipt of cardiac rehabilitation services to their level after receipt of such services:
(I) low density lipoprotein;
(II) triglycerides;
(III) body mass index;
(IV) systolic blood pressure;
(V) diastolic blood pressure; or
(VI) the need for cholesterol, blood pressure, and diabetes medications.
(B) To be eligible for an intensive cardiac rehabilitation program, an individual must have—
(i) had an acute myocardial infarction within the preceding 12 months;
(ii) had coronary bypass surgery;
(iii) stable angina pectoris;
(iv) had heart valve repair or replacement;
(v) had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting;
(vi) had a heart or heart-lung transplant;
(vii) stable, chronic heart failure (defined as patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks); or
(viii) any additional condition for which the Secretary has determined that a cardiac rehabilitation program shall be covered, unless the Secretary determines, using the same process used to determine that the condition is covered for a cardiac rehabilitation program, that such coverage is not supported by the clinical evidence.
(C) An intensive cardiac rehabilitation program may be provided in a series of 72 one-hour sessions (as defined in
(5) The Secretary shall establish standards to ensure that a physician with expertise in the management of individuals with cardiac pathophysiology who is licensed to practice medicine in the State in which a cardiac rehabilitation program (or the intensive cardiac rehabilitation program, as the case may be) is offered—
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is involved substantially in directing the progress of individual 1 in the program.
(fff) Pulmonary rehabilitation program
(1) The term "pulmonary rehabilitation program" means a program (as described in subsection (eee)(2) with respect to a program under this subsection) that furnishes the items and services described in paragraph (2) under the supervision of a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)).
(2) The items and services described in this paragraph are—
(A) physician-prescribed exercise;
(B) education or training (to the extent the education or training is closely and clearly related to the individual's care and treatment and is tailored to such individual's needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary may determine, but only if such items and services are—
(i) reasonable and necessary for the diagnosis or active treatment of the individual's condition;
(ii) reasonably expected to improve or maintain the individual's condition and functional level; and
(iii) furnished under such guidelines relating to the frequency and duration of such items and services as the Secretary shall establish, taking into account accepted norms of medical practice and the reasonable expectation of improvement of the individual.
(3) The Secretary shall establish standards to ensure that a physician with expertise in the management of individuals with respiratory pathophysiology who is licensed to practice medicine in the State in which a pulmonary rehabilitation program is offered—
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is involved substantially in directing the progress of individual 1 in the program.
(ggg) Kidney disease education services
(1) The term "kidney disease education services" means educational services that are—
(A) furnished to an individual with stage IV chronic kidney disease who, according to accepted clinical guidelines identified by the Secretary, will require dialysis or a kidney transplant;
(B) furnished, upon the referral of the physician managing the individual's kidney condition, by a qualified person (as defined in paragraph (2)); and
(C) designed—
(i) to provide comprehensive information (consistent with the standards set under paragraph (3)) regarding—
(I) the management of comorbidities, including for purposes of delaying the need for dialysis;
(II) the prevention of uremic complications; and
(III) each option for renal replacement therapy (including hemodialysis and peritoneal dialysis at home and in-center as well as vascular access options and transplantation);
(ii) to ensure that the individual has the opportunity to actively participate in the choice of therapy; and
(iii) to be tailored to meet the needs of the individual involved.
(2)(A) The term "qualified person" means—
(i) a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5)), who furnishes services for which payment may be made under the fee schedule established under
(ii) a provider of services located in a rural area (as defined in
(B) Such term does not include a provider of services (other than a provider of services described in subparagraph (A)(ii)) or a renal dialysis facility.
(3) The Secretary shall set standards for the content of such information to be provided under paragraph (1)(C)(i) after consulting with physicians, other health professionals, health educators, professional organizations, accrediting organizations, kidney patient organizations, dialysis facilities, transplant centers, network organizations described in
(4) No individual shall be furnished more than 6 sessions of kidney disease education services under this subchapter.
(hhh) Annual wellness visit
(1) The term "personalized prevention plan services" means the creation of a plan for an individual—
(A) that includes a health risk assessment (that meets the guidelines established by the Secretary under paragraph (4)(A)) of the individual that is completed prior to or as part of the same visit with a health professional described in paragraph (3); and
(B) that—
(i) takes into account the results of the health risk assessment; and
(ii) may contain the elements described in paragraph (2).
(2) Subject to paragraph (4)(H), the elements described in this paragraph are the following:
(A) The establishment of, or an update to, the individual's medical and family history.
(B) A list of current providers and suppliers that are regularly involved in providing medical care to the individual (including a list of all prescribed medications).
(C) A measurement of height, weight, body mass index (or waist circumference, if appropriate), blood pressure, and other routine measurements.
(D) Detection of any cognitive impairment.
(E) The establishment of, or an update to, the following:
(i) A screening schedule for the next 5 to 10 years, as appropriate, based on recommendations of the United States Preventive Services Task Force and the Advisory Committee on Immunization Practices, and the individual's health status, screening history, and age-appropriate preventive services covered under this subchapter.
(ii) A list of risk factors and conditions for which primary, secondary, or tertiary prevention interventions are recommended or are underway, including any mental health conditions or any such risk factors or conditions that have been identified through an initial preventive physical examination (as described under subsection (ww)(1)), and a list of treatment options and their associated risks and benefits.
(F) The furnishing of personalized health advice and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self-management, or community-based lifestyle interventions to reduce health risks and promote self-management and wellness, including weight loss, physical activity, smoking cessation, fall prevention, and nutrition.
(G) Screening for potential substance use disorders and referral for treatment as appropriate.
(H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)).
(I) Any other element determined appropriate by the Secretary.
(3) A health professional described in this paragraph is—
(A) a physician;
(B) a practitioner described in clause (i) of
(C) a medical professional (including a health educator, registered dietitian, or nutrition professional) or a team of medical professionals, as determined appropriate by the Secretary, under the supervision of a physician.
(4)(A) For purposes of paragraph (1)(A), the Secretary, not later than 1 year after March 23, 2010, shall establish publicly available guidelines for health risk assessments. Such guidelines shall be developed in consultation with relevant groups and entities and shall provide that a health risk assessment—
(i) identify chronic diseases, injury risks, modifiable risk factors, and urgent health needs of the individual; and
(ii) may be furnished—
(I) through an interactive telephonic or web-based program that meets the standards established under subparagraph (B);
(II) during an encounter with a health care professional;
(III) through community-based prevention programs; or
(IV) through any other means the Secretary determines appropriate to maximize accessibility and ease of use by beneficiaries, while ensuring the privacy of such beneficiaries.
(B) Not later than 1 year after March 23, 2010, the Secretary shall establish standards for interactive telephonic or web-based programs used to furnish health risk assessments under subparagraph (A)(ii)(I). The Secretary may utilize any health risk assessment developed under
(C)(i) Not later than 18 months after March 23, 2010, the Secretary shall develop and make available to the public a health risk assessment model. Such model shall meet the guidelines under subparagraph (A) and may be used to meet the requirement under paragraph (1)(A).
(ii) Any health risk assessment that meets the guidelines under subparagraph (A) and is approved by the Secretary may be used to meet the requirement under paragraph (1)(A).
(D) The Secretary may coordinate with community-based entities (including State Health Insurance Programs, Area Agencies on Aging, Aging and Disability Resource Centers, and the Administration on Aging) to—
(i) ensure that health risk assessments are accessible to beneficiaries; and
(ii) provide appropriate support for the completion of health risk assessments by beneficiaries.
(E) The Secretary shall establish procedures to make beneficiaries and providers aware of the requirement that a beneficiary complete a health risk assessment prior to or at the same time as receiving personalized prevention plan services.
(F) To the extent practicable, the Secretary shall encourage the use of, integration with, and coordination of health information technology (including use of technology that is compatible with electronic medical records and personal health records) and may experiment with the use of personalized technology to aid in the development of self-management skills and management of and adherence to provider recommendations in order to improve the health status of beneficiaries.
(G) A beneficiary shall be eligible to receive only an initial preventive physical examination (as defined under subsection (ww)(1)) during the 12-month period after the date that the beneficiary's coverage begins under part B and shall be eligible to receive personalized prevention plan services under this subsection each year thereafter provided that the beneficiary has not received either an initial preventive physical examination or personalized prevention plan services within the preceding 12-month period.
(H) The Secretary shall issue guidance that—
(i) identifies elements under paragraph (2) that are required to be provided to a beneficiary as part of their first visit for personalized prevention plan services; and
(ii) establishes a yearly schedule for appropriate provision of such elements thereafter.
(iii) Home infusion therapy
(1) The term "home infusion therapy" means the items and services described in paragraph (2) furnished by a qualified home infusion therapy supplier (as defined in paragraph (3)(D)) which are furnished in the individual's home (as defined in paragraph (3)(B)) to an individual—
(A) who is under the care of an applicable provider (as defined in paragraph (3)(A)); and
(B) with respect to whom a plan prescribing the type, amount, and duration of infusion therapy services that are to be furnished such individual has been established by a physician (as defined in subsection (r)(1)) and is periodically reviewed by a physician (as so defined) in coordination with the furnishing of home infusion drugs (as defined in paragraph (3)(C)) under part B.
(2) The items and services described in this paragraph are the following:
(A) Professional services, including nursing services, furnished in accordance with the plan.
(B) Training and education (not otherwise paid for as durable medical equipment (as defined in subsection (n)), remote monitoring, and monitoring services for the provision of home infusion therapy and home infusion drugs furnished by a qualified home infusion therapy supplier.
(3) For purposes of this subsection:
(A) The term "applicable provider" means—
(i) a physician;
(ii) a nurse practitioner; and
(iii) a physician assistant.
(B) The term "home" means a place of residence used as the home of an individual (as defined for purposes of subsection (n)).
(C) The term "home infusion drug" means a parenteral drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment (as defined in subsection (n)). Such term does not include the following:
(i) Insulin pump systems.
(ii) A self-administered drug or biological on a self-administered drug exclusion list.
Clause (ii) shall not apply to a self-administered drug or biological on a self-administered drug exclusion list if such drug or biological was included as a transitional home infusion drug under subparagraph (A)(iii) of
(D)(i) The term "qualified home infusion therapy supplier" means a pharmacy, physician, or other provider of services or supplier licensed by the State in which the pharmacy, physician, or provider or services or supplier furnishes items or services and that—
(I) furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs;
(II) ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis;
(III) is accredited by an organization designated by the Secretary pursuant to
(IV) meets such other requirements as the Secretary determines appropriate, taking into account the standards of care for home infusion therapy established by Medicare Advantage plans under part C and in the private sector.
(ii) A qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider of services, or supplier to meet the requirements of this subparagraph.
(jjj) Opioid use disorder treatment services; opioid treatment program
(1) Opioid use disorder treatment services
The term "opioid use disorder treatment services" means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including—
(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under
(B) dispensing and administration of such medications, if applicable;
(C) substance use counseling by a professional to the extent authorized under State law to furnish such services;
(D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law);
(E) toxicology testing, and
(F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).
(2) Opioid treatment program
The term "opioid treatment program" means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that—
(A) is enrolled under
(B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;
(C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and
(D) meets such additional conditions as the Secretary may find necessary to ensure—
(i) the health and safety of individuals being furnished services under such program; and
(ii) the effective and efficient furnishing of such services.
(kkk) Rural emergency hospital services; rural emergency hospital
(1) Rural emergency hospital services
(A) In general
The term "rural emergency hospital services" means the following services furnished by a rural emergency hospital (as defined in paragraph (2)) that do not exceed an annual per patient average of 24 hours in such rural emergency hospital:
(i) Emergency department services and observation care.
(ii) At the election of the rural emergency hospital, with respect to services furnished on an outpatient basis, other medical and health services as specified by the Secretary through rulemaking.
(B) Staffed emergency department
For purposes of subparagraph (A)(i), an emergency department of a rural emergency hospital shall be considered a staffed emergency department if it meets the following requirements:
(i) The emergency department is staffed 24 hours a day, 7 days a week.
(ii) A physician (as defined in subsection (r)(1)), nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in subsection (aa)(5)) is available to furnish rural emergency hospital services in the facility 24 hours a day.
(iii) Applicable staffing and staffing responsibilities under section 485.631 of title 42, Code of Federal Regulations (or any successor regulation).
(2) Rural emergency hospital
The term "rural emergency hospital" means a facility described in paragraph (3) that—
(A) is enrolled under
(B) does not provide any acute care inpatient services, other than those described in paragraph (6)(A);
(C) has in effect a transfer agreement with a level I or level II trauma center; 2
(D) meets—
(i) licensure requirements as described in paragraph (5);
(ii) the requirements of a staffed emergency department as described in paragraph (1)(B);
(iii) such staff training and certification requirements as the Secretary may require;
(iv) conditions of participation applicable to—
(I) critical access hospitals, with respect to emergency services under section 485.618 of title 42, Code of Federal Regulations (or any successor regulation); and
(II) hospital emergency departments under this subchapter, as determined applicable by the Secretary;
(v) such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished rural emergency hospital services; and
(vi) in the case where the rural emergency hospital includes a distinct part unit of the facility that is licensed as a skilled nursing facility, such distinct part meets the requirements applicable to skilled nursing facilities under this subchapter.
(3) Facility described
A facility described in this paragraph is a facility that as of December 27, 2020—
(A) was a critical access hospital; or
(B) was a subsection (d) hospital (as defined in
(4) Additional information
(A) Information
For purposes of paragraph (2)(A), a facility that submits an application for enrollment under
(i) An action plan for initiating rural emergency hospital services (as defined in paragraph (1)), including a detailed transition plan that lists the specific services that the facility will—
(I) retain;
(II) modify 11
(III) add; and
(IV) discontinue.
(ii) A description of services that the facility intends to furnish on an outpatient basis pursuant to paragraph (1)(A)(ii).
(iii) Information regarding how the facility intends to use the additional facility payment provided under
(iv) Such other information as the Secretary determines appropriate.
(B) Effect of enrollment
Such enrollment shall remain effective with respect to a facility until such time as—
(i) the facility elects to convert back to its prior designation as a critical access hospital or a subsection (d) hospital (as defined in
(ii) the Secretary determines the facility does not meet the requirements applicable to a rural emergency hospital under this subsection.
(5) Licensure
A facility may not operate as a rural emergency hospital in a State unless the facility—
(A) is located in a State that provides for the licensing of such hospitals under State or applicable local law; and
(B)(i) is licensed pursuant to such law; or
(ii) is approved by the agency of such State or locality responsible for licensing hospitals, as meeting the standards established for such licensing.
(6) Discretionary authority
A rural emergency hospital may—
(A) include a unit of the facility that is a distinct part licensed as a skilled nursing facility to furnish post-hospital extended care services; and
(B) be considered a hospital with less than 50 beds for purposes of the exception to the payment limit for rural health clinics under
(7) Quality measurement
(A) In general
The Secretary shall establish quality measurement reporting requirements for rural emergency hospitals, which may include the use of a small number of claims-based outcomes measures or surveys of patients with respect to their experience in the rural emergency hospital, in accordance with the succeeding provisions of this paragraph.
(B) Quality reporting by rural emergency hospitals
(i) In general
With respect to each year beginning with 2023, (or each year beginning on or after the date that is one year after one or more measures are first specified under subparagraph (C)), a rural emergency hospital shall submit data to the Secretary in accordance with clause (ii).
(ii) Submission of quality data
With respect to each such year, a rural emergency hospital shall submit to the Secretary data on quality measures specified under subparagraph (C). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
(C) Quality measures
(i) In general
Subject to clause (ii), any measure specified by the Secretary under this subparagraph must have been endorsed by the entity with a contract under
(ii) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(iii) Consideration of low case volume when specifying performance measures
The Secretary shall, in the selection of measures specified under this subparagraph, take into consideration ways to account for rural emergency hospitals that lack sufficient case volume to ensure that the performance rates for such measures are reliable.
(D) Public availability of data submitted
The Secretary shall establish procedures for making data submitted under subparagraph (B) available to the public regarding the performance of individual rural emergency hospitals. Such procedures shall ensure that a rural emergency hospital has the opportunity to review, and submit corrections for, the data that is to be made public with respect to the rural emergency hospital prior to such data being made public. Such information shall be posted on the Internet website of the Centers for Medicare & Medicaid Services in an easily understandable format as determined appropriate by the Secretary.
(8) Clarification regarding application of provisions relating to off-campus outpatient department of a provider
Nothing in this subsection,
(9) Implementation
There shall be no administrative or judicial review under
(A) The determination of whether a rural emergency hospital meets the requirements of this subsection.
(B) The establishment of requirements under this subsection by the Secretary, including requirements described in paragraphs (2)(D), (4), and (7).
(C) The determination of payment amounts under
(lll) Marriage and family therapist services; marriage and family therapist; mental health counselor services; mental health counselor
(1) Marriage and family therapist services
The term "marriage and family therapist services" means services furnished by a marriage and family therapist (as defined in paragraph (2)) for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital), which the marriage and family therapist is legally authorized to perform under State law (or the State regulatory mechanism provided by State law) of the State in which such services are furnished, as would otherwise be covered if furnished by a physician or as an incident to a physician's professional service.
(2) Marriage and family therapist
The term "marriage and family therapist" means an individual who—
(A) possesses a master's or doctor's degree which qualifies for licensure or certification as a marriage and family therapist pursuant to State law of the State in which such individual furnishes the services described in paragraph (1);
(B) is licensed or certified as a marriage and family therapist by the State in which such individual furnishes such services;
(C) after obtaining such degree has performed at least 2 years of clinical supervised experience in marriage and family therapy; and
(D) meets such other requirements as specified by the Secretary.
(3) Mental health counselor services
The term "mental health counselor services" means services furnished by a mental health counselor (as defined in paragraph (4)) for the diagnosis and treatment of mental illnesses (other than services furnished to an inpatient of a hospital), which the mental health counselor is legally authorized to perform under State law (or the State regulatory mechanism provided by the State law) of the State in which such services are furnished, as would otherwise be covered if furnished by a physician or as incident to a physician's professional service.
(4) Mental health counselor
The term "mental health counselor" means an individual who—
(A) possesses a master's or doctor's degree which qualifies for licensure or certification as a mental health counselor, clinical professional counselor, or professional counselor under the State law of the State in which such individual furnishes the services described in paragraph (3);
(B) is licensed or certified as a mental health counselor, clinical professional counselor, or professional counselor by the State in which the services are furnished;
(C) after obtaining such a degree has performed at least 2 years of clinical supervised experience in mental health counseling; and
(D) meets such other requirements as specified by the Secretary.
(mmm) Lymphedema compression treatment items
The term "lymphedema compression treatment items" means standard and custom fitted gradient compression garments and other items determined by the Secretary that are—
(1) furnished on or after January 1, 2024, to an individual with a diagnosis of lymphedema for the treatment of such condition;
(2) primarily and customarily used to serve a medical purpose and for the treatment of lymphedema, as determined by the Secretary; and
(3) prescribed by a physician (or a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in
(Aug. 14, 1935, ch. 531, title XVIII, §1861, as added
Editorial Notes
References in Text
Section 4071(b) of the Omnibus Budget Reconciliation Act of 1987, referred to in subsec. (s)(10)(A), is section 4071(b) of
Section 4072(e) of the Omnibus Budget Reconciliation Act of 1987, referred to in subsec. (s)(12), is section 4072(e) of
The Public Health Service Act, referred to in subsec. (v)(1)(M), is act July 1, 1944, ch. 373,
Section 329 of the Public Health Service Act, referred to in subsec. (aa)(2), was section 329 of act July 1, 1944, which was classified to
The Indian Self-Determination Act, referred to in subsec. (aa)(4)(D), is title I of
The Indian Health Care Improvement Act, referred to in subsec. (aa)(4)(D), is
The Internal Revenue Code of 1986, referred to in subsec. (ss)(1)(A), is classified generally to Title 26, Internal Revenue Code.
Clause (II) of
Amendments
2022—Subsec. (s)(2)(B).
Subsec. (s)(2)(Z).
Subsec. (s)(2)(II).
Subsec. (s)(2)(JJ).
Subsec. (aa)(1)(B).
Subsec. (aa)(1)(D).
Subsec. (aa)(3)(A).
Subsec. (dd)(2)(B)(i)(III).
Subsec. (ff).
Subsec. (ff)(1).
Subsec. (ff)(4).
Subsec. (zz).
Subsec. (lll).
Subsec. (mmm).
2020—Subsec. (e).
Subsec. (m).
Subsec. (m)(3).
Subsec. (o)(2).
Subsec. (s)(10)(A).
Subsec. (u).
Subsec. (dd)(4)(C).
Subsec. (kk)(1).
Subsec. (iii)(3)(C).
Subsec. (kkk).
2018—Subsec. (s)(2)(HH).
Subsec. (dd)(3)(B).
Subsec. (ww)(1).
Subsec. (ww)(2)(N), (O).
Subsec. (ww)(4).
Subsec. (eee)(1).
Subsec. (eee)(2)(A)(iii).
Subsec. (eee)(2)(B).
Subsec. (eee)(4)(A).
Subsec. (eee)(4)(B)(vii), (viii).
Subsec. (fff)(1).
Subsec. (hhh)(2)(G) to (I).
Subsec. (jjj).
2016—Subsec. (m).
Subsec. (s)(2)(GG).
Subsec. (iii).
2015—Subsec. (m)(5).
Subsec. (n).
Subsec. (o)(7).
"(7) provides the Secretary with a surety bond—
"(A) effective for a period of 4 years (as specified by the Secretary) or in the case of a change in the ownership or control of the agency (as determined by the Secretary) during or after such 4-year period, an additional period of time that the Secretary determines appropriate, such additional period not to exceed 4 years from the date of such change in ownership or control;
"(B) in a form specified by the Secretary; and
"(C) for a year in the period described in subparagraph (A) in an amount that is equal to the lesser of $50,000 or 10 percent of the aggregate amount of payments to the agency under this subchapter and subchapter XIX of this chapter for that year, as estimated by the Secretary that the Secretary determines is commensurate with the volume of the billing of the home health agency; and".
Subsec. (s)(2)(F).
2014—Subsec. (dd)(4)(C).
2012—Subsec. (v)(1)(T)(iv), (v).
Subsec. (v)(1)(V).
Subsec. (v)(1)(V)(i).
Subsec. (v)(1)(V)(ii).
Subsec. (v)(1)(W).
2011—Subsecs. (v)(1)(G)(i), (w)(2).
2010—Subsec. (o)(7)(C).
Subsec. (s)(2)(K).
Subsec. (s)(2)(FF).
Subsec. (aa)(3)(A).
Subsec. (ff)(3)(A).
Subsec. (ff)(3)(B)(iii), (iv).
Subsec. (ddd).
Subsec. (ddd)(1).
Subsec. (ddd)(3).
Subsec. (hhh).
Subsec. (hhh)(4)(G).
"(G)(i) A beneficiary shall only be eligible to receive an initial preventive physical examination (as defined under subsection (ww)(1)) at any time during the 12-month period after the date that the beneficiary's coverage begins under part B of this subchapter and shall be eligible to receive personalized prevention plan services under this subsection provided that the beneficiary has not received such services within the preceding 12-month period.
"(ii) The Secretary shall establish procedures to make beneficiaries aware of the option to select an initial preventive physical examination or personalized prevention plan services during the period of 12 months after the date that a beneficiary's coverage begins under part B of this subchapter, which shall include information regarding any relevant differences between such services."
2008—Subsec. (e).
Subsec. (p).
Subsec. (s)(2)(D).
Subsec. (s)(2)(F).
Subsec. (s)(2)(BB).
Subsec. (s)(2)(CC), (DD).
Subsec. (s)(2)(EE).
Subsec. (t)(2)(B).
Subsec. (aa)(2).
Subsec. (ll)(2) to (4).
Subsec. (ww)(1).
Subsec. (ww)(2)(M), (N).
Subsec. (ww)(3).
Subsec. (ddd).
Subsecs. (eee), (fff).
Subsec. (ggg).
2007—Subsec. (ccc).
2006—Subsec. (s)(2)(AA).
Subsec. (t)(2)(B)(ii)(I).
Subsec. (v)(1)(T).
Subsec. (v)(1)(V).
Subsec. (aa)(3).
Subsec. (aa)(4)(A)(i), (ii)(II).
Subsec. (ww)(2)(L).
Subsec. (bbb).
2003—Subsec. (d).
Subsec. (s)(2)(A).
Subsec. (s)(2)(K)(i).
Subsec. (s)(2)(K)(ii).
Subsec. (s)(2)(W).
Subsec. (s)(2)(X).
Subsec. (s)(2)(Y).
Subsec. (s)(2)(Z).
Subsec. (s)(7).
Subsec. (v)(1)(S)(ii)(III).
Subsec. (v)(1)(U).
Subsec. (v)(8).
Subsec. (aa)(1)(B).
Subsec. (dd)(2)(A)(i).
Subsec. (dd)(3)(B).
Subsec. (dd)(5)(D), (E).
Subsec. (ee)(2)(D).
Subsec. (mm).
Subsec. (tt)(1)(A), (2)(B).
Subsec. (ww).
Subsec. (xx).
Subsec. (yy).
Subsec. (zz).
Subsec. (aaa).
2000—Subsec. (s)(2)(A), (B).
Subsec. (s)(2)(J).
Subsec. (s)(2)(U).
Subsec. (s)(2)(V).
Subsec. (t)(1).
Subsec. (v)(1)(L)(x).
Subsec. (v)(1)(T)(ii).
Subsec. (v)(1)(T)(iii).
Subsec. (v)(1)(T)(iv).
Subsec. (ff)(3)(B).
"(i) providing the services described in section 1916(c)(4) of the Public Health Service Act; and
"(ii) meeting applicable licensing or certification requirements for community mental health centers in the State in which it is located."
Subsec. (nn)(1), (2).
Subsec. (pp)(1)(C).
Subsec. (pp)(2).
Subsec. (uu).
Subsec. (vv).
1999—Subsec. (o)(7).
Subsec. (p)(1).
Subsec. (r)(4).
Subsec. (s)(2)(J)(v).
Subsec. (s)(2)(T)(ii).
Subsec. (v)(1)(L)(ix), (x).
Subsec. (v)(1)(S)(ii)(I), (II).
Subsec. (aa)(2)(I).
Subsec. (ee)(3).
Subsec. (ss)(1)(G)(i).
1998—Subsec. (v)(1)(L)(i)(III) to (V).
Subsec. (v)(1)(L)(v).
Subsec. (v)(1)(L)(vi)(I).
Subsec. (v)(1)(L)(viii).
Subsec. (v)(1)(L)(ix).
1997—Subsec. (a).
Subsec. (b)(4).
Subsec. (e).
Subsec. (h).
Subsec. (h)(7).
Subsec. (m).
Subsec. (n).
Subsec. (o).
Subsec. (o)(7), (8).
Subsec. (p).
Subsec. (p)(4)(A)(v).
Subsec. (r)(5).
Subsec. (s)(2)(K)(i).
Subsec. (s)(2)(K)(ii).
Subsec. (s)(2)(K)(iii), (iv).
"(iii) services which would be physicians' services if furnished by a physician (as defined in subsection (r)(1) of this section) and which are performed by a nurse practitioner or clinical nurse specialist (as defined in subsection (aa)(5) of this section) working in collaboration (as defined in subsection (aa)(6) of this section) with a physician (as defined in subsection (r)(1) of this section) in a rural area (as defined in
"(iv) such services and supplies furnished as an incident to services described in clause (i) or (ii) as would be covered under subparagraph (A) if furnished as an incident to a physician's professional service;".
Subsec. (s)(2)(N) to (P).
Subsec. (s)(2)(R).
Subsec. (s)(2)(S).
Subsec. (s)(2)(T).
Subsec. (s)(12)(C).
Subsec. (s)(14).
Subsec. (s)(15) to (17).
Subsec. (u).
Subsec. (v)(1)(H)(i).
Subsec. (v)(1)(H)(ii).
Subsec. (v)(1)(L)(i).
Subsec. (v)(1)(L)(i)(I).
Subsec. (v)(1)(L)(i)(II).
Subsec. (v)(1)(L)(i)(III).
Subsec. (v)(1)(L)(i)(IV).
Subsec. (v)(1)(L)(iii).
Subsec. (v)(1)(L)(iv).
Subsec. (v)(1)(L)(v) to (vii).
Subsec. (v)(1)(O)(i).
Subsec. (v)(1)(O)(ii) to (iv).
Subsec. (v)(1)(S)(ii)(I), (II).
Subsec. (v)(1)(S)(ii)(III).
Subsec. (v)(1)(T).
Subsec. (v)(1)(U).
Subsec. (v)(7)(D).
Subsec. (v)(8).
Subsec. (w).
Subsec. (y).
Subsec. (y)(1).
Subsec. (aa)(2).
Subsec. (aa)(2)(I).
Subsec. (aa)(5).
Subsec. (aa)(7)(B).
Subsec. (cc)(2).
Subsec. (cc)(2)(I), (J).
Subsec. (dd)(1)(I).
Subsec. (dd)(2)(A)(ii)(I).
Subsec. (dd)(2)(B)(i).
Subsec. (dd)(5)(B).
Subsec. (dd)(5)(C).
Subsec. (ee)(2)(D).
Subsec. (ee)(2)(H).
Subsec. (mm).
"(1) The term 'rural primary care hospital' means a facility designated by the Secretary as a rural primary care hospital under
"(2) The term 'inpatient rural primary care hospital services' means items and services, furnished to an inpatient of a rural primary care hospital by such a hospital, that would be inpatient hospital services if furnished to an inpatient of a hospital by a hospital.
"(3) The term 'outpatient rural primary care hospital services' means medical and other health services furnished by a rural primary care hospital."
Subsec. (nn).
Subsec. (oo).
Subsec. (pp).
Subsec. (qq).
Subsec. (rr).
Subsec. (ss).
Subsec. (tt).
1996—Subsec. (aa)(4)(A)(i).
Subsec. (aa)(4)(A)(ii)(II).
1994—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (e)(4).
Subsec. (h)(3).
Subsec. (m)(2).
Subsec. (m)(5).
Subsec. (p).
Subsec. (s)(2)(K)(iii).
Subsec. (s)(2)(N).
Subsec. (s)(2)(O), (P).
Subsec. (s)(3).
Subsec. (v)(1)(L)(iii).
Subsec. (aa)(2).
Subsec. (aa)(5).
Subsec. (cc)(1)(B).
Subsec. (dd)(1)(B).
Subsec. (ee)(2)(D).
Subsec. (jj).
Subsec. (kk).
Subsec. (ll).
1993—Subsec. (s)(2)(J).
Subsec. (s)(2)(P).
Subsec. (s)(2)(Q).
Subsec. (t).
Subsec. (v)(1)(B).
Subsec. (v)(1)(L)(ii).
Subsec. (v)(1)(L)(iii).
Subsec. (v)(1)(S)(ii)(I).
Subsec. (v)(1)(S)(ii)(II).
Subsec. (aa)(4)(D).
Subsec. (gg)(2).
1990—Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (n).
Subsec. (s)(2)(E).
Subsec. (s)(2)(H)(i).
Subsec. (s)(2)(K)(i).
Subsec. (s)(2)(K)(ii).
Subsec. (s)(2)(K)(iii).
Subsec. (s)(2)(K)(iv).
Subsec. (s)(2)(O).
Subsec. (s)(2)(P).
Subsec. (s)(8).
Subsec. (s)(13).
Subsec. (v)(1)(E).
Subsec. (v)(1)(L)(iii).
"(I) utilize a wage index that is based on verified wage data obtained from home health agencies, and
"(II) base such limits on the most recent verified wage data available, which data may be for cost reporting periods beginning no earlier than July 1, 1985.
In the case of a home health agency that refuses to provide data, or deliberately provides false data, respecting wages for purposes of this clause upon the request of the Secretary, the Secretary may withhold up to 5 percent of the amount of the payments otherwise payable to the agency under this subchapter until such date as the Secretary determines that such data has been satisfactorily provided."
Subsec. (v)(1)(S)(ii)(I).
Subsec. (v)(1)(S)(ii)(II).
Subsec. (v)(1)(S)(ii)(III).
Subsec. (v)(1)(S)(ii)(IV).
Subsec. (aa).
Subsec. (aa)(1)(B).
Subsec. (aa)(2).
Subsec. (aa)(3).
Subsec. (aa)(4) to (6).
Subsec. (aa)(7).
Subsec. (ff)(3).
Subsec. (jj).
1989—Subsec. (a).
Subsec. (e).
Subsec. (i).
Subsec. (m).
Subsec. (m)(5).
Subsec. (s).
Subsec. (s)(2)(H)(ii).
Subsec. (s)(2)(J).
Subsec. (s)(2)(K).
Subsec. (s)(2)(N).
Subsec. (s)(12).
Subsec. (s)(13).
Subsec. (s)(14).
Subsec. (s)(15).
Subsec. (s)(16).
Subsec. (t).
Subsec. (u).
Subsec. (v)(1)(G)(i).
Subsec. (v)(1)(S).
Subsec. (v)(2)(A), (3).
Subsec. (w)(1).
Subsec. (w)(2).
Subsec. (y).
Subsec. (aa)(1)(B).
Subsec. (aa)(2).
Subsec. (aa)(2)(J), (K).
Subsec. (aa)(4).
Subsec. (hh).
Subsec. (ii).
Subsecs. (jj) to (ll).
Subsec. (mm).
Subsec. (mm)(3).
Subsec. (nn).
1988—Subsec. (a).
Subsec. (a)(2).
Subsec. (e).
Subsec. (i).
Subsec. (m).
Subsec. (n).
Subsec. (p).
Subsec. (s).
Subsec. (s)(2)(H)(ii).
Subsec. (s)(2)(J).
Subsec. (s)(2)(K)(i).
Subsec. (s)(2)(K)(i)(I).
Subsec. (s)(2)(M).
Subsec. (s)(10)(A).
Subsec. (s)(12).
Subsec. (s)(13).
Subsec. (s)(14).
Subsec. (s)(15).
Subsec. (s)(16).
Subsec. (t).
Subsec. (u).
Subsec. (v)(1)(G)(i).
Subsec. (v)(1)(L)(iii).
Subsec. (v)(2)(A), (3).
Subsec. (y).
Subsec. (y)(1).
Subsec. (y)(2).
Subsec. (y)(3).
Subsec. (y)(4).
Subsec. (bb)(2).
Subsec. (ff).
Subsec. (ff)(3).
Subsec. (gg).
Subsec. (hh).
Subsec. (ii).
Subsec. (jj).
Subsec. (kk).
Subsec. (ll).
1987—Subsec. (a)(2).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (b)(6).
Subsec. (e)(4).
Subsec. (g).
Subsec. (j).
Subsec. (n).
Subsec. (o)(6).
Subsec. (r)(3).
Subsec. (s).
Subsec. (s)(2)(B).
Subsec. (s)(2)(H)(ii).
Subsec. (s)(2)(J).
Subsec. (s)(2)(K)(i).
Subsec. (s)(2)(L).
Subsec. (s)(2)(M).
Subsec. (s)(10)(A).
Subsec. (s)(12).
Subsec. (s)(13), (14).
Subsec. (s)(15).
Subsec. (s)(16).
Subsec. (v)(1)(E).
Subsec. (v)(1)(L)(iii).
Subsec. (v)(1)(S).
Subsec. (v)(5)(A).
Subsec. (aa)(1)(B).
Subsec. (bb).
Subsec. (bb)(2).
Subsec. (cc)(1).
Subsec. (ee).
Subsec. (ff).
Subsec. (gg).
Subsec. (hh).
Subsec. (ii).
1986—Subsec. (b)(4).
Subsec. (e)(6).
Subsec. (g).
Subsec. (n).
Subsec. (r)(4).
Subsec. (s)(2)(D).
Subsec. (s)(2)(J).
Subsec. (s)(2)(K).
Subsec. (s)(11) to (15).
Subsec. (v)(1)(B).
Subsec. (v)(1)(G)(i).
Subsec. (v)(1)(L).
"(I) July 1, 1985, and before July 1, 1986, 120 percent,
"(II) July 1, 1986, and before July 1, 1987, 115 percent, or
"(III) July 1, 1987, 112 percent,
of the mean of the labor-related and nonlabor per visit costs for free standing home health agencies.
"(ii) Effective for cost reporting periods beginning on or after July 1, 1986, such limitations shall be applied on an aggregate basis for the agency, rather than on a discipline specific basis, with appropriate adjustment for administrative and general costs of hospital-based agencies."
Subsec. (v)(1)(O)(i).
Subsec. (v)(1)(O)(iv).
Subsec. (v)(1)(P).
Subsec. (v)(1)(Q).
Subsec. (v)(1)(R).
Subsec. (v)(5)(A).
Subsec. (bb).
Subsec. (ee).
1984—Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (j).
Subsec. (j)(2).
Subsec. (j)(13).
Subsec. (m)(5).
Subsec. (n).
Subsec. (p)(1).
Subsec. (p)(2).
Subsec. (r)(3).
Subsec. (s)(2)(H).
Subsec. (s)(2)(I).
Subsec. (s)(6).
Subsec. (s)(10).
Subsec. (u).
Subsec. (v)(1)(B).
Subsec. (v)(1)(C).
Subsec. (v)(1)(C)(i).
Subsec. (v)(1)(D).
Subsec. (v)(1)(E).
Subsec. (v)(1)(I)(i), (ii).
Subsec. (v)(1)(K).
Subsec. (v)(1)(O).
Subsec. (v)(3).
Subsec. (v)(7)(D).
Subsec. (z)(2).
Subsec. (aa)(2)(I).
Subsec. (cc)(1)(F).
Subsec. (cc)(1)(G).
Subsec. (cc)(2)(F).
Subsec. (dd)(2)(A)(ii)(I).
Subsec. (dd)(5).
1983—Subsec. (v)(1)(G)(i).
Subsec. (v)(2)(A).
Subsec. (v)(2)(B).
Subsec. (v)(3).
Subsec. (v)(7)(C).
Subsec. (z)(2).
1982—Subsec. (e)(C).
Subsec. (s)(2)(H).
Subsec. (u).
Subsec. (v)(1)(E).
Subsec. (v)(1)(G)(i).
Subsec. (v)(1)(H)(iii).
Subsec. (v)(1)(I).
Subsec. (v)(1)(J).
Subsec. (v)(1)(L).
Subsec. (v)(1)(M).
Subsec. (v)(1)(N).
Subsec. (v)(7).
Subsec. (v)(7)(C).
Subsec. (w)(1).
Subsec. (w)(2).
Subsec. (cc)(1).
Subsec. (dd).
1981—Subsec. (u).
Subsec. (v)(1)(G)(i).
Subsec. (v)(1)(G)(iv).
Subsec. (v)(1)(J).
Subsec. (v)(1)(K).
Subsec. (v)(1)(L).
Subsec. (w)(2).
Subsec. (bb).
1980—Subsec. (b)(7).
Subsec. (e).
Subsec. (i).
Subsec. (j)(13).
Subsec. (k)(2)(A).
Subsec. (m)(4).
Subsec. (n).
Subsec. (o).
Subsec. (o)(7).
Subsec. (r)(2).
Subsec. (r)(3).
Subsec. (r)(4).
Subsec. (s)(2)(G).
Subsec. (s)(10) to (14).
Subsec. (u).
Subsec. (v)(1)(G).
Subsec. (v)(1)(H).
Subsec. (v)(1)(I).
Subsec. (z).
Subsec. (aa)(1)(A).
Subsec. (bb).
Subsec. (cc).
1978—Subsec. (s)(2)(F).
1977—Subsec. (j)(11).
Subsec. (j)(13).
Subsec. (j)(14).
Subsec. (s).
Subsec. (s)(6).
Subsec. (v)(1)(F).
Subsec. (w)(2).
Subsec. (aa).
1975—Subsec. (e)(5).
Subsec. (j)(13).
Subsec. (w).
1972—Subsec. (a)(2).
Subsec. (b)(6).
Subsec. (b)(7).
Subsec. (e).
Subsec. (e)(8).
Subsec. (e)(9).
Subsecs. (f)(2), (g)(2).
Subsec. (h).
Subsec. (i).
Subsec. (j).
Subsec. (j)(10).
Subsec. (j)(11) to (13).
Subsec. (j)(15).
Subsec. (k).
Subsec. (l).
Subsec. (m)(7).
Subsec. (n).
Subsec. (o)(5), (6).
Subsec. (p).
Subsec. (q).
Subsec. (r).
Subsec. (s)(8).
Subsec. (u).
Subsec. (v)(1).
Subsec. (v)(3).
Subsec. (v)(4).
Subsec. (v)(5).
Subsec. (v)(6).
Subsec. (v)(7).
Subsecs. (w), (y).
Subsec. (z).
1971—Subsec. (e)(5).
1968—Subsec. (e).
Subsec. (p).
Subsec. (r)(3).
Subsec. (s).
Subsec. (s)(2)(A) to (C).
Subsec. (s)(2)(D).
Subsec. (s)(3).
Subsec. (s)(6).
Subsec. (s)(12), (13).
Subsec. (y)(3).
1966—Subsec. (v)(1).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2022 Amendment
Amendment by section 4121(a)(1), (2), (b) of
Amendment by section of 4124(a), (b)(1)(B), (2), (4)(A) of
Effective Date of 2020 Amendment
Amendment by section 125(a)(1), (d)(1) of
Secretary of Health and Human Services to prescribe regulations to apply the amendments made by section 3708 of
Amendment by section 3713(a) of
Effective Date of 2018 Amendment
Amendment by section 51006(a)(1) of
Effective Date of 2016 Amendment
Amendment by
Effective Date of 2015 Amendment
Amendment by
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2010 Amendment
Amendment by section 4103(a), (b) of
Amendment by section 4104(a) of
Effective Date of 2008 Amendment
Amendment by section 101(a)(1), (b)(1) of
Amendment by section 125(b)(2) of
Amendment by section 143(a), (b)(5), (6) of
Amendment by section 144(a)(1) of
Amendment by section 152(b)(1)(A), (B) of
Effective Date of 2006 Amendment
Amendment by section 5112(a), (b) of
Amendment by section 5114(a)(1), (b) of
Amendment by section 6001(f)(1) of
Effective Date of 2003 Amendment
Amendment by section 415(b) of
Amendment by section 512(c) of
Amendment by section 611(a), (b), (d)(2) of
Amendment by section 642(a) of
Amendment by section 946(a) of
Effective Date of 2000 Amendment
Amendment by section 1(a)(6) [title I, §103(a)] of
Amendment by section 1(a)(6) [title I, §105(a), (b)] of
Amendment by section 1(a)(6) [title IV, §430(b)] of
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title II, §201(k)] of
Amendment by section 1000(a)(6) [title III, §321(k)(7)–(9)] of
Effective Date of 1997 Amendment
Amendment by section 4102(a), (c) of
Amendment by section 4103(a) of
Amendment by section 4104(a)(1) of
Amendment by section 4105(a)(1), (b)(1) of
Amendment by section 4201(c)(1), (2) of
"(A)
"(B)
"(C)
"(i)
"(ii)
Amendment by section 4312(d), (e) of
Amendment by section 4432(b)(5)(D), (E) of
Amendment by sections 4445 and 4446 of
Amendment by section 4454(a)(1) of
Amendment by section 4511(a)(1)–(2)(B), (d) of
Amendment by section 4512(a) of
Amendment by section 4611(b) of
Effective Date of 1996 Amendment
Amendment by
Effective Date of 1994 Amendment
Amendment by section 145(b) of
Amendment by section 147(e)(1), (4), (5), (f)(3), (4)(A), (6)(A), (B), (E) of
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
Amendment by section 4008(h)(2)(A)(i) of
Amendment by section 4152(a)(2) of
Amendment by section 4155(a), (d) of
Amendment by section 4157(a) of
Amendment by section 4161(a)(1), (2), (5) of
Amendment by section 4162(a) of
Amendment by section 4163(a) of
Effective Date of 1989 Amendment
Amendment by section 6112(e)(1) of
Amendment by section 6113(a)–(b)(2) of
Amendment by section 6114(a), (d) of
Amendment by section 6131(a)(2) of
Amendment by section 101(a) of
Amendment by section 201(a) of
Effective Date of 1988 Amendment
Amendment by
Amendment by section 104(d)(4) of
Amendment by section 202(a) of
Amendment by section 203(b), (e)(1) of
Amendment by section 204(a) of
Amendment by section 205(b) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
"(A) The amendments made by subsection (b) [amending this section and
"(B) The Secretary of Health and Human Services shall implement the amendments made by subsection (b) so as to ensure that there is no additional cost to the medicare program by reason of such amendments."
"(1) The provisions of subsection (e) of section 4072 of this subpart [section 4072(e) of
"(2) In conducting the demonstration project pursuant to paragraph (1), in order to determine the cost effectiveness of including influenza vaccine in the medicare program, the Secretary of Health and Human Services is required to conduct a demonstration of the provision of influenza vaccine as a service for medicare beneficiaries and to expend $25,000,000 each year of the demonstration project for this purpose. In conducting this demonstration, the Secretary is authorized to purchase in bulk influenza vaccine and to distribute it in a manner to make it widely available to medicare beneficiaries, to develop projects to provide vaccine in the same manner as other covered medicare services in large scale demonstration projects, including statewide projects, and to engage in other appropriate use of moneys to provide influenza vaccine to medicare beneficiaries and evaluate the cost effectiveness of its use. In determining cost effectiveness, the Secretary shall consider the direct cost of the vaccine, the utilization of vaccine which might otherwise not have occurred, the costs of illnesses and nursing home days avoided, and other relevant factors, except that extended life for beneficiaries shall not be considered to reduce the cost effectiveness of the vaccine."
"(1) The amendments made by this section [amending this section and
"(2)(A) The Secretary of Health and Human Services (in this paragraph referred to as the 'Secretary'), shall establish a demonstration project to begin on October 1, 1988, to test the cost-effectiveness of furnishing therapeutic shoes under the medicare program to the extent provided under the amendments made by this section to a sample group of medicare beneficiaries.
"(B)(i) The demonstration project under subparagraph (A) shall be conducted for an initial period of 24 months. Not later than October 1, 1990, the Secretary shall report to the Congress on the results of such project. If the Secretary finds, on the basis of existing data, that furnishing therapeutic shoes under the medicare program to the extent provided under the amendments made by this section is cost-effective, the Secretary shall include such finding in such report, such project shall be discontinued, and the amendments made by this section shall become effective on November 1, 1990.
"(ii) If the Secretary determines that such finding cannot be made on the basis of existing data, such project shall continue for an additional 24 months. Not later than April 1, 1993, the Secretary shall submit a final report to the Congress on the results of such project. The amendments made by this section shall become effective on the first day of the first month to begin after such report is submitted to the Congress unless the report contains a finding by the Secretary that furnishing therapeutic shoes under the medicare program to the extent provided under the amendments made by this section is not cost-effective (in which case the amendments made by this section shall not become effective)."
[Amendments by section 4072 of
Amendment by section 4073(a), (c) of
Amendment by section 4077(b)(1), (4) of
Amendment by section 4084(c)(1) of
Amendments by section 4201(a)(1), (b)(1), (d)(1), (2), (5) of
Effective Date of 1986 Amendment
Amendment by section 9320(b), (c), (f) of
Amendment by section 9337(d) of
Amendment by section 9219(b)(1)(B) of
Effective Date of 1984 Amendment
Amendment by
"(1) Clause (i) of section 1861(v)(1)(O) of the Social Security Act [
"(2) Clause (iii) of section 1861(v)(1)(O) of such Act [
Amendment by section 2319(a) of
Amendment by section 2321(e) of
Amendment by section 2323(a) of
Amendment by section 2335(b) of
Amendment by section 2341(a), (c) of
Amendment by section 2342(a) of
Amendment by section 2354(b)(18)–(29) of
Effective Date of 1983 Amendment
Amendment by section 602(d) of
Amendment by
Effective Date of 1982 Amendment
Amendment by section 101(a)(2) of
Amendment by section 109(b)(2) of
Amendment by section 122(d) of
"(1) Any amendment to the Omnibus Budget Reconciliaton [Reconciliation] Act of 1981 [
"(2) Except as otherwise provided in this section, any amendment to the Social Security Act [
"(3) The amendments made by subsection (d) [amending this section and
Amendment by section 148(b) of
Effective Date of 1981 Amendment
Amendment by section 2121(c), (d) of
"(1) Subject to paragraph (2), the amendment made by subsection (a) [amending this section] shall apply to cost reporting periods ending after September 30, 1981.
"(2) In the case of a cost reporting period beginning before October 1, 1981, any reduction in payments resulting from the amendment made by subsection (a) shall be imposed only in proportion to the part of the period that occurs after September 30, 1981."
"(1) Subject to paragraph (2), the amendment made by subsection (a) [amending this section] shall apply to cost reporting periods ending after September 30, 1981.
"(2) In the case of a cost reporting period beginning before October 1, 1981, any reduction in payments resulting from the amendment made by subsection (a) shall be imposed only in proportion to the part of the period that occurs after September 30, 1981."
"(1) Subject to paragraph (2), the amendment made by subsection (a) [amending this section] shall apply to cost reporting periods ending after September 30, 1981.
"(2) In the case of a cost reporting period beginning before October 1, 1981, any reduction in payments resulting from the amendment made by subsection (a) shall be imposed only in proportion to the part of the period that occurs after September 30, 1981."
For effective date, savings, and transitional provisions relating to amendment by section 2193(c)(9) of
Effective Date of 1980 Amendment
Amendment by
"(1) the amendments made by this section [amending this section,
"(2) The Secretary of Health and Human Services shall take administrative action to assure that improvements, in accordance with the amendment made by subsection (n)(1) [amending this section], will be made not later than June 30, 1981."
Amendment by section 931(c), (d) of
Amendment by section 933(c)–(e) of
Amendment by section 936(a) of
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1977 Amendment
Amendment by
Amendment by section 3(a)(2) of
Amendment by section 19(b)(1) of
Effective Date of 1975 Amendment
Effective Date of 1972 Amendment
Amendment by section 211(b), (c)(2) of
"(1) The amendments made by subsection (a) [amending this section and
"(2) The amendments made by subsection (b) [amending this section and
"(3) The amendments made by subsection (c) [amending this section] shall be effective with respect to accounting periods beginning after the month in which there are promulgated, by the Secretary of Health, Education, and Welfare, final regulations implementing the provisions of section 1861(v)(5) of the Social Security Act [
Amendment by section 256(b) of
Amendment by section 283(a) of
Effective Date of 1968 Amendment
Amendment by section 129(a), (b), (c)(9)(C), (10), (11) of
Amendment by section 132(a) of
Amendment by section 133(a), (b) of
Amendment by section 143(a) of
Effective Date of 1966 Amendment
Amendment by
Construction of 2018 Amendment
Construction of 2008 Amendment
For construction of amendment by section 153(b)(3)(B) of
Implementation
Conforming References to Previous Part D
Application of 2003 Amendment to Physician Specialties
Amendment by section 303 of
Notwithstanding section 303(j) of
Frontier Extended Stay Clinic Demonstration Project
"(a)
"(b)
"(1) is located in a community where the closest short-term acute care hospital or critical access hospital is at least 75 miles away from the community or is inaccessible by public road; and
"(2) is designed to address the needs of—
"(A) seriously or critically ill or injured patients who, due to adverse weather conditions or other reasons, cannot be transferred quickly to acute care referral centers; or
"(B) patients who need monitoring and observation for a limited period of time.
"(c)
"(d)
"(1)
"(2)
"(e)
"(f)
"(g)
MedPAC Study of Coverage of Surgical First Assisting Services of Certified Registered Nurse First Assistants
"(a)
"(b)
"(c)
"(1)
"(2)
"(A) is a registered nurse and is licensed to practice nursing in the State in which the surgical first assisting services are performed;
"(B) has completed a minimum of 2,000 hours of first assisting a physician with surgery and related preoperative, intraoperative, and postoperative care; and
"(C) is certified as a registered nurse first assistant by an organization recognized by the Secretary."
Studies Relating to Vision Impairments
"(a)
"(1)
"(2)
"(3)
"(b)
Demonstration of Coverage of Chiropractic Services Under Medicare
"(a)
"(1)
"(A) care for neuromusculoskeletal conditions typical among eligible beneficiaries; and
"(B) diagnostic and other services that a chiropractor is legally authorized to perform by the State or jurisdiction in which such treatment is provided.
"(2)
"(3)
"(4)
"(b)
"(1)
"(2)
"(3)
"(4)
"(c)
"(1)
"(A)
"(B)
"(i) two shall be in rural areas; and
"(ii) two shall be in urban areas.
"(C)
"(2)
"(A)
"(B)
"(d)
"(1)
"(A) to determine whether eligible beneficiaries who use chiropractic services use a lesser overall amount of items and services for which payment is made under the medicare program than eligible beneficiaries who do not use such services;
"(B) to determine the cost of providing payment for chiropractic services under the medicare program;
"(C) to determine the satisfaction of eligible beneficiaries participating in the demonstration projects and the quality of care received by such beneficiaries; and
"(D) to evaluate such other matters as the Secretary determines is appropriate.
"(2)
"(e)
"(f)
"(1)
"(A)
"(B)
"(2)
Demonstration Project To Clarify the Definition of Homebound
"(a)
"(b)
"(1) the beneficiary has been certified by one physician as an individual who has a permanent and severe, disabling condition that is not expected to improve;
"(2) the beneficiary is dependent upon assistance from another individual with at least 3 out of the 5 activities of daily living for the rest of the beneficiary's life;
"(3) the beneficiary requires skilled nursing services for the rest of the beneficiary's life and the skilled nursing is more than medication management;
"(4) an attendant is required to visit the beneficiary on a daily basis to monitor and treat the beneficiary's medical condition or to assist the beneficiary with activities of daily living;
"(5) the beneficiary requires technological assistance or the assistance of another person to leave the home; and
"(6) the beneficiary does not regularly work in a paid position full-time or part-time outside the home.
"(c)
"(d)
"(e)
"(f)
"(1) An examination of whether the provision of home health services to medicare beneficiaries under the project has had any of the following effects:
"(A) Has adversely affected the provision of home health services under the medicare program.
"(B) Has directly caused an increase of expenditures under the medicare program for the provision of such services that is directly attributable to such clarification.
"(2) The specific data evidencing the amount of any increase in expenditures that is directly attributable to the demonstration project (expressed both in absolute dollar terms and as a percentage) above expenditures that would otherwise have been incurred for home health services under the medicare program.
"(3) Specific recommendations to exempt permanently and severely disabled homebound beneficiaries from restrictions on the length, frequency, and purpose of their absences from the home to qualify for home health services without incurring additional costs to the medicare program.
"(g)
"(h)
"(i)
"(j)
"(1)
"(2)
"(3)
Information on Medicare-Certified Skilled Nursing Facilities in Hospital Discharge Plans
Implementation of Amendments by Pub. L. 105–277
"(1)
"(2)
"(A)
"(B)
Study on Expansion of Medical Nutrition Therapy Services Benefit
Study on Medicare Coverage of Routine Thyroid Screening
"(a)
"(b)
GAO Study on Coverage of Surgical First Assisting Services of Certified Registered Nurse First Assistants
"(a)
"(1) Any impact on the quality of care furnished to medicare beneficiaries by reason of such coverage.
"(2) Appropriate education and training requirements for certified registered nurse first assistants who furnish such first assisting services.
"(3) Appropriate rates of payment under the program to such certified registered nurse first assistants for furnishing such services, taking into account the costs of compensation, overhead, and supervision attributable to certified registered nurse first assistants.
"(b)
MedPAC Study and Report on Medicare Coverage of Services Provided by Certain Nonphysician Providers
"(a)
"(1)
"(A) surgical technologist;
"(B) marriage counselor;
"(C) marriage and family therapist;
"(D) pastoral care counselor; and
"(E) licensed professional counselor of mental health.
"(2)
"(b)
Development of Patient Assessment Instruments
"(a)
"(1)
"(2)
"(A) elements that are common to the items and services described in subsection (b) may be readily comparable and are statistically compatible;
"(B) only elements necessary to meet program objectives are collected; and
"(C) the standard instruments supersede any other assessment instrument used before that date.
"(3)
"(b)
"(1) Inpatient and outpatient hospital services.
"(2) Inpatient and outpatient rehabilitation services.
"(3) Covered skilled nursing facility services.
"(4) Home health services.
"(5) Physical or occupational therapy or speech-language pathology services.
"(6) Items and services furnished to such individuals determined to have end stage renal disease.
"(7) Partial hospitalization services and other mental health services.
"(8) Any other service for which payment is made under such title as the Secretary determines to be appropriate."
Conforming References to Previous Part C
Deadline for Publication of Determination on Coverage of Screening Barium Enema
Establishment of Outcome Measures for Beneficiaries With Diabetes
"(1)
"(2)
Vaccines Outreach Expansion
"(a)
"(b)
Study on Preventive and Enhanced Benefits
Utilization Guidelines
Authorizing Payment for Paramedic Intercept Service Providers in Rural Communities
"(1) The ALS intercept services are provided under a contract with one or more volunteer ambulance services and are medically necessary based on the health condition of the individual being transported.
"(2) The volunteer ambulance service involved—
"(A) is certified as qualified to provide ambulance service for purposes of such section,
"(B) provides only basic life support services at the time of the intercept, and
"(C) is prohibited by State law from billing for any services.
"(3) The entity supplying the ALS intercept services—
"(A) is certified as qualified to provide such services under the medicare program under title XVIII of the Social Security Act [
"(B) bills all recipients who receive ALS intercept services from the entity, regardless of whether or not such recipients are medicare beneficiaries.
For purposes of this subsection, an area shall be treated as a rural area if it is designated as a rural area by any law or regulation of the State or if it is located in a rural census tract of a metropolitan statistical area (as determined under the most recent Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725))."
[
No Exceptions Permitted Based on Amendment to Subsection (v)(1)(L)
Study on Definition of Homebound
"(a)
"(b)
Revisions of Coverage for Immunosuppressive Drug Therapy
Freeze in Per Visit Cost Limits for Home Health Services
Study and Report on Effects of Coverage of Osteoporosis Drugs
Productivity Screening Guidelines Application to Staff in Rural Health Clinics
Development of Prospective Payment System for Home Health Services
Application of Budget-Neutral Basis
Transition Provisions for Determining Reasonable Costs for Home Health Agency Services
Permitting Dentist To Serve as Hospital Medical Director
Recognition of Costs of Certain Hospital-Based Nursing Schools
[
Dissemination of Rural Health Clinic Information
Treatment of Certain Facilities as Rural Health Clinics
Continued Use of Home Health Wage Index in Effect Prior to July 1, 1989, Until After July 1, 1991
Payment for Medical Escort or Medical Attendant on Commercial Airliner Allowed
"(a)
"(b)
Skilled Nursing Facility; Access and Visitation Rights
Moratorium on Prior Authorization for Home Health and Post-Hospital Extended Care Services
Delay in Publishing Regulations With Respect To Deeming Status of Entities
"(1) on any date prior to 6 months after the date on which the Secretary has published a proposed rule with respect to the deeming of the entity, and
"(2) until the Secretary publishes a final rule with respect to the deeming of the entity."
Development of Uniform Needs Assessment Instrument
Prior and Concurrent Authorization Demonstration Project
Considerations in Establishing Limits on Payment for Home Health Services
"(1) base such limitations on the most recent data available, which data may be for cost reporting periods beginning no earlier than October 1, 1983; and
"(2) take into account the changes in costs of home health agencies for billing and verification procedures that result from the Secretary's changing the requirements for such procedures, to the extent the changes in costs are not reflected in such data.
Paragraph (2) shall apply to changes in requirements effected before, on, or after July 1, 1986."
Comptroller General Study and Report on Cost Limits for Home Health Services
Reduction in Payment To Avoid Duplicate Payment for Services of Physician Assistants
Study and Report on Payments for Physician Assistants
Cost Limits for Routine Services for Urban and Rural Hospital-Based Skilled Nursing Facilities; Cost Reporting Periods Beginning On or After October 1, 1982, and Prior to July 1, 1984
Study and Report Relating to Requirements That Core Services Be Furnished Directly by Hospices
Report on Effect of 1982 Amendment on Hospital-Based Skilled Nursing Facilities
Elimination of Private Room Subsidy
"(a) The Secretary of Health and Human Services shall, pursuant to section 1861(v)(2) of the Social Security Act [
"(b) The Secretary of Health and Human Services shall first issue such final regulations (whether on an interim or other basis) as may be necessary to implement subsection (a) by October 1, 1982. If such regulations are promulgated on an interim final basis, the Secretary shall take such steps as may be necessary to provide opportunity for public comment, and appropriate revision based thereon, so as to provide that such regulations are not on an interim basis later than January 31, 1983."
Regulations Regarding Access to Books and Records
Compliance With the Life Safety Code or State Fire and Safety Code
Private, Nonprofit Health Care Clinics Qualifying, as of July 1, 1977, as Rural Health Clinics
"(1) on July 1, 1977, was operating and located in an area which on that date (A) was not an urbanized area (as defined by the Bureau of the Census) and (B) had a supply of physicians insufficient to meet the needs of the area (as determined by the Secretary), and
"(2) meets the definition of a rural health clinic under section 1861(aa)(2) [
shall be considered, for the purposes of title XVIII or XIX, respectively, of the Social Security Act [
Promulgation of Regulations Defining Costs Chargeable to Personal Funds of Patients in Skilled Nursing Facilities; Date of Issuance
[
Home Health Services; Grants for Establishment, Operation, Staffing, Etc., of Public and Nonprofit Private Agencies and Entities; Procedures; Payments; Authorization of Appropriations
Payment for Service of Physicians Rendered in a Teaching Hospital for Accounting Periods Beginning After June 30, 1975, and Prior to October 1, 1978; Studies, Reports, etc.; Effective Dates
Physical Therapy Services Requirements; Effective Date Postponement
Payment for Durable Medical Equipment
"(a) The Secretary is authorized to conduct reimbursement experiments designed to eliminate unreasonable expenses resulting from prolonged rentals of durable medical equipment described in section 1861(s)(6) of the Social Security Act [
"(b) Such experiment may be conducted in one or more geographic areas, as the Secretary deems appropriate, and may, pursuant to agreements with suppliers, provide for reimbursement for such equipment on a lump-sum basis whenever it is determined (in accordance with guidelines established by the Secretary) that a lump-sum payment would be more economical than the anticipated period of rental payments. Such experiments may also provide for incentives to beneficiaries (including waiver of the 20 percent coinsurance amount applicable under section 1833 of the Social Security Act [
"(c) The Secretary is authorized, at such time as he deems appropriate, to implement on a nationwide basis any such reimbursement procedures which he finds to be workable, desirable and economical and which are consistent with the purposes of this section."
Executive Documents
Respecting the Rights of Hospital Patients to Receive Visitors and to Designate Surrogate Decision Makers for Medical Emergencies
Memorandum of President of the United States, Apr. 15, 2010, 75 F.R. 20511, provided:
Memorandum for the Secretary of Health and Human Services
There are few moments in our lives that call for greater compassion and companionship than when a loved one is admitted to the hospital. In these hours of need and moments of pain and anxiety, all of us would hope to have a hand to hold, a shoulder on which to lean—a loved one to be there for us, as we would be there for them.
Yet every day, all across America, patients are denied the kindnesses and caring of a loved one at their sides—whether in a sudden medical emergency or a prolonged hospital stay. Often, a widow or widower with no children is denied the support and comfort of a good friend. Members of religious orders are sometimes unable to choose someone other than an immediate family member to visit them and make medical decisions on their behalf. Also uniquely affected are gay and lesbian Americans who are often barred from the bedsides of the partners with whom they may have spent decades of their lives—unable to be there for the person they love, and unable to act as a legal surrogate if their partner is incapacitated.
For all of these Americans, the failure to have their wishes respected concerning who may visit them or make medical decisions on their behalf has real consequences. It means that doctors and nurses do not always have the best information about patients' medications and medical histories and that friends and certain family members are unable to serve as intermediaries to help communicate patients' needs. It means that a stressful and at times terrifying experience for patients is senselessly compounded by indignity and unfairness. And it means that all too often, people are made to suffer or even to pass away alone, denied the comfort of companionship in their final moments while a loved one is left worrying and pacing down the hall.
Many States have taken steps to try to put an end to these problems. North Carolina recently amended its Patients' Bill of Rights to give each patient "the right to designate visitors who shall receive the same visitation privileges as the patient's immediate family members, regardless of whether the visitors are legally related to the patient"—a right that applies in every hospital in the State. Delaware, Nebraska, and Minnesota have adopted similar laws.
My Administration can expand on these important steps to ensure that patients can receive compassionate care and equal treatment during their hospital stays. By this memorandum, I request that you take the following steps:
1. Initiate appropriate rulemaking, pursuant to your authority under
2. Ensure that all hospitals participating in Medicare or Medicaid are in full compliance with regulations, codified at 42 CFR 482.13 and 42 CFR 489.102(a), promulgated to guarantee that all patients' advance directives, such as durable powers of attorney and health care proxies, are respected, and that patients' representatives otherwise have the right to make informed decisions regarding patients' care. Additionally, I request that you issue new guidelines, pursuant to your authority under
3. Provide additional recommendations to me, within 180 days of the date of this memorandum, on actions the Department of Health and Human Services can take to address hospital visitation, medical decisionmaking, or other health care issues that affect LGBT patients and their families.
This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
You are hereby authorized and directed to publish this memorandum in the Federal Register.
Barack Obama.
2 So in original. Probably should be followed by "and".
3 So in original. The word "and" probably should not appear.
4 So in original. Probably should be "have".
5 So in original. Probably should be "regulations".
6 So in original. Probably should be "subclauses."
7 So in original. The word "by" probably should not appear.
8 See References in Text note below.
9 So in original. Probably should be "paragraph (2)(H)(i)".
10 So in original. Probably should be "weight, body mass index,".
11 So in original. Probably should be followed by a semicolon.
§1395y. Exclusions from coverage and medicare as secondary payer
(a) Items or services specifically excluded
Notwithstanding any other provision of this subchapter, no payment may be made under part A or part B for any expenses incurred for items or services—
(1)(A) which, except for items and services described in a succeeding subparagraph or additional preventive services (as described in
(B) in the case of items and services described in
(C) in the case of hospice care, which are not reasonable and necessary for the palliation or management of terminal illness,
(D) in the case of clinical care items and services provided with the concurrence of the Secretary and with respect to research and experimentation conducted by, or under contract with, the Medicare Payment Advisory Commission or the Secretary, which are not reasonable and necessary to carry out the purposes of
(E) in the case of research conducted pursuant to
(F) in the case of screening mammography, which is performed more frequently than is covered under
(G) in the case of prostate cancer screening tests (as defined in
(H) in the case of colorectal cancer screening tests, which are performed more frequently than is covered under
(I) the frequency and duration of home health services which are in excess of normative guidelines that the Secretary shall establish by regulation,
(J) in the case of a drug or biological specified in
(K) in the case of an initial preventive physical examination, which is performed more than 1 year after the date the individual's first coverage period begins under part B,
(L) in the case of cardiovascular screening blood tests (as defined in
(M) in the case of a diabetes screening test (as defined in
(N) in the case of ultrasound screening for abdominal aortic aneurysm which is performed more frequently than is provided for under
(O) in the case of kidney disease education services (as defined in paragraph (1) of
(P) in the case of personalized prevention plan services (as defined in
(2) for which the individual furnished such items or services has no legal obligation to pay, and which no other person (by reason of such individual's membership in a prepayment plan or otherwise) has a legal obligation to provide or pay for, except in the case of Federally qualified health center services;
(3) which are paid for directly or indirectly by a governmental entity (other than under this chapter and other than under a health benefits or insurance plan established for employees of such an entity), except in the case of rural health clinic services, as defined in
(4) which are not provided within the United States (except for inpatient hospital services furnished outside the United States under the conditions described in
(5) which are required as a result of war, or of an act of war, occurring after the effective date of such individual's current coverage under such part;
(6) which constitute personal comfort items (except, in the case of hospice care, as is otherwise permitted under paragraph (1)(C));
(7) where such expenses are for routine physical checkups, eyeglasses (other than eyewear described in
(8) where such expenses are for orthopedic shoes or other supportive devices for the feet, other than shoes furnished pursuant to
(9) where such expenses are for custodial care (except, in the case of hospice care, as is otherwise permitted under paragraph (1)(C));
(10) where such expenses are for cosmetic surgery or are incurred in connection therewith, except as required for the prompt repair of accidental injury or for improvement of the functioning of a malformed body member;
(11) where such expenses constitute charges imposed by immediate relatives of such individual or members of his household;
(12) where such expenses are for services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth, except that payment may be made under part A in the case of inpatient hospital services in connection with the provision of such dental services if the individual, because of his underlying medical condition and clinical status or because of the severity of the dental procedure, requires hospitalization in connection with the provision of such services;
(13) where such expenses are for—
(A) the treatment of flat foot conditions and the prescription of supportive devices therefor,
(B) the treatment of subluxations of the foot, or
(C) routine foot care (including the cutting or removal of corns or calluses, the trimming of nails, and other routine hygienic care);
(14) which are other than physicians' services (as defined in regulations promulgated specifically for purposes of this paragraph), services described by
(15)(A) which are for services of an assistant at surgery in a cataract operation (including subsequent insertion of an intraocular lens) unless, before the surgery is performed, the appropriate quality improvement organization (under part B of subchapter XI) or a carrier under
(B) which are for services of an assistant at surgery to which
(16) in the case in which funds may not be used for such items and services under the Assisted Suicide Funding Restriction Act of 1997 [
(17) where the expenses are for an item or service furnished in a competitive acquisition area (as established by the Secretary under
(18) which are covered skilled nursing facility services described in
(19) which are for items or services which are furnished pursuant to a private contract described in
(20) in the case of outpatient physical therapy services, outpatient speech-language pathology services, or outpatient occupational therapy services furnished as an incident to a physician's professional services (as described in
(21) where such expenses are for home health services (including medical supplies described in
(22) subject to subsection (h), for which a claim is submitted other than in an electronic form specified by the Secretary;
(23) which are the technical component of advanced diagnostic imaging services described in
(24) where such expenses are for renal dialysis services (as defined in subparagraph (B) of
(25) not later than January 1, 2014, for which the payment is other than by electronic funds transfer (EFT) or an electronic remittance in a form as specified in ASC X12 835 Health Care Payment and Remittance Advice or subsequent standard.
Paragraph (7) shall not apply to Federally qualified health center services described in
(b) Medicare as secondary payer
(1) Requirements of group health plans
(A) Working aged under group health plans
(i) In general
A group health plan—
(I) may not take into account that an individual (or the individual's spouse) who is covered under the plan by virtue of the individual's current employment status with an employer is entitled to benefits under this subchapter under
(II) shall provide that any individual age 65 or older (and the spouse age 65 or older of any individual) who has current employment status with an employer shall be entitled to the same benefits under the plan under the same conditions as any such individual (or spouse) under age 65.
(ii) Exclusion of group health plan of a small employer
Clause (i) shall not apply to a group health plan unless the plan is a plan of, or contributed to by, an employer that has 20 or more employees for each working day in each of 20 or more calendar weeks in the current calendar year or the preceding calendar year.
(iii) Exception for small employers in multiemployer or multiple employer group health plans
Clause (i) also shall not apply with respect to individuals enrolled in a multiemployer or multiple employer group health plan if the coverage of the individuals under the plan is by virtue of current employment status with an employer that does not have 20 or more individuals in current employment status for each working day in each of 20 or more calendar weeks in the current calendar year and the preceding calendar year; except that the exception provided in this clause shall only apply if the plan elects treatment under this clause.
(iv) Exception for individuals with end stage renal disease
Subparagraph (C) shall apply instead of clause (i) to an item or service furnished in a month to an individual if for the month the individual is, or (without regard to entitlement under
(v) "Group health plan" defined
In this subparagraph, and subparagraph (C), the term "group health plan" has the meaning given such term in section 5000(b)(1) of the Internal Revenue Code of 1986, without regard to section 5000(d) of such Code.
(B) Disabled individuals in large group health plans
(i) In general
A large group health plan (as defined in clause (iii)) may not take into account that an individual (or a member of the individual's family) who is covered under the plan by virtue of the individual's current employment status with an employer is entitled to benefits under this subchapter under
(ii) Exception for individuals with end stage renal disease
Subparagraph (C) shall apply instead of clause (i) to an item or service furnished in a month to an individual if for the month the individual is, or (without regard to entitlement under
(iii) "Large group health plan" defined
In this subparagraph, the term "large group health plan" has the meaning given such term in section 5000(b)(2) of the Internal Revenue Code of 1986, without regard to section 5000(d) of such Code.
(C) Individuals with end stage renal disease
A group health plan (as defined in subparagraph (A)(v))—
(i) may not take into account that an individual is entitled to or eligible for benefits under this subchapter under
(ii) may not differentiate in the benefits it provides between individuals having end stage renal disease and other individuals covered by such plan on the basis of the existence of end stage renal disease, the need for renal dialysis, or in any other manner;
except that clause (ii) shall not prohibit a plan from paying benefits secondary to this subchapter when an individual is entitled to or eligible for benefits under this subchapter under
(D) Treatment of certain members of religious orders
In this subsection, an individual shall not be considered to be employed, or an employee, with respect to the performance of services as a member of a religious order which are considered employment only by virtue of an election made by the religious order under section 3121(r) of the Internal Revenue Code of 1986.
(E) General provisions
For purposes of this subsection:
(i) Aggregation rules
(I) All employers treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 shall be treated as a single employer.
(II) All employees of the members of an affiliated service group (as defined in section 414(m) of such Code) shall be treated as employed by a single employer.
(III) Leased employees (as defined in section 414(n)(2) of such Code) shall be treated as employees of the person for whom they perform services to the extent they are so treated under section 414(n) of such Code.
In applying sections of the Internal Revenue Code of 1986 under this clause, the Secretary shall rely upon regulations and decisions of the Secretary of the Treasury respecting such sections.
(ii) "Current employment status" defined
An individual has "current employment status" with an employer if the individual is an employee, is the employer, or is associated with the employer in a business relationship.
(iii) Treatment of self-employed persons as employers
The term "employer" includes a self-employed person.
(iv) Application to certain Postal Service annuitants or family members
Nothing in this paragraph shall prohibit a group health plan from determining an individual's eligibility to enroll in a health benefits plan offered under the Postal Service Health Benefits Program under
(F) Limitation on beneficiary liability
An individual who is entitled to benefits under this subchapter and is furnished an item or service for which such benefits are incorrectly paid is not liable for repayment of such benefits under this paragraph unless payment of such benefits was made to the individual.
(2) Medicare secondary payer
(A) In general
Payment under this subchapter may not be made, except as provided in subparagraph (B), with respect to any item or service to the extent that—
(i) payment has been made, or can reasonably be expected to be made, with respect to the item or service as required under paragraph (1), or
(ii) payment has been made 3 or can reasonably be expected to be made 3 under a workmen's compensation law or plan of the United States or a State or under an automobile or liability insurance policy or plan (including a self-insured plan) or under no fault insurance.
In this subsection, the term "primary plan" means a group health plan or large group health plan, to the extent that clause (i) applies, and a workmen's compensation law or plan, an automobile or liability insurance policy or plan (including a self-insured plan) or no fault insurance, to the extent that clause (ii) applies. An entity that engages in a business, trade, or profession shall be deemed to have a self-insured plan if it carries its own risk (whether by a failure to obtain insurance, or otherwise) in whole or in part.
(B) Conditional payment
(i) Authority to make conditional payment
The Secretary may make payment under this subchapter with respect to an item or service if a primary plan described in subparagraph (A)(ii) 4 has not made or cannot reasonably be expected to make payment with respect to such item or service promptly (as determined in accordance with regulations). Any such payment by the Secretary shall be conditioned on reimbursement to the appropriate Trust Fund in accordance with the succeeding provisions of this subsection.
(ii) Repayment required
Subject to paragraph (9), a primary plan, and an entity that receives payment from a primary plan, shall reimburse the appropriate Trust Fund for any payment made by the Secretary under this subchapter with respect to an item or service if it is demonstrated that such primary plan has or had a responsibility to make payment with respect to such item or service. A primary plan's responsibility for such payment may be demonstrated by a judgment, a payment conditioned upon the recipient's compromise, waiver, or release (whether or not there is a determination or admission of liability) of payment for items or services included in a claim against the primary plan or the primary plan's insured, or by other means. If reimbursement is not made to the appropriate Trust Fund before the expiration of the 60-day period that begins on the date notice of, or information related to, a primary plan's responsibility for such payment or other information is received, the Secretary may charge interest (beginning with the date on which the notice or other information is received) on the amount of the reimbursement until reimbursement is made (at a rate determined by the Secretary in accordance with regulations of the Secretary of the Treasury applicable to charges for late payments).
(iii) Action by United States
In order to recover payment made under this subchapter for an item or service, the United States may bring an action against any or all entities that are or were required or responsible (directly, as an insurer or self-insurer, as a third-party administrator, as an employer that sponsors or contributes to a group health plan, or large group health plan, or otherwise) to make payment with respect to the same item or service (or any portion thereof) under a primary plan. The United States may, in accordance with paragraph (3)(A) collect double damages against any such entity. In addition, the United States may recover under this clause from any entity that has received payment from a primary plan or from the proceeds of a primary plan's payment to any entity. The United States may not recover from a third-party administrator under this clause in cases where the third-party administrator would not be able to recover the amount at issue from the employer or group health plan and is not employed by or under contract with the employer or group health plan at the time the action for recovery is initiated by the United States or for whom it provides administrative services due to the insolvency or bankruptcy of the employer or plan. An action may not be brought by the United States under this clause with respect to payment owed unless the complaint is filed not later than 3 years after the date of the receipt of notice of a settlement, judgment, award, or other payment made pursuant to paragraph (8) relating to such payment owed.
(iv) Subrogation rights
The United States shall be subrogated (to the extent of payment made under this subchapter for such an item or service) to any right under this subsection of an individual or any other entity to payment with respect to such item or service under a primary plan.
(v) Waiver of rights
The Secretary may waive (in whole or in part) the provisions of this subparagraph in the case of an individual claim if the Secretary determines that the waiver is in the best interests of the program established under this subchapter.
(vi) Claims-filing period
Notwithstanding any other time limits that may exist for filing a claim under an employer group health plan, the United States may seek to recover conditional payments in accordance with this subparagraph where the request for payment is submitted to the entity required or responsible under this subsection to pay with respect to the item or service (or any portion thereof) under a primary plan within the 3-year period beginning on the date on which the item or service was furnished.
(vii) Use of website to determine final conditional reimbursement amount
(I) Notice to Secretary of expected date of a settlement, judgment, etc.
In the case of a payment made by the Secretary pursuant to clause (i) for items and services provided to the claimant, the claimant or applicable plan (as defined in paragraph (8)(F)) may at any time beginning 120 days before the reasonably expected date of a settlement, judgment, award, or other payment, notify the Secretary that a payment is reasonably expected and the expected date of such payment.
(II) Secretarial providing access to claims information through a website
The Secretary shall maintain and make available to individuals to whom items and services are furnished under this subchapter (and to authorized family or other representatives recognized under regulations and to an applicable plan which has obtained the consent of the individual) access to information on the claims for such items and services (including payment amounts for such claims), including those claims that relate to a potential settlement, judgment, award, or other payment. Such access shall be provided to an individual, representative, or plan through a website that requires a password to gain access to the information. The Secretary shall update the information on claims and payments on such website in as timely a manner as possible but not later than 15 days after the date that payment is made. Information related to claims and payments subject to the notice under subclause (I) shall be maintained and made available consistent with the following:
(aa) The information shall be as complete as possible and shall include provider or supplier name, diagnosis codes (if any), dates of service, and conditional payment amounts.
(bb) The information accurately identifies those claims and payments that are related to a potential settlement, judgment, award, or other payment to which the provisions of this subsection apply.
(cc) The website provides a method for the receipt of secure electronic communications with the individual, representative, or plan involved.
(dd) The website provides that information is transmitted from the website in a form that includes an official time and date that the information is transmitted.
(ee) The website shall permit the individual, representative, or plan to download a statement of reimbursement amounts (in this clause referred to as a "statement of reimbursement amount") on payments for claims under this subchapter relating to a potential settlement, judgment, award, or other payment.
(III) Use of timely web download as basis for final conditional amount
If an individual (or other claimant or applicable plan with the consent of the individual) obtains a statement of reimbursement amount from the website during the protected period as defined in subclause (V) and the related settlement, judgment, award or other payment is made during such period, then the last statement of reimbursement amount that is downloaded during such period and within 3 business days before the date of the settlement, judgment, award, or other payment shall constitute the final conditional amount subject to recovery under clause (ii) related to such settlement, judgment, award, or other payment.
(IV) Resolution of discrepancies
If the individual (or authorized representative) believes there is a discrepancy with the statement of reimbursement amount, the Secretary shall provide a timely process to resolve the discrepancy. Under such process the individual (or representative) must provide documentation explaining the discrepancy and a proposal to resolve such discrepancy. Within 11 business days after the date of receipt of such documentation, the Secretary shall determine whether there is a reasonable basis to include or remove claims on the statement of reimbursement. If the Secretary does not make such determination within the 11 business-day period, then the proposal to resolve the discrepancy shall be accepted. If the Secretary determines within such period that there is not a reasonable basis to include or remove claims on the statement of reimbursement, the proposal shall be rejected. If the Secretary determines within such period that there is a reasonable basis to conclude there is a discrepancy, the Secretary must respond in a timely manner by agreeing to the proposal to resolve the discrepancy or by providing documentation showing with good cause why the Secretary is not agreeing to such proposal and establishing an alternate discrepancy resolution. In no case shall the process under this subclause be treated as an appeals process or as establishing a right of appeal for a statement of reimbursement amount and there shall be no administrative or judicial review of the Secretary's determinations under this subclause.
(V) Protected period
In subclause (III), the term "protected period" means, with respect to a settlement, judgment, award or other payment relating to an injury or incident, the portion (if any) of the period beginning on the date of notice under subclause (I) with respect to such settlement, judgment, award, or other payment that is after the end of a Secretarial response period beginning on the date of such notice to the Secretary. Such Secretarial response period shall be a period of 65 days, except that such period may be extended by the Secretary for a period of an additional 30 days if the Secretary determines that additional time is required to address claims for which payment has been made. Such Secretarial response period shall be extended and shall not include any days for any part of which the Secretary determines (in accordance with regulations) that there was a failure in the claims and payment posting system and the failure was justified due to exceptional circumstances (as defined in such regulations). Such regulations shall define exceptional circumstances in a manner so that not more than 1 percent of the repayment obligations under this subclause would qualify as exceptional circumstances.
(VI) Effective date
The Secretary shall promulgate final regulations to carry out this clause not later than 9 months after January 10, 2013.
(VII) Website including successor technology
In this clause, the term "website" includes any successor technology.
(viii) Right of appeal for secondary payer determinations relating to liability insurance (including self-insurance), no fault insurance, and workers' compensation laws and plans
The Secretary shall promulgate regulations establishing a right of appeal and appeals process, with respect to any determination under this subsection for a payment made under this subchapter for an item or service for which the Secretary is seeking to recover conditional payments from an applicable plan (as defined in paragraph (8)(F)) that is a primary plan under subsection (A)(ii),5 under which the applicable plan involved, or an attorney, agent, or third party administrator on behalf of such plan, may appeal such determination. The individual furnished such an item or service shall be notified of the plan's intent to appeal such determination6
(C) Treatment of questionnaires
The Secretary may not fail to make payment under subparagraph (A) solely on the ground that an individual failed to complete a questionnaire concerning the existence of a primary plan.
(3) Enforcement
(A) Private cause of action
There is established a private cause of action for damages (which shall be in an amount double the amount otherwise provided) in the case of a primary plan which fails to provide for primary payment (or appropriate reimbursement) in accordance with paragraphs (1) and (2)(A).
(B) Reference to excise tax with respect to nonconforming group health plans
For provision imposing an excise tax with respect to nonconforming group health plans, see section 5000 of the Internal Revenue Code of 1986.
(C) Prohibition of financial incentives not to enroll in a group health plan or a large group health plan
It is unlawful for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits under this subchapter not to enroll (or to terminate enrollment) under a group health plan or a large group health plan which would (in the case of such enrollment) be a primary plan (as defined in paragraph (2)(A)). Any entity that violates the previous sentence is subject to a civil money penalty of not to exceed $5,000 for each such violation. The provisions of
(4) Coordination of benefits
Where payment for an item or service by a primary plan is less than the amount of the charge for such item or service and is not payment in full, payment may be made under this subchapter (without regard to deductibles and coinsurance under this subchapter) for the remainder of such charge, but—
(A) payment under this subchapter may not exceed an amount which would be payable under this subchapter for such item or service if paragraph (2)(A) did not apply; and
(B) payment under this subchapter, when combined with the amount payable under the primary plan, may not exceed—
(i) in the case of an item or service payment for which is determined under this subchapter on the basis of reasonable cost (or other cost-related basis) or under
(ii) in the case of an item or service for which payment is authorized under this subchapter on another basis—
(I) the amount which would be payable under the primary plan (without regard to deductibles and coinsurance under such plan), or
(II) the reasonable charge or other amount which would be payable under this subchapter (without regard to deductibles and coinsurance under this subchapter),
whichever is greater.
(5) Identification of secondary payer situations
(A) Requesting matching information
(i) Commissioner of Social Security
The Commissioner of Social Security shall, not less often than annually, transmit to the Secretary of the Treasury a list of the names and TINs of medicare beneficiaries (as defined in section 6103(l)(12) of the Internal Revenue Code of 1986) and request that the Secretary disclose to the Commissioner the information described in subparagraph (A) of such section.
(ii) Administrator
The Administrator of the Centers for Medicare & Medicaid Services shall request, not less often than annually, the Commissioner of the Social Security Administration to disclose to the Administrator the information described in subparagraph (B) of section 6103(l)(12) of the Internal Revenue Code of 1986.
(B) Disclosure to fiscal intermediaries and carriers
In addition to any other information provided under this subchapter to fiscal intermediaries and carriers, the Administrator shall disclose to such intermediaries and carriers (or to such a single intermediary or carrier as the Secretary may designate) the information received under subparagraph (A) for purposes of carrying out this subsection.
(C) Contacting employers
(i) In general
With respect to each individual (in this subparagraph referred to as an "employee") who was furnished a written statement under section 6051 of the Internal Revenue Code of 1986 by a qualified employer (as defined in section 6103(l)(12)(E)(iii) of such Code), as disclosed under subparagraph (B), the appropriate fiscal intermediary or carrier shall contact the employer in order to determine during what period the employee or employee's spouse may be (or have been) covered under a group health plan of the employer and the nature of the coverage that is or was provided under the plan (including the name, address, and identifying number of the plan).
(ii) Employer response
Within 30 days of the date of receipt of the inquiry, the employer shall notify the intermediary or carrier making the inquiry as to the determinations described in clause (i). An employer (other than a Federal or other governmental entity) who willfully or repeatedly fails to provide timely and accurate notice in accordance with the previous sentence shall be subject to a civil money penalty of not to exceed $1,000 for each individual with respect to which such an inquiry is made. The provisions of
(D) Obtaining information from beneficiaries
Before an individual applies for benefits under part A or enrolls under part B, the Administrator shall mail the individual a questionnaire to obtain information on whether the individual is covered under a primary plan and the nature of the coverage provided under the plan, including the name, address, and identifying number of the plan.
(E) End date
The provisions of this paragraph shall not apply to information required to be provided on or after July 1, 2016.
(6) Screening requirements for providers and suppliers
(A) In general
Notwithstanding any other provision of this subchapter, no payment may be made for any item or service furnished under part B unless the entity furnishing such item or service completes (to the best of its knowledge and on the basis of information obtained from the individual to whom the item or service is furnished) the portion of the claim form relating to the availability of other health benefit plans.
(B) Penalties
An entity that knowingly, willfully, and repeatedly fails to complete a claim form in accordance with subparagraph (A) or provides inaccurate information relating to the availability of other health benefit plans on a claim form under such subparagraph shall be subject to a civil money penalty of not to exceed $2,000 for each such incident. The provisions of
(7) Required submission of information by group health plans
(A) Requirement
On and after the first day of the first calendar quarter beginning after the date that is 1 year after December 29, 2007, an entity serving as an insurer or third party administrator for a group health plan, as defined in paragraph (1)(A)(v), and, in the case of a group health plan that is self-insured and self-administered, a plan administrator or fiduciary, shall—
(i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been—
(I) a primary plan to the program under this subchapter; or
(II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and
(ii) submit such information to the Secretary in a form and manner (including frequency) specified by the Secretary.
(B) Enforcement
(i) In general
An entity, a plan administrator, or a fiduciary described in subparagraph (A) that fails to comply with the requirements under such subparagraph shall be subject to a civil money penalty of $1,000 for each day of noncompliance for each individual for which the information under such subparagraph should have been submitted. The provisions of subsections (e) and (k) of
(ii) Deposit of amounts collected
Any amounts collected pursuant to clause (i) shall be deposited in the Federal Hospital Insurance Trust Fund under
(C) Sharing of information
Notwithstanding any other provision of law, under terms and conditions established by the Secretary, the Secretary—
(i) shall share information on entitlement under part A and enrollment under part B under this subchapter with entities, plan administrators, and fiduciaries described in subparagraph (A);
(ii) may share the entitlement and enrollment information described in clause (i) with entities and persons not described in such clause; and
(iii) may share information collected under this paragraph as necessary for purposes of the proper coordination of benefits.
(D) Implementation
Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.
(8) Required submission of information by or on behalf of liability insurance (including self-insurance), no fault insurance, and workers' compensation laws and plans
(A) Requirement
On and after the first day of the first calendar quarter beginning after the date that is 18 months after December 29, 2007, an applicable plan shall—
(i) determine whether a claimant (including an individual whose claim is unresolved) is entitled to benefits under the program under this subchapter on any basis; and
(ii) if the claimant is determined to be so entitled, submit the information described in subparagraph (B) with respect to the claimant to the Secretary in a form and manner (including frequency) specified by the Secretary.
(B) Required information
The information described in this subparagraph is—
(i) the identity of the claimant for which the determination under subparagraph (A) was made; and
(ii) such other information as the Secretary shall specify in order to enable the Secretary to make an appropriate determination concerning coordination of benefits, including any applicable recovery claim.
Not later than 18 months after January 10, 2013, the Secretary shall modify the reporting requirements under this paragraph so that an applicable plan in complying with such requirements is permitted but not required to access or report to the Secretary beneficiary social security account numbers or health identification claim numbers, except that the deadline for such modification shall be extended by one or more periods (specified by the Secretary) of up to 1 year each if the Secretary notifies the committees of jurisdiction of the House of Representatives and of the Senate that the prior deadline for such modification, without such extension, threatens patient privacy or the integrity of the secondary payer program under this subsection. Any such deadline extension notice shall include information on the progress being made in implementing such modification and the anticipated implementation date for such modification.
(C) Timing
Information shall be submitted under subparagraph (A)(ii) within a time specified by the Secretary after the claim is resolved through a settlement, judgment, award, or other payment (regardless of whether or not there is a determination or admission of liability).
(D) Claimant
For purposes of subparagraph (A), the term "claimant" includes—
(i) an individual filing a claim directly against the applicable plan; and
(ii) an individual filing a claim against an individual or entity insured or covered by the applicable plan.
(E) Enforcement
(i) In general
An applicable plan that fails to comply with the requirements under subparagraph (A) with respect to any claimant may be subject to a civil money penalty of up to $1,000 for each day of noncompliance with respect to each claimant. The provisions of subsections (e) and (k) of
(ii) Deposit of amounts collected
Any amounts collected pursuant to clause (i) shall be deposited in the Federal Hospital Insurance Trust Fund.
(F) Applicable plan
In this paragraph, the term "applicable plan" means the following laws, plans, or other arrangements, including the fiduciary or administrator for such law, plan, or arrangement:
(i) Liability insurance (including self-insurance).
(ii) No fault insurance.
(iii) Workers' compensation laws or plans.
(G) Sharing of information
(i) In general
The Secretary may share information collected under this paragraph as necessary for purposes of the proper coordination of benefits.
(ii) Specified information
In responding to any query made on or after the date that is 1 year after December 11, 2020, from an applicable plan related to a determination described in subparagraph (A)(i), the Secretary, notwithstanding any other provision of law, shall provide to such applicable plan—
(I) whether a claimant subject to the query is, or during the preceding 3-year period has been, entitled to benefits under the program under this subchapter on any basis; and
(II) to the extent applicable, the plan name and address of any Medicare Advantage plan under part C and any prescription drug plan under part D in which the claimant is enrolled or has been enrolled during such period.
(H) Implementation
Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.
(I) Regulations
Not later than 60 days after January 10, 2013, the Secretary shall publish a notice in the Federal Register soliciting proposals, which will be accepted during a 60-day period, for the specification of practices for which sanctions will and will not be imposed under subparagraph (E), including not imposing sanctions for good faith efforts to identify a beneficiary pursuant to this paragraph under an applicable entity responsible for reporting information. After considering the proposals so submitted, the Secretary, in consultation with the Attorney General, shall publish in the Federal Register, including a 60-day period for comment, proposed specified practices for which such sanctions will and will not be imposed. After considering any public comments received during such period, the Secretary shall issue final rules specifying such practices.
(9) Exception
(A) In general
Clause (ii) of paragraph (2)(B) and any reporting required by paragraph (8) shall not apply with respect to any settlement, judgment, award, or other payment by an applicable plan arising from liability insurance (including self-insurance) and from alleged physical trauma-based incidents (excluding alleged ingestion, implantation, or exposure cases) constituting a total payment obligation to a claimant of not more than the single threshold amount calculated by the Secretary under subparagraph (B) for the year involved.
(B) Annual computation of threshold
(i) In general
Not later than November 15 before each year, the Secretary shall calculate and publish a single threshold amount for settlements, judgments, awards, or other payments for obligations arising from liability insurance (including self-insurance) and for alleged physical trauma-based incidents (excluding alleged ingestion, implantation, or exposure cases) subject to this section for that year. The annual single threshold amount for a year shall be set such that the estimated average amount to be credited to the Medicare trust funds of collections of conditional payments from such settlements, judgments, awards, or other payments arising from liability insurance (including self-insurance) and for such alleged incidents subject to this section shall equal the estimated cost of collection incurred by the United States (including payments made to contractors) for a conditional payment arising from liability insurance (including self-insurance) and for such alleged incidents subject to this section for the year. At the time of calculating, but before publishing, the single threshold amount for 2014, the Secretary shall inform, and seek review of, the Comptroller General of the United States with regard to such amount.
(ii) Publication
The Secretary shall include, as part of such publication for a year—
(I) the estimated cost of collection incurred by the United States (including payments made to contractors) for a conditional payment arising from liability insurance (including self-insurance) and for such alleged incidents; and
(II) a summary of the methodology and data used by the Secretary in computing such threshold amount and such cost of collection.
(C) Exclusion of ongoing expenses
For purposes of this paragraph and with respect to a settlement, judgment, award, or other payment not otherwise addressed in clause (ii) of paragraph (2)(B) that includes ongoing responsibility for medical payments (excluding settlements, judgments, awards, or other payments made by a workers' compensation law or plan or no fault insurance), the amount utilized for calculation of the threshold described in subparagraph (A) shall include only the cumulative value of the medical payments made under this subchapter.
(D) Report to Congress
Not later than November 15 before each year, the Secretary shall submit to the Congress a report on the single threshold amount for settlements, judgments, awards, or other payments for conditional payment obligations arising from liability insurance (including self-insurance) and alleged incidents described in subparagraph (A) for that year and on the establishment and application of similar thresholds for such payments for conditional payment obligations arising from worker compensation cases and from no fault insurance cases subject to this section for the year. For each such report, the Secretary shall—
(i) calculate the threshold amount by using the methodology applicable to certain liability claims described in subparagraph (B); and
(ii) include a summary of the methodology and data used in calculating each threshold amount and the amount of estimated savings under this subchapter achieved by the Secretary implementing each such threshold.
(c) Drug products
No payment may be made under part B for any expenses incurred for—
(1) a drug product—
(A) which is described in section 107(c)(3) of the Drug Amendments of 1962,
(B) which may be dispensed only upon prescription,
(C) for which the Secretary has issued a notice of an opportunity for a hearing under subsection (e) of
(D) for which the Secretary has not determined there is a compelling justification for its medical need; and
(2) any other drug product—
(A) which is identical, related, or similar (as determined in accordance with section 310.6 of title 21 of the Code of Federal Regulations) to a drug product described in paragraph (1), and
(B) for which the Secretary has not determined there is a compelling justification for its medical need,
until such time as the Secretary withdraws such proposed order.
(d) Items or services provided for emergency medical conditions
For purposes of subsection (a)(1)(A), in the case of any item or service that is required to be provided pursuant to
(e) Item or service by excluded individual or entity or at direction of excluded physician; limitation of liability of beneficiaries with respect to services furnished by excluded individuals and entities
(1) No payment may be made under this subchapter with respect to any item or service (other than an emergency item or service, not including items or services furnished in an emergency room of a hospital) furnished—
(A) by an individual or entity during the period when such individual or entity is excluded pursuant to
(B) at the medical direction or on the prescription of a physician during the period when he is excluded pursuant to
(2) Where an individual eligible for benefits under this subchapter submits a claim for payment for items or services furnished by an individual or entity excluded from participation in the programs under this subchapter, pursuant to section 1320a–7, 1320a–7a, 1320c–5, 1320c–9 (as in effect on September 2, 1982), 1395u(j)(2), 1395y(d) (as in effect on August 18, 1987), or 1395cc of this title, and such beneficiary did not know or have reason to know that such individual or entity was so excluded, then, to the extent permitted by this subchapter, and notwithstanding such exclusion, payment shall be made for such items or services. In each such case the Secretary shall notify the beneficiary of the exclusion of the individual or entity furnishing the items or services. Payment shall not be made for items or services furnished by an excluded individual or entity to a beneficiary after a reasonable time (as determined by the Secretary in regulations) after the Secretary has notified the beneficiary of the exclusion of that individual or entity.
(f) Utilization guidelines for provision of home health services
The Secretary shall establish utilization guidelines for the determination of whether or not payment may be made, consistent with paragraph (1)(A) of subsection (a), under part A or part B for expenses incurred with respect to the provision of home health services, and shall provide for the implementation of such guidelines through a process of selective postpayment coverage review by intermediaries or otherwise.
(g) Contracts with quality improvement organizations
(1) The Secretary shall, in making the determinations under paragraphs (1) and (9) of subsection (a), and for the purposes of promoting the effective, efficient, and economical delivery of health care services, and of promoting the quality of services of the type for which payment may be made under this subchapter, enter into contracts with quality improvement organizations pursuant to part B of subchapter XI of this chapter.
(2) In addition to any funds otherwise available, there are appropriated to the Secretary, out of any monies in the Treasury not otherwise obligated, $200,000,000, to remain available until expended, for purposes of requiring multiple organizations described in paragraph (1) to provide to skilled nursing facilities (as defined in
(h) Waiver of electronic form requirement
(1) The Secretary—
(A) shall waive the application of subsection (a)(22) in cases in which—
(i) there is no method available for the submission of claims in an electronic form; or
(ii) the entity submitting the claim is a small provider of services or supplier; and
(B) may waive the application of such subsection in such unusual cases as the Secretary finds appropriate.
(2) For purposes of this subsection, the term "small provider of services or supplier" means—
(A) a provider of services with fewer than 25 full-time equivalent employees; or
(B) a physician, practitioner, facility, or supplier (other than provider of services) with fewer than 10 full-time equivalent employees.
(i) Awards and contracts for original research and experimentation of new and existing medical procedures; conditions
In order to supplement the activities of the Medicare Payment Advisory Commission under
(1) such procedure is not of sufficient commercial value to justify research and experimentation by a commercial organization;
(2) research and experimentation with respect to such procedure is not of a type that may appropriately be carried out by an institute, division, or bureau of the National Institutes of Health; and
(3) such procedure has the potential to be more cost-effective in the treatment of a condition than procedures currently in use with respect to such condition.
(j) Nonvoting members and experts
(1) Any advisory committee appointed to advise the Secretary on matters relating to the interpretation, application, or implementation of subsection (a)(1) shall assure the full participation of a nonvoting member in the deliberations of the advisory committee, and shall provide such nonvoting member access to all information and data made available to voting members of the advisory committee, other than information that—
(A) is exempt from disclosure pursuant to subsection (a) of
(B) the Secretary determines would present a conflict of interest relating to such nonvoting member.
(2) If an advisory committee described in paragraph (1) organizes into panels of experts according to types of items or services considered by the advisory committee, any such panel of experts may report any recommendation with respect to such items or services directly to the Secretary without the prior approval of the advisory committee or an executive committee thereof.
(k) Dental benefits under group health plans
(1) Subject to paragraph (2), a group health plan (as defined in subsection (a)(1)(A)(v)) 7 providing supplemental or secondary coverage to individuals also entitled to services under this subchapter shall not require a medicare claims determination under this subchapter for dental benefits specifically excluded under subsection (a)(12) as a condition of making a claims determination for such benefits under the group health plan.
(2) A group health plan may require a claims determination under this subchapter in cases involving or appearing to involve inpatient dental hospital services or dental services expressly covered under this subchapter pursuant to actions taken by the Secretary.
(l) National and local coverage determination process
(1) Factors and evidence used in making national coverage determinations
The Secretary shall make available to the public the factors considered in making national coverage determinations of whether an item or service is reasonable and necessary. The Secretary shall develop guidance documents to carry out this paragraph in a manner similar to the development of guidance documents under
(2) Timeframe for decisions on requests for national coverage determinations
In the case of a request for a national coverage determination that—
(A) does not require a technology assessment from an outside entity or deliberation from the Medicare Coverage Advisory Committee, the decision on the request shall be made not later than 6 months after the date of the request; or
(B) requires such an assessment or deliberation and in which a clinical trial is not requested, the decision on the request shall be made not later than 9 months after the date of the request.
(3) Process for public comment in national coverage determinations
(A) Period for proposed decision
Not later than the end of the 6-month period (or 9-month period for requests described in paragraph (2)(B)) that begins on the date a request for a national coverage determination is made, the Secretary shall make a draft of proposed decision on the request available to the public through the Internet website of the Centers for Medicare & Medicaid Services or other appropriate means.
(B) 30-day period for public comment
Beginning on the date the Secretary makes a draft of the proposed decision available under subparagraph (A), the Secretary shall provide a 30-day period for public comment on such draft.
(C) 60-day period for final decision
Not later than 60 days after the conclusion of the 30-day period referred to under subparagraph (B), the Secretary shall—
(i) make a final decision on the request;
(ii) include in such final decision summaries of the public comments received and responses to such comments;
(iii) make available to the public the clinical evidence and other data used in making such a decision when the decision differs from the recommendations of the Medicare Coverage Advisory Committee; and
(iv) in the case of a final decision under clause (i) to grant the request for the national coverage determination, the Secretary shall assign a temporary or permanent code (whether existing or unclassified) and implement the coding change.
(4) Consultation with outside experts in certain national coverage determinations
With respect to a request for a national coverage determination for which there is not a review by the Medicare Coverage Advisory Committee, the Secretary shall consult with appropriate outside clinical experts.
(5) Local coverage determination process
(A) Plan to promote consistency of coverage determinations
The Secretary shall develop a plan to evaluate new local coverage determinations to determine which determinations should be adopted nationally and to what extent greater consistency can be achieved among local coverage determinations.
(B) Consultation
The Secretary shall require the fiscal intermediaries or carriers providing services within the same area to consult on all new local coverage determinations within the area.
(C) Dissemination of information
The Secretary should serve as a center to disseminate information on local coverage determinations among fiscal intermediaries and carriers to reduce duplication of effort.
(D) Local coverage determinations
The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to make available on the Internet website of such contractor and on the Medicare Internet website, at least 45 days before the effective date of such determination, the following information:
(i) Such determination in its entirety.
(ii) Where and when the proposed determination was first made public.
(iii) Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.
(iv) A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence.
(v) An explanation of the rationale that supports such determination.
(6) National and local coverage determination defined
For purposes of this subsection—
(A) National coverage determination
The term "national coverage determination" means a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this subchapter.
(B) Local coverage determination
The term "local coverage determination" has the meaning given that in
(m) Coverage of routine costs associated with certain clinical trials of category A devices
(1) In general
In the case of an individual entitled to benefits under part A, or enrolled under part B, or both who participates in a category A clinical trial, the Secretary shall not exclude under subsection (a)(1) payment for coverage of routine costs of care (as defined by the Secretary) furnished to such individual in the trial.
(2) Category A clinical trial
For purposes of paragraph (1), a "category A clinical trial" means a trial of a medical device if—
(A) the trial is of an experimental/investigational (category A) medical device (as defined in regulations under section 405.201(b) of title 42, Code of Federal Regulations (as in effect as of September 1, 2003));
(B) the trial meets criteria established by the Secretary to ensure that the trial conforms to appropriate scientific and ethical standards; and
(C) in the case of a trial initiated before January 1, 2010, the device involved in the trial has been determined by the Secretary to be intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.
(n) Requirement of a surety bond for certain providers of services and suppliers
(1) In general
The Secretary may require a provider of services or supplier described in paragraph (2) to provide the Secretary on a continuing basis with a surety bond in a form specified by the Secretary in an amount (not less than $50,000) that the Secretary determines is commensurate with the volume of the billing of the provider of services or supplier. The Secretary may waive the requirement of a bond under the preceding sentence in the case of a provider of services or supplier that provides a comparable surety bond under State law.
(2) Provider of services or supplier described
A provider of services or supplier described in this paragraph is a provider of services or supplier the Secretary determines appropriate based on the level of risk involved with respect to the provider of services or supplier, and consistent with the surety bond requirements under
(o) Suspension of payments pending investigation of credible allegations of fraud
(1) In general
The Secretary may suspend payments to a provider of services or supplier under this subchapter pending an investigation of a credible allegation of fraud against the provider of services or supplier, unless the Secretary determines there is good cause not to suspend such payments.
(2) Consultation
The Secretary shall consult with the Inspector General of the Department of Health and Human Services in determining whether there is a credible allegation of fraud against a provider of services or supplier.
(3) Promulgation of regulations
The Secretary shall promulgate regulations to carry out this subsection, section 1395w–112(b)(7) of this section (including as applied pursuant to
(4) Credible allegation of fraud
In carrying out this subsection,
(Aug. 14, 1935, ch. 531, title XVIII, §1862, as added
Editorial Notes
References in Text
The Assisted Suicide Funding Restriction Act of 1997, referred to in subsec. (a)(16), is
The Internal Revenue Code of 1986, referred to in subsec. (b), is classified generally to Title 26, Internal Revenue Code.
Section 107(c)(3) of the Drug Amendments of 1962, referred to in subsec. (c)(1)(A), is section 107(c)(3) of
Codification
Amendments by section 301(a) to (c) of
Amendments
2022—Subsec. (b)(1)(E)(iv).
2021—Subsec. (g).
2020—Subsec. (b)(8)(G).
2018—Subsec. (b)(7)(A)(i).
Subsec. (o)(3).
Subsec. (o)(4).
2016—Subsec. (l)(5)(D).
2015—Subsec. (b)(5)(E).
2014—Subsec. (b)(9)(B)(i).
2013—Subsec. (b)(2)(B)(ii).
Subsec. (b)(2)(B)(iii).
Subsec. (b)(2)(B)(vii), (viii).
Subsec. (b)(8)(B).
Subsec. (b)(8)(E)(i).
Subsec. (b)(8)(I).
Subsec. (b)(9).
2011—Subsecs. (a)(15)(A), (g).
2010—Subsec. (a)(1)(P).
Subsec. (a)(7).
Subsec. (a)(25).
Subsec. (n).
Subsec. (o).
2008—Subsec. (a)(1)(A).
Subsec. (a)(1)(K).
Subsec. (a)(1)(O).
Subsec. (a)(20).
Subsec. (a)(23).
Subsec. (a)(24).
2007—Subsec. (b)(7), (8).
2006—Subsec. (a)(1)(N).
2003—Subsec. (a).
Subsec. (a)(1)(J).
Subsec. (a)(1)(K).
Subsec. (a)(1)(L).
Subsec. (a)(1)(M).
Subsec. (a)(7).
Subsec. (b)(1)(A).
Subsec. (b)(2)(A).
Subsec. (b)(2)(A)(ii).
Subsec. (b)(2)(B)(i).
Subsec. (b)(2)(B)(ii).
Subsec. (b)(2)(B)(iii).
Subsec. (b)(2)(B)(iv) to (vi).
Subsec. (b)(3)(A).
Subsec. (b)(5)(A)(ii).
Subsec. (d).
Subsec. (j).
Subsec. (j)(1).
Subsec. (k).
Subsec. (l).
Subsec. (m).
2001—Subsec. (a)(22).
Subsec. (h).
2000—Subsec. (a).
Subsec. (a)(1)(F).
Subsec. (a)(3).
Subsec. (a)(18).
1999—Subsec. (a)(7).
Subsec. (a)(21).
1997—Subsec. (a)(1)(D).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(1)(H).
Subsec. (a)(1)(I).
Subsec. (a)(7).
Subsec. (a)(14).
Subsec. (a)(16).
Subsec. (a)(17).
Subsec. (a)(18).
Subsec. (a)(19).
Subsec. (a)(20).
Subsec. (a)(21).
Subsec. (b)(1)(B)(i).
Subsec. (b)(1)(B)(iii), (iv).
Subsec. (b)(1)(C).
Subsec. (b)(1)(F).
Subsec. (b)(2)(B)(ii).
Subsec. (b)(2)(B)(v).
Subsec. (b)(5)(C)(iii).
Subsec. (i).
1996—Subsec. (b)(5)(B).
"(i) subparagraph (A), and
"(ii)
for purposes of carrying out this subsection".
Subsec. (b)(5)(C)(i).
Subsec. (h).
1994—Subsec. (a)(1)(F).
Subsec. (a)(14).
Subsec. (a)(15).
Subsec. (a)(16).
Subsec. (b)(1)(A)(i)(II).
Subsec. (b)(1)(A)(ii).
Subsec. (b)(1)(A)(v).
Subsec. (b)(1)(C).
Subsec. (b)(2)(B)(i).
Subsec. (b)(2)(C).
Subsec. (b)(3)(C).
Subsec. (b)(5)(C)(i).
Subsec. (b)(5)(D).
Subsec. (b)(6).
1993—Subsec. (b)(1)(A)(i).
"(I) may not take into account, for any item or service furnished to an individual 65 years of age or older at the time the individual is covered under the plan by reason of the current employment of the individual (or the individual's spouse), that the individual is entitled to benefits under this subchapter under
"(II) shall provide that any employee age 65 or older, and any employee's spouse age 65 or older, shall be entitled to the same benefits under the plan under the same conditions as any employee, and the spouse of such employee, under age 65."
Subsec. (b)(1)(A)(ii).
Subsec. (b)(1)(A)(iii).
Subsec. (b)(1)(A)(iv).
Subsec. (b)(1)(A)(v).
Subsec. (b)(1)(B).
Subsec. (b)(1)(B)(i).
Subsec. (b)(1)(B)(ii).
Subsec. (b)(1)(B)(iii).
Subsec. (b)(1)(B)(iv).
Subsec. (b)(1)(C).
Subsec. (b)(1)(E).
Subsec. (b)(5)(B).
Subsec. (b)(5)(C)(i).
Subsec. (b)(5)(C)(iii).
1990—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(1)(F).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(7).
Subsec. (a)(14).
Subsec. (a)(15).
Subsec. (b)(1)(B)(iii).
Subsec. (b)(1)(C).
Subsec. (b)(1)(C)(i).
"(I) the month in which a regular course of renal dialysis is initiated, or
"(II) in the case of an individual who receives a kidney transplant, the first month in which he would be eligible for benefits under part A of this subchapter (if he had filed an application for such benefits) under the provisions of
Subsec. (b)(3)(C).
Subsec. (b)(5)(C)(iii).
1989—
Subsec. (a)(1)(A).
Subsec. (a)(1)(E).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G), (6), (7).
Subsec. (a)(14).
Subsec. (b).
Subsec. (b)(1)(D).
Subsec. (b)(5).
Subsec. (c).
Subsec. (e)(1).
1988—Subsec. (a)(1)(A).
Subsec. (a)(1)(F).
Subsec. (a)(1)(G).
Subsec. (a)(6).
Subsec. (a)(7).
Subsec. (a)(15).
Subsec. (c).
Subsec. (e)(1).
Subsec. (e)(2).
1987—Subsec. (a)(1)(A).
Subsec. (a)(8).
Subsec. (a)(14).
Subsec. (b)(2)(A)(ii).
Subsec. (b)(4)(B)(i).
Subsec. (d).
Subsec. (e) [formerly §1395aaa].
Subsec. (h)(1)(B).
Subsec. (h)(1)(D).
Subsec. (h)(2)(C).
Subsec. (h)(4).
Subsec. (h)(4)(B).
1986—Subsec. (a)(1)(E).
Subsec. (a)(14).
Subsec. (a)(15).
Subsec. (a)(16).
Subsec. (b)(2)(A).
Subsec. (b)(3)(A)(i).
Subsec. (b)(3)(A)(iii).
Subsec. (b)(3)(A)(iv).
Subsec. (b)(4).
Subsec. (b)(5).
1984—Subsec. (a)(12).
Subsec. (b)(1).
Subsec. (b)(2)(B).
Subsec. (b)(3)(A)(i).
Subsec. (b)(3)(A)(ii).
Subsec. (b)(3)(A)(iii).
Subsec. (h).
Subsec. (i).
1983—Subsec. (a)(1)(A).
Subsec. (a)(1)(D).
Subsec. (a)(14).
Subsec. (b)(3)(A)(i).
1982—Subsec. (a)(1).
Subsec. (a)(6).
Subsec. (a)(7).
Subsec. (a)(9).
Subsec. (b)(1).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(3).
Subsec. (d)(1)(C).
Subsec. (f).
Subsec. (g).
1981—Subsec. (b).
Subsec. (c).
Subsec. (f).
1980—Subsec. (a)(1).
Subsec. (a)(7).
Subsec. (a)(12).
Subsec. (a)(13)(C).
Subsec. (b).
Subsec. (d)(4).
Subsec. (e).
1977—Subsec. (a)(3).
Subsec. (d)(1)(B).
Subsec. (d)(1)(C).
Subsec. (d)(4).
Subsec. (e).
1975—Subsec. (c).
1974—Subsec. (c).
1973—Subsec. (a)(12).
1972—Subsec. (a)(4).
Subsec. (a)(12).
Subsec. (c).
Subsec. (d).
1968—Subsec. (a)(7).
Subsec. (a)(13).
Statutory Notes and Related Subsidiaries
Effective Date of 2018 Amendment
Amendment by section 2008(c), (d) of
Effective Date of 2016 Amendment
Effective Date of 2015 Amendment
Effective Date of 2013 Amendment
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2010 Amendment
Amendment by section 4103(d) of
Effective Date of 2008 Amendment
Amendment by section 101(a)(3), (b)(3), (4) of
Amendment by section 143(b)(7) of
Amendment by section 152(b)(1)(D) of
Effective Date of 2006 Amendment
Amendment by
Effective Date of 2003 Amendment
"(1) in the case of subsection (a), as if included in the enactment of title III [sic] of the Medicare and Medicaid Budget Reconciliation Amendments of 1984 (
"(2) in the case of subsections (b) and (c), as if included in the enactment of section 953 of the Omnibus Reconciliation Act of 1980 (
Amendment by section 611(d)(1) of
Amendment by section 612(c) of
Amendment by section 613(c) of
Amendment by section 948(a) of
Effective Date of 2001 Amendment
Effective Date of 2000 Amendment
Amendment by section 1(a)(6) [title I, §102(c)] of
Amendment by section 1(a)(6) [title III, §313(a)] of
Amendment by section 1(a)(6) [title IV, §432(b)(1)] of
Amendment by section 1(a)(6) [title V, §522(b)] of
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §305(b)] of
Amendment by section 1000(a)(6) [title III, §321(k)(10)] of
Effective Date of 1997 Amendment
Amendment by
Amendment by section 4022(b)(1)(B) of
Amendment by section 4102(c) of
Amendment by section 4103(c) of
Amendment by section 4104(c)(3) of
Amendment by section 4201(c)(1) of
Amendment by section 4432(b)(1) of
Amendment by section 4507(a)(2)(B) of
Amendment by section 4511(a)(2)(C) of
Amendment by section 4541(b) of
Amendment by section 4603(c)(2)(C) of
Effective Date of 1994 Amendment
Amendment by section 145(c)(1) of
Amendment by section 147(e)(6) of
Amendment by section 156(a)(2)(D) of
Effective Date of 1993 Amendment
Amendment by section 13561(d)(1) of
Effective Date of 1990 Amendment
Amendment by section 4153(b)(2)(B) of
Amendment by section 4157(c)(1) of
Amendment by section 4161(a)(3)(C) of
Amendment by section 4163(d)(2)(A)(i)–(iii), (B) of
Effective Date of 1989 Amendment
Amendment by section 6115(b) of
Amendment by section 6202(b)(1) of
Amendment by
Effective Date of 1988 Amendment
Amendment by
Amendment by section 202(d) of
Amendment by section 204(d)(2) of
Amendment by section 205(e)(1) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
For effective date of amendment by section 4072(c) of
Amendment by
Effective Date of 1986 Amendment
"(1) Except as provided in paragraph (2), the amendments made by this section [enacting
"(2) The amendments made by subsection (c) [amending
Amendment by section 9320(h)(1) of
Amendment by section 9343(c)(1) of
Amendment by section 9307(a) of
Effective Date of 1984 Amendment
Amendment by section 2304(c) of
Amendment by section 2354(b)(30), (31) of
Effective Date of 1983 Amendment
Amendment by section 601(f) of
Amendment by
Effective Date of 1982 Amendment
Amendment by section 116(b) of
Amendment by section 122(f), (g)(1) of
Amendment by section 128(a)(2)–(4) of
Amendment by sections 142 and 148(a) of
Effective Date of 1981 Amendment
Effective Date of 1980 Amendment
Amendment by
Amendment by section 936(c) of
Effective Date of 1977 Amendment
Amendment by
Effective Date of 1973 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by section 211(c)(1) of
Amendment by section 256(c) of
Effective Date of 1968 Amendment
Amendment by section 127(b) of
Construction of 2008 Amendment
For construction of amendment by section 153(b)(2) of
Construction of 2007 Amendment
Construction of 2003 Amendment
Application of 2003 Amendment to Physician Specialties
Amendment by section 303 of
Notwithstanding section 303(j) of
Treatment of Hospitals for Certain Services Under Medicare Secondary Payor (MSP) Provisions
"(a)
"(b)
Annual Publication of List of National Coverage Determinations
Notification to Physicians of Excessive Home Health Visits
Distribution of Questionnaire by Contractor
Retroactive Exemption for Certain Situations Involving Religious Orders
GAO Study of Extension of Secondary Payer Period
Deadline for First Transmittal and Request of Matching Information
"(i) transmit to the Secretary of the Treasury information under paragraph (5)(A)(i) of section 1862(b) of the Social Security Act [
"(ii) request from the Secretary disclosure of information described in section 6013(l)(12)(A) of the Internal Revenue Code of 1986 [
by not later than 14 days after the date of the enactment of this Act [Dec. 19, 1989]."
Designation of Pediatric Hospitals as Meeting Certification as Heart Transplant Facility
"(1) the hospital's pediatric heart transplant program is operated jointly by the hospital and another facility that meets such criteria,
"(2) the unified program shares the same transplant surgeons and quality assurance program (including oversight committee, patient protocol, and patient selection criteria), and
"(3) the hospital demonstrates to the satisfaction of the Secretary that it is able to provide the specialized facilities, services, and personnel that are required by pediatric heart transplant patients."
Approval of Surgical Assistants for Procedures Performed April 1, 1986, to December 15, 1986
Extending Waiver of Liability Provisions to Hospice Programs
"(1)
"(2)
[
Study of Impact on Disabled Beneficiaries and Family of Amendments Relating to Large Group Health Plans and Medicare as Secondary Payer
Reinstatement of Waiver of Liability Presumption
Home Health Waiver of Liability
[
Recommendations and Guidelines for Elimination of Assistants at Surgery; Report to Congress
Pacemaker Reimbursement Review and Reform; Promulgation of Regulations; Effective Date of Pacemaker Registration
Payment for Debridement of Mycotic Toenails
Interim Waiver in Certain Cases of Billing Rule for Items and Services Other Than Physicians' Services
"(1) The Secretary of Health and Human Services may, for any cost reporting period beginning prior to October 1, 1986, waive the requirements of sections 1862(a)(14) and 1866(a)(1)(H) of the Social Security Act [
"(2) In the case of a hospital which is receiving payments pursuant to a waiver under paragraph (1), payment of the adjustment for indirect costs of approved educational activities shall be made as if the hospital were receiving under part A of title XVIII of the Social Security Act all the payments which are made under part B of such title solely by reason of such waiver.
"(3) Any waiver granted under paragraph (1) shall provide that, with respect to those items and services billed under part B of title XVIII of the Social Security Act solely by reason of such waiver—
"(A) payment under such part shall be equal to 100 percent of the reasonable charge or other applicable payment base for the items and services; and
"(B) the entity furnishing the items and services must agree to accept the amount paid pursuant to subparagraph (A) as the full charge for the items and services."
[
["(1) Section 602(k)(2) of the Social Security Amendments of 1983 (as added by subsection (a)) [set out above] shall apply to cost reporting periods beginning on or after January 1, 1986.
["(2) Section 602(k)(3) of the Social Security Amendments of 1983 (as added by subsection (a)) [set out above] shall apply to items and services furnished after the end of the 10-day period beginning on the date of the enactment of this Act [Apr. 7, 1986]."]
Prohibition of Payment for Ineffective Drugs
Establishment and Implementation of Guidelines
Report to Congressional Committees on Implementation of Certification Requirements Relating to Modification of Health Benefits Plan or Program; Failure To Submit Report
1 See References in Text note below.
2 So in original. The comma probably should not appear.
3 So in original. Probably should be "made,".
4 So in original. Probably should be"subparagraph (A)".
5 So in original. Probably should be "subparagraph (A),".
6 So in original. Probably should be followed by a period.
7 So in original. Probably should be "(b)(1)(A)(v))".
§1395z. Consultation with State agencies and other organizations to develop conditions of participation for providers of services
In carrying out his functions, relating to determination of conditions of participation by providers of services, under subsections (e)(9), (f)(4), (j)(15),1 (o)(6), (cc)(2)(I), and 2 (dd)(2), and (mm)(1) of
(Aug. 14, 1935, ch. 531, title XVIII, §1863, as added
Editorial Notes
References in Text
Subsection (j) of
Amendments
1994—
1990—
1989—
1988—
1984—
1982—
1980—
1972—
Statutory Notes and Related Subsidiaries
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by section 203(e)(2) of
Amendment by section 204(c)(1) of
Effective Date of 1984 Amendment
Amendment by section 2335(c) of
Amendment by section 2349(b)(1) of
Amendment by section 2354(b)(32) of
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1980 Amendment
Amendment by section 933(f) of
Effective Date of 1972 Amendment
Amendment by
Termination of Advisory Councils
Advisory councils in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by the Congress, its duration is otherwise provided by law. See
1 See References in Text note below.
2 So in original. The word "and" probably should not appear.
§1395aa. Agreements with States
(a) Use of State agencies to determine compliance by providers of services with conditions of participation
The Secretary shall make an agreement with any State which is able and willing to do so under which the services of the State health agency or other appropriate State agency (or the appropriate local agencies) will be utilized by him for the purpose of determining whether an institution therein is a hospital or skilled nursing facility, or whether an agency therein is a home health agency, or whether an agency is a hospice program or whether a facility therein is a rural health clinic as defined in
(b) Payment in advance or by way of reimbursement to State for performance of functions of subsection (a)
The Secretary shall pay any such State, in advance or by way of reimbursement, as may be provided in the agreement with it (and may make adjustments in such payments on account of overpayments or underpayments previously made), for the reasonable cost of performing the functions specified in subsection (a), and for the Federal Hospital Insurance Trust Fund's fair share of the costs attributable to the planning and other efforts directed toward coordination of activities in carrying out its agreement and other activities related to the provision of services similar to those for which payment may be made under part A, or related to the facilities and personnel required for the provision of such services, or related to improving the quality of such services.
(c) Use of State or local agencies to survey hospitals
The Secretary is authorized to enter into an agreement with any State under which the appropriate State or local agency which performs the certification function described in subsection (a) will survey, on a selective sample basis (or where the Secretary finds that a survey is appropriate because of substantial allegations of the existence of a significant deficiency or deficiencies which would, if found to be present, adversely affect health and safety of patients), provider entities that, pursuant to
(d) Fulfillment of requirements by States
The Secretary may not enter an agreement under this section with a State with respect to determining whether an institution therein is a skilled nursing facility unless the State meets the requirements specified in
(e) Prohibition of user fees for survey and certification
Notwithstanding any other provision of law, the Secretary may not impose, or require a State to impose, any fee on any facility or entity subject to a determination under subsection (a), or any renal dialysis facility subject to the requirements of
(Aug. 14, 1935, ch. 531, title XVIII, §1864, as added
Editorial Notes
Amendments
2020—Subsec. (a).
2008—Subsec. (c).
1997—Subsec. (a).
1996—Subsec. (c).
1994—Subsec. (a).
Subsec. (e).
1990—Subsec. (a).
Subsec. (e).
1989—Subsec. (a).
1988—Subsec. (a).
1987—Subsec. (a).
Subsec. (d).
1986—Subsec. (a).
1984—Subsec. (c).
1982—Subsec. (a).
1980—Subsec. (a).
1977—Subsec. (a).
1972—Subsec. (a).
Subsec. (c).
1968—Subsec. (a).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Amendment by section 125(d)(2) of
Effective Date of 2008 Amendment; Transition Rule
Amendment by
Effective Date of 1997 Amendment
Amendment by section 4106(c) of
Amendment by section 4201(c)(1) of
Effective Date of 1994 Amendment
Amendment by section 145(c)(3) of
Effective Date of 1990 Amendment
Amendment by section 4163(c)(2) of
Effective Date of 1989 Amendments
Amendment by section 6115(c) of
Amendment by
Effective Date of 1988 Amendments
Amendment by
Amendment by section 203(e)(3) of
Amendment by section 204(c)(2), (d)(3) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
For effective date of amendment by section 4072(d) of
Amendments by sections 4201(a)(2), (d)(4) and 4202(a)(1), (c) of
Amendment by section 4203(a)(1) of
Effective Date of 1986 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1980 Amendments
Amendment by
For effective date of amendment by section 933(g) of
Effective Date of 1977 Amendment
Amendment by
Effective Date of 1972 Amendment
Effective Date of 1968 Amendment
Amendment by section 133(f) of
Use of State or Local Agencies in Evaluating Laboratories
Nurse Aid Training and Competency Evaluation, Failure by State To Meet Guidelines
§1395bb. Effect of accreditation
(a) Accreditation by American Osteopathic Association or other national accreditation body
(1) If the Secretary finds that accreditation of a provider entity (as defined in paragraph (4)) by the American Osteopathic Association or any other national accreditation body demonstrates that all of the applicable conditions or requirements of this subchapter (other than the requirements of
(A) in the case of a provider entity not described in paragraph (3)(B), the Secretary shall treat such entity as meeting those conditions or requirements with respect to which the Secretary made such finding; or
(B) in the case of a provider entity described in paragraph (3)(B), the Secretary may treat such entity as meeting those conditions or requirements with respect to which the Secretary made such finding.
(2) In making such a finding, the Secretary shall consider, among other factors with respect to a national accreditation body, its requirements for accreditation, its survey procedures, its ability to provide adequate resources for conducting required surveys and supplying information for use in enforcement activities, its monitoring procedures for provider entities found out of compliance with the conditions or requirements, and its ability to provide the Secretary with necessary data for validation.
(3)(A) Except as provided in subparagraph (B), not later than 60 days after the date of receipt of a written request for a finding under paragraph (1) (with any documentation necessary to make a determination on the request), the Secretary shall publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing a period of at least 30 days for the public to comment on the request. The Secretary shall approve or deny a request for such a finding, and shall publish notice of such approval or denial, not later than 210 days after the date of receipt of the request (with such documentation). Such an approval shall be effective with respect to accreditation determinations made on or after such effective date (which may not be later than the date of publication of the approval) as the Secretary specifies in the publication notice.
(B) The 210-day and 60-day deadlines specified in subparagraph (A) shall not apply in the case of any request for a finding with respect to accreditation of a provider entity to which the conditions and requirements of
(4) For purposes of this section, the term "provider entity" means a provider of services, supplier, facility (including a renal dialysis facility), clinic, agency, or laboratory.
(b) Disclosure of accreditation survey
The Secretary may not disclose any accreditation survey (other than a survey with respect to a home health agency or, beginning on December 27, 2020, a hospice program) made and released to the Secretary by the American Osteopathic Association or any other national accreditation body, of an entity accredited by such body, except that the Secretary may disclose such a survey and information related to such a survey to the extent such survey and information relate to an enforcement action taken by the Secretary.
(c) Deficiencies
Notwithstanding any other provision of this subchapter, if the Secretary finds that a provider entity has significant deficiencies (as defined in regulations pertaining to health and safety), the entity shall, after the date of notice of such finding to the entity and for such period as may be prescribed in regulations, be deemed not to meet the conditions or requirements the entity has been treated as meeting pursuant to subsection (a)(1).
(d) State or local accreditation
For provisions relating to validation surveys of entities that are treated as meeting applicable conditions or requirements of this subchapter pursuant to subsection (a)(1), see
(e) Accreditation for dialysis facilities
With respect to an accreditation body that has received approval from the Secretary under subsection (a)(3)(A) for accreditation of provider entities that are required to meet the conditions and requirements under
(1) Validation surveys referred to in subsection (d).
(2) Accreditation program reviews (as defined in section 488.8(c) of title 42 of the Code of Federal Regulations, or a successor regulation).
(3) Performance reviews (as defined in section 488.8(a) of title 42 of the Code of Federal Regulations, or a successor regulation).
(Aug. 14, 1935, ch. 531, title XVIII, §1865, as added
Editorial Notes
Amendments
2020—Subsec. (b).
2018—Subsec. (a)(1).
Subsec. (a)(4).
Subsec. (e).
2008—Subsec. (a).
Subsec. (a)(1).
Subsec. (b).
Subsecs. (c), (d).
Subsec. (e).
2003—Subsec. (b)(3)(B).
1996—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
1994—Subsec. (a).
1990—Subsec. (a).
1989—Subsec. (a).
Subsec. (a)(2).
Subsec. (b).
1988—Subsec. (a).
1987—Subsec. (a).
1986—Subsec. (a).
1984—Subsec. (a).
1982—Subsec. (a).
Subsec. (b).
1972—
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment; Transition Rule
"(1) Subject to paragraph (2), the amendments made by this section [amending this section and
"(2) For purposes of title XVIII of the Social Security Act (
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1989 Amendment
"(1) Except as provided in paragraph (2), the amendments made by this section [amending this section] shall take effect on the date of the enactment of this Act [Dec. 19, 1989].
"(2) The amendments made by subsection (a) [amending this section] shall take effect 6 months after the date of the enactment of this Act."
Amendment by section 6115(c) of
Amendment by
Effective Date of 1988 Amendment
Amendment by
Amendment by section 204(c)(3), (d)(3) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4025(b) of
For effective date of amendment by section 4072(d) of
Effective Date of 1986 Amendment
Amendment by section 9305(c)(3) of
Amendment by section 9320(h)(3) of
Effective Date of 1984 Amendment
Effective Date of 1982 Amendment
Amendment by section 122(g)(4) of
Amendment by section 128(d)(3) of
Effective Date of 1972 Amendment
Amendment by section 234(h) of
Timing for Acceptance of Requests From Accreditation Organizations
Authority To Recognize the Joint Commission as a National Accreditation Body
§1395cc. Agreements with providers of services; enrollment processes
(a) Filing of agreements; eligibility for payment; charges with respect to items and services
(1) Any provider of services (except a fund designated for purposes of section 1395f(g) and
(A)(i) not to charge, except as provided in paragraph (2), any individual or any other person for items or services for which such individual is entitled to have payment made under this subchapter (or for which he would be so entitled if such provider of services had complied with the procedural and other requirements under or pursuant to this subchapter or for which such provider is paid pursuant to the provisions of
(B) not to charge any individual or any other person for items or services for which such individual is not entitled to have payment made under this subchapter because payment for expenses incurred for such items or services may not be made by reason of the provisions of paragraph (1) or (9) of
(C) to make adequate provision for return (or other disposition, in accordance with regulations) of any moneys incorrectly collected from such individual or other person,
(D) to promptly notify the Secretary of its employment of an individual who, at any time during the year preceding such employment, was employed in a managerial, accounting, auditing, or similar capacity (as determined by the Secretary by regulation) by an agency or organization which serves as a fiscal intermediary or carrier (for purposes of part A or part B, or both, of this subchapter) with respect to the provider,
(E) to release data with respect to patients of such provider upon request to an organization having a contract with the Secretary under part B of subchapter XI as may be necessary (i) to allow such organization to carry out its functions under such contract, or (ii) to allow such organization to carry out similar review functions under any contract the organization may have with a private or public agency paying for health care in the same area with respect to patients who authorize release of such data for such purposes,
(F)(i) in the case of hospitals which provide inpatient hospital services for which payment may be made under subsection (b), (c), or (d) of
(ii) in the case of hospitals, critical access hospitals, rural emergency hospitals, skilled nursing facilities, and home health agencies, to maintain an agreement with a quality improvement organization (which has a contract with the Secretary under part B of subchapter XI for the area in which the hospital, facility, or agency is located) to perform the functions described in paragraph (3)(A),
(G) in the case of hospitals which provide inpatient hospital services for which payment may be made under subsection (b) or (d) of
(H)(i) in the case of hospitals which provide services for which payment may be made under this subchapter and in the case of critical access hospitals which provide critical access hospital services, to have all items and services (other than physicians' services as defined in regulations for purposes of
(ii) in the case of skilled nursing facilities which provide covered skilled nursing facility services—
(I) that are furnished to an individual who is a resident of the skilled nursing facility during a period in which the resident is provided covered post-hospital extended care services (or, for services described in
(II) for which the individual is entitled to have payment made under this subchapter,
to have items and services (other than services described in
(I) in the case of a hospital, critical access hospital, or rural emergency hospital—
(i) to adopt and enforce a policy to ensure compliance with the requirements of
(ii) to maintain medical and other records related to individuals transferred to or from the hospital, critical access hospital, or rural emergency hospital for a period of five years from the date of the transfer, and
(iii) to maintain a list of physicians who are on call for duty after the initial examination to provide treatment necessary to stabilize an individual with an emergency medical condition,
(J) in the case of hospitals which provide inpatient hospital services for which payment may be made under this subchapter, to be a participating provider of medical care under any health plan contracted for under
(K) not to charge any individual or any other person for items or services for which payment under this subchapter is denied under
(L) in the case of hospitals which provide inpatient hospital services for which payment may be made under this subchapter, to be a participating provider of medical care under
(M) in the case of hospitals, to provide to each individual who is entitled to benefits under part A (or to a person acting on the individual's behalf), at or about the time of the individual's admission as an inpatient to the hospital, a written statement (containing such language as the Secretary prescribes consistent with this paragraph) which explains—
(i) the individual's rights to benefits for inpatient hospital services and for post-hospital services under this subchapter,
(ii) the circumstances under which such an individual will and will not be liable for charges for continued stay in the hospital,
(iii) the individual's right to appeal denials of benefits for continued inpatient hospital services, including the practical steps to initiate such an appeal, and
(iv) the individual's liability for payment for services if such a denial of benefits is upheld on appeal,
and which provides such additional information as the Secretary may specify,
(N) in the case of hospitals, critical access hospitals, and rural emergency hospitals—
(i) to make available to its patients the directory or directories of participating physicians (published under
(ii) if hospital personnel (including staff of any emergency or outpatient department) refer a patient to a nonparticipating physician for further medical care on an outpatient basis, the personnel must inform the patient that the physician is a nonparticipating physician and, whenever practicable, must identify at least one qualified participating physician who is listed in such a directory and from whom the patient may receive the necessary services,
(iii) to post conspicuously in any emergency department a sign (in a form specified by the Secretary) specifying rights of individuals under
(iv) to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital, critical access hospital, or rural emergency hospital participates in the medicaid program under a State plan approved under subchapter XIX,
(O) to accept as payment in full for services that are covered under this subchapter and are furnished to any individual enrolled with a Medicare+Choice organization under part C, with a PACE provider under
(P) in the case of home health agencies which provide home health services to individuals entitled to benefits under this subchapter who require catheters, catheter supplies, ostomy bags, and supplies related to ostomy care (described in
(Q) in the case of hospitals, skilled nursing facilities, home health agencies, and hospice programs, to comply with the requirement of subsection (f) (relating to maintaining written policies and procedures respecting advance directives),
(R) to contract only with a health care clearinghouse (as defined in
(S) in the case of a hospital that has a financial interest (as specified by the Secretary in regulations) in an entity to which individuals are referred as described in
(i) the nature of such financial interest,
(ii) the number of individuals who were discharged from the hospital and who were identified as requiring home health services, and
(iii) the percentage of such individuals who received such services from such provider (or another such provider),
(T) in the case of hospitals and critical access hospitals, to furnish to the Secretary such data as the Secretary determines appropriate pursuant to subparagraph (E) of
(U) in the case of hospitals which furnish inpatient hospital services for which payment may be made under this subchapter, to be a participating provider of medical care both—
(i) under the contract health services program funded by the Indian Health Service and operated by the Indian Health Service, an Indian tribe, or tribal organization (as those terms are defined in
(ii) under any program funded by the Indian Health Service and operated by an urban Indian organization with respect to the purchase of items and services for an eligible urban Indian (as those terms are defined in such section 1603),
in accordance with regulations promulgated by the Secretary regarding admission practices, payment methodology, and rates of payment (including the acceptance of no more than such payment rate as payment in full for such items and services,2
(V) in the case of hospitals that are not otherwise subject to the Occupational Safety and Health Act of 1970 [
(W) in the case of a hospital described in
(X) maintain and, upon request of the Secretary, provide access to documentation relating to written orders or requests for payment for durable medical equipment, certifications for home health services, or referrals for other items or services written or ordered by the provider under this subchapter, as specified by the Secretary, and
(Y) beginning 12 months after August 6, 2015, in the case of a hospital or critical access hospital, with respect to each individual who receives observation services as an outpatient at such hospital or critical access hospital for more than 24 hours, to provide to such individual not later than 36 hours after the time such individual begins receiving such services (or, if sooner, upon release)—
(i) such oral explanation of the written notification described in clause (ii), and such documentation of the provision of such explanation, as the Secretary determines to be appropriate;
(ii) a written notification (as specified by the Secretary pursuant to rulemaking and containing such language as the Secretary prescribes consistent with this paragraph) which—
(I) explains the status of the individual as an outpatient receiving observation services and not as an inpatient of the hospital or critical access hospital and the reasons for such status of such individual;
(II) explains the implications of such status on services furnished by the hospital or critical access hospital (including services furnished on an inpatient basis), such as implications for cost-sharing requirements under this title and for subsequent eligibility for coverage under this title for services furnished by a skilled nursing facility;
(III) includes such additional information as the Secretary determines appropriate;
(IV) either—
(aa) is signed by such individual or a person acting on such individual's behalf to acknowledge receipt of such notification; or
(bb) if such individual or person refuses to provide the signature described in item (aa), is signed by the staff member of the hospital or critical access hospital who presented the written notification and includes the name and title of such staff member, a certification that the notification was presented, and the date and time the notification was presented; and
(V) is written and formatted using plain language and is made available in appropriate languages as determined by the Secretary.
In the case of a hospital which has an agreement in effect with an organization described in subparagraph (F), which organization's contract with the Secretary under part B of subchapter XI is terminated on or after October 1, 1984, the hospital shall not be determined to be out of compliance with the requirement of such subparagraph during the six month period beginning on the date of the termination of that contract.
(2)(A) A provider of services may charge such individual or other person (i) the amount of any deduction or coinsurance amount imposed pursuant to section 1395e(a)(1), (a)(3), or (a)(4), section 1395l(b), or
(B) Where a provider of services has furnished, at the request of such individual, items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under this subchapter, such provider of services may also charge such individual or other person for such more expensive items or services to the extent that the amount customarily charged by it for the items or services furnished at such request exceeds the amount customarily charged by it for the items or services with respect to which payment may be made under this subchapter.
(C) A provider of services may in accordance with its customary practice also appropriately charge any such individual for any whole blood (or equivalent quantities of packed red blood cells, as defined under regulations) furnished him with respect to which a deductible is imposed under
(D) Where a provider of services customarily furnishes items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under this subchapter, such provider, notwithstanding the preceding provisions of this paragraph, may not, under the authority of subparagraph (B)(ii) of this paragraph, charge any individual or other person any amount for such items or services in excess of the amount of the payment which may otherwise be made for such items or services under this subchapter if the admitting physician has a direct or indirect financial interest in such provider.
(3)(A) Under the agreement required under paragraph (1)(F)(ii), the quality improvement organization must perform functions (other than those covered under an agreement under paragraph (1)(F)(i)) under the third sentence of
(B) For purposes of payment under this subchapter, the cost of such an agreement to the hospital, critical access hospital, rural emergency hospital, facility, or agency shall be considered a cost incurred by such hospital, critical access hospital, rural emergency hospital, facility, or agency in providing covered services under this subchapter and shall be paid directly by the Secretary to the quality improvement organization on behalf of such hospital, critical access hospital, rural emergency hospital, facility, or agency in accordance with a schedule established by the Secretary.
(C) Such payments—
(i) shall be transferred in appropriate proportions from the Federal Hospital Insurance Trust Fund and from the Federal Supplementary Medical Insurance Trust Fund, without regard to amounts appropriated in advance in appropriation Acts, in the same manner as transfers are made for payment for services provided directly to beneficiaries, and
(ii) shall not be less in the aggregate for a fiscal year—
(I) in the case of hospitals, than the amount specified in paragraph (1)(F)(i)(III), and
(II) in the case of facilities, critical access hospitals, rural emergency hospitals, and agencies, than the amounts the Secretary determines to be sufficient to cover the costs of such organizations' conducting the activities described in subparagraph (A) with respect to such facilities, critical access hospitals, rural emergency hospitals, or agencies under part B of subchapter XI.
(b) Termination or nonrenewal of agreements
(1) A provider of services may terminate an agreement with the Secretary under this section at such time and upon such notice to the Secretary and the public as may be provided in regulations, except that notice of more than six months shall not be required.
(2) The Secretary may refuse to enter into an agreement under this section or, upon such reasonable notice to the provider and the public as may be specified in regulations, may refuse to renew or may terminate such an agreement after the Secretary—
(A) has determined that the provider fails to comply substantially with the provisions of the agreement, with the provisions of this subchapter and regulations thereunder, or with a corrective action required under
(B) has determined that the provider fails substantially to meet the applicable provisions of
(C) has excluded the provider from participation in a program under this subchapter pursuant to
(D) has ascertained that the provider has been convicted of a felony under Federal or State law for an offense which the Secretary determines is detrimental to the best interests of the program or program beneficiaries.
(3) A termination of an agreement or a refusal to renew an agreement under this subsection shall become effective on the same date and in the same manner as an exclusion from participation under the programs under this subchapter becomes effective under
(4)(A) A hospital that fails to comply with the requirement of subsection (a)(1)(V) (relating to the Bloodborne Pathogens standard) is subject to a civil money penalty in an amount described in subparagraph (B), but is not subject to termination of an agreement under this section.
(B) The amount referred to in subparagraph (A) is an amount that is similar to the amount of civil penalties that may be imposed under section 17 of the Occupational Safety and Health Act of 1970 [
(C) A civil money penalty under this paragraph shall be imposed and collected in the same manner as civil money penalties under subsection (a) of
(c) Refiling after termination or nonrenewal; agreements with skilled nursing facilities
(1) Where the Secretary has terminated or has refused to renew an agreement under this subchapter with a provider of services, such provider may not file another agreement under this subchapter unless the Secretary finds that the reason for the termination or nonrenewal has been removed and that there is reasonable assurance that it will not recur.
(2) Where the Secretary has terminated or has refused to renew an agreement under this subchapter with a provider of services, the Secretary shall promptly notify each State agency which administers or supervises the administration of a State plan approved under subchapter XIX of such termination or nonrenewal.
(d) Decision to withhold payment for failure to review long-stay cases
If the Secretary finds that there is a substantial failure to make timely review in accordance with
(e) "Provider of services" defined
For purposes of this section, the term "provider of services" shall include—
(1) a clinic, rehabilitation agency, or public health agency if, in the case of a clinic or rehabilitation agency, such clinic or agency meets the requirements of
(2) a community mental health center (as defined in
(3) opioid treatment programs (as defined in paragraph (2) of
(f) Maintenance of written policies and procedures
(1) For purposes of subsection (a)(1)(Q) and sections 1395i–3(c)(2)(E),5 1395l(s), 1395w–25(i), 1395mm(c)(8), and 1395bbb(a)(6) of this title, the requirement of this subsection is that a provider of services, Medicare+Choice organization, or prepaid or eligible organization (as the case may be) maintain written policies and procedures with respect to all adult individuals receiving medical care by or through the provider or organization—
(A) to provide written information to each such individual concerning—
(i) an individual's rights under State law (whether statutory or as recognized by the courts of the State) to make decisions concerning such medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives (as defined in paragraph (3)), and
(ii) the written policies of the provider or organization respecting the implementation of such rights;
(B) to document in a prominent part of the individual's current medical record whether or not the individual has executed an advance directive;
(C) not to condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive;
(D) to ensure compliance with requirements of State law (whether statutory or as recognized by the courts of the State) respecting advance directives at facilities of the provider or organization; and
(E) to provide (individually or with others) for education for staff and the community on issues concerning advance directives.
Subparagraph (C) shall not be construed as requiring the provision of care which conflicts with an advance directive.
(2) The written information described in paragraph (1)(A) shall be provided to an adult individual—
(A) in the case of a hospital, at the time of the individual's admission as an inpatient,
(B) in the case of a skilled nursing facility, at the time of the individual's admission as a resident,
(C) in the case of a home health agency, in advance of the individual coming under the care of the agency,
(D) in the case of a hospice program, at the time of initial receipt of hospice care by the individual from the program, and
(E) in the case of an eligible organization (as defined in
(3) In this subsection, the term "advance directive" means a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State) and relating to the provision of such care when the individual is incapacitated.
(4) For construction relating to this subsection, see
(g) Penalties for improper billing
Except as permitted under subsection (a)(2), any person who knowingly and willfully presents, or causes to be presented, a bill or request for payment inconsistent with an arrangement under subsection (a)(1)(H) or in violation of the requirement for such an arrangement, is subject to a civil money penalty of not to exceed $2,000. The provisions of
(h) Dissatisfaction with determination of Secretary; appeal by institutions or agencies; single notice and hearing
(1)(A) Except as provided in paragraph (2), an institution or agency dissatisfied with a determination by the Secretary that it is not a provider of services or with a determination described in subsection (b)(2) shall be entitled to a hearing thereon by the Secretary (after reasonable notice) to the same extent as is provided in
(B) An institution or agency described in subparagraph (A) that has filed for a hearing under subparagraph (A) shall have expedited access to judicial review under this subparagraph in the same manner as providers of services, suppliers, and individuals entitled to benefits under part A or enrolled under part B, or both, may obtain expedited access to judicial review under the process established under
(C)(i) The Secretary shall develop and implement a process to expedite proceedings under this subsection in which—
(I) the remedy of termination of participation has been imposed;
(II) a remedy described in clause (i) or (iii) of
(III) a determination has been made as to a finding of substandard quality of care that results in the loss of approval of a skilled nursing facility's nurse aide training program.
(ii) Under such process under clause (i), priority shall be provided in cases of termination described in clause (i)(I).
(iii) Nothing in this subparagraph shall be construed to affect the application of any remedy imposed under
(2) An institution or agency is not entitled to separate notice and opportunity for a hearing under both
(i) Intermediate sanctions for psychiatric hospitals
(1) If the Secretary determines that a psychiatric hospital which has an agreement in effect under this section no longer meets the requirements for a psychiatric hospital under this subchapter and further finds that the hospital's deficiencies—
(A) immediately jeopardize the health and safety of its patients, the Secretary shall terminate such agreement; or
(B) do not immediately jeopardize the health and safety of its patients, the Secretary may terminate such agreement, or provide that no payment will be made under this subchapter with respect to any individual admitted to such hospital after the effective date of the finding, or both.
(2) If a psychiatric hospital, found to have deficiencies described in paragraph (1)(B), has not complied with the requirements of this subchapter—
(A) within 3 months after the date the hospital is found to be out of compliance with such requirements, the Secretary shall provide that no payment will be made under this subchapter with respect to any individual admitted to such hospital after the end of such 3-month period, or
(B) within 6 months after the date the hospital is found to be out of compliance with such requirements, no payment may be made under this subchapter with respect to any individual in the hospital until the Secretary finds that the hospital is in compliance with the requirements of this subchapter.
(j) Enrollment process for providers of services and suppliers
(1) Enrollment process
(A) In general
The Secretary shall establish by regulation a process for the enrollment of providers of services and suppliers under this subchapter. Such process shall include screening of providers and suppliers in accordance with paragraph (2), a provisional period of enhanced oversight in accordance with paragraph (3), disclosure requirements in accordance with paragraph (5), the imposition of temporary enrollment moratoria in accordance with paragraph (7), and the establishment of compliance programs in accordance with paragraph (9).
(B) Deadlines
The Secretary shall establish by regulation procedures under which there are deadlines for actions on applications for enrollment (and, if applicable, renewal of enrollment). The Secretary shall monitor the performance of medicare administrative contractors in meeting the deadlines established under this subparagraph.
(C) Consultation before changing provider enrollment forms
The Secretary shall consult with providers of services and suppliers before making changes in the provider enrollment forms required of such providers and suppliers to be eligible to submit claims for which payment may be made under this subchapter.
(2) Provider screening
(A) Procedures
Not later than 180 days after March 23, 2010, the Secretary, in consultation with the Inspector General of the Department of Health and Human Services, shall establish procedures under which screening is conducted with respect to providers of medical or other items or services and suppliers under the program under this subchapter, the Medicaid program under subchapter XIX, and the CHIP program under subchapter XXI.
(B) Level of screening
The Secretary shall determine the level of screening conducted under this paragraph according to the risk of fraud, waste, and abuse, as determined by the Secretary, with respect to the category of provider of medical or other items or services or supplier. Such screening—
(i) shall include a licensure check, which may include such checks across States; and
(ii) may, as the Secretary determines appropriate based on the risk of fraud, waste, and abuse described in the preceding sentence, include—
(I) a criminal background check;
(II) fingerprinting;
(III) unscheduled and unannounced site visits, including preenrollment site visits;
(IV) database checks (including such checks across States); and
(V) such other screening as the Secretary determines appropriate.
(C) Application fees
(i) Institutional providers
Except as provided in clause (ii), the Secretary shall impose a fee on each institutional provider of medical or other items or services or supplier (such as a hospital or skilled nursing facility) with respect to which screening is conducted under this paragraph in an amount equal to—
(I) for 2010, $500; and
(II) for 2011 and each subsequent year, the amount determined under this clause for the preceding year, adjusted by the percentage change in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year.
(ii) Hardship exception; waiver for certain Medicaid providers
The Secretary may, on a case-by-case basis, exempt a provider of medical or other items or services or supplier from the imposition of an application fee under this subparagraph if the Secretary determines that the imposition of the application fee would result in a hardship. The Secretary may waive the application fee under this subparagraph for providers enrolled in a State Medicaid program for whom the State demonstrates that imposition of the fee would impede beneficiary access to care.
(iii) Use of funds
Amounts collected as a result of the imposition of a fee under this subparagraph shall be used by the Secretary for program integrity efforts, including to cover the costs of conducting screening under this paragraph and to carry out this subsection and
(D) Application and enforcement
(i) New providers of services and suppliers
The screening under this paragraph shall apply, in the case of a provider of medical or other items or services or supplier who is not enrolled in the program under this subchapter, subchapter XIX, or subchapter XXI as of March 23, 2010, on or after the date that is 1 year after such date.
(ii) Current providers of services and suppliers
The screening under this paragraph shall apply, in the case of a provider of medical or other items or services or supplier who is enrolled in the program under this subchapter, subchapter XIX, or subchapter XXI as of such date, on or after the date that is 2 years after such date.
(iii) Revalidation of enrollment
Effective beginning on the date that is 180 days after such date, the screening under this paragraph shall apply with respect to the revalidation of enrollment of a provider of medical or other items or services or supplier in the program under this subchapter, subchapter XIX, or subchapter XXI.
(iv) Limitation on enrollment and revalidation of enrollment
In no case may a provider of medical or other items or services or supplier who has not been screened under this paragraph be initially enrolled or reenrolled in the program under this subchapter, subchapter XIX, or subchapter XXI on or after the date that is 3 years after such date.
(E) Use of information from the Department of Treasury concerning tax debts
In reviewing the application of a provider of services or supplier to enroll or reenroll under the program under this subchapter, the Secretary shall take into account the information supplied by the Secretary of the Treasury pursuant to section 6103(l)(22) of the Internal Revenue Code of 1986, in determining whether to deny such application or to apply enhanced oversight to such provider of services or supplier pursuant to paragraph (3) if the Secretary determines such provider of services or supplier owes such a debt.
(F) Expedited rulemaking
The Secretary may promulgate an interim final rule to carry out this paragraph.
(3) Provisional period of enhanced oversight for new providers of services and suppliers
(A) In general
The Secretary shall establish procedures to provide for a provisional period of not less than 30 days and not more than 1 year during which new providers of medical or other items or services and suppliers, as the Secretary determines appropriate, including categories of providers or suppliers, would be subject to enhanced oversight, such as prepayment review and payment caps, under the program under this subchapter, the Medicaid program under subchapter XIX.6 and the CHIP program under subchapter XXI.
(B) Implementation
The Secretary may establish by program instruction or otherwise the procedures under this paragraph.
(4) 90-day period of enhanced oversight for initial claims of DME suppliers
For periods beginning after January 1, 2011, if the Secretary determines that there is a significant risk of fraudulent activity among suppliers of durable medical equipment, in the case of a supplier of durable medical equipment who is within a category or geographic area under this subchapter identified pursuant to such determination and who is initially enrolling under such subchapter, the Secretary shall, notwithstanding
(5) Increased disclosure requirements
(A) Disclosure
A provider of medical or other items or services or supplier who submits an application for enrollment or revalidation of enrollment in the program under this subchapter, subchapter XIX, or subchapter XXI on or after the date that is 1 year after March 23, 2010, shall disclose (in a form and manner and at such time as determined by the Secretary) any current or previous affiliation (directly or indirectly) with a provider of medical or other items or services or supplier that has uncollected debt, has been or is subject to a payment suspension under a Federal health care program (as defined in
(B) Authority to deny enrollment
If the Secretary determines that such previous affiliation poses an undue risk of fraud, waste, or abuse, the Secretary may deny such application. Such a denial shall be subject to appeal in accordance with paragraph (7).
(6) Authority to adjust payments of providers of services and suppliers with the same tax identification number for medicare obligations
(A) In general
Notwithstanding any other provision of this subchapter, in the case of an applicable provider of services or supplier, the Secretary may make any necessary adjustments to payments to the applicable provider of services or supplier under the program under this subchapter in order to satisfy any amount described in subparagraph (B)(ii) due from such obligated provider of services or supplier.
(B) Definitions
In this paragraph:
(i) In general
The term "applicable provider of services or supplier" means a provider of services or supplier that has the same taxpayer identification number assigned under section 6109 of the Internal Revenue Code of 1986 as is assigned to the obligated provider of services or supplier under such section, regardless of whether the applicable provider of services or supplier is assigned a different billing number or national provider identification number under the program under this subchapter than is assigned to the obligated provider of services or supplier.
(ii) Obligated provider of services or supplier
The term "obligated provider of services or supplier" means a provider of services or supplier that owes an amount that is more than the amount required to be paid under the program under this subchapter (as determined by the Secretary).
(7) Temporary moratorium on enrollment of new providers; nonpayment
(A) In general
The Secretary may impose a temporary moratorium on the enrollment of new providers of services and suppliers, including categories of providers of services and suppliers, in the program under this subchapter, under the Medicaid program under subchapter XIX, or under the CHIP program under subchapter XXI if the Secretary determines such moratorium is necessary to prevent or combat fraud, waste, or abuse under either such program.
(B) Limitation on review
There shall be no judicial review under
(C) Nonpayment
(i) In general
No payment may be made under this subchapter or under a program described in subparagraph (A) with respect to an item or service described in clause (ii) furnished on or after October 1, 2017.
(ii) Item or service described
An item or service described in this clause is an item or service furnished—
(I) within a geographic area with respect to which a temporary moratorium imposed under subparagraph (A) is in effect; and
(II) by a provider of services or supplier that meets the requirements of clause (iii).
(iii) Requirements
For purposes of clause (ii), the requirements of this clause are that a provider of services or supplier—
(I) enrolls under this subchapter on or after the effective date of such temporary moratorium; and
(II) is within a category of providers of services and suppliers (as described in subparagraph (A)) subject to such temporary moratorium.
(iv) Prohibition on charges for specified items or services
In no case shall a provider of services or supplier described in clause (ii)(II) charge an individual or other person for an item or service described in clause (ii) furnished on or after October 1, 2017, to an individual entitled to benefits under part A or enrolled under part B or an individual under a program specified in subparagraph (A).
(8) Hearing rights in cases of denial or non-renewal
A provider of services or supplier whose application to enroll (or, if applicable, to renew enrollment) under this subchapter is denied may have a hearing and judicial review of such denial under the procedures that apply under subsection (h)(1)(A) to a provider of services that is dissatisfied with a determination by the Secretary.
(9) Compliance programs
(A) In general
On or after the date of implementation determined by the Secretary under subparagraph (C), a provider of medical or other items or services or supplier within a particular industry sector or category shall, as a condition of enrollment in the program under this subchapter, subchapter XIX, or subchapter XXI, establish a compliance program that contains the core elements established under subparagraph (B) with respect to that provider or supplier and industry or category.
(B) Establishment of core elements
The Secretary, in consultation with the Inspector General of the Department of Health and Human Services, shall establish core elements for a compliance program under subparagraph (A) for providers or suppliers within a particular industry or category.
(C) Timeline for implementation
The Secretary shall determine the timeline for the establishment of the core elements under subparagraph (B) and the date of the implementation of subparagraph (A) for providers or suppliers within a particular industry or category. The Secretary shall, in determining such date of implementation, consider the extent to which the adoption of compliance programs by a provider of medical or other items or services or supplier is widespread in a particular industry sector or with respect to a particular provider or supplier category.
(k) Quality reporting by cancer hospitals
(1) In general
For purposes of fiscal year 2014 and each subsequent fiscal year, a hospital described in
(2) Submission of quality data
For fiscal year 2014 and each subsequent fiscal year, each hospital described in such section shall submit to the Secretary data on quality measures specified under paragraph (3). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
(3) Quality measures
(A) In general
Subject to subparagraph (B), any measure specified by the Secretary under this paragraph must have been endorsed by the entity with a contract under
(B) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(C) Time frame
Not later than October 1, 2012, the Secretary shall publish the measures selected under this paragraph that will be applicable with respect to fiscal year 2014.
(4) Public availability of data submitted
The Secretary shall establish procedures for making data submitted under paragraph (4) available to the public. Such procedures shall ensure that a hospital described in
(Aug. 14, 1935, ch. 531, title XVIII, §1866, as added
Editorial Notes
References in Text
Section 222(a) of the Social Security Amendments of 1972, referred to in subsec. (a)(1)(O), is section 222(a) of
The Occupational Safety and Health Act of 1970, referred to in subsecs. (a)(1)(V) and (b)(4)(B), is
The Internal Revenue Code of 1986, referred to in subsec. (j)(2)(E), (6)(B)(i), is classified generally to Title 26, Internal Revenue Code.
Amendments
2022—Subsec. (e)(2).
2020—Subsec. (a)(1)(F)(ii).
Subsec. (a)(1)(I).
Subsec. (a)(1)(I)(ii).
Subsec. (a)(1)(N).
Subsec. (a)(1)(N)(i).
Subsec. (a)(1)(N)(iv).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B).
Subsec. (a)(3)(C)(ii)(II).
2018—Subsec. (a)(1)(L).
Subsec. (e)(3).
2016—Subsec. (j)(1)(A).
Subsec. (j)(7).
Subsec. (j)(7)(C).
Subsec. (j)(8), (9).
2015—Subsec. (a)(1)(W), (X).
Subsec. (a)(1)(Y).
2011—Subsec. (a)(1)(F).
Subsec. (a)(3).
2010—Subsec. (a)(1)(U).
Subsec. (a)(1)(V).
Subsec. (a)(1)(W).
Subsec. (j)(1)(A).
Subsec. (j)(2).
Subsec. (j)(2)(C).
"(I) for 2010, $200; and
"(II) for 2011 and each subsequent year, the amount determined under this clause for the preceding year, adjusted by the percentage change in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year."
Subsec. (j)(2)(E), (F).
Subsec. (j)(3).
Subsec. (j)(4), (5).
Subsec. (j)(6).
Subsec. (j)(6)(A).
Subsec. (j)(6)(B)(ii).
Subsec. (j)(7).
Subsec. (j)(8).
Subsec. (k).
2008—Subsec. (e)(1).
2003—
Subsec. (a)(1)(O).
Subsec. (a)(1)(T).
Subsec. (a)(1)(U).
Subsec. (a)(1)(V).
Subsec. (b)(2)(D).
Subsec. (b)(4).
Subsec. (h)(1).
Subsec. (j).
2000—Subsec. (a)(1)(H)(ii)(I).
1999—Subsec. (a)(1)(I)(iii).
Subsec. (a)(1)(N)(iv).
Subsec. (a)(1)(O).
Subsec. (a)(1)(Q).
Subsec. (a)(1)(R).
1997—Subsec. (a)(1)(A).
Subsec. (a)(1)(F)(ii).
Subsec. (a)(1)(H).
Subsec. (a)(1)(I), (N).
Subsec. (a)(1)(O).
Subsec. (a)(1)(S).
Subsec. (a)(2)(A).
Subsec. (a)(3).
Subsec. (b)(2)(D).
Subsec. (f)(1).
Subsec. (f)(1)(B).
Subsec. (f)(2)(E).
Subsec. (f)(4).
1996—Subsec. (a)(1)(R).
1994—Subsec. (a)(1)(H).
Subsec. (a)(2)(A).
Subsec. (d).
Subsec. (f)(1).
Subsec. (h)(1).
1991—Subsec. (a)(1)(J).
Subsec. (a)(1)(L).
1990—Subsec. (a)(1)(F)(i).
Subsec. (a)(1)(F)(ii).
Subsec. (a)(1)(H).
Subsec. (a)(1)(I)(i).
Subsec. (a)(1)(P).
Subsec. (a)(1)(Q).
Subsec. (e).
Subsec. (f).
1989—Subsec. (a)(1)(F)(i)(III).
Subsec. (a)(1)(F)(ii).
Subsec. (a)(1)(H).
Subsec. (a)(1)(I).
Subsec. (a)(1)(N).
Subsec. (a)(1)(N)(iii), (iv).
Subsec. (a)(1)(P).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(3)(A), (B).
Subsec. (a)(3)(C)(ii)(II).
Subsec. (d).
Subsec. (i).
1988—Subsec. (a)(1)(M).
Subsec. (a)(1)(N).
Subsec. (a)(1)(O).
Subsec. (a)(2)(A).
Subsec. (a)(3)(C)(ii).
Subsec. (d).
Subsec. (f).
Subsec. (g).
1987—Subsec. (a)(1)(F)(i)(III).
Subsec. (a)(1)(O).
Subsec. (a)(2)(A).
Subsec. (a)(3).
Subsec. (a)(3)(C)(ii).
Subsec. (a)(4).
Subsec. (b).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (g).
Subsec. (h).
1986—Subsec. (a)(1)(F).
Subsec. (a)(1)(H).
Subsec. (a)(1)(I).
Subsec. (a)(1)(J).
Subsec. (a)(1)(K).
Subsec. (a)(1)(L).
Subsec. (a)(1)(M).
Subsec. (a)(1)(N).
Subsec. (a)(2)(A).
Subsec. (a)(4).
Subsec. (e).
Subsec. (g).
1984—Subsec. (a)(1)(E).
Subsec. (a)(1)(F).
Subsec. (a)(2)(A).
Subsec. (b)(3).
Subsec. (b)(4).
Subsec. (d).
1983—Subsec. (a)(1).
Subsec. (a)(1)(F).
Subsec. (a)(1)(F) to (H).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B)(ii).
1982—Subsec. (a)(1)(B).
Subsec. (a)(1)(E).
Subsec. (a)(2)(A).
Subsec. (b).
Subsec. (b)(4)(A).
1981—Subsec. (a)(1).
1980—Subsec. (a)(2)(A).
Subsec. (c)(3).
Subsec. (f).
1978—Subsec. (a)(2)(A).
1977—Subsec. (a)(1)(D).
Subsec. (a)(3).
Subsec. (b)(2)(C).
Subsec. (b)(2)(F).
Subsec. (b)(2)(G).
Subsec. (c)(2).
1972—Subsec. (a)(1).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (a)(2)(D).
Subsec. (b).
Subsec. (c).
Subsec. (d).
1968—Subsec. (a)(2)(A).
Subsec. (a)(2)(C).
Subsec. (e).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2020 Amendment
Amendment by section 125(b)(1), (2)(A) of
Effective Date of 2018 Amendment
Amendment by
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2010 Amendment
Amendment by section 6406(b) of
Effective Date of 2008 Amendment
Amendment by
Effective Date of 2003 Amendment
Amendment by section 505(b) of
Amendment by section 932(b), (c)(1) of
"(1)
"(2)
"(3)
Effective Date of 2000 Amendment
Amendment by
Effective Date of 1999 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by
Amendment by section 4201(c)(1) of
Amendment by section 4302(a) of
Amendment by section 4321(b) of
Amendment by section 4432(b)(5)(F) of
Amendment by section 4511(a)(2)(D) of
Amendment by section 4541(a)(3) of
Amendments by section 4714(b)(1) of
Effective Date of 1994 Amendment
Amendment by section 147(e)(7) of
Amendment by section 156(a)(2)(E) of
Amendment by
Effective Date of 1990 Amendment
Amendment by section 4157(c)(2) of
Amendment by section 4162(b)(2) of
Amendment by section 4206(a) of
Effective Date of 1989 Amendment
Amendment by section 6112(e)(3) of
Amendment by section 101(a) of
Amendment by section 201(a) of
Effective Date of 1988 Amendment
Amendment by section 608(d)(3)(F), (19)(A) of
Amendment by section 104(d)(5) of
Amendment by section 202(h)(1) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4012(a) of
Amendment by section 4062(d)(4) of
Amendment by section 4212(e)(4) of
Amendment by
Effective Date of 1986 Amendment
Amendment by
Amendment by section 9320(h)(2) of
Amendment by section 9337(c)(2) of
Amendment by section 9343(c)(2), (3) of
Amendment by section 9121(a) of
Amendment by section 9403(b) of
Effective Date of 1984 Amendment
Amendment by section 2303(f) of
Amendment by section 2315(d) of
Amendment by section 2321(c) of
Amendment by section 2323(b)(3) of
Amendment by section 2335(d) of
Amendment by section 2347(a) of
Amendment by section 2354(b)(33), (34) of
Effective Date of 1983 Amendment
Amendment by section 602(f)(2) of
Subsec. (a)(1)(F) to (H) of this section, as added by section 602(f)(1)(C) of
Amendment by section 309(a)(5) of
Amendment by section 309(b)(11) of
Effective Date of 1982 Amendment
Amendment by section 122(g)(5), (6) of
Amendment by section 128(a)(5) of
Amendment by section 128(d)(4) of
Amendment by section 144 of
Effective Date of 1980 Amendment
Amendment by
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1977 Amendment
"(1) The amendments made by this section [amending this section and
"(2) In the case of a State plan for medical assistance under title XIX of the Social Security Act [
Amendment by section 3(b) of
Amendment by section 8(b) of
Amendment by section 13(b)(3) of
Effective Date of 1972 Amendment
Amendment by section 223(e), (g) of
Amendment by section 227(d)(2) of
Amendment by section 281(c) of
Effective Date of 1968 Amendment
Amendment by section 129(c)(12) of
Amendment by section 133(c) of
Amendment by section 135(b) of
Regulations
Rule of Construction
Nothing in section 102 of div. BB of
Disclosure of Medicare Terminated Providers and Suppliers to States
Office of the Inspector General Report on Compliance With and Enforcement of National Standards on Culturally and Linguistically Appropriate Services (CLAS) in Medicare
"(a)
"(1) the extent to which Medicare providers and plans are complying with the Office for Civil Rights' Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons and the Office of Minority Health's Culturally and Linguistically Appropriate Services Standards in health care; and
"(2) a description of the costs associated with or savings related to the provision of language services.
Such report shall include recommendations on improving compliance with CLAS Standards and recommendations on improving enforcement of CLAS Standards.
"(b)
GAO Study and Report on the Propagation of Concierge Care
"(a)
"(1)
"(A) is used by medicare beneficiaries (as defined in section 1802(b)(5)(A) of the Social Security Act (
"(B) has impacted upon the access of medicare beneficiaries (as so defined) to items and services for which reimbursement is provided under the medicare program under title XVIII of the Social Security Act (
"(2)
"(A) charges a membership fee or another incidental fee to an individual desiring to receive the health care item or service from such physician, practitioner, or other individual; or
"(B) requires the individual desiring to receive the health care item or service from such physician, practitioner, or other individual to purchase an item or service.
"(b)
Effect on State Law
Reports to Congress on Number of Hospitals Terminating or Not Renewing Provider Agreements
"(1) The Secretary of Health and Human Services shall periodically submit to the Congress a report on the number of hospitals that have terminated or failed to renew an agreement under section 1866 of the Social Security Act [
"(2) Not later than October 1, 1987, the Administrator of Veterans' Affairs shall submit to the Committees on Veterans' Affairs of the Senate and House of Representatives a report regarding implementation of this section [amending this section]. Thereafter, the Administrator shall notify such committees if any hospital terminates or fails to renew an agreement described in paragraph (1) for the reasons described in that paragraph."
[For termination, effective May 15, 2000, of provisions of law requiring submittal to Congress of any annual, semiannual, or other regular periodic report listed in House Document No. 103–7 (in which item 7 on page 96 identifies a report on "Hospitals that have terminated or failed to renew an agreement under section 1866 of Social Security Act as a result of the additional conditions imposed" authorized by
[For termination, effective May 15, 2000, of provisions of law requiring submittal to Congress of any annual, semiannual, or other regular periodic report listed in House Document No. 103–7 (in which item 7 on page 96 identifies a report on "Hospitals that have terminated or failed to renew an agreement under section 1866 of Social Security Act as a result of the additional conditions imposed" authorized by
Delay in Implementation of Requirement That Hospitals Maintain Agreements With Utilization and Quality Control Peer Review Organization
Interim Waiver in Certain Cases of Billing Rule for Items and Services Other Than Physicians' Services
For authority to waive the requirements of subsec. (a)(1)(H) of this section for any cost period prior to Oct. 1, 1986, where immediate compliance would threaten the stability of patient care, see section 602(k) of
Private Sector Review Initiative
"(a) The Secretary of Health and Human Services shall undertake an initiative to improve medical review by intermediaries and carriers under title XVIII of the Social Security Act [
"(b) Where such review activity results in the denial of payment to providers of services under title XVIII of the Social Security Act [
Agreements Filed and Accepted Prior to Oct. 30, 1972, Deemed To Be for Specified Term Ending Dec. 31, 1973
1 See References in Text note below.
2 So in original. The comma probably should be preceded by a closing parenthesis.
3 So in original. Probably should be preceded by "section".
4 So in original. Probably should be subsection "(a)(1)(V)".
5 So in original. Probably should refer to section 1395i–3(c)(1)(E).
6 So in original. Probably should be a comma.
§1395cc–1. Demonstration of application of physician volume increases to group practices
(a) Demonstration program authorized
(1) In general
The Secretary shall conduct demonstration projects to test and, if proven effective, expand the use of incentives to health care groups participating in the program under this subchapter that—
(A) encourage coordination of the care furnished to individuals under the programs under parts A and B by institutional and other providers, practitioners, and suppliers of health care items and services;
(B) encourage investment in administrative structures and processes to ensure efficient service delivery; and
(C) reward physicians for improving health outcomes.
Such projects shall focus on the efficiencies of furnishing health care in a group-practice setting as compared to the efficiencies of furnishing health care in other health care delivery systems.
(2) Administration by contract
Except as otherwise specifically provided, the Secretary may administer the program under this section in accordance with
(3) Definitions
For purposes of this section, terms have the following meanings:
(A) Physician
Except as the Secretary may otherwise provide, the term "physician" means any individual who furnishes services which may be paid for as physicians' services under this subchapter.
(B) Health care group
The term "health care group" means a group of physicians (as defined in subparagraph (A)) organized at least in part for the purpose of providing physicians' services under this subchapter. As the Secretary finds appropriate, a health care group may include a hospital and any other individual or entity furnishing items or services for which payment may be made under this subchapter that is affiliated with the health care group under an arrangement structured so that such individual or entity participates in a demonstration under this section and will share in any bonus earned under subsection (d).
(b) Eligibility criteria
(1) In general
The Secretary is authorized to establish criteria for health care groups eligible to participate in a demonstration under this section, including criteria relating to numbers of health care professionals in, and of patients served by, the group, scope of services provided, and quality of care.
(2) Payment method
A health care group participating in the demonstration under this section shall agree with respect to services furnished to beneficiaries within the scope of the demonstration (as determined under subsection (c))—
(A) to be paid on a fee-for-service basis; and
(B) that payment with respect to all such services furnished by members of the health care group to such beneficiaries shall (where determined appropriate by the Secretary) be made to a single entity.
(3) Data reporting
A health care group participating in a demonstration under this section shall report to the Secretary such data, at such times and in such format as the Secretary requires, for purposes of monitoring and evaluation of the demonstration under this section.
(c) Patients within scope of demonstration
(1) In general
The Secretary shall specify, in accordance with this subsection, the criteria for identifying those patients of a health care group who shall be considered within the scope of the demonstration under this section for purposes of application of subsection (d) and for assessment of the effectiveness of the group in achieving the objectives of this section.
(2) Other criteria
The Secretary may establish additional criteria for inclusion of beneficiaries within a demonstration under this section, which may include frequency of contact with physicians in the group or other factors or criteria that the Secretary finds to be appropriate.
(3) Notice requirements
In the case of each beneficiary determined to be within the scope of a demonstration under this section with respect to a specific health care group, the Secretary shall ensure that such beneficiary is notified of the incentives, and of any waivers of coverage or payment rules, applicable to such group under such demonstration.
(d) Incentives
(1) Performance target
The Secretary shall establish for each health care group participating in a demonstration under this section—
(A) a base expenditure amount, equal to the average total payments under parts A and B for patients served by the health care group on a fee-for-service basis in a base period determined by the Secretary; and
(B) an annual per capita expenditure target for patients determined to be within the scope of the demonstration, reflecting the base expenditure amount adjusted for risk and expected growth rates.
(2) Incentive bonus
The Secretary shall pay to each participating health care group (subject to paragraph (4)) a bonus for each year under the demonstration equal to a portion of the medicare savings realized for such year relative to the performance target.
(3) Additional bonus for process and outcome improvements
At such time as the Secretary has established appropriate criteria based on evidence the Secretary determines to be sufficient, the Secretary shall also pay to a participating health care group (subject to paragraph (4)) an additional bonus for a year, equal to such portion as the Secretary may designate of the saving to the program under this subchapter resulting from process improvements made by and patient outcome improvements attributable to activities of the group.
(4) Limitation
The Secretary shall limit bonus payments under this section as necessary to ensure that the aggregate expenditures under this subchapter (inclusive of bonus payments) with respect to patients within the scope of the demonstration do not exceed the amount which the Secretary estimates would be expended if the demonstration projects under this section were not implemented.
(Aug. 14, 1935, ch. 531, title XVIII, §1866A, as added
Statutory Notes and Related Subsidiaries
GAO Report
§1395cc–2. Provisions for administration of demonstration program
(a) General administrative authority
(1) Beneficiary eligibility
Except as otherwise provided by the Secretary, an individual shall only be eligible to receive benefits under the program under
(A) is enrolled under the program under part B and entitled to benefits under part A; and
(B) is not enrolled in a Medicare+Choice plan under part C, an eligible organization under a contract under
(2) Secretary's discretion as to scope of program
The Secretary may limit the implementation of the demonstration program to—
(A) a geographic area (or areas) that the Secretary designates for purposes of the program, based upon such criteria as the Secretary finds appropriate;
(B) a subgroup (or subgroups) of beneficiaries or individuals and entities furnishing items or services (otherwise eligible to participate in the program), selected on the basis of the number of such participants that the Secretary finds consistent with the effective and efficient implementation of the program;
(C) an element (or elements) of the program that the Secretary determines to be suitable for implementation; or
(D) any combination of any of the limits described in subparagraphs (A) through (C).
(3) Voluntary receipt of items and services
Items and services shall be furnished to an individual under the demonstration program only at the individual's election.
(4) Agreements
The Secretary is authorized to enter into agreements with individuals and entities to furnish health care items and services to beneficiaries under the demonstration program.
(5) Program standards and criteria
The Secretary shall establish performance standards for the demonstration program including, as applicable, standards for quality of health care items and services, cost-effectiveness, beneficiary satisfaction, and such other factors as the Secretary finds appropriate. The eligibility of individuals or entities for the initial award, continuation, and renewal of agreements to provide health care items and services under the program shall be conditioned, at a minimum, on performance that meets or exceeds such standards.
(6) Administrative review of decisions affecting individuals and entities furnishing services
An individual or entity furnishing services under the demonstration program shall be entitled to a review by the program administrator (or, if the Secretary has not contracted with a program administrator, by the Secretary) of a decision not to enter into, or to terminate, or not to renew, an agreement with the entity to provide health care items or services under the program.
(7) Secretary's review of marketing materials
An agreement with an individual or entity furnishing services under the demonstration program shall require the individual or entity to guarantee that it will not distribute materials that market items or services under the program without the Secretary's prior review and approval.
(8) Payment in full
(A) In general
Except as provided in subparagraph (B), an individual or entity receiving payment from the Secretary under a contract or agreement under the demonstration program shall agree to accept such payment as payment in full, and such payment shall be in lieu of any payments to which the individual or entity would otherwise be entitled under this subchapter.
(B) Collection of deductibles and coinsurance
Such individual or entity may collect any applicable deductible or coinsurance amount from a beneficiary.
(b) Contracts for program administration
(1) In general
The Secretary may administer the demonstration program through a contract with a program administrator in accordance with the provisions of this subsection.
(2) Scope of program administrator contracts
The Secretary may enter into such contracts for a limited geographic area, or on a regional or national basis.
(3) Eligible contractors
The Secretary may contract for the administration of the program with—
(A) an entity that, under a contract under
(B) any other entity with substantial experience in managing the type of program concerned.
(4) Contract award, duration, and renewal
(A) In general
A contract under this subsection shall be for an initial term of up to three years, renewable for additional terms of up to three years.
(B) Noncompetitive award and renewal for entities administering part A or part B payments
The Secretary may enter or renew a contract under this subsection with an entity described in paragraph (3)(A) without regard to the requirements of
(5) Applicability of Federal Acquisition Regulation
The Federal Acquisition Regulation shall apply to program administration contracts under this subsection.
(6) Performance standards
The Secretary shall establish performance standards for the program administrator including, as applicable, standards for the quality and cost-effectiveness of the program administered, and such other factors as the Secretary finds appropriate. The eligibility of entities for the initial award, continuation, and renewal of program administration contracts shall be conditioned, at a minimum, on performance that meets or exceeds such standards.
(7) Functions of program administrator
A program administrator shall perform any or all of the following functions, as specified by the Secretary:
(A) Agreements with entities furnishing health care items and services
Determine the qualifications of entities seeking to enter or renew agreements to provide services under the demonstration program, and as appropriate enter or renew (or refuse to enter or renew) such agreements on behalf of the Secretary.
(B) Establishment of payment rates
Negotiate or otherwise establish, subject to the Secretary's approval, payment rates for covered health care items and services.
(C) Payment of claims or fees
Administer payments for health care items or services furnished under the program.
(D) Payment of bonuses
Using such guidelines as the Secretary shall establish, and subject to the approval of the Secretary, make bonus payments as described in subsection (c)(2)(B) to entities furnishing items or services for which payment may be made under the program.
(E) Oversight
Monitor the compliance of individuals and entities with agreements under the program with the conditions of participation.
(F) Administrative review
Conduct reviews of adverse determinations specified in subsection (a)(6).
(G) Review of marketing materials
Conduct a review of marketing materials proposed by an entity furnishing services under the program.
(H) Additional functions
Perform such other functions as the Secretary may specify.
(8) Limitation of liability
The provisions of
(9) Information sharing
Notwithstanding
(c) Rules applicable to both program agreements and program administration contracts
(1) Records, reports, and audits
The Secretary is authorized to require entities with agreements to provide health care items or services under the demonstration program, and entities with program administration contracts under subsection (b), to maintain adequate records, to afford the Secretary access to such records (including for audit purposes), and to furnish such reports and other materials (including audited financial statements and performance data) as the Secretary may require for purposes of implementation, oversight, and evaluation of the program and of individuals' and entities' effectiveness in performance of such agreements or contracts.
(2) Bonuses
Notwithstanding any other provision of law, but subject to subparagraph (B)(ii), the Secretary may make bonus payments under the demonstration program from the Federal Health Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund in amounts that do not exceed the amounts authorized under the program in accordance with the following:
(A) Payments to program administrators
The Secretary may make bonus payments under the program to program administrators.
(B) Payments to entities furnishing services
(i) In general
Subject to clause (ii), the Secretary may make bonus payments to individuals or entities furnishing items or services for which payment may be made under the demonstration program, or may authorize the program administrator to make such bonus payments in accordance with such guidelines as the Secretary shall establish and subject to the Secretary's approval.
(ii) Limitations
The Secretary may condition such payments on the achievement of such standards related to efficiency, improvement in processes or outcomes of care, or such other factors as the Secretary determines to be appropriate.
(3) Antidiscrimination limitation
The Secretary shall not enter into an agreement with an entity to provide health care items or services under the demonstration program, or with an entity to administer the program, unless such entity guarantees that it will not deny, limit, or condition the coverage or provision of benefits under the program, for individuals eligible to be enrolled under such program, based on any health status-related factor described in section 2702(a)(1) 1 of the Public Health Service Act.
(d) Limitations on judicial review
The following actions and determinations with respect to the demonstration program shall not be subject to review by a judicial or administrative tribunal:
(1) Limiting the implementation of the program under subsection (a)(2).
(2) Establishment of program participation standards under subsection (a)(5) or the denial or termination of, or refusal to renew, an agreement with an entity to provide health care items and services under the program.
(3) Establishment of program administration contract performance standards under subsection (b)(6), the refusal to renew a program administration contract, or the noncompetitive award or renewal of a program administration contract under subsection (b)(4)(B).
(4) Establishment of payment rates, through negotiation or otherwise, under a program agreement or a program administration contract.
(5) A determination with respect to the program (where specifically authorized by the program authority or by subsection (c)(2))—
(A) as to whether cost savings have been achieved, and the amount of savings; or
(B) as to whether, to whom, and in what amounts bonuses will be paid.
(e) Application limited to parts A and B
None of the provisions of this section or of the demonstration program shall apply to the programs under part C.
(f) Reports to Congress
Not later than two years after December 21, 2000, and biennially thereafter for six years, the Secretary shall report to Congress on the use of authorities under the demonstration program. Each report shall address the impact of the use of those authorities on expenditures, access, and quality under the programs under this subchapter.
(Aug. 14, 1935, ch. 531, title XVIII, §1866B, as added
Editorial Notes
References in Text
Section 2702 of the Public Health Service Act, referred to in subsec. (c)(3), is section 2702 of act July 1, 1944, which was classified to
Codification
In subsec. (b)(4)(B), "
Amendments
2003—Subsec. (b)(7)(D).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
1 See References in Text note below.
§1395cc–3. Health care quality demonstration program
(a) Definitions
In this section:
(1) Beneficiary
The term "beneficiary" means an individual who is entitled to benefits under part A and enrolled under part B, including any individual who is enrolled in a Medicare Advantage plan under part C.
(2) Health care group
(A) In general
The term "health care group" means—
(i) a group of physicians that is organized at least in part for the purpose of providing physician's services under this subchapter;
(ii) an integrated health care delivery system that delivers care through coordinated hospitals, clinics, home health agencies, ambulatory surgery centers, skilled nursing facilities, rehabilitation facilities and clinics, and employed, independent, or contracted physicians; or
(iii) an organization representing regional coalitions of groups or systems described in clause (i) or (ii).
(B) Inclusion
As the Secretary determines appropriate, a health care group may include a hospital or any other individual or entity furnishing items or services for which payment may be made under this subchapter that is affiliated with the health care group under an arrangement structured so that such hospital, individual, or entity participates in a demonstration project under this section.
(3) Physician
Except as otherwise provided for by the Secretary, the term "physician" means any individual who furnishes services that may be paid for as physicians' services under this subchapter.
(b) Demonstration projects
The Secretary shall establish a demonstration program under which the Secretary shall approve demonstration projects that examine health delivery factors that encourage the delivery of improved quality in patient care, including—
(1) the provision of incentives to improve the safety of care provided to beneficiaries;
(2) the appropriate use of best practice guidelines by providers and services by beneficiaries;
(3) reduced scientific uncertainty in the delivery of care through the examination of variations in the utilization and allocation of services, and outcomes measurement and research;
(4) encourage shared decision making between providers and patients;
(5) the provision of incentives for improving the quality and safety of care and achieving the efficient allocation of resources;
(6) the appropriate use of culturally and ethnically sensitive health care delivery; and
(7) the financial effects on the health care marketplace of altering the incentives for care delivery and changing the allocation of resources.
(c) Administration by contract
(1) In general
Except as otherwise provided in this section, the Secretary may administer the demonstration program established under this section in a manner that is similar to the manner in which the demonstration program established under
(2) Alternative payment systems
A health care group that receives assistance under this section may, with respect to the demonstration project to be carried out with such assistance, include proposals for the use of alternative payment systems for items and services provided to beneficiaries by the group that are designed to—
(A) encourage the delivery of high quality care while accomplishing the objectives described in subsection (b); and
(B) streamline documentation and reporting requirements otherwise required under this subchapter.
(3) Benefits
A health care group that receives assistance under this section may, with respect to the demonstration project to be carried out with such assistance, include modifications to the package of benefits available under the original medicare fee-for-service program under parts A and B or the package of benefits available through a Medicare Advantage plan under part C. The criteria employed under the demonstration program under this section to evaluate outcomes and determine best practice guidelines and incentives shall not be used as a basis for the denial of medicare benefits under the demonstration program to patients against their wishes (or if the patient is incompetent, against the wishes of the patient's surrogate) on the basis of the patient's age or expected length of life or of the patient's present or predicted disability, degree of medical dependency, or quality of life.
(d) Eligibility criteria
To be eligible to receive assistance under this section, an entity shall—
(1) be a health care group;
(2) meet quality standards established by the Secretary, including—
(A) the implementation of continuous quality improvement mechanisms that are aimed at integrating community-based support services, primary care, and referral care;
(B) the implementation of activities to increase the delivery of effective care to beneficiaries;
(C) encouraging patient participation in preference-based decisions;
(D) the implementation of activities to encourage the coordination and integration of medical service delivery; and
(E) the implementation of activities to measure and document the financial impact on the health care marketplace of altering the incentives of health care delivery and changing the allocation of resources; and
(3) meet such other requirements as the Secretary may establish.
(e) Waiver authority
The Secretary may waive such requirements of this subchapter and subchapter XI as may be necessary to carry out the purposes of the demonstration program established under this section.
(f) Budget neutrality
With respect to the period of the demonstration program under subsection (b), the aggregate expenditures under this subchapter for such period shall not exceed the aggregate expenditures that would have been expended under this subchapter if the program established under this section had not been implemented.
(g) Notice requirements
In the case of an individual that receives health care items or services under a demonstration program carried out under this section, the Secretary shall ensure that such individual is notified of any waivers of coverage or payment rules that are applicable to such individual under this subchapter as a result of the participation of the individual in such program.
(h) Participation and support by Federal agencies
In carrying out the demonstration program under this section, the Secretary may direct—
(1) the Director of the National Institutes of Health to expand the efforts of the Institutes to evaluate current medical technologies and improve the foundation for evidence-based practice;
(2) the Administrator of the Agency for Healthcare Research and Quality to, where possible and appropriate, use the program under this section as a laboratory for the study of quality improvement strategies and to evaluate, monitor, and disseminate information relevant to such program; and
(3) the Administrator of the Centers for Medicare & Medicaid Services and the Administrator of the Center for Medicare Choices to support linkages of relevant medicare data to registry information from participating health care groups for the beneficiary populations served by the participating groups, for analysis supporting the purposes of the demonstration program, consistent with the applicable provisions of the Health Insurance Portability and Accountability Act of 1996.
(Aug. 14, 1935, ch. 531, title XVIII, §1866C, as added
Editorial Notes
References in Text
The Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (h)(3), is
Amendments
2010—Subsec. (b).
Subsec. (f).
§1395cc–4. National pilot program on payment bundling
(a) Implementation
(1) In general
The Secretary shall establish a pilot program for integrated care during an episode of care provided to an applicable beneficiary around a hospitalization in order to improve the coordination, quality, and efficiency of health care services under this subchapter.
(2) Definitions
In this section:
(A) Applicable beneficiary
The term "applicable beneficiary" means an individual who—
(i) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B of such subchapter, but not enrolled under part C or a PACE program under
(ii) is admitted to a hospital for an applicable condition.
(B) Applicable condition
The term "applicable condition" means 1 or more of 10 conditions selected by the Secretary. In selecting conditions under the preceding sentence, the Secretary shall take into consideration the following factors:
(i) Whether the conditions selected include a mix of chronic and acute conditions.
(ii) Whether the conditions selected include a mix of surgical and medical conditions.
(iii) Whether a condition is one for which there is evidence of an opportunity for providers of services and suppliers to improve the quality of care furnished while reducing total expenditures under this subchapter.
(iv) Whether a condition has significant variation in—
(I) the number of readmissions; and
(II) the amount of expenditures for post-acute care spending under this subchapter.
(v) Whether a condition is high-volume and has high post-acute care expenditures under this subchapter.
(vi) Which conditions the Secretary determines are most amenable to bundling across the spectrum of care given practice patterns under this subchapter.
(C) Applicable services
The term "applicable services" means the following:
(i) Acute care inpatient services.
(ii) Physicians' services delivered in and outside of an acute care hospital setting.
(iii) Outpatient hospital services, including emergency department services.
(iv) Post-acute care services, including home health services, skilled nursing services, inpatient rehabilitation services, and inpatient hospital services furnished by a long-term care hospital.
(v) Other services the Secretary determines appropriate.
(D) Episode of care
(i) In general
Subject to clause (ii), the term "episode of care" means, with respect to an applicable condition and an applicable beneficiary, the period that includes—
(I) the 3 days prior to the admission of the applicable beneficiary to a hospital for the applicable condition;
(II) the length of stay of the applicable beneficiary in such hospital; and
(III) the 30 days following the discharge of the applicable beneficiary from such hospital.
(ii) Establishment of period by the Secretary
The Secretary, as appropriate, may establish a period (other than the period described in clause (i)) for an episode of care under the pilot program.
(E) Physicians' services
The term "physicians' services" has the meaning given such term in
(F) Pilot program
The term "pilot program" means the pilot program under this section.
(G) Provider of services
The term "provider of services" has the meaning given such term in
(H) Readmission
The term "readmission" has the meaning given such term in
(I) Supplier
The term "supplier" has the meaning given such term in
(3) Deadline for implementation
The Secretary shall establish the pilot program not later than January 1, 2013.
(b) Developmental phase
(1) Determination of patient assessment instrument
The Secretary shall determine which patient assessment instrument (such as the Continuity Assessment Record and Evaluation (CARE) tool) shall be used under the pilot program to evaluate the applicable condition of an applicable beneficiary for purposes of determining the most clinically appropriate site for the provision of post-acute care to the applicable beneficiary.
(2) Development of quality measures for an episode of care and for post-acute care
(A) In general
The Secretary, in consultation with the Agency for Healthcare Research and Quality and the entity with a contract under
(i) for episodes of care; and
(ii) for post-acute care.
(B) Site-neutral post-acute care quality measures
Any quality measures developed under subparagraph (A)(ii) shall be site-neutral.
(C) Coordination with quality measure development and endorsement procedures
The Secretary shall ensure that the development of quality measures under subparagraph (A) is done in a manner that is consistent with the measures developed and endorsed under section 1 1395aaa and 1395aaa–1 of this title that are applicable to all post-acute care settings.
(c) Details
(1) Duration
(A) In general
Subject to subparagraph (B), the pilot program shall be conducted for a period of 5 years.
(B) Expansion
The Secretary may, at any point after January 1, 2016, expand the duration and scope of the pilot program, to the extent determined appropriate by the Secretary, if—
(i) the Secretary determines that such expansion is expected to—
(I) reduce spending under this subchapter without reducing the quality of care; or
(II) improve the quality of care and reduce spending;
(ii) the Chief Actuary of the Centers for Medicare & Medicaid Services certifies that such expansion would reduce program spending under this subchapter; and
(iii) the Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under this subchapter for individuals.
(2) Participating providers of services and suppliers
(A) In general
An entity comprised of providers of services and suppliers, including a hospital, a physician group, a skilled nursing facility, and a home health agency, who are otherwise participating under this subchapter, may submit an application to the Secretary to provide applicable services to applicable individuals under this section.
(B) Requirements
The Secretary shall develop requirements for entities to participate in the pilot program under this section. Such requirements shall ensure that applicable beneficiaries have an adequate choice of providers of services and suppliers under the pilot program.
(3) Payment methodology
(A) In general
(i) Establishment of payment methods
The Secretary shall develop payment methods for the pilot program for entities participating in the pilot program. Such payment methods may include bundled payments and bids from entities for episodes of care. The Secretary shall make payments to the entity for services covered under this section.
(ii) No additional program expenditures
Payments under this section for applicable items and services under this subchapter (including payment for services described in subparagraph (B)) for applicable beneficiaries for a year shall be established in a manner that does not result in spending more for such entity for such beneficiaries than would otherwise be expended for such entity for such beneficiaries for such year if the pilot program were not implemented, as estimated by the Secretary.
(B) Inclusion of certain services
A payment methodology tested under the pilot program shall include payment for the furnishing of applicable services and other appropriate services, such as care coordination, medication reconciliation, discharge planning, transitional care services, and other patient-centered activities as determined appropriate by the Secretary.
(C) Bundled payments
(i) In general
A bundled payment under the pilot program shall—
(I) be comprehensive, covering the costs of applicable services and other appropriate services furnished to an individual during an episode of care (as determined by the Secretary); and
(II) be made to the entity which is participating in the pilot program.
(ii) Requirement for provision of applicable services and other appropriate services
Applicable services and other appropriate services for which payment is made under this subparagraph shall be furnished or directed by the entity which is participating in the pilot program.
(D) Payment for post-acute care services after the episode of care
The Secretary shall establish procedures, in the case where an applicable beneficiary requires continued post-acute care services after the last day of the episode of care, under which payment for such services shall be made.
(4) Quality measures
(A) In general
The Secretary shall establish quality measures (including quality measures of process, outcome, and structure) related to care provided by entities participating in the pilot program. Quality measures established under the preceding sentence shall include measures of the following:
(i) Functional status improvement.
(ii) Reducing rates of avoidable hospital readmissions.
(iii) Rates of discharge to the community.
(iv) Rates of admission to an emergency room after a hospitalization.
(v) Incidence of health care acquired infections.
(vi) Efficiency measures.
(vii) Measures of patient-centeredness of care.
(viii) Measures of patient perception of care.
(ix) Other measures, including measures of patient outcomes, determined appropriate by the Secretary.
(B) Reporting on quality measures
(i) In general
A entity shall submit data to the Secretary on quality measures established under subparagraph (A) during each year of the pilot program (in a form and manner, subject to clause (iii), specified by the Secretary).
(ii) Submission of data through electronic health record
To the extent practicable, the Secretary shall specify that data on measures be submitted under clause (i) through the use of an qualified electronic health record (as defined in
(d) Waiver
The Secretary may waive such provisions of this subchapter and subchapter XI as may be necessary to carry out the pilot program.
(e) Independent evaluation and reports on pilot program
(1) Independent evaluation
The Secretary shall conduct an independent evaluation of the pilot program, including the extent to which the pilot program has—
(A) improved quality measures established under subsection (c)(4)(A);
(B) improved health outcomes;
(C) improved applicable beneficiary access to care; and
(D) reduced spending under this subchapter.
(2) Reports
(A) Interim report
Not later than 2 years after the implementation of the pilot program, the Secretary shall submit to Congress a report on the initial results of the independent evaluation conducted under paragraph (1).
(B) Final report
Not later than 3 years after the implementation of the pilot program, the Secretary shall submit to Congress a report on the final results of the independent evaluation conducted under paragraph (1).
(f) Consultation
The Secretary shall consult with representatives of small rural hospitals, including critical access hospitals (as defined in
(g) Application of pilot program to continuing care hospitals
(1) In general
In conducting the pilot program, the Secretary shall apply the provisions of the program so as to separately pilot test the continuing care hospital model.
(2) Special rules
In pilot testing the continuing care hospital model under paragraph (1), the following rules shall apply:
(A) Such model shall be tested without the limitation to the conditions selected under subsection (a)(2)(B).
(B) Notwithstanding subsection (a)(2)(D), an episode of care shall be defined as the full period that a patient stays in the continuing care hospital plus the first 30 days following discharge from such hospital.
(3) Continuing care hospital defined
In this subsection, the term "continuing care hospital" means an entity that has demonstrated the ability to meet patient care and patient safety standards and that provides under common management the medical and rehabilitation services provided in inpatient rehabilitation hospitals and units (as defined in
(h) Administration
(Aug. 14, 1935, ch. 531, title XVIII, §1866D, as added and amended
Editorial Notes
References in Text
Parts A, B, and C, referred to in subsec. (a)(2)(A)(i), are classified to sections 1395c et seq., 1395j et seq., and 1395w–21 et seq., respectively, of this title.
Codification
Another section 1866D of act Aug. 14, 1935, was renumbered section 1866E and is classified to
Amendments
2010—
Subsec. (a)(2)(B).
Subsec. (c)(1)(B).
Subsec. (g).
1 So in original. Probably should be "sections".
2 See References in Text note below.
§1395cc–5. Independence at home medical practice demonstration program
(a) Establishment
(1) In general
The Secretary shall conduct a demonstration program (in this section referred to as the "demonstration program") to test a payment incentive and service delivery model that utilizes physician and nurse practitioner directed home-based primary care teams designed to reduce expenditures and improve health outcomes in the provision of items and services under this subchapter to applicable beneficiaries (as defined in subsection (d)).
(2) Requirement
The demonstration program shall test whether a model described in paragraph (1), which is accountable for providing comprehensive, coordinated, continuous, and accessible care to high-need populations at home and coordinating health care across all treatment settings, results in—
(A) reducing preventable hospitalizations;
(B) preventing hospital readmissions;
(C) reducing emergency room visits;
(D) improving health outcomes commensurate with the beneficiaries' stage of chronic illness;
(E) improving the efficiency of care, such as by reducing duplicative diagnostic and laboratory tests;
(F) reducing the cost of health care services covered under this subchapter; and
(G) achieving beneficiary and family caregiver satisfaction.
(b) Independence at home medical practice
(1) Independence at home medical practice defined
In this section:
(A) In general
The term "independence at home medical practice" means a legal entity that—
(i) is comprised of an individual physician or nurse practitioner or group of physicians and nurse practitioners that provides care as part of a team that includes physicians, nurses, physician assistants, pharmacists, and other health and social services staff as appropriate who have experience providing home-based primary care to applicable beneficiaries, make in-home visits, and are available 24 hours per day, 7 days per week to carry out plans of care that are tailored to the individual beneficiary's chronic conditions and designed to achieve the results in subsection (a);
(ii) is organized at least in part for the purpose of providing physicians' services;
(iii) has documented experience in providing home-based primary care services to high-cost chronically ill beneficiaries, as determined appropriate by the Secretary;
(iv) furnishes services to at least 200 applicable beneficiaries (as defined in subsection (d)) during each year of the demonstration program;
(v) has entered into an agreement with the Secretary;
(vi) uses electronic health information systems, remote monitoring, and mobile diagnostic technology; and
(vii) meets such other criteria as the Secretary determines to be appropriate to participate in the demonstration program.
The entity shall report on quality measures (in such form, manner, and frequency as specified by the Secretary, which may be for the group, for providers of services and suppliers, or both) and report to the Secretary (in a form, manner, and frequency as specified by the Secretary) such data as the Secretary determines appropriate to monitor and evaluate the demonstration program.
(B) Physician
The term "physician" includes, except as the Secretary may otherwise provide, any individual who furnishes services for which payment may be made as physicians' services and has the medical training or experience to fulfill the physician's role described in subparagraph (A)(i).
(2) Participation of nurse practitioners and physician assistants
Nothing in this section shall be construed to prevent a nurse practitioner or physician assistant from participating in, or leading, a home-based primary care team as part of an independence at home medical practice if—
(A) all the requirements of this section are met;
(B) the nurse practitioner or physician assistant, as the case may be, is acting consistent with State law; and
(C) the nurse practitioner or physician assistant has the medical training or experience to fulfill the nurse practitioner or physician assistant role described in paragraph (1)(A)(i).
(3) Inclusion of providers and practitioners
Nothing in this subsection shall be construed as preventing an independence at home medical practice from including a provider of services or a participating practitioner described in
(4) Quality and performance standards
The Secretary shall develop quality performance standards for independence at home medical practices participating in the demonstration program.
(c) Payment methodology
(1) Establishment of target spending level
The Secretary shall establish an estimated annual spending target, for the amount the Secretary estimates would have been spent in the absence of the demonstration, for items and services covered under parts A and B furnished to applicable beneficiaries for each qualifying independence at home medical practice under this section. Such spending targets shall be determined on a per capita basis. Such spending targets shall include a risk corridor that takes into account normal variation in expenditures for items and services covered under parts A and B furnished to such beneficiaries with the size of the corridor being related to the number of applicable beneficiaries furnished services by each independence at home medical practice. The spending targets may also be adjusted for other factors as the Secretary determines appropriate.
(2) Incentive payments
Subject to performance on quality measures, a qualifying independence at home medical practice is eligible to receive an incentive payment under this section if actual expenditures for a year for the applicable beneficiaries it enrolls are less than the estimated spending target established under paragraph (1) for such year. An incentive payment for such year shall be equal to a portion (as determined by the Secretary) of the amount by which actual expenditures (including incentive payments under this paragraph) for applicable beneficiaries under parts A and B for such year are estimated to be less than 5 percent less than the estimated spending target for such year, as determined under paragraph (1).
(d) Applicable beneficiaries
(1) Definition
In this section, the term "applicable beneficiary" means, with respect to a qualifying independence at home medical practice, an individual who the practice has determined—
(A) is entitled to benefits under part A and enrolled for benefits under part B;
(B) is not enrolled in a Medicare Advantage plan under part C or a PACE program under
(C) has 2 or more chronic illnesses, such as congestive heart failure, diabetes, other dementias designated by the Secretary, chronic obstructive pulmonary disease, ischemic heart disease, stroke, Alzheimer's Disease and neurodegenerative diseases, and other diseases and conditions designated by the Secretary which result in high costs under this subchapter;
(D) within the past 12 months has had a nonelective hospital admission;
(E) within the past 12 months has received acute or subacute rehabilitation services;
(F) has 2 or more functional dependencies requiring the assistance of another person (such as bathing, dressing, toileting, walking, or feeding); and
(G) meets such other criteria as the Secretary determines appropriate.
(2) Patient election to participate
The Secretary shall determine an appropriate method of ensuring that applicable beneficiaries have agreed to enroll in an independence at home medical practice under the demonstration program. Enrollment in the demonstration program shall be voluntary.
(3) Beneficiary access to services
Nothing in this section shall be construed as encouraging physicians or nurse practitioners to limit applicable beneficiary access to services covered under this subchapter and applicable beneficiaries shall not be required to relinquish access to any benefit under this subchapter as a condition of receiving services from an independence at home medical practice.
(e) Implementation
(1) Starting date
The demonstration program shall begin no later than January 1, 2012. Agreements with an independence at home medical practice under the demonstration program may cover not more than a 10-year period.
(2) No physician duplication in demonstration participation
The Secretary shall not pay an independence at home medical practice under this section that participates in
(3) No beneficiary duplication in demonstration participation
The Secretary shall ensure that no applicable beneficiary enrolled in an independence at home medical practice under this section is participating in the programs under
(4) Preference
In approving an independence at home medical practice, the Secretary shall give preference to practices that are—
(A) located in high-cost areas of the country;
(B) have experience in furnishing health care services to applicable beneficiaries in the home; and
(C) use electronic medical records, health information technology, and individualized plans of care.
(5) Limitation on number of practices
In selecting qualified independence at home medical practices to participate under the demonstration program, the Secretary shall limit the number of such practices so that the number of applicable beneficiaries that may participate in the demonstration program does not exceed 20,000. An applicable beneficiary that participates in the demonstration program by reason of the increase from 10,000 to 15,000 in the preceding sentence pursuant to the amendment made by section 50301(a)(1)(B)(i) of the Advancing Chronic Care, Extenders, and Social Services Act shall be considered in the spending target estimates under paragraph (1) of subsection (c) and the incentive payment calculations under paragraph (2) of such subsection for the sixth through tenth years of such program. An applicable beneficiary that participates in the demonstration program by reason of the increase from 15,000 to 20,000 in the first sentence of this paragraph pursuant to the amendment made by section 105 of division CC of the Consolidated Appropriations Act, 2021 shall be considered in the spending target estimates under paragraph (1) of subsection (c) and the incentive payment calculations under paragraph (2) of such subsection for the eighth through tenth years of such program.
(6) Waiver
The Secretary may waive such provisions of this subchapter and subchapter XI as the Secretary determines necessary in order to implement the demonstration program.
(7) Administration
(f) Evaluation and monitoring
(1) In general
The Secretary shall evaluate each independence at home medical practice under the demonstration program to assess whether the practice achieved the results described in subsection (a).
(2) Monitoring applicable beneficiaries
The Secretary may monitor data on expenditures and quality of services under this subchapter after an applicable beneficiary discontinues receiving services under this subchapter through a qualifying independence at home medical practice.
(g) Reports to Congress
The Secretary shall conduct an independent evaluation of the demonstration program and submit to Congress a final report, including best practices under the demonstration program, including, to the extent practicable, with respect to the use of electronic health information systems, as described in subsection (b)(1)(A)(vi). Such report shall include an analysis of the demonstration program on coordination of care, expenditures under this subchapter, applicable beneficiary access to services, and the quality of health care services provided to applicable beneficiaries.
(h) Funding
For purposes of administering and carrying out the demonstration program, other than for payments for items and services furnished under this subchapter and incentive payments under subsection (c), in addition to funds otherwise appropriated, there shall be transferred to the Secretary for the Center for Medicare & Medicaid Services Program Management Account from the Federal Hospital Insurance Trust Fund under
(i) Termination
(1) Mandatory termination
The Secretary shall terminate an agreement with an independence at home medical practice if—
(A) the Secretary estimates or determines that such practice did not achieve savings for the third of 3 consecutive years under the demonstration program; or
(B) such practice fails to meet quality standards during any year of the demonstration program.
(2) Permissive termination
The Secretary may terminate an agreement with an independence at home medical practice for such other reasons determined appropriate by the Secretary.
(Aug. 14, 1935, ch. 531, title XVIII, §1866E, formerly §1866D, as added and renumbered §1866E,
Editorial Notes
References in Text
Parts A, B, and C, referred to in subsecs. (c) and (d)(1)(A), (B), are classified to sections 1395c et seq., 1395j et seq., and 1395w–21 et seq., respectively, of this title.
Section 50301(a)(1)(B)(i) of the Advancing Chronic Care, Extenders, and Social Services Act, referred to in subsec. (e)(5), probably means section 50301(a)(1)(B)(i) of the Advancing Chronic Care, Extenders, and Social Services (ACCESS) Act, div. E of
Section 105 of division CC of the Consolidated Appropriations Act, 2021, referred to in subsec. (e)(5), is section 105 of div. CC of
Amendments
2020—Subsec. (e)(1).
Subsec. (e)(5).
Subsec. (h).
2018—Subsec. (e)(1).
Subsec. (e)(5).
Subsec. (g).
Subsec. (i)(1)(A).
2015—Subsec. (e)(1).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Effective Date of 2018 Amendment
§1395cc–6. Opioid use disorder treatment demonstration program
(a) Implementation of 4-year demonstration program
(1) In general
Not later than January 1, 2021, the Secretary shall implement a 4-year demonstration program under this subchapter (in this section referred to as the "Program") to increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce expenditures under this subchapter. Under the Program, the Secretary shall make payments under subsection (e) to participants (as defined in subsection (c)(1)(A)) for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams, or arranging for such services to be furnished, to applicable beneficiaries participating in the Program.
(2) Opioid use disorder treatment services
For purposes of this section, the term "opioid use disorder treatment services"—
(A) means, with respect to an applicable beneficiary, services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under
(B) includes—
(i) medication-assisted treatment;
(ii) treatment planning;
(iii) psychiatric, psychological, or counseling services (or any combination of such services), as appropriate;
(iv) social support services, as appropriate; and
(v) care management and care coordination services, including coordination with other providers of services and suppliers not on an opioid use disorder care team.
(b) Program design
(1) In general
The Secretary shall design the Program in such a manner to allow for the evaluation of the extent to which the Program accomplishes the following purposes:
(A) Reduces hospitalizations and emergency department visits.
(B) Increases use of medication-assisted treatment for opioid use disorders.
(C) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV).
(D) Does not increase the total spending on items and services under this subchapter.
(E) Reduces deaths from opioid overdose.
(F) Reduces the utilization of inpatient residential treatment.
(2) Consultation
In designing the Program, including the criteria under subsection (e)(2)(A), the Secretary shall, not later than 3 months after October 24, 2018, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups.
(c) Participants; opioid use disorder care teams
(1) Participants
(A) Definition
In this section, the term "participant" means an entity or individual—
(i) that is otherwise enrolled under this subchapter and that is—
(I) a physician (as defined in
(II) a group practice comprised of at least one physician described in subclause (I);
(III) a hospital outpatient department;
(IV) a federally qualified health center (as defined in
(V) a rural health clinic (as defined in
(VI) a community mental health center (as defined in
(VII) a clinic certified as a certified community behavioral health clinic pursuant to section 223 of the Protecting Access to Medicare Act of 2014; or
(VIII) any other individual or entity specified by the Secretary;
(ii) that applied for and was selected to participate in the Program pursuant to an application and selection process established by the Secretary; and
(iii) that establishes an opioid use disorder care team (as defined in paragraph (2)) through employing or contracting with health care practitioners described in paragraph (2)(A), and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the Program.
(B) Preference
In selecting participants for the Program, the Secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence.
(2) Opioid use disorder care teams
(A) In general
For purposes of this section, the term "opioid use disorder care team" means a team of health care practitioners established by a participant described in paragraph (1)(A) that—
(i) shall include—
(I) at least one physician (as defined in
(II) at least one eligible practitioner (as defined in paragraph (3)), who may be a physician who meets the criterion in subclause (I); and
(ii) may include other practitioners licensed under State law to furnish psychiatric, psychological, counseling, and social services to applicable beneficiaries.
(B) Requirements for receipt of payment under program
In order to receive payments under subsection (e), each participant in the Program shall—
(i) furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services;
(ii) meet minimum criteria, as established by the Secretary; and
(iii) submit to the Secretary, in such form, manner, and frequency as specified by the Secretary, with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team, data and such other information as the Secretary determines appropriate to—
(I) monitor and evaluate the Program;
(II) determine if minimum criteria are met under clause (ii); and
(III) determine the incentive payment under subsection (e).
(3) Eligible practitioner defined
For purposes of this section, the term "eligible practitioner" means a physician or other health care practitioner, such as a nurse practitioner, that—
(A) is enrolled under
(B) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment.
(d) Participation of applicable beneficiaries
(1) Applicable beneficiary defined
In this section, the term "applicable beneficiary" means an individual who—
(A) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B;
(B) is not enrolled in a Medicare Advantage plan under part C;
(C) has a current diagnosis for an opioid use disorder; and
(D) meets such other criteria as the Secretary determines appropriate.
Such term shall include an individual who is dually eligible for benefits under this subchapter and subchapter XIX if such individual satisfies the criteria described in subparagraphs (A) through (D).
(2) Voluntary beneficiary participation; limitation on number of beneficiaries
An applicable beneficiary may participate in the Program on a voluntary basis and may terminate participation in the Program at any time. Not more than 20,000 applicable beneficiaries may participate in the Program at any time.
(3) Services
In order to participate in the Program, an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant. Participation under the Program shall not affect coverage of or payment for any other item or service under this subchapter for the applicable beneficiary.
(4) Beneficiary access to services
Nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this subchapter, and applicable beneficiaries shall not be required to relinquish access to any benefit under this subchapter as a condition of receiving services from a participant in the Program.
(e) Payments
(1) Per applicable beneficiary per month care management fee
(A) In general
The Secretary shall establish a schedule of per applicable beneficiary per month care management fees. Such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this subchapter to the health care practitioners in the participant's opioid use disorder care team or, if applicable, to the participant. A participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries, including services not otherwise eligible for payment under this subchapter.
(B) Payment amounts
In carrying out subparagraph (A), the Secretary may—
(i) consider payments otherwise payable under this subchapter for opioid use disorder treatment services and the needs of applicable beneficiaries;
(ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care;
(iii) pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months, to reflect the greater time and costs required for the planning and initiation of treatment, as compared to maintenance of treatment; and
(iv) take into account whether a participant's opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services.
(C) No duplicate payment
The Secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month.
(2) Incentive payments
(A) In general
Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid (using a methodology established and at a time determined appropriate by the Secretary) to participants based on the performance of participants with respect to criteria, as determined appropriate by the Secretary, in accordance with subparagraph (B).
(B) Criteria
(i) In general
Criteria described in subparagraph (A) may include consideration of the following:
(I) Patient engagement and retention in treatment.
(II) Evidence-based medication-assisted treatment.
(III) Other criteria established by the Secretary.
(ii) Required consultation and consideration
In determining criteria described in subparagraph (A), the Secretary shall—
(I) consult with stakeholders, including clinicians in the primary care community and in the field of addiction medicine; and
(II) consider existing clinical guidelines for the treatment of opioid use disorders.
(C) No duplicate payment
The Secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary.
(f) Multipayer strategy
In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the Program under subsection (e)(2)(C). The Secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the Program.
(g) Evaluation
(1) In general
The Secretary shall conduct an intermediate and final evaluation of the program. Each such evaluation shall determine the extent to which each of the purposes described in subsection (b) have been accomplished under the Program.
(2) Reports
The Secretary shall submit to Congress—
(A) a report with respect to the intermediate evaluation under paragraph (1) not later than 3 years after the date of the implementation of the Program; and
(B) a report with respect to the final evaluation under paragraph (1) not later than 6 years after such date.
(h) Funding
(1) Administrative funding
For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under
(2) Care management fees and incentives
For the purposes of making payments under subsection (e), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under
(3) Availability
Amounts transferred under this subsection for a fiscal year shall be available until expended.
(i) Waivers
The Secretary may waive any provision of this subchapter as may be necessary to carry out the Program under this section.
(Aug. 14, 1935, ch. 531, title XVIII, §1866F, as added
Editorial Notes
References in Text
Section 223 of the Protecting Access to Medicare Act of 2014, referred to in subsec. (c)(1)(A)(i)(VII), is section 223 of
Amendments
2022—Subsec. (c)(3)(C).
§1395cc–7. Extension of Acute Hospital Care at Home initiative
(a) In general
(1) Extension
With respect to inpatient hospital admissions occurring during the period beginning on the first day after the end of the emergency period described in
(2) Acute Hospital Care at Home waivers and flexibilities
For the purposes of paragraph (1), the waivers and flexibilities described in this paragraph are the following waivers and flexibilities that were made available to individual hospitals under the Acute Hospital Care at Home initiative of the Secretary during the emergency period described in
(A) Subject to paragraph (3)(D), waiver of the requirements to provide 24-hour nursing services on premises and for the immediate availability of a registered nurse under section 482.23(b) of title 42, Code of Federal Regulations (or any successor regulation), and the waivers of the physical environment and Life Safety Code requirements under section 482.41 of title 42, Code of Federal Regulations (or any successor regulation).
(B) Flexibility to allow a hospital to furnish inpatient services, including routine services, outside the hospital under arrangements, as described in Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID–19 (87 Fed. Reg. 71748 et seq.).
(C) Waiver of the telehealth requirements under clause (i) 1 of
(D) Other waivers and flexibilities that, as of December 29, 2022, were in place for such initiative during such emergency period.
(3) Specified criteria
For purposes of paragraph (1), the specified criteria for granting such waivers and flexibilities to individual hospitals are:
(A) The hospital shall indicate to the Secretary the criteria it would use to ensure that hospital services be furnished only to an individual who requires an inpatient level of care, and shall require that a physician document in the medical record of each such individual that the individual meets such criteria.
(B) The hospital and any other entities providing services under arrangements with the hospital shall ensure that the standard of care to treat an individual at home is the same as the standard of care to treat such individual as an inpatient of the hospital.
(C) The hospital shall ensure that an individual is only eligible for services under paragraph (1) if the individual is a hospital inpatient or is a patient of the hospital's emergency department for whom the hospital determines that an inpatient level of care is required (as described in subparagraph (A)).
(D) The hospital shall meet all patient safety standards determined appropriate by the Secretary, in addition to those that otherwise apply to the hospital, except those for which the waivers and flexibilities under this subsection apply.
(E) The hospital shall provide to the Secretary, at a time, form and manner determined by the Secretary, any data and information the Secretary determines necessary to do the following:
(i) Monitor the quality of care furnished, and to the extent practicable, ensure the safety of individuals and analyze costs of such care.
(ii) Undertake the study described in subsection (b).
(F) The hospital meets such other requirements and conditions as the Secretary determines appropriate.
(4) Termination
The Secretary may terminate a hospital from participation in such initiative (and the waivers and flexibilities applicable to such hospital) if the Secretary determines that the hospital no longer meets the criteria described in paragraph (3).
(b) Study and report
(1) In general
The Secretary shall conduct a study to—
(A) analyze, to the extent practicable, the criteria established by hospitals under the Acute Hospital Care at Home initiative of the Secretary to determine which individuals may be furnished services under such initiative; and
(B) analyze and compare, to the extent practicable—
(i) quality of care furnished to individuals with similar conditions and characteristics in the inpatient setting and through the Acute Hospital Care at Home initiative, including health outcomes, hospital readmission rates, hospital mortality rates, length of stay, infection rates, and patient experience of care;
(ii) clinical conditions treated and diagnosis-related groups of discharges from the inpatient setting and under the Acute Hospital Care at Home initiative;
(iii) costs incurred by furnishing care in the inpatient setting and through the Acute Hospital Care at Home initiative;
(iv) the quantity, mix and intensity of such services (such as in-person visits and virtual contacts with patients) furnished in the Acute Hospital Care at Home initiative and furnished in the inpatient setting; and
(v) socioeconomic information on beneficiaries treated under the initiative, including racial and ethnic data, income, and whether such beneficiaries are dually eligible for benefits under this subchapter and subchapter XIX.
(2) Report
Not later than September 30, 2024, the Secretary of Health and Human Services shall post on a website of the Centers for Medicare & Medicaid Services a report on the study conducted under paragraph (1).
(3) Funding
In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2023, out of any amounts in the Treasury not otherwise appropriated, $5,000,000, to remain available until expended, for purposes of carrying out this subsection.
(c) Implementation
Notwithstanding any other provision of law, the Secretary may implement this section by program instruction or otherwise.
(d) Publicly available information
The Secretary shall, as feasible, make the information collected under subsections (a)(3)(E) and (b)(1) available on the Medicare.gov internet website (or a successor website).
(Aug. 14, 1935, ch. 531, title XVIII, §1866G, as added
Editorial Notes
References in Text
Section 4113(a) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, referred to in subsec. (a)(2)(C), is section 4113(a) of div. FF of
1 So in original. Probably should be "clause (iii)". See References in Text note below.
§1395dd. Examination and treatment for emergency medical conditions and women in labor
(a) Medical screening requirement
In the case of a hospital that has a hospital emergency department, if any individual (whether or not eligible for benefits under this subchapter) comes to the emergency department and a request is made on the individual's behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital's emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition (within the meaning of subsection (e)(1)) exists.
(b) Necessary stabilizing treatment for emergency medical conditions and labor
(1) In general
If any individual (whether or not eligible for benefits under this subchapter) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either—
(A) within the staff and facilities available at the hospital, for such further medical examination and such treatment as may be required to stabilize the medical condition, or
(B) for transfer of the individual to another medical facility in accordance with subsection (c).
(2) Refusal to consent to treatment
A hospital is deemed to meet the requirement of paragraph (1)(A) with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual's behalf) of the risks and benefits to the individual of such examination and treatment, but the individual (or a person acting on the individual's behalf) refuses to consent to the examination and treatment. The hospital shall take all reasonable steps to secure the individual's (or person's) written informed consent to refuse such examination and treatment.
(3) Refusal to consent to transfer
A hospital is deemed to meet the requirement of paragraph (1) with respect to an individual if the hospital offers to transfer the individual to another medical facility in accordance with subsection (c) and informs the individual (or a person acting on the individual's behalf) of the risks and benefits to the individual of such transfer, but the individual (or a person acting on the individual's behalf) refuses to consent to the transfer. The hospital shall take all reasonable steps to secure the individual's (or person's) written informed consent to refuse such transfer.
(c) Restricting transfers until individual stabilized
(1) Rule
If an individual at a hospital has an emergency medical condition which has not been stabilized (within the meaning of subsection (e)(3)(B)), the hospital may not transfer the individual unless—
(A)(i) the individual (or a legally responsible person acting on the individual's behalf) after being informed of the hospital's obligations under this section and of the risk of transfer, in writing requests transfer to another medical facility,
(ii) a physician (within the meaning of
(iii) if a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as defined by the Secretary in regulations) has signed a certification described in clause (ii) after a physician (as defined in
(B) the transfer is an appropriate transfer (within the meaning of paragraph (2)) to that facility.
A certification described in clause (ii) or (iii) of subparagraph (A) shall include a summary of the risks and benefits upon which the certification is based.
(2) Appropriate transfer
An appropriate transfer to a medical facility is a transfer—
(A) in which the transferring hospital provides the medical treatment within its capacity which minimizes the risks to the individual's health and, in the case of a woman in labor, the health of the unborn child;
(B) in which the receiving facility—
(i) has available space and qualified personnel for the treatment of the individual, and
(ii) has agreed to accept transfer of the individual and to provide appropriate medical treatment;
(C) in which the transferring hospital sends to the receiving facility all medical records (or copies thereof), related to the emergency condition for which the individual has presented, available at the time of the transfer, including records related to the individual's emergency medical condition, observations of signs or symptoms, preliminary diagnosis, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) provided under paragraph (1)(A), and the name and address of any on-call physician (described in subsection (d)(1)(C)) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment;
(D) in which the transfer is effected through qualified personnel and transportation equipment, as required including the use of necessary and medically appropriate life support measures during the transfer; and
(E) which meets such other requirements as the Secretary may find necessary in the interest of the health and safety of individuals transferred.
(d) Enforcement
(1) Civil money penalties
(A) A participating hospital that negligently violates a requirement of this section is subject to a civil money penalty of not more than $50,000 (or not more than $25,000 in the case of a hospital with less than 100 beds) for each such violation. The provisions of
(B) Subject to subparagraph (C), any physician who is responsible for the examination, treatment, or transfer of an individual in a participating hospital, including a physician on-call for the care of such an individual, and who negligently violates a requirement of this section, including a physician who—
(i) signs a certification under subsection (c)(1)(A) that the medical benefits reasonably to be expected from a transfer to another facility outweigh the risks associated with the transfer, if the physician knew or should have known that the benefits did not outweigh the risks, or
(ii) misrepresents an individual's condition or other information, including a hospital's obligations under this section,
is subject to a civil money penalty of not more than $50,000 for each such violation and, if the violation is gross and flagrant or is repeated, to exclusion from participation in this subchapter and State health care programs. The provisions of
(C) If, after an initial examination, a physician determines that the individual requires the services of a physician listed by the hospital on its list of on-call physicians (required to be maintained under
(2) Civil enforcement
(A) Personal harm
Any individual who suffers personal harm as a direct result of a participating hospital's violation of a requirement of this section may, in a civil action against the participating hospital, obtain those damages available for personal injury under the law of the State in which the hospital is located, and such equitable relief as is appropriate.
(B) Financial loss to other medical facility
Any medical facility that suffers a financial loss as a direct result of a participating hospital's violation of a requirement of this section may, in a civil action against the participating hospital, obtain those damages available for financial loss, under the law of the State in which the hospital is located, and such equitable relief as is appropriate.
(C) Limitations on actions
No action may be brought under this paragraph more than two years after the date of the violation with respect to which the action is brought.
(3) Consultation with quality improvement organizations
In considering allegations of violations of the requirements of this section in imposing sanctions under paragraph (1) or in terminating a hospital's participation under this subchapter, the Secretary shall request the appropriate quality improvement organization (with a contract under part B of subchapter XI) to assess whether the individual involved had an emergency medical condition which had not been stabilized, and provide a report on its findings. Except in the case in which a delay would jeopardize the health or safety of individuals, the Secretary shall request such a review before effecting a sanction under paragraph (1) and shall provide a period of at least 60 days for such review. Except in the case in which a delay would jeopardize the health or safety of individuals, the Secretary shall also request such a review before making a compliance determination as part of the process of terminating a hospital's participation under this subchapter for violations related to the appropriateness of a medical screening examination, stabilizing treatment, or an appropriate transfer as required by this section, and shall provide a period of 5 days for such review. The Secretary shall provide a copy of the organization's report to the hospital or physician consistent with confidentiality requirements imposed on the organization under such part B.
(4) Notice upon closing an investigation
The Secretary shall establish a procedure to notify hospitals and physicians when an investigation under this section is closed.
(e) Definitions
In this section:
(1) The term "emergency medical condition" means—
(A) a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in—
(i) placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,
(ii) serious impairment to bodily functions, or
(iii) serious dysfunction of any bodily organ or part; or
(B) with respect to a pregnant woman who is having contractions—
(i) that there is inadequate time to effect a safe transfer to another hospital before delivery, or
(ii) that transfer may pose a threat to the health or safety of the woman or the unborn child.
(2) The term "participating hospital" means a hospital that has entered into a provider agreement under
(3)(A) The term "to stabilize" means, with respect to an emergency medical condition described in paragraph (1)(A), to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility, or, with respect to an emergency medical condition described in paragraph (1)(B), to deliver (including the placenta).
(B) The term "stabilized" means, with respect to an emergency medical condition described in paragraph (1)(A), that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility, or, with respect to an emergency medical condition described in paragraph (1)(B), that the woman has delivered (including the placenta).
(4) The term "transfer" means the movement (including the discharge) of an individual outside a hospital's facilities at the direction of any person employed by (or affiliated or associated, directly or indirectly, with) the hospital, but does not include such a movement of an individual who (A) has been declared dead, or (B) leaves the facility without the permission of any such person.
(5) The term "hospital" includes a critical access hospital (as defined in
(f) Preemption
The provisions of this section do not preempt any State or local law requirement, except to the extent that the requirement directly conflicts with a requirement of this section.
(g) Nondiscrimination
A participating hospital that has specialized capabilities or facilities (such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers as identified by the Secretary in regulation) shall not refuse to accept an appropriate transfer of an individual who requires such specialized capabilities or facilities if the hospital has the capacity to treat the individual.
(h) No delay in examination or treatment
A participating hospital may not delay provision of an appropriate medical screening examination required under subsection (a) or further medical examination and treatment required under subsection (b) in order to inquire about the individual's method of payment or insurance status.
(i) Whistleblower protections
A participating hospital may not penalize or take adverse action against a qualified medical person described in subsection (c)(1)(A)(iii) or a physician because the person or physician refuses to authorize the transfer of an individual with an emergency medical condition that has not been stabilized or against any hospital employee because the employee reports a violation of a requirement of this section.
(Aug. 14, 1935, ch. 531, title XVIII, §1867, as added
Editorial Notes
Prior Provisions
A prior section 1395dd, act Aug. 14, 1935, ch. 531, title XVIII, §1867, as added July 30, 1965,
Amendments
2020—Subsec. (e)(5).
2011—Subsec. (d)(3).
2003—Subsec. (d)(1)(B).
Subsec. (d)(3).
Subsec. (d)(4).
Subsec. (e)(1)(B).
Subsec. (e)(2).
1997—Subsec. (e)(5).
1994—Subsec. (d)(3).
1990—Subsec. (c)(2)(C).
Subsec. (d)(1).
"(A) termination of its provider agreement under this subchapter in accordance with
"(B) at the option of the Secretary, suspension of such agreement for such period of time as the Secretary determines to be appropriate, upon reasonable notice to the hospital and to the public."
Subsec. (d)(1)(B).
Subsec. (d)(2).
Subsec. (d)(2)(A).
Subsec. (d)(3).
Subsec. (i).
1989—
Subsec. (a).
Subsec. (b).
Subsec. (b)(1).
Subsec. (b)(1)(A).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(1)(A)(i).
Subsec. (c)(1)(A)(ii).
Subsec. (c)(1)(A)(iii).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
Subsec. (c)(2)(C).
Subsec. (c)(2)(D).
Subsec. (c)(2)(E).
Subsec. (d)(2)(B).
Subsec. (d)(2)(C).
"(i) is employed by, or under contract with, the participating hospital, and
"(ii) acting as such an employee or under such a contract, has professional responsibility for the provision of examinations or treatments for the individual, or transfers of the individual, with respect to which the violation occurred."
Subsec. (e)(1).
"(A) placing the patient's health in serious jeopardy,
"(B) serious impairment to bodily functions, or
"(C) serious dysfunction of any bodily organ or part."
Subsec. (e)(2).
Subsec. (e)(3).
Subsec. (e)(4).
Subsec. (e)(4)(A).
Subsec. (e)(4)(B).
Subsec. (e)(5).
Subsec. (e)(6).
Subsecs. (g) to (i).
1988—Subsec. (d)(1).
Subsec. (d)(2).
1987—Subsec. (d)(1).
Subsec. (d)(2).
1986—Subsec. (b)(2), (3).
Subsec. (e)(3).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Amendment by
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2003 Amendment
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by section 4008(b)(1)–(3)(A) of
Amendment by section 4207(a)(1)(A) of
Effective Date of 1989 Amendment
Effective Date of 1988 Amendment
Amendment by
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Effective Date of 1986 Amendment
Amendment by
Effective Date
Short Title
This section is popularly known as the Emergency Medical Treatment and Labor Act (EMTALA).
Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group
"(a)
"(b)
"(1) 4 shall be representatives of hospitals, including at least one public hospital, that have experience with the application of EMTALA and at least 2 of which have not been cited for EMTALA violations;
"(2) 7 shall be practicing physicians drawn from the fields of emergency medicine, cardiology or cardiothoracic surgery, orthopedic surgery, neurosurgery, pediatrics or a pediatric subspecialty, obstetrics-gynecology, and psychiatry, with not more than one physician from any particular field;
"(3) 2 shall represent patients;
"(4) 2 shall be staff involved in EMTALA investigations from different regional offices of the Centers for Medicare & Medicaid Services; and
"(5) 1 shall be from a State survey office involved in EMTALA investigations and 1 shall be from a peer review organization, both of whom shall be from areas other than the regions represented under paragraph (4).
In selecting members described in paragraphs (1) through (3), the Secretary shall consider qualified individuals nominated by organizations representing providers and patients.
"(c)
"(1) shall review EMTALA regulations;
"(2) may provide advice and recommendations to the Secretary with respect to those regulations and their application to hospitals and physicians;
"(3) shall solicit comments and recommendations from hospitals, physicians, and the public regarding the implementation of such regulations; and
"(4) may disseminate information on the application of such regulations to hospitals, physicians, and the public.
"(d)
"(1)
"(2)
"(e)
"(f)
Federal Reimbursement of Emergency Health Services Furnished to Undocumented Aliens
"(a)
"(1)
"(2)
"(b)
"(1)
"(A)
"(B)
"(i) the total amount available for allotments under this paragraph for the fiscal year; and
"(ii) the percentage of undocumented aliens residing in the State as compared to the total number of such aliens residing in all States, as determined by the Statistics Division of the Immigration and Naturalization Service, as of January 2003, based on the 2000 decennial census.
"(2)
"(A)
"(B)
"(i) the total amount available for allotments under this paragraph for the fiscal year; and
"(ii) the percentage of undocumented alien apprehensions in the State in that fiscal year as compared to the total of such apprehensions for all such States for the preceding fiscal year.
"(C)
"(c)
"(1)
"(2)
"(A)
"(i) the amount that the provider demonstrates was incurred for the provision of such services; or
"(ii) amounts determined under a methodology established by the Secretary for purposes of this subsection.
"(B)
"(3)
"(A) may establish different methodologies for types of eligible providers;
"(B) may base payments for hospital services on estimated hospital charges, adjusted to estimated cost, through the application of hospital-specific cost-to-charge ratios;
"(C) shall provide for the election by a hospital to receive either payments to the hospital for—
"(i) hospital and physician services; or
"(ii) hospital services and for a portion of the on-call payments made by the hospital to physicians; and
"(D) shall make quarterly payments under this section to eligible providers.
If a hospital makes the election under subparagraph (C)(i), the hospital shall pass on payments for services of a physician to the physician and may not charge any administrative or other fee with respect to such payments.
"(4)
"(5)
"(A) Undocumented aliens.
"(B) Aliens who have been paroled into the United States at a United States port of entry for the purpose of receiving eligible services.
"(C) Mexican citizens permitted to enter the United States for not more than 72 hours under the authority of a biometric machine readable border crossing identification card (also referred to as a 'laser visa') issued in accordance with the requirements of regulations prescribed under section 101(a)(6) of the Immigration and Nationality Act (
"(d)
"(1)
"(A)
"(B)
"(2)
"(e)
"(1)
"(2)
"(3)
"(4)
"(5)
"(6)
Inspector General Study of Prohibition on Hospital Employment of Physicians
Executive Documents
Ex. Ord. No. 13952. Protecting Vulnerable Newborn and Infant Children
Ex. Ord. No. 13952, Sept. 25, 2020, 85 F.R. 62187, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Despite these laws, some hospitals refuse the required medical screening examination and stabilizing treatment or otherwise do not provide potentially lifesaving medical treatment to extremely premature or disabled infants, even when parents plead for such treatment. Hospitals might refuse to provide treatment to extremely premature infants—born alive before 24 weeks of gestation—because they believe these infants may not survive, may have to live with long-term disabilities, or may have a quality-of-life deemed to be inadequate. Active treatment of extremely premature infants has, however, been shown to improve their survival rates. And the denial of such treatment, or discouragement of parents from seeking such treatment for their children, devalues the lives of these children and may violate Federal law.
(b) The Secretary shall, as appropriate and consistent with applicable law, ensure that Federal funding disbursed by the Department of Health and Human Services is expended in full compliance with EMTALA and section 504 of the Rehab Act, as interpreted consistent with the Born-Alive Infants Protection Act, as reflected in the policy set forth in section 2 of this order.
(i) The Secretary shall, as appropriate and to the fullest extent permitted by law, investigate complaints of violations of applicable Federal laws with respect to infants born alive, including infants who have an emergency medical condition in need of stabilizing treatment or infants with disabilities whose parents seek medical treatment for their infants. The Secretary shall also clarify, in an easily understandable format, the process by which parents and hospital staff may submit such complaints for investigation under applicable Federal laws.
(ii) The Secretary shall take all appropriate enforcement action against individuals and organizations found through investigation to have violated applicable Federal laws, up to and including terminating Federal funding for non-compliant programs and activities.
(c) The Secretary shall, as appropriate and consistent with applicable law, prioritize the allocation of Department of Health and Human Services discretionary grant funding and National Institutes of Health research dollars for programs and activities conducting research to develop treatments that may improve survival—especially survival without impairment—of infants born alive, including premature infants or infants with disabilities, who have an emergency medical condition in need of stabilizing treatment.
(d) The Secretary shall, as appropriate and consistent with applicable law, prioritize the allocation of Department of Health and Human Services discretionary grant funding to programs and activities, including hospitals, that provide training to medical personnel regarding the provision of life-saving medical treatment to all infants born alive, including premature infants or infants with disabilities, who have an emergency medical condition in need of stabilizing treatment.
(e) The Secretary shall, as necessary and consistent with applicable law, issue such regulations or guidance as may be necessary to implement this order.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Donald J. Trump.
1 So in original. Probably should be followed by a comma.
§1395ee. Practicing Physicians Advisory Council; Council for Technology and Innovation
(a) Repealed. Pub. L. 111–148, title III, §3134(b)(2), Mar. 23, 2010, 124 Stat. 435
(b) Council for Technology and Innovation
(1) Establishment
The Secretary shall establish a Council for Technology and Innovation within the Centers for Medicare & Medicaid Services (in this section referred to as "CMS").
(2) Composition
The Council shall be composed of senior CMS staff and clinicians and shall be chaired by the Executive Coordinator for Technology and Innovation (appointed or designated under paragraph (4)).
(3) Duties
The Council shall coordinate the activities of coverage, coding, and payment processes under this subchapter with respect to new technologies and procedures, including new drug therapies, and shall coordinate the exchange of information on new technologies between CMS and other entities that make similar decisions.
(4) Executive Coordinator for Technology and Innovation
The Secretary shall appoint (or designate) a noncareer appointee (as defined in
(c) Physician-focused payment models
(1) Technical Advisory Committee
(A) Establishment
There is established an ad hoc committee to be known as the "Physician-Focused Payment Model Technical Advisory Committee" (referred to in this subsection as the "Committee").
(B) Membership
(i) Number and appointment
The Committee shall be composed of 11 members appointed by the Comptroller General of the United States.
(ii) Qualifications
The membership of the Committee shall include individuals with national recognition for their expertise in physician-focused payment models and related delivery of care. No more than 5 members of the Committee shall be providers of services or suppliers, or representatives of providers of services or suppliers.
(iii) Prohibition on Federal employment
A member of the Committee shall not be an employee of the Federal Government.
(iv) Ethics disclosure
The Comptroller General shall establish a system for public disclosure by members of the Committee of financial and other potential conflicts of interest relating to such members. Members of the Committee shall be treated as employees of Congress for purposes of applying subchapter I of
(v) Date of initial appointments
The initial appointments of members of the Committee shall be made by not later than 180 days after April 16, 2015.
(C) Term; vacancies
(i) Term
The terms of members of the Committee shall be for 3 years except that the Comptroller General shall designate staggered terms for the members first appointed.
(ii) Vacancies
Any member appointed to fill a vacancy occurring before the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member's term until a successor has taken office. A vacancy in the Committee shall be filled in the manner in which the original appointment was made.
(D) Duties
The Committee shall meet, as needed, to provide comments and recommendations to the Secretary, as described in paragraph (2)(C), on physician-focused payment models.
(E) Compensation of members
(i) In general
Except as provided in clause (ii), a member of the Committee shall serve without compensation.
(ii) Travel expenses
A member of the Committee shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for an employee of an agency under subchapter I of
(F) Operational and technical support
(i) In general
The Assistant Secretary for Planning and Evaluation shall provide technical and operational support for the Committee, which may be by use of a contractor. The Office of the Actuary of the Centers for Medicare & Medicaid Services shall provide to the Committee actuarial assistance as needed.
(ii) Funding
The Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under
(G) Application
(2) Criteria and process for submission and review of physician-focused payment models
(A) Criteria for assessing physician-focused payment models
(i) Rulemaking
Not later than November 1, 2016, the Secretary shall, through notice and comment rulemaking, following a request for information, establish criteria for physician-focused payment models, including models for specialist physicians, that could be used by the Committee for making comments and recommendations pursuant to paragraph (1)(D).
(ii) MedPAC submission of comments
During the comment period for the proposed rule described in clause (i), the Medicare Payment Advisory Commission may submit comments to the Secretary on the proposed criteria under such clause.
(iii) Updating
The Secretary may update the criteria established under this subparagraph through rulemaking.
(B) Stakeholder submission of physician-focused payment models
On an ongoing basis, individuals and stakeholder entities may submit to the Committee proposals for physician-focused payment models that such individuals and entities believe meet the criteria described in subparagraph (A).
(C) Committee review of models submitted
The Committee, on a periodic basis—
(i) shall review models submitted under subparagraph (B);
(ii) may provide individuals and stakeholder entities who submitted such models with—
(I) initial feedback on such models regarding the extent to which such models meet the criteria described in subparagraph (A); and
(II) an explanation of the basis for the feedback provided under subclause (I); and
(iii) shall prepare comments and recommendations regarding whether such models meet the criteria described in subparagraph (A) and submit such comments and recommendations to the Secretary.
(D) Secretary review and response
The Secretary shall review the comments and recommendations submitted by the Committee under subparagraph (C) and post a detailed response to such comments and recommendations on the Internet website of the Centers for Medicare & Medicaid Services.
(3) Rule of construction
Nothing in this subsection shall be construed to impact the development or testing of models under this subchapter or subchapters XI, XIX, or XXI.
(Aug. 14, 1935, ch. 531, title XVIII, §1868, as added
Editorial Notes
Prior Provisions
A prior section 1395ee, act Aug. 14, 1935, ch. 531, title XVIII, §1868, as added July 30, 1965,
Amendments
2022—Subsec. (c)(1)(B)(iv).
Subsec. (c)(1)(G).
2018—Subsec. (c)(2)(C).
2015—Subsec. (c).
2010—Subsec. (a).
2003—
Subsec. (a).
Subsec. (b).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See
§1395ff. Determinations; appeals
(a) Initial determinations
(1) Promulgations of regulations
The Secretary shall promulgate regulations and make initial determinations with respect to benefits under part A or part B in accordance with those regulations for the following:
(A) The initial determination of whether an individual is entitled to benefits under such parts.
(B) The initial determination of the amount of benefits available to the individual under such parts.
(C) Any other initial determination with respect to a claim for benefits under such parts, including an initial determination by the Secretary that payment may not be made, or may no longer be made, for an item or service under such parts, an initial determination made by a quality improvement organization under
(2) Deadlines for making initial determinations
(A) In general
Subject to subparagraph (B), in promulgating regulations under paragraph (1), initial determinations shall be concluded by not later than the 45-day period beginning on the date the fiscal intermediary or the carrier, as the case may be, receives a claim for benefits from an individual as described in paragraph (1). Notice of such determination shall be mailed to the individual filing the claim before the conclusion of such 45-day period.
(B) Clean claims
Subparagraph (A) shall not apply with respect to any claim that is subject to the requirements of
(3) Redeterminations
(A) In general
In promulgating regulations under paragraph (1) with respect to initial determinations, such regulations shall provide for a fiscal intermediary or a carrier to make a redetermination with respect to a claim for benefits that is denied in whole or in part.
(B) Limitations
(i) Appeal rights
No initial determination may be reconsidered or appealed under subsection (b) unless the fiscal intermediary or carrier has made a redetermination of that initial determination under this paragraph.
(ii) Decisionmaker
No redetermination may be made by any individual involved in the initial determination.
(C) Deadlines
(i) Filing for redetermination
A redetermination under subparagraph (A) shall be available only if notice is filed with the Secretary to request the redetermination by not later than the end of the 120-day period beginning on the date the individual receives notice of the initial determination under paragraph (2).
(ii) Concluding redeterminations
Redeterminations shall be concluded by not later than the 60-day period beginning on the date the fiscal intermediary or the carrier, as the case may be, receives a request for a redetermination. Notice of such determination shall be mailed to the individual filing the claim before the conclusion of such 60-day period.
(D) Construction
For purposes of the succeeding provisions of this section a redetermination under this paragraph shall be considered to be part of the initial determination.
(4) Requirements of notice of determinations
With respect to an initial determination insofar as it results in a denial of a claim for benefits—
(A) the written notice on the determination shall include—
(i) the reasons for the determination, including whether a local medical review policy or a local coverage determination was used;
(ii) the procedures for obtaining additional information concerning the determination, including the information described in subparagraph (B); and
(iii) notification of the right to seek a redetermination or otherwise appeal the determination and instructions on how to initiate such a redetermination under this section;
(B) such written notice shall be provided in printed form and written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both; and
(C) the individual provided such written notice may obtain, upon request, information on the specific provision of the policy, manual, or regulation used in making the redetermination.
(5) Requirements of notice of redeterminations
With respect to a redetermination insofar as it results in a denial of a claim for benefits—
(A) the written notice on the redetermination shall include—
(i) the specific reasons for the redetermination;
(ii) as appropriate, a summary of the clinical or scientific evidence used in making the redetermination;
(iii) a description of the procedures for obtaining additional information concerning the redetermination; and
(iv) notification of the right to appeal the redetermination and instructions on how to initiate such an appeal under this section;
(B) such written notice shall be provided in printed form and written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both; and
(C) the individual provided such written notice may obtain, upon request, information on the specific provision of the policy, manual, or regulation used in making the redetermination.
(b) Appeal rights
(1) In general
(A) Reconsideration of initial determination
Subject to subparagraph (D), any individual dissatisfied with any initial determination under subsection (a)(1) shall be entitled to reconsideration of the determination, and, subject to subparagraphs (D) and (E), a hearing thereon by the Secretary to the same extent as is provided in
(B) Representation by provider or supplier
(i) In general
(ii) Mandatory waiver of right to payment from beneficiary
Any person that furnishes services or items to an individual may not represent an individual under this section with respect to the issue described in
(iii) Prohibition on payment for representation
If a person furnishes services or items to an individual and represents the individual under this section, the person may not impose any financial liability on such individual in connection with such representation.
(iv) Requirements for representatives of a beneficiary
The provisions of
(C) Succession of rights in cases of assignment
The right of an individual to an appeal under this section with respect to an item or service may be assigned to the provider of services or supplier of the item or service upon the written consent of such individual using a standard form established by the Secretary for such an assignment.
(D) Time limits for filing appeals
(i) Reconsiderations
Reconsideration under subparagraph (A) shall be available only if the individual described in subparagraph (A) files notice with the Secretary to request reconsideration by not later than the end of the 180-day period beginning on the date the individual receives notice of the redetermination under subsection (a)(3), or within such additional time as the Secretary may allow.
(ii) Hearings conducted by the Secretary
The Secretary shall establish in regulations time limits for the filing of a request for a hearing by the Secretary in accordance with provisions in
(E) Amounts in controversy
(i) In general
A hearing (by the Secretary) shall not be available to an individual under this section if the amount in controversy is less than $100, and judicial review shall not be available to the individual if the amount in controversy is less than $1,000.
(ii) Aggregation of claims
In determining the amount in controversy, the Secretary, under regulations, shall allow two or more appeals to be aggregated if the appeals involve—
(I) the delivery of similar or related services to the same individual by one or more providers of services or suppliers, or
(II) common issues of law and fact arising from services furnished to two or more individuals by one or more providers of services or suppliers.
(iii) Adjustment of dollar amounts
For requests for hearings or judicial review made in a year after 2004, the dollar amounts specified in clause (i) shall be equal to such dollar amounts increased by the percentage increase in the medical care component of the consumer price index for all urban consumers (U.S. city average) for July 2003 to the July preceding the year involved. Any amount determined under the previous sentence that is not a multiple of $10 shall be rounded to the nearest multiple of $10.
(F) Expedited proceedings
(i) Expedited determination
In the case of an individual who has received notice from a provider of services that such provider plans—
(I) to terminate services provided to an individual and a physician certifies that failure to continue the provision of such services is likely to place the individual's health at significant risk, or
(II) to discharge the individual from the provider of services,
the individual may request, in writing or orally, an expedited determination or an expedited reconsideration of an initial determination made under subsection (a)(1), as the case may be, and the Secretary shall provide such expedited determination or expedited reconsideration.
(ii) Reference to expedited access to judicial review
For the provision relating to expedited access to judicial review, see paragraph (2).
(G) Reopening and revision of determinations
The Secretary may reopen or revise any initial determination or reconsidered determination described in this subsection under guidelines established by the Secretary in regulations.
(2) Expedited access to judicial review
(A) In general
The Secretary shall establish a process under which a provider of services or supplier that furnishes an item or service or an individual entitled to benefits under part A or enrolled under part B, or both, who has filed an appeal under paragraph (1) (other than an appeal filed under paragraph (1)(F)(i)) may obtain access to judicial review when a review entity (described in subparagraph (D)), on its own motion or at the request of the appellant, determines that the Departmental Appeals Board does not have the authority to decide the question of law or regulation relevant to the matters in controversy and that there is no material issue of fact in dispute. The appellant may make such request only once with respect to a question of law or regulation for a specific matter in dispute in a case of an appeal.
(B) Prompt determinations
If, after or coincident with appropriately filing a request for an administrative hearing, the appellant requests a determination by the appropriate review entity that the Departmental Appeals Board does not have the authority to decide the question of law or regulations relevant to the matters in controversy and that there is no material issue of fact in dispute, and if such request is accompanied by the documents and materials as the appropriate review entity shall require for purposes of making such determination, such review entity shall make a determination on the request in writing within 60 days after the date such review entity receives the request and such accompanying documents and materials. Such a determination by such review entity shall be considered a final decision and not subject to review by the Secretary.
(C) Access to judicial review
(i) In general
If the appropriate review entity—
(I) determines that there are no material issues of fact in dispute and that the only issues to be adjudicated are ones of law or regulation that the Departmental Appeals Board does not have authority to decide; or
(II) fails to make such determination within the period provided under subparagraph (B),
then the appellant may bring a civil action as described in this subparagraph.
(ii) Deadline for filing
Such action shall be filed, in the case described in—
(I) clause (i)(I), within 60 days of the date of the determination described in such clause; or
(II) clause (i)(II), within 60 days of the end of the period provided under subparagraph (B) for the determination.
(iii) Venue
Such action shall be brought in the district court of the United States for the judicial district in which the appellant is located (or, in the case of an action brought jointly by more than one applicant, the judicial district in which the greatest number of applicants are located) or in the District Court for the District of Columbia.
(iv) Interest on any amounts in controversy
Where a provider of services or supplier is granted judicial review pursuant to this paragraph, the amount in controversy (if any) shall be subject to annual interest beginning on the first day of the first month beginning after the 60-day period as determined pursuant to clause (ii) and equal to the rate of interest on obligations issued for purchase by the Federal Supplementary Medical Insurance Trust Fund for the month in which the civil action authorized under this paragraph is commenced, to be awarded by the reviewing court in favor of the prevailing party. No interest awarded pursuant to the preceding sentence shall be deemed income or cost for the purposes of determining reimbursement due providers of services or suppliers under this subchapter.
(D) Review entity defined
For purposes of this subsection, the term "review entity" means an entity of up to three reviewers who are administrative law judges or members of the Departmental Appeals Board selected for purposes of making determinations under this paragraph.
(3) Requiring full and early presentation of evidence by providers
A provider of services or supplier may not introduce evidence in any appeal under this section that was not presented at the reconsideration conducted by the qualified independent contractor under subsection (c), unless there is good cause which precluded the introduction of such evidence at or before that reconsideration.
(c) Conduct of reconsiderations by independent contractors
(1) In general
The Secretary shall enter into contracts with qualified independent contractors to conduct reconsiderations of initial determinations made under subparagraphs (B) and (C) of subsection (a)(1). Contracts shall be for an initial term of three years and shall be renewable on a triennial basis thereafter.
(2) Qualified independent contractor
For purposes of this subsection, the term "qualified independent contractor" means an entity or organization that is independent of any organization under contract with the Secretary that makes initial determinations under subsection (a)(1), and that meets the requirements established by the Secretary consistent with paragraph (3).
(3) Requirements
Any qualified independent contractor entering into a contract with the Secretary under this subsection shall meet all of the following requirements:
(A) In general
The qualified independent contractor shall perform such duties and functions and assume such responsibilities as may be required by the Secretary to carry out the provisions of this subsection, and shall have sufficient medical, legal, and other expertise (including knowledge of the program under this subchapter) and sufficient staffing to make reconsiderations under this subsection.
(B) Reconsiderations
(i) In general
The qualified independent contractor shall review initial determinations. Where an initial determination is made with respect to whether an item or service is reasonable and necessary for the diagnosis or treatment of illness or injury (under
(ii) Effect of national and local coverage determinations
(I) National coverage determinations
If the Secretary has made a national coverage determination pursuant to the requirements established under the third sentence of
(II) Local coverage determinations
If the Secretary has made a local coverage determination, such determination shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration under this section. Notwithstanding the previous sentence, the qualified independent contractor shall consider the local coverage determination in making such decision.
(III) Absence of national or local coverage determination
In the absence of such a national coverage determination or local coverage determination, the qualified independent contractor shall make a decision with respect to the reconsideration based on applicable information, including clinical experience and medical, technical, and scientific evidence.
(C) Deadlines for decisions
(i) Reconsiderations
Except as provided in clauses (iii) and (iv), the qualified independent contractor shall conduct and conclude a reconsideration under subparagraph (B), and mail the notice of the decision with respect to the reconsideration by not later than the end of the 60-day period beginning on the date a request for reconsideration has been timely filed.
(ii) Consequences of failure to meet deadline
In the case of a failure by the qualified independent contractor to mail the notice of the decision by the end of the period described in clause (i) or to provide notice by the end of the period described in clause (iii), as the case may be, the party requesting the reconsideration or appeal may request a hearing before the Secretary, notwithstanding any requirements for a reconsidered determination for purposes of the party's right to such hearing.
(iii) Expedited reconsiderations
The qualified independent contractor shall perform an expedited reconsideration under subsection (b)(1)(F) as follows:
(I) Deadline for decision
Notwithstanding
(II) Consultation with beneficiary
In such reconsideration, the qualified independent contractor shall solicit the views of the individual involved.
(III) Special rule for hospital discharges
A reconsideration of a discharge from a hospital shall be conducted under this clause in accordance with the provisions of paragraphs (2), (3), and (4) of
(iv) Extension
An individual requesting a reconsideration under this subparagraph may be granted such additional time as the individual specifies (not to exceed 14 days) for the qualified independent contractor to conclude the reconsideration. The individual may request such additional time orally or in writing.
(D) Qualifications for reviewers
The requirements of subsection (g) shall be met (relating to qualifications of reviewing professionals).
(E) Explanation of decision
Any decision with respect to a reconsideration of a qualified independent contractor shall be in writing, be written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include (to the extent appropriate) and shall include 1 a detailed explanation of the decision as well as a discussion of the pertinent facts and applicable regulations applied in making such decision, and 2 a notification of the right to appeal such determination and instructions on how to initiate such appeal under this section 3 and 3 in the case of a determination of whether an item or service is reasonable and necessary for the diagnosis or treatment of illness or injury (under
(F) Notice requirements
Whenever a qualified independent contractor makes a decision with respect to a reconsideration under this subsection, the qualified independent contractor shall promptly notify the entity responsible for the payment of claims under part A or part B of such decision.
(G) Dissemination of decisions on reconsiderations
Each qualified independent contractor shall make available all decisions with respect to reconsiderations of such qualified independent contractors to fiscal intermediaries (under
(H) Ensuring consistency in decisions
Each qualified independent contractor shall monitor its decisions with respect to reconsiderations to ensure the consistency of such decisions with respect to requests for reconsideration of similar or related matters.
(I) Data collection
(i) In general
Consistent with the requirements of clause (ii), a qualified independent contractor shall collect such information relevant to its functions, and keep and maintain such records in such form and manner as the Secretary may require to carry out the purposes of this section and shall permit access to and use of any such information and records as the Secretary may require for such purposes.
(ii) Type of data collected
Each qualified independent contractor shall keep accurate records of each decision made, consistent with standards established by the Secretary for such purpose. Such records shall be maintained in an electronic database in a manner that provides for identification of the following:
(I) Specific claims that give rise to appeals.
(II) Situations suggesting the need for increased education for providers of services, physicians, or suppliers.
(III) Situations suggesting the need for changes in national or local coverage determination.
(IV) Situations suggesting the need for changes in local coverage determinations.
(iii) Annual reporting
Each qualified independent contractor shall submit annually to the Secretary (or otherwise as the Secretary may request) records maintained under this paragraph for the previous year.
(J) Hearings by the Secretary
The qualified independent contractor shall (i) submit such information as is required for an appeal of a decision of the contractor, and (ii) participate in such hearings as required by the Secretary.
(K) Independence requirements
(i) In general
Subject to clause (ii), a qualified independent contractor shall not conduct any activities in a case unless the entity—
(I) is not a related party (as defined in subsection (g)(5));
(II) does not have a material familial, financial, or professional relationship with such a party in relation to such case; and
(III) does not otherwise have a conflict of interest with such a party.
(ii) Exception for reasonable compensation
Nothing in clause (i) shall be construed to prohibit receipt by a qualified independent contractor of compensation from the Secretary for the conduct of activities under this section if the compensation is provided consistent with clause (iii).
(iii) Limitations on entity compensation
Compensation provided by the Secretary to a qualified independent contractor in connection with reviews under this section shall not be contingent on any decision rendered by the contractor or by any reviewing professional.
(4) Number of qualified independent contractors
The Secretary shall enter into contracts with a sufficient number of qualified independent contractors (but not fewer than 4 such contractors) to conduct reconsiderations consistent with the timeframes applicable under this subsection.
(5) Limitation on qualified independent contractor liability
No qualified independent contractor having a contract with the Secretary under this subsection and no person who is employed by, or who has a fiduciary relationship with, any such qualified independent contractor or who furnishes professional services to such qualified independent contractor, shall be held by reason of the performance of any duty, function, or activity required or authorized pursuant to this subsection or to a valid contract entered into under this subsection, to have violated any criminal law, or to be civilly liable under any law of the United States or of any State (or political subdivision thereof) provided due care was exercised in the performance of such duty, function, or activity.
(d) Deadlines for hearings by the Secretary; notice
(1) Hearing by administrative law judge
(A) In general
Except as provided in subparagraph (B), an administrative law judge shall conduct and conclude a hearing on a decision of a qualified independent contractor under subsection (c) and render a decision on such hearing by not later than the end of the 90-day period beginning on the date a request for hearing has been timely filed.
(B) Waiver of deadline by party seeking hearing
The 90-day period under subparagraph (A) shall not apply in the case of a motion or stipulation by the party requesting the hearing to waive such period.
(2) Departmental Appeals Board review
(A) In general
The Departmental Appeals Board of the Department of Health and Human Services shall conduct and conclude a review of the decision on a hearing described in paragraph (1) and make a decision or remand the case to the administrative law judge for reconsideration by not later than the end of the 90-day period beginning on the date a request for review has been timely filed.
(B) DAB hearing procedure
In reviewing a decision on a hearing under this paragraph, the Departmental Appeals Board shall review the case de novo.
(3) Consequences of failure to meet deadlines
(A) Hearing by administrative law judge
In the case of a failure by an administrative law judge to render a decision by the end of the period described in paragraph (1), the party requesting the hearing may request a review by the Departmental Appeals Board of the Department of Health and Human Services, notwithstanding any requirements for a hearing for purposes of the party's right to such a review.
(B) Departmental Appeals Board review
In the case of a failure by the Departmental Appeals Board to render a decision by the end of the period described in paragraph (2), the party requesting the hearing may seek judicial review, notwithstanding any requirements for a hearing for purposes of the party's right to such judicial review.
(4) Notice
Notice of the decision of an administrative law judge shall be in writing in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include—
(A) the specific reasons for the determination (including, to the extent appropriate, a summary of the clinical or scientific evidence used in making the determination);
(B) the procedures for obtaining additional information concerning the decision; and
(C) notification of the right to appeal the decision and instructions on how to initiate such an appeal under this section.
(e) Administrative provisions
(1) Limitation on review of certain regulations
A regulation or instruction that relates to a method for determining the amount of payment under part B and that was initially issued before January 1, 1981, shall not be subject to judicial review.
(2) Outreach
The Secretary shall perform such outreach activities as are necessary to inform individuals entitled to benefits under this subchapter and providers of services and suppliers with respect to their rights of, and the process for, appeals made under this section. The Secretary shall use the toll-free telephone number maintained by the Secretary under
(3) Continuing education requirement for qualified independent contractors and administrative law judges
The Secretary shall provide to each qualified independent contractor, and, in consultation with the Commissioner of Social Security, to administrative law judges that decide appeals of reconsiderations of initial determinations or other decisions or determinations under this section, such continuing education with respect to coverage of items and services under this subchapter or policies of the Secretary with respect to part B of subchapter XI as is necessary for such qualified independent contractors and administrative law judges to make informed decisions with respect to appeals.
(4) Reports
(A) Annual report to Congress
The Secretary shall submit to Congress an annual report describing the number of appeals for the previous year, identifying issues that require administrative or legislative actions, and including any recommendations of the Secretary with respect to such actions. The Secretary shall include in such report an analysis of determinations by qualified independent contractors with respect to inconsistent decisions and an analysis of the causes of any such inconsistencies.
(B) Survey
Not less frequently than every 5 years, the Secretary shall conduct a survey of a valid sample of individuals entitled to benefits under this subchapter who have filed appeals of determinations under this section, providers of services, and suppliers to determine the satisfaction of such individuals or entities with the process for appeals of determinations provided for under this section and education and training provided by the Secretary with respect to that process. The Secretary shall submit to Congress a report describing the results of the survey, and shall include any recommendations for administrative or legislative actions that the Secretary determines appropriate.
(f) Review of coverage determinations
(1) National coverage determinations
(A) In general
Review of any national coverage determination shall be subject to the following limitations:
(i) Such a determination shall not be reviewed by any administrative law judge.
(ii) Such a determination shall not be held unlawful or set aside on the ground that a requirement of
(iii) Upon the filing of a complaint by an aggrieved party, such a determination shall be reviewed by the Departmental Appeals Board of the Department of Health and Human Services. In conducting such a review, the Departmental Appeals Board—
(I) shall review the record and shall permit discovery and the taking of evidence to evaluate the reasonableness of the determination, if the Board determines that the record is incomplete or lacks adequate information to support the validity of the determination;
(II) may, as appropriate, consult with appropriate scientific and clinical experts; and
(III) shall defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.
(iv) The Secretary shall implement a decision of the Departmental Appeals Board within 30 days of receipt of such decision.
(v) A decision of the Departmental Appeals Board constitutes a final agency action and is subject to judicial review.
(B) Definition of national coverage determination
For purposes of this section, the term "national coverage determination" means a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this subchapter, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this subchapter or a determination with respect to the amount of payment made for a particular item or service so covered.
(2) Local coverage determination
(A) In general
Review of any local coverage determination shall be subject to the following limitations:
(i) Upon the filing of a complaint by an aggrieved party, such a determination shall be reviewed by an administrative law judge. The administrative law judge—
(I) shall review the record and shall permit discovery and the taking of evidence to evaluate the reasonableness of the determination, if the administrative law judge determines that the record is incomplete or lacks adequate information to support the validity of the determination;
(II) may, as appropriate, consult with appropriate scientific and clinical experts; and
(III) shall defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.
(ii) Upon the filing of a complaint by an aggrieved party, a decision of an administrative law judge under clause (i) shall be reviewed by the Departmental Appeals Board of the Department of Health and Human Services.
(iii) The Secretary shall implement a decision of the administrative law judge or the Departmental Appeals Board within 30 days of receipt of such decision.
(iv) A decision of the Departmental Appeals Board constitutes a final agency action and is subject to judicial review.
(B) Definition of local coverage determination
For purposes of this section, the term "local coverage determination" means a determination by a fiscal intermediary or a carrier under part A or part B, as applicable, respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis under such parts, in accordance with
(C) Local coverage determinations for clinical diagnostic laboratory tests
For provisions relating to local coverage determinations for clinical diagnostic laboratory tests, see
(3) No material issues of fact in dispute
In the case of a determination that may otherwise be subject to review under paragraph (1)(A)(iii) or paragraph (2)(A)(i), where the moving party alleges that—
(A) there are no material issues of fact in dispute, and
(B) the only issue of law is the constitutionality of a provision of this subchapter, or that a regulation, determination, or ruling by the Secretary is invalid,
the moving party may seek review by a court of competent jurisdiction without filing a complaint under such paragraph and without otherwise exhausting other administrative remedies.
(4) Pending national coverage determinations
(A) In general
In the event the Secretary has not issued a national coverage or noncoverage determination with respect to a particular type or class of items or services, an aggrieved person (as described in paragraph (5)) may submit to the Secretary a request to make such a determination with respect to such items or services. By not later than the end of the 90-day period beginning on the date the Secretary receives such a request (notwithstanding the receipt by the Secretary of new evidence (if any) during such 90-day period), the Secretary shall take one of the following actions:
(i) Issue a national coverage determination, with or without limitations.
(ii) Issue a national noncoverage determination.
(iii) Issue a determination that no national coverage or noncoverage determination is appropriate as of the end of such 90-day period with respect to national coverage of such items or services.
(iv) Issue a notice that states that the Secretary has not completed a review of the request for a national coverage determination and that includes an identification of the remaining steps in the Secretary's review process and a deadline by which the Secretary will complete the review and take an action described in clause (i), (ii), or (iii).
(B) Deemed action by the Secretary
In the case of an action described in subparagraph (A)(iv), if the Secretary fails to take an action referred to in such clause by the deadline specified by the Secretary under such clause, then the Secretary is deemed to have taken an action described in subparagraph (A)(iii) as of the deadline.
(C) Explanation of determination
When issuing a determination under subparagraph (A), the Secretary shall include an explanation of the basis for the determination. An action taken under subparagraph (A) (other than clause (iv)) is deemed to be a national coverage determination for purposes of review under paragraph (1)(A).
(5) Standing
An action under this subsection seeking review of a national coverage determination or local coverage determination may be initiated only by individuals entitled to benefits under part A, or enrolled under part B, or both, who are in need of the items or services that are the subject of the coverage determination.
(6) Publication on the Internet of decisions of hearings of the Secretary
Each decision of a hearing by the Secretary with respect to a national coverage determination shall be made public, and the Secretary shall publish each decision on the Medicare 4 Internet site of the Department of Health and Human Services. The Secretary shall remove from such decision any information that would identify any individual, provider of services, or supplier.
(7) Annual report on national coverage determinations
(A) In general
Not later than December 1 of each year, beginning in 2001, the Secretary shall submit to Congress a report that sets forth a detailed compilation of the actual time periods that were necessary to complete and fully implement national coverage determinations that were made in the previous fiscal year for items, services, or medical devices not previously covered as a benefit under this subchapter, including, with respect to each new item, service, or medical device, a statement of the time taken by the Secretary to make and implement the necessary coverage, coding, and payment determinations, including the time taken to complete each significant step in the process of making and implementing such determinations.
(B) Publication of reports on the Internet
The Secretary shall publish each report submitted under clause (i) on the medicare Internet site of the Department of Health and Human Services.
(8) Construction
Nothing in this subsection shall be construed as permitting administrative or judicial review pursuant to this section insofar as such review is explicitly prohibited or restricted under another provision of law.
(g) Qualifications of reviewers
(1) In general
In reviewing determinations under this section, a qualified independent contractor shall assure that—
(A) each individual conducting a review shall meet the qualifications of paragraph (2);
(B) compensation provided by the contractor to each such reviewer is consistent with paragraph (3); and
(C) in the case of a review by a panel described in subsection (c)(3)(B) composed of physicians or other health care professionals (each in this subsection referred to as a "reviewing professional"), a reviewing professional meets the qualifications described in paragraph (4) and, where a claim is regarding the furnishing of treatment by a physician (allopathic or osteopathic) or the provision of items or services by a physician (allopathic or osteopathic), a reviewing professional shall be a physician (allopathic or osteopathic).
(2) Independence
(A) In general
Subject to subparagraph (B), each individual conducting a review in a case shall—
(i) not be a related party (as defined in paragraph (5));
(ii) not have a material familial, financial, or professional relationship with such a party in the case under review; and
(iii) not otherwise have a conflict of interest with such a party.
(B) Exception
Nothing in subparagraph (A) shall be construed to—
(i) prohibit an individual, solely on the basis of a participation agreement with a fiscal intermediary, carrier, or other contractor, from serving as a reviewing professional if—
(I) the individual is not involved in the provision of items or services in the case under review;
(II) the fact of such an agreement is disclosed to the Secretary and the individual entitled to benefits under part A or enrolled under part B, or both, or such individual's authorized representative, and neither party objects; and
(III) the individual is not an employee of the intermediary, carrier, or contractor and does not provide services exclusively or primarily to or on behalf of such intermediary, carrier, or contractor;
(ii) prohibit an individual who has staff privileges at the institution where the treatment involved takes place from serving as a reviewer merely on the basis of having such staff privileges if the existence of such privileges is disclosed to the Secretary and such individual (or authorized representative), and neither party objects; or
(iii) prohibit receipt of compensation by a reviewing professional from a contractor if the compensation is provided consistent with paragraph (3).
For purposes of this paragraph, the term "participation agreement" means an agreement relating to the provision of health care services by the individual and does not include the provision of services as a reviewer under this subsection.
(3) Limitations on reviewer compensation
Compensation provided by a qualified independent contractor to a reviewer in connection with a review under this section shall not be contingent on the decision rendered by the reviewer.
(4) Licensure and expertise
Each reviewing professional shall be—
(A) a physician (allopathic or osteopathic) who is appropriately credentialed or licensed in one or more States to deliver health care services and has medical expertise in the field of practice that is appropriate for the items or services at issue; or
(B) a health care professional who is legally authorized in one or more States (in accordance with State law or the State regulatory mechanism provided by State law) to furnish the health care items or services at issue and has medical expertise in the field of practice that is appropriate for such items or services.
(5) Related party defined
For purposes of this section, the term "related party" means, with respect to a case under this subchapter involving a specific individual entitled to benefits under part A or enrolled under part B, or both, any of the following:
(A) The Secretary, the medicare administrative contractor involved, or any fiduciary, officer, director, or employee of the Department of Health and Human Services, or of such contractor.
(B) The individual (or authorized representative).
(C) The health care professional that provides the items or services involved in the case.
(D) The institution at which the items or services (or treatment) involved in the case are provided.
(E) The manufacturer of any drug or other item that is included in the items or services involved in the case.
(F) Any other party determined under any regulations to have a substantial interest in the case involved.
(h) Prior determination process for certain items and services
(1) Establishment of process
(A) In general
With respect to a medicare administrative contractor that has a contract under
(B) Eligible requester
For purposes of this subsection, each of the following shall be an eligible requester:
(i) A participating physician, but only with respect to physicians' services to be furnished to an individual who is entitled to benefits under this subchapter and who has consented to the physician making the request under this subsection for those physicians' services.
(ii) An individual entitled to benefits under this subchapter, but only with respect to a physicians' service for which the individual receives, from a physician, an advance beneficiary notice under
(2) Secretarial flexibility
The Secretary shall establish by regulation reasonable limits on the physicians' services for which a prior determination of coverage may be requested under this subsection. In establishing such limits, the Secretary may consider the dollar amount involved with respect to the physicians' service, administrative costs and burdens, and other relevant factors.
(3) Request for prior determination
(A) In general
Subject to paragraph (2), under the process established under this subsection an eligible requester may submit to the contractor a request for a determination, before the furnishing of a physicians' service, as to whether the physicians' service is covered under this subchapter consistent with the applicable requirements of
(B) Accompanying documentation
The Secretary may require that the request be accompanied by a description of the physicians' service, supporting documentation relating to the medical necessity for the physicians' service, and any other appropriate documentation. In the case of a request submitted by an eligible requester who is described in paragraph (1)(B)(ii), the Secretary may require that the request also be accompanied by a copy of the advance beneficiary notice involved.
(4) Response to request
(A) In general
Under such process, the contractor shall provide the eligible requester with written notice of a determination as to whether—
(i) the physicians' service is so covered;
(ii) the physicians' service is not so covered; or
(iii) the contractor lacks sufficient information to make a coverage determination with respect to the physicians' service.
(B) Contents of notice for certain determinations
(i) Noncoverage
If the contractor makes the determination described in subparagraph (A)(ii), the contractor shall include in the notice a brief explanation of the basis for the determination, including on what national or local coverage or noncoverage determination (if any) the determination is based, and a description of any applicable rights under subsection (a).
(ii) Insufficient information
If the contractor makes the determination described in subparagraph (A)(iii), the contractor shall include in the notice a description of the additional information required to make the coverage determination.
(C) Deadline to respond
Such notice shall be provided within the same time period as the time period applicable to the contractor providing notice of initial determinations on a claim for benefits under subsection (a)(2)(A).
(D) Informing beneficiary in case of physician request
In the case of a request by a participating physician under paragraph (1)(B)(i), the process shall provide that the individual to whom the physicians' service is proposed to be furnished shall be informed of any determination described in subparagraph (A)(ii) (relating to a determination of non-coverage) and the right (referred to in paragraph (6)(B)) to obtain the physicians' service and have a claim submitted for the physicians' service.
(5) Binding nature of positive determination
If the contractor makes the determination described in paragraph (4)(A)(i), such determination shall be binding on the contractor in the absence of fraud or evidence of misrepresentation of facts presented to the contractor.
(6) Limitation on further review
(A) In general
Contractor determinations described in paragraph (4)(A)(ii) or (4)(A)(iii) (relating to pre-service claims) are not subject to further administrative appeal or judicial review under this section or otherwise.
(B) Decision not to seek prior determination or negative determination does not impact right to obtain services, seek reimbursement, or appeal rights
Nothing in this subsection shall be construed as affecting the right of an individual who—
(i) decides not to seek a prior determination under this subsection with respect to physicians' services; or
(ii) seeks such a determination and has received a determination described in paragraph (4)(A)(ii),
from receiving (and submitting a claim for) such physicians' services and from obtaining administrative or judicial review respecting such claim under the other applicable provisions of this section. Failure to seek a prior determination under this subsection with respect to physicians' service shall not be taken into account in such administrative or judicial review.
(C) No prior determination after receipt of services
Once an individual is provided physicians' services, there shall be no prior determination under this subsection with respect to such physicians' services.
(i) Mediation process for local coverage determinations
(1) Establishment of process
The Secretary shall establish a mediation process under this subsection through the use of a physician trained in mediation and employed by the Centers for Medicare & Medicaid Services.
(2) Responsibility of mediator
Under the process established in paragraph (1), such a mediator shall mediate in disputes between groups representing providers of services, suppliers (as defined in
(Aug. 14, 1935, ch. 531, title XVIII, §1869, as added
Editorial Notes
Amendments
2014—Subsec. (f)(2)(C).
2011—Subsec. (a)(1)(C).
Subsec. (c)(3)(G).
2003—Subsec. (a)(3)(C)(ii).
Subsec. (a)(4), (5).
Subsec. (b)(1)(A).
Subsec. (b)(1)(E)(iii).
Subsec. (b)(1)(F)(ii).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (c)(3)(A).
Subsec. (c)(3)(B)(i).
Subsec. (c)(3)(C)(i).
Subsec. (c)(3)(D).
Subsec. (c)(3)(E).
Subsec. (c)(3)(I)(ii)(III).
Subsec. (c)(3)(I)(ii)(IV).
Subsec. (c)(3)(J)(i).
Subsec. (c)(3)(K).
Subsec. (c)(4).
Subsec. (d).
Subsec. (d)(4).
Subsec. (f)(2)(A)(i).
Subsec. (f)(4)(A)(iv).
Subsec. (f)(4)(B).
Subsec. (f)(4)(C).
Subsec. (g).
Subsec. (h).
Subsec. (i).
2000—
Subsec. (f).
1997—Subsec. (b)(2)(B).
1994—Subsec. (b)(1).
1987—Subsec. (a).
Subsec. (b)(2).
Subsec. (b)(3)(B).
Subsec. (b)(5).
Subsec. (c).
1986—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
Subsec. (b)(2).
Subsec. (b)(3), (4).
1984—Subsec. (b)(1)(B).
1972—Subsec. (b).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2003 Amendment
Amendment by section 932(a) of
"(1)
"(2)
"(3)
"(4)
Amendment by section 948(b)(1), (c) of
Effective Date of 2000 Amendment
Amendment by section §1(a)(6) [title V, §521(a)] of
Amendment by section 1(a)(6) [title V, §522(a)] of
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1987 Amendment
"(1) The amendment made by subsection (a) [amending this section] shall take effect on the date of the enactment of this Act [Dec. 22, 1987].
"(2) The amendment made by subsection (b) [amending this section] shall apply to requests for hearings filed after the end of the 60-day period beginning on the date of the enactment of this Act."
Amendment by
Effective Date of 1986 Amendment
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1972 Amendment
"(1) The provisions of subparagraphs (A) and (B) of section 1869(b)(1) of the Social Security Act [
"(2) The provisions of paragraph (2) and subparagraph (C) of paragraph (1) of section 1869(b) of the Social Security Act [
"(A) in or after the month in which this Act is enacted [Oct. 1972], or
"(B) before the month in which this Act is enacted [Oct. 1972], but only if a civil action with respect to a final decision of the Secretary of Health, Education, and Welfare on such claim has not been commenced under such section 1869(b) [
Transfer of Responsibility for Medicare Appeals
"(a)
"(1)
"(2)
"(A)
"(B)
"(C)
"(D)
"(E)
"(F)
"(G)
"(i) filing appeals with administrative law judges electronically; and
"(ii) conducting hearings using tele- or video-conference technologies.
"(H)
"(I)
"(J)
"(K)
"(L)
"(M)
"(3)
"(4) GAO
"(b)
"(1)
"(2)
"(3)
"(4)
"(5)
"(6)
"(c)
"(1) increase the number of administrative law judges (and their staffs) under subsection (b)(4);
"(2) improve education and training opportunities for administrative law judges (and their staffs); and
"(3) increase the staff of the Departmental Appeals Board."
Transition
Process for Correction of Minor Errors and Omissions Without Pursuing Appeals Process
"(a)
"(b)
Study of Aggregation Rule for Claims for Similar Physicians' Services
Medicare Hearings and Appeals
"(a)
"(b)
"(1) The Secretary of Health and Human Services and the Comptroller General of the United States shall each conduct a study on holding hearings under section 1869(b)(1) of the Social Security Act [
"(2) The studies under paragraph (1) shall focus on whether telephone hearings allow for a full and fair evidentiary hearing, in general, or with respect to any particular category of claims and shall examine the possible improvements to the hearing process (such as cost-effectiveness, convenience to the claimant, and reduction in time under the process) resulting from the use of such hearings as compared to the adoption of other changes to the process (such as expansions in staff and resources)."
2 So in original. The word "and" probably should not appear.
3 So in original. A comma probably should appear.
4 So in original. Probably should not be capitalized.
§1395gg. Overpayment on behalf of individuals and settlement of claims for benefits on behalf of deceased individuals
(a) Payments to providers of services or other person regarded as payment to individuals
Any payment under this subchapter to any provider of services or other person with respect to any items or services furnished any individual shall be regarded as a payment to such individual.
(b) Incorrect payments on behalf of individuals; payment adjustment
Where—
(1) more than the correct amount is paid under this subchapter to a provider of services or other person for items or services furnished an individual and the Secretary determines (A) that, within such period as he may specify, the excess over the correct amount cannot be recouped from such provider of services or other person, or (B) that such provider of services or other person was without fault with respect to the payment of such excess over the correct amount, or
(2) any payment has been made under
proper adjustments shall be made, under regulations prescribed (after consultation with the Railroad Retirement Board) by the Secretary, by decreasing subsequent payments—
(3) to which such individual is entitled under subchapter II of this chapter or under the Railroad Retirement Act of 1974 [
(4) if such individual dies before such adjustment has been completed, to which any other individual is entitled under subchapter II of this chapter or under the Railroad Retirement Act of 1974 [
As soon as practicable after any adjustment under paragraph (3) or (4) is determined to be necessary, the Secretary, for purposes of this section,
(c) Exception to subsection (b) payment adjustment
There shall be no adjustment as provided in subsection (b) (nor shall there be recovery) in any case where the incorrect payment has been made (including payments under
(d) Liability of certifying or disbursing officer for failure to recoup
No certifying or disbursing officer shall be held liable for any amount certified or paid by him to any provider of services or other person where the adjustment or recovery of such amount is waived under subsection (c) or where adjustment under subsection (b) is not completed prior to the death of all persons against whose benefits such adjustment is authorized.
(e) Settlement of claims for benefits under this subchapter on behalf of deceased individuals
If an individual, who received services for which payment may be made to such individual under this subchapter, dies, and payment for such services was made (other than under this subchapter), and the individual died before any payment due him under this subchapter with respect to such services was completed, payment of the amount due (including the amount of any unnegotiated checks) shall be made—
(1) if the payment for such services was made (before or after such individual's death) by a person other than the deceased individual, to the person or persons determined by the Secretary under regulations to have paid for such services, or if the payment for such services was made by the deceased individual before his death, to the legal representative of the estate of such deceased individual, if any;
(2) if there is no person who meets the requirements of paragraph (1), to the person, if any, who is determined by the Secretary to be the surviving spouse of the deceased individual and who was either living in the same household with the deceased at the time of his death or was, for the month in which the deceased individual died, entitled to a monthly benefit on the basis of the same wages and self-employment income as was the deceased individual;
(3) if there is no person who meets the requirements of paragraph (1) or (2), or if the person who meets such requirements dies before the payment due him under this subchapter is completed, to the child or children, if any, of the deceased individual who were, for the month in which the deceased individual died, entitled to monthly benefits on the basis of the same wages and self-employment income as was the deceased individual (and, in case there is more than one such child, in equal parts to each such child);
(4) if there is no person who meets the requirements of paragraph (1), (2), or (3), or if each person who meets such requirements dies before the payment due him under this subchapter is completed, to the parent or parents, if any, of the deceased individual who were, for the month in which the deceased individual died, entitled to monthly benefits on the basis of the same wages and self-employment income as was the deceased individual (and, in case there is more than one such parent, in equal parts to each such parent);
(5) if there is no person who meets the requirements of paragraph (1), (2), (3), or (4), or if each person who meets such requirements dies before the payment due him under this subchapter is completed, to the person, if any, determined by the Secretary to be the surviving spouse of the deceased individual;
(6) if there is no person who meets the requirements of paragraph (1), (2), (3), (4), or (5), or if each person who meets such requirements dies before the payment due him under this subchapter is completed, to the person or persons, if any, determined by the Secretary to be the child or children of the deceased individual (and, in case there is more than one such child, in equal parts to each such child);
(7) if there is no person who meets the requirements of paragraph (1), (2), (3), (4), (5), or (6), or if each person who meets such requirements dies before the payment due him under this subchapter is completed, to the parent or parents, if any, of the deceased individual (and, in case there is more than one such parent, in equal parts to each such parent); or
(8) if there is no person who meets the requirements of paragraph (1), (2), (3), (4), (5), (6), or (7), or if each person who meets such requirements dies before the payment due him under this subchapter is completed, to the legal representatives of the estate of the deceased individual, if any.
(f) Settlement of claims for section 1395k benefits on behalf of deceased individuals
If an individual who received medical and other health services for which payment may be made under
(1) if the person or persons who furnished the services agree to the terms of assignment specified in
(2) if the person or persons who furnished the services do not agree to the terms of assignment specified in
but only in such amount and subject to such conditions as would be applicable if the individual who received the services had not died.
(g) Refund of premiums for deceased individuals
If an individual, who is enrolled under
(h) Appeals by providers of services or suppliers
Notwithstanding subsection (f) or any other provision of law, the Secretary shall permit a provider of services or supplier to appeal any determination of the Secretary under this subchapter relating to services rendered under this subchapter to an individual who subsequently dies if there is no other party available to appeal such determination.
(Aug. 14, 1935, ch. 531, title XVIII, §1870, as added
Editorial Notes
References in Text
The Railroad Retirement Act of 1974, referred to in subsec. (b), is act Aug. 29, 1935, ch. 812, as amended generally by
Amendments
2013—Subsecs. (b), (c).
2003—Subsec. (h).
1988—
Subsec. (f)(1), (2).
1987—
Subsec. (f)(1), (2).
1982—Subsec. (c).
1980—Subsec. (f).
1974—Subsec. (b).
1972—Subsec. (b).
Subsec. (c).
Subsec. (g).
1968—
Subsecs. (e), (f).
Statutory Notes and Related Subsidiaries
Effective Date of 2013 Amendment
Effective Date of 2003 Amendment
Effective Date of 1988 Amendment
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4096(a)(2) of
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1980 Amendment
Effective Date of 1974 Amendment
Amendment by
Effective Date of 1972 Amendment
Waiver of Liability Limiting Recoupment in Certain Cases
§1395hh. Regulations
(a) Authority to prescribe regulations; ineffectiveness of substantive rules not promulgated by regulation
(1) The Secretary shall prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this subchapter. When used in this subchapter, the term "regulations" means, unless the context otherwise requires, regulations prescribed by the Secretary.
(2) No rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under this subchapter shall take effect unless it is promulgated by the Secretary by regulation under paragraph (1).
(3)(A) The Secretary, in consultation with the Director of the Office of Management and Budget, shall establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation or an interim final regulation.
(B) Such timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but shall not be longer than 3 years except under exceptional circumstances. If the Secretary intends to vary such timeline with respect to the publication of a final regulation, the Secretary shall cause to have published in the Federal Register notice of the different timeline by not later than the timeline previously established with respect to such regulation. Such notice shall include a brief explanation of the justification for such variation.
(C) In the case of interim final regulations, upon the expiration of the regular timeline established under this paragraph for the publication of a final regulation after opportunity for public comment, the interim final regulation shall not continue in effect unless the Secretary publishes (at the end of the regular timeline and, if applicable, at the end of each succeeding 1-year period) a notice of continuation of the regulation that includes an explanation of why the regular timeline (and any subsequent 1-year extension) was not complied with. If such a notice is published, the regular timeline (or such timeline as previously extended under this paragraph) for publication of the final regulation shall be treated as having been extended for 1 additional year.
(D) The Secretary shall annually submit to Congress a report that describes the instances in which the Secretary failed to publish a final regulation within the applicable regular timeline under this paragraph and that provides an explanation for such failures.
(4) If the Secretary publishes a final regulation that includes a provision that is not a logical outgrowth of a previously published notice of proposed rulemaking or interim final rule, such provision shall be treated as a proposed regulation and shall not take effect until there is the further opportunity for public comment and a publication of the provision again as a final regulation.
(b) Notice of proposed regulations; public comment
(1) Except as provided in paragraph (2), before issuing in final form any regulation under subsection (a), the Secretary shall provide for notice of the proposed regulation in the Federal Register and a period of not less than 60 days for public comment thereon.
(2) Paragraph (1) shall not apply where—
(A) a statute specifically permits a regulation to be issued in interim final form or otherwise with a shorter period for public comment,
(B) a statute establishes a specific deadline for the implementation of a provision and the deadline is less than 150 days after the date of the enactment of the statute in which the deadline is contained, or
(C) subsection (b) of
(c) Publication of certain rules; public inspection; changes in data collection and retrieval
(1) The Secretary shall publish in the Federal Register, not less frequently than every 3 months, a list of all manual instructions, interpretative rules, statements of policy, and guidelines of general applicability which—
(A) are promulgated to carry out this subchapter, but
(B) are not published pursuant to subsection (a)(1) and have not been previously published in a list under this subsection.
(2) Effective June 1, 1988, each fiscal intermediary and carrier administering claims for extended care, post-hospital extended care, home health care, and durable medical equipment benefits under this subchapter shall make available to the public all interpretative materials, guidelines, and clarifications of policies which relate to payments for such benefits.
(3) The Secretary shall to the extent feasible make such changes in automated data collection and retrieval by the Secretary and fiscal intermediaries with agreements under
(e) 1 Retroactivity of substantive changes; reliance upon written guidance
(1)(A) A substantive change in regulations, manual instructions, interpretative rules, statements of policy, or guidelines of general applicability under this subchapter shall not be applied (by extrapolation or otherwise) retroactively to items and services furnished before the effective date of the change, unless the Secretary determines that—
(i) such retroactive application is necessary to comply with statutory requirements; or
(ii) failure to apply the change retroactively would be contrary to the public interest.
(B)(i) Except as provided in clause (ii), a substantive change referred to in subparagraph (A) shall not become effective before the end of the 30-day period that begins on the date that the Secretary has issued or published, as the case may be, the substantive change.
(ii) The Secretary may provide for such a substantive change to take effect on a date that precedes the end of the 30-day period under clause (i) if the Secretary finds that waiver of such 30-day period is necessary to comply with statutory requirements or that the application of such 30-day period is contrary to the public interest. If the Secretary provides for an earlier effective date pursuant to this clause, the Secretary shall include in the issuance or publication of the substantive change a finding described in the first sentence, and a brief statement of the reasons for such finding.
(C) No action shall be taken against a provider of services or supplier with respect to noncompliance with such a substantive change for items and services furnished before the effective date of such a change.
(2)(A) If—
(i) a provider of services or supplier follows the written guidance (which may be transmitted electronically) provided by the Secretary or by a medicare contractor (as defined in
(ii) the Secretary determines that the provider of services or supplier has accurately presented the circumstances relating to such items, services, and claim to the contractor in writing; and
(iii) the guidance was in error;
the provider of services or supplier shall not be subject to any penalty or interest under this subchapter or the provisions of subchapter XI insofar as they relate to this subchapter (including interest under a repayment plan under
(B) Subparagraph (A) shall not be construed as preventing the recoupment or repayment (without any additional penalty) relating to an overpayment insofar as the overpayment was solely the result of a clerical or technical operational error.
(f) Report on areas of inconsistency or conflict
(1) Not later than 2 years after December 8, 2003, and every 3 years thereafter, the Secretary shall submit to Congress a report with respect to the administration of this subchapter and areas of inconsistency or conflict among the various provisions under law and regulation.
(2) In preparing a report under paragraph (1), the Secretary shall collect—
(A) information from individuals entitled to benefits under part A or enrolled under part B, or both, providers of services, and suppliers and from the Medicare Beneficiary Ombudsman with respect to such areas of inconsistency and conflict; and
(B) information from medicare contractors that tracks the nature of written and telephone inquiries.
(3) A report under paragraph (1) shall include a description of efforts by the Secretary to reduce such inconsistency or conflicts, and recommendations for legislation or administrative action that the Secretary determines appropriate to further reduce such inconsistency or conflicts.
(Aug. 14, 1935, ch. 531, title XVIII, §1871, as added
Editorial Notes
Amendments
2003—Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (e).
Subsec. (e)(1)(B), (C).
Subsec. (e)(2).
Subsec. (f).
1987—Subsec. (a).
Subsec. (c).
1986—
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Effective Date of 1987 Amendment
Amendment by
Effective Date of 1986 Amendment
Regulations
Section 4039(g) of title IV of
Requiring the Posting and Periodic Update of Opioid Prescribing Guidance for Medicare Beneficiaries
"(a)
"(b)
"(1)
"(2)
"(A) Medical professional organizations.
"(B) Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act (
"(C) Health care consumers or groups representing such consumers.
"(D) Other entities determined appropriate by the Secretary."
GAO Study on Advisory Opinion Authority
"(1)
"(2)
1 So in original. No subsec. (d) has been enacted.
§1395ii. Application of certain provisions of subchapter II
The provisions of
(Aug. 14, 1935, ch. 531, title XVIII, §1872, as added
Editorial Notes
Amendments
1994—
1984—
1972—
Statutory Notes and Related Subsidiaries
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by
§1395jj. Designation of organization or publication by name
Designation in this subchapter, by name, of any nongovernmental organization or publication shall not be affected by change of name of such organization or publication, and shall apply to any successor organization or publication which the Secretary finds serves the purpose for which such designation is made.
(Aug. 14, 1935, ch. 531, title XVIII, §1873, as added
§1395kk. Administration of insurance programs
(a) Functions of Secretary; performance directly or by contract
Except as otherwise provided in this subchapter and in the Railroad Retirement Act of 1974 [
(b) Contracts to secure special data, actuarial information, etc.
The Secretary may contract with any person, agency, or institution to secure on a reimbursable basis such special data, actuarial information, and other information as may be necessary in the carrying out of his functions under this subchapter.
(c) Oaths and affirmations
In the course of any hearing, investigation, or other proceeding that he is authorized to conduct under this subchapter, the Secretary may administer oaths and affirmations.
(d) Inclusion of Medicare provider and supplier payments in Federal Payment Levy Program
(1) In general
The Centers for Medicare & Medicaid Services shall take all necessary steps to participate in the Federal Payment Levy Program under section 6331(h) of the Internal Revenue Code of 1986 as soon as possible and shall ensure that—
(A) at least 50 percent of all payments under parts A and B are processed through such program beginning within 1 year after July 15, 2008; 1
(B) at least 75 percent of all payments under parts A and B are processed through such program beginning within 2 years after July 15, 2008; and
(C) all payments under parts A and B are processed through such program beginning not later than September 30, 2011.
(2) Assistance
The Financial Management Service and the Internal Revenue Service shall provide assistance to the Centers for Medicare & Medicaid Services to ensure that all payments described in paragraph (1) are included in the Federal Payment Levy Program by the deadlines specified in that subsection.
(e) Availability of data
(1) In general
Subject to paragraph (4), the Secretary shall make available to qualified entities (as defined in paragraph (2)) data described in paragraph (3) for the evaluation of the performance of providers of services and suppliers.
(2) Qualified entities
For purposes of this subsection, the term "qualified entity" means a public or private entity that—
(A) is qualified (as determined by the Secretary) to use claims data to evaluate the performance of providers of services and suppliers on measures of quality, efficiency, effectiveness, and resource use; and
(B) agrees to meet the requirements described in paragraph (4) and meets such other requirements as the Secretary may specify, such as ensuring security of data.
(3) Data described
The data described in this paragraph are standardized extracts (as determined by the Secretary) of claims data under parts A, B, and D for items and services furnished under such parts for one or more specified geographic areas and time periods requested by a qualified entity. Beginning July 1, 2016, if the Secretary determines appropriate, the data described in this paragraph may also include standardized extracts (as determined by the Secretary) of claims data under subchapters XIX and XXI for assistance provided under such subchapters for one or more specified geographic areas and time periods requested by a qualified entity. The Secretary shall take such actions as the Secretary deems necessary to protect the identity of individuals entitled to or enrolled for benefits under such parts or under subchapters 2 XIX or XXI.
(4) Requirements
(A) Fee
Data described in paragraph (3) shall be made available to a qualified entity under this subsection at a fee equal to the cost of making such data available. Any fee collected pursuant to the preceding sentence shall be deposited, for periods prior to July 1, 2016, into the Federal Supplementary Medical Insurance Trust Fund under
(B) Specification of uses and methodologies
A qualified entity requesting data under this subsection shall—
(i) submit to the Secretary a description of the methodologies that such qualified entity will use to evaluate the performance of providers of services and suppliers using such data;
(ii)(I) except as provided in subclause (II), if available, use standard measures, such as measures endorsed by the entity with a contract under
(II) use alternative measures if the Secretary, in consultation with appropriate stakeholders, determines that use of such alternative measures would be more valid, reliable, responsive to consumer preferences, cost-effective, or relevant to dimensions of quality and resource use not addressed by such standard measures;
(iii) include data made available under this subsection with claims data from sources other than claims data under this subchapter in the evaluation of performance of providers of services and suppliers;
(iv) only include information on the evaluation of performance of providers and suppliers in reports described in subparagraph (C);
(v) make available to providers of services and suppliers, upon their request, data made available under this subsection; and
(vi) prior to their release, submit to the Secretary the format of reports under subparagraph (C).
(C) Reports
Any report by a qualified entity evaluating the performance of providers of services and suppliers using data made available under this subsection shall—
(i) include an understandable description of the measures, which shall include quality measures and the rationale for use of other measures described in subparagraph (B)(ii)(II), risk adjustment methods, physician attribution methods, other applicable methods, data specifications and limitations, and the sponsors, so that consumers, providers of services and suppliers, health plans, researchers, and other stakeholders can assess such reports;
(ii) be made available confidentially, to any provider of services or supplier to be identified in such report, prior to the public release of such report, and provide an opportunity to appeal and correct errors;
(iii) only include information on a provider of services or supplier in an aggregate form as determined appropriate by the Secretary; and
(iv) except as described in clause (ii), be made available to the public.
(D) Approval and limitation of uses
The Secretary shall not make data described in paragraph (3) available to a qualified entity unless the qualified entity agrees to release the information on the evaluation of performance of providers of services and suppliers. Such entity shall only use such data, and information derived from such evaluation, for the reports under subparagraph (C). Data released to a qualified entity under this subsection shall not be subject to discovery or admission as evidence in judicial or administrative proceedings without consent of the applicable provider of services or supplier.
(f) Requirement for the Secretary to establish policies and claims edits relating to incarcerated individuals, individuals not lawfully present, and deceased individuals
The Secretary shall establish and maintain procedures, including procedures for using claims processing edits, updating eligibility information to improve provider accessibility, and conducting recoupment activities such as through recovery audit contractors, in order to ensure that payment is not made under this subchapter for items and services furnished to an individual who is one of the following:
(1) An individual who is incarcerated.
(2) An individual who is not lawfully present in the United States and who is not eligible for coverage under this subchapter.
(3) A deceased individual.
(g) Requirement for enrollment data reporting
(1) In general
Each year (beginning with 2016), the Secretary shall submit to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report on Medicare enrollment data (and, in the case of part A, on data on individuals receiving benefits under such part) as of a date in such year specified by the Secretary. Such data shall be presented—
(A) by Congressional district and State; and
(B) in a manner that provides for such data based on—
(i) fee-for-service enrollment (as defined in paragraph (2));
(ii) enrollment under part C (including separate for aggregate enrollment in MA–PD plans and aggregate enrollment in MA plans that are not MA–PD plans); and
(iii) enrollment under part D.
(2) Fee-for-service enrollment defined
For purpose of paragraph (1)(B)(i), the term "fee-for-service enrollment" means aggregate enrollment (including receipt of benefits other than through enrollment) under—
(A) part A only;
(B) part B only; and
(C) both part A and part B.
(Aug. 14, 1935, ch. 531, title XVIII, §1874, as added and amended
Editorial Notes
References in Text
The Railroad Retirement Act of 1974, referred to in subsec. (a), is act Aug. 29, 1935, ch. 812, as amended generally by
The Internal Revenue Code of 1986, referred to in subsec. (d)(1), is classified generally to Title 26, Internal Revenue Code.
July 15, 2008, referred to in subsec. (d)(1)(A) and (B), was in the original "the date of the enactment of this section" and "such date", which were translated as meaning the date of enactment of
Amendments
2016—Subsec. (g).
2015—Subsec. (e).
Subsec. (e)(3).
Subsec. (e)(4)(A).
Subsec. (f).
2010—Subsec. (e).
2008—Subsec. (d).
1974—Subsec. (a).
1972—Subsec. (c).
1965—Subsec. (a).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Effective Date of 2008 Amendment
Amendment by
Effective Date of 1974 Amendment
Amendment by
Effective Date of 1965 Amendment
Amendment by
Report
1 See References in Text note below.
2 So in original. Probably should be "subchapter".
§1395kk–1. Contracts with medicare administrative contractors
(a) Authority
(1) Authority to enter into contracts
The Secretary may enter into contracts with any eligible entity to serve as a medicare administrative contractor with respect to the performance of any or all of the functions described in paragraph (4) or parts of those functions (or, to the extent provided in a contract, to secure performance thereof by other entities).
(2) Eligibility of entities
An entity is eligible to enter into a contract with respect to the performance of a particular function described in paragraph (4) only if—
(A) the entity has demonstrated capability to carry out such function;
(B) the entity complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement;
(C) the entity has sufficient assets to financially support the performance of such function; and
(D) the entity meets such other requirements as the Secretary may impose.
(3) Medicare administrative contractor defined
For purposes of this subchapter and subchapter XI—
(A) In general
The term "medicare administrative contractor" means an agency, organization, or other person with a contract under this section.
(B) Appropriate medicare administrative contractor
With respect to the performance of a particular function in relation to an individual entitled to benefits under part A or enrolled under part B, or both, a specific provider of services or supplier (or class of such providers of services or suppliers), the "appropriate" medicare administrative contractor is the medicare administrative contractor that has a contract under this section with respect to the performance of that function in relation to that individual, provider of services or supplier or class of provider of services or supplier.
(4) Functions described
The functions referred to in paragraphs (1) and (2) are payment functions (including the function of developing local coverage determinations, as defined in
(A) Determination of payment amounts
Determining (subject to the provisions of
(B) Making payments
Making payments described in subparagraph (A) (including receipt, disbursement, and accounting for funds in making such payments).
(C) Beneficiary education and assistance
Providing education and outreach to individuals entitled to benefits under part A or enrolled under part B, or both, and providing assistance to those individuals with specific issues, concerns, or problems.
(D) Provider consultative services
Providing consultative services to institutions, agencies, and other persons to enable them to establish and maintain fiscal records necessary for purposes of this subchapter and otherwise to qualify as providers of services or suppliers.
(E) Communication with providers
Communicating to providers of services and suppliers any information or instructions furnished to the medicare administrative contractor by the Secretary, and facilitating communication between such providers and suppliers and the Secretary.
(F) Provider education and technical assistance
Performing the functions relating to provider education, training, and technical assistance.
(G) Improper payment outreach and education program
Having in place an improper payment outreach and education program described in subsection (h).
(H) Additional functions
Performing such other functions, including (subject to paragraph (5)) functions under the Medicare Integrity Program under
(5) Relationship to MIP contracts
(A) Nonduplication of duties
In entering into contracts under this section, the Secretary shall assure that functions of medicare administrative contractors in carrying out activities under parts A and B do not duplicate activities carried out under a contract entered into under the Medicare Integrity Program under
(B) Construction
An entity shall not be treated as a medicare administrative contractor merely by reason of having entered into a contract with the Secretary under
(6) Application of Federal Acquisition Regulation
Except to the extent inconsistent with a specific requirement of this section, the Federal Acquisition Regulation applies to contracts under this section.
(b) Contracting requirements
(1) Use of competitive procedures
(A) In general
Except as provided in laws with general applicability to Federal acquisition and procurement or in subparagraph (B), the Secretary shall use competitive procedures when entering into contracts with medicare administrative contractors under this section, taking into account performance quality as well as price and other factors.
(B) Renewal of contracts
The Secretary may renew a contract with a medicare administrative contractor under this section from term to term without regard to
(C) Transfer of functions
The Secretary may transfer functions among medicare administrative contractors consistent with the provisions of this paragraph. The Secretary shall ensure that performance quality is considered in such transfers. The Secretary shall provide public notice (whether in the Federal Register or otherwise) of any such transfer (including a description of the functions so transferred, a description of the providers of services and suppliers affected by such transfer, and contact information for the contractors involved).
(D) Incentives for quality
(i) In general
Subject to clauses (ii) and (iii), the Secretary shall provide incentives for medicare administrative contractors to provide quality service and to promote efficiency.
(ii) Improper payment rate reduction incentives
The Secretary shall provide incentives for medicare administrative contractors to reduce the improper payment error rates in their jurisdictions.
(iii) Incentives
The incentives provided for under clause (ii)—
(I) may include a sliding scale of award fee payments and additional incentives to medicare administrative contractors that either reduce the improper payment rates in their jurisdictions to certain thresholds, as determined by the Secretary, or accomplish tasks, as determined by the Secretary, that further improve payment accuracy; and
(II) may include substantial reductions in award fee payments under cost-plus-award-fee contracts, for medicare administrative contractors that reach an upper end improper payment rate threshold or other threshold as determined by the Secretary, or fail to accomplish tasks, as determined by the Secretary, that further improve payment accuracy.
(2) Compliance with requirements
No contract under this section shall be entered into with any medicare administrative contractor unless the Secretary finds that such medicare administrative contractor will perform its obligations under the contract efficiently and effectively and will meet such requirements as to financial responsibility, legal authority, quality of services provided, and other matters as the Secretary finds pertinent.
(3) Performance requirements
(A) Development of specific performance requirements
(i) In general
The Secretary shall develop contract performance requirements to carry out the specific requirements applicable under this subchapter to a function described in subsection (a)(4) and shall develop standards for measuring the extent to which a contractor has met such requirements. Such requirements shall include specific performance duties expected of a medical director of a medicare administrative contractor, including requirements relating to professional relations and the availability of such director to conduct medical determination activities within the jurisdiction of such a contractor.
(ii) Consultation
In developing such performance requirements and standards for measurement, the Secretary shall consult with providers of services, organizations representative of beneficiaries under this subchapter, and organizations and agencies performing functions necessary to carry out the purposes of this section with respect to such performance requirements.
(iii) Publication of standards
The Secretary shall make such performance requirements and measurement standards available to the public.
(iv) Contractor performance transparency
To the extent possible without compromising the process for entering into and renewing contracts with medicare administrative contractors under this section, the Secretary shall make available to the public the performance of each medicare administrative contractor with respect to such performance requirements and measurement standards.
(B) Considerations
The Secretary shall include, as one of the standards developed under subparagraph (A), provider and beneficiary satisfaction levels.
(C) Inclusion in contracts
All contractor performance requirements shall be set forth in the contract between the Secretary and the appropriate medicare administrative contractor. Such performance requirements—
(i) shall reflect the performance requirements published under subparagraph (A), but may include additional performance requirements;
(ii) shall be used for evaluating contractor performance under the contract; and
(iii) shall be consistent with the written statement of work provided under the contract.
(4) Information requirements
The Secretary shall not enter into a contract with a medicare administrative contractor under this section unless the contractor agrees—
(A) to furnish to the Secretary such timely information and reports as the Secretary may find necessary in performing his functions under this subchapter; and
(B) to maintain such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of the information and reports under subparagraph (A) and otherwise to carry out the purposes of this subchapter.
(5) Surety bond
A contract with a medicare administrative contractor under this section may require the medicare administrative contractor, and any of its officers or employees certifying payments or disbursing funds pursuant to the contract, or otherwise participating in carrying out the contract, to give surety bond to the United States in such amount as the Secretary may deem appropriate.
(c) Terms and conditions
(1) In general
A contract with any medicare administrative contractor under this section may contain such terms and conditions as the Secretary finds necessary or appropriate and may provide for advances of funds to the medicare administrative contractor for the making of payments by it under subsection (a)(4)(B).
(2) Prohibition on mandates for certain data collection
The Secretary may not require, as a condition of entering into, or renewing, a contract under this section, that the medicare administrative contractor match data obtained other than in its activities under this subchapter with data used in the administration of this subchapter for purposes of identifying situations in which the provisions of
(d) Limitation on liability of medicare administrative contractors and certain officers
(1) Certifying officer
No individual designated pursuant to a contract under this section as a certifying officer shall, in the absence of the reckless disregard of the individual's obligations or the intent by that individual to defraud the United States, be liable with respect to any payments certified by the individual under this section.
(2) Disbursing officer
No disbursing officer shall, in the absence of the reckless disregard of the officer's obligations or the intent by that officer to defraud the United States, be liable with respect to any payment by such officer under this section if it was based upon an authorization (which meets the applicable requirements for such internal controls established by the Comptroller General of the United States) of a certifying officer designated as provided in paragraph (1) of this subsection.
(3) Liability of medicare administrative contractor
(A) In general
No medicare administrative contractor shall be liable to the United States for a payment by a certifying or disbursing officer unless, in connection with such payment, the medicare administrative contractor acted with reckless disregard of its obligations under its medicare administrative contract or with intent to defraud the United States.
(B) Relationship to False Claims Act
Nothing in this subsection shall be construed to limit liability for conduct that would constitute a violation of
(4) Indemnification by Secretary
(A) In general
Subject to subparagraphs (B) and (D), in the case of a medicare administrative contractor (or a person who is a director, officer, or employee of such a contractor or who is engaged by the contractor to participate directly in the claims administration process) who is made a party to any judicial or administrative proceeding arising from or relating directly to the claims administration process under this subchapter, the Secretary may, to the extent the Secretary determines to be appropriate and as specified in the contract with the contractor, indemnify the contractor and such persons.
(B) Conditions
The Secretary may not provide indemnification under subparagraph (A) insofar as the liability for such costs arises directly from conduct that is determined by the judicial proceeding or by the Secretary to be criminal in nature, fraudulent, or grossly negligent. If indemnification is provided by the Secretary with respect to a contractor before a determination that such costs arose directly from such conduct, the contractor shall reimburse the Secretary for costs of indemnification.
(C) Scope of indemnification
Indemnification by the Secretary under subparagraph (A) may include payment of judgments, settlements (subject to subparagraph (D)), awards, and costs (including reasonable legal expenses).
(D) Written approval for settlements or compromises
A contractor or other person described in subparagraph (A) may not propose to negotiate a settlement or compromise of a proceeding described in such subparagraph without the prior written approval of the Secretary to negotiate such settlement or compromise. Any indemnification under subparagraph (A) with respect to amounts paid under a settlement or compromise of a proceeding described in such subparagraph are conditioned upon prior written approval by the Secretary of the final settlement or compromise.
(E) Construction
Nothing in this paragraph shall be construed—
(i) to change any common law immunity that may be available to a medicare administrative contractor or person described in subparagraph (A); or
(ii) to permit the payment of costs not otherwise allowable, reasonable, or allocable under the Federal Acquisition Regulation.
(e) Requirements for information security
(1) Development of information security program
A medicare administrative contractor that performs the functions referred to in subparagraphs (A) and (B) of subsection (a)(4) (relating to determining and making payments) shall implement a contractor-wide information security program to provide information security for the operation and assets of the contractor with respect to such functions under this subchapter. An information security program under this paragraph shall meet the requirements for information security programs imposed on Federal agencies under paragraphs (1) through (8) of section 3544(b) 1 of title 44 (other than the requirements under paragraphs (2)(D)(i), (5)(A), and (5)(B) of such section).
(2) Independent audits
(A) Performance of annual evaluations
Each year a medicare administrative contractor that performs the functions referred to in subparagraphs (A) and (B) of subsection (a)(4) (relating to determining and making payments) shall undergo an evaluation of the information security of the contractor with respect to such functions under this subchapter. The evaluation shall—
(i) be performed by an entity that meets such requirements for independence as the Inspector General of the Department of Health and Human Services may establish; and
(ii) test the effectiveness of information security control techniques of an appropriate subset of the contractor's information systems (as defined in
(B) Deadline for initial evaluation
(i) New contractors
In the case of a medicare administrative contractor covered by this subsection that has not previously performed the functions referred to in subparagraphs (A) and (B) of subsection (a)(4) (relating to determining and making payments) as a fiscal intermediary or carrier under
(ii) Other contractors
In the case of a medicare administrative contractor covered by this subsection that is not described in clause (i), the first independent evaluation conducted pursuant to subparagraph (A) shall be completed within 1 year after the date the contractor commences functions referred to in clause (i) under this section.
(C) Reports on evaluations
(i) To the Department of Health and Human Services
The results of independent evaluations under subparagraph (A) shall be submitted promptly to the Inspector General of the Department of Health and Human Services and to the Secretary.
(ii) To Congress
The Inspector General of the Department of Health and Human Services shall submit to Congress annual reports on the results of such evaluations, including assessments of the scope and sufficiency of such evaluations.
(iii) Agency reporting
The Secretary shall address the results of such evaluations in reports required under section 3544(c) 1 of title 44.
(f) Incentives to improve contractor performance in provider education and outreach
The Secretary shall use specific claims payment error rates or similar methodology of medicare administrative contractors in the processing or reviewing of medicare claims in order to give such contractors an incentive to implement effective education and outreach programs for providers of services and suppliers.
(g) Communications with beneficiaries, providers of services and suppliers
(1) Communication strategy
The Secretary shall develop a strategy for communications with individuals entitled to benefits under part A or enrolled under part B, or both, and with providers of services and suppliers under this subchapter.
(2) Response to written inquiries
Each medicare administrative contractor shall, for those providers of services and suppliers which submit claims to the contractor for claims processing and for those individuals entitled to benefits under part A or enrolled under part B, or both, with respect to whom claims are submitted for claims processing, provide general written responses (which may be through electronic transmission) in a clear, concise, and accurate manner to inquiries of providers of services, suppliers, and individuals entitled to benefits under part A or enrolled under part B, or both, concerning the programs under this subchapter within 45 business days of the date of receipt of such inquiries.
(3) Response to toll-free lines
The Secretary shall ensure that each medicare administrative contractor shall provide, for those providers of services and suppliers which submit claims to the contractor for claims processing and for those individuals entitled to benefits under part A or enrolled under part B, or both, with respect to whom claims are submitted for claims processing, a toll-free telephone number at which such individuals, providers of services, and suppliers may obtain information regarding billing, coding, claims, coverage, and other appropriate information under this subchapter.
(4) Monitoring of contractor responses
(A) In general
Each medicare administrative contractor shall, consistent with standards developed by the Secretary under subparagraph (B)—
(i) maintain a system for identifying who provides the information referred to in paragraphs (2) and (3); and
(ii) monitor the accuracy, consistency, and timeliness of the information so provided.
(B) Development of standards
(i) In general
The Secretary shall establish and make public standards to monitor the accuracy, consistency, and timeliness of the information provided in response to written and telephone inquiries under this subsection. Such standards shall be consistent with the performance requirements established under subsection (b)(3).
(ii) Evaluation
In conducting evaluations of individual medicare administrative contractors, the Secretary shall take into account the results of the monitoring conducted under subparagraph (A) taking into account as performance requirements the standards established under clause (i). The Secretary shall, in consultation with organizations representing providers of services, suppliers, and individuals entitled to benefits under part A or enrolled under part B, or both, establish standards relating to the accuracy, consistency, and timeliness of the information so provided.
(C) Direct monitoring
Nothing in this paragraph shall be construed as preventing the Secretary from directly monitoring the accuracy, consistency, and timeliness of the information so provided.
(5) Authorization of appropriations
There are authorized to be appropriated such sums as are necessary to carry out this subsection.
(h) Improper payment outreach and education program
(1) In general
In order to reduce improper payments under this subchapter, each medicare administrative contractor shall establish and have in place an improper payment outreach and education program under which the contractor, through outreach, education, training, and technical assistance or other activities, shall provide providers of services and suppliers located in the region covered by the contract under this section with the information described in paragraph (2). The activities described in the preceding sentence shall be conducted on a regular basis.
(2) Information to be provided through activities
The information to be provided under such payment outreach and education program shall include information the Secretary determines to be appropriate, which may include the following information:
(A) A list of the providers' or suppliers' most frequent and expensive payment errors over the last quarter.
(B) Specific instructions regarding how to correct or avoid such errors in the future.
(C) A notice of new topics that have been approved by the Secretary for audits conducted by recovery audit contractors under
(D) Specific instructions to prevent future issues related to such new audits.
(E) Other information determined appropriate by the Secretary.
(3) Priority
A medicare administrative contractor shall give priority to activities under such program that will reduce improper payments that are one or more of the following:
(A) Are for items and services that have the highest rate of improper payment.
(B) Are for items and service 2 that have the greatest total dollar amount of improper payments.
(C) Are due to clear misapplication or misinterpretation of Medicare policies.
(D) Are clearly due to common and inadvertent clerical or administrative errors.
(E) Are due to other types of errors that the Secretary determines could be prevented through activities under the program.
(4) Information on improper payments from recovery audit contractors
(A) In general
In order to assist medicare administrative contractors in carrying out improper payment outreach and education programs, the Secretary shall provide each contractor with a complete list of the types of improper payments identified by recovery audit contractors under
(B) Information
The information described in subparagraph (A) shall include information such as the following:
(i) Providers of services and suppliers that have the highest rate of improper payments.
(ii) Providers of services and suppliers that have the greatest total dollar amounts of improper payments.
(iii) Items and services furnished in the region that have the highest rates of improper payments.
(iv) Items and services furnished in the region that are responsible for the greatest total dollar amount of improper payments.
(v) Other information the Secretary determines would assist the contractor in carrying out the program.
(5) Communications
Communications with providers of services and suppliers under an improper payment outreach and education program are subject to the standards and requirements of subsection (g).
(Aug. 14, 1935, ch. 531, title XVIII, §1874A, as added and amended
Editorial Notes
References in Text
The text of
Codification
In subsec. (b)(1)(B), "
Amendments
2015—Subsec. (a)(4)(G), (H).
Subsec. (b)(1)(B).
Subsec. (b)(1)(D).
Subsec. (b)(3)(A)(iv).
Subsec. (h).
2010—Subsec. (h).
2003—Subsec. (b)(3)(A)(i).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Statutory Notes and Related Subsidiaries
Effective Date of 2015 Amendment
"(1)
"(2)
Effective Date of 2003 Amendment
"(1)
"(2)
"(3)
Effective Date; Transition Rule
"(1)
"(A)
"(B)
"(C)
"(2)
"(A)
"(B)
"(3)
Construction
"(1) to compromise or affect existing legal remedies for addressing fraud or abuse, whether it be criminal prosecution, civil enforcement, or administrative remedies, including under
"(2) to prevent or impede the Department of Health and Human Services in any way from its ongoing efforts to eliminate waste, fraud, and abuse in the medicare program.
Furthermore, the consolidation of medicare administrative contracting set forth in this division [
Consideration of Incorporation of Current Law Standards
References
Secretarial Submission of Legislative Proposal
Reports on Implementation
"(1)
"(2)
"(A) The number of contracts that have been competitively bid as of such date.
"(B) The distribution of functions among contracts and contractors.
"(C) A timeline for complete transition to full competition.
"(D) A detailed description of how the Secretary has modified oversight and management of medicare contractors to adapt to full competition."
Application to Fiscal Intermediaries and Carriers
"(1)
"(2)
Policy Development Regarding Evaluation and Management (E & M) Documentation Guidelines
"(a)
"(1) has developed the guidelines in collaboration with practicing physicians (including both generalists and specialists) and provided for an assessment of the proposed guidelines by the physician community;
"(2) has established a plan that contains specific goals, including a schedule, for improving the use of such guidelines;
"(3) has conducted appropriate and representative pilot projects under subsection (b) to test such guidelines;
"(4) finds, based on reports submitted under subsection (b)(5) with respect to pilot projects conducted for such or related guidelines, that the objectives described in subsection (c) will be met in the implementation of such guidelines; and
"(5) has established, and is implementing, a program to educate physicians on the use of such guidelines and that includes appropriate outreach.
The Secretary shall make changes to the manner in which existing evaluation and management documentation guidelines are implemented to reduce paperwork burdens on physicians.
"(b)
"(1)
"(2)
"(A) be voluntary;
"(B) be of sufficient length as determined by the Secretary (but in no case to exceed 1 year) to allow for preparatory physician and medicare contractor education, analysis, and use and assessment of potential evaluation and management guidelines; and
"(C) be conducted, in development and throughout the planning and operational stages of the project, in consultation with practicing physicians (including both generalists and specialists).
"(3)
"(A) at least one shall focus on a peer review method by physicians (not employed by a medicare contractor) which evaluates medical record information for claims submitted by physicians identified as statistical outliers relative to codes used for billing purposes for such services;
"(B) at least one shall focus on an alternative method to detailed guidelines based on physician documentation of face to face encounter time with a patient;
"(C) at least one shall be conducted for services furnished in a rural area and at least one for services furnished outside such an area; and
"(D) at least one shall be conducted in a setting where physicians bill under physicians' services in teaching settings and at least one shall be conducted in a setting other than a teaching setting.
"(4)
"(A) different types of physician practices, including those with fewer than 10 full-time-equivalent employees (including physicians); and
"(B) the costs of physician compliance, including education, implementation, auditing, and monitoring.
"(5)
"(c)
"(1) identify clinically relevant documentation needed to code accurately and assess coding levels accurately;
"(2) decrease the level of non-clinically pertinent and burdensome documentation time and content in the physician's medical record;
"(3) increase accuracy by reviewers; and
"(4) educate both physicians and reviewers.
"(d)
"(1)
"(2)
"(A) the development of a simpler, alternative system of requirements for documentation accompanying claims for evaluation and management physician services for which payment is made under title XVIII of the Social Security Act [
"(B) consideration of systems other than current coding and documentation requirements for payment for such physician services.
"(3)
"(4)
"(5)
"(A) Not later than October 1, 2005, the Secretary shall submit to Congress a report on the results of the study conducted under paragraph (1).
"(B) The Medicare Payment Advisory Commission shall conduct an analysis of the results of the study included in the report under subparagraph (A) and shall submit a report on such analysis to Congress.
"(e)
"(f)
"(1) the term 'rural area' has the meaning given that term in section 1886(d)(2)(D) of the Social Security Act (
"(2) the term 'teaching settings' are those settings described in section 415.150 of title 42, Code of Federal Regulations."
1 See References in Text note below.
2 So in original. Probably should be "services".
§1395kk–2. Expanding availability of Medicare data
(a) Expanding uses of Medicare data by qualified entities
(1) Additional analyses
(A) In general
Subject to subparagraph (B), to the extent consistent with applicable information, privacy, security, and disclosure laws (including paragraph (3)), notwithstanding paragraph (4)(B) of section 1874(e) of the Social Security Act (
(B) Limitations with respect to analyses
(i) Employers
Any analyses provided or sold under subparagraph (A) to an employer described in paragraph (9)(A)(iii) may only be used by such employer for purposes of providing health insurance to employees and retirees of the employer.
(ii) Health insurance issuers
A qualified entity may not provide or sell an analysis to a health insurance issuer described in paragraph (9)(A)(iv) unless the issuer is providing the qualified entity with data under section 1874(e)(4)(B)(iii) of the Social Security Act (
(2) Access to certain data
(A) Access
To the extent consistent with applicable information, privacy, security, and disclosure laws (including paragraph (3)), notwithstanding paragraph (4)(B) of section 1874(e) of the Social Security Act (
(i) provide or sell the combined data described in paragraph (4)(B)(iii) of such section to authorized users described in clauses (i), (ii), and (v) of paragraph (9)(A) for non-public use, including for the purposes described in subparagraph (B); or
(ii) subject to subparagraph (C), provide Medicare claims data to authorized users described in clauses (i), (ii), and (v),1 of paragraph (9)(A) for non-public use, including for the purposes described in subparagraph (B).
(B) Purposes described
The purposes described in this subparagraph are assisting providers of services and suppliers in developing and participating in quality and patient care improvement activities, including developing new models of care.
(C) Medicare claims data must be provided at no cost
A qualified entity may not charge a fee for providing the data under subparagraph (A)(ii).
(3) Protection of information
(A) In general
Except as provided in subparagraph (B), an analysis or data that is provided or sold under paragraph (1) or (2) shall not contain information that individually identifies a patient.
(B) Information on patients of the provider of services or supplier
To the extent consistent with applicable information, privacy, security, and disclosure laws, an analysis or data that is provided or sold to a provider of services or supplier under paragraph (1) or (2) may contain information that individually identifies a patient of such provider or supplier, including with respect to items and services furnished to the patient by other providers of services or suppliers.
(C) Prohibition on using analyses or data for marketing purposes
An authorized user shall not use an analysis or data provided or sold under paragraph (1) or (2) for marketing purposes.
(4) Data use agreement
A qualified entity and an authorized user described in clauses (i), (ii), and (v) of paragraph (9)(A) shall enter into an agreement regarding the use of any data that the qualified entity is providing or selling to the authorized user under paragraph (2). Such agreement shall describe the requirements for privacy and security of the data and, as determined appropriate by the Secretary, any prohibitions on using such data to link to other individually identifiable sources of information. If the authorized user is not a covered entity under the rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996, the agreement shall identify the relevant regulations, as determined by the Secretary, that the user shall comply with as if it were acting in the capacity of such a covered entity.
(5) No redisclosure of analyses or data
(A) In general
Except as provided in subparagraph (B), an authorized user that is provided or sold an analysis or data under paragraph (1) or (2) shall not redisclose or make public such analysis or data or any analysis using such data.
(B) Permitted redisclosure
A provider of services or supplier that is provided or sold an analysis or data under paragraph (1) or (2) may, as determined by the Secretary, redisclose such analysis or data for the purposes of performance improvement and care coordination activities but shall not make public such analysis or data or any analysis using such data.
(6) Opportunity for providers of services and suppliers to review
Prior to a qualified entity providing or selling an analysis to an authorized user under paragraph (1), to the extent that such analysis would individually identify a provider of services or supplier who is not being provided or sold such analysis, such qualified entity shall provide such provider or supplier with the opportunity to appeal and correct errors in the manner described in section 1874(e)(4)(C)(ii) of the Social Security Act (
(7) Assessment for a breach
(A) In general
In the case of a breach of a data use agreement under this section or section 1874(e) of the Social Security Act (
(i) an agreement between the Secretary and a qualified entity; and
(ii) an agreement between a qualified entity and an authorized user.
(B) Assessment
The assessment under subparagraph (A) shall be an amount up to $100 for each individual entitled to, or enrolled for, benefits under part A of title XVIII of the Social Security Act [
(i) in the case of an agreement described in subparagraph (A)(i), for whom the Secretary provided data on to the qualified entity under paragraph (2); and
(ii) in the case of an agreement described in subparagraph (A)(ii), for whom the qualified entity provided data on to the authorized user under paragraph (2).
(C) Deposit of amounts collected
Any amounts collected pursuant to this paragraph shall be deposited in Federal 2 Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (
(8) Annual reports
Any qualified entity that provides or sells an analysis or data under paragraph (1) or (2) shall annually submit to the Secretary a report that includes—
(A) a summary of the analyses provided or sold, including the number of such analyses, the number of purchasers of such analyses, and the total amount of fees received for such analyses;
(B) a description of the topics and purposes of such analyses;
(C) information on the entities who received the data under paragraph (2), the uses of the data, and the total amount of fees received for providing, selling, or sharing the data; and
(D) other information determined appropriate by the Secretary.
(9) Definitions
In this subsection and subsection (b):
(A) Authorized user
The term "authorized user" means the following:
(i) A provider of services.
(ii) A supplier.
(iii) An employer (as defined in
(iv) A health insurance issuer (as defined in
(v) A medical society or hospital association.
(vi) Any entity not described in clauses (i) through (v) that is approved by the Secretary (other than an employer or health insurance issuer not described in clauses (iii) and (iv), respectively, as determined by the Secretary).
(B) Provider of services
The term "provider of services" has the meaning given such term in section 1861(u) of the Social Security Act (
(C) Qualified entity
The term "qualified entity" has the meaning given such term in section 1874(e)(2) of the Social Security Act (
(D) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(E) Supplier
The term "supplier" has the meaning given such term in section 1861(d) of the Social Security Act (
(b) Access to Medicare data by qualified clinical data registries to facilitate quality improvement
(1) Access
(A) In general
To the extent consistent with applicable information, privacy, security, and disclosure laws, beginning July 1, 2016, the Secretary shall, at the request of a qualified clinical data registry under section 1848(m)(3)(E) of the Social Security Act (
(B) Data described
The data described in this subparagraph is—
(i) claims data under the Medicare program under title XVIII of the Social Security Act [
(ii) if the Secretary determines appropriate, claims data under the Medicaid program under title XIX of such Act [
(2) Fee
Data described in paragraph (1)(B) shall be provided to a qualified clinical data registry under paragraph (1) at a fee equal to the cost of providing such data. Any fee collected pursuant to the preceding sentence shall be deposited in the Centers for Medicare & Medicaid Services Program Management Account.
(
Editorial Notes
References in Text
The Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (a)(4), is
The Social Security Act, referred to in subsecs. (a)(7)(B) and (b)(1)(B), is act Aug. 14, 1935, ch. 531,
Codification
Section is comprised of section 105 of
Section was enacted as part of the Medicare Access and CHIP Reauthorization Act of 2015, and not as part of the Social Security Act which comprises this chapter.
1 So in original. The comma probably should not appear.
2 So in original. Probably should be preceded by "the".
3 So in original. Probably should be "1395kk(e)(2))."
§1395ll. Studies and recommendations
(a) Health care of the aged and disabled
The Secretary shall carry on studies and develop recommendations to be submitted from time to time to the Congress relating to health care of the aged and the disabled, including studies and recommendations concerning (1) the adequacy of existing personnel and facilities for health care for purposes of the programs under parts A and B of this subchapter; (2) methods for encouraging the further development of efficient and economical forms of health care which are a constructive alternative to inpatient hospital care; and (3) the effects of the deductibles and coinsurance provisions upon beneficiaries, persons who provide health services, and the financing of the program.
(b) Operation and administration of insurance programs
The Secretary shall make a continuing study of the operation and administration of this subchapter (including a validation of the accreditation process of national accreditation bodies under
(Aug. 14, 1935, ch. 531, title XVIII, §1875, as added
Editorial Notes
References in Text
Section 226 of the Social Security Amendments of 1972, referred to in subsec. (b), is section 226 of
Section 402 of the Social Security Amendments of 1967, referred to in subsec. (b), is section 402 of
Section 222(a) of the Social Security Amendments of 1972, referred to in subsec. (b), is section 222(a) of
Amendments
2008—Subsec. (b).
2003—Subsec. (b).
1989—Subsec. (c).
Subsec. (c)(7).
1988—Subsec. (c)(3).
"(A) from the Federal Hospital Insurance Trust Fund $4,000,000 for fiscal year 1987 and $5,000,000 for each of fiscal years 1988 and 1989, and
"(B) from the Federal Supplementary Medical Insurance Trust Fund $2,000,000 for fiscal year 1987 and $2,500,000 for each of fiscal years 1988 and 1989."
1987—Subsec. (c)(3)(B).
1986—Subsec. (c).
1984—Subsec. (b).
1972—Subsec. (a).
Subsec. (b).
1968—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2008 Amendment; Transition Rule
Amendment by
Effective Date of 1989 Amendment
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by section 226(d) of
Institute of Medicine Evaluation and Report on Health Care Performance Measures
"(a)
"(1)
"(2)
"(A) catalogue, review, and evaluate the validity of leading health care performance measures;
"(B) catalogue and evaluate the success and utility of alternative performance incentive programs in public or private sector settings; and
"(C) identify and prioritize options to implement policies that align performance with payment under the medicare program that indicate—
"(i) the performance measurement set to be used and how that measurement set will be updated;
"(ii) the payment policy that will reward performance; and
"(iii) the key implementation issues (such as data and information technology requirements) that must be addressed.
"(3)
"(4)
"(b)
"(c)
GAO Study on Access to Physicians' Services
"(a)
"(1) an assessment of the use by beneficiaries of such services through an analysis of claims submitted by physicians for such services under part B of the medicare program [
"(2) an examination of changes in the use by beneficiaries of physicians' services over time; and
"(3) an examination of the extent to which physicians are not accepting new medicare beneficiaries as patients.
"(b)
"(1) data from claims submitted by physicians under part B of the medicare program [
"(2) access by medicare beneficiaries to physicians' services may have improved, remained constant, or deteriorated over time."
Study on Enrollment Procedures for Groups That Retain Independent Contractor Physicians
"(a)
"(1) review the issuance of individual medicare provider numbers and the possible medicare program integrity vulnerabilities of the current process;
"(2) review direct and indirect costs associated with the current process incurred by the medicare program and groups that retain independent contractor physicians;
"(3) assess the effect on program integrity by the enrollment of groups that retain independent contractor hospital-based physicians; and
"(4) develop suggested procedures for the enrollment of these groups.
"(b)
GAO Studies and Reports on Medicare Payments
"(a) GAO
"(1)
"(A) coding and billing;
"(B) documentation requirements; and
"(C) the calculation of overpayments.
"(2)
"(b) GAO
"(1)
"(2)
"(A) a reduction in paperwork, an ease of administration, or an appropriate change in oversight and review may be accomplished; or
"(B) additional payments or education are needed to assist physicians and other health care providers in understanding and complying with any legal or regulatory requirements."
Study and Report Regarding Utilization of Physicians' Services by Medicare Beneficiaries
"(1)
"(2)
"(A) The various methods for accurately estimating the economic impact on expenditures for physicians' services under the original medicare fee-for-service program under parts A and B of title XVIII of the Social Security Act (
"(i) improvements in medical capabilities;
"(ii) advancements in scientific technology;
"(iii) demographic changes in the types of medicare beneficiaries that receive benefits under such program; and
"(iv) geographic changes in locations where medicare beneficiaries receive benefits under such program.
"(B) The rate of usage of physicians' services under the original medicare fee-for-service program under parts A and B of title XVIII of the Social Security Act (
"(C) Other factors that may be reliable predictors of beneficiary utilization of physicians' services under the original medicare fee-for-service program under parts A and B of title XVIII of the Social Security Act (
"(3)
"(4)
"(A) an analysis and evaluation of the report submitted under paragraph (3); and
"(B) such recommendations as it determines are appropriate."
Study of Adult Day Care Services
Study To Develop a Strategy for Quality Review and Assurance
Special Treatment of States Formerly Under Waiver
For treatment of hospitals in States which have had a waiver approved under this section, upon termination of waiver, see section 9202(j) of
Drug Detoxification Medicare Coverage and Facility Incentives
Legislative Recommendations Regarding Reimbursement for Optometrists' Services
Demonstration Projects, Studies, and Reports: Nutritional Therapy, Second Opinion Cost-Sharing, Services of Registered Dietitians, Services of Clinical Social Workers, Orthopedic Shoes, Respiratory Therapy Services, and Foot Conditions; Grants, Payments, and Expenditures
Demonstration Project Relating to the Terminally Ill
Report to Congress With Respect to Urban or Rural Comprehensive Mental Health Centers and Centers for Treatment of Alcoholism and Drug Abuse; Submission No Later Than June 13, 1978
Study and Review by Comptroller General of Administrative Structure for Processing Medicare Claims; Report to Congress
Report by Secretary of Health, Education, and Welfare on Delivery of Home Health and Other In-Home Services; Contents; Consultation Requirements; Submission to Congress
1 So in original. Probably should be followed by a comma.
§1395mm. Payments to health maintenance organizations and competitive medical plans
(a) Rates and adjustments
(1)(A) The Secretary shall annually determine, and shall announce (in a manner intended to provide notice to interested parties) not later than September 7 before the calendar year concerned—
(i) a per capita rate of payment for each class of individuals who are enrolled under this section with an eligible organization which has entered into a risk-sharing contract and who are entitled to benefits under part A and enrolled under part B, and
(ii) a per capita rate of payment for each class of individuals who are so enrolled with such an organization and who are enrolled under part B only.
For purposes of this section, the term "risk-sharing contract" means a contract entered into under subsection (g) and the term "reasonable cost reimbursement contract" means a contract entered into under subsection (h).
(B) The Secretary shall define appropriate classes of members, based on age, disability status, and such other factors as the Secretary determines to be appropriate, so as to ensure actuarial equivalence. The Secretary may add to, modify, or substitute for such classes, if such changes will improve the determination of actuarial equivalence.
(C) The annual per capita rate of payment for each such class shall be equal to 95 percent of the adjusted average per capita cost (as defined in paragraph (4)) for that class.
(D) In the case of an eligible organization with a risk-sharing contract, the Secretary shall make monthly payments in advance and in accordance with the rate determined under subparagraph (C) and except as provided in subsection (g)(2), to the organization for each individual enrolled with the organization under this section.
(E)(i) The amount of payment under this paragraph may be retroactively adjusted to take into account any difference between the actual number of individuals enrolled in the plan under this section and the number of such individuals estimated to be so enrolled in determining the amount of the advance payment.
(ii)(I) Subject to subclause (II), the Secretary may make retroactive adjustments under clause (i) to take into account individuals enrolled during the period beginning on the date on which the individual enrolls with an eligible organization (which has a risk-sharing contract under this section) under a health benefit plan operated, sponsored, or contributed to by the individual's employer or former employer (or the employer or former employer of the individual's spouse) and ending on the date on which the individual is enrolled in the plan under this section, except that for purposes of making such retroactive adjustments under this clause, such period may not exceed 90 days.
(II) No adjustment may be made under subclause (I) with respect to any individual who does not certify that the organization provided the individual with the explanation described in subsection (c)(3)(E) at the time the individual enrolled with the organization.
(F)(i) At least 45 days before making the announcement under subparagraph (A) for a year (beginning with the announcement for 1991), the Secretary shall provide for notice to eligible organizations of proposed changes to be made in the methodology or benefit coverage assumptions from the methodology and assumptions used in the previous announcement and shall provide such organizations an opportunity to comment on such proposed changes.
(ii) In each announcement made under subparagraph (A) for a year (beginning with the announcement for 1991), the Secretary shall include an explanation of the assumptions (including any benefit coverage assumptions) and changes in methodology used in the announcement in sufficient detail so that eligible organizations can compute per capita rates of payment for classes of individuals located in each county (or equivalent area) which is in whole or in part within the service area of such an organization.
(2) With respect to any eligible organization which has entered into a reasonable cost reimbursement contract, payments shall be made to such plan in accordance with subsection (h)(2) rather than paragraph (1).
(3) Subject to subsections (c)(2)(B)(ii) and (c)(7), payments under a contract to an eligible organization under paragraph (1) or (2) shall be instead of the amounts which (in the absence of the contract) would be otherwise payable, pursuant to
(4) For purposes of this section, the term "adjusted average per capita cost" means the average per capita amount that the Secretary estimates in advance (on the basis of actual experience, or retrospective actuarial equivalent based upon an adequate sample and other information and data, in a geographic area served by an eligible organization or in a similar area, with appropriate adjustments to assure actuarial equivalence) would be payable in any contract year for services covered under parts A and B, or part B only, and types of expenses otherwise reimbursable under parts A and B, or part B only (including administrative costs incurred by organizations described in
(5) The payment to an eligible organization under this section for individuals enrolled under this section with the organization and entitled to benefits under part A and enrolled under part B shall be made from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund. The portion of that payment to the organization for a month to be paid by each trust fund shall be determined as follows:
(A) In regard to expenditures by eligible organizations having risk-sharing contracts, the allocation shall be determined each year by the Secretary based on the relative weight that benefits from each fund contribute to the adjusted average per capita cost.
(B) In regard to expenditures by eligible organizations operating under a reasonable cost reimbursement contract, the initial allocation shall be based on the plan's most recent budget, such allocation to be adjusted, as needed, after cost settlement to reflect the distribution of actual expenditures.
The remainder of that payment shall be paid by the former trust fund.
(6) Subject to subsections (c)(2)(B)(ii) and (c)(7), if an individual is enrolled under this section with an eligible organization having a risk-sharing contract, only the eligible organization shall be entitled to receive payments from the Secretary under this subchapter for services furnished to the individual.
(b) Definitions; requirements
For purposes of this section, the term "eligible organization" means a public or private entity (which may be a health maintenance organization or a competitive medical plan), organized under the laws of any State, which—
(1) is a qualified health maintenance organization (as defined in section 300e–9(d) 1 of this title), or
(2) meets the following requirements:
(A) The entity provides to enrolled members at least the following health care services:
(i) Physicians' services performed by physicians (as defined in
(ii) Inpatient hospital services.
(iii) Laboratory, X-ray, emergency, and preventive services.
(iv) Out-of-area coverage.
(B) The entity is compensated (except for deductibles, coinsurance, and copayments) for the provision of health care services to enrolled members by a payment which is paid on a periodic basis without regard to the date the health care services are provided and which is fixed without regard to the frequency, extent, or kind of health care service actually provided to a member.
(C) The entity provides physicians' services primarily (i) directly through physicians who are either employees or partners of such organization, or (ii) through contracts with individual physicians or one or more groups of physicians (organized on a group practice or individual practice basis).
(D) The entity assumes full financial risk on a prospective basis for the provision of the health care services listed in subparagraph (A), except that such entity may—
(i) obtain insurance or make other arrangements for the cost of providing to any enrolled member health care services listed in subparagraph (A) the aggregate value of which exceeds $5,000 in any year,
(ii) obtain insurance or make other arrangements for the cost of health care service listed in subparagraph (A) provided to its enrolled members other than through the entity because medical necessity required their provision before they could be secured through the entity,
(iii) obtain insurance or make other arrangements for not more than 90 percent of the amount by which its costs for any of its fiscal years exceed 115 percent of its income for such fiscal year, and
(iv) make arrangements with physicians or other health professionals, health care institutions, or any combination of such individuals or institutions to assume all or part of the financial risk on a prospective basis for the provision of basic health services by the physicians or other health professionals or through the institutions.
(E) The entity has made adequate provision against the risk of insolvency, which provision is satisfactory to the Secretary.
Paragraph (2)(A)(ii) shall not apply to an entity which had contracted with a single State agency administering a State plan approved under subchapter XIX for the provision of services (other than inpatient hospital services) to individuals eligible for such services under such State plan on a prepaid risk basis prior to 1970.
(c) Enrollment in plan; duties of organization to enrollees
(1) The Secretary may not enter into a contract under this section with an eligible organization unless it meets the requirements of this subsection and subsection (e) with respect to members enrolled under this section.
(2)(A) The organization must provide to members enrolled under this section, through providers and other persons that meet the applicable requirements of this subchapter and part A of subchapter XI—
(i) only those services covered under parts A and B of this subchapter, for those members entitled to benefits under part A and enrolled under part B, or
(ii) only those services covered under part B, for those members enrolled only under such part,
which are available to individuals residing in the geographic area served by the organization, except that (I) the organization may provide such members with such additional health care services as the members may elect, at their option, to have covered, and (II) in the case of an organization with a risk-sharing contract, the organization may provide such members with such additional health care services as the Secretary may approve. The Secretary shall approve any such additional health care services which the organization proposes to offer to such members, unless the Secretary determines that including such additional services will substantially discourage enrollment by covered individuals with the organization.
(B) If there is a national coverage determination made in the period beginning on the date of an announcement under subsection (a)(1)(A) and ending on the date of the next announcement under such subsection that the Secretary projects will result in a significant change in the costs to the organization of providing the benefits that are the subject of such national coverage determination and that was not incorporated in the determination of the per capita rate of payment included in the announcement made at the beginning of such period—
(i) such determination shall not apply to risk-sharing contracts under this section until the first contract year that begins after the end of such period; and
(ii) if such coverage determination provides for coverage of additional benefits or under additional circumstances, subsection (a)(3) shall not apply to payment for such additional benefits or benefits provided under such additional circumstances until the first contract year that begins after the end of such period,
unless otherwise required by law.
(3)(A)(i) Each eligible organization must have an open enrollment period, for the enrollment of individuals under this section, of at least 30 days duration every year and including the period or periods specified under clause (ii), and must provide that at any time during which enrollments are accepted, the organization will accept up to the limits of its capacity (as determined by the Secretary) and without restrictions, except as may be authorized in regulations, individuals who are eligible to enroll under subsection (d) in the order in which they apply for enrollment, unless to do so would result in failure to meet the requirements of subsection (f) or would result in the enrollment of enrollees substantially nonrepresentative, as determined in accordance with regulations of the Secretary, of the population in the geographic area served by the organization.
(ii)(I) If a risk-sharing contract under this section is not renewed or is otherwise terminated, eligible organizations with risk-sharing contracts under this section and serving a part of the same service area as under the terminated contract are required to have an open enrollment period for individuals who were enrolled under the terminated contract as of the date of notice of such termination. If a risk-sharing contract under this section is renewed in a manner that discontinues coverage for individuals residing in part of the service area, eligible organizations with risk-sharing contracts under this section and enrolling individuals residing in that part of the service area are required to have an open enrollment period for individuals residing in the part of the service area who were enrolled under the contract as of the date of notice of such discontinued coverage.
(II) The open enrollment periods required under subclause (I) shall be for 30 days and shall begin 30 days after the date that the Secretary provides notice of such requirement.
(III) Enrollment under this clause shall be effective 30 days after the end of the open enrollment period, or, if the Secretary determines that such date is not feasible, such other date as the Secretary specifies.
(B) An individual may enroll under this section with an eligible organization in such manner as may be prescribed in regulations and may terminate his enrollment with the eligible organization as of the beginning of the first calendar month following the date on which the request is made for such termination (or, in the case of financial insolvency of the organization, as may be prescribed by regulations) or, in the case of such an organization with a reasonable cost reimbursement contract, as may be prescribed by regulations. In the case of an individual's termination of enrollment, the organization shall provide the individual with a copy of the written request for termination of enrollment and a written explanation of the period (ending on the effective date of the termination) during which the individual continues to be enrolled with the organization and may not receive benefits under this subchapter other than through the organization.
(C) The Secretary may prescribe the procedures and conditions under which an eligible organization that has entered into a contract with the Secretary under this subsection may inform individuals eligible to enroll under this section with the organization about the organization, or may enroll such individuals with the organization. No brochures, application forms, or other promotional or informational material may be distributed by an organization to (or for the use of) individuals eligible to enroll with the organization under this section unless (i) at least 45 days before its distribution, the organization has submitted the material to the Secretary for review and (ii) the Secretary has not disapproved the distribution of the material. The Secretary shall review all such material submitted and shall disapprove such material if the Secretary determines, in the Secretary's discretion, that the material is materially inaccurate or misleading or otherwise makes a material misrepresentation.
(D) The organization must provide assurances to the Secretary that it will not expel or refuse to re-enroll any such individual because of the individual's health status or requirements for health care services, and that it will notify each such individual of such fact at the time of the individual's enrollment.
(E) Each eligible organization shall provide each enrollee, at the time of enrollment and not less frequently than annually thereafter, an explanation of the enrollee's rights under this section, including an explanation of—
(i) the enrollee's rights to benefits from the organization,
(ii) the restrictions on payments under this subchapter for services furnished other than by or through the organization,
(iii) out-of-area coverage provided by the organization,
(iv) the organization's coverage of emergency services and urgently needed care, and
(v) appeal rights of enrollees.
(F) Each eligible organization that provides items and services pursuant to a contract under this section shall provide assurances to the Secretary that in the event the organization ceases to provide such items and services, the organization shall provide or arrange for supplemental coverage of benefits under this subchapter related to a pre-existing condition with respect to any exclusion period, to all individuals enrolled with the entity who receive benefits under this subchapter, for the lesser of six months or the duration of such period.
(G)(i) Each eligible organization having a risk-sharing contract under this section shall notify individuals eligible to enroll with the organization under this section and individuals enrolled with the organization under this section that—
(I) the organization is authorized by law to terminate or refuse to renew the contract, and
(II) termination or nonrenewal of the contract may result in termination of the enrollments of individuals enrolled with the organization under this section.
(ii) The notice required by clause (i) shall be included in—
(I) any marketing materials described in subparagraph (C) that are distributed by an eligible organization to individuals eligible to enroll under this section with the organization, and
(II) any explanation provided to enrollees by the organization pursuant to subparagraph (E).
(4) The organization must—
(A) make the services described in paragraph (2) (and such other health care services as such individuals have contracted for) (i) available and accessible to each such individual, within the area served by the organization, with reasonable promptness and in a manner which assures continuity, and (ii) when medically necessary, available and accessible twenty-four hours a day and seven days a week, and
(B) provide for reimbursement with respect to services which are described in subparagraph (A) and which are provided to such an individual other than through the organization, if (i) the services were medically necessary and immediately required because of an unforeseen illness, injury, or condition and (ii) it was not reasonable given the circumstances to obtain the services through the organization.
(5)(A) The organization must provide meaningful procedures for hearing and resolving grievances between the organization (including any entity or individual through which the organization provides health care services) and members enrolled with the organization under this section.
(B) A member enrolled with an eligible organization under this section who is dissatisfied by reason of his failure to receive any health service to which he believes he is entitled and at no greater charge than he believes he is required to pay is entitled, if the amount in controversy is $100 or more, to a hearing before the Secretary to the same extent as is provided in
(6) The organization must have arrangements, established in accordance with regulations of the Secretary, for an ongoing quality assurance program for health care services it provides to such individuals, which program (A) stresses health outcomes and (B) provides review by physicians and other health care professionals of the process followed in the provision of such health care services.
(7) A risk-sharing contract under this section shall provide that in the case of an individual who is receiving inpatient hospital services from a subsection (d) hospital (as defined in
(A) enrollment with an eligible organization under this section—
(i) payment for such services until the date of the individual's discharge shall be made under this subchapter as if the individual were not enrolled with the organization,
(ii) the organization shall not be financially responsible for payment for such services until the date after the date of the individual's discharge, and
(iii) the organization shall nonetheless be paid the full amount otherwise payable to the organization under this section; or
(B) termination of enrollment with an eligible organization under this section—
(i) the organization shall be financially responsible for payment for such services after such date and until the date of the individual's discharge,
(ii) payment for such services during the stay shall not be made under
(iii) the organization shall not receive any payment with respect to the individual under this section during the period the individual is not enrolled.
(8) A contract under this section shall provide that the eligible organization shall meet the requirement of
(d) Right to enroll with contracting organization in geographic area
Subject to the provisions of subsection (c)(3), every individual entitled to benefits under part A and enrolled under part B or enrolled under part B only (other than an individual medically determined to have end-stage renal disease) shall be eligible to enroll under this section with any eligible organization with which the Secretary has entered into a contract under this section and which serves the geographic area in which the individual resides.
(e) Limitation on charges; election of coverage; "adjusted community rate" defined; workmen's compensation and insurance benefits
(1) In no case may—
(A) the portion of an eligible organization's premium rate and the actuarial value of its deductibles, coinsurance, and copayments charged (with respect to services covered under parts A and B) to individuals who are enrolled under this section with the organization and who are entitled to benefits under part A and enrolled under part B, or
(B) the portion of its premium rate and the actuarial value of its deductibles, coinsurance, and copayments charged (with respect to services covered under part B) to individuals who are enrolled under this section with the organization and enrolled under part B only
exceed the actuarial value of the coinsurance and deductibles that would be applicable on the average to individuals enrolled under this section with the organization (or, if the Secretary finds that adequate data are not available to determine that actuarial value, the actuarial value of the coinsurance and deductibles applicable on the average to individuals in the area, in the State, or in the United States, eligible to enroll under this section with the organization, or other appropriate data) and entitled to benefits under part A and enrolled under part B, or enrolled under part B only, respectively, if they were not members of an eligible organization.
(2) If the eligible organization provides to its members enrolled under this section services in addition to services covered under parts A and B of this subchapter, election of coverage for such additional services (unless such services have been approved by the Secretary under subsection (c)(2)) shall be optional for such members and such organization shall furnish such members with information on the portion of its premium rate or other charges applicable to such additional services. In no case may the sum of—
(A) the portion of such organization's premium rate charged, with respect to such additional services, to members enrolled under this section, and
(B) the actuarial value of its deductibles, coinsurance, and copayments charged, with respect to such services to such members
exceed the adjusted community rate for such services.
(3) For purposes of this section, the term "adjusted community rate" for a service or services means, at the election of an eligible organization, either—
(A) the rate of payment for that service or services which the Secretary annually determines would apply to a member enrolled under this section with an eligible organization if the rate of payment were determined under a "community rating system" (as defined in
(B) such portion of the weighted aggregate premium, which the Secretary annually estimates would apply to a member enrolled under this section with the eligible organization, as the Secretary annually estimates is attributable to that service or services,
but adjusted for differences between the utilization characteristics of the members enrolled with the eligible organization under this section and the utilization characteristics of the other members of the organization (or, if the Secretary finds that adequate data are not available to adjust for those differences, the differences between the utilization characteristics of members in other eligible organizations, or individuals in the area, in the State, or in the United States, eligible to enroll under this section with an eligible organization and the utilization characteristics of the rest of the population in the area, in the State, or in the United States, respectively).
(4) Notwithstanding any other provision of law, the eligible organization may (in the case of the provision of services to a member enrolled under this section for an illness or injury for which the member is entitled to benefits under a workmen's compensation law or plan of the United States or a State, under an automobile or liability insurance policy or plan, including a self-insured plan, or under no fault insurance) charge or authorize the provider of such services to charge, in accordance with the charges allowed under such law or policy—
(A) the insurance carrier, employer, or other entity which under such law, plan, or policy is to pay for the provision of such services, or
(B) such member to the extent that the member has been paid under such law, plan, or policy for such services.
(f) Membership requirements
(1) For contract periods beginning before January 1, 1999, each eligible organization with which the Secretary enters into a contract under this section shall have, for the duration of such contract, an enrolled membership at least one-half of which consists of individuals who are not entitled to benefits under this subchapter.
(2) Subject to paragraph (4), the Secretary may modify or waive the requirement imposed by paragraph (1) only—
(A) to the extent that more than 50 percent of the population of the area served by the organization consists of individuals who are entitled to benefits under this subchapter or under a State plan approved under subchapter XIX, or
(B) in the case of an eligible organization that is owned and operated by a governmental entity, only with respect to a period of three years beginning on the date the organization first enters into a contract under this section, and only if the organization has taken and is making reasonable efforts to enroll individuals who are not entitled to benefits under this subchapter or under a State plan approved under subchapter XIX.
(3) If the Secretary determines that an eligible organization has failed to comply with the requirements of this subsection, the Secretary may provide for the suspension of enrollment of individuals under this section or of payment to the organization under this section for individuals newly enrolled with the organization, after the date the Secretary notifies the organization of such noncompliance.
(4) Effective for contract periods beginning after December 31, 1996, the Secretary may waive or modify the requirement imposed by paragraph (1) to the extent the Secretary finds that it is in the public interest.
(g) Risk-sharing contract
(1) The Secretary may enter a risk-sharing contract with any eligible organization, as defined in subsection (b), which has at least 5,000 members, except that the Secretary may enter into such a contract with an eligible organization that has fewer members if the organization primarily serves members residing outside of urbanized areas.
(2) Each risk-sharing contract shall provide that—
(A) if the adjusted community rate, as defined in subsection (e)(3), for services under parts A and B (as reduced for the actuarial value of the coinsurance and deductibles under those parts) for members enrolled under this section with the organization and entitled to benefits under part A and enrolled in part B, or
(B) if the adjusted community rate for services under part B (as reduced for the actuarial value of the coinsurance and deductibles under that part) for members enrolled under this section with the organization and entitled to benefits under part B only
is less than the average of the per capita rates of payment to be made under subsection (a)(1) at the beginning of an annual contract period for members enrolled under this section with the organization and entitled to benefits under part A and enrolled in part B, or enrolled in part B only, respectively, the eligible organization shall provide to members enrolled under a risk-sharing contract under this section with the organization and entitled to benefits under part A and enrolled in part B, or enrolled in part B only, respectively, the additional benefits described in paragraph (3) which are selected by the eligible organization and which the Secretary finds are at least equal in value to the difference between that average per capita payment and the adjusted community rate (as so reduced); except that this paragraph shall not apply with respect to any organization which elects to receive a lesser payment to the extent that there is no longer a difference between the average per capita payment and adjusted community rate (as so reduced) and except that an organization (with the approval of the Secretary) may provide that a part of the value of such additional benefits be withheld and reserved by the Secretary as provided in paragraph (5). If the Secretary finds that there is insufficient enrollment experience to determine an average of the per capita rates of payment to be made under subsection (a)(1) at the beginning of a contract period, the Secretary may determine such an average based on the enrollment experience of other contracts entered into under this section.
(3) The additional benefits referred to in paragraph (2) are—
(A) the reduction of the premium rate or other charges made with respect to services furnished by the organization to members enrolled under this section, or
(B) the provision of additional health benefits,
or both.
(4) Repealed.
(5) An organization having a risk-sharing contract under this section may (with the approval of the Secretary) provide that a part of the value of additional benefits otherwise required to be provided by reason of paragraph (2) be withheld and reserved in the Federal Hospital Insurance Trust Fund and in the Federal Supplementary Medical Insurance Trust Fund (in such proportions as the Secretary determines to be appropriate) by the Secretary for subsequent annual contract periods, to the extent required to stabilize and prevent undue fluctuations in the additional benefits offered in those subsequent periods by the organization in accordance with paragraph (3). Any of such value of additional benefits which is not provided to members of the organization in accordance with paragraph (3) prior to the end of such period, shall revert for the use of such trust funds.
(6)(A) A risk-sharing contract under this section shall require the eligible organization to provide prompt payment (consistent with the provisions of
(B) In the case of an eligible organization which the Secretary determines, after notice and opportunity for a hearing, has failed to make payments of amounts in compliance with subparagraph (A), the Secretary may provide for direct payment of the amounts owed to providers and suppliers for such covered services furnished to individuals enrolled under this section under the contract. If the Secretary provides for such direct payments, the Secretary shall provide for an appropriate reduction in the amount of payments otherwise made to the organization under this section to reflect the amount of the Secretary's payments (and costs incurred by the Secretary in making such payments).
(h) Reasonable cost reimbursement contract; requirements
(1) If—
(A) the Secretary is not satisfied that an eligible organization has the capacity to bear the risk of potential losses under a risk-sharing contract under this section, or
(B) the eligible organization so elects or has an insufficient number of members to be eligible to enter into a risk-sharing contract under subsection (g)(1),
the Secretary may, if he is otherwise satisfied that the eligible organization is able to perform its contractual obligations effectively and efficiently, enter into a contract with such organization pursuant to which such organization is reimbursed on the basis of its reasonable cost (as defined in
(2) A reasonable cost reimbursement contract under this subsection may, at the option of such organization, provide that the Secretary—
(A) will reimburse hospitals and skilled nursing facilities either for the reasonable cost (as determined under
(B) will deduct the amount of such reimbursement from payment which would otherwise be made to such organization.
If such an eligible organization pays a hospital or skilled nursing facility directly, the amount paid shall not exceed the reasonable cost of the services (as determined under
(3) Payments made to an organization with a reasonable cost reimbursement contract shall be subject to appropriate retroactive corrective adjustment at the end of each contract year so as to assure that such organization is paid for the reasonable cost actually incurred (excluding any part of incurred cost found to be unnecessary in the efficient delivery of health services) or the amounts otherwise determined under
(4) Any reasonable cost reimbursement contract with an eligible organization under this subsection shall provide that the Secretary shall require, at such time following the expiration of each accounting period of the eligible organization (and in such form and in such detail) as he may prescribe—
(A) that the organization report to him in an independently certified financial statement its per capita incurred cost based on the types of components of expenses otherwise reimbursable under this subchapter for providing services described in subsection (a)(1), including therein, in accordance with accounting procedures prescribed by the Secretary, its methods of allocating costs between individuals enrolled under this section and other individuals enrolled with such organization;
(B) that failure to report such information as may be required may be deemed to constitute evidence of likely overpayment on the basis of which appropriate collection action may be taken;
(C) that in any case in which an eligible organization is related to another organization by common ownership or control, a consolidated financial statement shall be filed and that the allowable costs for such organization may not include costs for the types of expense otherwise reimbursable under this subchapter, in excess of those which would be determined to be reasonable in accordance with regulations (providing for limiting reimbursement to costs rather than charges to the eligible organization by related organizations and owners) issued by the Secretary; and
(D) that in any case in which compensation is paid by an eligible organization substantially in excess of what is normally paid for similar services by similar practitioners (regardless of method of compensation), such compensation may as appropriate be considered to constitute a distribution of profits.
(5)(A) After August 5, 1997, the Secretary may not enter into a reasonable cost reimbursement contract under this subsection (if the contract is not in effect as of August 5, 1997), except for a contract with an eligible organization which, immediately previous to entering into such contract, had an agreement in effect under
(B) Subject to subparagraph (C), the Secretary shall approve an application for a modification to a reasonable cost contract under this section in order to expand the service area of such contract if—
(i) such application is submitted to the Secretary on or before September 1, 2003; and
(ii) the Secretary determines that the organization with the contract continues to meet the requirements applicable to such organizations and contracts under this section.
(C)(i) Subject to clause (ii), a reasonable cost reimbursement contract under this subsection may be extended or renewed indefinitely.
(ii) Subject to clause (iv), for any period beginning on or after January 1, 2016, a reasonable cost reimbursement contract under this subsection may not be extended or renewed for a service area insofar as such area during the entire previous year was within the service area of—
(I) 2 or more MA regional plans described in clause (iii), provided that all such plans are not offered by the same Medicare Advantage organization; or
(II) 2 or more MA local plans described in clause (iii), provided that all such plans are not offered by the same Medicare Advantage organization.
(iii) A plan described in this clause for a year for a service area is a plan described in
(I) With respect to any portion of the cost plan service area involved that is within a Metropolitan Statistical Area with a population of more than 250,000 and counties contiguous to such Metropolitan Statistical Area that are not in another Metropolitan Statistical Area with a population of more than 250,000, 5,000 individuals. If the service area includes a portion in more than 1 Metropolitan Statistical Area with a population of more than 250,000, the minimum enrollment determination under the preceding sentence shall be made with respect to each such Metropolitan Statistical Area (and such applicable contiguous counties to such Metropolitan Statistical Area).
(II) With respect to any other portion of such cost plan service area, 1,500 individuals.
(iv) In the case of an eligible organization that is offering a reasonable cost reimbursement contract that may no longer be extended or renewed because of the application of clause (ii), or where such contract has been extended or renewed but the eligible organization has informed the Secretary in writing not later than a date determined appropriate by the Secretary that such organization voluntarily plans not to seek renewal of the reasonable cost reimbursement contract, the following shall apply:
(I) Notwithstanding such clause, such contract may be extended or renewed for the two years subsequent to 2016. The final year in which such contract is extended or renewed is referred to in this subsection as the "last reasonable cost reimbursement contract year for the contract".
(II) The organization may not enroll a new enrollee under such contract during the last reasonable cost reimbursement contract year for the contract (but may continue to enroll new enrollees through the end of the year immediately preceding such year) unless such enrollee is any of the following:
(aa) An individual who chooses enrollment in the reasonable cost contract during the annual election period with respect to such last year.
(bb) An individual whose spouse, at the time of the individual's enrollment 2 is an enrollee under the reasonable cost reimbursement contract.
(cc) An individual who is covered under an employer group health plan that offers coverage through the reasonable cost reimbursement contract.
(dd) An individual who becomes entitled to benefits under part A, or enrolled under part B, and was enrolled in a plan offered by the eligible organization immediately prior to the individual's enrollment under the reasonable cost reimbursement contract.
(III) Not later than a date determined appropriate by the Secretary prior to the beginning of the last reasonable cost reimbursement contract year for the contract, the organization shall provide notice to the Secretary as to whether the organization will apply to have the contract converted over, in whole or in part, and offered as a Medicare Advantage plan under part C for the year following the last reasonable cost reimbursement contract year for the contract.
(IV) If the organization provides the notice described in subclause (III) that the contract will be converted, in whole or in part, the organization shall, not later than a date determined appropriate by the Secretary, provide the Secretary with such information as the Secretary determines appropriate in order to carry out
(V) In the case that the organization enrolls a new enrollee under such contract during the last reasonable cost reimbursement contract year for the contract, the organization shall provide the individual with a notification that such year is the last year for such contract.
(v) If an eligible organization that is offering a reasonable cost reimbursement contract that is extended or renewed pursuant to clause (iv) provides the notice described in clause (iv)(III) that the contract will be converted, in whole or in part, the following shall apply:
(I) The deemed enrollment under
(II) The special rule for quality increase under
(III) During the last reasonable cost reimbursement contract year for the contract and the year immediately preceding such year, the eligible organization, or the corporate parent organization of the eligible organization, shall be permitted to offer an MA plan in the area that such contract is being offered and enroll Medicare Advantage eligible individuals in such MA plan and such cost plan.
(i) Duration, termination, effective date, and terms of contract; powers and duties of Secretary
(1) Each contract under this section shall be for a term of at least one year, as determined by the Secretary, and may be made automatically renewable from term to term in the absence of notice by either party of intention to terminate at the end of the current term; except that in accordance with procedures established under paragraph (9), the Secretary may at any time terminate any such contract or may impose the intermediate sanctions described in paragraph (6)(B) or (6)(C) (whichever is applicable) on the eligible organization if the Secretary determines that the organization—
(A) has failed substantially to carry out the contract;
(B) is carrying out the contract in a manner substantially inconsistent with the efficient and effective administration of this section; or
(C) no longer substantially meets the applicable conditions of subsections (b), (c), (e), and (f).
(2) The effective date of any contract executed pursuant to this section shall be specified in the contract.
(3) Each contract under this section—
(A) shall provide that the Secretary, or any person or organization designated by him—
(i) shall have the right to inspect or otherwise evaluate (I) the quality, appropriateness, and timeliness of services performed under the contract and (II) the facilities of the organization when there is reasonable evidence of some need for such inspection, and
(ii) shall have the right to audit and inspect any books and records of the eligible organization that pertain (I) to the ability of the organization to bear the risk of potential financial losses, or (II) to services performed or determinations of amounts payable under the contract;
(B) shall require the organization with a risk-sharing contract to provide (and pay for) written notice in advance of the contract's termination, as well as a description of alternatives for obtaining benefits under this subchapter, to each individual enrolled under this section with the organization; and
(C)(i) shall require the organization to comply with subsections (a) and (c) of
(ii) shall require the organization to provide and supply information (described in
(iii) shall require the organization to notify the Secretary of loans and other special financial arrangements which are made between the organization and subcontractors, affiliates, and related parties; and
(D) shall contain such other terms and conditions not inconsistent with this section (including requiring the organization to provide the Secretary with such information) as the Secretary may find necessary and appropriate.
(4) The Secretary may not enter into a risk-sharing contract with an eligible organization if a previous risk-sharing contract with that organization under this section was terminated at the request of the organization within the preceding five-year period, except in circumstances which warrant special consideration, as determined by the Secretary.
(5) The authority vested in the Secretary by this section may be performed without regard to such provisions of law or regulations relating to the making, performance, amendment, or modification of contracts of the United States as the Secretary may determine to be inconsistent with the furtherance of the purpose of this subchapter.
(6)(A) If the Secretary determines that an eligible organization with a contract under this section—
(i) fails substantially to provide medically necessary items and services that are required (under law or under the contract) to be provided to an individual covered under the contract, if the failure has adversely affected (or has substantial likelihood of adversely affecting) the individual;
(ii) imposes premiums on individuals enrolled under this section in excess of the premiums permitted;
(iii) acts to expel or to refuse to re-enroll an individual in violation of the provisions of this section;
(iv) engages in any practice that would reasonably be expected to have the effect of denying or discouraging enrollment (except as permitted by this section) by eligible individuals with the organization whose medical condition or history indicates a need for substantial future medical services;
(v) misrepresents or falsifies information that is furnished—
(I) to the Secretary under this section, or
(II) to an individual or to any other entity under this section;
(vi) fails to comply with the requirements of subsection (g)(6)(A) or paragraph (8); or
(vii) in the case of a risk-sharing contract, employs or contracts with any individual or entity that is excluded from participation under this subchapter under
the Secretary may provide, in addition to any other remedies authorized by law, for any of the remedies described in subparagraph (B).
(B) The remedies described in this subparagraph are—
(i) civil money penalties of not more than $25,000 for each determination under subparagraph (A) or, with respect to a determination under clause (iv) or (v)(I) of such subparagraph, of not more than $100,000 for each such determination, plus, with respect to a determination under subparagraph (A)(ii), double the excess amount charged in violation of such subparagraph (and the excess amount charged shall be deducted from the penalty and returned to the individual concerned), and plus, with respect to a determination under subparagraph (A)(iv), $15,000 for each individual not enrolled as a result of the practice involved,
(ii) suspension of enrollment of individuals under this section after the date the Secretary notifies the organization of a determination under subparagraph (A) and until the Secretary is satisfied that the basis for such determination has been corrected and is not likely to recur, or
(iii) suspension of payment to the organization under this section for individuals enrolled after the date the Secretary notifies the organization of a determination under subparagraph (A) and until the Secretary is satisfied that the basis for such determination has been corrected and is not likely to recur.
(C) In the case of an eligible organization for which the Secretary makes a determination under paragraph (1), the basis of which is not described in subparagraph (A), the Secretary may apply the following intermediate sanctions:
(i) Civil money penalties of not more than $25,000 for each determination under paragraph (1) if the deficiency that is the basis of the determination has directly adversely affected (or has the substantial likelihood of adversely affecting) an individual covered under the organization's contract.
(ii) Civil money penalties of not more than $10,000 for each week beginning after the initiation of procedures by the Secretary under paragraph (9) during which the deficiency that is the basis of a determination under paragraph (1) exists.
(iii) Suspension of enrollment of individuals under this section after the date the Secretary notifies the organization of a determination under paragraph (1) and until the Secretary is satisfied that the deficiency that is the basis for the determination has been corrected and is not likely to recur.
(D) The provisions of
(7)(A) Each risk-sharing contract with an eligible organization under this section shall provide that the organization will maintain a written agreement with a quality improvement organization (which has a contract with the Secretary under part B of subchapter XI for the area in which the eligible organization is located) or with an entity selected by the Secretary under section 1320c–3(a)(4)(C) 1 of this title under which the review organization will perform functions under
(B) For purposes of payment under this subchapter, the cost of such agreement to the eligible organization shall be considered a cost incurred by a provider of services in providing covered services under this subchapter and shall be paid directly by the Secretary to the review organization on behalf of such eligible organization in accordance with a schedule established by the Secretary.
(C) Such payments—
(i) shall be transferred in appropriate proportions from the Federal Hospital Insurance Trust Fund and from the Supplementary Medical Insurance Trust Fund, without regard to amounts appropriated in advance in appropriation Acts, in the same manner as transfers are made for payment for services provided directly to beneficiaries, and
(ii) shall not be less in the aggregate for such organizations for a fiscal year than the amounts the Secretary determines to be sufficient to cover the costs of such organizations' conducting activities described in subparagraph (A) with respect to such eligible organizations under part B of subchapter XI.
(8)(A) Each contract with an eligible organization under this section shall provide that the organization may not operate any physician incentive plan (as defined in subparagraph (B)) unless the following requirements are met:
(i) No specific payment is made directly or indirectly under the plan to a physician or physician group as an inducement to reduce or limit medically necessary services provided with respect to a specific individual enrolled with the organization.
(ii) If the plan places a physician or physician group at substantial financial risk (as determined by the Secretary) for services not provided by the physician or physician group, the organization—
(I) provides stop-loss protection for the physician or group that is adequate and appropriate, based on standards developed by the Secretary that take into account the number of physicians placed at such substantial financial risk in the group or under the plan and the number of individuals enrolled with the organization who receive services from the physician or the physician group, and
(II) conducts periodic surveys of both individuals enrolled and individuals previously enrolled with the organization to determine the degree of access of such individuals to services provided by the organization and satisfaction with the quality of such services.
(iii) The organization provides the Secretary with descriptive information regarding the plan, sufficient to permit the Secretary to determine whether the plan is in compliance with the requirements of this subparagraph.
(B) In this paragraph, the term "physician incentive plan" means any compensation arrangement between an eligible organization and a physician or physician group that may directly or indirectly have the effect of reducing or limiting services provided with respect to individuals enrolled with the organization.
(9) The Secretary may terminate a contract with an eligible organization under this section or may impose the intermediate sanctions described in paragraph (6) on the organization in accordance with formal investigation and compliance procedures established by the Secretary under which—
(A) the Secretary first provides the organization with the reasonable opportunity to develop and implement a corrective action plan to correct the deficiencies that were the basis of the Secretary's determination under paragraph (1) and the organization fails to develop or implement such a plan;
(B) in deciding whether to impose sanctions, the Secretary considers aggravating factors such as whether an organization has a history of deficiencies or has not taken action to correct deficiencies the Secretary has brought to the organization's attention;
(C) there are no unreasonable or unnecessary delays between the finding of a deficiency and the imposition of sanctions; and
(D) the Secretary provides the organization with reasonable notice and opportunity for hearing (including the right to appeal an initial decision) before imposing any sanction or terminating the contract.
(j) Payment in full and limitation on actual charges; physicians, providers of services, or renal dialysis facilities not under contract with organization
(1)(A) In the case of physicians' services or renal dialysis services described in paragraph (2) which are furnished by a participating physician or provider of services or renal dialysis facility to an individual enrolled with an eligible organization under this section and enrolled under part B, the applicable participation agreement is deemed to provide that the physician or provider of services or renal dialysis facility will accept as payment in full from the eligible organization the amount that would be payable to the physician or provider of services or renal dialysis facility under part B and from the individual under such part, if the individual were not enrolled with an eligible organization under this section.
(B) In the case of physicians' services described in paragraph (2) which are furnished by a nonparticipating physician, the limitations on actual charges for such services otherwise applicable under part B (to services furnished by individuals not enrolled with an eligible organization under this section) shall apply in the same manner as such limitations apply to services furnished to individuals not enrolled with such an organization.
(2) The physicians' services or renal dialysis services described in this paragraph are physicians' services or renal dialysis services which are furnished to an enrollee of an eligible organization under this section by a physician, provider of services, or renal dialysis facility who is not under a contract with the organization.
(k) Risk-sharing contracts
(1) Except as provided in paragraph (2)—
(A) on or after the date standards for Medicare+Choice organizations and plans are first established under
(B) for any contract year beginning on or after January 1, 1999, the Secretary shall not renew any such contract.
(2) An individual who is enrolled in part B only and is enrolled in an eligible organization with a risk-sharing contract under this section on December 31, 1998, may continue enrollment in such organization in accordance with regulations described in
(3) Notwithstanding subsection (a), the Secretary shall provide that payment amounts under risk-sharing contracts under this section for months in a year (beginning with January 1998) shall be computed—
(A) with respect to individuals entitled to benefits under both parts A and B, by substituting payment rates under
(B) with respect to individuals only entitled to benefits under part B, by substituting an appropriate proportion of such rates (reflecting the relative proportion of payments under this subchapter attributable to such part) for the payment rates otherwise established under subsection (a).
(4) The following requirements shall apply to eligible organizations with risk-sharing contracts under this section in the same manner as they apply to Medicare+Choice organizations under part C:
(A) Data collection requirements under
(B) Restrictions on imposition of premium taxes under
(C) The requirement to accept enrollment of new enrollees during November 1998 under
(D) Payments under
(Aug. 14, 1935, ch. 531, title XVIII, §1876, as added and amended
Editorial Notes
References in Text
Amendments
2015—Subsec. (h)(5)(C)(ii).
Subsec. (h)(5)(C)(iii)(I).
Subsec. (h)(5)(C)(iii)(II).
Subsec. (h)(5)(C)(iv), (v).
2014—Subsec. (h)(5)(C)(ii).
2013—Subsec. (h)(5)(C)(ii).
2011—Subsec. (i)(7)(A).
2010—Subsec. (h)(5)(C)(ii).
2008—Subsec. (h)(5)(C)(ii).
Subsec. (h)(5)(C)(ii)(I), (II).
Subsec. (h)(5)(C)(iii)(I).
2007—Subsec. (h)(5)(C)(ii).
2003—Subsec. (c)(2)(B).
Subsec. (c)(5)(B).
Subsec. (h)(5)(C).
Subsec. (j)(2).
2000—Subsec. (h)(5)(B), (C).
1999—Subsec. (h)(5)(B).
1997—Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(4).
Subsec. (h)(5).
Subsec. (k).
1996—Subsec. (i)(1).
"(A) has failed substantially to carry out the contract,
"(B) is carrying out the contract in a manner inconsistent with the efficient and effective administration of this section, or
"(C) no longer substantially meets the applicable conditions of subsections (b), (c), (e), and (f) of this section."
Subsec. (i)(6)(B).
Subsec. (i)(6)(C).
Subsec. (i)(6)(D).
Subsec. (i)(7)(A).
Subsec. (i)(9).
1994—Subsec. (a)(1)(E)(ii)(I).
Subsec. (a)(3).
Subsec. (c)(5)(B).
1990—Subsec. (a)(1)(E).
Subsec. (a)(6).
Subsec. (c)(2).
Subsec. (c)(8).
Subsec. (i)(6)(A)(vi).
Subsec. (i)(8).
Subsec. (j)(1)(A).
Subsec. (j)(2).
"(A) are emergency services or out-of-area coverage (described in clauses (iii) and (iv) of subsection (b)(2)(A) of this section), and
"(B) are furnished to an enrollee of an eligible organization under this section by a person who is not under a contract with the organization."
1989—Subsec. (a)(1)(F).
Subsec. (a)(5).
Subsec. (c)(3)(A)(i).
Subsec. (c)(3)(A)(ii).
Subsecs. (e)(1), (g)(3)(A).
Subsec. (g)(5).
Subsec. (i)(6)(A)(vii).
Subsec. (j).
1988—Subsec. (a)(5).
"(A) the product of (i) the number of such individuals for the month who have attained age 65, and (ii) the monthly actuarial rate for supplementary medical insurance for the month as determined under
"(B) the product of (i) the number of such individuals for the month who have not attained age 65, and (ii) the monthly actuarial rate for supplementary medical insurance for the month as determined under
Subsec. (c)(3)(F).
Subsec. (e)(1).
Subsec. (f)(3).
"(A) An eligible organization described in subparagraph (B) may elect, for purposes of enrollment and residency requirements under this section and for determining the compliance of a subdivision, subsidiary, or affiliate described in subparagraph (B)(iii) with the requirement of paragraph (1) for the period before October 1, 1992, to have members described in subparagraph (B)(iii) who receive services through the subdivision, subsidiary, or affiliate considered to be members of the parent organization.
"(B) An eligible organization described in this subparagraph is an eligible organization which—
"(i) is described in
"(ii) has members who have a collectively bargained contractual right to obtain health benefits from the organization;
"(iii) elects to provide benefits under a risk-sharing contract to individuals residing in a service area, who have a collectively bargained contractual right to obtain benefits from the organization, through a subdivision, subsidiary, or affiliate which itself is an eligible organization serving the area and which is owned or controlled by the parent eligible organization; and
"(iv) has assumed any risk of insolvency and quality assurance with respect to individuals receiving benefits through such a subdivision, subsidiary, or affiliate."
Subsec. (f)(3)(A).
Subsec. (f)(4).
Subsec. (g)(3)(A).
Subsec. (g)(5).
Subsec. (i)(6)(A).
Subsec. (i)(6)(B).
Subsec. (i)(6)(B)(i).
Subsec. (i)(7)(A).
Subsec. (i)(7)(B).
1987—Subsec. (c)(3)(F).
Subsec. (c)(3)(G).
Subsec. (f)(3), (4).
Subsec. (g)(4).
"(A) will reimburse hospitals and skilled nursing facilities either for payment amounts determined in accordance with
"(B) will deduct the amount of such reimbursement for payment which would otherwise be made to such organization."
Subsec. (g)(5).
Subsec. (i)(6).
"(6)(A) Any eligible organization with a risk-sharing contract under this section that fails substantially to provide medically necessary items and services that are required (under law or such contract) to be provided to individuals covered under such contract, if the failure has adversely affected (or has a substantial likelihood of adversely affecting) these individuals, is subject to a civil money penalty of not more than $10,000 for each such failure.
"(B) The provisions of
Subsec. (i)(7)(A).
Subsec. (i)(7)(B).
1986—Subsec. (a)(1)(A).
Subsec. (a)(3).
Subsec. (a)(6).
Subsec. (c)(3)(B).
Subsec. (c)(3)(C).
Subsec. (c)(7).
Subsec. (c)(3)(E).
Subsec. (f)(2).
"(A) special circumstances warrant such modification or waiver, and
"(B) the eligible organization has taken and is making reasonable efforts to enroll individuals who are not entitled to benefits under this subchapter or under a State plan approved under subchapter XIX of this chapter."
Subsec. (f)(3).
Subsec. (g)(6).
Subsec. (i)(1)(C).
Subsec. (i)(3)(C).
Subsec. (i)(6).
Subsec. (i)(7).
1984—Subsec. (b)(2)(D).
Subsec. (c)(3)(A).
Subsec. (c)(4)(A)(i).
Subsec. (g)(2).
Subsec. (g)(4)(A).
Subsec. (g)(5).
1983—Subsec. (a)(5)(A)(ii).
Subsec. (a)(5)(B)(ii).
Subsec. (g)(1).
Subsec. (g)(4).
1982—
1978—Subsec. (b)(2)(B).
1976—Subsec. (b).
Subsec. (h).
Subsec. (i)(6)(B).
Subsec. (k).
1973—Subsec. (a)(3)(A)(ii).
Subsec. (g)(2).
1972—Subsec. (i).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2011 Amendment
Amendment by
Effective Date of 1996 Amendment
Amendment by section 231(g) of
Effective Date of 1994 Amendment
Amendment by
Amendment by
Effective Date of 1990 Amendment
Amendment by section 4206(b)(1) of
Effective Date of 1989 Amendments
Amendment by section 201(a) of
Amendment by section 202(a) of
Effective Date of 1988 Amendments
Amendment by
Amendment by section 202(f) of
Amendment by section 211(c)(3) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Effective Date of 1986 Amendments
"(A)
"(B)
"(C)
"(i) as of the date of the enactment of this Act, has been granted, under paragraph (2) of section 1876(f) of the Social Security Act [
"(ii) does not meet the requirement for such modification or waiver under the amendment made by paragraph (1) of this subsection,
the organization shall make, and continue to make, reasonable efforts to meet scheduled enrollment goals, consistent with a schedule of compliance approved by the Secretary of Health and Human Services. If the Secretary determines that the organization has complied, or made significant progress towards compliance, with such schedule of compliance, the Secretary may extend such waiver. If the Secretary determines that the organization has not complied with such schedule, the Secretary may provide for a sanction described in section 1876(f)(3) of the Social Security Act [
"(D)
"(i) before January 1, 1996, section 1876(f) of the Social Security Act [
"(ii) beginning on January 1, 1990, the Secretary of Health and Human Services shall conduct an annual review of the organization to determine the organization's compliance with the quality assurance requirements of section 1876(c)(6) of such Act [
"(iii) after January 1, 1990, if the organization receives an unfavorable review under clause (ii), the Secretary, after notice to the organization of the unfavorable review and an opportunity to correct any deficiencies identified during the review, may provide for the sanction described in section 1876(f)(3) of such Act [
"(1)
"(2)
"(3)
"(B) Such amendment also shall not apply so as to require the submission of material which is distributed before July 1, 1986.
"(C) Such amendment shall also not apply to material which the Secretary determines has been prepared before the date of the enactment of this Act [Apr. 7, 1986] and for which a commitment for distribution has been made, if the application of such amendment would constitute a hardship for the organization involved.
"(4)
"(5)
Effective Date of 1984 Amendment
Amendment by section 2354(b)(37), (38) of
Effective Date of 1983 Amendments; Transitional Rule
Amendment by section 602(g) of
Amendment by section 606(a)(3)(H) of
Amendment by section 309(b)(12) of
Effective Date of 1982 Amendment
"(1) Subject to paragraph (2), the amendment made by subsection (a) [amending this section] shall apply with respect to services furnished on or after the initial effective date (as defined in paragraph (4)), except that such amendment shall not apply—
"(A) with respect to services furnished by an eligible organization to any individual who is enrolled with that organization under an existing cost contract (as defined in paragraph (3)(A)) and entitled to benefits under part A [
"(i) the individual requests at any time that the amendment apply, or
"(ii) the Secretary determines at any time that the amendment should apply to all members of the organization because of administrative costs or other administrative burdens involved and so informs in advance each affected member of the eligible organization;
"(B) with respect to services furnished by an eligible organization during the five-year period beginning on the initial effective date, if—
"(i) the organization has an existing risk-sharing contract (as defined in paragraph (3)(B)) on the initial effective date, or
"(ii) on the date of the enactment of this Act [Sept. 3, 1982] the organization was furnishing services pursuant to an existing demonstration project (as defined in paragraph (3)(C)), such demonstration project is concluded before the initial effective date, and before such initial effective date the organization enters into an existing risk-sharing contract,
unless the organization requests that the amendment apply earlier; or
"(C) with respect to services furnished by an eligible organization during the period of an existing demonstration project if on the initial effective date the organization was furnishing services pursuant to the project and if the project concludes after such date.
"(2)(A) In the case of an eligible organization which has in effect an existing cost contract (as defined in paragraph (3)(A)) on the initial effective date, the organization may receive payment under a new risk-sharing contract with respect to a current, nonrisk medicare enrollee (as defined in subparagraph (C)) only to the extent that the organization enrolls, for each such enrollee, two new medicare enrollees (as defined in subparagraph (D)). The selection of those current nonrisk medicare enrollees with respect to whom payment may be so received under a new risk-sharing contract shall be made in a nonbiased manner.
"(B) Subparagraph (A) shall not be construed to prevent an eligible organization from providing for enrollment, on a basis described in subsection (a)(6) of section 1876 of the Social Security Act [
"(i) payment to the organization with respect to such enrollees shall only be made in accordance with the terms of a reasonable cost reimbursement contract, and
"(ii) no payment may be made under section 1876 of such Act [
Individuals enrolled with the organization under this subparagraph shall be considered to be individuals enrolled with the organization for the purpose of meeting the requirement of section 1876(g)(2) of the Social Security Act [
"(C) For purposes of this paragraph, the term 'current, nonrisk medicare enrollee' means, with respect to an organization, an individual who on the initial effective date—
"(i) is enrolled with that organization under an existing cost contract, and
"(ii) is entitled to benefits under part A [
"(D) For purposes of this paragraph, the term 'new medicare enrollee' means, with respect to an organization, an individual who—
"(i) is enrolled with the organization after the date the organization first enters into a new risk-sharing contract,
"(ii) at the time of such enrollment is entitled to benefits under part A, or enrolled in part B, of title XVIII of the Social Security Act, and
"(iii) was not enrolled with the organization at the time the individual became entitled to benefits under part A, or to enroll in part B, of such title.
"(E) The preceding provisions of this paragraph shall not to [sic] apply to payments made for current, nonrisk medicare enrollees for months beginning with April 1987.
"(3) For purposes of this subsection:
"(A) The term 'existing cost contract' means a contract which is entered into under section 1876 of the Social Security Act [
"(B) The term 'existing risk-sharing contract' means a contract entered into under section 1876(i)(2)(A) of the Social Security Act [
"(C) The term 'existing demonstration project' means a demonstration project under section 402(a) of the Social Security Amendments of 1967 [
"(D) The term 'new risk-sharing contract' means a contract entered into under section 1876(g) of the Social Security Act [
"(E) The term 'reasonable cost reimbursement contract' means a contract entered into under section 1876(h) of such Act [
"(4) As used in this section, the term 'initial effective date' means—
"(A) the first day of the thirteenth month which begins after the date of the enactment of this Act [Sept. 3, 1982], or
"(B) the first day of the first month [Feb. 1, 1985] after the month in which the Secretary of Health and Human Services notifies the Committee on Finance of the Senate and the Committees on Ways and Means and on Energy and Commerce of the House of Representatives that he is reasonably certain that the methodology to make appropriate adjustments (referred to in section 1876(a)(4) of the Social Security Act [
whichever is later."
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1976 Amendment
Effective Date of 1973 Amendment
Effective Date
Report on Impact
Transition Rule for PSO Enrollment
Requirements With Respect to Actuarial Equivalence of AAPCC
"(1)(A) Not later than October 1, 1995, the Secretary of Health and Human Services (in this subsection referred to as the 'Secretary') shall submit a proposal to the Congress that provides for revisions to the payment method to be applied in years beginning with 1997 for organizations with a risk-sharing contract under section 1876(g) of the Social Security Act [
"(B) In proposing the revisions required under subparagraph (A), the Secretary shall consider—
"(i) the difference in costs associated with medicare beneficiaries with differing health status and demographic characteristics; and
"(ii) the effects of using alternative geographic classifications on the determinations of costs associated with beneficiaries residing in different areas.
"(2) Not later than 3 months after the date of submittal of the proposal under paragraph (1), the Comptroller General shall review the proposal and shall report to Congress on the appropriateness of the proposed modifications."
[Amendment by section 122(g) of
Study of Chiropractic Services
Effect on State Law
Conscientious objections of health care provider under State law unaffected by enactment of subsec. (c)(8) of this section, see section 4206(c) of
Notice of Methodology Used in Making Announcements Under Subsection (a)(1)(A)
Adjustment of Contracts With Prepaid Health Plans
"(1) with eligible organizations under section 1876 of the Social Security Act [
"(2) with health maintenance organizations under section 1876(i)(2)(A) of such Act [
Adjustment of Contracts With Prepaid Health Plans
"(1) modify contracts under section 1876 of the Social Security Act [
"(2) require such organizations and organizations paid under section 1833(a)(1)(A) of such Act [
The Secretary shall also provide for appropriate modifications of contracts with health maintenance organizations under section 1876(i)(2)(A) of the Social Security Act [
Provision of Medicare DRG Rates for Certain Payments and Data on Inpatient Cost Pass-Through Items
Medicare Payment Demonstration Projects
"(a)
"(1) The Secretary of Health and Human Services (in this subsection referred to as the 'Secretary') may provide for capitation demonstration projects (in this subsection referred to as 'projects') with an entity which is an eligible organization with a contract with the Secretary under section 1876 of the Social Security Act [
"(2) The Secretary may not conduct more than 3 projects and may not expend, from funds under title XVIII of the Social Security Act [
"(3) The per capita rate of payment under a project—
"(A) may be based on the adjusted average per capita cost (as defined in section 1876(a)(4) of the Social Security Act [
"(B) the rate of payment may not exceed the lesser of—
"(i) 95 percent of the adjusted average per capita cost described in subparagraph (A), or
"(ii)(I) in the 4th year or 5th year of a project, 115 percent of the adjusted average per capita cost (as defined in section 1876(a)(4) of such Act [
"(II) in any subsequent year of a project, 95 percent of the adjusted average per capita cost (as defined in section 1876(a)(4) [
"(4) If the payment amounts made to a project are greater than the costs of the project (as determined by the Secretary or, if applicable, on the basis of adjusted community rates described in section 1876(e)(3) of the Social Security Act [
"(A) may retain the surplus, but not to exceed 5 percent of the average adjusted per capita cost determined in accordance with paragraph (3)(A), and
"(B) with respect to any additional surplus not retained by the project, shall apply such surplus to additional benefits for individuals served by the project or return such surplus to the Secretary.
"(5) Enrollment under the project shall be voluntary. Individuals enrolled with the project may terminate such enrollment as of the beginning of the first calendar month following the date on which the request is made for such termination. Upon such termination, such individuals shall retain the same rights to other health benefits that such individuals would have had if they had never enrolled with the project without any exclusion or waiting period for pre-existing conditions.
"(6) The requirements of—
"(A) subsection (c)(3)(C) (relating to dissemination of information),
"(B) subsection (c)(3)(E) (annual statement of rights),
"(C) subsection (c)(5) (grievance procedures),
"(D) subsection (c)(6) (on-going quality),
"(E) subsection (g)(6) (relating to prompt payment of claims),
"(F) subsection (i)(3)(A) and (B) (relating to access to information and termination notices),
"(G) subsection (i)(6) (relating to providing necessary services), and
"(H) subsection (i)(7) (relating to agreements with peer review [now "quality improvement"] organizations),
of section 1876 of the Social Security Act [
"(7) The benefits provided under a project must be at least actuarially equivalent to the combination of the benefits available under title XVIII of the Social Security Act [
"(8) A project shall comply with all applicable State laws.
"(9) The Secretary may not authorize a project unless the entity offering the project demonstrates to the satisfaction of the Secretary that it has the necessary financial reserves to pay for any liability for benefits under the project (including those liabilities for health benefits under medicare and any supplemental benefits).
"(10) The Comptroller General shall monitor projects under this subsection and shall report periodically (not less often than once every year) to the Committee on Finance of the Senate and the Committee on Energy and Commerce and Committee on Ways and Means of the House of Representatives on the status of such projects and the effect on such projects of the requirements of this section and shall submit a final report to each such committee on the results of such projects.
"(b)
"(1) The Secretary of Health and Human Services (in this subsection referred to as the 'Secretary') is specifically authorized to conduct demonstration projects under this subsection for the purpose of testing alternative payment methodologies pertaining to capitation payments under title XVIII of the Social Security Act [
"(A) computing adjustments to the average per capita cost under section 1876 of such Act [
"(B) accounting for geographic variations in cost in the adjusted average per capita costs applicable to an eligible organization under such section which differs from payments currently provided on a county-by-county basis.
"(2) No project may be conducted under this subsection—
"(A) with an entity which is not an eligible organization (as defined in section 1876(b) of the Social Security Act [
"(B) unless the project meets all the requirements of subsections (c) and (i)(3) of section 1876 of such Act [
"(3) There are authorized to be appropriated to carry out projects under this subsection $5,000,000 in each of fiscal years 1989 and 1990.
"(c)
[For termination, effective May 15, 2000, of provisions of law requiring submittal to Congress of any annual, semiannual, or other regular periodic report listed in House Document No. 103–7 (in which the requirement to report not less than once every year to certain committees of Congress under section 4015(a)(10) of
GAO Study and Reports on Medicare Capitation
Demonstration Projects To Provide Payment on a Prepaid, Capitated Basis for Community Nursing and Ambulatory Care Furnished to Medicare Beneficiaries
"(a)
"(b)
"(1)
"(2)
"(A)
"(i) the period beginning with October 1, 2000, and ending with December 31, 2000, shall be determined by actuarially adjusting the actual capitation rate paid for such services in 1999 for inflation, utilization, and other changes to the CNO service package, and by reducing such adjusted capitation rate by 10 percent in the case of the demonstration sites located in Arizona, Minnesota, and Illinois, and 15 percent for the demonstration site located in New York; and
"(ii) 2001 shall be determined by actuarially adjusting the capitation rate determined under clause (i) for inflation, utilization, and other changes to the CNO service package.
"(B)
"(i) the case management fee per enrollee per month for—
"(I) the period described in subparagraph (A)(i) shall be determined by actuarially adjusting the case management fee for 1999 for inflation; and
"(II) 2001 shall be determined by actuarially adjusting the amount determined under subclause (I) for inflation; and
"(ii) such case management fee shall be paid only for enrollees who are classified as moderately frail or frail pursuant to criteria established by the Secretary.
"(C)
"(i) protocols for periodic telephonic contact with enrollees based on—
"(I) the results of such standardized written health assessment; and
"(II) the application of appropriate care planning approaches;
"(ii) disease management programs for targeted diseases (such as congestive heart failure, arthritis, diabetes, and hypertension) that are highly prevalent in the enrolled populations;
"(iii) systems and protocols to track enrollees through hospitalizations, including pre-admission planning, concurrent management during inpatient hospital stays, and post-discharge assessment, planning, and follow-up; and
"(iv) standardized patient educational materials for specified diseases and health conditions.
"(D)
"(i) enrollee satisfaction surveys; and
"(ii) reporting on specified quality indicators for the enrolled population.
"(c)
"(1)
"(A) evaluates such demonstration projects for the period beginning July 1, 1997, and ending December 31, 1999, on a site-specific basis with respect to the impact on per beneficiary spending, specific health utilization measures, and enrollee satisfaction; and
"(B) includes a similar evaluation of such projects for the portion of the extension period that occurs after September 30, 2000.
"(2)
"(3)
"(A) data for all individuals who—
"(i) were enrolled in such demonstration projects as of the first day of the period under evaluation; and
"(ii) were enrolled for a minimum of 6 months thereafter; with
"(B) data for a matched sample of individuals who are enrolled under part B of title XVIII of the Social Security Act [
[
"(a)
"(b)
"(1) The term 'community nursing and ambulatory care' means the following services:
"(A) Part-time or intermittent nursing care furnished by or under the supervision of registered professional nurses.
"(B) Physical, occupational, or speech therapy.
"(C) Social and related services supportive of a plan of ambulatory care.
"(D) Part-time or intermittent services of a home health aide.
"(E) Medical supplies (other than drugs and biologicals) and durable medical equipment while under a plan of care.
"(F) Medical and other health services described in paragraphs (2)(H)(ii) and (5) through (9) of section 1861(s) of the Social Security Act [
"(G) Rural health clinic services described in section 1861(aa)(1)(C) of such Act [
"(H) Certain other related services listed in section 1915(c)(4)(B) of such Act [
"(2) The term 'eligible organization' means a public or private entity, organized under the laws of any State, which meets the following requirements:
"(A) The entity (or a division or part of such entity) is primarily engaged in the direct provision of community nursing and ambulatory care.
"(B) The entity provides directly, or through arrangements with other qualified personnel, the services described in paragraph (1).
"(C) The entity provides that all nursing care (including services of home health aids) is furnished by or under the supervision of a registered nurse.
"(D) The entity provides that all services are furnished by qualified staff and are coordinated by a registered professional nurse.
"(E) The entity has policies governing the furnishing of community nursing and ambulatory care that are developed by registered professional nurses in cooperation with (as appropriate) other professionals.
"(F) The entity maintains clinical records on all patients.
"(G) The entity has protocols and procedures to assure, when appropriate, timely referral to or consultation with other health care providers or professionals.
"(H) The entity complies with applicable State and local laws governing the provision of community nursing and ambulatory care to patients.
"(I) The requirements of subparagraphs (B), (D), and (E) of section 1876(b)(2) of the Social Security Act [
"(c)
"(1) The Secretary may not enter into an agreement with an eligible organization to conduct a demonstration project under this section unless the organization meets the requirements of this subsection and subsection (e) with respect to members enrolled with the organization under this section.
"(2) The organization shall have an open enrollment period for the enrollment of individuals under this section. The duration of such period of enrollment and any other requirement pertaining to enrollment or termination of enrollment shall be specified in the agreement with the organization.
"(3) The organization must provide to members enrolled with the organization under this section, through providers and other persons that meet the applicable requirements of titles XVIII and XIX of the Social Security Act [
"(4) The organization must make community nursing and ambulatory care (and such other health care services as such individuals have contracted for) available and accessible to each individual enrolled with the organization under this section, within the area served by the organization, with reasonable promptness and in a manner which assures continuity.
"(5) Section 1876(c)(5) of the Social Security Act [
"(6) The organization must have arrangements, established in accordance with regulations of the Secretary, for an ongoing quality assurance program for health care services it provides to such individuals under the demonstration project conducted under this section, which program (A) stresses health outcomes and (B) provides review by health care professionals of the process followed in the provision of such health care services.
"(7) Under a demonstration project under this section—
"(A) the Secretary could require the organization to provide financial or other assurances (including financial risk-sharing) that minimize the inappropriate substitution of other services under title XVIII of such Act [
"(B) if the Secretary determines that the organization has failed to perform in accordance with the requirements of the project (including meeting financial responsibility requirements under the project, any pattern of disproportionate or inappropriate institutionalization) the Secretary shall, after notice, terminate the project.
"(d)
"(1) The Secretary shall determine for each 12-month period in which a demonstration project is conducted under this section, and shall announce (in a manner intended to provide notice to interested parties) not later than three months before the beginning of such period, with respect to each eligible organization conducting a demonstration project under this section, a per capita rate of payment for each class of individuals who are enrolled with such organization who are entitled to benefits under part A and enrolled under part B of title XVIII of the Social Security Act [
"(2)(A) Except as provided in paragraph (3), the per capita rate of payment under paragraph (1) shall be determined in accordance with this paragraph.
"(B) The Secretary shall define appropriate classes of members, based on age, disability status, and such other factors as the Secretary determines to be appropriate, so as to ensure actuarial equivalence. The Secretary may add to, modify, or substitute for such classes, if such changes will improve the determination of actuarial equivalence.
"(C) The per capita rate of payment under paragraph (1) for each such class shall be equal to 95 percent of the adjusted average per capita cost (as defined in subparagraph (D)) for that class.
"(D) For purposes of subparagraph (C), the term 'adjusted average per capita cost' means the average per capita amount that the Secretary estimates in advance (on the basis of actual experience, or retrospective actuarial equivalent based upon an adequate sample and other information and data, in a geographic area served by an eligible organization or in a similar area, with appropriate adjustments to assure actuarial equivalence) would be payable in any contract year for those services covered under parts A and B of title XVIII of the Social Security Act [
"(3) The Secretary shall, in consultation with providers, health policy experts, and consumer groups develop capitation-based reimbursement rates for such classes of individuals entitled to benefits under part A and enrolled under part B of the Social Security Act [probably means parts A and B of title XVIII of that Act,
"(4)(A) In the case of an eligible organization conducting a demonstration project under this section, the Secretary shall make monthly payments in advance and in accordance with the rate determined under paragraph (2) or (3), except as provided in subsection (e)(3)(B), to the organization for each individual enrolled with the organization.
"(B) The amount of payment under paragraph (2) or (3) may be retroactively adjusted to take into account any difference between the actual number of individuals enrolled in the plan under this section and the number of such individuals estimated to be so enrolled in determining the amount of the advance payment.
"(5) The payment to an eligible organization under this section for individuals enrolled under this section with the organization and entitled to benefits under part A and enrolled under part B of the Social Security Act shall be made from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund established under such Act [
"(6) During any period in which an individual is enrolled with an eligible organization conducting a demonstration project under this section, only the eligible organization (and no other individual or person) shall be entitled to receive payments from the Secretary under this title [probably means title XVIII of the Social Security Act,
"(e)
"(1) In no case may the portion of an eligible organization's premium rate and the actuarial value of its deductibles, coinsurance, and copayments charged (with respect to community nursing and ambulatory care) to individuals who are enrolled under this section with the organization, exceed the actuarial value of the coinsurance and deductibles that would be applicable on the average to individuals enrolled under this section with the organization (or, if the Secretary finds that adequate data are not available to determine that actuarial value, the actuarial value of the coinsurance and deductibles applicable on the average to individuals in the area, in the State, or in the United States, eligible to enroll under this section with the organization, or other appropriate data) and entitled to benefits under part A and enrolled under part B of the Social Security Act [probably means parts A and B of title XVIII of that Act,
"(2) If the eligible organization provides to its members enrolled under this section services in addition to community nursing and ambulatory care, election of coverage for such additional services shall be optional for such members and such organization shall furnish such members with information on the portion of its premium rate or other charges applicable to such additional services. In no case may the sum of—
"(A) the portion of such organization's premium rate charged, with respect to such additional services, to members enrolled under this section, and
"(B) the actuarial value of its deductibles, coinsurance, and copayments charged, with respect to such services to such members
exceed the adjusted community rate for such services (as defined in section 1876(e)(3) of the Social Security Act [
"(3)(A) Subject to subparagraphs (B) and (C), each agreement to conduct a demonstration project under this section shall provide that if—
"(i) the adjusted community rate, referred to in paragraph (2), for community nursing and ambulatory care covered under parts A and B of title XVIII of the Social Security Act [
is less than
"(ii) the average of the per capita rates of payment to be made under subsection (d)(1) at the beginning of the 12-month period (as determined on such basis as the Secretary determines appropriate) described in such subsection for members enrolled under this section with the organization,
the eligible organization shall provide to such members the additional benefits described in section 1876(g)(3) of the Social Security Act [
"(B) Subparagraph (A) shall not apply with respect to any organization which elects to receive a lesser payment to the extent that there is no longer a difference between the average per capita payment and adjusted community rate (as so reduced).
"(C) An organization conducting a demonstration project under this section may provide (with the approval of the Secretary) that a part of the value of such additional benefits under subparagraph (A) be withheld and reserved by the Secretary as provided in section 1876(g)(5) of the Social Security Act [
"(4) The provisions of paragraphs (3), (5), and (6) of section 1876(g) of the Social Security Act [
"(5) Section 1876(e)(4) of the Social Security Act [
"(f)
"(g)
Study of AAPCC and ACR
Allowing Medicare Beneficiaries To Disenroll at Local Social Security Offices
Use of Reserve Funds
Phase-in of Enrollment Period by Secretary
Stabilization Fund; Establishment Limitation; Uses; Report to Congress
Study of Additional Benefits Selected by Eligible Organizations
Study Evaluating the Extent of, and Reasons for, Termination by Medicare Beneficiaries of Membership in Organizations With Contracts Under This Section
Reimbursement for Services
"(1) Notwithstanding the provisions of section 1814 and section 1833 of the Social Security Act [
"(2) With respect to individuals who are members of organizations which have entered into a risk-sharing contract with the Secretary pursuant to subsection (i)(2)(A) [of this section] prior to July 1, 1973, and who, although eligible to have payment made pursuant to section 1876 of such Act [
"(3) If the Secretary determines that the per capita cost of any such organization in any contract year for providing services to individuals described in paragraph (2), when combined with the cost of the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund in such year for providing out-of-plan services to such individuals, is less than or greater than the adjusted average per capita cost (as defined in section 1876(a)(3) of such Act [
1 See References in Text note below.
2 So in original. Probably should be followed by a comma.
§1395nn. Limitation on certain physician referrals
(a) Prohibition of certain referrals
(1) In general
Except as provided in subsection (b), if a physician (or an immediate family member of such physician) has a financial relationship with an entity specified in paragraph (2), then—
(A) the physician may not make a referral to the entity for the furnishing of designated health services for which payment otherwise may be made under this subchapter, and
(B) the entity may not present or cause to be presented a claim under this subchapter or bill to any individual, third party payor, or other entity for designated health services furnished pursuant to a referral prohibited under subparagraph (A).
(2) Financial relationship specified
For purposes of this section, a financial relationship of a physician (or an immediate family member of such physician) with an entity specified in this paragraph is—
(A) except as provided in subsections (c) and (d), an ownership or investment interest in the entity, or
(B) except as provided in subsection (e), a compensation arrangement (as defined in subsection (h)(1)) between the physician (or an immediate family member of such physician) and the entity.
An ownership or investment interest described in subparagraph (A) may be through equity, debt, or other means and includes an interest in an entity that holds an ownership or investment interest in any entity providing the designated health service.
(b) General exceptions to both ownership and compensation arrangement prohibitions
Subsection (a)(1) shall not apply in the following cases:
(1) Physicians' services
In the case of physicians' services (as defined in
(2) In-office ancillary services
In the case of services (other than durable medical equipment (excluding infusion pumps) and parenteral and enteral nutrients, equipment, and supplies)—
(A) that are furnished—
(i) personally by the referring physician, personally by a physician who is a member of the same group practice as the referring physician, or personally by individuals who are directly supervised by the physician or by another physician in the group practice, and
(ii)(I) in a building in which the referring physician (or another physician who is a member of the same group practice) furnishes physicians' services unrelated to the furnishing of designated health services, or
(II) in the case of a referring physician who is a member of a group practice, in another building which is used by the group practice—
(aa) for the provision of some or all of the group's clinical laboratory services, or
(bb) for the centralized provision of the group's designated health services (other than clinical laboratory services),
unless the Secretary determines other terms and conditions under which the provision of such services does not present a risk of program or patient abuse, and
(B) that are billed by the physician performing or supervising the services, by a group practice of which such physician is a member under a billing number assigned to the group practice, or by an entity that is wholly owned by such physician or such group practice,
if the ownership or investment interest in such services meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse. Such requirements shall, with respect to magnetic resonance imaging, computed tomography, positron emission tomography, and any other designated health services specified under subsection (h)(6)(D) that the Secretary determines appropriate, include a requirement that the referring physician inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred from a person other than a person described in subparagraph (A)(i) and provide such individual with a written list of suppliers (as defined in
(3) Prepaid plans
In the case of services furnished by an organization—
(A) with a contract under
(B) described in
(C) receiving payments on a prepaid basis, under a demonstration project under
(D) that is a qualified health maintenance organization (within the meaning of section 300e–9(d) 1 of this title) to an individual enrolled with the organization, or
(E) that is a Medicare+Choice organization under part C that is offering a coordinated care plan described in
(4) Other permissible exceptions
In the case of any other financial relationship which the Secretary determines, and specifies in regulations, does not pose a risk of program or patient abuse.
(5) Electronic prescribing
An exception established by regulation under
(c) General exception related only to ownership or investment prohibition for ownership in publicly traded securities and mutual funds
Ownership of the following shall not be considered to be an ownership or investment interest described in subsection (a)(2)(A):
(1) Ownership of investment securities (including shares or bonds, debentures, notes, or other debt instruments) which may be purchased on terms generally available to the public and which are—
(A)(i) securities listed on the New York Stock Exchange, the American Stock Exchange, or any regional exchange in which quotations are published on a daily basis, or foreign securities listed on a recognized foreign, national, or regional exchange in which quotations are published on a daily basis, or
(ii) traded under an automated interdealer quotation system operated by the National Association of Securities Dealers, and
(B) in a corporation that had, at the end of the corporation's most recent fiscal year, or on average during the previous 3 fiscal years, stockholder equity exceeding $75,000,000.
(2) Ownership of shares in a regulated investment company as defined in section 851(a) of the Internal Revenue Code of 1986, if such company had, at the end of the company's most recent fiscal year, or on average during the previous 3 fiscal years, total assets exceeding $75,000,000.
(d) Additional exceptions related only to ownership or investment prohibition
The following, if not otherwise excepted under subsection (b), shall not be considered to be an ownership or investment interest described in subsection (a)(2)(A):
(1) Hospitals in Puerto Rico
In the case of designated health services provided by a hospital located in Puerto Rico.
(2) Rural providers
In the case of designated health services furnished in a rural area (as defined in
(A) substantially all of the designated health services furnished by the entity are furnished to individuals residing in such a rural area;
(B) effective for the 18-month period beginning on December 8, 2003, the entity is not a specialty hospital (as defined in subsection (h)(7)); and
(C) in the case where the entity is a hospital, the hospital meets the requirements of paragraph (3)(D).
(3) Hospital ownership
In the case of designated health services provided by a hospital (other than a hospital described in paragraph (1)) if—
(A) the referring physician is authorized to perform services at the hospital;
(B) effective for the 18-month period beginning on December 8, 2003, the hospital is not a specialty hospital (as defined in subsection (h)(7));
(C) the ownership or investment interest is in the hospital itself (and not merely in a subdivision of the hospital); and
(D) the hospital meets the requirements described in subsection (i)(1) not later than 18 months after March 23, 2010.
(e) Exceptions relating to other compensation arrangements
The following shall not be considered to be a compensation arrangement described in subsection (a)(2)(B):
(1) Rental of office space; rental of equipment
(A) Office space
Payments made by a lessee to a lessor for the use of premises if—
(i) the lease is set out in writing, signed by the parties, and specifies the premises covered by the lease,
(ii) the space rented or leased does not exceed that which is reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the lessee when being used by the lessee, except that the lessee may make payments for the use of space consisting of common areas if such payments do not exceed the lessee's pro rata share of expenses for such space based upon the ratio of the space used exclusively by the lessee to the total amount of space (other than common areas) occupied by all persons using such common areas,
(iii) the lease provides for a term of rental or lease for at least 1 year,
(iv) the rental charges over the term of the lease are set in advance, are consistent with fair market value, and are not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
(v) the lease would be commercially reasonable even if no referrals were made between the parties, and
(vi) the lease meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(B) Equipment
Payments made by a lessee of equipment to the lessor of the equipment for the use of the equipment if—
(i) the lease is set out in writing, signed by the parties, and specifies the equipment covered by the lease,
(ii) the equipment rented or leased does not exceed that which is reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the lessee when being used by the lessee,
(iii) the lease provides for a term of rental or lease of at least 1 year,
(iv) the rental charges over the term of the lease are set in advance, are consistent with fair market value, and are not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
(v) the lease would be commercially reasonable even if no referrals were made between the parties, and
(vi) the lease meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(C) Holdover lease arrangements
In the case of a holdover lease arrangement for the lease of office space or equipment, which immediately follows a lease arrangement described in subparagraph (A) for the use of such office space or subparagraph (B) for the use of such equipment and that expired after a term of at least 1 year, payments made by the lessee to the lessor pursuant to such holdover lease arrangement, if—
(i) the lease arrangement met the conditions of subparagraph (A) for the lease of office space or subparagraph (B) for the use of equipment when the arrangement expired;
(ii) the holdover lease arrangement is on the same terms and conditions as the immediately preceding arrangement; and
(iii) the holdover arrangement continues to satisfy the conditions of subparagraph (A) for the lease of office space or subparagraph (B) for the use of equipment.
(2) Bona fide employment relationships
Any amount paid by an employer to a physician (or an immediate family member of such physician) who has a bona fide employment relationship with the employer for the provision of services if—
(A) the employment is for identifiable services,
(B) the amount of the remuneration under the employment—
(i) is consistent with the fair market value of the services, and
(ii) is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician,
(C) the remuneration is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the employer, and
(D) the employment meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
Subparagraph (B)(ii) shall not prohibit the payment of remuneration in the form of a productivity bonus based on services performed personally by the physician (or an immediate family member of such physician).
(3) Personal service arrangements
(A) In general
Remuneration from an entity under an arrangement (including remuneration for specific physicians' services furnished to a nonprofit blood center) if—
(i) the arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement,
(ii) the arrangement covers all of the services to be provided by the physician (or an immediate family member of such physician) to the entity,
(iii) the aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement,
(iv) the term of the arrangement is for at least 1 year,
(v) the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and except in the case of a physician incentive plan described in subparagraph (B), is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
(vi) the services to be performed under the arrangement do not involve the counseling or promotion or a business arrangement or other activity that violates any State or Federal law, and
(vii) the arrangement meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(B) Physician incentive plan exception
(i) In general
In the case of a physician incentive plan (as defined in clause (ii)) between a physician and an entity, the compensation may be determined in a manner (through a withhold, capitation, bonus, or otherwise) that takes into account directly or indirectly the volume or value of any referrals or other business generated between the parties, if the plan meets the following requirements:
(I) No specific payment is made directly or indirectly under the plan to a physician or a physician group as an inducement to reduce or limit medically necessary services provided with respect to a specific individual enrolled with the entity.
(II) In the case of a plan that places a physician or a physician group at substantial financial risk as determined by the Secretary pursuant to
(III) Upon request by the Secretary, the entity provides the Secretary with access to descriptive information regarding the plan, in order to permit the Secretary to determine whether the plan is in compliance with the requirements of this clause.
(ii) "Physician incentive plan" defined
For purposes of this subparagraph, the term "physician incentive plan" means any compensation arrangement between an entity and a physician or physician group that may directly or indirectly have the effect of reducing or limiting services provided with respect to individuals enrolled with the entity.
(C) Holdover personal service arrangement
In the case of a holdover personal service arrangement, which immediately follows an arrangement described in subparagraph (A) that expired after a term of at least 1 year, remuneration from an entity pursuant to such holdover personal service arrangement, if—
(i) the personal service arrangement met the conditions of subparagraph (A) when the arrangement expired;
(ii) the holdover personal service arrangement is on the same terms and conditions as the immediately preceding arrangement; and
(iii) the holdover arrangement continues to satisfy the conditions of subparagraph (A).
(4) Remuneration unrelated to the provision of designated health services
In the case of remuneration which is provided by a hospital to a physician if such remuneration does not relate to the provision of designated health services.
(5) Physician recruitment
In the case of remuneration which is provided by a hospital to a physician to induce the physician to relocate to the geographic area served by the hospital in order to be a member of the medical staff of the hospital, if—
(A) the physician is not required to refer patients to the hospital,
(B) the amount of the remuneration under the arrangement is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician, and
(C) the arrangement meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(6) Isolated transactions
In the case of an isolated financial transaction, such as a one-time sale of property or practice, if—
(A) the requirements described in subparagraphs (B) and (C) of paragraph (2) are met with respect to the entity in the same manner as they apply to an employer, and
(B) the transaction meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(7) Certain group practice arrangements with a hospital
(A) 2 In general
An arrangement between a hospital and a group under which designated health services are provided by the group but are billed by the hospital if—
(i) with respect to services provided to an inpatient of the hospital, the arrangement is pursuant to the provision of inpatient hospital services under
(ii) the arrangement began before December 19, 1989, and has continued in effect without interruption since such date,
(iii) with respect to the designated health services covered under the arrangement, substantially all of such services furnished to patients of the hospital are furnished by the group under the arrangement,
(iv) the arrangement is pursuant to an agreement that is set out in writing and that specifies the services to be provided by the parties and the compensation for services provided under the agreement,
(v) the compensation paid over the term of the agreement is consistent with fair market value and the compensation per unit of services is fixed in advance and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
(vi) the compensation is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the entity, and
(vii) the arrangement between the parties meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(8) Payments by a physician for items and services
Payments made by a physician—
(A) to a laboratory in exchange for the provision of clinical laboratory services, or
(B) to an entity as compensation for other items or services if the items or services are furnished at a price that is consistent with fair market value.
(9) Physician wellness programs
A bona fide mental health or behavioral health improvement or maintenance program offered to a physician by an entity, if—
(A) such program—
(i) consists of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program;
(ii) is made available to a physician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in appropriate strategies to promote the mental health and resiliency of such physician;
(iii) is set out in a written policy, approved in advance of the operation of the program by the governing body of the entity providing such program (and which shall be updated accordingly in advance to substantial changes to the operation of such program), that includes—
(I) a description of the content and duration of the program;
(II) a description of the evidence-based support for the design of the program;
(III) the estimated cost of the program;
(IV) the personnel (including the qualifications of such personnel) conducting the program; and
(V) the method by which such entity will evaluate the use and success of the program;
(iv) is offered by an entity described in subparagraph (B) with a formal medical staff to all physicians who practice in the geographic area served by such entity, including physicians who hold bona fide appointments to the medical staff of such entity or otherwise have clinical privileges at such entity;
(v) is offered to all such physicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a physician for such entity;
(vi) is evidence-based and conducted by a qualified health professional; and
(vii) meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient abuse;
(B) such entity is—
(i) a hospital;
(ii) an ambulatory surgical center;
(iii) a community health center;
(iv) a rural emergency hospital;
(v) a rural health clinic;
(vi) a skilled nursing facility; or
(vii) a similar entity, as determined by the Secretary; and
(C) neither the provision of such program, nor the value of such program, are contingent upon the number or value of referrals made by a physician to such entity or the amount or value of other business generated by such physician for the entity.
(f) Reporting requirements
Each entity providing covered items or services for which payment may be made under this subchapter shall provide the Secretary with the information concerning the entity's ownership, investment, and compensation arrangements, including—
(1) the covered items and services provided by the entity, and
(2) the names and unique physician identification numbers of all physicians with an ownership or investment interest (as described in subsection (a)(2)(A)), or with a compensation arrangement (as described in subsection (a)(2)(B)), in the entity, or whose immediate relatives have such an ownership or investment interest or who have such a compensation relationship with the entity.
Such information shall be provided in such form, manner, and at such times as the Secretary shall specify. The requirement of this subsection shall not apply to designated health services provided outside the United States or to entities which the Secretary determines provides 3 services for which payment may be made under this subchapter very infrequently.
(g) Sanctions
(1) Denial of payment
No payment may be made under this subchapter for a designated health service which is provided in violation of subsection (a)(1).
(2) Requiring refunds for certain claims
If a person collects any amounts that were billed in violation of subsection (a)(1), the person shall be liable to the individual for, and shall refund on a timely basis to the individual, any amounts so collected.
(3) Civil money penalty and exclusion for improper claims
Any person that presents or causes to be presented a bill or a claim for a service that such person knows or should know is for a service for which payment may not be made under paragraph (1) or for which a refund has not been made under paragraph (2) shall be subject to a civil money penalty of not more than $15,000 for each such service. The provisions of
(4) Civil money penalty and exclusion for circumvention schemes
Any physician or other entity that enters into an arrangement or scheme (such as a cross-referral arrangement) which the physician or entity knows or should know has a principal purpose of assuring referrals by the physician to a particular entity which, if the physician directly made referrals to such entity, would be in violation of this section, shall be subject to a civil money penalty of not more than $100,000 for each such arrangement or scheme. The provisions of
(5) Failure to report information
Any person who is required, but fails, to meet a reporting requirement of subsection (f) is subject to a civil money penalty of not more than $10,000 for each day for which reporting is required to have been made. The provisions of
(6) Advisory opinions
(A) In general
The Secretary shall issue written advisory opinions concerning whether a referral relating to designated health services (other than clinical laboratory services) is prohibited under this section. Each advisory opinion issued by the Secretary shall be binding as to the Secretary and the party or parties requesting the opinion.
(B) Application of certain rules
The Secretary shall, to the extent practicable, apply the rules under subsections (b)(3) and (b)(4) and take into account the regulations promulgated under subsection (b)(5) of
(C) Regulations
In order to implement this paragraph in a timely manner, the Secretary may promulgate regulations that take effect on an interim basis, after notice and pending opportunity for public comment.
(D) Applicability
This paragraph shall apply to requests for advisory opinions made after the date which is 90 days after August 5, 1997, and before the close of the period described in
(h) Definitions and special rules
For purposes of this section:
(1) Compensation arrangement; remuneration
(A) The term "compensation arrangement" means any arrangement involving any remuneration between a physician (or an immediate family member of such physician) and an entity other than an arrangement involving only remuneration described in subparagraph (C).
(B) The term "remuneration" includes any remuneration, directly or indirectly, overtly or covertly, in cash or in kind.
(C) Remuneration described in this subparagraph is any remuneration consisting of any of the following:
(i) The forgiveness of amounts owed for inaccurate tests or procedures, mistakenly performed tests or procedures, or the correction of minor billing errors.
(ii) The provision of items, devices, or supplies that are used solely to—
(I) collect, transport, process, or store specimens for the entity providing the item, device, or supply, or
(II) order or communicate the results of tests or procedures for such entity.
(iii) A payment made by an insurer or a self-insured plan to a physician to satisfy a claim, submitted on a fee for service basis, for the furnishing of health services by that physician to an individual who is covered by a policy with the insurer or by the self-insured plan, if—
(I) the health services are not furnished, and the payment is not made, pursuant to a contract or other arrangement between the insurer or the plan and the physician,
(II) the payment is made to the physician on behalf of the covered individual and would otherwise be made directly to such individual,
(III) the amount of the payment is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account directly or indirectly the volume or value of any referrals, and
(IV) the payment meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(D)
(E)
(i) not later than 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant, the parties obtain the required signatures; and
(ii) the compensation arrangement otherwise complies with all criteria of the applicable exception.
(2) Employee
An individual is considered to be "employed by" or an "employee" of an entity if the individual would be considered to be an employee of the entity under the usual common law rules applicable in determining the employer-employee relationship (as applied for purposes of section 3121(d)(2) of the Internal Revenue Code of 1986).
(3) Fair market value
The term "fair market value" means the value in arms length transactions, consistent with the general market value, and, with respect to rentals or leases, the value of rental property for general commercial purposes (not taking into account its intended use) and, in the case of a lease of space, not adjusted to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor where the lessor is a potential source of patient referrals to the lessee.
(4) Group practice
(A) Definition of group practice
The term "group practice" means a group of 2 or more physicians legally organized as a partnership, professional corporation, foundation, not-for-profit corporation, faculty practice plan, or similar association—
(i) in which each physician who is a member of the group provides substantially the full range of services which the physician routinely provides, including medical care, consultation, diagnosis, or treatment, through the joint use of shared office space, facilities, equipment and personnel,
(ii) for which substantially all of the services of the physicians who are members of the group are provided through the group and are billed under a billing number assigned to the group and amounts so received are treated as receipts of the group,
(iii) in which the overhead expenses of and the income from the practice are distributed in accordance with methods previously determined,
(iv) except as provided in subparagraph (B)(i), in which no physician who is a member of the group directly or indirectly receives compensation based on the volume or value of referrals by the physician,
(v) in which members of the group personally conduct no less than 75 percent of the physician-patient encounters of the group practice, and
(vi) which meets such other standards as the Secretary may impose by regulation.
(B) Special rules
(i) Profits and productivity bonuses
A physician in a group practice may be paid a share of overall profits of the group, or a productivity bonus based on services personally performed or services incident to such personally performed services, so long as the share or bonus is not determined in any manner which is directly related to the volume or value of referrals by such physician.
(ii) Faculty practice plans
In the case of a faculty practice plan associated with a hospital, institution of higher education, or medical school with an approved medical residency training program in which physician members may provide a variety of different specialty services and provide professional services both within and outside the group, as well as perform other tasks such as research, subparagraph (A) shall be applied only with respect to the services provided within the faculty practice plan.
(5) Referral; referring physician
(A) Physicians' services
Except as provided in subparagraph (C), in the case of an item or service for which payment may be made under part B, the request by a physician for the item or service, including the request by a physician for a consultation with another physician (and any test or procedure ordered by, or to be performed by (or under the supervision of) that other physician), constitutes a "referral" by a "referring physician".
(B) Other items
Except as provided in subparagraph (C), the request or establishment of a plan of care by a physician which includes the provision of the designated health service constitutes a "referral" by a "referring physician".
(C) Clarification respecting certain services integral to a consultation by certain specialists
A request by a pathologist for clinical diagnostic laboratory tests and pathological examination services, a request by a radiologist for diagnostic radiology services, and a request by a radiation oncologist for radiation therapy, if such services are furnished by (or under the supervision of) such pathologist, radiologist, or radiation oncologist pursuant to a consultation requested by another physician does not constitute a "referral" by a "referring physician".
(6) Designated health services
The term "designated health services" means any of the following items or services:
(A) Clinical laboratory services.
(B) Physical therapy services.
(C) Occupational therapy services.
(D) Radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services.
(E) Radiation therapy services and supplies.
(F) Durable medical equipment and supplies.
(G) Parenteral and enteral nutrients, equipment, and supplies.
(H) Prosthetics, orthotics, and prosthetic devices and supplies.
(I) Home health services.
(J) Outpatient prescription drugs.
(K) Inpatient and outpatient hospital services.
(L) Outpatient speech-language pathology services.
(7) Specialty hospital
(A) In general
For purposes of this section, except as provided in subparagraph (B), the term "specialty hospital" means a subsection (d) hospital (as defined in
(i) Patients with a cardiac condition.
(ii) Patients with an orthopedic condition.
(iii) Patients receiving a surgical procedure.
(iv) Any other specialized category of services that the Secretary designates as inconsistent with the purpose of permitting physician ownership and investment interests in a hospital under this section.
(B) Exception
For purposes of this section, the term "specialty hospital" does not include any hospital—
(i) determined by the Secretary—
(I) to be in operation before November 18, 2003; or
(II) under development as of such date;
(ii) for which the number of physician investors at any time on or after such date is no greater than the number of such investors as of such date;
(iii) for which the type of categories described in subparagraph (A) at any time on or after such date is no different than the type of such categories as of such date;
(iv) for which any increase in the number of beds occurs only in the facilities on the main campus of the hospital and does not exceed 50 percent of the number of beds in the hospital as of November 18, 2003, or 5 beds, whichever is greater; and
(v) that meets such other requirements as the Secretary may specify.
(i) Requirements for hospitals to qualify for rural provider and hospital exception to ownership or investment prohibition
(1) Requirements described
For purposes of subsection (d)(3)(D), the requirements described in this paragraph for a hospital are as follows:
(A) Provider agreement
The hospital had—
(i) physician ownership or investment on December 31, 2010; and
(ii) a provider agreement under
(B) Limitation on expansion of facility capacity
Except as provided in paragraph (3), the number of operating rooms, procedure rooms, and beds for which the hospital is licensed at any time on or after March 23, 2010, is no greater than the number of operating rooms, procedure rooms, and beds for which the hospital is licensed as of such date.
(C) Preventing conflicts of interest
(i) The hospital submits to the Secretary an annual report containing a detailed description of—
(I) the identity of each physician owner or investor and any other owners or investors of the hospital; and
(II) the nature and extent of all ownership and investment interests in the hospital.
(ii) The hospital has procedures in place to require that any referring physician owner or investor discloses to the patient being referred, by a time that permits the patient to make a meaningful decision regarding the receipt of care, as determined by the Secretary—
(I) the ownership or investment interest, as applicable, of such referring physician in the hospital; and
(II) if applicable, any such ownership or investment interest of the treating physician.
(iii) The hospital does not condition any physician ownership or investment interests either directly or indirectly on the physician owner or investor making or influencing referrals to the hospital or otherwise generating business for the hospital.
(iv) The hospital discloses the fact that the hospital is partially owned or invested in by physicians—
(I) on any public website for the hospital; and
(II) in any public advertising for the hospital.
(D) Ensuring bona fide investment
(i) The percentage of the total value of the ownership or investment interests held in the hospital, or in an entity whose assets include the hospital, by physician owners or investors in the aggregate does not exceed such percentage as of March 23, 2010.
(ii) Any ownership or investment interests that the hospital offers to a physician owner or investor are not offered on more favorable terms than the terms offered to a person who is not a physician owner or investor.
(iii) The hospital (or any owner or investor in the hospital) does not directly or indirectly provide loans or financing for any investment in the hospital by a physician owner or investor.
(iv) The hospital (or any owner or investor in the hospital) does not directly or indirectly guarantee a loan, make a payment toward a loan, or otherwise subsidize a loan, for any individual physician owner or investor or group of physician owners or investors that is related to acquiring any ownership or investment interest in the hospital.
(v) Ownership or investment returns are distributed to each owner or investor in the hospital in an amount that is directly proportional to the ownership or investment interest of such owner or investor in the hospital.
(vi) Physician owners and investors do not receive, directly or indirectly, any guaranteed receipt of or right to purchase other business interests related to the hospital, including the purchase or lease of any property under the control of other owners or investors in the hospital or located near the premises of the hospital.
(vii) The hospital does not offer a physician owner or investor the opportunity to purchase or lease any property under the control of the hospital or any other owner or investor in the hospital on more favorable terms than the terms offered to an individual who is not a physician owner or investor.
(E) Patient safety
(i) Insofar as the hospital admits a patient and does not have any physician available on the premises to provide services during all hours in which the hospital is providing services to such patient, before admitting the patient—
(I) the hospital discloses such fact to a patient; and
(II) following such disclosure, the hospital receives from the patient a signed acknowledgment that the patient understands such fact.
(ii) The hospital has the capacity to—
(I) provide assessment and initial treatment for patients; and
(II) refer and transfer patients to hospitals with the capability to treat the needs of the patient involved.
(F) Limitation on application to certain converted facilities
The hospital was not converted from an ambulatory surgical center to a hospital on or after March 23, 2010.
(2) Publication of information reported
The Secretary shall publish, and update on an annual basis, the information submitted by hospitals under paragraph (1)(C)(i) on the public Internet website of the Centers for Medicare & Medicaid Services.
(3) Exception to prohibition on expansion of facility capacity
(A) Process
(i) Establishment
The Secretary shall establish and implement a process under which a hospital that is an applicable hospital (as defined in subparagraph (E)) or is a high Medicaid facility described in subparagraph (F) may apply for an exception from the requirement under paragraph (1)(B).
(ii) Opportunity for community input
The process under clause (i) shall provide individuals and entities in the community in which the applicable hospital applying for an exception is located with the opportunity to provide input with respect to the application.
(iii) Timing for implementation
The Secretary shall implement the process under clause (i) on February 1, 2012.
(iv) Regulations
Not later than January 1, 2012, the Secretary shall promulgate regulations to carry out the process under clause (i).
(B) Frequency
The process described in subparagraph (A) shall permit an applicable hospital to apply for an exception up to once every 2 years.
(C) Permitted increase
(i) In general
Subject to clause (ii) and subparagraph (D), an applicable hospital granted an exception under the process described in subparagraph (A) may increase the number of operating rooms, procedure rooms, and beds for which the applicable hospital is licensed above the baseline number of operating rooms, procedure rooms, and beds of the applicable hospital (or, if the applicable hospital has been granted a previous exception under this paragraph, above the number of operating rooms, procedure rooms, and beds for which the hospital is licensed after the application of the most recent increase under such an exception).
(ii) 100 percent increase limitation
The Secretary shall not permit an increase in the number of operating rooms, procedure rooms, and beds for which an applicable hospital is licensed under clause (i) to the extent such increase would result in the number of operating rooms, procedure rooms, and beds for which the applicable hospital is licensed exceeding 200 percent of the baseline number of operating rooms, procedure rooms, and beds of the applicable hospital.
(iii) Baseline number of operating rooms, procedure rooms, and beds
In this paragraph, the term "baseline number of operating rooms, procedure rooms, and beds" means the number of operating rooms, procedure rooms, and beds for which the applicable hospital is licensed as of March 23, 2010 (or, in the case of a hospital that did not have a provider agreement in effect as of such date but does have such an agreement in effect on December 31, 2010, the effective date of such provider agreement).
(D) Increase limited to facilities on the main campus of the hospital
Any increase in the number of operating rooms, procedure rooms, and beds for which an applicable hospital is licensed pursuant to this paragraph may only occur in facilities on the main campus of the applicable hospital.
(E) Applicable hospital
In this paragraph, the term "applicable hospital" means a hospital—
(i) that is located in a county in which the percentage increase in the population during the most recent 5-year period (as of the date of the application under subparagraph (A)) is at least 150 percent of the percentage increase in the population growth of the State in which the hospital is located during that period, as estimated by Bureau of the Census;
(ii) whose annual percent of total inpatient admissions that represent inpatient admissions under the program under subchapter XIX is equal to or greater than the average percent with respect to such admissions for all hospitals located in the county in which the hospital is located;
(iii) that does not discriminate against beneficiaries of Federal health care programs and does not permit physicians practicing at the hospital to discriminate against such beneficiaries;
(iv) that is located in a State in which the average bed capacity in the State is less than the national average bed capacity; and
(v) that has an average bed occupancy rate that is greater than the average bed occupancy rate in the State in which the hospital is located.
(F) High Medicaid facility described
A high Medicaid facility described in this subparagraph is a hospital that—
(i) is not the sole hospital in a county;
(ii) with respect to each of the 3 most recent years for which data are available, has an annual percent of total inpatient admissions that represent inpatient admissions under subchapter XIX that is estimated to be greater than such percent with respect to such admissions for any other hospital located in the county in which the hospital is located; and
(iii) meets the conditions described in subparagraph (E)(iii).
(G) Procedure rooms
In this subsection, the term "procedure rooms" includes rooms in which catheterizations, angiographies, angiograms, and endoscopies are performed, except such term shall not include emergency rooms or departments (exclusive of rooms in which catheterizations, angiographies, angiograms, and endoscopies are performed).
(H) Publication of final decisions
Not later than 60 days after receiving a complete application under this paragraph, the Secretary shall publish in the Federal Register the final decision with respect to such application.
(I) Limitation on review
There shall be no administrative or judicial review under
(4) Collection of ownership and investment information
For purposes of subparagraphs (A)(i) and (D)(i) of paragraph (1), the Secretary shall collect physician ownership and investment information for each hospital.
(5) Physician owner or investor defined
For purposes of this subsection, the term "physician owner or investor" means a physician (or an immediate family member of such physician) with a direct or an indirect ownership or investment interest in the hospital.
(6) Clarification
Nothing in this subsection shall be construed as preventing the Secretary from revoking a hospital's provider agreement if not in compliance with regulations implementing
(Aug. 14, 1935, ch. 531, title XVIII, §1877, as added
Editorial Notes
References in Text
Section 222(a) of the Social Security Amendments of 1972, referred to in subsec. (b)(3)(C), is section 222(a) of
The Internal Revenue Code, referred to in subsecs. (c)(2) and (h)(2), is classified generally to Title 26, Internal Revenue Code.
Prior Provisions
A prior section 1395nn, act Aug. 14, 1935, ch. 531, title XVIII, §1877, as added and amended Oct. 30, 1972,
Amendments
2022—Subsec. (e)(9).
2018—Subsec. (e)(1)(C).
Subsec. (e)(3)(C).
Subsec. (h)(1)(D).
Subsec. (h)(1)(E).
2010—Subsec. (b)(2).
Subsec. (d)(2)(C).
Subsec. (d)(3)(D).
Subsec. (i).
Subsec. (i)(1)(A)(i).
Subsec. (i)(3)(A)(i).
Subsec. (i)(3)(A)(iii).
Subsec. (i)(3)(A)(iv).
Subsec. (i)(3)(C)(iii).
Subsec. (i)(3)(F) to (I).
2008—Subsec. (h)(6)(L).
2003—Subsec. (b)(5).
Subsec. (d)(2).
Subsec. (d)(3)(B), (C).
Subsec. (h)(7).
1999—Subsec. (b)(3)(C).
Subsec. (b)(3)(D).
Subsec. (b)(3)(E).
1997—Subsec. (g)(6).
1994—Subsec. (f).
Subsec. (f)(2).
Subsec. (h)(6).
1993—Subsecs. (a) to (e).
Subsec. (f).
Subsec. (g)(1).
Subsec. (h).
1990—Subsec. (b)(4), (5).
Subsec. (f).
Subsec. (f)(2).
Subsec. (g)(5).
Subsec. (h)(6).
Subsec. (h)(7).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2010 Amendment
Effective Date of 2008 Amendment
Amendment by
Effective Date of 1999 Amendment
Effective Date of 1994 Amendment
Effective Date of 1993 Amendment
"(1)
"(A) made on or after January 1, 1992, in the case of clinical laboratory services, and
"(B) made after December 31, 1994, in the case of other designated health services.
"(2)
"(A) the second sentence of subsection (a)(2), and subsections (b)(2)(B) and (d)(2), of section 1877 of the Social Security Act [
"(B) section 1877(b)(4) of the Social Security Act [
"(C) the requirements of section 1877(c)(2) of the Social Security Act [
"(D) section 1877(e)(3) of the Social Security Act [
"(E) the requirements of clauses (iv) and (v) of section 1877(h)(4)(A), and of clause (i) of section 1877(h)(4)(B), of the Social Security Act [
"(F) section 1877(h)(4)(B) of the Social Security Act [
[
Effective Date of 1990 Amendment
Effective Date
"(1) Except as provided in paragraph (2), the amendments made by this section [enacting this section and amending
"(2) The reporting requirement of section 1877(f) of the Social Security Act [
Deadline for Certain Regulations
Enforcement
"(1)
"(2)
Medicare Self-Referral Disclosure Protocol
"(a)
"(1)
"(A) a specific person, official, or office to whom such disclosures shall be made; and
"(B) instruction on the implication of the SRDP on corporate integrity agreements and corporate compliance agreements.
"(2)
"(3)
"(b)
"(1) The nature and extent of the improper or illegal practice.
"(2) The timeliness of such self-disclosure.
"(3) The cooperation in providing additional information related to the disclosure.
"(4) Such other factors as the Secretary considers appropriate.
"(c)
"(1) the number of health care providers of services and suppliers making disclosures pursuant to the SRDP;
"(2) the amounts collected pursuant to the SRDP;
"(3) the types of violations reported under the SRDP; and
"(4) such other information as may be necessary to evaluate the impact of this section."
Application of Exception for Hospitals Under Development
"(1) whether architectural plans have been completed, funding has been received, zoning requirements have been met, and necessary approvals from appropriate State agencies have been received; and
"(2) any other evidence the Secretary determines would indicate whether a hospital is under development as of such date."
Studies
"(1)
"(A) any differences in the costs of health care services furnished to patients by physician-owned specialty hospitals and the costs of such services furnished by local full-service community hospitals within specific diagnosis-related groups;
"(B) the extent to which specialty hospitals, relative to local full-service community hospitals, treat patients in certain diagnosis-related groups within a category, such as cardiology, and an analysis of the selection;
"(C) the financial impact of physician-owned specialty hospitals on local full-service community hospitals;
"(D) how the current diagnosis-related group system should be updated to better reflect the cost of delivering care in a hospital setting; and
"(E) the proportions of payments received, by type of payer, between the specialty hospitals and local full-service community hospitals.
"(2) HHS
"(A) to determine the percentage of patients admitted to physician-owned specialty hospitals who are referred by physicians with an ownership interest;
"(B) to determine the referral patterns of physician owners, including the percentage of patients they referred to physician-owned specialty hospitals and the percentage of patients they referred to local full-service community hospitals for the same condition;
"(C) to compare the quality of care furnished in physician-owned specialty hospitals and in local full-service community hospitals for similar conditions and patient satisfaction with such care; and
"(D) to assess the differences in uncompensated care, as defined by the Secretary, between the specialty hospital and local full-service community hospitals, and the relative value of any tax exemption available to such hospitals.
"(3)
GAO Study of Ownership by Referring Physicians
Statistical Summary of Comparative Utilization
1 See References in Text note below.
2 So in original. No subpar. (B) has been enacted.
3 So in original. Probably should be "provide".
§1395oo. Provider Reimbursement Review Board
(a) Establishment
Any provider of services which has filed a required cost report within the time specified in regulations may obtain a hearing with respect to such cost report by a Provider Reimbursement Review Board (hereinafter referred to as the "Board") which shall be established by the Secretary in accordance with subsection (h) and (except as provided in subsection (g)(2)) any hospital which receives payments in amounts computed under subsection (b) or (d) of
(1) such provider—
(A)(i) is dissatisfied with a final determination of the organization serving as its fiscal intermediary pursuant to
(ii) is dissatisfied with a final determination of the Secretary as to the amount of the payment under subsection (b) or (d) of
(B) has not received such final determination from such intermediary on a timely basis after filing such report, where such report complied with the rules and regulations of the Secretary relating to such report, or
(C) has not received such final determination on a timely basis after filing a supplementary cost report, where such cost report did not so comply and such supplementary cost report did so comply,
(2) the amount in controversy is $10,000 or more, and
(3) such provider files a request for a hearing within 180 days after notice of the intermediary's final determination under paragraph (1)(A)(i), or with respect to appeals under paragraph (1)(A)(ii), 180 days after notice of the Secretary's final determination, or with respect to appeals pursuant to paragraph (1) (B) or (C), within 180 days after notice of such determination would have been received if such determination had been made on a timely basis.
(b) Appeals by groups
The provisions of subsection (a) shall apply to any group of providers of services if each provider of services in such group would, upon the filing of an appeal (but without regard to the $10,000 limitation), be entitled to such a hearing, but only if the matters in controversy involve a common question of fact or interpretation of law or regulations and the amount in controversy is, in the aggregate, $50,000 or more.
(c) Right to counsel; rules of evidence
At such hearing, the provider of services shall have the right to be represented by counsel, to introduce evidence, and to examine and cross-examine witnesses. Evidence may be received at any such hearing even though inadmissible under rules of evidence applicable to court procedure.
(d) Decisions of Board
A decision by the Board shall be based upon the record made at such hearing, which shall include the evidence considered by the intermediary and such other evidence as may be obtained or received by the Board, and shall be supported by substantial evidence when the record is viewed as a whole. The Board shall have the power to affirm, modify, or reverse a final determination of the fiscal intermediary with respect to a cost report and to make any other revisions on matters covered by such cost report (including revisions adverse to the provider of services) even though such matters were not considered by the intermediary in making such final determination.
(e) Rules and regulations
The Board shall have full power and authority to make rules and establish procedures, not inconsistent with the provisions of this subchapter or regulations of the Secretary, which are necessary or appropriate to carry out the provisions of this section. In the course of any hearing the Board may administer oaths and affirmations. The provisions of subsections (d) and (e) of
(f) Finality of decision; judicial review; determinations of Board authority; jurisdiction; venue; interest on amount in controversy
(1) A decision of the Board shall be final unless the Secretary, on his own motion, and within 60 days after the provider of services is notified of the Board's decision, reverses, affirms, or modifies the Board's decision. Providers shall have the right to obtain judicial review of any final decision of the Board, or of any reversal, affirmance, or modification by the Secretary, by a civil action commenced within 60 days of the date on which notice of any final decision by the Board or of any reversal, affirmance, or modification by the Secretary is received. Providers shall also have the right to obtain judicial review of any action of the fiscal intermediary which involves a question of law or regulations relevant to the matters in controversy whenever the Board determines (on its own motion or at the request of a provider of services as described in the following sentence) that it is without authority to decide the question, by a civil action commenced within sixty days of the date on which notification of such determination is received. If a provider of services may obtain a hearing under subsection (a) and has filed a request for such a hearing, such provider may file a request for a determination by the Board of its authority to decide the question of law or regulations relevant to the matters in controversy (accompanied by such documents and materials as the Board shall require for purposes of rendering such determination). The Board shall render such determination in writing within thirty days after the Board receives the request and such accompanying documents and materials, and the determination shall be considered a final decision and not subject to review by the Secretary. If the Board fails to render such determination within such period, the provider may bring a civil action (within sixty days of the end of such period) with respect to the matter in controversy contained in such request for a hearing. Such action shall be brought in the district court of the United States for the judicial district in which the provider is located (or, in an action brought jointly by several providers, the judicial district in which the greatest number of such providers are located) or in the District Court for the District of Columbia and shall be tried pursuant to the applicable provisions under
(2) Where a provider seeks judicial review pursuant to paragraph (1), the amount in controversy shall be subject to annual interest beginning on the first day of the first month beginning after the 180-day period as determined pursuant to subsection (a)(3) and equal to the rate of interest on obligations issued for purchase by the Federal Hospital Insurance Trust Fund for the month in which the civil action authorized under paragraph (1) is commenced, to be awarded by the reviewing court in favor of the prevailing party.
(3) No interest awarded pursuant to paragraph (2) shall be deemed income or cost for the purposes of determining reimbursement due providers under this chapter.
(g) Certain findings not reviewable
(1) The finding of a fiscal intermediary that no payment may be made under this subchapter for any expenses incurred for items or services furnished to an individual because such items or services are listed in
(2) The determinations and other decisions described in
(h) Composition and compensation
The Board shall be composed of five members appointed by the Secretary without regard to the provisions of title 5 governing appointments in the competitive services. Two of such members shall be representative of providers of services. All of the members of the Board shall be persons knowledgeable in the field of payment of providers of services, and at least one of them shall be a certified public accountant. Members of the Board shall be entitled to receive compensation at rates fixed by the Secretary, but not exceeding the rate specified (at the time the service involved is rendered by such members) for grade GS–18 in
(i) Technical and clerical assistance
The Board is authorized to engage such technical assistance as may be required to carry out its functions, and the Secretary shall, in addition, make available to the Board such secretarial, clerical, and other assistance as the Board may require to carry out its functions.
(j) "Provider of services" defined
In this section, the term "provider of services" includes a rural health clinic and a Federally qualified health center.
(Aug. 14, 1935, ch. 531, title XVIII, §1878, as added
Editorial Notes
Amendments
1993—Subsec. (f)(2).
1990—Subsec. (j).
1984—Subsec. (c).
Subsec. (e).
Subsec. (f)(1).
1983—Subsec. (a).
Subsec. (a)(1)(A).
Subsec. (a)(3).
Subsec. (f)(1).
Subsec. (g).
Subsec. (h).
1980—Subsec. (f)(1).
1974—Subsec. (f).
Statutory Notes and Related Subsidiaries
Effective Date of 1993 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by section 4161(a)(6) of
Amendment by section 4161(b)(4) of
Effective Date of 1984 Amendment
Amendment by section 2354(b)(39), (40) of
Effective Date of 1983 Amendment
Amendment by
Effective Date of 1974 Amendment
Effective Date
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Review of Provider Reimbursement Review Board Decisions
"(1) the amendments made by section 602(h)(2)(A) of that Act [amending this section] shall be effective with respect to any appeal or action brought on or after April 20, 1983; and
"(2) the amendments made by section 602(h)(2)(B) of that Act [amending this section] shall be effective with respect to any appeal or action brought on or after the date of the enactment of this Act [July 18, 1984]."
§1395pp. Limitation on liability where claims are disallowed
(a) Conditions prerequisite to payment for items and services notwithstanding determination of disallowance
Where—
(1) a determination is made that, by reason of section 1395y(a)(1) or (9) of this title or by reason of a coverage denial described in subsection (g), payment may not be made under part A or part B of this subchapter for any expenses incurred for items or services furnished an individual by a provider of services or by another person pursuant to an assignment under
(2) both such individual and such provider of services or such other person, as the case may be, did not know, and could not reasonably have been expected to know, that payment would not be made for such items or services under such part A or part B,
then to the extent permitted by this subchapter, payment shall, notwithstanding such determination, be made for such items or services (and for such period of time as the Secretary finds will carry out the objectives of this subchapter), as though section 1395y(a)(1) and
(b) Knowledge of person or provider that payment could not be made; indemnification of individual
In any case in which the provisions of paragraphs (1) and (2) of subsection (a) are met, except that such provider or such other person, as the case may be, knew, or could be expected to know, that payment for such services or items could not be made under such part A or part B, then the Secretary shall, upon proper application filed within such time as may be prescribed in regulations, indemnify the individual (referred to in such paragraphs) for any payments received from such individual by such provider or such other person, as the case may be, for such items or services. Any payments made by the Secretary as indemnification shall be deemed to have been made to such provider or such other person, as the case may be, and shall be treated as overpayments, recoverable from such provider or such other person, as the case may be, under applicable provisions of law. In each such case the Secretary shall notify such individual of the conditions under which indemnification is made and in the case of comparable situations arising thereafter with respect to such individual, he shall, by reason of such notice (or similar notices provided before the enactment of this section), be deemed to have knowledge that payment cannot be made for such items or services. No item or service for which an individual is indemnified under this subsection shall be taken into account in applying any limitation on the amount of items and services for which payment may be made to or on behalf of the individual under this subchapter.
(c) Knowledge of both provider and individual to whom items or services were furnished that payment could not be made
No payments shall be made under this subchapter in any cases in which the provisions of paragraph (1) of subsection (a) are met, but both the individual to whom the items or services were furnished and the provider of service or other person, as the case may be, who furnished the items or services knew, or could reasonably have been expected to know, that payment could not be made for items or services under part A or part B by reason of section 1395y(a)(1) or (a)(9) of this title or by reason of a coverage denial described in subsection (g).
(d) Exercise of rights
In any case arising under subsection (b) (but without regard to whether payments have been made by the individual to the provider or other person) or subsection (c), the provider or other person shall have the same rights that an individual has under
(e) Payment where beneficiary not at fault
Where payment for inpatient hospital services or extended care services may not be made under part A of this subchapter on behalf of an individual entitled to benefits under such part solely because of an unintentional, inadvertent, or erroneous action with respect to the transfer of such individual from a hospital or skilled nursing facility that meets the requirements of section 1395x(e) or (j) of this title by such a provider of services acting in good faith in accordance with the advice of a utilization review committee, quality improvement organization, or fiscal intermediary, or on the basis of a clearly erroneous administrative decision by a provider of services, the Secretary shall take such action with respect to the payment of such benefits as he determines may be necessary to correct the effects of such unintentional, inadvertent, or erroneous action.
(f) Presumption with respect to coverage denial; rebuttal; requirements; "fiscal intermediary" defined
(1) A home health agency which meets the applicable requirements of paragraphs (3) and (4) shall be presumed to meet the requirement of subsection (a)(2).
(2) The presumption of paragraph (1) with respect to specific services may be rebutted by actual or imputed knowledge of the facts described in subsection (a)(2), including any of the following:
(A) Notice by the fiscal intermediary of the fact that payment may not be made under this subchapter with respect to the services.
(B) It is clear and obvious that the provider should have known at the time the services were furnished that they were excluded from coverage.
(3) The requirements of this paragraph are as follows:
(A) The agency complies with requirements of the Secretary under this subchapter respecting timely submittal of bills for payment and medical documentation.
(B) The agency program has reasonable procedures to notify promptly each patient (and the patient's physician) where it is determined that a patient is being or will be furnished items or services which are excluded from coverage under this subchapter.
(4)(A) The requirement of this paragraph is that, on the basis of bills submitted by a home health agency during the previous quarter, the rate of denial of bills for the agency by reason of a coverage denial described in subsection (g) does not exceed 2.5 percent, computed based on visits for home health services billed.
(B) For purposes of determining the rate of denial of bills for a home health agency under subparagraph (A), a bill shall not be considered to be denied until the expiration of the 60-day period that begins on the date such bill is denied by the fiscal intermediary, or, with respect to such a denial for which the agency requests reconsideration, until the fiscal intermediary issues a decision denying payment for such bill.
(5) In this subsection, the term "fiscal intermediary" means, with respect to a home health agency, an agency or organization with an agreement under
(6) The Secretary shall monitor the proportion of denied bills submitted by home health agencies for which reconsideration is requested, and shall notify Congress if the proportion of denials reversed upon reconsideration increases significantly.
(g) Coverage denial defined
The coverage denial described in this subsection is—
(1) with respect to the provision of home health services to an individual, a failure to meet the requirements of
(A) is or was not confined to his home, or
(B) does or did not need skilled nursing care on an intermittent basis; and
(2) with respect to the provision of hospice care to an individual, a determination that the individual is not terminally ill.
(h) Supplier responsibility for items furnished on assignment basis
If a supplier of medical equipment and supplies (as defined in
(1) furnishes an item or service to a beneficiary for which no payment may be made by reason of
(2) furnishes an item or service to a beneficiary for which payment is denied in advance under
(3) furnishes an item or service to a beneficiary for which no payment may be made by reason of
any expenses incurred for items and services furnished to an individual by such a supplier on an assignment-related basis shall be the responsibility of such supplier. The individual shall have no financial responsibility for such expenses and the supplier shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected from the individual for such items or services. The provisions of
(i) Hospice program eligibility recertification
The provisions of this section shall apply with respect to a denial of a payment under this subchapter by reason of
(Aug. 14, 1935, ch. 531, title XVIII, §1879, as added
Editorial Notes
Amendments
2014—Subsec. (i).
2011—Subsec. (a).
Subsec. (e).
1997—Subsec. (g).
1994—Subsec. (h).
1989—Subsec. (f)(1).
Subsec. (f)(4).
Subsec. (f)(6).
1987—Subsec. (b).
1986—Subsec. (a).
Subsec. (c).
Subsec. (d).
Subsecs. (f), (g).
1982—Subsec. (a).
Subsec. (e).
1980—Subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date of 2011 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1989 Amendment
Effective Date of 1987 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by section 9341(a)(3) of
Effective Date of 1982 Amendment
Amendment by
Effective Date of 1980 Amendment
Effective Date
Provisions Relating to Advance Beneficiary Notices; Report on Prior Determination Process
"(1)
"(2)
"(3) GAO
"(4) GAO
"(A) information concerning—
"(i) the number and types of procedures for which a prior determination has been sought;
"(ii) determinations made under the process;
"(iii) the percentage of beneficiaries prevailing;
"(iv) in those cases in which the beneficiaries do not prevail, the reasons why such beneficiaries did not prevail; and
"(v) changes in receipt of services resulting from the application of such process;
"(B) an evaluation of whether the process was useful for physicians (and other suppliers) and beneficiaries, whether it was timely, and whether the amount of information required was burdensome to physicians and beneficiaries; and
"(C) recommendations for improvements or continuation of such process.
"(5)
Reports to Congress on Denials of Bills for Payment
§1395qq. Indian Health Service facilities
(a) Eligibility for payments; conditions and requirements
A hospital or skilled nursing facility of the Indian Health Service, whether operated by such Service or by an Indian tribe or tribal organization (as those terms are defined in
(b) Eligibility based on submission of plan to achieve compliance with conditions and requirements; twelve-month period
Notwithstanding subsection (a), a hospital or skilled nursing facility of the Indian Health Service which does not meet all of the conditions and requirements of this subchapter which are applicable generally to hospitals or skilled nursing facilities (as the case may be), but which submits to the Secretary within six months after September 30, 1976, an acceptable plan for achieving compliance with such conditions and requirements, shall be deemed to meet such conditions and requirements (and to be eligible for payments under this subchapter), without regard to the extent of its actual compliance with such conditions and requirements, during the first 12 months after the month in which such plan is submitted.
(c) Payments into special fund for improvements to achieve compliance with conditions and requirements; certification of compliance by Secretary
Notwithstanding any other provision of this subchapter, payments to which any hospital or skilled nursing facility of the Indian Health Service is entitled by reason of this section shall be placed in a special fund to be held by the Secretary and used by him (to such extent or in such amounts as are provided in appropriation Acts) exclusively for the purpose of making any improvements in the hospitals and skilled nursing facilities of such Service which may be necessary to achieve compliance with the applicable conditions and requirements of this subchapter. The preceding sentence shall cease to apply when the Secretary determines and certifies that substantially all of the hospitals and skilled nursing facilities of such Service in the United States are in compliance with such conditions and requirements.
(d) Report by Secretary; status of facilities in complying with conditions and requirements
The annual report of the Secretary which is required by
(e) Services provided by Indian Health Service, Indian tribe, or tribal organization
(1)(A) Notwithstanding
(B) Payment shall not be made for services under subparagraph (A) to the extent that payment is otherwise made for such services under this subchapter.
(2) The services described in this paragraph are the following:
(A) Services for which payment is made under
(B) Services furnished by a practitioner described in
(C) Services furnished by a physical therapist or occupational therapist as described in
(3) Subsection (c) shall not apply to payments made under this subsection.
(f) Cross reference
For provisions relating to the authority of certain Indian tribes, tribal organizations, and Alaska Native health organizations to elect to directly bill for, and receive payment for, health care services provided by a hospital or clinic of such tribes or organizations and for which payment may be made under this subchapter, see
(Aug. 14, 1935, ch. 531, title XVIII, §1880, as added
Editorial Notes
References in Text
Codification
Amendments
2010—Subsec. (e)(1)(A).
2003—Subsec. (e)(1)(A).
2000—Subsec. (e).
Subsec. (f).
1992—Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 2010 Amendment
Effective Date of 2000 Amendment
Amendment by section 1(a)(6) [title IV, §432(a)] of
Amendment by
Medicare Payments Not Considered in Determining Appropriations for Indian Health Care
Preference in Services for Indians With Medicare Coverage Not Authorized
1 See References in Text note below.
§1395rr. End stage renal disease program
(a) Type, duration, and scope of benefits
The benefits provided by parts A and B of this subchapter shall include benefits for individuals who have been determined to have end stage renal disease as provided in
(b) Payments with respect to services; dialysis; regulations; physicians' services; target reimbursement rates; home dialysis supplies and equipment; self-care home dialysis support services; self-care dialysis units; hepatitis B vaccine
(1) Payments under this subchapter with respect to services, in addition to services for which payment would otherwise be made under this subchapter, furnished to individuals who have been determined to have end stage renal disease shall include (A) payments on behalf of such individuals to providers of services and renal dialysis facilities which meet such requirements as the Secretary shall by regulation prescribe for institutional dialysis services and supplies (including self-dialysis services in a self-care dialysis unit maintained by the provider or facility), transplantation services, self-care home dialysis support services which are furnished by the provider or facility, and routine professional services performed by a physician during a maintenance dialysis episode if payments for his other professional services furnished to an individual who has end stage renal disease are made on the basis specified in paragraph (3)(A)(i) of this subsection, (B) payments to or on behalf of such individuals for home dialysis supplies and equipment, and (C) payments to a supplier of home dialysis supplies and equipment that is not a provider of services, a renal dialysis facility, or a physician for self-administered erythropoietin as described in section 1395x(s)(2)(P) 1 of this title if the Secretary finds that the patient receiving such drug from such a supplier can safely and effectively administer the drug (in accordance with the applicable methods and standards established by the Secretary pursuant to such section). The requirements prescribed by the Secretary under subparagraph (A) shall include requirements for a minimum utilization rate for transplantations. Beginning 180 days after February 9, 2018, an initial survey of a provider of services or a renal dialysis facility to determine if the conditions and requirements under this paragraph are met shall be initiated not later than 90 days after such date on which both the provider enrollment form (without regard to whether such form is submitted prior to or after such date of enactment) has been determined by the Secretary to be complete and the provider's enrollment status indicates approval is pending the results of such survey.
(2)(A) With respect to payments for dialysis services furnished by providers of services and renal dialysis facilities to individuals determined to have end stage renal disease for which payments may be made under part B of this subchapter, such payments (unless otherwise provided in this section) shall be equal to 80 percent of the amounts determined in accordance with subparagraph (B); and with respect to payments for services for which payments may be made under part A of this subchapter, the amounts of such payments (which amounts shall not exceed, in respect to costs in procuring organs attributable to payments made to an organ procurement agency or histocompatibility laboratory, the costs incurred by that agency or laboratory) shall be determined in accordance with
(B) The Secretary shall prescribe in regulations any methods and procedures to (i) determine the costs incurred by providers of services and renal dialysis facilities in furnishing covered services to individuals determined to have end stage renal disease, and (ii) determine, on a cost-related basis or other economical and equitable basis (including any basis authorized under
(C) Such regulations, in the case of services furnished by proprietary providers and facilities (other than hospital outpatient departments) may include, if the Secretary finds it feasible and appropriate, provision for recognition of a reasonable rate of return on equity capital, providing such rate of return does not exceed the rate of return stipulated in
(D) For purposes of
(3)(A) With respect to payments for physicians' services furnished to individuals determined to have end stage renal disease, the Secretary shall pay 80 percent of the amounts calculated for such services—
(i) on a reasonable charge basis (but may, in such case, make payment on the basis of the prevailing charges of other physicians for comparable services or, for services furnished on or after January 1, 1992, on the basis described in
(ii) subject to subparagraph (B), on a comprehensive monthly fee or other basis (which effectively encourages the efficient delivery of dialysis services and provides incentives for the increased use of home dialysis) for an aggregate of services provided over a period of time (as defined in regulations).
(B)(i) For purposes of subparagraph (A)(ii), subject to clauses (ii) and (iii), an individual determined to have end stage renal disease receiving home dialysis may choose to receive monthly end stage renal disease-related clinical assessments furnished on or after January 1, 2019, via telehealth.
(ii) Except as provided in clause (iii), clause (i) shall apply to an individual only if the individual receives a face-to-face clinical assessment, without the use of telehealth—
(I) in the case of the initial 3 months of home dialysis of such individual, at least monthly; and
(II) after such initial 3 months, at least once every 3 consecutive months.
(iii) The Secretary may waive the provisions of clause (ii) during the emergency period described in
(4)(A) Pursuant to agreements with approved providers of services and renal dialysis facilities, the Secretary may make payments to such providers and facilities for the cost of home dialysis supplies and equipment and self-care home dialysis support services furnished to patients whose self-care home dialysis is under the direct supervision of such provider or facility, on the basis of a target reimbursement rate (as defined in paragraph (6)) or on the basis of a method established under paragraph (7).
(B) The Secretary shall make payments to a supplier of home dialysis supplies and equipment furnished to a patient whose self-care home dialysis is not under the direct supervision of an approved provider of services or renal dialysis facility only in accordance with a written agreement under which—
(i) the patient certifies that the supplier is the sole provider of such supplies and equipment to the patient,
(ii) the supplier agrees to receive payment for the cost of such supplies and equipment only on an assignment-related basis, and
(iii) the supplier certifies that it has entered into a written agreement with an approved provider of services or renal dialysis facility under which such provider or facility agrees to furnish to such patient all self-care home dialysis support services and all other necessary dialysis services and supplies, including institutional dialysis services and supplies and emergency services.
(5) An agreement under paragraph (4) shall require, in accordance with regulations prescribed by the Secretary, that the provider or facility will—
(A) assume full responsibility for directly obtaining or arranging for the provision of—
(i) such medically necessary dialysis equipment as is prescribed by the attending physician;
(ii) dialysis equipment maintenance and repair services;
(iii) the purchase and delivery of all necessary medical supplies; and
(iv) where necessary, the services of trained home dialysis aides;
(B) perform all such administrative functions and maintain such information and records as the Secretary may require to verify the transactions and arrangements described in subparagraph (A);
(C) submit such cost reports, data, and information as the Secretary may require with respect to the costs incurred for equipment, supplies, and services furnished to the facility's home dialysis patient population; and
(D) provide for full access for the Secretary to all such records, data, and information as he may require to perform his functions under this section.
(6) The Secretary shall establish, for each calendar year, commencing with January 1, 1979, a target reimbursement rate for home dialysis which shall be adjusted for regional variations in the cost of providing home dialysis. In establishing such a rate, the Secretary shall include—
(A) the Secretary's estimate of the cost of providing medically necessary home dialysis supplies and equipment;
(B) an allowance, in an amount determined by the Secretary, to cover the cost of providing personnel to aid in home dialysis; and
(C) an allowance, in an amount determined by the Secretary, to cover administrative costs and to provide an incentive for the efficient delivery of home dialysis;
but in no event (except as may be provided in regulations under paragraph (7)) shall such target rate exceed 75 percent of the national average payment, adjusted for regional variations, for maintenance dialysis services furnished in approved providers and facilities during the preceding fiscal year. Any such target rate so established shall be utilized, without renegotiation of the rate, throughout the calendar year for which it is established. During the last quarter of each calendar year, the Secretary shall establish a home dialysis target reimbursement rate for the next calendar year based on the most recent data available to the Secretary at the time. In establishing any rate under this paragraph, the Secretary may utilize a competitive-bid procedure, a prenegotiated rate procedure, or any other procedure (including methods established under paragraph (7)) which the Secretary determines is appropriate and feasible in order to carry out this paragraph in an effective and efficient manner.
(7) Subject to paragraph (12), the Secretary shall provide by regulation for a method (or methods) for determining prospectively the amounts of payments to be made for dialysis services furnished by providers of services and renal dialysis facilities to individuals in a facility and to such individuals at home. Such method (or methods) shall provide for the prospective determination of a rate (or rates) for each mode of care based on a single composite weighted formula (which takes into account the mix of patients who receive dialysis services at a facility or at home and the relative costs of providing such services in such settings) for hospital-based facilities and such a single composite weighted formula for other renal dialysis facilities, or based on such other method or combination of methods which differentiate between hospital-based facilities and other renal dialysis facilities and which the Secretary determines, after detailed analysis, will more effectively encourage the more efficient delivery of dialysis services and will provide greater incentives for increased use of home dialysis than through the single composite weighted formulas. The amount of a payment made under any method other than a method based on a single composite weighted formula may not exceed the amount (or, in the case of continuous cycling peritoneal dialysis, 130 percent of the amount) of the median payment that would have been made under the formula for hospital-based facilities. Subject to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, the Secretary shall provide for such exceptions to such methods as may be warranted by unusual circumstances (including the special circumstances of sole facilities located in isolated, rural areas and of pediatric facilities). Each application for such an exception shall be deemed to be approved unless the Secretary disapproves it by not later than 60 working days after the date the application is filed. The Secretary may provide that such method will serve in lieu of any target reimbursement rate that would otherwise be established under paragraph (6). The Secretary shall reduce the amount of each composite rate payment under this paragraph for each treatment by 50 cents (subject to such adjustments as may be required to reflect modes of dialysis other than hemodialysis) and provide for payment of such amount to the organizations (designated under subsection (c)(1)(A)) for such organizations' necessary and proper administrative costs incurred in carrying out the responsibilities described in subsection (c)(2). The Secretary shall provide that amounts paid under the previous sentence shall be distributed to the organizations described in subsection (c)(1)(A) to ensure equitable treatment of all such network organizations. The Secretary in distributing any such payments to network organizations shall take into account—
(A) the geographic size of the network area;
(B) the number of providers of end stage renal disease services in the network area;
(C) the number of individuals who are entitled to end stage renal disease services in the network area; and
(D) the proportion of the aggregate administrative funds collected in the network area.
The Secretary shall increase the amount of each composite rate payment for dialysis services furnished during 2000 by 1.2 percent above such composite rate payment amounts for such services furnished on December 31, 1999, for such services furnished on or after January 1, 2001, and before January 1, 2005, by 2.4 percent above such composite rate payment amounts for such services furnished on December 31, 2000, and for such services furnished on or after January 1, 2005, by 1.6 percent above such composite rate payment amounts for such services furnished on December 31, 2004.
(8) For purposes of this subchapter, the term "home dialysis supplies and equipment" means medically necessary supplies and equipment (including supportive equipment) required by an individual suffering from end stage renal disease in connection with renal dialysis carried out in his home (as defined in regulations), including obtaining, installing, and maintaining such equipment.
(9) For purposes of this subchapter, the term "self-care home dialysis support services", to the extent permitted in regulation, means—
(A) periodic monitoring of the patient's home adaptation, including visits by qualified provider or facility personnel (as defined in regulations), so long as this is done in accordance with a plan prepared and periodically reviewed by a professional team (as defined in regulations) including the individual's physician;
(B) installation and maintenance of dialysis equipment;
(C) testing and appropriate treatment of the water; and
(D) such additional supportive services as the Secretary finds appropriate and desirable.
(10) For purposes of this subchapter, the term "self-care dialysis unit" means a renal dialysis facility or a distinct part of such facility or of a provider of services, which has been approved by the Secretary to make self-dialysis services, as defined by the Secretary in regulations, available to individuals who have been trained for self-dialysis. A self-care dialysis unit must, at a minimum, furnish the services, equipment and supplies needed for self-care dialysis, have patient-staff ratios which are appropriate to self-dialysis (allowing for such appropriate lesser degree of ongoing medical supervision and assistance of ancillary personnel than is required for full care maintenance dialysis), and meet such other requirements as the Secretary may prescribe with respect to the quality and cost-effectiveness of services.
(11)(A) Hepatitis B vaccine and its administration, when provided to a patient determined to have end stage renal disease, shall not be included as dialysis services for purposes of payment under any prospective payment amount or comprehensive fee established under this section. Payment for such vaccine and its administration shall be made separately in accordance with
(B) Erythropoietin, when provided to a patient determined to have end stage renal disease, shall not be included as a dialysis service for purposes of payment under any prospective payment amount or comprehensive fee established under this section, and subject to paragraphs (12) and (13) payment for such item shall be made separately—
(i) in the case of erythropoietin provided by a physician, in accordance with
(ii) in the case of erythropoietin provided by a provider of services, renal dialysis facility, or other supplier of home dialysis supplies and equipment—
(I) for erythropoietin provided during 1994, in an amount equal to $10 per thousand units (rounded to the nearest 100 units), and
(II) for erythropoietin provided during a subsequent year, in an amount determined to be appropriate by the Secretary, except that such amount may not exceed the amount determined under this clause for the previous year increased by the percentage increase (if any) in the implicit price deflator for gross national product (as published by the Department of Commerce) for the second quarter of the preceding year over the implicit price deflator for the second quarter of the second preceding year.
(C) The amount payable to a supplier of home dialysis supplies and equipment that is not a provider of services, a renal dialysis facility, or a physician for erythropoietin shall be determined in the same manner as the amount payable to a renal dialysis facility for such item.
(12)(A) Subject to paragraph (14), in lieu of payment under paragraph (7) beginning with services furnished on January 1, 2005, the Secretary shall establish a basic case-mix adjusted prospective payment system for dialysis services furnished by providers of services and renal dialysis facilities in a year to individuals in a facility and to such individuals at home. The case-mix under such system shall be for a limited number of patient characteristics. Under such system, the payment rate for dialysis services furnished on or after January 1, 2009, by providers of services shall be the same as the payment rate (computed without regard to this sentence) for such services furnished by renal dialysis facilities, and in applying the geographic index under subparagraph (D) to providers of services, the labor share shall be based on the labor share otherwise applied for renal dialysis facilities.
(B) The system described in subparagraph (A) shall include—
(i) the services comprising the composite rate established under paragraph (7); and
(ii) the difference between payment amounts under this subchapter for separately billed drugs and biologicals (including erythropoietin) and acquisition costs of such drugs and biologicals, as determined by the Inspector General reports to the Secretary as required by section 623(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—
(I) beginning with 2005, for such drugs and biologicals for which a billing code exists prior to January 1, 2004; and
(II) beginning with 2007, for such drugs and biologicals for which a billing code does not exist prior to January 1, 2004,
adjusted to 2005, or 2007, respectively, as determined to be appropriate by the Secretary.
(C)(i) In applying subparagraph (B)(ii) for 2005, such payment amounts under this subchapter shall be determined using the methodology specified in paragraph (13)(A)(i).
(ii) For 2006, the Secretary shall provide for an adjustment to the payments under clause (i) to reflect the difference between the payment amounts using the methodology under paragraph (13)(A)(i) and the payment amount determined using the methodology applied by the Secretary under paragraph (13)(A)(iii) of such paragraph, as estimated by the Secretary.
(D) The Secretary shall adjust the payment rates under such system by a geographic index as the Secretary determines to be appropriate. If the Secretary applies a geographic index under this paragraph that differs from the index applied under paragraph (7) the Secretary shall phase-in the application of the index under this paragraph over a multiyear period.
(E)(i) Such system shall be designed to result in the same aggregate amount of expenditures for such services, as estimated by the Secretary, as would have been made for 2005 if this paragraph did not apply.
(ii) The adjustment made under subparagraph (B)(ii)(II) shall be done in a manner to result in the same aggregate amount of expenditures after such adjustment as would otherwise have been made for such services for 2006 or 2007, respectively, as estimated by the Secretary, if this paragraph did not apply.
(F) Beginning with 2006, the Secretary shall annually increase the basic case-mix adjusted payment amounts established under this paragraph, by an amount determined by—
(i) applying the estimated growth in expenditures for drugs and biologicals (including erythropoietin) that are separately billable to the component of the basic case-mix adjusted system described in subparagraph (B)(ii); and
(ii) converting the amount determined in clause (i) to an increase applicable to the basic case-mix adjusted payment amounts established under subparagraph (B).
Except as provided in subparagraph (G), nothing in this paragraph or paragraph (14) shall be construed as providing for an update to the composite rate component of the basic case-mix adjusted system under subparagraph (B) or under the system under paragraph (14).
(G) The Secretary shall increase the amount of the composite rate component of the basic case-mix adjusted system under subparagraph (B) for dialysis services—
(i) furnished on or after January 1, 2006, and before April 1, 2007, by 1.6 percent above the amount of such composite rate component for such services furnished on December 31, 2005;
(ii) furnished on or after April 1, 2007, and before January 1, 2009, by 1.6 percent above the amount of such composite rate component for such services furnished on March 31, 2007;
(iii) furnished on or after January 1, 2009, and before January 1, 2010, by 1.0 percent above the amount of such composite rate component for such services furnished on December 31, 2008; and
(iv) furnished on or after January 1, 2010, by 1.0 percent above the amount of such composite rate component for such services furnished on December 31, 2009.
(H) There shall be no administrative or judicial review under
(13)(A) Subject to paragraph (14), the payment amounts under this subchapter for separately billed drugs and biologicals furnished in a year, beginning with 2004, are as follows:
(i) For such drugs and biologicals (other than erythropoietin) furnished in 2004, the amount determined under
(ii) For such drugs and biologicals (including erythropoietin) furnished in 2005, the acquisition cost of the drug or biological, as determined by the Inspector General reports to the Secretary as required by section 623(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Insofar as the Inspector General has not determined the acquisition cost with respect to a drug or biological, the Secretary shall determine the payment amount for such drug or biological.
(iii) For such drugs and biologicals (including erythropoietin) furnished in 2006 and subsequent years, such acquisition cost or the amount determined under
(B) Drugs and biologicals (including erythropoietin) which were separately billed under this subsection on the day before December 8, 2003, shall continue to be separately billed on and after such date, subject to paragraph (14).
(14)(A)(i) Subject to subparagraph (E), for services furnished on or after January 1, 2011, the Secretary shall implement a payment system under which a single payment is made under this subchapter to a provider of services or a renal dialysis facility for renal dialysis services (as defined in subparagraph (B)) in lieu of any other payment (including a payment adjustment under paragraph (12)(B)(ii)) and for such services and items furnished pursuant to paragraph (4).
(ii) In implementing the system under this paragraph the Secretary shall ensure that the estimated total amount of payments under this subchapter for 2011 for renal dialysis services shall equal 98 percent of the estimated total amount of payments for renal dialysis services, including payments under paragraph (12)(B)(ii), that would have been made under this subchapter with respect to services furnished in 2011 if such system had not been implemented. In making the estimation under subclause (I), the Secretary shall use per patient utilization data from 2007, 2008, or 2009, whichever has the lowest per patient utilization.
(B) For purposes of this paragraph, the term "renal dialysis services" includes—
(i) items and services included in the composite rate for renal dialysis services as of December 31, 2010;
(ii) erythropoiesis stimulating agents and any oral form of such agents that are furnished to individuals for the treatment of end stage renal disease;
(iii) other drugs and biologicals that are furnished to individuals for the treatment of end stage renal disease and for which payment was (before the application of this paragraph) made separately under this subchapter, and any oral equivalent form of such drug or biological; and
(iv) diagnostic laboratory tests and other items and services not described in clause (i) that are furnished to individuals for the treatment of end stage renal disease.
Such term does not include vaccines.
(C) The system under this paragraph may provide for payment on the basis of services furnished during a week or month or such other appropriate unit of payment as the Secretary specifies.
(D) Such system—
(i) shall include a payment adjustment based on case mix that may take into account patient weight, body mass index, comorbidities, length of time on dialysis, age, race, ethnicity, and other appropriate factors;
(ii) shall include a payment adjustment for high cost outliers due to unusual variations in the type or amount of medically necessary care, including variations in the amount of erythropoiesis stimulating agents necessary for anemia management;
(iii) shall include a payment adjustment that reflects the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services, and for payment for renal dialysis services furnished on or after January 1, 2011, and before January 1, 2014, such payment adjustment shall not be less than 10 percent; and
(iv) may include such other payment adjustments as the Secretary determines appropriate, such as a payment adjustment—
(I) for pediatric providers of services and renal dialysis facilities;
(II) by a geographic index, such as the index referred to in paragraph (12)(D), as the Secretary determines to be appropriate; and
(III) for providers of services or renal dialysis facilities located in rural areas.
The Secretary shall take into consideration the unique treatment needs of children and young adults in establishing such system.
(E)(i) The Secretary shall provide for a four-year phase-in (in equal increments) of the payment amount under the payment system under this paragraph, with such payment amount being fully implemented for renal dialysis services furnished on or after January 1, 2014.
(ii) A provider of services or renal dialysis facility may make a one-time election to be excluded from the phase-in under clause (i) and be paid entirely based on the payment amount under the payment system under this paragraph. Such an election shall be made prior to January 1, 2011, in a form and manner specified by the Secretary, and is final and may not be rescinded.
(iii) The Secretary shall make an adjustment to the payments under this paragraph for years during which the phase-in under clause (i) is applicable so that the estimated total amount of payments under this paragraph, including payments under this subparagraph, shall equal the estimated total amount of payments that would otherwise occur under this paragraph without such phase-in.
(F)(i)(I) Subject to subclauses (II) and (III) and clause (ii), beginning in 2012, the Secretary shall annually increase payment amounts established under this paragraph by an ESRD market basket percentage increase factor for a bundled payment system for renal dialysis services that reflects changes over time in the prices of an appropriate mix of goods and services included in renal dialysis services. In order to accomplish the purposes of subparagraph (I) with respect to 2016, 2017, and 2018, after determining the increase factor described in the preceding sentence for each of 2016, 2017, and 2018, the Secretary shall reduce such increase factor by 1.25 percentage points for each of 2016 and 2017 and by 1 percentage point for 2018.
(II) Subject to subclause (III), for 2012 and each subsequent year, after determining the increase factor described in subclause (I), the Secretary shall reduce such increase factor by the productivity adjustment described in
(III) Notwithstanding subclauses (I) and (II), in order to accomplish the purposes of subparagraph (I) with respect to 2015, the increase factor described in subclause (I) for 2015 shall be 0.0 percent pursuant to the regulation issued by the Secretary on December 2, 2013, entitled "Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Final Rule" (78 Fed. Reg. 72156).
(ii) For years during which a phase-in of the payment system pursuant to subparagraph (E) is applicable, the following rules shall apply to the portion of the payment under the system that is based on the payment of the composite rate that would otherwise apply if the system under this paragraph had not been enacted:
(I) The update under clause (i) shall not apply.
(II) Subject to clause (i)(II), the Secretary shall annually increase such composite rate by the ESRD market basket percentage increase factor described in clause (i)(I).
(G) There shall be no administrative or judicial review under
(H) Erythropoiesis stimulating agents and other drugs and biologicals shall be treated as prescribed and dispensed or administered and available only under part B if they are—
(i) furnished to an individual for the treatment of end stage renal disease; and
(ii) included in subparagraph (B) for purposes of payment under this paragraph.
(I) For services furnished on or after January 1, 2014, and before January 1, 2015, the Secretary shall, by comparing per patient utilization data from 2007 with such data from 2012, make reductions to the single payment that would otherwise apply under this paragraph for renal dialysis services to reflect the Secretary's estimate of the change in the utilization of drugs and biologicals described in clauses (ii), (iii), and (iv) of subparagraph (B) (other than oral-only ESRD-related drugs, as such term is used in the final rule promulgated by the Secretary in the Federal Register on August 12, 2010 (75 Fed. Reg. 49030)). In making reductions under the preceding sentence, the Secretary shall take into account the most recently available data on average sales prices and changes in prices for drugs and biological 2 reflected in the ESRD market basket percentage increase factor under subparagraph (F).
(c) Renal disease network areas; coordinating councils, executive committees, and medical review boards; national end stage renal disease medical information system; functions of network organizations
(1)(A)(i) For the purpose of assuring effective and efficient administration of the benefits provided under this section, the Secretary shall, in accordance with such criteria as he finds necessary to assure the performance of the responsibilities and functions specified in paragraph (2)—
(I) establish at least 17 end stage renal disease network areas, and
(II) for each such area, designate a network administrative organization which, in accordance with regulations of the Secretary, shall establish (aa) a network council of renal dialysis and transplant facilities located in the area and (bb) a medical review board, which has a membership including at least one patient representative and physicians, nurses, and social workers engaged in treatment relating to end stage renal disease.
The Secretary shall publish in the Federal Register a description of the geographic area that he determines, after consultation with appropriate professional and patient organizations, constitutes each network area and the criteria on the basis of which such determination is made.
(ii)(I) In order to determine whether the Secretary should enter into, continue, or terminate an agreement with a network administrative organization designated for an area established under clause (i), the Secretary shall develop and publish in the Federal Register standards, criteria, and procedures to evaluate an applicant organization's capabilities to perform (and, in the case of an organization with which such an agreement is in effect, actual performance of) the responsibilities described in paragraph (2). The Secretary shall evaluate each applicant based on quality and scope of services and may not accord more than 20 percent of the weight of the evaluation to the element of price.
(II) An agreement with a network administrative organization may be terminated by the Secretary only if he finds, after applying such standards and criteria, that the organization has failed to perform its prescribed responsibilities effectively and efficiently. If such an agreement is to be terminated, the Secretary shall select a successor to the agreement on the basis of competitive bidding and in a manner that provides an orderly transition.
(B) At least one patient representative shall serve as a member of each network council and each medical review board.
(C) The Secretary shall, in regulations, prescribe requirements with respect to membership in network organizations by individuals (and the relatives of such individuals) (i) who have an ownership or control interest in a facility or provider which furnishes services referred to in
(2) The network organizations of each network shall be responsible, in addition to such other duties and functions as may be prescribed by the Secretary, for—
(A) encouraging, consistent with sound medical practice, the use of those treatment settings most compatible with the successful rehabilitation of the patient and the participation of patients, providers of services, and renal disease facilities in vocational rehabilitation programs;
(B) developing criteria and standards relating to the quality and appropriateness of patient care and with respect to working with patients, facilities, and providers in encouraging participation in vocational rehabilitation programs; and network goals with respect to the placement of patients in self-care settings and undergoing or preparing for transplantation;
(C) evaluating the procedure by which facilities and providers in the network assess the appropriateness of patients for proposed treatment modalities;
(D) implementing a procedure for evaluating and resolving patient grievances;
(E) conducting on-site reviews of facilities and providers as necessary (as determined by a medical review board or the Secretary), utilizing standards of care established by the network organization to assure proper medical care;
(F) collecting, validating, and analyzing such data as are necessary to prepare the reports required by subparagraph (H) and to assure the maintenance of the registry established under paragraph (7);
(G) identifying facilities and providers that are not cooperating toward meeting network goals and assisting such facilities and providers in developing appropriate plans for correction and reporting to the Secretary on facilities and providers that are not providing appropriate medical care; and
(H) submitting an annual report to the Secretary on July 1 of each year which shall include a full statement of the network's goals, data on the network's performance in meeting its goals (including data on the comparative performance of facilities and providers with respect to the identification and placement of suitable candidates in self-care settings and transplantation and encouraging participation in vocational rehabilitation programs), identification of those facilities that have consistently failed to cooperate with network goals, and recommendations with respect to the need for additional or alternative services or facilities in the network in order to meet the network goals, including self-dialysis training, transplantation, and organ procurement facilities.
(3) Where the Secretary determines, on the basis of the data contained in the network's annual report and such other relevant data as may be available to him, that a facility or provider has consistently failed to cooperate with network plans and goals or to follow the recommendations of the medical review board, he may terminate or withhold certification of such facility or provider (for purposes of payment for services furnished to individuals with end stage renal disease) until he determines that such provider or facility is making reasonable and appropriate efforts to cooperate with the network's plans and goals. If the Secretary determines that the facility's or provider's failure to cooperate with network plans and goals does not jeopardize patient health or safety or justify termination of certification, he may instead, after reasonable notice to the provider or facility and to the public, impose such other sanctions as he determines to be appropriate, which sanctions may include denial of reimbursement with respect to some or all patients admitted to the facility after the date of notice to the facility or provider, and graduated reduction in reimbursement for all patients.
(4) The Secretary shall, in determining whether to certify additional facilities or expansion of existing facilities within a network, take into account the network's goals and performance as reflected in the network's annual report.
(5) The Secretary, after consultation with appropriate professional and planning organizations, shall provide such guidelines with respect to the planning and delivery of renal disease services as are necessary to assist network organizations in their development of their respective networks' goals to promote the optimum use of self-dialysis and transplantation by suitable candidates for such modalities.
(6) It is the intent of the Congress that the maximum practical number of patients who are medically, socially, and psychologically suitable candidates for home dialysis or transplantation should be so treated and that the maximum practical number of patients who are suitable candidates for vocational rehabilitation services be given access to such services and encouraged to return to gainful employment. The Secretary shall consult with appropriate professional and network organizations and consider available evidence relating to developments in research, treatment methods, and technology for home dialysis and transplantation.
(7) The Secretary shall establish a national end stage renal disease registry the purpose of which shall be to assemble and analyze the data reported by network organizations, transplant centers, and other sources on all end stage renal disease patients in a manner that will permit—
(A) the preparation of the annual report to the Congress required under subsection (g); 1
(B) an identification of the economic impact, cost-effectiveness, and medical efficacy of alternative modalities of treatment;
(C) an evaluation with respect to the most appropriate allocation of resources for the treatment and research into the cause of end stage renal disease;
(D) the determination of patient mortality and morbidity rates, and trends in such rates, and other indices of quality of care; and
(E) such other analyses relating to the treatment and management of end stage renal disease as will assist the Congress in evaluating the end stage renal disease program under this section.
The Secretary shall provide for such coordination of data collection activities, and such consolidation of existing end stage renal disease data systems, as is necessary to achieve the purpose of such registry, shall determine the appropriate location of the registry, and shall provide for the appointment of a professional advisory group to assist the Secretary in the formulation of policies and procedures relevant to the management of such registry.
(8) The provisions of
(d) Donors of kidney for transplant surgery
Notwithstanding any provision to the contrary in
(e) Reimbursement of providers, facilities, and nonprofit entities for costs of artificial kidney and automated dialysis peritoneal machines for home dialysis
(1) Notwithstanding any other provision of this subchapter, the Secretary may, pursuant to agreements with approved providers of services, renal dialysis facilities, and nonprofit entities which the Secretary finds can furnish equipment economically and efficiently, reimburse such providers, facilities, and nonprofit entities (without regard to the deductible and coinsurance provisions of this subchapter) for the reasonable cost of the purchase, installation, maintenance and reconditioning for subsequent use of artificial kidney and automated dialysis peritoneal machines (including supportive equipment) which are to be used exclusively by entitled individuals dialyzing at home.
(2) An agreement under this subsection shall require that the provider, facility, or other entity will—
(A) make the equipment available for use only by entitled individuals dialyzing at home;
(B) recondition the equipment, as needed, for reuse by such individuals throughout the useful life of the equipment, including modification of the equipment consistent with advances in research and technology;
(C) provide for full access for the Secretary to all records and information relating to the purchase, maintenance, and use of the equipment; and
(D) submit such reports, data, and information as the Secretary may require with respect to the cost, management, and use of the equipment.
(3) For purposes of this section, the term "supportive equipment" includes blood pumps, heparin pumps, bubble detectors, other alarm systems, and such other items as the Secretary may determine are medically necessary.
(f) Experiments, studies, and pilot projects
(1) The Secretary shall initiate and carry out, at selected locations in the United States, pilot projects under which financial assistance in the purchase of new or used durable medical equipment for renal dialysis is provided to individuals suffering from end stage renal disease at the time home dialysis is begun, with provision for a trial period to assure successful adaptation to home dialysis before the actual purchase of such equipment.
(2) The Secretary shall conduct experiments to evaluate methods for reducing the costs of the end stage renal disease program. Such experiments shall include (without being limited to) reimbursement for nurses and dialysis technicians to assist with home dialysis, and reimbursement to family members assisting with home dialysis.
(3) The Secretary shall conduct experiments to evaluate methods of dietary control for reducing the costs of the end stage renal disease program, including (without being limited to) the use of protein-controlled products to delay the necessity for, or reduce the frequency of, dialysis in the treatment of end stage renal disease.
(4) The Secretary shall conduct a comprehensive study of methods for increasing public participation in kidney donation and other organ donation programs.
(5) The Secretary shall conduct a full and complete study of the reimbursement of physicians for services furnished to patients with end stage renal disease under this subchapter, giving particular attention to the range of payments to physicians for such services, the average amounts of such payments, and the number of hours devoted to furnishing such services to patients at home, in renal disease facilities, in hospitals, and elsewhere.
(6) The Secretary shall conduct a study of the number of patients with end stage renal disease who are not eligible for benefits with respect to such disease under this subchapter (by reason of this section or otherwise), and of the economic impact of such noneligibility of such individuals. Such study shall include consideration of mechanisms whereby governmental and other health plans might be instituted or modified to permit the purchase of actuarially sound coverage for the costs of end stage renal disease.
(7)(A) The Secretary shall establish protocols on standards and conditions for the reuse of dialyzer filters for those facilities and providers which voluntarily elect to reuse such filters.
(B) With respect to dialysis services furnished on or after January 1, 1988 (or July 1, 1988, with respect to protocols that relate to the reuse of bloodlines), no dialysis facility may reuse dialysis supplies (other than dialyzer filters) unless the Secretary has established a protocol with respect to the reuse of such supplies and the facility follows the protocol so established.
(C) The Secretary shall incorporate protocols established under this paragraph, and the requirement of subparagraph (B), into the requirements for facilities prescribed under subsection (b)(1)(A) and failure to follow such a protocol or requirement subjects such a facility to denial of participation in the program established under this section and to denial of payment for dialysis treatment not furnished in compliance with such a protocol or in violation of such requirement.
(8) The Secretary shall submit to the Congress no later than October 1, 1979, a full report on the experiments conducted under paragraphs (1), (2), (3), and (7), and the studies under paragraphs (4), (5), (6), and (7). Such report shall include any recommendations for legislative changes which the Secretary finds necessary or desirable as a result of such experiments and studies.
(g) Conditional approval of dialysis facilities; restriction-of-payments notice to public and facility; notice and hearing; judicial review
(1) In any case where the Secretary—
(A) finds that a renal dialysis facility is not in substantial compliance with requirements for such facilities prescribed under subsection (b)(1)(A),
(B) finds that the facility's deficiencies do not immediately jeopardize the health and safety of patients, and
(C) has given the facility a reasonable opportunity to correct its deficiencies,
the Secretary may, in lieu of terminating approval of the facility, determine that payment under this subchapter shall be made to the facility only for services furnished to individuals who were patients of the facility before the effective date of the notice.
(2) The Secretary's decision to restrict payments under this subsection shall be made effective only after such notice to the public and to the facility as may be prescribed in regulations, and shall remain in effect until (A) the Secretary finds that the facility is in substantial compliance with the requirements under subsection (b)(1)(A), or (B) the Secretary terminates the agreement under this subchapter with the facility.
(3) A facility dissatisfied with a determination by the Secretary under paragraph (1) shall be entitled to a hearing thereon by the Secretary (after reasonable notice) to the same extent as is provided in
(h) Quality incentives in the end-stage renal disease program
(1) Quality incentives
(A) In general
With respect to renal dialysis services (as defined in subsection (b)(14)(B)) furnished on or after January 1, 2012, in the case of a provider of services or a renal dialysis facility that does not meet the requirement described in subparagraph (B) with respect to the year, payments otherwise made to such provider or facility under the system under subsection (b)(14) for such services shall be reduced by up to 2.0 percent, as determined appropriate by the Secretary.
(B) Requirement
The requirement described in this subparagraph is that the provider or facility meets (or exceeds) the total performance score under paragraph (3) with respect to performance standards established by the Secretary with respect to measures specified in paragraph (2).
(C) No effect in subsequent years
The reduction under subparagraph (A) shall apply only with respect to the year involved, and the Secretary shall not take into account such reduction in computing the single payment amount under the system under paragraph (14) in a subsequent year.
(2) Measures
(A) In general
The measures specified under this paragraph with respect to the year involved shall include—
(i) measures on anemia management that reflect the labeling approved by the Food and Drug Administration for such management and measures on dialysis adequacy;
(ii) to the extent feasible, such measure (or measures) of patient satisfaction as the Secretary shall specify;
(iii) for 2016 and subsequent years, measures described in subparagraph (E)(i); and
(iv) such other measures as the Secretary specifies, including, to the extent feasible, measures on—
(I) iron management;
(II) bone mineral metabolism; and
(III) vascular access, including for maximizing the placement of arterial venous fistula.
(B) Use of endorsed measures
(i) In general
Subject to clause (ii), any measure specified by the Secretary under subparagraph (A)(iv) must have been endorsed by the entity with a contract under
(ii) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(C) Updating measures
The Secretary shall establish a process for updating the measures specified under subparagraph (A) in consultation with interested parties.
(D) Consideration
In specifying measures under subparagraph (A), the Secretary shall consider the availability of measures that address the unique treatment needs of children and young adults with kidney failure.
(E) Measures specific to the conditions treated with oral-only drugs
(i) In general
The measures described in this subparagraph are measures specified by the Secretary that are specific to the conditions treated with oral-only drugs. To the extent feasible, such measures shall be outcomes-based measures.
(ii) Consultation
In specifying the measures under clause (i), the Secretary shall consult with interested stakeholders.
(iii) Use of endorsed measures
(I) In general
Subject to subclause (I), any measures specified under clause (i) must have been endorsed by the entity with a contract under
(II) Exception
If the entity with a contract under
(3) Performance scores
(A) Total performance score
(i) In general
Subject to clause (ii), the Secretary shall develop a methodology for assessing the total performance of each provider of services and renal dialysis facility based on performance standards with respect to the measures selected under paragraph (2) for a performance period established under paragraph (4)(D) (in this subsection referred to as the "total performance score").
(ii) Application
For providers of services and renal dialysis facilities that do not meet (or exceed) the total performance score established by the Secretary, the Secretary shall ensure that the application of the methodology developed under clause (i) results in an appropriate distribution of reductions in payment under paragraph (1) among providers and facilities achieving different levels of total performance scores, with providers and facilities achieving the lowest total performance scores receiving the largest reduction in payment under paragraph (1)(A).
(iii) Weighting of measures
In calculating the total performance score, the Secretary shall weight the scores with respect to individual measures calculated under subparagraph (B) to reflect priorities for quality improvement, such as weighting scores to ensure that providers of services and renal dialysis facilities have strong incentives to meet or exceed anemia management and dialysis adequacy performance standards, as determined appropriate by the Secretary.
(B) Performance score with respect to individual measures
The Secretary shall also calculate separate performance scores for each measure, including for dialysis adequacy and anemia management.
(4) Performance standards
(A) Establishment
Subject to subparagraph (E), the Secretary shall establish performance standards with respect to measures selected under paragraph (2) for a performance period with respect to a year (as established under subparagraph (D)).
(B) Achievement and improvement
The performance standards established under subparagraph (A) shall include levels of achievement and improvement, as determined appropriate by the Secretary.
(C) Timing
The Secretary shall establish the performance standards under subparagraph (A) prior to the beginning of the performance period for the year involved.
(D) Performance period
The Secretary shall establish the performance period with respect to a year. Such performance period shall occur prior to the beginning of such year.
(E) Special rule
The Secretary shall initially use as the performance standard for the measures specified under paragraph (2)(A)(i) for a provider of services or a renal dialysis facility the lesser of—
(i) the performance of such provider or facility for such measures in the year selected by the Secretary under the second sentence of subsection (b)(14)(A)(ii); or
(ii) a performance standard based on the national performance rates for such measures in a period determined by the Secretary.
(5) Limitation on review
There shall be no administrative or judicial review under
(A) The determination of the amount of the payment reduction under paragraph (1).
(B) The establishment of the performance standards and the performance period under paragraph (4).
(C) The specification of measures under paragraph (2).
(D) The methodology developed under paragraph (3) that is used to calculate total performance scores and performance scores for individual measures.
(6) Public reporting
(A) In general
The Secretary shall establish procedures for making information regarding performance under this subsection available to the public, including—
(i) the total performance score achieved by the provider of services or renal dialysis facility under paragraph (3) and appropriate comparisons of providers of services and renal dialysis facilities to the national average with respect to such scores; and
(ii) the performance score achieved by the provider or facility with respect to individual measures.
(B) Opportunity to review
The procedures established under subparagraph (A) shall ensure that a provider of services and a renal dialysis facility has the opportunity to review the information that is to be made public with respect to the provider or facility prior to such data being made public.
(C) Certificates
(i) In general
The Secretary shall provide certificates to providers of services and renal dialysis facilities who furnish renal dialysis services under this section to display in patient areas. The certificate shall indicate the total performance score achieved by the provider or facility under paragraph (3).
(ii) Display
Each facility or provider receiving a certificate under clause (i) shall prominently display the certificate at the provider or facility.
(D) Web-based list
The Secretary shall establish a list of providers of services and renal dialysis facilities who furnish renal dialysis services under this section that indicates the total performance score and the performance score for individual measures achieved by the provider and facility under paragraph (3). Such information shall be posted on the Internet website of the Centers for Medicare & Medicaid Services in an easily understandable format.
(Aug. 14, 1935, ch. 531, title XVIII, §1881, as added
Editorial Notes
References in Text
Section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, referred to in subsec. (b)(7), is section 1(a)(6) [title IV, §422(a)(2)] of
Section 623(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (b)(12)(B)(ii), (13)(A)(ii), is section 623(c) of
Subsection (g), referred to in subsec. (c)(7)(A), was repealed, and subsec. (h) was redesignated (g), by
Amendments
2020—Subsec. (b)(3)(B)(i).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(B)(iii).
2018—Subsec. (b)(1).
Subsec. (b)(3).
2014—Subsec. (b)(14)(F)(i)(I).
Subsec. (b)(14)(F)(i)(II).
Subsec. (b)(14)(F)(i)(III).
Subsec. (b)(14)(I).
Subsec. (h)(2)(A)(iii), (iv).
Subsec. (h)(2)(B)(i).
Subsec. (h)(2)(E).
2013—Subsec. (b)(14)(I).
2010—Subsec. (b)(14)(F)(i).
Subsec. (b)(14)(F)(ii)(II).
2008—Subsec. (b)(12)(A).
Subsec. (b)(12)(F).
Subsec. (b)(12)(G).
Subsec. (b)(13)(A).
Subsec. (b)(13)(B).
Subsec. (b)(14).
Subsec. (h).
2006—Subsec. (b)(12)(F).
Subsec. (b)(12)(G).
Subsec. (b)(12)(H).
2003—Subsec. (b)(7).
Subsec. (b)(11)(B).
Subsec. (b)(12), (13).
2000—Subsec. (b)(7).
1999—Subsec. (b)(7).
1994—Subsec. (g)(3).
1993—Subsec. (b)(1)(C).
Subsec. (b)(11)(B)(ii)(I).
1990—Subsec. (b)(1).
Subsec. (b)(11).
1989—Subsec. (b)(3)(A).
Subsec. (b)(4).
Subsec. (b)(7).
Subsec. (c)(8).
1987—Subsec. (b)(1).
Subsec. (b)(2)(C).
Subsec. (c)(2)(F).
Subsec. (c)(6).
Subsec. (f)(7)(B).
Subsec. (g).
Subsec. (h).
1986—Subsec. (b)(7).
Subsec. (c)(1)(A).
Subsec. (c)(1)(B).
Subsec. (c)(2)(A).
Subsec. (c)(2)(B).
Subsec. (c)(2)(D) to (F).
Subsec. (c)(2)(G).
Subsec. (c)(2)(H).
Subsec. (c)(3).
Subsec. (c)(6).
Subsec. (c)(7).
Subsec. (f)(7).
1984—Subsecs. (a), (b)(1), (2)(A), (B), (3), (8).
Subsec. (b)(11).
Subsec. (c)(3).
1983—Subsec. (b)(2)(A).
1981—Subsec. (b)(2)(B).
Subsec. (b)(3)(B).
Subsec. (b)(4).
Subsec. (b)(6).
Subsec. (b)(7) to (10).
1980—Subsec. (e)(1).
Subsec. (e)(2).
Subsec. (g).
Statutory Notes and Related Subsidiaries
Effective Date of 1994 Amendment
Amendment by
Effective Date of 1993 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by section 4201(d)(2) of
Effective Date of 1989 Amendment
Effective Date of 1987 Amendment
Amendment by section 4065(b) of
Amendment by
Effective Date of 1986 Amendment
[
Effective Date of 1984 Amendment
Amendment by
Amendment by section 2323(c) of
Amendment by section 2354(b)(41) of
Effective Date of 1983 Amendment
Amendment by
Effective Date of 1981 Amendment
Effective Date
Section effective with respect to services, supplies, and equipment furnished after the third calendar month beginning after June 13, 1978, except that provisions for the implementation of an incentive reimbursement system for dialysis services furnished in facilities and providers to become effective with respect to a facility's or provider's first accounting period beginning after the last day of the twelfth month following the month of June 1978, and except that provisions for reimbursement rates for home dialysis to become effective on Apr. 1, 1979, see section 6 of
Construction of 2008 Amendment
Drug Designations
"(1) determining when a product is no longer an oral-only drug; and
"(2) including new injectable and intravenous products into the bundled payment under such system."
Audits of Cost Reports of ESRD Providers as Recommended by MedPAC
"(1)
"(2)
Delay of Implementation of Oral-Only ESRD-Related Drugs in the ESRD Prospective Payment System; Monitoring
"(1)
"(2)
Analysis of Case Mix Payment Adjustments
"(1) conduct an analysis of the case mix payment adjustments being used under section 1881(b)(14)(D)(i) of the Social Security Act (
"(2) make appropriate revisions to such case mix payment adjustments."
Inspector General Studies on ESRD Drugs
"(1)
"(2)
"(A)
"(B)
"(3)
"(A) determine the difference between the amount of payment made to end stage renal disease facilities under title XVIII of the Social Security Act [
"(B) estimate the rates of growth of expenditures for such drugs and biologicals billed by such facilities.
"(4)
"(A)
"(B)
Demonstration of Bundled Case-Mix Adjusted Payment System for ESRD Services
Report on a Bundled Prospective Payment System for End Stage Renal Disease Services
"(1)
"(A)
"(B)
"(2)
"(A)
"(B)
"(C)
"(D)
"(E)
"(F)
"(G)
Prohibition on Exceptions
"(A)
"(B)
"(C)
"(D)
Development of ESRD Market Basket
"(1)
"(A) technology used in furnishing dialysis services;
"(B) the manner or method of furnishing dialysis services; and
"(C) the amounts by which the payments under such section for all services billed by a facility for a year exceed the aggregate allowable audited costs of such services for such facility for such year.
"(2)
Inclusion of Additional Services in Composite Rate
"(1)
"(2)
GAO Study on Access to Services
Special Rule for Payment for 2001
"(1) for services furnished on or after January 1, 2001, and before April 1, 2001, shall be the composite rate payment determined under the provisions of law in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(2) for services furnished on or after April 1, 2001, and before January 1, 2002, shall be the composite rate payment (as determined taking into account the amendment made by subsection (a)(1)) increased by a transitional percentage allowance equal to 0.39 percent (to account for the timing of implementation of the CPI update)."
Study on Payment Level for Home Hemodialysis
Renal Dialysis-Related Services
"(a)
"(b)
PROPAC Study on ESRD Composite Rates
"(1)
"(A)
"(B)
"(i) hemodialysis and other modalities of treatment,
"(ii) the appropriate services to be included in such payments,
"(iii) the adjustment factors to be incorporated including facility characteristics, such as hospital versus free-standing facilities, urban versus rural, size and mix of services,
"(iv) adjustments for labor and nonlabor costs,
"(v) comparative profit margins for all types of renal dialysis providers of service and renal dialysis facilities,
"(vi) adjustments for patient complexity, such as age, diagnosis, case mix, and pediatric services, and
"(vii) efficient costs related to high quality of care and positive outcomes for all treatment modalities.
"(2)
"(3)
[Prospective Payment Assessment Commission (ProPAC) was terminated and its assets and staff transferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of
Staff-Assisted Home Dialysis Demonstration Project
"(a)
"(1)
"(2)
"(b)
"(1)
"(A)
"(B)
"(i) technical assistance with the operation of a hemodialysis machine in the patient's home and with such patient's care during in-home hemodialysis; and
"(ii) administration of medications within the patient's home to maintain the patency of the extra corporeal circuit.
"(2)
"(A)
"(B)
"(I) the rate determined under clause (ii) with respect to a provider of services or a renal dialysis facility; and
"(II) the factor by which the labor portion of the composite rate determined under section 1881(b)(7) of the Social Security Act [
"(ii) The rate determined under this clause, with respect to a provider of services or renal dialysis facility, shall be equal to the difference between—
"(I) two-thirds of the labor portion of the composite rate applicable under section 1881(b)(7) of such Act to the provider or facility, and
"(II) the product of the national median hourly wage for a home hemodialysis staff assistant and the national median time expended in the provision of home hemodialysis staff assistant services (taking into account time expended in travel and predialysis patient care).
"(iii) For purposes of clause (ii)(II)—
"(I) the national median hourly wage for a home hemodialysis staff assistant and the national median average time expended for home hemodialysis staff assistant services shall be determined annually on the basis of the most recent data available, and
"(II) the national median hourly wage for a home hemodialysis staff assistant shall be the sum of 65 percent of the national median hourly wage for a licensed practical nurse and 35 percent of the national median hourly wage for a registered nurse.
"(C)
"(c)
"(1)
"(A) the individual is not a resident of a nursing facility;
"(B) the individual is an end stage renal disease patient entitled to benefits under title XVIII of the Social Security Act [
"(C) the individual's physician certifies that the individual is confined to a bed or wheelchair and cannot transfer themselves [sic] from a bed to a chair;
"(D) the individual has a serious medical condition (as specified by the Secretary) which would be exacerbated by travel to and from a dialysis facility;
"(E) the individual is eligible for ambulance transportation to receive routine maintenance dialysis treatments, and, based on the individual's medical condition, there is reasonable expectation that such transportation will be used by the individual for a period of at least 6 consecutive months, such that the cost of ambulance transportation can reasonably be expected to meet or exceed the cost of home hemodialysis staff assistance as provided under subsection (b)(2); and
"(F) no family member or other individual is available to provide such assistance to the individual.
"(2)
"(3)
"(d)
"(1) meets minimum qualifications as specified by the Secretary; and
"(2) meets any applicable qualifications as specified under the law of the State in which the home hemodialysis staff assistant is providing services.
"(e)
"(1)
"(2)
"(f)
"(1) For fiscal year 1991, $4,000,000.
"(2) For fiscal year 1992, $4,000,000.
"(3) For fiscal year 1993, $3,000,000.
"(4) For fiscal year 1994, $2,000,000.
"(5) For fiscal year 1995, $1,000,000."
Studies of End-Stage Renal Disease Program
"(1) The Secretary of Health and Human Services (in this subsection referred to as the 'Secretary') shall arrange for a study of the end-stage renal disease program within the medicare program.
"(2) Among other items, the study shall address—
"(A) access to treatment by both individuals eligible for medicare benefits and those not eligible for such benefits;
"(B) the quality of care provided to end-stage renal disease beneficiaries, as measured by clinical indicators, functional status of patients, and patient satisfaction;
"(C) the effect of reimbursement on quality of treatment;
"(D) major epidemiological and demographic changes in the end-stage renal disease population that may affect access to treatment, the quality of care, or the resource requirements of the program; and
"(E) the adequacy of existing data systems to monitor these matters on a continuing basis.
"(3) The Secretary shall submit to Congress, not later than 3 years after the date of the enactment of this Act [Dec. 22, 1987], a report on the study.
"(4) The Secretary shall request the National Academy of Sciences, acting through the Institute of Medicine, to submit an application to conduct the study described in this section. If the Academy submits an acceptable application, the Secretary shall enter into an appropriate arrangement with the Academy for the conduct of the study. If the Academy does not submit an acceptable application to conduct the study, the Secretary may request one or more appropriate nonprofit private entities to submit an application to conduct the study and may enter into an appropriate arrangement for the conduct of the study by the entity which submits the best acceptable application."
Rates for Dialysis Services
[
Study and Report on Medicare Payment Rate Reductions for Patients With End Stage Renal Disease
Deadline for Establishing New End Stage Renal Disease Network Areas; Transition
"(2)
"(3)
Report on Establishment of National End Stage Renal Disease Registry
Deadline for Establishment of Protocols on Reuse of Dialyzer Filters
[
Limitation on Merger of End Stage Renal Disease Networks
1 See References in Text note below.
2 So in original. Probably should be "biologicals".
§1395rr–1. Medicare coverage for individuals exposed to environmental health hazards
(a) Deeming of individuals as eligible for medicare benefits
(1) In general
For purposes of eligibility for benefits under this subchapter, an individual determined under subsection (c) to be an environmental exposure affected individual described in subsection (e)(2) shall be deemed to meet the conditions specified in
(2) Discretionary deeming
For purposes of eligibility for benefits under this subchapter, the Secretary may deem an individual determined under subsection (c) to be an environmental exposure affected individual described in subsection (e)(3) to meet the conditions specified in
(3) Effective date of coverage
An Individual 1 who is deemed eligible for benefits under this subchapter under paragraph (1) or (2) shall be—
(A) entitled to benefits under the program under Part 1 A as of the date of such deeming; and
(B) eligible to enroll in the program under Part 1 B beginning with the month in which such deeming occurs.
(b) Pilot program for care of certain individuals residing in emergency declaration areas
(1) Program; purpose
(A) Primary pilot program
The Secretary shall establish a pilot program in accordance with this subsection to provide innovative approaches to furnishing comprehensive, coordinated, and cost-effective care under this subchapter to individuals described in paragraph (2)(A).
(B) Optional pilot programs
The Secretary may establish a separate pilot program, in accordance with this subsection, with respect to each geographic area subject to an emergency declaration (other than the declaration of June 17, 2009), in order to furnish such comprehensive, coordinated and cost-effective care to individuals described in subparagraph (2)(B) who reside in each such area.
(2) Individual described
For purposes of paragraph (1), an individual described in this paragraph is an individual who enrolls in part B, submits to the Secretary an application to participate in the applicable pilot program under this subsection, and—
(A) is an environmental exposure affected individual described in subsection (e)(2) who resides in or around the geographic area subject to an emergency declaration made as of June 17, 2009; or
(B) is an environmental exposure affected individual described in subsection (e)(3) who—
(i) is deemed under subsection (a)(2); and
(ii) meets such other criteria or conditions for participation in a pilot program under paragraph (1)(B) as the Secretary specifies.
(3) Flexible benefits and services
A pilot program under this subsection may provide for the furnishing of benefits, items, or services not otherwise covered or authorized under this subchapter, if the Secretary determines that furnishing such benefits, items, or services will further the purposes of such pilot program (as described in paragraph (1)).
(4) Innovative reimbursement methodologies
For purposes of the pilot program under this subsection, the Secretary—
(A) shall develop and implement appropriate methodologies to reimburse providers for furnishing benefits, items, or services for which payment is not otherwise covered or authorized under this subchapter, if such benefits, items, or services are furnished pursuant to paragraph (3); and
(B) may develop and implement innovative approaches to reimbursing providers for any benefits, items, or services furnished under this subsection.
(5) Limitation
Consistent with
(6) Waiver authority
The Secretary may waive such provisions of this subchapter and subchapter XI as are necessary to carry out pilot programs under this subsection.
(7) Funding
For purposes of carrying out pilot programs under this subsection, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under
(8) Waiver of budget neutrality
The Secretary shall not require that pilot programs under this subsection be budget neutral with respect to expenditures under this subchapter.
(c) Determinations
(1) By the Commissioner of Social Security
For purposes of this section, the Commissioner of Social Security, in consultation with the Secretary, and using the cost allocation method prescribed in
(2) By the Secretary
The Secretary shall determine eligibility for pilot programs under subsection (b).
(d) Emergency declaration defined
For purposes of this section, the term "emergency declaration" means a declaration of a public health emergency under
(e) Environmental exposure affected individual defined
(1) In general
For purposes of this section, the term "environmental exposure affected individual" means—
(A) an individual described in paragraph (2); and
(B) an individual described in paragraph (3).
(2) Individual described
(A) In general
An individual described in this paragraph is any individual who—
(i) is diagnosed with 1 or more conditions described in subparagraph (B);
(ii) as demonstrated in such manner as the Secretary determines appropriate, has been present for an aggregate total of 6 months in the geographic area subject to an emergency declaration specified in subsection (b)(2)(A), during a period ending—
(I) not less than 10 years prior to such diagnosis; and
(II) prior to the implementation of all the remedial and removal actions specified in the Record of Decision for Operating Unit 4 and the Record of Decision for Operating Unit 7;
(iii) files an application for benefits under this subchapter (or has an application filed on behalf of the individual), including pursuant to this section; and
(iv) is determined under this section to meet the criteria in this subparagraph.
(B) Conditions described
For purposes of subparagraph (A), the following conditions are described in this subparagraph:
(i) Asbestosis, pleural thickening, or pleural plaques as established by—
(I) interpretation by a "B Reader" qualified physician of a plain chest x-ray or interpretation of a computed tomographic radiograph of the chest by a qualified physician, as determined by the Secretary; or
(II) such other diagnostic standards as the Secretary specifies,
except that this clause shall not apply to pleural thickening or pleural plaques unless there are symptoms or conditions requiring medical treatment as a result of these diagnoses.
(ii) Mesothelioma, or malignancies of the lung, colon, rectum, larynx, stomach, esophagus, pharynx, or ovary, as established by—
(I) pathologic examination of biopsy tissue;
(II) cytology from bronchioalveolar lavage; or
(III) such other diagnostic standards as the Secretary specifies.
(iii) Any other diagnosis which the Secretary, in consultation with the Commissioner of Social Security, determines is an asbestos-related medical condition, as established by such diagnostic standards as the Secretary specifies.
(3) Other individual described
An individual described in this paragraph is any individual who—
(A) is not an individual described in paragraph (2);
(B) is diagnosed with a medical condition caused by the exposure of the individual to a public health hazard to which an emergency declaration applies, based on such medical conditions, diagnostic standards, and other criteria as the Secretary specifies;
(C) as demonstrated in such manner as the Secretary determines appropriate, has been present for an aggregate total of 6 months in the geographic area subject to the emergency declaration involved, during a period determined appropriate by the Secretary;
(D) files an application for benefits under this subchapter (or has an application filed on behalf of the individual), including pursuant to this section; and
(E) is determined under this section to meet the criteria in this paragraph.
(Aug. 14, 1935, ch. 531, title XVIII, §1881A, as added
Editorial Notes
References in Text
Parts A and B, referred to in subsecs. (a)(3) and (b)(2), are classified to sections 1395c et seq. and 1395j et seq., respectively, of this title.
1 So in original. Probably should not be capitalized.
§1395ss. Certification of medicare supplemental health insurance policies
(a) Submission of policy by insurer
(1) The Secretary shall establish a procedure whereby medicare supplemental policies (as defined in subsection (g)(1)) may be certified by the Secretary as meeting minimum standards and requirements set forth in subsection (c). Such procedure shall provide an opportunity for any insurer to submit any such policy, and such additional data as the Secretary finds necessary, to the Secretary for his examination and for his certification thereof as meeting the standards and requirements set forth in subsection (c). Subject to subsections (k)(3), (m), and (n), such certification shall remain in effect if the insurer files a notarized statement with the Secretary no later than June 30 of each year stating that the policy continues to meet such standards and requirements and if the insurer submits such additional data as the Secretary finds necessary to independently verify the accuracy of such notarized statement. Where the Secretary determines such a policy meets (or continues to meet) such standards and requirements, he shall authorize the insurer to have printed on such policy (but only in accordance with such requirements and conditions as the Secretary may prescribe) an emblem which the Secretary shall cause to be designed for use as an indication that a policy has received the Secretary's certification. The Secretary shall provide each State commissioner or superintendent of insurance with a list of all the policies which have received his certification.
(2) No medicare supplemental policy may be issued in a State on or after the date specified in subsection (p)(1)(C) unless—
(A) the State's regulatory program under subsection (b)(1) provides for the application and enforcement of the standards and requirements set forth in such subsection (including the 1991 NAIC Model Regulation or 1991 Federal Regulation (as the case may be)) by the date specified in subsection (p)(1)(C); or
(B) if the State's program does not provide for the application and enforcement of such standards and requirements, the policy has been certified by the Secretary under paragraph (1) as meeting the standards and requirements set forth in subsection (c) (including such applicable standards) by such date.
Any person who issues a medicare supplemental policy, on and after the effective date specified in subsection (p)(1)(C), in violation of this paragraph is subject to a civil money penalty of not to exceed $25,000 for each such violation. The provisions of
(b) Standards and requirements; periodic review by Secretary
(1) Any medicare supplemental policy issued in any State which the Secretary determines has established under State law a regulatory program that—
(A) provides for the application and enforcement of standards with respect to such policies equal to or more stringent than the NAIC Model Standards (as defined in subsection (g)(2)(A)), except as otherwise provided by subparagraph (H);
(B) includes requirements equal to or more stringent than the requirements described in paragraphs (2) through (5) of subsection (c);
(C) provides that—
(i) information with respect to the actual ratio of benefits provided to premiums collected under such policies will be reported to the State on forms conforming to those developed by the National Association of Insurance Commissioners for such purpose, or
(ii) such ratios will be monitored under the program in an alternative manner approved by the Secretary, and that a copy of each such policy, the most recent premium for each such policy, and a listing of the ratio of benefits provided to premiums collected for the most recent 3-year period for each such policy issued or sold in the State is maintained and made available to interested persons;
(D) provides for application and enforcement of the standards and requirements described in subparagraphs (A), (B), and (C) to all medicare supplemental policies (as defined in subsection (g)(1)) issued in such State,
(E) provides the Secretary periodically (but at least annually) with a list containing the name and address of the issuer of each such policy and the name and number of each such policy (including an indication of policies that have been previously approved, newly approved, or withdrawn from approval since the previous list was provided),
(F) reports to the Secretary on the implementation and enforcement of standards and requirements of this paragraph at intervals established by the Secretary,
(G) provides for a process for approving or disapproving proposed premium increases with respect to such policies, and establishes a policy for the holding of public hearings prior to approval of a premium increase, and
(H) in the case of a policy that meets the standards under subparagraph (A) except that benefits under the policy are limited to items and services furnished by certain entities (or reduced benefits are provided when items or services are furnished by other entities), provides for the application of requirements equal to or more stringent than the requirements under subsection (t),
shall be deemed (subject to subsections (k)(3), (m), and (n), for so long as the Secretary finds that such State regulatory program continues to meet the standards and requirements of this paragraph) to meet the standards and requirements set forth in subsection (c). Each report required under subparagraph (F) shall include information on loss ratios of policies sold in the State, frequency and types of instances in which policies approved by the State fail to meet the standards and requirements of this paragraph, actions taken by the State to bring such policies into compliance, information regarding State programs implementing consumer protection provisions, and such further information as the Secretary in consultation with the National Association of Insurance Commissioners may specify.
(2) The Secretary periodically shall review State regulatory programs to determine if they continue to meet the standards and requirements specified in paragraph (1). If the Secretary finds that a State regulatory program no longer meets the standards and requirements, before making a final determination, the Secretary shall provide the State an opportunity to adopt such a plan of correction as would permit the State regulatory program to continue to meet such standards and requirements. If the Secretary makes a final determination that the State regulatory program, after such an opportunity, fails to meet such standards and requirements, the program shall no longer be considered to have in operation a program meeting such standards and requirements.
(3) Notwithstanding paragraph (1), a medicare supplemental policy offered in a State shall not be deemed to meet the standards and requirements set forth in subsection (c), with respect to an advertisement (whether through written, radio, or television medium) used (or, at a State's option, to be used) for the policy in the State, unless the entity issuing the policy provides a copy of each advertisement to the Commissioner of Insurance (or comparable officer identified by the Secretary) of that State for review or approval to the extent it may be required under State law.
(c) Requisite findings
The Secretary shall certify under this section any medicare supplemental policy, or continue certification of such a policy, only if he finds that such policy (or, with respect to paragraph (3) or the requirement described in subsection (s), the issuer of the policy)—
(1) meets or exceeds (either in a single policy or, in the case of nonprofit hospital and medical service associations, in one or more policies issued in conjunction with one another) the NAIC Model Standards (except as otherwise provided by subsection (t));
(2) meets the requirements of subsection (r);
(3)(A) accepts a notice under
(B) where such a notice is received—
(i) provides notice to such physician or supplier and the beneficiary of the payment determination under the policy, and
(ii) provides any payment covered by such policy directly to the participating physician or supplier involved;
(C) provides each enrollee at the time of enrollment a card listing the policy name and number and a single mailing address to which notices under
(D) agrees to pay any user fees established under
(E) provides to the Secretary at least annually, for transmittal to carriers, a single mailing address to which notices under
(4) may, during a period of not less than 30 days after the policy is issued, be returned for a full refund of any premiums paid (without regard to the manner in which the purchase of the policy was solicited); and
(5) meets the applicable requirements of subsections (o) through (t).
(d) Criminal penalties; civil penalties for certain violations
(1) Whoever knowingly and willfully makes or causes to be made or induces or seeks to induce the making of any false statement or representation of a material fact with respect to the compliance of any policy with the standards and requirements set forth in subsection (c) or in regulations promulgated pursuant to such subsection, or with respect to the use of the emblem designed by the Secretary under subsection (a), shall be fined under title 18 or imprisoned not more than 5 years, or both, and, in addition to or in lieu of such a criminal penalty, is subject to a civil money penalty of not to exceed $5,000 for each such prohibited act.
(2) Whoever falsely assumes or pretends to be acting, or misrepresents in any way that he is acting, under the authority of or in association with, the program of health insurance established by this subchapter, or any Federal agency, for the purpose of selling or attempting to sell insurance, or in such pretended character demands, or obtains money, paper, documents, or anything of value, shall be fined under title 18 or imprisoned not more than 5 years, or both, and, in addition to or in lieu of such a criminal penalty, is subject to a civil money penalty of not to exceed $5,000 for each such prohibited act.
(3)(A)(i) It is unlawful for a person to sell or issue to an individual entitled to benefits under part A or enrolled under part B of this subchapter (including an individual electing a Medicare+Choice plan under
(I) a health insurance policy with knowledge that the policy duplicates health benefits to which the individual is otherwise entitled under this subchapter or subchapter XIX,
(II) in the case of an individual not electing a Medicare+Choice plan, a medicare supplemental policy with knowledge that the individual is entitled to benefits under another medicare supplemental policy or in the case of an individual electing a Medicare+Choice plan, a medicare supplemental policy with knowledge that the policy duplicates health benefits to which the individual is otherwise entitled under the Medicare+Choice plan or under another medicare supplemental policy, or
(III) a health insurance policy (other than a medicare supplemental policy) with knowledge that the policy duplicates health benefits to which the individual is otherwise entitled, other than benefits to which the individual is entitled under a requirement of State or Federal law.
(ii) Whoever violates clause (i) shall be fined under title 18 or imprisoned not more than 5 years, or both, and, in addition to or in lieu of such a criminal penalty, is subject to a civil money penalty of not to exceed $25,000 (or $15,000 in the case of a person other than the issuer of the policy) for each such prohibited act.
(iii) A seller (who is not the issuer of a health insurance policy) shall not be considered to violate clause (i)(II) with respect to the sale of a medicare supplemental policy if the policy is sold in compliance with subparagraph (B).
(iv) For purposes of this subparagraph, a health insurance policy (other than a Medicare supplemental policy) providing for benefits which are payable to or on behalf of an individual without regard to other health benefit coverage of such individual is not considered to "duplicate" any health benefits under this subchapter, under subchapter XIX, or under a health insurance policy, and subclauses (I) and (III) of clause (i) do not apply to such a policy.
(v) For purposes of this subparagraph, a health insurance policy (or a rider to an insurance contract which is not a health insurance policy) is not considered to "duplicate" health benefits under this subchapter or under another health insurance policy if it—
(I) provides health care benefits only for long-term care, nursing home care, home health care, or community-based care, or any combination thereof,
(II) coordinates against or excludes items and services available or paid for under this subchapter or under another health insurance policy, and
(III) for policies sold or issued on or after the end of the 90-day period beginning on August 21, 1996, discloses such coordination or exclusion in the policy's outline of coverage.
For purposes of this clause, the terms "coordinates" and "coordination" mean, with respect to a policy in relation to health benefits under this subchapter or under another health insurance policy, that the policy under its terms is secondary to, or excludes from payment, items and services to the extent available or paid for under this subchapter or under another health insurance policy.
(vi)(I) An individual entitled to benefits under part A or enrolled under part B of this subchapter who is applying for a health insurance policy (other than a policy described in subclause (III)) shall be furnished a disclosure statement described in clause (vii) for the type of policy being applied for. Such statement shall be furnished as a part of (or together with) the application for such policy.
(II) Whoever issues or sells a health insurance policy (other than a policy described in subclause (III)) to an individual described in subclause (I) and fails to furnish the appropriate disclosure statement as required under such subclause shall be fined under title 18, or imprisoned not more than 5 years, or both, and, in addition to or in lieu of such a criminal penalty, is subject to a civil money penalty of not to exceed $25,000 (or $15,000 in the case of a person other than the issuer of the policy) for each such violation.
(III) A policy described in this subclause (to which subclauses (I) and (II) do not apply) is a Medicare supplemental policy, a policy described in clause (v), or a health insurance policy identified under 60 Federal Register 30880 (June 12, 1995) as a policy not required to have a disclosure statement.
(IV) Any reference in this section to the revised NAIC model regulation (referred to in subsection (m)(1)(A)) is deemed a reference to such regulation as revised by section 171(m)(2) of the Social Security Act Amendments of 1994 (
(vii) The disclosure statement described in this clause for a type of policy is the statement specified under subparagraph (D) of this paragraph (as in effect before August 21, 1996) for that type of policy, as revised as follows:
(I) In each statement, amend the second line to read as follows:
"THIS IS NOT MEDICARE SUPPLEMENT
INSURANCE".
(II) In each statement, strike the third line and insert the following: "Some health care services paid for by Medicare may also trigger the payment of benefits under this policy.".
(III) In each statement not described in subclause (V), strike the boldface matter that begins "This insurance" and all that follows up to the next paragraph that begins "Medicare".
(IV) In each statement not described in subclause (V), insert before the boxed matter (that states "Before You Buy This Insurance") the following: "This policy must pay benefits without regard to other health benefit coverage to which you may be entitled under Medicare or other insurance.".
(V) In a statement relating to policies providing both nursing home and non-institutional coverage, to policies providing nursing home benefits only, or policies providing home care benefits only, amend the sentence that begins "Federal law" to read as follows: "Federal law requires us to inform you that in certain situations this insurance may pay for some care also covered by Medicare.".
(viii)(I) Subject to subclause (II), nothing in this subparagraph shall restrict or preclude a State's ability to regulate health insurance policies, including any health insurance policy that is described in clause (iv), (v), or (vi)(III).
(II) A State may not declare or specify, in statute, regulation, or otherwise, that a health insurance policy (other than a Medicare supplemental policy) or rider to an insurance contract which is not a health insurance policy, that is described in clause (iv), (v), or (vi)(III) and that is sold, issued, or renewed to an individual entitled to benefits under part A or enrolled under part B "duplicates" health benefits under this subchapter or under a Medicare supplemental policy.
(B)(i) It is unlawful for a person to issue or sell a medicare supplemental policy to an individual entitled to benefits under part A or enrolled under part B, whether directly, through the mail, or otherwise, unless—
(I) the person obtains from the individual, as part of the application for the issuance or purchase and on a form described in clause (ii), a written statement signed by the individual stating, to the best of the individual's knowledge, what health insurance policies (including any Medicare+Choice plan) the individual has, from what source, and whether the individual is entitled to any medical assistance under subchapter XIX, whether as a qualified medicare beneficiary or otherwise, and
(II) the written statement is accompanied by a written acknowledgment, signed by the seller of the policy, of the request for and receipt of such statement.
(ii) The statement required by clause (i) shall be made on a form that—
(I) states in substance that a medicare-eligible individual does not need more than one medicare supplemental policy,
(II) states in substance that individuals may be eligible for benefits under the State medicaid program under subchapter XIX and that such individuals who are entitled to benefits under that program usually do not need a medicare supplemental policy and that benefits and premiums under any such policy shall be suspended upon request of the policyholder during the period (of not longer than 24 months) of entitlement to benefits under such subchapter and may be reinstituted upon loss of such entitlement, and
(III) states that counseling services may be available in the State to provide advice concerning the purchase of medicare supplemental policies and enrollment under the medicaid program and may provide the telephone number for such services.
(iii)(I) Except as provided in subclauses (II) and (III), if the statement required by clause (i) is not obtained or indicates that the individual has a medicare supplemental policy or indicates that the individual is entitled to any medical assistance under subchapter XIX, the sale of a medicare supplemental policy shall be considered to be a violation of subparagraph (A).
(II) Subclause (I) shall not apply in the case of an individual who has a medicare supplemental policy, if the individual indicates in writing, as part of the application for purchase, that the policy being purchased replaces such other policy and indicates an intent to terminate the policy being replaced when the new policy becomes effective and the issuer or seller certifies in writing that such policy will not, to the best of the issuer's or seller's knowledge, duplicate coverage (taking into account any such replacement).
(III) If the statement required by clause (i) is obtained and indicates that the individual is entitled to any medical assistance under subchapter XIX, the sale of the policy is not in violation of clause (i) (insofar as such clause relates to such medical assistance), if (aa) a State medicaid plan under such subchapter pays the premiums for the policy, (bb) in the case of a qualified medicare beneficiary described in
(iv) Whoever issues or sells a medicare supplemental policy in violation of this subparagraph shall be fined under title 18, or imprisoned not more than 5 years, or both, and, in addition to or in lieu of such a criminal penalty, is subject to a civil money penalty of not to exceed $25,000 (or $15,000 in the case of a seller who is not the issuer of a policy) for each such violation.
(C) Subparagraph (A) shall not apply with respect to the sale or issuance of a group policy or plan of one or more employers or labor organizations, or of the trustees of a fund established by one or more employers or labor organizations (or combination thereof), for employees or former employees (or combination thereof) or for members or former members (or combination thereof) of the labor organizations.
(4)(A) Whoever knowingly, directly or through his agent, mails or causes to be mailed any matter for a prohibited purpose (as determined under subparagraph (B)) shall be fined under title 18 or imprisoned not more than 5 years, or both, and, in addition to or in lieu of such a criminal penalty, is subject to a civil money penalty of not to exceed $5,000 for each such prohibited act.
(B) For purposes of subparagraph (A), a prohibited purpose means the advertising, solicitation, or offer for sale of a medicare supplemental policy, or the delivery of such a policy, in or into any State in which such policy has not been approved by the State commissioner or superintendent of insurance.
(C) Subparagraph (A) shall not apply in the case of a person who mails or causes to be mailed a medicare supplemental policy into a State if such person has ascertained that the party insured under such policy to whom (or on whose behalf) such policy is mailed is located in such State on a temporary basis.
(D) Subparagraph (A) shall not apply in the case of a person who mails or causes to be mailed a duplicate copy of a medicare supplemental policy previously issued to the party to whom (or on whose behalf) such duplicate copy is mailed.
(E) Subparagraph (A) shall not apply in the case of an issuer who mails or causes to be mailed a policy, certificate, or other matter solely to comply with the requirements of subsection (q).
(5) The provisions of
(e) Dissemination of information
(1) The Secretary shall provide to all individuals entitled to benefits under this subchapter (and, to the extent feasible, to individuals about to become so entitled) such information as will permit such individuals to evaluate the value of medicare supplemental policies to them and the relationship of any such policies to benefits provided under this subchapter.
(2) The Secretary shall—
(A) inform all individuals entitled to benefits under this subchapter (and, to the extent feasible, individuals about to become so entitled) of—
(i) the actions and practices that are subject to sanctions under subsection (d), and
(ii) the manner in which they may report any such action or practice to an appropriate official of the Department of Health and Human Services (or to an appropriate State official), and
(B) publish the toll-free telephone number for individuals to report suspected violations of the provisions of such subsection.
(3) The Secretary shall provide individuals entitled to benefits under this subchapter (and, to the extent feasible, individuals about to become so entitled) with a listing of the addresses and telephone numbers of State and Federal agencies and offices that provide information and assistance to individuals with respect to the selection of medicare supplemental policies.
(f) Study and evaluation of comparative effectiveness of various State approaches to regulating medicare supplemental policies; report to Congress no later than January 1, 1982; periodic evaluations
(1)(A) The Secretary shall, in consultation with Federal and State regulatory agencies, the National Association of Insurance Commissioners, private insurers, and organizations representing consumers and the aged, conduct a comprehensive study and evaluation of the comparative effectiveness of various State approaches to the regulation of medicare supplemental policies in (i) limiting marketing and agent abuse, (ii) assuring the dissemination of such information to individuals entitled to benefits under this subchapter (and to other consumers) as is necessary to permit informed choice, (iii) promoting policies which provide reasonable economic benefits for such individuals, (iv) reducing the purchase of unnecessary duplicative coverage, (v) improving price competition, and (vi) establishing effective approved State regulatory programs described in subsection (b).
(B) Such study shall also address the need for standards or certification of health insurance policies, other than medicare supplemental policies, sold to individuals eligible for benefits under this subchapter.
(C) The Secretary shall, no later than January 1, 1982, submit a report to the Congress on the results of such study and evaluation, accompanied by such recommendations as the Secretary finds warranted by such results with respect to the need for legislative or administrative changes to accomplish the objectives set forth in subparagraphs (A) and (B), including the need for a mandatory Federal regulatory program to assure the marketing of appropriate types of medicare supplemental policies, and such other means as he finds may be appropriate to enhance effective State regulation of such policies.
(2) The Secretary shall submit to the Congress no later than July 1, 1982, and periodically as may be appropriate thereafter (but not less often than once every 2 years), a report evaluating the effectiveness of the certification procedure and the criminal penalties established under this section, and shall include in such reports an analysis of—
(A) the impact of such procedure and penalties on the types, market share, value, and cost to individuals entitled to benefits under this subchapter of medicare supplemental policies which have been certified by the Secretary;
(B) the need for any change in the certification procedure to improve its administration or effectiveness; and
(C) whether the certification program and criminal penalties should be continued.
(3) The Secretary shall provide information via a toll-free telephone number on medicare supplemental policies (including the relationship of State programs under subchapter XIX to such policies).
(g) Definitions
(1) For purposes of this section, a medicare supplemental policy is a health insurance policy or other health benefit plan offered by a private entity to individuals who are entitled to have payment made under this subchapter, which provides reimbursement for expenses incurred for services and items for which payment may be made under this subchapter but which are not reimbursable by reason of the applicability of deductibles, coinsurance amounts, or other limitations imposed pursuant to this subchapter; but does not include a prescription drug plan under part D or a Medicare+Choice plan or any such policy or plan of one or more employers or labor organizations, or of the trustees of a fund established by one or more employers or labor organizations (or combination thereof), for employees or former employees (or combination thereof) or for members or former members (or combination thereof) of the labor organizations and does not include a policy or plan of an eligible organization (as defined in
(2) For purposes of this section:
(A) The term "NAIC Model Standards" means the "NAIC Model Regulation to Implement the Individual Accident and Sickness Insurance Minimum Standards Act", adopted by the National Association of Insurance Commissioners on June 6, 1979, as it applies to medicare supplemental policies.
(B) The term "State with an approved regulatory program" means a State for which the Secretary has made a determination under subsection (b)(1).
(C) The State in which a policy is issued means—
(i) in the case of an individual policy, the State in which the policyholder resides; and
(ii) in the case of a group policy, the State in which the holder of the master policy resides.
(h) Rules and regulations
The Secretary shall prescribe such regulations as may be necessary for the effective, efficient, and equitable administration of the certification procedure established under this section. The Secretary shall first issue final regulations to implement the certification procedure established under subsection (a) not later than March 1, 1981.
(i) Commencement of certification program
(1) No medicare supplemental policy shall be certified and no such policy may be issued bearing the emblem authorized by the Secretary under subsection (a) until July 1, 1982. On and after such date policies certified by the Secretary may bear such emblem, including policies which were issued prior to such date and were subsequently certified, and insurers may notify holders of such certified policies issued prior to such date using such emblem in the notification.
(2)(A) The Secretary shall not implement the certification program established under subsection (a) with respect to policies issued in a State unless the Panel makes a finding that such State cannot be expected to have established, by July 1, 1982, an approved State regulatory program meeting the standards and requirements of subsection (b)(1). If the Panel makes such a finding, the Secretary shall implement such program under subsection (a) with respect to medicare supplemental policies issued in such State, until such time as the Panel determines that such State has a program that meets the standards and requirements of subsection (b)(1).
(B) Any finding by the Panel under subparagraph (A) shall be transmitted in writing, not later than January 1, 1982, to the Committee on Finance of the Senate and to the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives and shall not become effective until 60 days after the date of its transmittal to the Committees of the Congress under this subparagraph. In counting such days, days on which either House is not in session because of an adjournment sine die or an adjournment of more than three days to a day certain are excluded in the computation.
(j) State regulation of policies issued in other States
Nothing in this section shall be construed so as to affect the right of any State to regulate medicare supplemental policies which, under the provisions of this section, are considered to be issued in another State.
(k) Amended NAIC Model Regulation or Federal model standards applicable; effective date; medicare supplemental policy and State regulatory program meeting applicable standards
(1)(A) If, within the 90-day period beginning on July 1, 1988, the National Association of Insurance Commissioners (in this subsection referred to as the "Association") amends the NAIC Model Regulation adopted on June 6, 1979 (as it relates to medicare supplemental policies), with respect to matters such as minimum benefit standards, loss ratios, disclosure requirements, and replacement requirements and provisions otherwise necessary to reflect the changes in law made by the Medicare Catastrophic Coverage Act of 1988, except as provided in subsection (m), subsection (g)(2)(A) shall be applied in a State, effective on and after the date specified in subparagraph (B), as if the reference to the Model Regulation adopted on June 6, 1979, were a reference to the Model Regulation as amended by the Association in accordance with this paragraph (in this subsection and subsection (l) referred to as the "amended NAIC Model Regulation").
(B) The date specified in this subparagraph for a State is the earlier of the date the State adopts standards equal to or more stringent than the amended NAIC Model Regulation or 1 year after the date the Association first adopts such amended Regulation.
(2)(A) If the Association does not amend the NAIC Model Regulation within the 90-day period specified in paragraph (1)(A), the Secretary shall promulgate, not later than 60 days after the end of such period, Federal model standards (in this subsection and subsection (1) 1 referred to as "Federal model standards") for medicare supplemental policies to reflect the changes in law made by the Medicare Catastrophic Coverage Act of 1988, and subsection (g)(2)(A) shall be applied in a State, effective on and after the date specified in subparagraph (B), as if the reference to the Model Regulation adopted on June 6, 1979, were a reference to Federal model standards.
(B) The date specified in this subparagraph for a State is the earlier of the date the State adopts standards equal to or more stringent than the Federal model standards or 1 year after the date the Secretary first promulgates such standards.
(3) Notwithstanding any other provision of this section (except as provided in subsections (l), (m), and (n))—
(A) no medicare supplemental policy may be certified by the Secretary pursuant to subsection (a),
(B) no certification made pursuant to subsection (a) shall remain in effect, and
(C) no State regulatory program shall be found to meet (or to continue to meet) the requirements of subsection (b)(1)(A),
unless such policy meets (or such program provides for the application of standards equal to or more stringent than) the standards set forth in the amended NAIC Model Regulation or the Federal model standards (as the case may be) by the date specified in paragraph (1)(B) or (2)(B) (as the case may be).
(l) Transitional compliance with NAIC Model Transition Regulation; "qualifying medicare supplemental policy" and "NAIC Model Transition Regulation" defined
(1) Until the date specified in paragraph (3), in the case of a qualifying medicare supplemental policy described in paragraph (2) issued—
(A) before January 1, 1989, the policy is deemed to remain in compliance with this section if the insurer issuing the policy complies with the NAIC Model Transition Regulation (including giving notices to subscribers and filing for premium adjustments with the State as described in section 5.B. of such Regulation) by January 1, 1989; or
(B) on or after January 1, 1989, the policy is deemed to be in compliance with this section if the insurer issuing the policy complies with the NAIC Model Transition Regulation before the date of the sale of the policy.
(2) In paragraph (1), the term "qualifying medicare supplemental policy" means a medicare supplemental policy—
(A) issued in a State which—
(i) has not adopted standards equal to or more stringent than the NAIC Model Transition Regulation by January 1, 1989, and
(ii) has not adopted standards equal to or more stringent than the amended NAIC Model Regulation (or Federal model standards) by January 1, 1989; and
(B) which has been issued in compliance with this section (as in effect on June 1, 1988).
(3)(A) The date specified in this paragraph is the earlier of—
(i) the first date a State adopts, after January 1, 1989, standards equal to or more stringent than the NAIC Model Transition Regulation or equal to or more stringent than the amended NAIC Model Regulation (or Federal model standards), as the case may be, or
(ii) the later of (I) the date specified in subsection (k)(1)(B) or (k)(2)(B) (as the case may be), or (II) the date specified in subparagraph (B).
(B) In the case of a State which the Secretary identifies as—
(i) requiring State legislation (other than legislation appropriating funds) in order for medicare supplemental policies to meet standards described in subparagraph (A)(i), but
(ii) having a legislature which is not scheduled to meet in 1989 in a legislative session in which such legislation may be considered,
the date specified in this subparagraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after January 1, 1989, and in which legislation described in clause (i) may be considered. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.
(4) In the case of a medicare supplemental policy in effect on January 1, 1989, and offered in a State which, as of such date—
(A) has adopted standards equal to or more stringent than the amended NAIC Model Regulation (or Federal model standards), but
(B) does not have in effect standards equal to or more stringent than the NAIC Model Transition Regulation (or otherwise requiring notice substantially the same as the notice required in section 5.B. of such Regulation),
the policy shall not be deemed to meet the standards in subsection (c) unless each individual who is entitled to benefits under this subchapter and is a policyholder under such policy on January 1, 1989, is sent such a notice in any appropriate form by not later than January 31, 1989, that explains—
(A) the improved benefits under this subchapter contained in the Medicare Catastrophic Coverage Act of 1988, and
(B) how these improvements affect the benefits contained in the policies and the premium for the policy.
(5) In this subsection, the term "NAIC Model Transition Regulation" refers to the standards contained in the "Model Regulation to Implement Transitional Requirements for the Conversion of Medicare Supplement Insurance Benefits and Premiums to Conform to Medicare Program Revisions" (as adopted by the National Association of Insurance Commissioners in September 1987).
(m) Revision of amended NAIC Model Regulation and amended Federal model standards; effective dates; medicare supplemental policy and State regulatory program meeting applicable standards
(1)(A) If, within the 90-day period beginning on December 13, 1989, the National Association of Insurance Commissioners (in this subsection and subsection (n) referred to as the "Association") revises the amended NAIC Model Regulation (referred to in subsection (k)(1)(A) and adopted on September 20, 1988) to improve such regulation and otherwise to reflect the changes in law made by the Medicare Catastrophic Coverage Repeal Act of 1989, subsection (g)(2)(A) shall be applied in a State, effective on and after the date specified in subparagraph (B), as if the reference to the Model Regulation adopted on June 6, 1979, were a reference to the amended NAIC Model Regulation (referred to in subsection (k)(1)(A)) as revised by the Association in accordance with this paragraph (in this subsection and subsection (n) referred to as the "revised NAIC Model Regulation").
(B) The date specified in this subparagraph for a State is the earlier of the date the State adopts standards equal to or more stringent than the revised NAIC Model Regulation or 1 year after the date the Association first adopts such revised Regulation.
(2)(A) If the Association does not revise the amended NAIC Model Regulation, within the 90-day period specified in paragraph (1)(A), the Secretary shall promulgate, not later than 60 days after the end of such period, revised Federal model standards (in this subsection and subsection (n) referred to as "revised Federal model standards") for medicare supplemental policies to improve such standards and otherwise to reflect the changes in law made by the Medicare Catastrophic Coverage Repeal Act of 1989, subsection (g)(2)(A) shall be applied in a State, effective on and after the date specified in subparagraph (B), as if the reference to the Model Regulation adopted on June 6, 1979, were a reference to the revised Federal model standards.
(B) The date specified in this subparagraph for a State is the earlier of the date the State adopts standards equal to or more stringent than the revised Federal model standards or 1 year after the date the Secretary first promulgates such standards.
(3) Notwithstanding any other provision of this section (except as provided in subsection (n))—
(A) no medicare supplemental policy may be certified by the Secretary pursuant to subsection (a),
(B) no certification made pursuant to subsection (a) shall remain in effect, and
(C) no State regulatory program shall be found to meet (or to continue to meet) the requirements of subsection (b)(1)(A),
unless such policy meets (or such program provides for the application of standards equal to or more stringent than) the standards set forth in the revised NAIC Model Regulation or the revised Federal model standards (as the case may be) by the date specified in paragraph (1)(B) or (2)(B) (as the case may be).
(n) Transition compliance with revision of NAIC Model Regulation and Federal model standards
(1) Until the date specified in paragraph (4), in the case of a qualifying medicare supplemental policy described in paragraph (3) issued in a State—
(A) before the transition deadline, the policy is deemed to remain in compliance with the standards described in subsection (b)(1)(A) only if the insurer issuing the policy complies with the transition provision described in paragraph (2), or
(B) on or after the transition deadline, the policy is deemed to be in compliance with the standards described in subsection (b)(1)(A) only if the insurer issuing the policy complies with the revised NAIC Model Regulation or the revised Federal model standards (as the case may be) before the date of the sale of the policy.
In this paragraph, the term "transition deadline" means 1 year after the date the Association adopts the revised NAIC Model Regulation or 1 year after the date the Secretary promulgates revised Federal model standards (as the case may be).
(2) The transition provision described in this paragraph is—
(A) such transition provision as the Association provides, by not later than December 15, 1989, so as to provide for an appropriate transition (i) to restore benefit provisions which are no longer duplicative as a result of the changes in benefits under this subchapter made by the Medicare Catastrophic Coverage Repeal Act of 1989 and (ii) to eliminate the requirement of payment for the first 8 days of coinsurance for extended care services, or
(B) if the Association does not provide for a transition provision by the date described in subparagraph (A), such transition provision as the Secretary shall provide, by January 1, 1990, so as to provide for an appropriate transition described in subparagraph (A).
(3) In paragraph (1), the term "qualifying medicare supplemental policy" means a medicare supplemental policy which has been issued in compliance with this section as in effect on the date before December 13, 1989.
(4)(A) The date specified in this paragraph for a policy issued in a State is—
(i) the first date a State adopts, after December 13, 1989, standards equal to or more stringent than the revised NAIC Model Regulation (or revised Federal model standards), as the case may be, or
(ii) the date specified in subparagraph (B),
whichever is earlier.
(B) In the case of a State which the Secretary identifies, in consultation with the Association, as—
(i) requiring State legislation (other than legislation appropriating funds) in order for medicare supplemental policies to meet standards described in subparagraph (A)(i), but
(ii) having a legislature which is not scheduled to meet in 1990 in a legislative session in which such legislation may be considered,
the date specified in this subparagraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after January 1, 1990. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.
(5) In the case of a medicare supplemental policy in effect on January 1, 1990, the policy shall not be deemed to meet the standards in subsection (c) unless each individual who is entitled to benefits under this subchapter and is a policyholder or certificate holder under such policy on such date is sent a notice in an appropriate form by not later than January 31, 1990, that explains—
(A) the changes in benefits under this subchapter effected by the Medicare Catastrophic Coverage Repeal Act of 1989, and
(B) how these changes may affect the benefits contained in such policy and the premium for the policy.
(6)(A) Except as provided in subparagraph (B), in the case of an individual who had in effect, as of December 31, 1988, a medicare supplemental policy with an insurer (as a policyholder or, in the case of a group policy, as a certificate holder) and the individual terminated coverage under such policy before December 13, 1989, no medicare supplemental policy of the insurer shall be deemed to meet the standards in subsection (c) unless the insurer—
(i) provides written notice, no earlier than December 15, 1989, and no later than January 30, 1990, to the policyholder or certificate holder (at the most recent available address) of the offer described in clause (ii), and
(ii) offers the individual, during a period of at least 60 days beginning not later than February 1, 1990, reinstitution of coverage (with coverage effective as of January 1, 1990), under the terms which (I) do not provide for any waiting period with respect to treatment of pre-existing conditions, (II) provides for coverage which is substantially equivalent to coverage in effect before the date of such termination, and (III) provides for classification of premiums on which terms are at least as favorable to the policyholder or certificate holder as the premium classification terms that would have applied to the policyholder or certificate holder had the coverage never terminated.
(B) An insurer is not required to make the offer under subparagraph (A)(ii) in the case of an individual who is a policyholder or certificate holder in another medicare supplemental policy as of December 13, 1989, if (as of January 1, 1990) the individual is not subject to a waiting period with respect to treatment of a pre-existing condition under such other policy.
(o) Requirements of group benefits; core group benefits; uniform outline of coverage
The requirements of this subsection are as follows:
(1) Each medicare supplemental policy shall provide for coverage of a group of benefits consistent with subsections (p), (v) 2 (w), and (y).
(2) If the medicare supplemental policy provides for coverage of a group of benefits other than the core group of basic benefits described in subsection (p)(2)(B), the issuer of the policy must make available to the individual a medicare supplemental policy with only such core group of basic benefits.
(3) The issuer of the policy has provided, before the sale of the policy, an outline of coverage that uses uniform language and format (including layout and print size) that facilitates comparison among medicare supplemental policies and comparison with medicare benefits.
(4) The issuer of the medicare supplemental policy complies with subsection (s)(2)(E) and subsection (x).
(5) In addition to the requirement under paragraph (2), the issuer of the policy must make available to the individual at least Medicare supplemental policies with benefit packages classified as "C" or "F".
(p) Standards for group benefits
(1)(A) If, within 9 months after November 5, 1990, the National Association of Insurance Commissioners (in this subsection referred to as the "Association") changes the revised NAIC Model Regulation (described in subsection (m)) to incorporate—
(i) limitations on the groups or packages of benefits that may be offered under a medicare supplemental policy consistent with paragraphs (2) and (3) of this subsection,
(ii) uniform language and definitions to be used with respect to such benefits,
(iii) uniform format to be used in the policy with respect to such benefits, and
(iv) other standards to meet the additional requirements imposed by the amendments made by the Omnibus Budget Reconciliation Act of 1990,
subsection (g)(2)(A) shall be applied in each State, effective for policies issued to policyholders on and after the date specified in subparagraph (C), as if the reference to the Model Regulation adopted on June 6, 1979, were a reference to the revised NAIC Model Regulation as changed under this subparagraph (such changed regulation referred to in this section as the "1991 NAIC Model Regulation").
(B) If the Association does not make the changes in the revised NAIC Model Regulation within the 9-month period specified in subparagraph (A), the Secretary shall promulgate, not later than 9 months after the end of such period, a regulation and subsection (g)(2)(A) shall be applied in each State, effective for policies issued to policyholders on and after the date specified in subparagraph (C), as if the reference to the Model Regulation adopted on June 6, 1979, were a reference to the revised NAIC Model Regulation as changed by the Secretary under this subparagraph (such changed regulation referred to in this section as the "1991 Federal Regulation").
(C)(i) Subject to clause (ii), the date specified in this subparagraph for a State is the date the State adopts the 1991 NAIC Model Regulation or 1991 Federal Regulation or 1 year after the date the Association or the Secretary first adopts such standards, whichever is earlier.
(ii) In the case of a State which the Secretary identifies, in consultation with the Association, as—
(I) requiring State legislation (other than legislation appropriating funds) in order for medicare supplemental policies to meet the 1991 NAIC Model Regulation or 1991 Federal Regulation, but
(II) having a legislature which is not scheduled to meet in 1992 in a legislative session in which such legislation may be considered,
the date specified in this subparagraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after January 1, 1992. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.
(D) In promulgating standards under this paragraph, the Association or Secretary shall consult with a working group composed of representatives of issuers of medicare supplemental policies, consumer groups, medicare beneficiaries, and other qualified individuals. Such representatives shall be selected in a manner so as to assure balanced representation among the interested groups.
(E) If benefits (including deductibles and coinsurance) under this subchapter are changed and the Secretary determines, in consultation with the Association, that changes in the 1991 NAIC Model Regulation or 1991 Federal Regulation are needed to reflect such changes, the preceding provisions of this paragraph shall apply to the modification of standards previously established in the same manner as they applied to the original establishment of such standards.
(2) The benefits under the 1991 NAIC Model Regulation or 1991 Federal Regulation shall provide—
(A) for such groups or packages of benefits as may be appropriate taking into account the considerations specified in paragraph (3) and the requirements of the succeeding subparagraphs;
(B) for identification of a core group of basic benefits common to all policies; and
(C) that, subject to paragraph (4)(B), the total number of different benefit packages (counting the core group of basic benefits described in subparagraph (B) and each other combination of benefits that may be offered as a separate benefit package) that may be established in all the States and by all issuers shall not exceed 10 plus the 2 plans described in paragraph (11)(A).
(3) The benefits under paragraph (2) shall, to the extent possible—
(A) provide for benefits that offer consumers the ability to purchase the benefits that are available in the market as of November 5, 1990; and
(B) balance the objectives of (i) simplifying the market to facilitate comparisons among policies, (ii) avoiding adverse selection, (iii) providing consumer choice, (iv) providing market stability, and (v) promoting competition.
(4)(A)(i) Except as provided in subparagraph (B) or paragraph (6), no State with a regulatory program approved under subsection (b)(1) may provide for or permit the grouping of benefits (or language or format with respect to such benefits) under a medicare supplemental policy unless such grouping meets the applicable 1991 NAIC Model Regulation or 1991 Federal Regulation.
(ii) Except as provided in subparagraph (B), the Secretary may not provide for or permit the grouping of benefits (or language or format with respect to such benefits) under a medicare supplemental policy seeking approval by the Secretary unless such grouping meets the applicable 1991 NAIC Model Regulation or 1991 Federal Regulation.
(B) With the approval of the State (in the case of a policy issued in a State with an approved regulatory program) or the Secretary (in the case of any other policy), the issuer of a medicare supplemental policy may offer new or innovative benefits in addition to the benefits provided in a policy that otherwise complies with the applicable 1991 NAIC Model Regulation or 1991 Federal Regulation. Any such new or innovative benefits may include benefits that are not otherwise available and are cost-effective and shall be offered in a manner which is consistent with the goal of simplification of medicare supplemental policies.
(5)(A) Except as provided in subparagraph (B), this subsection shall not be construed as preventing a State from restricting the groups of benefits that may be offered in medicare supplemental policies in the State.
(B) A State with a regulatory program approved under subsection (b)(1) may not restrict under subparagraph (A) the offering of a medicare supplemental policy consisting only of the core group of benefits described in paragraph (2)(B).
(6) The Secretary may waive the application of standards described in clauses (i) through (iii) of paragraph (1)(A) in those States that on November 5, 1990, had in place an alternative simplification program.
(7) This subsection shall not be construed as preventing an issuer of a medicare supplemental policy who otherwise meets the requirements of this section from providing, through an arrangement with a vendor, for discounts from that vendor to policyholders or certificateholders for the purchase of items or services not covered under its medicare supplemental policies.
(8) Any person who sells or issues a medicare supplemental policy, on and after the effective date specified in paragraph (1)(C) (but subject to paragraph (10)), in violation of the applicable 1991 NAIC Model Regulation or 1991 Federal Regulation insofar as such regulation relates to the requirements of subsection (o) or (q) or clause (i), (ii), or (iii) of paragraph (1)(A) is subject to a civil money penalty of not to exceed $25,000 (or $15,000 in the case of a seller who is not an issuer of a policy) for each such violation. The provisions of
(9)(A) Anyone who sells a medicare supplemental policy to an individual shall make available for sale to the individual a medicare supplemental policy with only the core group of basic benefits (described in paragraph (2)(B)).
(B) Anyone who sells a medicare supplemental policy to an individual shall provide the individual, before the sale of the policy, an outline of coverage which describes the benefits under the policy. Such outline shall be on a standard form approved by the State regulatory program or the Secretary (as the case may be) consistent with the 1991 NAIC Model Regulation or 1991 Federal Regulation under this subsection.
(C) Whoever sells a medicare supplemental policy in violation of this paragraph is subject to a civil money penalty of not to exceed $25,000 (or $15,000 in the case of a seller who is not the issuer of the policy) for each such violation. The provisions of
(D) Subject to paragraph (10), this paragraph shall apply to sales of policies occurring on or after the effective date specified in paragraph (1)(C).
(10) No penalty may be imposed under paragraph (8) or (9) in the case of a seller who is not the issuer of a policy until the Secretary has published a list of the groups of benefit packages that may be sold or issued consistent with paragraph (1)(A)(i).
(11)(A) For purposes of paragraph (2), the benefit packages described in this subparagraph are as follows:
(i) The benefit package classified as "F" under the standards established by such paragraph, except that it has a high deductible feature.
(ii) The benefit package classified as "J" under the standards established by such paragraph, except that it has a high deductible feature.
(B) For purposes of subparagraph (A), a high deductible feature is one which—
(i) requires the beneficiary of the policy to pay annual out-of-pocket expenses (other than premiums) in the amount specified in subparagraph (C) before the policy begins payment of benefits, and
(ii) covers 100 percent of covered out-of-pocket expenses once such deductible has been satisfied in a year.
(C) The amount specified in this subparagraph—
(i) for 1998 and 1999 is $1,500, and
(ii) for a subsequent year, is the amount specified in this subparagraph for the previous year increased by the percentage increase in the Consumer Price Index for all urban consumers (all items; U.S. city average) for the 12-month period ending with August of the preceding year.
If any amount determined under clause (ii) is not a multiple of $10, it shall be rounded to the nearest multiple of $10.
(q) Guaranteed renewal of policies; termination; suspension
The requirements of this subsection are as follows:
(1) Each medicare supplemental policy shall be guaranteed renewable and—
(A) the issuer may not cancel or nonrenew the policy solely on the ground of health status of the individual; and
(B) the issuer shall not cancel or nonrenew the policy for any reason other than nonpayment of premium or material misrepresentation.
(2) If the medicare supplemental policy is terminated by the group policyholder and is not replaced as provided under paragraph (4), the issuer shall offer certificateholders an individual medicare supplemental policy which (at the option of the certificateholder)—
(A) provides for continuation of the benefits contained in the group policy, or
(B) provides for such benefits as otherwise meets 3 the requirements of this section.
(3) If an individual is a certificateholder in a group medicare supplemental policy and the individual terminates membership in the group, the issuer shall—
(A) offer the certificateholder the conversion opportunity described in paragraph (2), or
(B) at the option of the group policyholder, offer the certificateholder continuation of coverage under the group policy.
(4) If a group medicare supplemental policy is replaced by another group medicare supplemental policy purchased by the same policyholder, issuer 4 of the replacement policy shall offer coverage to all persons covered under the old group policy on its date of termination. Coverage under the new group policy shall not result in any exclusion for preexisting conditions that would have been covered under the group policy being replaced.
(5)(A) Each medicare supplemental policy shall provide that benefits and premiums under the policy shall be suspended at the request of the policyholder for the period (not to exceed 24 months) in which the policyholder has applied for and is determined to be entitled to medical assistance under subchapter XIX, but only if the policyholder notifies the issuer of such policy within 90 days after the date the individual becomes entitled to such assistance. If such suspension occurs and if the policyholder or certificate holder loses entitlement to such medical assistance, such policy shall be automatically reinstituted (effective as of the date of termination of such entitlement) under terms described in subsection (n)(6)(A)(ii) as of the termination of such entitlement if the policyholder provides notice of loss of such entitlement within 90 days after the date of such loss.
(B) Nothing in this section shall be construed as affecting the authority of a State, under subchapter XIX, to purchase a medicare supplemental policy for an individual otherwise entitled to assistance under such subchapter.
(C) Any person who issues a medicare supplemental policy and fails to comply with the requirements of this paragraph or paragraph (6) is subject to a civil money penalty of not to exceed $25,000 for each such violation. The provisions of
(6) Each medicare supplemental policy shall provide that benefits and premiums under the policy shall be suspended at the request of the policyholder if the policyholder is entitled to benefits under
(r) Required ratio of aggregate benefits to aggregate premiums
(1) A medicare supplemental policy may not be issued or renewed (or otherwise provide coverage after the date described in subsection (p)(1)(C)) in any State unless—
(A) the policy can be expected for periods after the effective date of these provisions (as estimated for the entire period for which rates are computed to provide coverage, on the basis of incurred claims experience and earned premiums for such periods and in accordance with a uniform methodology, including uniform reporting standards, developed by the National Association of Insurance Commissioners) to return to policyholders in the form of aggregate benefits provided under the policy, at least 75 percent of the aggregate amount of premiums collected in the case of group policies and at least 65 percent in the case of individual policies; and
(B) the issuer of the policy provides for the issuance of a proportional refund, or a credit against future premiums of a proportional amount, based on the premium paid and in accordance with paragraph (2), of the amount of premiums received necessary to assure that the ratio of aggregate benefits provided to the aggregate premiums collected (net of such refunds or credits) complies with the expectation required under subparagraph (A), treating policies of the same type as a single policy for each standard package.
For purposes of applying subparagraph (A) only, policies issued as a result of solicitations of individuals through the mails or by mass media advertising (including both print and broadcast advertising) shall be deemed to be individual policies. For the purpose of calculating the refund or credit required under paragraph (1)(B) for a policy issued before the date specified in subsection (p)(1)(C), the refund or credit calculation shall be based on the aggregate benefits provided and premiums collected under all such policies issued by an insurer in a State (separated as to individual and group policies) and shall be based only on aggregate benefits provided and premiums collected under such policies after the date specified in section 171(m)(4) of the Social Security Act Amendments of 1994.
(2)(A) Paragraph (1)(B) shall be applied with respect to each type of policy by standard package. Paragraph (1)(B) shall not apply to a policy until 12 months following issue. The Comptroller General, in consultation with the National Association of Insurance Commissioners, shall submit to Congress a report containing recommendations on adjustments in the percentages under paragraph (1)(A) that may be appropriate. In the case of a policy issued before the date specified in subsection (p)(1)(C), paragraph (1)(B) shall not apply until 1 year after the date specified in section 171(m)(4) of the Social Security Act Amendments of 1994.
(B) A refund or credit required under paragraph (1)(B) shall be made to each policyholder insured under the applicable policy as of the last day of the year involved.
(C) Such a refund or credit shall include interest from the end of the calendar year involved until the date of the refund or credit at a rate as specified by the Secretary for this purpose from time to time which is not less than the average rate of interest for 13-week Treasury notes.
(D) For purposes of this paragraph and paragraph (1)(B), refunds or credits against premiums due shall be made, with respect to a calendar year, not later than the third quarter of the succeeding calendar year.
(3) The provisions of this subsection do not preempt a State from requiring a higher percentage than that specified in paragraph (1)(A).
(4) The Secretary shall submit in October of each year (beginning with 1993) a report to the Committees on Energy and Commerce and Ways and Means of the House of Representatives and the Committee on Finance of the Senate on loss ratios under medicare supplemental policies and the use of sanctions, such as a required rebate or credit or the disallowance of premium increases, for policies that fail to meet the requirements of this subsection (relating to loss ratios). Such report shall include a list of the policies that failed to comply with such loss ratio requirements or other requirements of this section.
(5) The Secretary may perform audits with respect to the compliance of medicare supplemental policies with the loss ratio requirements of this subsection and shall report the results of such audits to the State involved.
(6)(A) A person who fails to provide refunds or credits as required in paragraph (1)(B) is subject to a civil money penalty of not to exceed $25,000 for each policy issued for which such failure occurred. The provisions of
(B) Each issuer of a policy subject to the requirements of paragraph (1)(B) shall be liable to the policyholder or, in the case of a group policy, to the certificate holder for credits required under such paragraph.
(s) Coverage for pre-existing conditions
(1) If a medicare supplemental policy replaces another medicare supplemental policy, the issuer of the replacing policy shall waive any time periods applicable to preexisting conditions, waiting period, elimination periods and probationary periods in the new medicare supplemental policy for similar benefits to the extent such time was spent under the original policy.
(2)(A) The issuer of a medicare supplemental policy may not deny or condition the issuance or effectiveness of a medicare supplemental policy, or discriminate in the pricing of the policy, because of health status, claims experience, receipt of health care, or medical condition in the case of an individual for whom an application is submitted prior to or during the 6 month period beginning with the first month as of the first day on which the individual is 65 years of age or older and is enrolled for benefits under part B.
(B) Subject to subparagraphs (C) and (D), subparagraph (A) shall not be construed as preventing the exclusion of benefits under a policy, during its first 6 months, based on a pre-existing condition for which the policyholder received treatment or was otherwise diagnosed during the 6 months before the policy became effective.
(C) If a medicare supplemental policy or certificate replaces another such policy or certificate which has been in effect for 6 months or longer, the replacing policy may not provide any time period applicable to pre-existing conditions, waiting periods, elimination periods, and probationary periods in the new policy or certificate for similar benefits.
(D) In the case of a policy issued during the 6-month period described in subparagraph (A) to an individual who is 65 years of age or older as of the date of issuance and who as of the date of the application for enrollment has a continuous period of creditable coverage (as defined in section 2701(c) 5 of the Public Health Service Act) of—
(i) at least 6 months, the policy may not exclude benefits based on a pre-existing condition; or
(ii) less than 6 months, if the policy excludes benefits based on a preexisting condition, the policy shall reduce the period of any preexisting condition exclusion by the aggregate of the periods of creditable coverage (if any, as so defined) applicable to the individual as of the enrollment date.
The Secretary shall specify the manner of the reduction under clause (ii), based upon the rules used by the Secretary in carrying out section 2701(a)(3) of such Act.
(E) An issuer of a medicare supplemental policy shall not deny or condition the issuance or effectiveness of the policy (including the imposition of any exclusion of benefits under the policy based on a pre-existing condition) and shall not discriminate in the pricing of the policy (including the adjustment of premium rates) of an individual on the basis of the genetic information with respect to such individual.
(F)
(i) denying or conditioning the issuance or effectiveness of the policy or increasing the premium for an employer based on the manifestation of a disease or disorder of an individual who is covered under the policy; or
(ii) increasing the premium for any policy issued to an individual based on the manifestation of a disease or disorder of an individual who is covered under the policy (in such case, the manifestation of a disease or disorder in one individual cannot also be used as genetic information about other group members and to further increase the premium for the employer).
(3)(A) The issuer of a medicare supplemental policy—
(i) may not deny or condition the issuance or effectiveness of a medicare supplemental policy described in subparagraph (C) that is offered and is available for issuance to new enrollees by such issuer;
(ii) may not discriminate in the pricing of such policy, because of health status, claims experience, receipt of health care, or medical condition; and
(iii) may not impose an exclusion of benefits based on a preexisting condition under such policy,
in the case of an individual described in subparagraph (B) who seeks to enroll under the policy during the period specified in subparagraph (E) and who submits evidence of the date of termination or disenrollment along with the application for such medicare supplemental policy.
(B) An individual described in this subparagraph is an individual described in any of the following clauses:
(i) The individual is enrolled under an employee welfare benefit plan that provides health benefits that supplement the benefits under this subchapter and the plan terminates or ceases to provide all such supplemental health benefits to the individual.
(ii) The individual is enrolled with a Medicare+Choice organization under a Medicare+Choice plan under part C, and there are circumstances permitting discontinuance of the individual's election of the plan under the first sentence of
(iii) The individual is enrolled with an eligible organization under a contract under
(iv) The individual is enrolled under a medicare supplemental policy under this section and such enrollment ceases because—
(I) of the bankruptcy or insolvency of the issuer or because of other involuntary termination of coverage or enrollment under such policy and there is no provision under applicable State law for the continuation or conversion of such coverage;
(II) the issuer of the policy substantially violated a material provision of the policy; or
(III) the issuer (or an agent or other entity acting on the issuer's behalf) materially misrepresented the policy's provisions in marketing the policy to the individual.
(v) The individual—
(I) was enrolled under a medicare supplemental policy under this section,
(II) subsequently terminates such enrollment and enrolls, for the first time, with any Medicare+Choice organization under a Medicare+Choice plan under part C, any eligible organization under a contract under
(III) the subsequent enrollment under subclause (II) is terminated by the enrollee during any period within the first 12 months of such enrollment (during which the enrollee is permitted to terminate such subsequent enrollment under
(vi) The individual, upon first becoming eligible for benefits under part A at age 65, enrolls in a Medicare+Choice plan under part C or in a PACE program under
(C)(i) Subject to clauses (ii) and (iii), a medicare supplemental policy described in this subparagraph is a medicare supplemental policy which has a benefit package classified as "A", "B", "C", or "F" under the standards established under subsection (p)(2).
(ii)(I) Subject to subclause (II), only for purposes of an individual described in subparagraph (B)(v), a medicare supplemental policy described in this subparagraph is the same medicare supplemental policy referred to in such subparagraph in which the individual was most recently previously enrolled, if available from the same issuer, or, if not so available, a policy described in clause (i).
(II) If the medicare supplemental policy referred to in subparagraph (B)(v) was a medigap Rx policy (as defined in subsection (v)(6)(A)), a medicare supplemental policy described in this subparagraph is such policy in which the individual was most recently enrolled as modified under subsection (v)(2)(C)(i) or, at the election of the individual, a policy referred to in subsection (v)(3)(A)(i).
(iii) Only for purposes of an individual described in subparagraph (B)(vi) and subject to subsection (v)(1), a medicare supplemental policy described in this subparagraph shall include any medicare supplemental policy.
(iv) For purposes of applying this paragraph in the case of a State that provides for offering of benefit packages other than under the classification referred to in clause (i), the references to benefit packages in such clause are deemed references to comparable benefit packages offered in such State.
(D) At the time of an event described in subparagraph (B) because of which an individual ceases enrollment or loses coverage or benefits under a contract or agreement, policy, or plan, the organization that offers the contract or agreement, the insurer offering the policy, or the administrator of the plan, respectively, shall notify the individual of the rights of the individual under this paragraph, and obligations of issuers of medicare supplemental policies, under subparagraph (A).
(E) For purposes of subparagraph (A), the time period specified in this subparagraph is—
(i) in the case of an individual described in subparagraph (B)(i), the period beginning on the date the individual receives a notice of termination or cessation of all supplemental health benefits (or, if no such notice is received, notice that a claim has been denied because of such a termination or cessation) and ending on the date that is 63 days after the applicable notice;
(ii) in the case of an individual described in clause (ii), (iii), (v), or (vi) of subparagraph (B) whose enrollment is terminated involuntarily, the period beginning on the date that the individual receives a notice of termination and ending on the date that is 63 days after the date the applicable coverage is terminated;
(iii) in the case of an individual described in subparagraph (B)(iv)(I), the period beginning on the earlier of (I) the date that the individual receives a notice of termination, a notice of the issuer's bankruptcy or insolvency, or other such similar notice, if any, and (II) the date that the applicable coverage is terminated, and ending on the date that is 63 days after the date the coverage is terminated;
(iv) in the case of an individual described in clause (ii), (iii), (iv)(II), (iv)(III), (v), or (vi) of subparagraph (B) who disenrolls voluntarily, the period beginning on the date that is 60 days before the effective date of the disenrollment and ending on the date that is 63 days after such effective date; and
(v) in the case of an individual described in subparagraph (B) but not described in the preceding provisions of this subparagraph, the period beginning on the effective date of the disenrollment and ending on the date that is 63 days after such effective date.
(F)(i) Subject to clause (ii), for purposes of this paragraph—
(I) in the case of an individual described in subparagraph (B)(v) (or deemed to be so described, pursuant to this subparagraph) whose enrollment with an organization or provider described in subclause (II) of such subparagraph is involuntarily terminated within the first 12 months of such enrollment, and who, without an intervening enrollment, enrolls with another such organization or provider, such subsequent enrollment shall be deemed to be an initial enrollment described in such subparagraph; and
(II) in the case of an individual described in clause (vi) of subparagraph (B) (or deemed to be so described, pursuant to this subparagraph) whose enrollment with a plan or in a program described in such clause is involuntarily terminated within the first 12 months of such enrollment, and who, without an intervening enrollment, enrolls in another such plan or program, such subsequent enrollment shall be deemed to be an initial enrollment described in such clause.
(ii) For purposes of clauses (v) and (vi) of subparagraph (B), no enrollment of an individual with an organization or provider described in clause (v)(II), or with a plan or in a program described in clause (vi), may be deemed to be an initial enrollment under this clause after the 2-year period beginning on the date on which the individual first enrolled with such an organization, provider, plan, or program.
(4) Any issuer of a medicare supplemental policy that fails to meet the requirements of this subsection is subject to a civil money penalty of not to exceed $5,000 for each such failure. The provisions of
(t) Medicare select policies
(1) If a medicare supplemental policy meets the 1991 NAIC Model Regulation or 1991 Federal Regulation and otherwise complies with the requirements of this section except that benefits under the policy are restricted to items and services furnished by certain entities (or reduced benefits are provided when items or services are furnished by other entities), the policy shall nevertheless be treated as meeting those standards if—
(A) full benefits are provided for items and services furnished through a network of entities which have entered into contracts or agreements with the issuer of the policy;
(B) full benefits are provided for items and services furnished by other entities if the services are medically necessary and immediately required because of an unforeseen illness, injury, or condition and it is not reasonable given the circumstances to obtain the services through the network;
(C) the network offers sufficient access;
(D) the issuer of the policy has arrangements for an ongoing quality assurance program for items and services furnished through the network;
(E)(i) the issuer of the policy provides to each enrollee at the time of enrollment an explanation of (I) the restrictions on payment under the policy for services furnished other than by or through the network, (II) out of area coverage under the policy, (III) the policy's coverage of emergency services and urgently needed care, and (IV) the availability of a policy through the entity that meets the standards in the 1991 NAIC Model Regulation or 1991 Federal Regulation without reference to this subsection and the premium charged for such policy, and
(ii) each enrollee prior to enrollment acknowledges receipt of the explanation provided under clause (i); and
(F) the issuer of the policy makes available to individuals, in addition to the policy described in this subsection, any policy (otherwise offered by the issuer to individuals in the State) that meets the standards in the 1991 NAIC Model Regulation or 1991 Federal Regulation and other requirements of this section without reference to this subsection.
(2) If the Secretary determines that an issuer of a policy approved under paragraph (1)—
(A) fails substantially to provide medically necessary items and services to enrollees seeking such items and services through the issuer's network, if the failure has adversely affected (or has substantial likelihood of adversely affecting) the individual,
(B) imposes premiums on enrollees in excess of the premiums approved by the State,
(C) acts to expel an enrollee for reasons other than nonpayment of premiums, or
(D) does not provide the explanation required under paragraph (1)(E)(i) or does not obtain the acknowledgment required under paragraph (1)(E)(ii),
the issuer is subject to a civil money penalty in an amount not to exceed $25,000 for each such violation. The provisions of
(3) The Secretary may enter into a contract with an entity whose policy has been certified under paragraph (1) or has been approved by a State under subsection (b)(1)(H) to determine whether items and services (furnished to individuals entitled to benefits under this subchapter and under that policy) are not allowable under
(u) Additional rules relating to individuals enrolled in MSA plans and in private fee-for-service plans
(1) It is unlawful for a person to sell or issue a policy described in paragraph (2) to an individual with knowledge that the individual has in effect under
(2)(A) A policy described in this subparagraph is a health insurance policy (other than a policy described in subparagraph (B)) that provides for coverage of expenses that are otherwise required to be counted toward meeting the annual deductible amount provided under the MSA plan.
(B) A policy described in this subparagraph is any of the following:
(i) A policy that provides coverage (whether through insurance or otherwise) for accidents, disability, dental care, vision care, or long-term care.
(ii) A policy of insurance to which substantially all of the coverage relates to—
(I) liabilities incurred under workers' compensation laws,
(II) tort liabilities,
(III) liabilities relating to ownership or use of property, or
(IV) such other similar liabilities as the Secretary may specify by regulations.
(iii) A policy of insurance that provides coverage for a specified disease or illness.
(iv) A policy of insurance that pays a fixed amount per day (or other period) of hospitalization.
(v) Rules relating to medigap policies that provide prescription drug coverage
(1) Prohibition on sale, issuance, and renewal of new policies that provide prescription drug coverage
(A) In general
Notwithstanding any other provision of law, on or after January 1, 2006, a medigap Rx policy (as defined in paragraph (6)(A)) may not be sold, issued, or renewed under this section—
(i) to an individual who is a part D enrollee (as defined in paragraph (6)(B)); or
(ii) except as provided in subparagraph (B), to an individual who is not a part D enrollee.
(B) Continuation permitted for non-part D enrollees
Subparagraph (A)(ii) shall not apply to the renewal of a medigap Rx policy that was issued before January 1, 2006.
(C) Construction
Nothing in this subsection shall be construed as preventing the offering on and after January 1, 2006, of "H", "I", and "J" policies described in paragraph (2)(D)(i) if the benefit packages are modified in accordance with paragraph (2)(C).
(2) Elimination of duplicative coverage upon part D enrollment
(A) In general
In the case of an individual who is covered under a medigap Rx policy and enrolls under a part D plan—
(i) before the end of the initial part D enrollment period, the individual may—
(I) enroll in a medicare supplemental policy without prescription drug coverage under paragraph (3); or
(II) continue the policy in effect subject to the modification described in subparagraph (C)(i); or
(ii) after the end of such period, the individual may continue the policy in effect subject to such modification.
(B) Notice required to be provided to current policyholders with medigap Rx policy
No medicare supplemental policy of an issuer shall be deemed to meet the standards in subsection (c) unless the issuer provides written notice (in accordance with standards of the Secretary established in consultation with the National Association of Insurance Commissioners) during the 60-day period immediately preceding the initial part D enrollment period, to each individual who is a policyholder or certificate holder of a medigap Rx policy (at the most recent available address of that individual) of the following:
(i) If the individual enrolls in a plan under part D during the initial enrollment period under
(I) continuing enrollment in the individual's current plan, but the plan's coverage of prescription drugs will be modified under subparagraph (C)(i); or
(II) enrolling in another medicare supplemental policy pursuant to paragraph (3).
(ii) If the individual does not enroll in a plan under part D during such period, the individual may continue enrollment in the individual's current plan without change, but—
(I) the individual will not be guaranteed the option of enrollment in another medicare supplemental policy pursuant to paragraph (3); and
(II) if the current plan does not provide creditable prescription drug coverage (as defined in
(iii) Such other information as the Secretary may specify (in consultation with the National Association of Insurance Commissioners), including the potential impact of such election on premiums for medicare supplemental policies.
(C) Modification
(i) In general
The policy modification described in this subparagraph is the elimination of prescription coverage for expenses of prescription drugs incurred after the effective date of the individual's coverage under a part D plan and the appropriate adjustment of premiums to reflect such elimination of coverage.
(ii) Continuation of renewability and application of modification
No medicare supplemental policy of an issuer shall be deemed to meet the standards in subsection (c) unless the issuer—
(I) continues renewability of medigap Rx policies that it has issued, subject to subclause (II); and
(II) applies the policy modification described in clause (i) in the cases described in clauses (i)(II) and (ii) of subparagraph (A).
(D) References to Rx policies
(i) H, I, and J policies
Any reference to a benefit package classified as "H", "I", or "J" (including the benefit package classified as "J" with a high deductible feature, as described in subsection (p)(11)) under the standards established under subsection (p)(2) shall be construed as including a reference to such a package as modified under subparagraph (C) and such packages as modified shall not be counted as a separate benefit package under such subsection.
(ii) Application in waivered States
Except for the modification provided under subparagraph (C), the waivers previously in effect under subsection (p)(2) shall continue in effect.
(3) Availability of substitute policies with guaranteed issue
(A) In general
The issuer of a medicare supplemental policy—
(i) may not deny or condition the issuance or effectiveness of a medicare supplemental policy that has a benefit package classified as "A", "B", "C", or "F" (including the benefit package classified as "F" with a high deductible feature, as described in subsection (p)(11)), under the standards established under subsection (p)(2), or a benefit package described in subparagraph (A) or (B) of subsection (w)(2) and that is offered and is available for issuance to new enrollees by such issuer;
(ii) may not discriminate in the pricing of such policy, because of health status, claims experience, receipt of health care, or medical condition; and
(iii) may not impose an exclusion of benefits based on a pre-existing condition under such policy,
in the case of an individual described in subparagraph (B) who seeks to enroll under the policy not later than 63 days after the effective date of the individual's coverage under a part D plan.
(B) Individual covered
An individual described in this subparagraph with respect to the issuer of a medicare supplemental policy is an individual who—
(i) enrolls in a part D plan during the initial part D enrollment period;
(ii) at the time of such enrollment was enrolled in a medigap Rx policy issued by such issuer; and
(iii) terminates enrollment in such policy and submits evidence of such termination along with the application for the policy under subparagraph (A).
(C) Special rule for waivered States
For purposes of applying this paragraph in the case of a State that provides for offering of benefit packages other than under the classification referred to in subparagraph (A)(i), the references to benefit packages in such subparagraph are deemed references to comparable benefit packages offered in such State.
(4) Enforcement
(A) Penalties for duplication
The penalties described in subsection (d)(3)(A)(ii) shall apply with respect to a violation of paragraph (1)(A).
(B) Guaranteed issue
The provisions of paragraph (4) of subsection (s) shall apply with respect to the requirements of paragraph (3) in the same manner as they apply to the requirements of such subsection.
(5) Construction
Any provision in this section or in a medicare supplemental policy relating to guaranteed renewability of coverage shall be deemed to have been met with respect to a part D enrollee through the continuation of the policy subject to modification under paragraph (2)(C) or the offering of a substitute policy under paragraph (3). The previous sentence shall not be construed to affect the guaranteed renewability of such a modified or substitute policy.
(6) Definitions
For purposes of this subsection:
(A) Medigap Rx policy
The term "medigap Rx policy" means a medicare supplemental policy—
(i) which has a benefit package classified as "H", "I", or "J" (including the benefit package classified as "J" with a high deductible feature, as described in subsection (p)(11)) under the standards established under subsection (p)(2), without regard to this subsection; and
(ii) to which such standards do not apply (or to which such standards have been waived under subsection (p)(6)) but which provides benefits for prescription drugs.
Such term does not include a policy with a benefit package as classified under clause (i) which has been modified under paragraph (2)(C)(i).
(B) Part D enrollee
The term "part D enrollee" means an individual who is enrolled in a part D plan.
(C) Part D plan
The term "part D plan" means a prescription drug plan or an MA–PD plan (as defined for purposes of part D).
(D) Initial part D enrollment period
The term "initial part D enrollment period" means the initial enrollment period described in
(w) Development of new standards for medicare supplemental policies
(1) In general
The Secretary shall request the National Association of Insurance Commissioners to review and revise the standards for benefit packages under subsection (p)(1), taking into account the changes in benefits resulting from enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and to otherwise update standards to reflect other changes in law included in such Act. Such revision shall incorporate the inclusion of the 2 benefit packages described in paragraph (2). Such revisions shall be made consistent with the rules applicable under subsection (p)(1)(E) with the reference to the "1991 NAIC Model Regulation" deemed a reference to the NAIC Model Regulation as published in the Federal Register on December 4, 1998, and as subsequently updated by the National Association of Insurance Commissioners to reflect previous changes in law (and subsection (v)) and the reference to "date of enactment of this subsection" deemed a reference to December 8, 2003. To the extent practicable, such revision shall provide for the implementation of revised standards for benefit packages as of January 1, 2006.
(2) New benefit packages
The benefit packages described in this paragraph are the following (notwithstanding any other provision of this section relating to a core benefit package):
(A) First new benefit package
A benefit package consisting of the following:
(i) Subject to clause (ii), coverage of 50 percent of the cost-sharing otherwise applicable under parts A and B, except there shall be no coverage of the part B deductible and coverage of 100 percent of any cost-sharing otherwise applicable for preventive benefits.
(ii) Coverage for all hospital inpatient coinsurance and 365 extra lifetime days of coverage of inpatient hospital services (as in the current core benefit package).
(iii) A limitation on annual out-of-pocket expenditures under parts A and B to $4,000 in 2006 (or, in a subsequent year, to such limitation for the previous year increased by an appropriate inflation adjustment specified by the Secretary).
(B) Second new benefit package
A benefit package consisting of the benefit package described in subparagraph (A), except as follows:
(i) Substitute "75 percent" for "50 percent" in clause (i) of such subparagraph.
(ii) Substitute "$2,000" for "$4,000" in clause (iii) of such subparagraph.
(x) Limitations on genetic testing and information
(1) Genetic testing
(A) Limitation on requesting or requiring genetic testing
An issuer of a medicare supplemental policy shall not request or require an individual or a family member of such individual to undergo a genetic test.
(B) Rule of construction
Subparagraph (A) shall not be construed to limit the authority of a health care professional who is providing health care services to an individual to request that such individual undergo a genetic test.
(C) Rule of construction regarding payment
(i) In general
Nothing in subparagraph (A) shall be construed to preclude an issuer of a medicare supplemental policy from obtaining and using the results of a genetic test in making a determination regarding payment (as such term is defined for the purposes of applying the regulations promulgated by the Secretary under part C of subchapter XI and section 264 of the Health Insurance Portability and Accountability Act of 1996, as may be revised from time to time) consistent with subsection (s)(2)(E).
(ii) Limitation
For purposes of clause (i), an issuer of a medicare supplemental policy may request only the minimum amount of information necessary to accomplish the intended purpose.
(D) Research exception
Notwithstanding subparagraph (A), an issuer of a medicare supplemental policy may request, but not require, that an individual or a family member of such individual undergo a genetic test if each of the following conditions is met:
(i) The request is made pursuant to research that complies with part 46 of title 45, Code of Federal Regulations, or equivalent Federal regulations, and any applicable State or local law or regulations for the protection of human subjects in research.
(ii) The issuer clearly indicates to each individual, or in the case of a minor child, to the legal guardian of such child, to whom the request is made that—
(I) compliance with the request is voluntary; and
(II) non-compliance will have no effect on enrollment status or premium or contribution amounts.
(iii) No genetic information collected or acquired under this subparagraph shall be used for underwriting, determination of eligibility to enroll or maintain enrollment status, premium rating, or the creation, renewal, or replacement of a plan, contract, or coverage for health insurance or health benefits.
(iv) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to the exception provided for under this subparagraph, including a description of the activities conducted.
(v) The issuer complies with such other conditions as the Secretary may by regulation require for activities conducted under this subparagraph.
(2) Prohibition on collection of genetic information
(A) In general
An issuer of a medicare supplemental policy shall not request, require, or purchase genetic information for underwriting purposes (as defined in paragraph (3)).
(B) Prohibition on collection of genetic information prior to enrollment
An issuer of a medicare supplemental policy shall not request, require, or purchase genetic information with respect to any individual prior to such individual's enrollment under the policy in connection with such enrollment.
(C) Incidental collection
If an issuer of a medicare supplemental policy obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning any individual, such request, requirement, or purchase shall not be considered a violation of subparagraph (B) if such request, requirement, or purchase is not in violation of subparagraph (A).
(3) Definitions
In this subsection:
(A) Family member
The term "family member" means with respect to an individual, any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of such individual.
(B) Genetic information
(i) In general
The term "genetic information" means, with respect to any individual, information about—
(I) such individual's genetic tests,
(II) the genetic tests of family members of such individual, and
(III) subject to clause (iv), the manifestation of a disease or disorder in family members of such individual.
(ii) Inclusion of genetic services and participation in genetic research
Such term includes, with respect to any individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such individual or any family member of such individual.
(iii) Exclusions
The term "genetic information" shall not include information about the sex or age of any individual.
(C) Genetic test
(i) In general
The term "genetic test" means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.
(ii) Exceptions
The term "genetic test" does not mean—
(I) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes; or
(II) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.
(D) Genetic services
The term "genetic services" means—
(i) a genetic test;
(ii) genetic counseling (including obtaining, interpreting, or assessing genetic information); or
(iii) genetic education.
(E) Underwriting purposes
The term "underwriting purposes" means, with respect to a medicare supplemental policy—
(i) rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the policy;
(ii) the computation of premium or contribution amounts under the policy;
(iii) the application of any pre-existing condition exclusion under the policy; and
(iv) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
(F) Issuer of a medicare supplemental policy
The term "issuer of a medicare supplemental policy" includes a third-party administrator or other person acting for or on behalf of such issuer.
(4) Genetic information of a fetus or embryo
Any reference in this section to genetic information concerning an individual or family member of an individual shall—
(A) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic information of any fetus carried by such pregnant woman; and
(B) with respect to an individual or family member utilizing an assisted reproductive technology, include genetic information of any embryo legally held by the individual or family member.
(y) Development of new standards for certain medicare supplemental policies
(1) In general
The Secretary shall request the National Association of Insurance Commissioners to review and revise the standards for benefit packages described in paragraph (2) under subsection (p)(1), to otherwise update standards to include requirements for nominal cost sharing to encourage the use of appropriate physicians' services under part B. Such revisions shall be based on evidence published in peer-reviewed journals or current examples used by integrated delivery systems and made consistent with the rules applicable under subsection (p)(1)(E) with the reference to the "1991 NAIC Model Regulation" deemed a reference to the NAIC Model Regulation as published in the Federal Register on December 4, 1998, and as subsequently updated by the National Association of Insurance Commissioners to reflect previous changes in law and the reference to "date of enactment of this subsection" deemed a reference to March 23, 2010. To the extent practicable, such revision shall provide for the implementation of revised standards for benefit packages as of January 1, 2015.
(2) Benefit packages described
The benefit packages described in this paragraph are benefit packages classified as "C" and "F".
(z) Limitation on certain medigap policies for newly eligible Medicare beneficiaries
(1) In general
Notwithstanding any other provision of this section, on or after January 1, 2020, a medicare supplemental policy that provides coverage of the part B deductible, including any such policy (or rider to such a policy) issued under a waiver granted under subsection (p)(6), may not be sold or issued to a newly eligible Medicare beneficiary.
(2) Newly eligible Medicare beneficiary defined
In this subsection, the term "newly eligible Medicare beneficiary" means an individual who is neither of the following:
(A) An individual who has attained age 65 before January 1, 2020.
(B) An individual who was entitled to benefits under part A pursuant to
(3) Treatment of waivered States
In the case of a State described in subsection (p)(6), nothing in this section shall be construed as preventing the State from modifying its alternative simplification program under such subsection so as to eliminate the coverage of the part B deductible for any medical supplemental policy sold or issued under such program to a newly eligible Medicare beneficiary on or after January 1, 2020.
(4) Treatment of references to certain policies
In the case of a newly eligible Medicare beneficiary, except as the Secretary may otherwise provide, any reference in this section to a medicare supplemental policy which has a benefit package classified as "C" or "F" shall be deemed, as of January 1, 2020, to be a reference to a medicare supplemental policy which has a benefit package classified as "D" or "G", respectively.
(5) Enforcement
The penalties described in clause (ii) of subsection (d)(3)(A) shall apply with respect to a violation of paragraph (1) in the same manner as it applies to a violation of clause (i) of such subsection.
(Aug. 14, 1935, ch. 531, title XVIII, §1882, as added
Editorial Notes
References in Text
Section 171(m) of the Social Security Act Amendments of 1994, referred to in subsecs. (d)(3)(A)(vi)(IV) and (r)(1), (2)(A), is section 171(m) of
Section 603(c) of the Social Security Amendments of 1983, referred to in subsec. (g)(1), is section 603(c) of
Section 2355 of the Deficit Reduction Act of 1984, referred to in subsec. (g)(1), is section 2355 of
Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986, referred to in subsec. (g)(1), is section 9412(b) of
The Medicare Catastrophic Coverage Act of 1988, referred to in subsecs. (k)(1)(A), (2)(A) and (l)(4)(A), is
The Medicare Catastrophic Coverage Repeal Act of 1989, referred to in subsecs. (m)(1)(A), (2)(A) and (n)(2)(A), (5)(A), is
The Omnibus Budget Reconciliation Act of 1990, referred to in subsec. (p)(1)(A)(iv), is
Section 2701 of the Public Health Service Act, referred to in subsec. (s)(2)(D), is section 2701 of act July 1, 1944, which was classified to
Paragraphs (2)(A), (B) and (3)(C)–(E) of
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (w)(1), is
Section 264 of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (x)(1)(C)(i), is section 264 of
Amendments
2015—Subsec. (z).
2010—Subsec. (o)(1).
Subsec. (y).
2008—Subsec. (o)(4).
Subsec. (o)(5).
Subsec. (s)(2)(E), (F).
Subsec. (x).
Subsec. (x)(4).
2007—Subsec. (r)(5).
2003—Subsec. (d)(3)(A)(i)(II).
Subsec. (d)(3)(B)(iii)(II).
Subsec. (g)(1).
Subsec. (g)(2)(A).
Subsec. (o)(1).
Subsec. (p)(2)(B).
Subsec. (s)(3)(A)(iii).
Subsec. (s)(3)(C)(ii).
Subsec. (s)(3)(C)(iii).
Subsec. (v).
Subsec. (w).
2000—Subsec. (s)(3)(A).
Subsec. (s)(3)(E).
"(E)(i) An individual described in subparagraph (B)(ii) may elect to apply subparagraph (A) by substituting, for the date of termination of enrollment, the date on which the individual was notified by the Medicare+Choice organization of the impending termination or discontinuance of the Medicare+Choice plan it offers in the area in which the individual resides, but only if the individual disenrolls from the plan as a result of such notification.
"(ii) In the case of an individual making such an election, the issuer involved shall accept the application of the individual submitted before the date of termination of enrollment, but the coverage under subparagraph (A) shall only become effective upon termination of coverage under the Medicare+Choice plan involved."
Subsec. (s)(3)(F).
1999—Subsec. (g)(1).
Subsec. (q)(5)(C).
Subsec. (q)(6).
Subsec. (s)(2)(D).
Subsec. (s)(3)(A).
Subsec. (s)(3)(B)(ii).
Subsec. (s)(3)(B)(v)(II).
Subsec. (s)(3)(B)(vi).
Subsec. (s)(3)(E).
1998—Subsec. (l)(6).
1997—Subsec. (d)(3)(A)(i).
Subsec. (d)(3)(A)(i)(II).
Subsec. (d)(3)(A)(vi)(III).
Subsec. (d)(3)(B)(i)(I).
Subsec. (g)(1).
Subsec. (p)(2)(C).
Subsec. (p)(11).
Subsec. (s)(2)(B).
Subsec. (s)(2)(D).
Subsec. (s)(3).
Subsec. (s)(4).
Subsec. (u).
1996—Subsec. (d)(3)(A)(iii).
Subsec. (d)(3)(A)(iv) to (viii).
Subsec. (d)(3)(C).
Subsec. (d)(3)(D).
1994—Subsec. (a)(2).
Subsec. (a)(2)(A).
Subsec. (b)(1).
Subsecs. (b)(1)(B), (c)(5).
Subsec. (d)(3)(A).
Subsec. (d)(3)(B)(ii)(II).
Subsec. (d)(3)(B)(iii)(I).
Subsec. (d)(3)(B)(iii)(II).
Subsec. (d)(3)(B)(iii)(III).
Subsec. (d)(3)(C).
Subsec. (d)(3)(D).
Subsec. (d)(4)(D).
Subsec. (d)(4)(E).
Subsec. (f)(3).
Subsec. (g)(1).
Subsec. (g)(2)(B).
Subsec. (o).
Subsec. (p).
Subsec. (p)(1)(A).
Subsec. (p)(1)(B).
Subsec. (p)(1)(C)(i).
Subsec. (p)(1)(C)(ii)(I), (E).
Subsec. (p)(2).
Subsec. (p)(2)(C).
Subsec. (p)(4).
Subsec. (p)(4)(A)(i).
Subsec. (p)(6).
Subsec. (p)(7).
Subsec. (p)(8).
Subsec. (p)(9)(B).
Subsec. (p)(9)(D).
Subsec. (p)(10).
Subsec. (q)(2).
Subsec. (q)(4).
Subsec. (q)(5)(A), (B).
Subsec. (r)(1).
Subsec. (r)(1)(A).
Subsec. (r)(1)(B).
Subsec. (r)(2)(A).
Subsec. (r)(2)(C), (D).
Subsec. (r)(4).
Subsec. (r)(6)(A).
Subsec. (r)(6)(B).
Subsec. (s)(2)(A).
Subsec. (s)(2)(B).
Subsec. (t)(1).
Subsec. (t)(1)(A).
Subsec. (t)(1)(E)(i), (F).
Subsec. (t)(2).
1990—
Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(1)(D).
Subsec. (b)(1)(F).
Subsec. (b)(1)(G).
Subsec. (b)(1)(H).
Subsec. (b)(2).
"(A) There is hereby established a panel (hereinafter in this section referred to as the 'Panel') to be known as the Supplemental Health Insurance Panel. The Panel shall consist of the Secretary, who shall serve as the Chairman, and four State commissioners or superintendents of insurance, who shall be appointed by the Secretary and serve at his pleasure. Such members shall first be appointed not later than December 31, 1980.
"(B) A majority of the members of the Panel shall constitute a quorum, but a lesser number may conduct hearings.
"(C) The Secretary shall provide such technical, secretarial, clerical, and other assistance as the Panel may require.
"(D) There are authorized to be appropriated such sums as may be necessary to carry out this paragraph.
"(E) Members of the Panel shall be allowed, while away from their homes or regular places of business in the performance of services for the Panel, travel expenses (including per diem in lieu of subsistence) in the same manner as persons employed intermittently in the Government service are allowed expenses under
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(5).
Subsec. (d)(3)(A).
Subsec. (d)(3)(B).
Subsec. (d)(4)(B).
"(i) the policy has been certified by the Secretary pursuant to subsection (c) of this section or was issued in a State with an approved regulatory program (as defined in subsection (g)(2)(B) of this section);
"(ii) the policy has been approved by the commissioners or superintendents of insurance in States in which more than 30 percent of such policies are sold; or
"(iii) the State has in effect a law which the commissioner or superintendent of insurance of the State has determined gives him the authority to review, and to approve, or effectively bar from sale in the State, such policy;
except that such a policy shall not be deemed to be approved by a State commissioner or superintendent of insurance if the State notifies the Secretary that such policy has been submitted for approval to the State and has been specifically disapproved by such State after providing appropriate notice and opportunity for hearing pursuant to the procedures (if any) of the State."
Subsec. (g)(1).
Subsecs. (o), (p).
Subsec. (q).
Subsec. (q)(5).
Subsec. (r).
Subsec. (s).
Subsec. (t).
1989—Subsecs. (a), (b)(1).
Subsec. (k)(1)(A).
Subsec. (k)(3).
Subsecs. (m), (n).
1988—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(1)(D), (E).
Subsec. (b)(2)(A).
Subsec. (b)(3).
Subsec. (c).
Subsec. (c)(3).
Subsec. (c)(3)(A).
Subsec. (c)(3)(B)(i).
Subsec. (c)(3)(B)(ii).
Subsec. (c)(4).
Subsec. (d).
Subsec. (d)(5).
Subsec. (e).
Subsecs. (k), (l).
1987—Subsec. (b)(1)(B).
Subsec. (b)(1)(D).
Subsec. (c).
Subsec. (c)(3).
Subsec. (d)(1).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Committee on Interstate and Foreign Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives immediately prior to noon on Jan. 3, 1981, by House Resolution No. 549, Ninety-sixth Congress, Mar. 25, 1980. Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
Effective Date of 2008 Amendment
Effective Date of 1999 Amendments
Amendment by section 1000(a)(6) [title III, §321(k)(13), (14)] of
Amendment by section 1000(a)(6) [title V, §501(a)(2)] of
Effective Date of 1997 Amendment
"(1)
"(2)
"(3)
"(1)
"(2)
Effective Date of 1996 Amendment
"(1) Except as provided in this subsection, the amendment made by subsection (a) [amending this section] shall be effective as if included in the enactment of section 4354 of the Omnibus Budget Reconciliation Act of 1990 [
"(2)(A) Clause (vi) of section 1882(d)(3)(A) of the Social Security Act [
"(i) a health insurance policy described in section 1882(d)(3)(A)(iv) of such Act (as added by subsection (a)), after the date of the enactment of this Act [Aug. 21, 1996], or
"(ii) another health insurance policy after the end of the 30-day period beginning on the date of the enactment of this Act.
"(B) A seller or issuer of a health insurance policy may substitute, for the disclosure statement described in clause (vii) of such section, the statement specified under section 1882(d)(3)(D) of the Social Security Act (as in effect before the date of the enactment of this Act), without the revision specified in such clause."
Effective Date of 1994 Amendment
"(1) the amendments made by subsection (d)(1) [amending this section] shall take effect on the date of the enactment of this Act [Oct. 31, 1994], but no penalty shall be imposed under section 1882(d)(3)(A) of the Social Security Act [
"(2) the amendments made by subsection (d)(2)(A) [amending this section] and by subparagraphs (A), (B), and (E) of subsection (e)(1) [amending this section] shall be effective on the date specified in subsection (m)(4) [set out as a note below]; and
"(3) the amendment made by subsection (g)(2) [amending this section] shall take effect on January 1, 1995, and shall apply to individuals who attain 65 years of age or older on or after the effective date of section 1882(s)(2) of the Social Security Act [
Effective Date of 1990 Amendment
Amendment by section 4358(a), (b)(1), (2) of
Effective Date of 1989 Amendment
Effective Date of 1988 Amendment
"(1) Except as provided in paragraphs (2) and (3), the amendments made by this section [amending this section] shall take effect on the date of the enactment of this Act [July 1, 1988].
"(2) The amendments made by subsections (a) and (b) [amending this section] shall become effective on the date specified in subsection (k)(1)(B) or (k)(2)(B) of section 1882 of the Social Security Act [
"(3) The amendment made by subsection (e) [amending this section] shall apply to medicare supplemental policies as of January 1, 1989, with respect to advertising used on or after such date.
"(4) The Secretary of Health and Human Services shall provide for the reappointment of members to the Supplemental Health Insurance Panel (under section 1882(b)(2) of the Social Security Act [
Except as specifically provided in section 411 of
Amendment by section 428(b) of
Effective Date of 1987 Amendment
"(A) The amendments made by subsection (b) [amending this section] shall apply to medicare supplemental policies as of January 1, 1989 (or, if applicable, the date established under subparagraph (B)).
"(B) In the case of a State which the Secretary of Health and Human Services identifies as—
"(i) requiring State legislation (other than legislation appropriating funds) in order for medicare supplemental policies to be changed to meet the requirements of section 1882(c)(3) of the Social Security Act [
"(ii) having a legislature which is not scheduled to meet in 1988 in a legislative session in which such legislation may be considered or which has not enacted such legislation before July 1, 1988,
the date specified in this subparagraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after January 1, 1989, and in which legislation described in clause (i) may be considered."
Amendment by
Effective Date
Rule of Construction
"(1)
"(2)
Implementation of NAIC Recommendations
"(1)
"(2)
"(A)
"(B)
"(C)
Study of Medigap Policies
"(1)
"(2)
"(A) The level of coverage provided by each type of medicare supplemental policy.
"(B) The current enrollment levels in each type of medicare supplemental policy.
"(C) The availability of each type of medicare supplemental policy to medicare beneficiaries over age 65½.
"(D) The number and type of medicare supplemental policies offered in each State.
"(E) The average out-of-pocket costs (including premiums) per beneficiary under each type of medicare supplemental policy.
"(2)[(3)]
Conforming Benefits to Changes in Terminology for Hospital Outpatient Department Cost Sharing
Transition Provisions
"(1)
"(2) NAIC
"(3)
"(4)
"(A)
"(i) the date the State changes its statutes or regulations to conform its regulatory program to the changes made by this section, or
"(ii) July 1, 2009.
"(B)
"(i) requiring State legislation (other than legislation appropriating funds) to conform its regulatory program to the changes made in this section, but
"(ii) having a legislature which is not scheduled to meet in 2009 in a legislative session in which such legislation may be considered, the date specified in this paragraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after July 1, 2009. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature."
"(1)
"(2) NAIC
"(3)
"(4)
"(A)
"(i) the date the State changes its statutes or regulations to conform its regulatory program to the changes made by this section, or
"(ii) 1 year after the date the NAIC or the Secretary first makes the modifications under paragraph (2) or (3), respectively.
"(B)
"(i) requiring State legislation (other than legislation appropriating funds) to conform its regulatory program to the changes made in this section, but
"(ii) having a legislature which is not scheduled to meet in 1999 in a legislative session in which such legislation may be considered,
the date specified in this paragraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after July 1, 1999. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature."
"(1)
"(2)
"(A) includes a cause of action which arose, or which is based on or evidenced by any act or omission which occurred, during the transition period; and
"(B) relates to the application of section 1882(d)(3)(A) of the Social Security Act to any act or omission with respect to the sale, issuance, or renewal of any health insurance policy that is described in clause (iv) or (v) of such section (as amended by subsection (a)).
"(3)
"(4)
Applicability of Disclosure Requirement
State Regulatory Programs
"(1)
"(2) NAIC
"(3)
"(4)
"(A)
"(i) the date the State changes its statutes or regulations to conform its regulatory program to the changes made by this section, or
"(ii) 1 year after the date the NAIC or the Secretary first makes the modifications under paragraph (2) or (3), respectively.
"(B)
"(i) requiring State legislation (other than legislation appropriating funds) to conform its regulatory program to the changes made in this section, but
"(ii) having a legislature which is not scheduled to meet in 1996 in a legislative session in which such legislation may be considered,
the date specified in this paragraph is the first day of the first calendar quarter beginning after the close of the first legislative session of the State legislature that begins on or after January 1, 1996. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature."
Evaluation of 1990 Amendments
1 So in original. Probably should be "subsection (l)".
2 So in original. Probably should be followed by a comma.
3 So in original. Probably should be "meet".
4 So in original. Probably should be preceded by "the".
5 See References in Text note below.
§1395ss–1. Clarification
Any health insurance policy that provides reimbursement for expenses incurred for items and services for which payment may be made under title XVIII of the Social Security Act [
(
Editorial Notes
References in Text
The Social Security Act, referred to in text, is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Medicare Improvements for Patients and Providers Act of 2008, and not as part of the Social Security Act which comprises this chapter.
§1395tt. Hospital providers of extended care services
(a) Hospital facility agreements; reasonable costs of services
(1) Any hospital which has an agreement under
(2)(A) Notwithstanding any other provision of this subchapter, payment to any hospital (other than a critical access hospital) for services furnished under an agreement entered into under this section shall be based upon the reasonable cost of the services as determined under subparagraph (B).
(B)(i) The reasonable cost of the services consists of the reasonable cost of routine services (determined under clause (ii)) and the reasonable cost of ancillary services (determined under clause (iii)).
(ii) The reasonable cost of routine services furnished during any calendar year by a hospital under an agreement under this section is equal to the product of—
(I) the number of patient-days during the year for which the services were furnished, and
(II) the average reasonable cost per patient-day, such average reasonable cost per patient-day being the average rate per patient-day paid for routine services during the most recent year for which cost reporting data are available with respect to such services (increased in a compounded manner by the applicable increase for payments for routine service costs of skilled nursing facilities under subsections (a) through (d) of
(iii) The reasonable cost of ancillary services shall be determined in the same manner as the reasonable cost of ancillary services provided for inpatient hospital services.
(3) Notwithstanding any other provision of this subchapter, a critical access hospital shall be paid for covered skilled nursing facility services furnished under an agreement entered into under this section on the basis of equal to 101 percent of the reasonable costs of such services (as determined under
(b) Eligible facilities
The Secretary may not enter into an agreement under this section with any hospital unless, except as provided under subsection (g), the hospital is located in a rural area and has less than 100 beds.
(c) Terms and conditions of facility agreements
An agreement with a hospital under this section shall, except as otherwise provided under regulations of the Secretary, be of the same duration and subject to termination on the same conditions as are agreements with skilled nursing facilities under
(d) Post-hospital extended care services
Any agreement with a hospital under this section shall provide that payment for services will be made only for services for which payment would be made as post-hospital extended care services if those services had been furnished by a skilled nursing facility under an agreement entered into under
(e) Reimbursement for routine hospital services
During a period for which a hospital has in effect an agreement under this section, in order to allocate routine costs between hospital and long-term care services for purposes of determining payment for inpatient hospital services, the total reimbursement due for routine services from all classes of long-term care patients (including this subchapter, subchapter XIX, and private pay patients) shall be subtracted from the hospital's total routine costs before calculations are made to determine this subchapter reimbursement for routine hospital services.
(f) Conditions applicable to skilled nursing facilities
A hospital which enters into an agreement with the Secretary under this section shall be required to meet those conditions applicable to skilled nursing facilities relating to discharge planning and the social services function (and staffing requirements to satisfy it) which are promulgated by the Secretary under
(g) Agreements on demonstration basis
The Secretary may enter into an agreement under this section on a demonstration basis with any hospital which does not meet the requirement of subsection (b)(1), if the hospital otherwise meets the requirements of this section.
(Aug. 14, 1935, ch. 531, title XVIII, §1883, as added
Editorial Notes
Amendments
2003—Subsec. (a)(3).
2000—Subsec. (a)(2)(A).
Subsec. (a)(3).
1999—Subsec. (a)(1).
Subsec. (b).
"(1) except as provided under subsection (g) of this section, the hospital is located in a rural area and has less than 100 beds, and
"(2) the hospital has been granted a certificate of need for the provision of long-term care services from the State health planning and development agency (designated under
Subsec. (c).
Subsec. (d).
1997—Subsec. (a)(2)(B)(ii)(II).
1990—Subsec. (a)(2)(B)(ii)(II).
1989—Subsecs. (d)(1), (f).
1988—Subsec. (d)(1).
Subsec. (d)(3).
Subsec. (f).
1987—Subsec. (b)(1).
Subsec. (d).
Subsec. (f).
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Amendment by
Effective Date of 2000 Amendment
Effective Date of 1999 Amendment
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1990 Amendment
Effective Date of 1989 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Amendment by section 104(d)(6) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Amendment by section 4201(d)(3) of
Effective Date
Hold Harmless for Amendment by Pub. L. 101–508
Swing Beds Certified Prior to May 1, 1987
Report of Hospital Admissions for Extended Care Services
Report on Hospital Providers of Extended Care, Skilled Nursing, and Intermediate Care Services
§1395uu. Payments to promote closing or conversion of underutilized hospital facilities
(a) Transitional allowances; procedures applicable
Any hospital may file an application with the Secretary (in such form and including such data and information as the Secretary may require) for establishment of a transitional allowance under this subchapter with respect to the closing or conversion of an underutilized hospital facility. The Secretary also may establish procedures, consistent with this section, by which a hospital, before undergoing an actual closure or conversion of a hospital facility, can have a determination made as to whether or not it will be eligible for a transitional allowance under this section with respect to such closure or conversion.
(b) Allowable costs as transitional allowances; findings and determinations
If the Secretary finds, after consideration of an application under subsection (a), that—
(1) the hospital's closure or conversion—
(A) is formally initiated after September 30, 1981,
(B) is expected to benefit the program under this subchapter by (i) eliminating excess bed capacity, (ii) discontinuing an underutilized service for which there are adequate alternative sources, or (iii) substituting for the underutilized service some other service which is needed in the area, and
(C) is consistent with the findings of an appropriate health planning agency and with any applicable State program for reduction in the number of hospital beds in the State, and
(2) in the case of a complete closure of a hospital—
(A) the hospital is a private nonprofit hospital or a local governmental hospital, and
(B) the closure is not for replacement of the hospital,
the Secretary may include as an allowable cost in the hospital's reasonable cost (for the purpose of making payments to the hospital under this subchapter) an amount (in this section referred to as a "transitional allowance"), as provided in subsection (c).
(c) Factors determinative of transitional allowance
(1) Each transitional allowance established shall be reasonably related to the prior or prospective use of the facility involved under this subchapter and shall recognize—
(A) in the case of a facility conversion or closure (other than a complete closure of a hospital)—
(i) in the case of a private nonprofit or local governmental hospital, that portion of the hospital's costs attributable to capital assets of the facility which have been taken into account in determining reasonable cost for purposes of determining the amount of payment to the hospital under this subchapter, and
(ii) in the case of any hospital, transitional operating cost increases related to the conversion or closure to the extent that such operating costs exceed amounts ordinarily reimbursable under this subchapter; and
(B) in the case of complete closure of a hospital, the outstanding portion of actual debt obligations previously recognized as reasonable for purposes of reimbursement under this subchapter, less any salvage value of the hospital.
(2) A transitional allowance shall be for a period (not to exceed 20 years) specified by the Secretary, except that, in the case of a complete closure described in paragraph (1)(B), the Secretary may provide for a lump-sum allowance where the Secretary determines that such a one-time allowance is more efficient and economical.
(3) A transitional allowance shall take effect on a date established by the Secretary, but not earlier than the date of completion of the closure or conversion concerned.
(4) A transitional allowance shall not be considered in applying the limits to costs recognized as reasonable pursuant to the third sentence of subparagraph (A) and subparagraph (L)(i) of
(d) Hearing to review determination
A hospital dissatisfied with a determination of the Secretary on its application under this section may obtain an informal or formal hearing, at the discretion of the Secretary, by filing (in such form and within such time period as the Secretary establishes) a request for such a hearing. The Secretary shall make a final determination on such application within 30 days after the last day of such hearing.
(Aug. 14, 1935, ch. 531, title XVIII, §1884, as added
Editorial Notes
Amendments
1982—Subsec. (d).
Statutory Notes and Related Subsidiaries
Effective Date of 1982 Amendment
Amendment by
Effective Date
Payments To Promote Closure and Conversion of Underutilized Hospital Facilities
Establishment and Evaluation of Transitional Allowances; Report and Recommendations to Congress
§1395vv. Withholding payments from certain medicaid providers
(a) Adjustments by Secretary
The Secretary may adjust, in accordance with this section, payments under parts A and B to any institution which has in effect an agreement with the Secretary under
(1) has (or previously had) in effect an agreement with a State agency to furnish medical care and services under a State plan approved under subchapter XIX, and
(2) from which (or from whom) such State agency (A) has been unable to recover overpayments made under the State plan, or (B) has been unable to collect the information necessary to enable it to determine the amount (if any) of the overpayments made to such institution or person under the State plan.
(b) Implementing regulations; notice, opportunity to be heard, etc.
The Secretary shall by regulation provide procedures for implementation of this section, which procedures shall—
(1) assure that the authority under this section is exercised only on behalf of a State agency which demonstrates to the Secretary's satisfaction that it has provided adequate notice of a determination or of a need for information, and an opportunity to appeal such determination or to provide such information,
(2) determine the amount of the payment to which the institution or person would otherwise be entitled under this subchapter which shall be treated as a setoff against overpayments under subchapter XIX, and
(3) assure the restoration to the institution or person of amounts withheld under this section which are ultimately determined to be in excess of overpayments under subchapter XIX and to which the institution or person would otherwise be entitled under this subchapter.
(c) Payment to States of amounts recovered
Notwithstanding any other provision of this chapter, from the trust funds established under
(Aug. 14, 1935, ch. 531, title XVIII, §1885, as added
§1395ww. Payments to hospitals for inpatient hospital services
(a) Determination of costs for inpatient hospital services; limitations; exemptions; "operating costs of inpatient hospital services" defined
(1)(A)(i) The Secretary, in determining the amount of the payments that may be made under this subchapter with respect to operating costs of inpatient hospital services (as defined in paragraph (4)) shall not recognize as reasonable (in the efficient delivery of health services) costs for the provision of such services by a hospital for a cost reporting period to the extent such costs exceed the applicable percentage (as determined under clause (ii)) of the average of such costs for all hospitals in the same grouping as such hospital for comparable time periods.
(ii) For purposes of clause (i), the applicable percentage for hospital cost reporting periods beginning—
(I) on or after October 1, 1982, and before October 1, 1983, is 120 percent;
(II) on or after October 1, 1983, and before October 1, 1984, is 115 percent; and
(III) on or after October 1, 1984, is 110 percent.
(B)(i) For purposes of subparagraph (A) the Secretary shall establish case mix indexes for all short-term hospitals, and shall set limits for each hospital based upon the general mix of types of medical cases with respect to which such hospital provides services for which payment may be made under this subchapter.
(ii) The Secretary shall set such limits for a cost reporting period of a hospital—
(I) by updating available data for a previous period to the immediate preceding cost reporting period by the estimated average rate of change of hospital costs industry-wide, and
(II) by projecting for the cost reporting period by the applicable percentage increase (as defined in subsection (b)(3)(B)).
(C) The limitation established under subparagraph (A) for any hospital shall in no event be lower than the allowable operating costs of inpatient hospital services (as defined in paragraph (4)) recognized under this subchapter for such hospital for such hospital's last cost reporting period prior to the hospital's first cost reporting period for which this section is in effect.
(D) Subparagraph (A) shall not apply to cost reporting periods beginning on or after October 1, 1983.
(2) The Secretary shall provide for such exemptions from, and exceptions and adjustments to, the limitation established under paragraph (1)(A) as he deems appropriate, including those which he deems necessary to take into account—
(A) the special needs of sole community hospitals, of new hospitals, of risk based health maintenance organizations, and of hospitals which provide atypical services or essential community services, and to take into account extraordinary circumstances beyond the hospital's control, medical and paramedical education costs, significantly fluctuating population in the service area of the hospital, and unusual labor costs,
(B) the special needs of psychiatric hospitals and of public or other hospitals that serve a significantly disproportionate number of patients who have low income or are entitled to benefits under part A of this subchapter, and
(C) a decrease in the inpatient hospital services that a hospital provides and that are customarily provided directly by similar hospitals which results in a significant distortion in the operating costs of inpatient hospital services.
(3) The limitation established under paragraph (1)(A) shall not apply with respect to any hospital which—
(A) is located outside of a standard metropolitan statistical area, and
(B)(i) has less than 50 beds, and
(ii) was in operation and had less than 50 beds on September 3, 1982.
(4) For purposes of this section, the term "operating costs of inpatient hospital services" includes all routine operating costs, ancillary service operating costs, and special care unit operating costs with respect to inpatient hospital services as such costs are determined on an average per admission or per discharge basis (as determined by the Secretary), and includes the costs of all services for which payment may be made under this subchapter that are provided by the hospital (or by an entity wholly owned or operated by the hospital) to the patient during the 3 days (or, in the case of a hospital that is not a subsection (d) hospital, during the 1 day) immediately preceding the date of the patient's admission if such services are diagnostic services (including clinical diagnostic laboratory tests) or are other services related to the admission (as defined by the Secretary). Such term does not include costs of approved educational activities, a return on equity capital, other capital-related costs (as defined by the Secretary for periods before October 1, 1987), for cost reporting periods beginning on or after October 1, 2020, costs related to hematopoietic stem cell acquisition for the purpose of an allogeneic hematopoietic stem cell transplant (as described in subsection (d)(5)(M)), or costs with respect to administering blood clotting factors to individuals with hemophilia. In applying the first sentence of this paragraph, the term "other services related to the admission" includes all services that are not diagnostic services (other than ambulance and maintenance renal dialysis services) for which payment may be made under this subchapter that are provided by a hospital (or an entity wholly owned or operated by the hospital) to a patient—
(A) on the date of the patient's inpatient admission; or
(B) during the 3 days (or, in the case of a hospital that is not a subsection (d) hospital, during the 1 day) immediately preceding the date of such admission unless the hospital demonstrates (in a form and manner, and at a time, specified by the Secretary) that such services are not related (as determined by the Secretary) to such admission.
(b) Computation of payment; definitions; exemptions; adjustments
(1) Notwithstanding
(A) are less than or equal to the target amount (as defined in paragraph (3)) for that hospital for that period, the amount of the payment with respect to such operating costs payable under part A on a per discharge or per admission basis (as the case may be) shall be equal to the amount of such operating costs, plus—
(i) 15 percent of the amount by which the target amount exceeds the amount of the operating costs, or
(ii) 2 percent of the target amount,
whichever is less;
(B) are greater than the target amount but do not exceed 110 percent of the target amount, the amount of the payment with respect to those operating costs payable under part A on a per discharge basis shall equal the target amount; or
(C) are greater than 110 percent of the target amount, the amount of the payment with respect to such operating costs payable under part A on a per discharge or per admission basis (as the case may be) shall be equal to (i) the target amount, plus (ii) in the case of cost reporting periods beginning on or after October 1, 1991, an additional amount equal to 50 percent of the amount by which the operating costs exceed 110 percent of the target amount (except that such additional amount may not exceed 10 percent of the target amount) after any exceptions or adjustments are made to such target amount for the cost reporting period;
plus the amount, if any, provided under paragraph (2), except that in no case may the amount payable under this subchapter (other than on the basis of a DRG prospective payment rate determined under subsection (d)) with respect to operating costs of inpatient hospital services exceed the maximum amount payable with respect to such costs pursuant to subsection (a).
(2)(A) Except as provided in subparagraph (E), in addition to the payment computed under paragraph (1), in the case of an eligible hospital (described in subparagraph (B)) for a cost reporting period beginning on or after October 1, 1997, the amount of payment on a per discharge basis under paragraph (1) shall be increased by the lesser of—
(i) 50 percent of the amount by which the operating costs are less than the expected costs (as defined in subparagraph (D)) for the period; or
(ii) 1 percent of the target amount for the period.
(B) For purposes of this paragraph, an "eligible hospital" means with respect to a cost reporting period, a hospital—
(i) that has received payments under this subsection for at least 3 full cost reporting periods before that cost reporting period, and
(ii) whose operating costs for the period are less than the least of its target amount, its trended costs (as defined in subparagraph (C)), or its expected costs (as defined in subparagraph (D)) for the period.
(C) For purposes of subparagraph (B)(ii), the term "trended costs" means for a hospital cost reporting period ending in a fiscal year—
(i) in the case of a hospital for which its cost reporting period ending in fiscal year 1996 was its third or subsequent full cost reporting period for which it receives payments under this subsection, the lesser of the operating costs or target amount for that hospital for its cost reporting period ending in fiscal year 1996, or
(ii) in the case of any other hospital, the operating costs for that hospital for its third full cost reporting period for which it receives payments under this subsection,
increased (in a compounded manner) for each succeeding fiscal year (through the fiscal year involved) by the market basket percentage increase for the fiscal year.
(D) For purposes of this paragraph, the term "expected costs", with respect to the cost reporting period ending in a fiscal year, means the lesser of the operating costs of inpatient hospital services or target amount per discharge for the previous cost reporting period updated by the market basket percentage increase (as defined in paragraph (3)(B)(iii)) for the fiscal year.
(E)(i) In the case of an eligible hospital that is a hospital or unit that is within a class of hospital described in clause (ii) with a 12-month cost reporting period beginning before November 29, 1999, in determining the amount of the increase under subparagraph (A), the Secretary shall substitute for the percentage of the target amount applicable under subparagraph (A)(ii)—
(I) for a cost reporting period beginning on or after October 1, 2000, and before September 30, 2001, 1.5 percent; and
(II) for a cost reporting period beginning on or after October 1, 2001, and before September 30, 2002, 2 percent.
(ii) For purposes of clause (i), each of the following shall be treated as a separate class of hospital:
(I) Hospitals described in clause (i) of subsection (d)(1)(B) and psychiatric units described in the matter following clause (v) of such subsection.
(II) Hospitals described in clause (iv) of such subsection.
(3)(A) Except as provided in subparagraph (C) and succeeding subparagraphs, and in paragraph (7)(A)(ii), for purposes of this subsection, the term "target amount" means, with respect to a hospital for a particular 12-month cost reporting period—
(i) in the case of the first such reporting period for which this subsection is in effect, the allowable operating costs of inpatient hospital services (as defined in subsection (a)(4)) recognized under this subchapter for such hospital for the preceding 12-month cost reporting period, and
(ii) in the case of a later reporting period, the target amount for the preceding 12-month cost reporting period,
increased by the applicable percentage increase under subparagraph (B) for that particular cost reporting period.
(B)(i) For purposes of subsection (d) and subsection (j) for discharges occurring during a fiscal year, the "applicable percentage increase" shall be—
(I) for fiscal year 1986, ½ percent,
(II) for fiscal year 1987, 1.15 percent,
(III) for fiscal year 1988, 3.0 percent for hospitals located in a rural area, 1.5 percent for hospitals located in a large urban area (as defined in subsection (d)(2)(D)), and 1.0 percent for hospitals located in other urban areas,
(IV) for fiscal year 1989, the market basket percentage increase minus 1.5 percentage points for hospitals located in a rural area, the market basket percentage increase minus 2.0 percentage points for hospitals located in a large urban area, and the market basket percentage increase minus 2.5 percentage points for hospitals located in other urban areas,
(V) for fiscal year 1990, the market basket percentage increase plus 4.22 percentage points for hospitals located in a rural area, the market basket percentage increase plus 0.12 percentage points for hospitals located in a large urban area, and the market basket percentage increase minus 0.53 percentage points for hospitals located in other urban areas,
(VI) for fiscal year 1991, the market basket percentage increase minus 2.0 percentage points for hospitals in a large urban or other urban area, and the market basket percentage increase minus 0.7 percentage point for hospitals located in a rural area,
(VII) for fiscal year 1992, the market basket percentage increase minus 1.6 percentage points for hospitals in a large urban or other urban area, and the market basket percentage increase minus 0.6 percentage point for hospitals located in a rural area,
(VIII) for fiscal year 1993, the market basket percentage increase minus 1.55 percentage point for hospitals in a large urban or other urban area, and the market basket percentage increase minus 0.55 1 for hospitals located in a rural area,
(IX) for fiscal year 1994, the market basket percentage increase minus 2.5 percentage points for hospitals located in a large urban or other urban area, and the market basket percentage increase minus 1.0 percentage point for hospitals located in a rural area,
(X) for fiscal year 1995, the market basket percentage increase minus 2.5 percentage points for hospitals located in a large urban or other urban area, and such percentage increase for hospitals located in a rural area as will provide for the average standardized amount determined under subsection (d)(3)(A) for hospitals located in a rural area being equal to such average standardized amount for hospitals located in an urban area (other than a large urban area),
(XI) for fiscal year 1996, the market basket percentage increase minus 2.0 percentage points for hospitals in all areas,
(XII) for fiscal year 1997, the market basket percentage increase minus 0.5 percentage point for hospitals in all areas,
(XIII) for fiscal year 1998, 0 percent,
(XIV) for fiscal year 1999, the market basket percentage increase minus 1.9 percentage points for hospitals in all areas,
(XV) for fiscal year 2000, the market basket percentage increase minus 1.8 percentage points for hospitals in all areas,
(XVI) for fiscal year 2001, the market basket percentage increase for hospitals in all areas,
(XVII) for fiscal year 2002, the market basket percentage increase minus 0.55 percentage points for hospitals in all areas,
(XVIII) for fiscal year 2003, the market basket percentage increase minus 0.55 percentage points for hospitals in all areas,
(XIX) for each of fiscal years 2004 through 2006, subject to clause (vii), the market basket percentage increase for hospitals in all areas; 2 and
(XX) for each subsequent fiscal year, subject to clauses (viii), (ix), (xi), and (xii), the market basket percentage increase for hospitals in all areas.
(ii) For purposes of subparagraphs (A) and (E), the "applicable percentage increase" for 12-month cost reporting periods beginning during—
(I) fiscal year 1986, is 0.5 percent,
(II) fiscal year 1987, is 1.15 percent,
(III) fiscal year 1988, is the market basket percentage increase minus 2.0 percentage points,
(IV) a subsequent fiscal year ending on or before September 30, 1993, is the market basket percentage increase,
(V) fiscal years 1994 through 1997, is the market basket percentage increase minus the applicable reduction (as defined in clause (v)(II)), or in the case of a hospital for a fiscal year for which the hospital's update adjustment percentage (as defined in clause (v)(I)) is at least 10 percent, the market basket percentage increase,
(VI) for fiscal year 1998, is 0 percent,
(VII) for fiscal years 1999 through 2002, is the applicable update factor specified under clause (vi) for the fiscal year, and
(VIII) subsequent fiscal years is the market basket percentage increase.
(iii) For purposes of this subparagraph, the term "market basket percentage increase" means, with respect to cost reporting periods and discharges occurring in a fiscal year, the percentage, estimated by the Secretary before the beginning of the period or fiscal year, by which the cost of the mix of goods and services (including personnel costs but excluding nonoperating costs) comprising routine, ancillary, and special care unit inpatient hospital services, based on an index of appropriately weighted indicators of changes in wages and prices which are representative of the mix of goods and services included in such inpatient hospital services, for the period or fiscal year will exceed the cost of such mix of goods and services for the preceding 12-month cost reporting period or fiscal year.
(iv) For purposes of subparagraphs (C) and (D), the "applicable percentage increase" is—
(I) for 12-month cost reporting periods beginning during fiscal years 1986 through 1993, the applicable percentage increase specified in clause (ii),
(II) for fiscal year 1994, the market basket percentage increase minus 2.3 percentage points (adjusted to exclude any portion of a cost reporting period beginning during fiscal year 1993 for which the applicable percentage increase is determined under subparagraph (I)),
(III) for fiscal year 1995, the market basket percentage increase minus 2.2 percentage points, and
(IV) for fiscal year 1996 and each subsequent fiscal year, the applicable percentage increase under clause (i).
(v) For purposes of clause (ii)(V)—
(I) a hospital's "update adjustment percentage" for a fiscal year is the percentage by which the hospital's allowable operating costs of inpatient hospital services recognized under this subchapter for the cost reporting period beginning in fiscal year 1990 exceeds the hospital's target amount (as determined under subparagraph (A)) for such cost reporting period, increased for each fiscal year (beginning with fiscal year 1994) by the sum of any of the hospital's applicable reductions under subclause (V) for previous fiscal years; and
(II) the "applicable reduction" with respect to a hospital for a fiscal year is the lesser of 1 percentage point or the percentage point difference between 10 percent and the hospital's update adjustment percentage for the fiscal year.
(vi) For purposes of clause (ii)(VII) for a fiscal year, if a hospital's allowable operating costs of inpatient hospital services recognized under this subchapter for the most recent cost reporting period for which information is available—
(I) is equal to, or exceeds, 110 percent of the hospital's target amount (as determined under subparagraph (A)) for such cost reporting period, the applicable update factor specified under this clause is the market basket percentage;
(II) exceeds 100 percent, but is less than 110 percent, of such target amount for the hospital, the applicable update factor specified under this clause is 0 percent or, if greater, the market basket percentage minus 0.25 percentage points for each percentage point by which such allowable operating costs (expressed as a percentage of such target amount) is less than 110 percent of such target amount;
(III) is equal to, or less than 100 percent, but exceeds 2/3 of such target amount for the hospital, the applicable update factor specified under this clause is 0 percent or, if greater, the market basket percentage minus 2.5 percentage points; or
(IV) does not exceed 2/3 of such target amount for the hospital, the applicable update factor specified under this clause is 0 percent.
(vii)(I) For purposes of clause (i)(XIX) for fiscal years 2005 and 2006, in a case of a subsection (d) hospital that does not submit data to the Secretary in accordance with subclause (II) with respect to such a fiscal year, the applicable percentage increase under such clause for such fiscal year shall be reduced by 0.4 percentage points. Such reduction shall apply only with respect to the fiscal year involved, and the Secretary shall not take into account such reduction in computing the applicable percentage increase under clause (i)(XIX) for a subsequent fiscal year.
(II) For fiscal years 2005 and 2006, each subsection (d) hospital shall submit to the Secretary quality data (for a set of 10 indicators established by the Secretary as of November 1, 2003) that relate to the quality of care furnished by the hospital in inpatient settings in a form and manner, and at a time, specified by the Secretary for purposes of this clause, but with respect to fiscal year 2005, the Secretary shall provide for a 30-day grace period for the submission of data by a hospital.
(viii)(I) For purposes of clause (i) for fiscal year 2007 and each subsequent fiscal year, in the case of a subsection (d) hospital that does not submit, to the Secretary in accordance with this clause, data required to be submitted on measures selected under this clause with respect to such a fiscal year, the applicable percentage increase under clause (i) for such fiscal year shall be reduced by 2.0 percentage points (or, beginning with fiscal year 2015, by one-quarter of such applicable percentage increase (determined without regard to clause (ix), (xi), or (xii))). Such reduction shall apply only with respect to the fiscal year involved and the Secretary shall not take into account such reduction in computing the applicable percentage increase under clause (i) for a subsequent fiscal year, and the Secretary and the Medicare Payment Advisory Commission shall carry out the requirements under section 5001(b) of the Deficit Reduction Act of 2005.
(II) Each subsection (d) hospital shall submit data on measures selected under this clause to the Secretary in a form and manner, and at a time, specified by the Secretary for purposes of this clause. The Secretary may require hospitals to submit data on measures that are not used for the determination of value-based incentive payments under subsection (o).
(III) The Secretary shall expand, beyond the measures specified under clause (vii)(II) and consistent with the succeeding subclauses, the set of measures that the Secretary determines to be appropriate for the measurement of the quality of care (including medication errors) furnished by hospitals in inpatient settings.
(IV) Effective for payments beginning with fiscal year 2007, in expanding the number of measures under subclause (III), the Secretary shall begin to adopt the baseline set of performance measures as set forth in the November 2005 report by the Institute of Medicine of the National Academy of Sciences under section 238(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
(V) Effective for payments for fiscal years 2008 through 2012, the Secretary shall add other measures that reflect consensus among affected parties and, to the extent feasible and practicable, shall include measures set forth by one or more national consensus building entities.
(VI) For purposes of this clause and clause (vii), the Secretary may replace any measures or indicators in appropriate cases, such as where all hospitals are effectively in compliance or the measures or indicators have been subsequently shown not to represent the best clinical practice.
(VII) The Secretary shall establish procedures for making information regarding measures submitted under this clause available to the public. Such procedures shall ensure that a hospital has the opportunity to review the data that are to be made public with respect to the hospital prior to such data being made public. The Secretary shall report quality measures of process, structure, outcome, patients' perspectives on care, efficiency, and costs of care that relate to services furnished in inpatient settings in hospitals on the Internet website of the Centers for Medicare & Medicaid Services.
(VIII) Effective for payments beginning with fiscal year 2013, with respect to quality measures for outcomes of care, the Secretary shall provide for such risk adjustment as the Secretary determines to be appropriate to maintain incentives for hospitals to treat patients with severe illnesses or conditions.
(IX)(aa) Subject to item (bb), effective for payments beginning with fiscal year 2013, each measure specified by the Secretary under this clause shall be endorsed by the entity with a contract under
(bb) In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(X) To the extent practicable, the Secretary shall, with input from consensus organizations and other stakeholders, take steps to ensure that the measures specified by the Secretary under this clause are coordinated and aligned with quality measures applicable to—
(aa) physicians under
(bb) other providers of services and suppliers under this subchapter.
(XI) The Secretary shall establish a process to validate measures specified under this clause as appropriate. Such process shall include the auditing of a number of randomly selected hospitals sufficient to ensure validity of the reporting program under this clause as a whole and shall provide a hospital with an opportunity to appeal the validation of measures reported by such hospital.
(XII)(aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2020, such survey may not include questions about communication by hospital staff with an individual about such individual's pain unless such questions take into account, as applicable, whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain.
(bb) The Secretary shall not include on the Hospital Compare internet website any measures based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 or 2019 about communication by hospital staff with an individual about such individual's pain.
(ix)(I) For purposes of clause (i) for fiscal year 2015 and each subsequent fiscal year, in the case of an eligible hospital (as defined in subsection (n)(6)) that is not a meaningful EHR user (as defined in subsection (n)(3)) for an EHR reporting period for such fiscal year, three-quarters of the applicable percentage increase otherwise applicable under clause (i) (determined without regard to clause (viii), (xi), or (xii)) for such fiscal year shall be reduced by 331/3 percent for fiscal year 2015, 662/3 percent for fiscal year 2016, and 100 percent for fiscal year 2017 and each subsequent fiscal year. Such reduction shall apply only with respect to the fiscal year involved and the Secretary shall not take into account such reduction in computing the applicable percentage increase under clause (i) for a subsequent fiscal year.
(II) The Secretary may, on a case-by-case basis (and, with respect to the application of subclause (I) for fiscal year 2017, for categories of subsection (d) hospitals, as established by the Secretary and posted on the Internet website of the Centers for Medicare & Medicaid Services prior to December 15, 2015, an application for which must be submitted to the Secretary by not later than April 1, 2016), exempt an eligible hospital from the application of subclause (I) with respect to a fiscal year if the Secretary determines, subject to annual renewal, that requiring such hospital to be a meaningful EHR user during such fiscal year would result in a significant hardship, such as in the case of a hospital in a rural area without sufficient Internet access. The Secretary shall exempt an eligible hospital from the application of the payment adjustment under subclause (I) with respect to a fiscal year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such hospital is decertified under a program kept or recognized pursuant to
(III) For fiscal year 2015 and each subsequent fiscal year, a State in which hospitals are paid for services under
(IV) For purposes of this clause, the term "EHR reporting period" means, with respect to a fiscal year, any period (or periods) as specified by the Secretary.
(x)(I) The Secretary shall develop standard Internet website reports tailored to meet the needs of various stakeholders such as hospitals, patients, researchers, and policymakers. The Secretary shall seek input from such stakeholders in determining the type of information that is useful and the formats that best facilitate the use of the information.
(II) The Secretary shall modify the Hospital Compare Internet website to make the use and navigation of that website readily available to individuals accessing it.
(xi)(I) For 2012 and each subsequent fiscal year, after determining the applicable percentage increase described in clause (i) and after application of clauses (viii) and (ix), such percentage increase shall be reduced by the productivity adjustment described in subclause (II).
(II) The productivity adjustment described in this subclause, with respect to a percentage, factor, or update for a fiscal year, year, cost reporting period, or other annual period, is a productivity adjustment equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multi-factor productivity (as projected by the Secretary for the 10-year period ending with the applicable fiscal year, year, cost reporting period, or other annual period).
(III) The application of subclause (I) may result in the applicable percentage increase described in clause (i) being less than 0.0 for a fiscal year, and may result in payment rates under this section for a fiscal year being less than such payment rates for the preceding fiscal year.
(xii) After determining the applicable percentage increase described in clause (i), and after application of clauses (viii), (ix), and (xi), the Secretary shall reduce such applicable percentage increase—
(I) for each of fiscal years 2010 and 2011, by 0.25 percentage point;
(II) for each of fiscal years 2012 and 2013, by 0.1 percentage point;
(III) for fiscal year 2014, by 0.3 percentage point;
(IV) for each of fiscal years 2015 and 2016, by 0.2 percentage point; and
(V) for each of fiscal years 2017, 2018, and 2019, by 0.75 percentage point.
The application of this clause may result in the applicable percentage increase described in clause (i) being less than 0.0 for a fiscal year, and may result in payment rates under this section for a fiscal year being less than such payment rates for the preceding fiscal year.
(C) In the case of a hospital that is a sole community hospital (as defined in subsection (d)(5)(D)(iii)), subject to subparagraphs (I) and (L), the term "target amount" means—
(i) with respect to the first 12-month cost reporting period in which this subparagraph is applied to the hospital—
(I) the allowable operating costs of inpatient hospital services (as defined in subsection (a)(4)) recognized under this subchapter for the hospital for the 12-month cost reporting period (in this subparagraph referred to as the "base cost reporting period") preceding the first cost reporting period for which this subsection was in effect with respect to such hospital, increased (in a compounded manner) by—
(II) the applicable percentage increases applied to such hospital under this paragraph for cost reporting periods after the base cost reporting period and up to and including such first 12-month cost reporting period,
(ii) with respect to a later cost reporting period beginning before fiscal year 1994, the target amount for the preceding 12-month cost reporting period, increased by the applicable percentage increase under subparagraph (B)(iv) for discharges occurring in the fiscal year in which that later cost reporting period begins,
(iii) with respect to discharges occurring in fiscal year 1994, the target amount for the cost reporting period beginning in fiscal year 1993 increased by the applicable percentage increase under subparagraph (B)(iv), or
(iv) with respect to discharges occurring in fiscal year 1995 and each subsequent fiscal year, the target amount for the preceding year increased by the applicable percentage increase under subparagraph (B)(iv).
There shall be substituted for the base cost reporting period described in clause (i) a hospital's cost reporting period (if any) beginning during fiscal year 1987 if such substitution results in an increase in the target amount for the hospital.
(D) For cost reporting periods ending on or before September 30, 1994, and for discharges occurring on or after October 1, 1997, and before January 1, 2025, in the case of a hospital that is a medicare-dependent, small rural hospital (as defined in subsection (d)(5)(G)), subject to subparagraph (K), the term "target amount" means—
(i) with respect to the first 12-month cost reporting period in which this subparagraph is applied to the hospital—
(I) the allowable operating costs of inpatient hospital services (as defined in subsection (a)(4)) recognized under this subchapter for the hospital for the 12-month cost reporting period (in this subparagraph referred to as the "base cost reporting period") preceding the first cost reporting period for which this subsection was in effect with respect to such hospital, increased (in a compounded manner) by—
(II) the applicable percentage increases applied to such hospital under this paragraph for cost reporting periods after the base cost reporting period and up to and including such first 12-month cost reporting period, or
(ii) with respect to a later cost reporting period beginning before fiscal year 1994, the target amount for the preceding 12-month cost reporting period, increased by the applicable percentage increase under subparagraph (B)(iv) for discharges occurring in the fiscal year in which that later cost reporting period begins,
(iii) with respect to discharges occurring in fiscal year 1994, the target amount for the cost reporting period beginning in fiscal year 1993 increased by the applicable percentage increase under subparagraph (B)(iv), and
(iv) with respect to discharges occurring during fiscal year 1998 through fiscal year 2024 and the portion of fiscal year 2025 beginning on October 1, 2024, and ending on December 31, 2024, the target amount for the preceding year increased by the applicable percentage increase under subparagraph (B)(iv).
There shall be substituted for the base cost reporting period described in clause (i) a hospital's cost reporting period (if any) beginning during fiscal year 1987 if such substitution results in an increase in the target amount for the hospital.
(E) In the case of a hospital described in clause (v) of subsection (d)(1)(B), the term "target amount" means—
(i) with respect to the first 12-month cost reporting period in which this subparagraph is applied to the hospital—
(I) the allowable operating costs of inpatient hospital services (as defined in subsection (a)(4)) recognized under this subchapter for the hospital for the 12-month cost reporting period (in this subparagraph referred to as the "base cost reporting period") preceding the first cost reporting period for which this subsection was in effect with respect to such hospital, increased (in a compounded manner) by—
(II) the sum of the applicable percentage increases applied to such hospital under this paragraph for cost reporting periods after the base cost reporting period and up to and including such first 12-month cost reporting period, or
(ii) with respect to a later cost reporting period, the target amount for the preceding 12-month cost reporting period, increased by the applicable percentage increase under subparagraph (B)(ii) for that later cost reporting period.
There shall be substituted for the base cost reporting period described in clause (i) a hospital's cost reporting period (if any) beginning during fiscal year 1987 if such substitution results in an increase in the target amount for the hospital.
(F)(i) In the case of a hospital (or unit described in the matter following clause (v) of subsection (d)(1)(B)) that received payment under this subsection for inpatient hospital services furnished during cost reporting periods beginning before October 1, 1990, that is within a class of hospital described in clause (iii), and that elects (in a form and manner determined by the Secretary) this subparagraph to apply to the hospital, the target amount for the hospital's 12-month cost reporting period beginning during fiscal year 1998 is equal to the average described in clause (ii).
(ii) The average described in this clause for a hospital or unit shall be determined by the Secretary as follows:
(I) The Secretary shall determine the allowable operating costs for inpatient hospital services for the hospital or unit for each of the 5 cost reporting periods for which the Secretary has the most recent settled cost reports as of August 5, 1997.
(II) The Secretary shall increase the amount determined under subclause (I) for each cost reporting period by the applicable percentage increase under subparagraph (B)(ii) for each subsequent cost reporting period up to the cost reporting period described in clause (i).
(III) The Secretary shall identify among such 5 cost reporting periods the cost reporting periods for which the amount determined under subclause (II) is the highest, and the lowest.
(IV) The Secretary shall compute the averages of the amounts determined under subclause (II) for the 3 cost reporting periods not identified under subclause (III).
(iii) For purposes of this subparagraph, each of the following shall be treated as a separate class of hospital:
(I) Hospitals described in clause (i) of subsection (d)(1)(B) and psychiatric units described in the matter following clause (v) of such subsection.
(II) Hospitals described in clause (ii) of such subsection and rehabilitation units described in the matter following clause (v) of such subsection.
(III) Hospitals described in clause (iii) of such subsection.
(IV) Hospitals described in clause (iv) of such subsection.
(V) Hospitals described in clause (v) of such subsection.
(G)(i) In the case of a qualified long-term care hospital (as defined in clause (ii)) that elects (in a form and manner determined by the Secretary) this subparagraph to apply to the hospital, the target amount for the hospital's 12-month cost reporting period beginning during fiscal year 1998 is equal to the allowable operating costs of inpatient hospital services (as defined in subsection (a)(4)) recognized under this subchapter for the hospital for the 12-month cost reporting period beginning during fiscal year 1996, increased by the applicable percentage increase for the cost reporting period beginning during fiscal year 1997.
(ii) In clause (i), a "qualified long-term care hospital" means, with respect to a cost reporting period, a hospital described in clause (iv) of subsection (d)(1)(B) during each of the 2 cost reporting periods for which the Secretary has the most recent settled cost reports as of August 5, 1997, for each of which—
(I) the hospital's allowable operating costs of inpatient hospital services recognized under this subchapter exceeded 115 percent of the hospital's target amount, and
(II) the hospital would have a disproportionate patient percentage of at least 70 percent (as determined by the Secretary under subsection (d)(5)(F)(vi)) if the hospital were a subsection (d) hospital.
(H)(i) In the case of a hospital or unit that is within a class of hospital described in clause (iv), for a cost reporting period beginning during fiscal years 1998 through 2002, the target amount for such a hospital or unit may not exceed the amount as updated up to or for such cost reporting period under clause (ii).
(ii)(I) In the case of a hospital or unit that is within a class of hospital described in clause (iv), the Secretary shall estimate the 75th percentile of the target amounts for such hospitals within such class for cost reporting periods ending during fiscal year 1996, as adjusted under clause (iii).
(II) The Secretary shall update the amount determined under subclause (I), for each cost reporting period after the cost reporting period described in such subclause and up to the first cost reporting period beginning on or after October 1, 1997, by a factor equal to the market basket percentage increase.
(III) For cost reporting periods beginning during each of fiscal years 1999 through 2002, subject to subparagraph (J), the Secretary shall update such amount by a factor equal to the market basket percentage increase.
(iii) In applying clause (ii)(I) in the case of a hospital or unit, the Secretary shall provide for an appropriate adjustment to the labor-related portion of the amount determined under such subparagraph to take into account differences between average wage-related costs in the area of the hospital and the national average of such costs within the same class of hospital.
(iv) For purposes of this subparagraph, each of the following shall be treated as a separate class of hospital:
(I) Hospitals described in clause (i) of subsection (d)(1)(B) and psychiatric units described in the matter following clause (v) of such subsection.
(II) Hospitals described in clause (ii) of such subsection and rehabilitation units described in the matter following clause (v) of such subsection.
(III) Hospitals described in clause (iv) of such subsection.
(I)(i) Subject to subparagraph (L), for cost reporting periods beginning on or after October 1, 2000, in the case of a sole community hospital there shall be substituted for the amount otherwise determined under subsection (d)(5)(D)(i), if such substitution results in a greater amount of payment under this section for the hospital—
(I) with respect to discharges occurring in fiscal year 2001, 75 percent of the amount otherwise applicable to the hospital under subsection (d)(5)(D)(i) (referred to in this clause as the "subsection (d)(5)(D)(i) amount") and 25 percent of the rebased target amount (as defined in clause (ii));
(II) with respect to discharges occurring in fiscal year 2002, 50 percent of the subsection (d)(5)(D)(i) amount and 50 percent of the rebased target amount;
(III) with respect to discharges occurring in fiscal year 2003, 25 percent of the subsection (d)(5)(D)(i) amount and 75 percent of the rebased target amount; and
(IV) with respect to discharges occurring after fiscal year 2003, 100 percent of the rebased target amount.
(ii) For purposes of this subparagraph, the "rebased target amount" has the meaning given the term "target amount" in subparagraph (C) except that—
(I) there shall be substituted for the base cost reporting period the 12-month cost reporting period beginning during fiscal year 1996;
(II) any reference in subparagraph (C)(i) to the "first cost reporting period" described in such subparagraph is deemed a reference to the first cost reporting period beginning on or after October 1, 2000; and
(III) applicable increase percentage shall only be applied under subparagraph (C)(iv) for discharges occurring in fiscal years beginning with fiscal year 2002.
(iii) In no case shall a hospital be denied treatment as a sole community hospital or payment (on the basis of a target rate as such as a hospital) because data are unavailable for any cost reporting period due to changes in ownership, changes in fiscal intermediaries, or other extraordinary circumstances, so long as data for at least one applicable base cost reporting period is available.
(J) For cost reporting periods beginning during fiscal year 2001, for a hospital described in subsection (d)(1)(B)(iv)—
(i) the limiting or cap amount otherwise determined under subparagraph (H) shall be increased by 2 percent; and
(ii) the target amount otherwise determined under subparagraph (A) shall be increased by 25 percent (subject to the limiting or cap amount determined under subparagraph (H), as increased by clause (i)).
(K)(i) With respect to discharges occurring on or after October 1, 2006, in the case of a medicare-dependent, small rural hospital, for purposes of applying subparagraph (D)—
(I) there shall be substituted for the base cost reporting period described in subparagraph (D)(i) the 12-month cost reporting period beginning during fiscal year 2002; and
(II) any reference in such subparagraph to the "first cost reporting period" described in such subparagraph is deemed a reference to the first cost reporting period beginning on or after October 1, 2006.
(ii) This subparagraph shall only apply to a hospital if the substitution described in clause (i)(I) results in an increase in the target amount under subparagraph (D) for the hospital.
(L)(i) For cost reporting periods beginning on or after January 1, 2009, in the case of a sole community hospital there shall be substituted for the amount otherwise determined under subsection (d)(5)(D)(i) of this section, if such substitution results in a greater amount of payment under this section for the hospital, the subparagraph (L) rebased target amount.
(ii) For purposes of this subparagraph, the term "subparagraph (L) rebased target amount" has the meaning given the term "target amount" in subparagraph (C), except that—
(I) there shall be substituted for the base cost reporting period the 12-month cost reporting period beginning during fiscal year 2006;
(II) any reference in subparagraph (C)(i) to the "first cost reporting period" described in such subparagraph is deemed a reference to the first cost reporting period beginning on or after January 1, 2009; and
(III) the applicable percentage increase shall only be applied under subparagraph (C)(iv) for discharges occurring on or after January 1, 2009.
(4)(A)(i) The Secretary shall provide for an exception and adjustment to (and in the case of a hospital described in subsection (d)(1)(B)(iii), may provide an exemption from) the method under this subsection for determining the amount of payment to a hospital where events beyond the hospital's control or extraordinary circumstances, including changes in the case mix of such hospital, create a distortion in the increase in costs for a cost reporting period (including any distortion in the costs for the base period against which such increase is measured). The Secretary may provide for such other exemptions from, and exceptions and adjustments to, such method as the Secretary deems appropriate, including the assignment of a new base period which is more representative, as determined by the Secretary, of the reasonable and necessary cost of inpatient services and including those which he deems necessary to take into account a decrease in the inpatient hospital services that a hospital provides and that are customarily provided directly by similar hospitals which results in a significant distortion in the operating costs of inpatient hospital services. The Secretary shall announce a decision on any request for an exemption, exception, or adjustment under this paragraph not later than 180 days after receiving a completed application from the intermediary for such exemption, exception, or adjustment, and shall include in such decision a detailed explanation of the grounds on which such request was approved or denied.
(ii) The payment reductions under paragraph (3)(B)(ii)(V) shall not be considered by the Secretary in making adjustments pursuant to clause (i). In making such reductions, the Secretary shall treat the applicable update factor described in paragraph (3)(B)(vi) for a fiscal year as being equal to the market basket percentage for that year.
(B) In determining under subparagraph (A) whether to assign a new base period which is more representative of the reasonable and necessary cost to a hospital of providing inpatient services, the Secretary shall take into consideration—
(i) changes in applicable technologies and medical practices, or differences in the severity of illness among patients, that increase the hospital's costs;
(ii) whether increases in wages and wage-related costs for hospitals located in the geographic area in which the hospital is located exceed the average of the increases in such costs paid by hospitals in the United States; and
(iii) such other factors as the Secretary considers appropriate in determining increases in the hospital's costs of providing inpatient services.
(C) Paragraph (1) shall not apply to payment of hospitals which is otherwise determined under paragraph (3) of
(5) In the case of any hospital having any cost reporting period of other than a 12-month period, the Secretary shall determine the 12-month period which shall be used for purposes of this section.
(6) In the case of any hospital which becomes subject to the taxes under section 3111 of the Internal Revenue Code of 1986, with respect to any or all of its employees, for part or all of a cost reporting period, and was not subject to such taxes with respect to any or all of its employees for all or part of the 12-month base cost reporting period referred to in subsection (b)(3)(A)(i), the Secretary shall provide for an adjustment by increasing the base period amount described in such subsection for such hospital by an amount equal to the amount of such taxes which would have been paid or accrued by such hospital for such base period if such hospital had been subject to such taxes for all of such base period with respect to all its employees, minus the amount of any such taxes actually paid or accrued for such base period.
(7)(A) Notwithstanding paragraph (1), in the case of a hospital or unit that is within a class of hospital described in subparagraph (B) which first receives payments under this section on or after October 1, 1997—
(i) for each of the first 2 cost reporting periods for which the hospital has a settled cost report, the amount of the payment with respect to operating costs described in paragraph (1) under part A on a per discharge or per admission basis (as the case may be) is equal to the lesser of—
(I) the amount of operating costs for such respective period, or
(II) 110 percent of the national median (as estimated by the Secretary) of the target amount for hospitals in the same class as the hospital for cost reporting periods ending during fiscal year 1996, updated by the hospital market basket increase percentage to the fiscal year in which the hospital first received payments under this section, as adjusted under subparagraph (C); and
(ii) for purposes of computing the target amount for the subsequent cost reporting period, the target amount for the preceding cost reporting period is equal to the amount determined under clause (i) for such preceding period.
(B) For purposes of this paragraph, each of the following shall be treated as a separate class of hospital:
(i) Hospitals described in clause (i) of subsection (d)(1)(B) and psychiatric units described in the matter following clause (v) of such subsection.
(ii) Hospitals described in clause (ii) of such subsection and rehabilitation units described in the matter following clause (v) of such subsection.
(iii) Hospitals described in clause (iv) of such subsection.
(C) In applying subparagraph (A)(i)(II) in the case of a hospital or unit, the Secretary shall provide for an appropriate adjustment to the labor-related portion of the amount determined under such subparagraph to take into account differences between average wage-related costs in the area of the hospital and the national average of such costs within the same class of hospital.
(c) Payment in accordance with State hospital reimbursement control system; amount of payment; discontinuance of payments
(1) The Secretary may provide, in his discretion, that payment with respect to services provided by a hospital in a State may be made in accordance with a hospital reimbursement control system in a State, rather than in accordance with the other provisions of this subchapter, if the chief executive officer of the State requests such treatment and if—
(A) the Secretary determines that the system, if approved under this subsection, will apply (i) to substantially all non-Federal acute care hospitals (as defined by the Secretary) in the State and (ii) to the review of at least 75 percent of all revenues or expenses in the State for inpatient hospital services and of revenues or expenses for inpatient hospital services provided under the State's plan approved under subchapter XIX;
(B) the Secretary has been provided satisfactory assurances as to the equitable treatment under the system of all entities (including Federal and State programs) that pay hospitals for inpatient hospital services, of hospital employees, and of hospital patients;
(C) the Secretary has been provided satisfactory assurances that under the system, over 36-month periods (the first such period beginning with the first month in which this subsection applies to that system in the State), the amount of payments made under this subchapter under such system will not exceed the amount of payments which would otherwise have been made under this subchapter not using such system;
(D) the Secretary determines that the system will not preclude an eligible organization (as defined in
(E) the Secretary determines that the system requires hospitals to meet the requirement of
The Secretary cannot deny the application of a State under this subsection on the ground that the State's hospital reimbursement control system is based on a payment methodology other than on the basis of a diagnosis-related group or on the ground that the amount of payments made under this subchapter under such system must be less than the amount of payments which would otherwise have been made under this subchapter not using such system. If the Secretary determines that the conditions described in subparagraph (C) are based on maintaining payment amounts at no more than a specified percentage increase above the payment amounts in a base period, the State has the option of applying such test (for inpatient hospital services under part A) on an aggregate payment basis or on the basis of the amount of payment per inpatient discharge or admission. If the Secretary determines that the conditions described in subparagraph (C) are based on maintaining aggregate payment amounts below a national average percentage increase in total payments under part A for inpatient hospital services, the Secretary cannot deny the application of a State under this subsection on the ground that the State's rate of increase in such payments for such services must be less than such national average rate of increase.
(2) In determining under paragraph (1)(C) the amount of payment which would otherwise have been made under this subchapter for a State, the Secretary may provide for appropriate adjustment of such amount to take into account previous reductions effected in the amount of payments made under this subchapter in the State due to the operation of the hospital reimbursement control system in the State if the system has resulted in an aggregate rate of increase in operating costs of inpatient hospital services (as defined in subsection (a)(4)) under this subchapter for hospitals in the State which is less than the aggregate rate of increase in such costs under this subchapter for hospitals in the United States.
(3) The Secretary shall discontinue payments under a system described in paragraph (1) if the Secretary—
(A) determines that the system no longer meets the requirements of subparagraphs (A), (D), and (E) of paragraph (1) and, if applicable, the requirements of paragraph (5), or
(B) has reason to believe that the assurances described in subparagraph (B) or (C) of paragraph (1) (or, if applicable, in paragraph (5)) are not being (or will not be) met.
(4) The Secretary shall approve the request of a State under paragraph (1) with respect to a hospital reimbursement control system if—
(A) the requirements of subparagraphs (A), (B), (C), (D), and (E) of paragraph (1) have been met with respect to the system, and
(B) with respect to that system a waiver of certain requirements of this subchapter has been approved on or before (and which is in effect as of) April 20, 1983, pursuant to
With respect to a State system described in this paragraph, the Secretary shall judge the effectiveness of such system on the basis of its rate of increase or inflation in inpatient hospital payments for individuals under this subchapter, as compared to the national rate of increase or inflation for such payments, with the State retaining the option to have the test applied on the basis of the aggregate payments under the State system as compared to aggregate payments which would have been made under the national system since October 1, 1984, to the most recent date for which annual data are available.
(5) The Secretary shall approve the request of a State under paragraph (1) with respect to a hospital reimbursement control system if—
(A) the requirements of subparagraphs (A), (B), (C), (D), and (E) of paragraph (1) have been met with respect to the system;
(B) the Secretary determines that the system—
(i) is operated directly by the State or by an entity designated pursuant to State law,
(ii) provides for payment of hospitals covered under the system under a methodology (which sets forth exceptions and adjustments, as well as any method for changes in the methodology) by which rates or amounts to be paid for hospital services during a specified period are established under the system prior to the defined rate period, and
(iii) hospitals covered under the system will make such reports (in lieu of cost and other reports, identified by the Secretary, otherwise required under this subchapter) as the Secretary may require in order to properly monitor assurances provided under this subsection;
(C) the State has provided the Secretary with satisfactory assurances that operation of the system will not result in any change in hospital admission practices which result in—
(i) a significant reduction in the proportion of patients (receiving hospital services covered under the system) who have no third-party coverage and who are unable to pay for hospital services,
(ii) a significant reduction in the proportion of individuals admitted to hospitals for inpatient hospital services for which payment is (or is likely to be) less than the anticipated charges for or costs of such services,
(iii) the refusal to admit patients who would be expected to require unusually costly or prolonged treatment for reasons other than those related to the appropriateness of the care available at the hospital, or
(iv) the refusal to provide emergency services to any person who is in need of emergency services if the hospital provides such services;
(D) any change by the State in the system which has the effect of materially reducing payments to hospitals can only take effect upon 60 days notice to the Secretary and to the hospitals the payment to which is likely to be materially affected by the change; and
(E) the State has provided the Secretary with satisfactory assurances that in the development of the system the State has consulted with local governmental officials concerning the impact of the system on public hospitals.
The Secretary shall respond to requests of States under this paragraph within 60 days of the date the request is submitted to the Secretary.
(6) If the Secretary determines that the assurances described in paragraph (1)(C) have not been met with respect to any 36-month period, the Secretary may reduce payments under this subchapter to hospitals under the system in an amount equal to the amount by which the payment under this subchapter under such system for such period exceeded the amount of payments which would otherwise have been made under this subchapter not using such system.
(7) In the case of a State which made a request under paragraph (5) before December 31, 1984, for the approval of a State hospital reimbursement control system and which request was approved—
(A) in applying paragraphs (1)(C) and (6), a reference to a "36-month period" is deemed a reference to a "48-month period", and
(B) in order to allow the State the opportunity to provide the assurances described in paragraph (1)(C) for a 48-month period, the Secretary may not discontinue payments under the system, under the authority of paragraph (3)(A) because the Secretary has reason to believe that such assurances are not being (or will not be) met, before July 1, 1986.
(d) Inpatient hospital service payments on basis of prospective rates; Medicare Geographical Classification Review Board
(1)(A) Notwithstanding
(i) beginning on or after October 1, 1983, and before October 1, 1984, is equal to the sum of—
(I) the target percentage (as defined in subparagraph (C)) of the hospital's target amount for the cost reporting period (as defined in subsection (b)(3)(A) of this section, but determined without the application of subsection (a)), and
(II) the DRG percentage (as defined in subparagraph (C)) of the regional adjusted DRG prospective payment rate determined under paragraph (2) for such discharges;
(ii) beginning on or after October 1, 1984, and before October 1, 1987, is equal to the sum of—
(I) the target percentage (as defined in subparagraph (C)) of the hospital's target amount for the cost reporting period (as defined in subsection (b)(3)(A), but determined without the application of subsection (a)), and
(II) the DRG percentage (as defined in subparagraph (C)) of the applicable combined adjusted DRG prospective payment rate determined under subparagraph (D) for such discharges; or
(iii) beginning on or after April 1, 1988, is equal to—
(I) the national adjusted DRG prospective payment rate determined under paragraph (3) for such discharges, or
(II) for discharges occurring during a fiscal year ending on or before September 30, 1996, the sum of 85 percent of the national adjusted DRG prospective payment rate determined under paragraph (3) for such discharges and 15 percent of the regional adjusted DRG prospective payment rate determined under such paragraph, but only if the average standardized amount (described in clause (i)(I) or clause (ii)(I) of paragraph (3)(D)) for hospitals within the region of, and in the same large urban or other area (or, for discharges occurring during a fiscal year ending on or before September 30, 1994, the same large urban or other area) as, the hospital is greater than the average standardized amount (described in the respective clause) for hospitals within the United States in that type of area for discharges occurring during such fiscal year.
(B) As used in this section, the term "subsection (d) hospital" means a hospital located in one of the fifty States or the District of Columbia other than—
(i) a psychiatric hospital (as defined in
(ii) a rehabilitation hospital (as defined by the Secretary),
(iii) a hospital whose inpatients are predominantly individuals under 18 years of age,
(iv) a hospital which has an average inpatient length of stay (as determined by the Secretary) of greater than 25 days,
(v)(I) a hospital that the Secretary has classified, at any time on or before December 31, 1990,3 (or, in the case of a hospital that, as of December 19, 1989, is located in a State operating a demonstration project under
(II) a hospital that was recognized as a comprehensive cancer center or clinical cancer research center by the National Cancer Institute of the National Institutes of Health as of April 20, 1983, that is located in a State which, as of December 19, 1989, was not operating a demonstration project under
(III) a hospital that was recognized as a clinical cancer research center by the National Cancer Institute of the National Institutes of Health as of February 18, 1998, that has never been reimbursed for inpatient hospital services pursuant to a reimbursement system under a demonstration project under
(vi) a hospital that first received payment under this subsection in 1986 which has an average inpatient length of stay (as determined by the Secretary) of greater than 20 days and that has 80 percent or more of its annual medicare inpatient discharges with a principal diagnosis that reflects a finding of neoplastic disease in the 12-month cost reporting period ending in fiscal year 1997;
and, in accordance with regulations of the Secretary, does not include a psychiatric or rehabilitation unit of the hospital which is a distinct part of the hospital (as defined by the Secretary). A hospital that was classified by the Secretary on or before September 30, 1995, as a hospital described in clause (iv) (as in effect as of such date) shall continue to be so classified (or, in the case of a hospital described in clause (iv)(II), as so in effect, shall be classified under clause (vi) on and after the effective date of such clause (vi) and for cost reporting periods beginning on or after January 1, 2015, shall not be subject to subsection (m) as of the date of such classification) notwithstanding that it is located in the same building as, or on the same campus as, another hospital.
(C) For purposes of this subsection, for cost reporting periods beginning—
(i) on or after October 1, 1983, and before October 1, 1984, the "target percentage" is 75 percent and the "DRG percentage" is 25 percent;
(ii) on or after October 1, 1984, and before October 1, 1985, the "target percentage" is 50 percent and the "DRG percentage" is 50 percent;
(iii) on or after October 1, 1985, and before October 1, 1986, the "target percentage" is 45 percent and the "DRG percentage" is 55 percent; and
(iv) on or after October 1, 1986, and before October 1, 1987, the "target percentage" is 25 percent and the "DRG percentage" is 75 percent.
(D) For purposes of subparagraph (A)(ii)(II), the "applicable combined adjusted DRG prospective payment rate" for discharges occurring—
(i) on or after October 1, 1984, and before October 1, 1986, is a combined rate consisting of 25 percent of the national adjusted DRG prospective payment rate, and 75 percent of the regional adjusted DRG prospective payment rate, determined under paragraph (3) for such discharges; and
(ii) on or after October 1, 1986, and before October 1, 1987, is a combined rate consisting of 50 percent of the national adjusted DRG prospective payment rate, and 50 percent of the regional adjusted DRG prospective payment rate, determined under paragraph (3) for such discharges.
(E) For purposes of subclauses (II) and (III) of subparagraph (B)(v) only, the term "principal finding of neoplastic disease" means the condition established after study to be chiefly responsible for occasioning the admission of a patient to a hospital, except that only discharges with ICD–9–CM principal diagnosis codes of 140 through 239, V58.0, V58.1, V66.1, V66.2, or 990 will be considered to reflect such a principal diagnosis.
(2) The Secretary shall determine a national adjusted DRG prospective payment rate, for each inpatient hospital discharge in fiscal year 1984 involving inpatient hospital services of a subsection (d) hospital in the United States, and shall determine a regional adjusted DRG prospective payment rate for such discharges in each region, for which payment may be made under part A of this subchapter. Each such rate shall be determined for hospitals located in urban or rural areas within the United States or within each such region, respectively, as follows:
(A)
(B)
(i) updating for fiscal year 1983 by the estimated average rate of change of hospital costs industry-wide between the cost reporting period used under such subparagraph and fiscal year 1983 and the most recent case-mix data available, and
(ii) projecting for fiscal year 1984 by the applicable percentage increase (as defined in subsection (b)(3)(B)) for fiscal year 1984.
(C)
(i) excluding an estimate of indirect medical education costs (taking into account, for discharges occurring after September 30, 1986, the amendments made by section 9104(a) of the Medicare and Medicaid Budget Reconciliation Amendments of 1985), except that the Secretary shall not take into account any reduction in the amount of additional payments under paragraph (5)(B)(ii) resulting from the amendment made by section 4621(a)(1) of the Balanced Budget Act of 1997 or any additional payments under such paragraph resulting from the application of section 111 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, of section 302 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, or the Medicare Prescription Drug, Improvement, and Modernization Act of 2003,
(ii) adjusting for variations among hospitals by area in the average hospital wage level,
(iii) adjusting for variations in case mix among hospitals, and
(iv) for discharges occurring on or after October 1, 1986, excluding an estimate of the additional payments to certain hospitals to be made under paragraph (5)(F), except that the Secretary shall not exclude additional payments under such paragraph made as a result of the enactment of section 6003(c) of the Omnibus Budget Reconciliation Act of 1989, the enactment of section 4002(b) of the Omnibus Budget Reconciliation Act of 1990, the enactment of section 303 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, or the enactment of section 402(a)(1) 4 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
(D)
(i) for all subsection (d) hospitals located in an urban area within the United States or that region, respectively, and
(ii) for all subsection (d) hospitals located in a rural area within the United States or that region, respectively.
For purposes of this subsection, the term "region" means one of the nine census divisions, comprising the fifty States and the District of Columbia, established by the Bureau of the Census for statistical and reporting purposes; the term "urban area" means an area within a Metropolitan Statistical Area (as defined by the Office of Management and Budget) or within such similar area as the Secretary has recognized under subsection (a) by regulation; the term "large urban area" means, with respect to a fiscal year, such an urban area which the Secretary determines (in the publications described in subsection (e)(5) before the fiscal year) has a population of more than 1,000,000 (as determined by the Secretary based on the most recent available population data published by the Bureau of the Census); and the term "rural area" means any area outside such an area or similar area. A hospital located in a Metropolitan Statistical Area shall be deemed to be located in the region in which the largest number of the hospitals in the same Metropolitan Statistical Area are located, or, at the option of the Secretary, the region in which the majority of the inpatient discharges (with respect to which payments are made under this subchapter) from hospitals in the same Metropolitan Statistical Area are made.
(E)
(F)
(G)
(i) for hospitals located in an urban area in the United States or that region (respectively), to the product of—
(I) the average standardized amount (computed under subparagraph (D), reduced under subparagraph (E), and adjusted under subparagraph (F)) for hospitals located in an urban area in the United States or that region, and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group; and
(ii) for hospitals located in a rural area in the United States or that region (respectively), to the product of—
(I) the average standardized amount (computed under subparagraph (D), reduced under subparagraph (E), and adjusted under subparagraph (F)) for hospitals located in a rural area in the United States or that region, and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group.
(H)
(3) The Secretary shall determine a national adjusted DRG prospective payment rate, for each inpatient hospital discharge in a fiscal year after fiscal year 1984 involving inpatient hospital services of a subsection (d) hospital in the United States, and shall determine, for fiscal years before fiscal year 1997, a regional adjusted DRG prospective payment rate for such discharges in each region for which payment may be made under part A of this subchapter. Each such rate shall be determined for hospitals located in large urban, other urban, or rural areas within the United States and within each such region, respectively, as follows:
(A)
(ii) For discharges occurring in a fiscal year beginning on or after October 1, 1987, and ending on or before September 30, 1994, the Secretary shall compute an average standardized amount for hospitals located in a large urban area, for hospitals located in a rural area, and for hospitals located in other urban areas, within the United States and within each region, equal to the respective average standardized amount computed for the previous fiscal year under this subparagraph increased by the applicable percentage increase under subsection (b)(3)(B)(i) with respect to hospitals located in the respective areas for the fiscal year involved.
(iii) For discharges occurring in the fiscal year beginning on October 1, 1994, the average standardized amount for hospitals located in a rural area shall be equal to the average standardized amount for hospitals located in an urban area. For discharges occurring on or after October 1, 1994, the Secretary shall adjust the ratio of the labor portion to non-labor portion of each average standardized amount to equal such ratio for the national average of all standardized amounts.
(iv)(I) Subject to subclause (II), for discharges occurring in a fiscal year beginning on or after October 1, 1995, the Secretary shall compute an average standardized amount for hospitals located in a large urban area and for hospitals located in other areas within the United States and within each region equal to the respective average standardized amount computed for the previous fiscal year under this subparagraph increased by the applicable percentage increase under subsection (b)(3)(B)(i) with respect to hospitals located in the respective areas for the fiscal year involved.
(II) For discharges occurring in a fiscal year (beginning with fiscal year 2004), the Secretary shall compute a standardized amount for hospitals located in any area within the United States and within each region equal to the standardized amount computed for the previous fiscal year under this subparagraph for hospitals located in a large urban area (or, beginning with fiscal year 2005, for all hospitals in the previous fiscal year) increased by the applicable percentage increase under subsection (b)(3)(B)(i) for the fiscal year involved.
(v) Average standardized amounts computed under this paragraph shall be adjusted to reflect the most recent case-mix data available.
(vi) Insofar as the Secretary determines that the adjustments under paragraph (4)(C)(i) for a previous fiscal year (or estimates that such adjustments for a future fiscal year) did (or are likely to) result in a change in aggregate payments under this subsection during the fiscal year that are a result of changes in the coding or classification of discharges that do not reflect real changes in case mix, the Secretary may adjust the average standardized amounts computed under this paragraph for subsequent fiscal years so as to eliminate the effect of such coding or classification changes.
(B)
(C)
(ii)
(D)
(i) for fiscal years before fiscal year 2004, for hospitals located in a large urban area in the United States or that region (respectively), to the product of—
(I) the average standardized amount (computed under subparagraph (A), reduced under subparagraph (B), and adjusted or reduced under subparagraph (C)) for the fiscal year for hospitals located in such a large urban area in the United States or that region, and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group;
(ii) for fiscal years before fiscal year 2004, for hospitals located in other areas in the United States or that region (respectively), to the product of—
(I) the average standardized amount (computed under subparagraph (A), reduced under subparagraph (B), and adjusted or reduced under subparagraph (C)) for the fiscal year for hospitals located in other areas in the United States or that region, and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group; and
(iii) for a fiscal year beginning after fiscal year 2003, for hospitals located in all areas, to the product of—
(I) the applicable standardized amount (computed under subparagraph (A)), reduced under subparagraph (B), and adjusted or reduced under subparagraph (C) for the fiscal year; and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group.
(E)
(i)
(ii)
(iii)
(I)
(II)
(III)
(IV)
(iv)
(I)
(II)
(III)
(IV)
(4)(A) The Secretary shall establish a classification of inpatient hospital discharges by diagnosis-related groups and a methodology for classifying specific hospital discharges within these groups.
(B) For each such diagnosis-related group the Secretary shall assign an appropriate weighting factor which reflects the relative hospital resources used with respect to discharges classified within that group compared to discharges classified within other groups.
(C)(i) The Secretary shall adjust the classifications and weighting factors established under subparagraphs (A) and (B), for discharges in fiscal year 1988 and at least annually thereafter, to reflect changes in treatment patterns, technology (including a new medical service or technology under paragraph (5)(K)), and other factors which may change the relative use of hospital resources.
(ii) For discharges in fiscal year 1990, the Secretary shall reduce the weighting factor for each diagnosis-related group by 1.22 percent.
(iii) Any such adjustment under clause (i) for discharges in a fiscal year (beginning with fiscal year 1991) or payments under paragraph (5)(M) (beginning with fiscal year 2021) shall be made in a manner that assures that the aggregate payments under this subsection for discharges in the fiscal year are not greater or less than those that would have been made for discharges in the year without such adjustment or payments under paragraph (5)(M).
(iv)(I) For discharges occurring during the emergency period described in
(II) Any adjustment under subclause (I) shall not be taken into account in applying budget neutrality under clause (iii) 5
(III) In the case of a State for which the Secretary has waived all or part of this section under the authority of
(D)(i) For discharges occurring on or after October 1, 2008, the diagnosis-related group to be assigned under this paragraph for a discharge described in clause (ii) shall be a diagnosis-related group that does not result in higher payment based on the presence of a secondary diagnosis code described in clause (iv).
(ii) A discharge described in this clause is a discharge which meets the following requirements:
(I) The discharge includes a condition identified by a diagnosis code selected under clause (iv) as a secondary diagnosis.
(II) But for clause (i), the discharge would have been classified to a diagnosis-related group that results in a higher payment based on the presence of a secondary diagnosis code selected under clause (iv).
(III) At the time of admission, no code selected under clause (iv) was present.
(iii) As part of the information required to be reported by a hospital with respect to a discharge of an individual in order for payment to be made under this subsection, for discharges occurring on or after October 1, 2007, the information shall include the secondary diagnosis of the individual at admission.
(iv) By not later than October 1, 2007, the Secretary shall select diagnosis codes associated with at least two conditions, each of which codes meets all of the following requirements (as determined by the Secretary):
(I) Cases described by such code have a high cost or high volume, or both, under this subchapter.
(II) The code results in the assignment of a case to a diagnosis-related group that has a higher payment when the code is present as a secondary diagnosis.
(III) The code describes such conditions that could reasonably have been prevented through the application of evidence-based guidelines.
The Secretary may from time to time revise (through addition or deletion of codes) the diagnosis codes selected under this clause so long as there are diagnosis codes associated with at least two conditions selected for discharges occurring during any fiscal year.
(v) In selecting and revising diagnosis codes under clause (iv), the Secretary shall consult with the Centers for Disease Control and Prevention and other appropriate entities.
(vi) Any change resulting from the application of this subparagraph shall not be taken into account in adjusting the weighting factors under subparagraph (C)(i) or in applying budget neutrality under subparagraph (C)(iii).
(5)(A)(i) For discharges occurring during fiscal years ending on or before September 30, 1997, the Secretary shall provide for an additional payment for a subsection (d) hospital for any discharge in a diagnosis-related group, the length of stay of which exceeds the mean length of stay for discharges within that group by a fixed number of days, or exceeds such mean length of stay by some fixed number of standard deviations, whichever is the fewer number of days.
(ii) For cases which are not included in clause (i), a subsection (d) hospital may request additional payments in any case where charges, adjusted to cost, exceed a fixed multiple of the applicable DRG prospective payment rate, or exceed such other fixed dollar amount, whichever is greater, or, for discharges in fiscal years beginning on or after October 1, 1994, exceed the sum of the applicable DRG prospective payment rate plus any amounts payable under subparagraphs (B) and (F) plus a fixed dollar amount determined by the Secretary.
(iii) The amount of such additional payment under clauses (i) and (ii) shall be determined by the Secretary and shall (except as payments under clause (i) are required to be reduced to take into account the requirements of clause (v)) approximate the marginal cost of care beyond the cutoff point applicable under clause (i) or (ii).
(iv) The total amount of the additional payments made under this subparagraph for discharges in a fiscal year may not be less than 5 percent nor more than 6 percent of the total payments projected or estimated to be made based on DRG prospective payment rates for discharges in that year.
(v) The Secretary shall provide that—
(I) the day outlier percentage for fiscal year 1995 shall be 75 percent of the day outlier percentage for fiscal year 1994;
(II) the day outlier percentage for fiscal year 1996 shall be 50 percent of the day outlier percentage for fiscal year 1994; and
(III) the day outlier percentage for fiscal year 1997 shall be 25 percent of the day outlier percentage for fiscal year 1994.
(vi) For purposes of this subparagraph, the term "day outlier percentage" means, for a fiscal year, the percentage of the total additional payments made by the Secretary under this subparagraph for discharges in that fiscal year which are additional payments under clause (i).
(B) The Secretary shall provide for an additional payment amount for subsection (d) hospitals with indirect costs of medical education, in an amount computed in the same manner as the adjustment for such costs under regulations (in effect as of January 1, 1983) under subsection (a)(2), except as follows:
(i) The amount of such additional payment shall be determined by multiplying (I) the sum of the amount determined under paragraph (1)(A)(ii)(II) (or, if applicable, the amount determined under paragraph (1)(A)(iii)) and, for cases qualifying for additional payment under subparagraph (A)(i), the amount paid to the hospital under subparagraph (A), by (II) the indirect teaching adjustment factor described in clause (ii).
(ii) For purposes of clause (i)(II), the indirect teaching adjustment factor is equal to c × (((1+r) to the nth power) −1), where "r" is the ratio of the hospital's full-time equivalent interns and residents to beds and "n" equals .405. Subject to clause (ix), for discharges occurring—
(I) on or after October 1, 1988, and before October 1, 1997, "c" is equal to 1.89;
(II) during fiscal year 1998, "c" is equal to 1.72;
(III) during fiscal year 1999, "c" is equal to 1.6;
(IV) during fiscal year 2000, "c" is equal to 1.47;
(V) during fiscal year 2001, "c" is equal to 1.54;
(VI) during fiscal year 2002, "c" is equal to 1.6;
(VII) on or after October 1, 2002, and before April 1, 2004, "c" is equal to 1.35;
(VIII) on or after April 1, 2004, and before October 1, 2004, "c" is equal to 1.47;
(IX) during fiscal year 2005, "c" is equal to 1.42;
(X) during fiscal year 2006, "c" is equal to 1.37;
(XI) during fiscal year 2007, "c" is equal to 1.32; and
(XII) on or after October 1, 2007, "c" is equal to 1.35.
(iii) In determining such adjustment the Secretary shall not distinguish between those interns and residents who are employees of a hospital and those interns and residents who furnish services to a hospital but are not employees of such hospital.
(iv)(I) Effective for discharges occurring on or after October 1, 1997, and before July 1, 2010, all the time spent by an intern or resident in patient care activities under an approved medical residency training program at an entity in a nonhospital setting shall be counted towards the determination of full-time equivalency if the hospital incurs all, or substantially all, of the costs for the training program in that setting.
(II) Effective for discharges occurring on or after July 1, 2010, all the time spent by an intern or resident in patient care activities in a nonprovider setting shall be counted towards the determination of full-time equivalency if a hospital incurs the costs of the stipends and fringe benefits of the intern or resident during the time the intern or resident spends in that setting. If more than one hospital incurs these costs, either directly or through a third party, such hospitals shall count a proportional share of the time, as determined by written agreement between the hospitals, that a resident spends training in that setting.
(v) In determining the adjustment with respect to a hospital for discharges occurring on or after October 1, 1997, the total number of full-time equivalent interns and residents in the fields of allopathic and osteopathic medicine in either a hospital or nonhospital setting may not exceed the number (or, 130 percent of such number in the case of a hospital located in a rural area) of such full-time equivalent interns and residents in the hospital with respect to the hospital's most recent cost reporting period ending on or before December 31, 1996. Rules similar to the rules of subsection (h)(4)(F)(ii) shall apply for purposes of this clause. The provisions of subsections (h)(4)(H)(vi), (h)(7), (h)(8), (h)(9), and (h)(10) shall apply with respect to the first sentence of this clause in the same manner as they apply with respect to subsection (h)(4)(F)(i).
(vi) For purposes of clause (ii)—
(I) "r" may not exceed the ratio of the number of interns and residents, subject to the limit under clause (v), with respect to the hospital for its most recent cost reporting period to the hospital's available beds (as defined by the Secretary) during that cost reporting period, and
(II) for the hospital's cost reporting periods beginning on or after October 1, 1997, subject to the limits described in clauses (iv) and (v), the total number of full-time equivalent residents for payment purposes shall equal the average of the actual full-time equivalent resident count for the cost reporting period and the preceding two cost reporting periods.
In the case of the first cost reporting period beginning on or after October 1, 1997, subclause (II) shall be applied by using the average for such period and the preceding cost reporting period.
(vii) If any cost reporting period beginning on or after October 1, 1997, is not equal to twelve months, the Secretary shall make appropriate modifications to ensure that the average full-time equivalent residency count pursuant to subclause (II) of clause (vi) is based on the equivalent of full twelve-month cost reporting periods.
(viii) Rules similar to the rules of paragraphs (2)(F)(iv) and (4)(H) of subsection (h) shall apply for purposes of clauses (v) and (vi).
(ix) For discharges occurring on or after July 1, 2005, insofar as an additional payment amount under this subparagraph is attributable to resident positions redistributed to a hospital under subsection (h)(7)(B), in computing the indirect teaching adjustment factor under clause (ii) the adjustment shall be computed in a manner as if "c" were equal to 0.66 with respect to such resident positions.
(x) For discharges occurring on or after July 1, 2011, insofar as an additional payment amount under this subparagraph is attributable to resident positions distributed to a hospital under subsection (h)(8)(B), the indirect teaching adjustment factor shall be computed in the same manner as provided under clause (ii) with respect to such resident positions.
(xi)(I) The provisions of subparagraph (K) of subsection (h)(4) shall apply under this subparagraph in the same manner as they apply under such subsection.
(II) In determining the hospital's number of full-time equivalent residents for purposes of this subparagraph, all the time spent by an intern or resident in an approved medical residency training program in non-patient care activities, such as didactic conferences and seminars, as such time and activities are defined by the Secretary, that occurs in the hospital shall be counted toward the determination of full-time equivalency if the hospital—
(aa) is recognized as a subsection (d) hospital;
(bb) is recognized as a subsection (d) Puerto Rico hospital;
(cc) is reimbursed under a reimbursement system authorized under
(dd) is a provider-based hospital outpatient department.
(III) In determining the hospital's number of full-time equivalent residents for purposes of this subparagraph, all the time spent by an intern or resident in an approved medical residency training program in research activities that are not associated with the treatment or diagnosis of a particular patient, as such time and activities are defined by the Secretary, shall not be counted toward the determination of full-time equivalency.
(xii) For discharges occurring on or after July 1, 2023, insofar as an additional payment amount under this subparagraph is attributable to resident positions distributed to a hospital under subsection (h)(9), the indirect teaching adjustment factor shall be computed in the same manner as provided under clause (ii) with respect to such resident positions.
(xiii) For discharges occurring on or after July 1, 2026, insofar as an additional payment amount under this subparagraph is attributable to resident positions distributed to a hospital under subsection (h)(10), the indirect teaching adjustment factor shall be computed in the same manner as provided under clause (ii) with respect to such resident positions.
(C)(i) The Secretary shall provide for such exceptions and adjustments to the payment amounts established under this subsection (other than under paragraph (9)) as the Secretary deems appropriate to take into account the special needs of regional and national referral centers (including those hospitals of 275 or more beds located in rural areas). A hospital which is classified as a rural hospital may appeal to the Secretary to be classified as a rural referral center under this clause on the basis of criteria (established by the Secretary) which shall allow the hospital to demonstrate that it should be so reclassified by reason of certain of its operating characteristics being similar to those of a typical urban hospital located in the same census region and which shall not require a rural osteopathic hospital to have more than 3,000 discharges in a year in order to be classified as a rural referral center. Such characteristics may include wages, scope of services, service area, and the mix of medical specialties. The Secretary shall publish the criteria not later than August 17, 1984, for implementation by October 1, 1984. An appeal allowed under this clause must be submitted to the Secretary (in such form and manner as the Secretary may prescribe) during the quarter before the first quarter of the hospital's cost reporting period (or, in the case of a cost reporting period beginning during October 1984, during the first quarter of that period), and the Secretary must make a final determination with respect to such appeal within 60 days after the date the appeal was submitted. Any payment adjustments necessitated by a reclassification based upon the appeal shall be effective at the beginning of such cost reporting period.
(ii) The Secretary shall provide, under clause (i), for the classification of a rural hospital as a regional referral center if the hospital has a case mix index equal to or greater than the median case mix index for hospitals (other than hospitals with approved teaching programs) located in an urban area in the same region (as defined in paragraph (2)(D)), has at least 5,000 discharges a year or, if less, the median number of discharges in urban hospitals in the region in which the hospital is located (or, in the case of a rural osteopathic hospital, meets the criterion established by the Secretary under clause (i) with respect to the annual number of discharges for such hospitals), and meets any other criteria established by the Secretary under clause (i).
(D)(i) For any cost reporting period beginning on or after April 1, 1990, with respect to a subsection (d) hospital which is a sole community hospital, payment under paragraph (1)(A) shall be—
(I) an amount based on 100 percent of the hospital's target amount for the cost reporting period, as defined in subsection (b)(3)(C), or
(II) the amount determined under paragraph (1)(A)(iii),
whichever results in greater payment to the hospital.
(ii) In the case of a sole community hospital that experiences, in a cost reporting period compared to the previous cost reporting period, a decrease of more than 5 percent in its total number of inpatient cases due to circumstances beyond its control, the Secretary shall provide for such adjustment to the payment amounts under this subsection (other than under paragraph (9)) as may be necessary to fully compensate the hospital for the fixed costs it incurs in the period in providing inpatient hospital services, including the reasonable cost of maintaining necessary core staff and services.
(iii) For purposes of this subchapter, the term "sole community hospital" means any hospital—
(I) that the Secretary determines is located more than 35 road miles from another hospital,
(II) that, by reason of factors such as the time required for an individual to travel to the nearest alternative source of appropriate inpatient care (in accordance with standards promulgated by the Secretary), location, weather conditions, travel conditions, or absence of other like hospitals (as determined by the Secretary), is the sole source of inpatient hospital services reasonably available to individuals in a geographic area who are entitled to benefits under part A, or
(III) that is located in a rural area and designated by the Secretary as an essential access community hospital under
(iv) The Secretary shall promulgate a standard for determining whether a hospital meets the criteria for classification as a sole community hospital under clause (iii)(II) because of the time required for an individual to travel to the nearest alternative source of appropriate inpatient care.
(v) If the Secretary determines that, in the case of a hospital located in a rural area and designated by the Secretary as an essential access community hospital under
(E)(i) The Secretary shall estimate the amount of reimbursement made for services described in
(ii) The Secretary shall provide for an adjustment to the payment for subsection (d) hospitals in each fiscal year so as appropriately to reflect the net amount described in clause (i).
(F)(i) Subject to subsection (r), for discharges occurring on or after May 1, 1986, the Secretary shall provide, in accordance with this subparagraph, for an additional payment amount for each subsection (d) hospital which—
(I) serves a significantly disproportionate number of low-income patients (as defined in clause (v)), or
(II) is located in an urban area, has 100 or more beds, and can demonstrate that its net inpatient care revenues (excluding any of such revenues attributable to this subchapter or State plans approved under subchapter XIX), during the cost reporting period in which the discharges occur, for indigent care from State and local government sources exceed 30 percent of its total of such net inpatient care revenues during the period.
(ii) Subject to clause (ix), the amount of such payment for each discharge shall be determined by multiplying (I) the sum of the amount determined under paragraph (1)(A)(ii)(II) (or, if applicable, the amount determined under paragraph (1)(A)(iii)) and, for cases qualifying for additional payment under subparagraph (A)(i), the amount paid to the hospital under subparagraph (A) for that discharge, by (II) the disproportionate share adjustment percentage established under clause (iii) or (iv) for the cost reporting period in which the discharge occurs.
(iii) The disproportionate share adjustment percentage for a cost reporting period for a hospital described in clause (i)(II) is equal to 35 percent.
(iv) The disproportionate share adjustment percentage for a cost reporting period for a hospital that is not described in clause (i)(II) and that—
(I) is located in an urban area and has 100 or more beds or is described in the second sentence of clause (v), is equal to the percent determined in accordance with the applicable formula described in clause (vii);
(II) is located in an urban area and has less than 100 beds, is equal to 5 percent or, subject to clause (xiv) and for discharges occurring on or after April 1, 2001, is equal to the percent determined in accordance with clause (xiii);
(III) is located in a rural area and is not described in subclause (IV) or (V) or in the second sentence of clause (v), is equal to 4 percent or, subject to clause (xiv) and for discharges occurring on or after April 1, 2001, is equal to the percent determined in accordance with clause (xii);
(IV) is located in a rural area, is classified as a rural referral center under subparagraph (C), and is classified as a sole community hospital under subparagraph (D), is equal to 10 percent or, if greater, the percent determined in accordance with the applicable formula described in clause (viii) or, subject to clause (xiv) and for discharges occurring on or after April 1, 2001, the greater of the percentages determined under clause (x) or (xi);
(V) is located in a rural area, is classified as a rural referral center under subparagraph (C), and is not classified as a sole community hospital under subparagraph (D), is equal to the percent determined in accordance with the applicable formula described in clause (viii) or, subject to clause (xiv) and for discharges occurring on or after April 1, 2001, is equal to the percent determined in accordance with clause (xi); or
(VI) is located in a rural area, is classified as a sole community hospital under subparagraph (D), and is not classified as a rural referral center under subparagraph (C), is 10 percent or, subject to clause (xiv) and for discharges occurring on or after April 1, 2001, is equal to the percent determined in accordance with clause (x).
(v) In this subparagraph, a hospital "serves a significantly disproportionate number of low income patients" for a cost reporting period if the hospital has a disproportionate patient percentage (as defined in clause (vi)) for that period which equals, or exceeds—
(I) 15 percent, if the hospital is located in an urban area and has 100 or more beds,
(II) 30 percent (or 15 percent, for discharges occurring on or after April 1, 2001), if the hospital is located in a rural area and has more than 100 beds, or is located in a rural area and is classified as a sole community hospital under subparagraph (D),
(III) 40 percent (or 15 percent, for discharges occurring on or after April 1, 2001), if the hospital is located in an urban area and has less than 100 beds, or
(IV) 45 percent (or 15 percent, for discharges occurring on or after April 1, 2001), if the hospital is located in a rural area and is not described in subclause (II).
A hospital located in a rural area and with 500 or more beds also "serves a significantly disproportionate number of low income patients" for a cost reporting period if the hospital has a disproportionate patient percentage (as defined in clause (vi)) for that period which equals or exceeds a percentage specified by the Secretary.
(vi) In this subparagraph, the term "disproportionate patient percentage" means, with respect to a cost reporting period of a hospital, the sum of—
(I) the fraction (expressed as a percentage), the numerator of which is the number of such hospital's patient days for such period which were made up of patients who (for such days) were entitled to benefits under part A of this subchapter and were entitled to supplementary security income benefits (excluding any State supplementation) under subchapter XVI of this chapter, and the denominator of which is the number of such hospital's patient days for such fiscal year which were made up of patients who (for such days) were entitled to benefits under part A of this subchapter, and
(II) the fraction (expressed as a percentage), the numerator of which is the number of the hospital's patient days for such period which consist of patients who (for such days) were eligible for medical assistance under a State plan approved under subchapter XIX, but who were not entitled to benefits under part A of this subchapter, and the denominator of which is the total number of the hospital's patient days for such period.
In determining under subclause (II) the number of the hospital's patient days for such period which consist of patients who (for such days) were eligible for medical assistance under a State plan approved under subchapter XIX, the Secretary may, to the extent and for the period the Secretary determines appropriate, include patient days of patients not so eligible but who are regarded as such because they receive benefits under a demonstration project approved under subchapter XI.
(vii) The formula used to determine the disproportionate share adjustment percentage for a cost reporting period for a hospital described in clause (iv)(I) is—
(I) in the case of such a hospital with a disproportionate patient percentage (as defined in clause (vi)) greater than 20.2—
(a) for discharges occurring on or after April 1, 1990, and on or before December 31, 1990, (P−20.2)(.65) + 5.62,
(b) for discharges occurring on or after January 1, 1991, and on or before September 30, 1993, (P−20.2)(.7) + 5.62,
(c) for discharges occurring on or after October 1, 1993, and on or before September 30, 1994, (P−20.2)(.8) + 5.88, and
(d) for discharges occurring on or after October 1, 1994, (P−20.2)(.825) + 5.88; or
(II) in the case of any other such hospital—
(a) for discharges occurring on or after April 1, 1990, and on or before December 31, 1990, (P−15)(.6) + 2.5,
(b) for discharges occurring on or after January 1, 1991, and on or before September 30, 1993, (P−15)(.6) + 2.5,6
(c) for discharges occurring on or after October 1, 1993, (P−15)(.65) + 2.5,
where "P" is the hospital's disproportionate patient percentage (as defined in clause (vi)).
(viii) Subject to clause (xiv), the formula used to determine the disproportionate share adjustment percentage for a cost reporting period for a hospital described in clause (iv)(IV) or (iv)(V) is the percentage determined in accordance with the following formula: (P−30)(.6) + 4.0, where "P" is the hospital's disproportionate patient percentage (as defined in clause (vi)).
(ix) In the case of discharges occurring—
(I) during fiscal year 1998, the additional payment amount otherwise determined under clause (ii) shall be reduced by 1 percent;
(II) during fiscal year 1999, such additional payment amount shall be reduced by 2 percent;
(III) during fiscal years 2000 and 2001, such additional payment amount shall be reduced by 3 percent and 2 percent, respectively;
(IV) during fiscal year 2002, such additional payment amount shall be reduced by 3 percent; and
(V) during fiscal year 2003 and each subsequent fiscal year, such additional payment amount shall be reduced by 0 percent.
(x) Subject to clause (xiv), for purposes of clause (iv)(VI) (relating to sole community hospitals), in the case of a hospital for a cost reporting period with a disproportionate patient percentage (as defined in clause (vi)) that—
(I) is less than 19.3, the disproportionate share adjustment percentage is determined in accordance with the following formula: (P−15)(.65) + 2.5;
(II) is equal to or exceeds 19.3, but is less than 30.0, such adjustment percentage is equal to 5.25 percent; or
(III) is equal to or exceeds 30, such adjustment percentage is equal to 10 percent,
where "P" is the hospital's disproportionate patient percentage (as defined in clause (vi)).
(xi) Subject to clause (xiv), for purposes of clause (iv)(V) (relating to rural referral centers), in the case of a hospital for a cost reporting period with a disproportionate patient percentage (as defined in clause (vi)) that—
(I) is less than 19.3, the disproportionate share adjustment percentage is determined in accordance with the following formula: (P−15)(.65) + 2.5;
(II) is equal to or exceeds 19.3, but is less than 30.0, such adjustment percentage is equal to 5.25 percent; or
(III) is equal to or exceeds 30, such adjustment percentage is determined in accordance with the following formula: (P−30)(.6) + 5.25,
where "P" is the hospital's disproportionate patient percentage (as defined in clause (vi)).
(xii) Subject to clause (xiv), for purposes of clause (iv)(III) (relating to small rural hospitals generally), in the case of a hospital for a cost reporting period with a disproportionate patient percentage (as defined in clause (vi)) that—
(I) is less than 19.3, the disproportionate share adjustment percentage is determined in accordance with the following formula: (P−15)(.65) + 2.5; or
(II) is equal to or exceeds 19.3, such adjustment percentage is equal to 5.25 percent,
where "P" is the hospital's disproportionate patient percentage (as defined in clause (vi)).
(xiii) Subject to clause (xiv), for purposes of clause (iv)(II) (relating to urban hospitals with less than 100 beds), in the case of a hospital for a cost reporting period with a disproportionate patient percentage (as defined in clause (vi)) that—
(I) is less than 19.3, the disproportionate share adjustment percentage is determined in accordance with the following formula: (P−15)(.65) + 2.5; or
(II) is equal to or exceeds 19.3, such adjustment percentage is equal to 5.25 percent,
where "P" is the hospital's disproportionate patient percentage (as defined in clause (vi)).
(xiv)(I) In the case of discharges occurring on or after April 1, 2004, subject to subclause (II), there shall be substituted for the disproportionate share adjustment percentage otherwise determined under clause (iv) (other than subclause (I)) or under clause (viii), (x), (xi), (xii), or (xiii), the disproportionate share adjustment percentage determined under clause (vii) (relating to large, urban hospitals).
(II) Under subclause (I), the disproportionate share adjustment percentage shall not exceed 12 percent for a hospital that is not classified as a rural referral center under subparagraph (C) or, in the case of discharges occurring on or after October 1, 2006, as a medicare-dependent, small rural hospital under subparagraph (G)(iv).
(G)(i) For any cost reporting period beginning on or after April 1, 1990, and before October 1, 1994, or discharges occurring on or after October 1, 1997, and before January 1, 2025, in the case of a subsection (d) hospital which is a medicare-dependent, small rural hospital, payment under paragraph (1)(A) shall be equal to the sum of the amount determined under clause (ii) and the amount determined under paragraph (1)(A)(iii).
(ii) The amount determined under this clause is—
(I) for discharges occurring during the 36-month period beginning with the first day of the cost reporting period that begins on or after April 1, 1990, the amount by which the hospital's target amount for the cost reporting period (as defined in subsection (b)(3)(D)) exceeds the amount determined under paragraph (1)(A)(iii); and
(II) for discharges occurring during any subsequent cost reporting period (or portion thereof) and before October 1, 1994, or discharges occurring on or after October 1, 1997, and before January 1, 2025, 50 percent (or 75 percent in the case of discharges occurring on or after October 1, 2006) of the amount by which the hospital's target amount for the cost reporting period or for discharges in the fiscal year (as defined in subsection (b)(3)(D)) exceeds the amount determined under paragraph (1)(A)(iii).
(iii) In the case of a medicare dependent, small rural hospital that experiences, in a cost reporting period compared to the previous cost reporting period, a decrease of more than 5 percent in its total number of inpatient cases due to circumstances beyond its control, the Secretary shall provide for such adjustment to the payment amounts under this subsection (other than under paragraph (9)) as may be necessary to fully compensate the hospital for the fixed costs it incurs in the period in providing inpatient hospital services, including the reasonable cost of maintaining necessary core staff and services.
(iv) The term "medicare-dependent, small rural hospital" means, with respect to any cost reporting period to which clause (i) applies, any hospital—
(I) that is located in—
(aa) a rural area; or
(bb) a State with no rural area (as defined in paragraph (2)(D)) and satisfies any of the criteria in subclause (I), (II), or (III) of paragraph (8)(E)(ii),
(II) that has not more than 100 beds,
(III) that is not classified as a sole community hospital under subparagraph (D), and
(IV) for which not less than 60 percent of its inpatient days or discharges during the cost reporting period beginning in fiscal year 1987, or two of the three most recently audited cost reporting periods for which the Secretary has a settled cost report, were attributable to inpatients entitled to benefits under part A.
Subclause (I)(bb) shall apply for purposes of payment under clause (ii) only for discharges of a hospital occurring on or after the effective date of a determination of medicare-dependent small rural hospital status made by the Secretary with respect to the hospital after February 9, 2018. For purposes of applying subclause (II) of paragraph (8)(E)(ii) under subclause (I)(bb), such subclause (II) shall be applied by inserting "as of January 1, 2018," after "such State" each place it appears.
(H) The Secretary may provide for such adjustments to the payment amounts under this subsection as the Secretary deems appropriate to take into account the unique circumstances of hospitals located in Alaska and Hawaii.
(I)(i) The Secretary shall provide by regulation for such other exceptions and adjustments to such payment amounts under this subsection as the Secretary deems appropriate.
(ii) In making adjustments under clause (i) for transfer cases (as defined by the Secretary) in a fiscal year, not taking in account the effect of subparagraph (J), the Secretary may make adjustments to each of the average standardized amounts determined under paragraph (3) to assure that the aggregate payments made under this subsection for such fiscal year are not greater or lesser than those that would have otherwise been made in such fiscal year.
(J)(i) The Secretary shall treat the term "transfer case" (as defined in subparagraph (I)(ii)) as including the case of a qualified discharge (as defined in clause (ii)), which is classified within a diagnosis-related group described in clause (iii), and which occurs on or after October 1, 1998. In the case of a qualified discharge for which a substantial portion of the costs of care are incurred in the early days of the inpatient stay (as defined by the Secretary), in no case may the payment amount otherwise provided under this subsection exceed an amount equal to the sum of—
(I) 50 percent of the amount of payment under this subsection for transfer cases (as established under subparagraph (I)(i)), and
(II) 50 percent of the amount of payment which would have been made under this subsection with respect to the qualified discharge if no transfer were involved.
(ii) For purposes of clause (i), subject to clause (iii), the term "qualified discharge" means a discharge classified with a diagnosis-related group (described in clause (iii)) of an individual from a subsection (d) hospital, if upon such discharge the individual—
(I) is admitted as an inpatient to a hospital or hospital unit that is not a subsection (d) hospital for the provision of inpatient hospital services;
(II) is admitted to a skilled nursing facility;
(III) is provided home health services from a home health agency, if such services relate to the condition or diagnosis for which such individual received inpatient hospital services from the subsection (d) hospital, and if such services are provided within an appropriate period (as determined by the Secretary);
(IV) for discharges occurring on or after October 1, 2018, is provided hospice care by a hospice program; or
(V) for discharges occurring on or after October 1, 2000, the individual receives post discharge services described in clause (iv)(I).
(iii) Subject to clause (iv), a diagnosis-related group described in this clause is—
(I) 1 of 10 diagnosis-related groups selected by the Secretary based upon a high volume of discharges classified within such groups and a disproportionate use of post discharge services described in clause (ii); and
(II) a diagnosis-related group specified by the Secretary under clause (iv)(II).
(iv) The Secretary shall include in the proposed rule published under subsection (e)(5)(A) for fiscal year 2001, a description of the effect of this subparagraph. The Secretary shall include in the proposed rule published for fiscal year 2019, a description of the effect of clause (ii)(IV). The Secretary may include in the proposed rule (and in the final rule published under paragraph (6)) for fiscal year 2001 or a subsequent fiscal year, a description of—
(I) post-discharge services not described in subclauses (I), (II), (III), and, in the case of proposed and final rules for fiscal year 2019 and subsequent fiscal years, (IV) of clause (ii), the receipt of which results in a qualified discharge; and
(II) diagnosis-related groups described in clause (iii)(I) in addition to the 10 selected under such clause.
(K)(i) Effective for discharges beginning on or after October 1, 2001, the Secretary shall establish a mechanism to recognize the costs of new medical services and technologies under the payment system established under this subsection. Such mechanism shall be established after notice and opportunity for public comment (in the publications required by subsection (e)(5) for a fiscal year or otherwise). Such mechanism shall be modified to meet the requirements of clause (viii).
(ii) The mechanism established pursuant to clause (i) shall—
(I) apply to a new medical service or technology if, based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate (applying a threshold specified by the Secretary that is the lesser of 75 percent of the standardized amount (increased to reflect the difference between cost and charges) or 75 percent of one standard deviation for the diagnosis-related group involved);
(II) provide for the collection of data with respect to the costs of a new medical service or technology described in subclause (I) for a period of not less than two years and not more than three years beginning on the date on which an inpatient hospital code is issued with respect to the service or technology;
(III) provide for additional payment to be made under this subsection with respect to discharges involving a new medical service or technology described in subclause (I) that occur during the period described in subclause (II) in an amount that adequately reflects the estimated average cost of such service or technology; and
(IV) provide that discharges involving such a service or technology that occur after the close of the period described in subclause (II) will be classified within a new or existing diagnosis-related group with a weighting factor under paragraph (4)(B) that is derived from cost data collected with respect to discharges occurring during such period.
(iii) For purposes of clause (ii)(II), the term "inpatient hospital code" means any code that is used with respect to inpatient hospital services for which payment may be made under this subsection and includes an alphanumeric code issued under the International Classification of Diseases, 9th Revision, Clinical Modification ("ICD–9–CM") and its subsequent revisions.
(iv) For purposes of clause (ii)(III), the term "additional payment" means, with respect to a discharge for a new medical service or technology described in clause (ii)(I), an amount that exceeds the prospective payment rate otherwise applicable under this subsection to discharges involving such service or technology that would be made but for this subparagraph.
(v) The requirement under clause (ii)(III) for an additional payment may be satisfied by means of a new-technology group (described in subparagraph (L)), an add-on payment, a payment adjustment, or any other similar mechanism for increasing the amount otherwise payable with respect to a discharge under this subsection. The Secretary may not establish a separate fee schedule for such additional payment for such services and technologies, by utilizing a methodology established under subsection (a) or (h) of
(vi) For purposes of this subparagraph and subparagraph (L), a medical service or technology will be considered a "new medical service or technology" if the service or technology meets criteria established by the Secretary after notice and an opportunity for public comment.
(vii) Under the mechanism under this subparagraph, the Secretary shall provide for the addition of new diagnosis and procedure codes in April 1 of each year, but the addition of such codes shall not require the Secretary to adjust the payment (or diagnosis-related group classification) under this subsection until the fiscal year that begins after such date.
(viii) The mechanism established pursuant to clause (i) shall be adjusted to provide, before publication of a proposed rule, for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of individuals entitled to benefits under part A as follows:
(I) The Secretary shall make public and periodically update a list of all the services and technologies for which an application for additional payment under this subparagraph is pending.
(II) The Secretary shall accept comments, recommendations, and data from the public regarding whether the service or technology represents a substantial improvement.
(III) The Secretary shall provide for a meeting at which organizations representing hospitals, physicians, such individuals, manufacturers, and any other interested party may present comments, recommendations, and data to the clinical staff of the Centers for Medicare & Medicaid Services before publication of a notice of proposed rulemaking regarding whether service or technology represents a substantial improvement.
(ix) Before establishing any add-on payment under this subparagraph with respect to a new technology, the Secretary shall seek to identify one or more diagnosis-related groups associated with such technology, based on similar clinical or anatomical characteristics and the cost of the technology. Within such groups the Secretary shall assign an eligible new technology into a diagnosis-related group where the average costs of care most closely approximate the costs of care of using the new technology. No add-on payment under this subparagraph shall be made with respect to such new technology and this clause shall not affect the application of paragraph (4)(C)(iii).
(L)(i) In establishing the mechanism under subparagraph (K), the Secretary may establish new-technology groups into which a new medical service or technology will be classified if, based on the estimated average costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate.
(ii) Such groups—
(I) shall not be based on the costs associated with a specific new medical service or technology; but
(II) shall, in combination with the applicable standardized amounts and the weighting factors assigned to such groups under paragraph (4)(B), reflect such cost cohorts as the Secretary determines are appropriate for all new medical services and technologies that are likely to be provided as inpatient hospital services in a fiscal year.
(iii) The methodology for classifying specific hospital discharges within a diagnosis-related group under paragraph (4)(A) or a new-technology group shall provide that a specific hospital discharge may not be classified within both a diagnosis-related group and a new-technology group.
(M)(i) For cost reporting periods beginning on or after October 1, 2020, in the case of a subsection (d) hospital that furnishes an allogeneic hematopoietic stem cell transplant to an individual during such a period, payment to such hospital for hematopoietic stem cell acquisition shall be made on a reasonable cost basis. The items included in such hematopoietic stem cell acquisition shall be specified by the Secretary through rulemaking.
(ii) For purposes of this subparagraph, the term "allogeneic hematopoietic stem cell transplant" means, with respect to an individual, the intravenous infusion of hematopoietic cells derived from bone marrow, peripheral blood stem cells, or cord blood, but not including embryonic stem cells, of a donor to an individual that are or may be used to restore hematopoietic function in such individual having an inherited or acquired deficiency or defect.
(6) The Secretary shall provide for publication in the Federal Register, on or before the August 1 before each fiscal year (beginning with fiscal year 1984), of a description of the methodology and data used in computing the adjusted DRG prospective payment rates under this subsection, including any adjustments required under subsection (e)(1)(B).
(7) There shall be no administrative or judicial review under
(A) the determination of the requirement, or the proportional amount, of any adjustment effected pursuant to subsection (e)(1) or the determination of the applicable percentage increase under paragraph (12)(A)(ii),
(B) the establishment of diagnosis-related groups, of the methodology for the classification of discharges within such groups, and of the appropriate weighting factors thereof under paragraph (4), including the selection and revision of codes under paragraph (4)(D), and
(C) the determination of whether services provided prior to a patient's inpatient admission are related to the admission (as described in subsection (a)(4)).
(8)(A) In the case of any hospital which is located in an area which is, at any time after April 20, 1983, reclassified from an urban to a rural area, payments to such hospital for the first two cost reporting periods for which such reclassification is effective shall be made as follows:
(i) For the first such cost reporting period, payment shall be equal to the amount payable to such hospital for such reporting period on the basis of the rural classification, plus an amount equal to two-thirds of the amount (if any) by which—
(I) the amount which would have been payable to such hospital for such reporting period on the basis of an urban classification, exceeds
(II) the amount payable to such hospital for such reporting period on the basis of the rural classification.
(ii) For the second such cost reporting period, payment shall be equal to the amount payable to such hospital for such reporting period on the basis of the rural classification, plus an amount equal to one-third of the amount (if any) by which—
(I) the amount which would have been payable to such hospital for such reporting period on the basis of an urban classification, exceeds
(II) the amount payable to such hospital for such reporting period on the basis of the rural classification.
(B)(i) For purposes of this subsection, the Secretary shall treat a hospital located in a rural county adjacent to one or more urban areas as being located in the urban metropolitan statistical area to which the greatest number of workers in the county commute, if the rural county would otherwise be considered part of an urban area, under the standards for designating Metropolitan Statistical Areas (and for designating New England County Metropolitan Areas) described in clause (ii), if the commuting rates used in determining outlying counties (or, for New England, similar recognized areas) were determined on the basis of the aggregate number of resident workers who commute to (and, if applicable under the standards, from) the central county or counties of all contiguous Metropolitan Statistical Areas (or New England County Metropolitan Areas).
(ii) The standards described in this clause for cost reporting periods beginning in a fiscal year—
(I) before fiscal year 2003, are the standards published in the Federal Register on January 3, 1980, or, at the election of the hospital with respect to fiscal years 2001 and 2002, standards so published on March 30, 1990; and
(II) after fiscal year 2002, are the standards published in the Federal Register by the Director of the Office of Management and Budget based on the most recent available decennial population data.
Subparagraphs (C) and (D) shall not apply with respect to the application of subclause (I).
(C)(i) If the application of subparagraph (B) or a decision of the Medicare Geographic Classification Review Board or the Secretary under paragraph (10), by treating hospitals located in a rural county or counties as being located in an urban area, or by treating hospitals located in one urban area as being located in another urban area—
(I) reduces the wage index for that urban area (as applied under this subsection) by 1 percentage point or less, the Secretary, in calculating such wage index under this subsection, shall exclude those hospitals so treated, or
(II) reduces the wage index for that urban area by more than 1 percentage point (as applied under this subsection), the Secretary shall calculate and apply such wage index under this subsection separately to hospitals located in such urban area (excluding all the hospitals so treated) and to the hospitals so treated (as if such hospitals were located in such urban area).
(ii) If the application of subparagraph (B) or a decision of the Medicare Geographic Classification Review Board or the Secretary under paragraph (10), by treating hospitals located in a rural county or counties as not being located in the rural area in a State, reduces the wage index for that rural area (as applied under this subsection), the Secretary shall calculate and apply such wage index under this subsection as if the hospitals so treated had not been excluded from calculation of the wage index for that rural area.
(iii) The application of subparagraph (B) or a decision of the Medicare Geographic Classification Review Board or the Secretary under paragraph (10) may not result in the reduction of any county's wage index to a level below the wage index for rural areas in the State in which the county is located.
(iv) The application of subparagraph (B) or a decision of the Medicare Geographic Classification Review Board or of the Secretary under paragraph (10) may not result in a reduction in an urban area's wage index if—
(I) the urban area has a wage index below the wage index for rural areas in the State in which it is located; or
(II) the urban area is located in a State that is composed of a single urban area.
(v) This subparagraph shall apply with respect to discharges occurring in a fiscal year only if the Secretary uses a method for making adjustments to the DRG prospective payment rate for area differences in hospital wage levels under paragraph (3)(E) for the fiscal year that is based on the use of Metropolitan Statistical Area classifications.
(D) The Secretary shall make a proportional adjustment in the standardized amounts determined under paragraph (3) to assure that the provisions of subparagraphs (B) and (C) or a decision of the Medicare Geographic Classification Review Board or the Secretary under paragraph (10) do not result in aggregate payments under this section that are greater or less than those that would otherwise be made.
(E)(i) For purposes of this subsection, not later than 60 days after the receipt of an application (in a form and manner determined by the Secretary) from a subsection (d) hospital described in clause (ii), the Secretary shall treat the hospital as being located in the rural area (as defined in paragraph (2)(D)) of the State in which the hospital is located.
(ii) For purposes of clause (i), a subsection (d) hospital described in this clause is a subsection (d) hospital that is located in an urban area (as defined in paragraph (2)(D)) and satisfies any of the following criteria:
(I) The hospital is located in a rural census tract of a metropolitan statistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)).
(II) The hospital is located in an area designated by any law or regulation of such State as a rural area (or is designated by such State as a rural hospital).
(III) The hospital would qualify as a rural, regional, or national referral center under paragraph (5)(C) or as a sole community hospital under paragraph (5)(D) if the hospital were located in a rural area.
(IV) The hospital meets such other criteria as the Secretary may specify.
(9)(A) Notwithstanding
(i) the applicable Puerto Rico percentage (specified in subparagraph (E)) of the Puerto Rico adjusted DRG prospective payment rate (determined under subparagraph (B) or (C)) for such discharges,
(ii) the applicable Federal percentage (specified in subparagraph (E)) of—
(I) for discharges beginning in a fiscal year beginning on or after October 1, 1997, and before October 1, 2003, the discharge-weighted average of—
(aa) the national adjusted DRG prospective payment rate (determined under paragraph (3)(D)) for hospitals located in a large urban area,
(bb) such rate for hospitals located in other urban areas, and
(cc) such rate for hospitals located in a rural area,
for such discharges, adjusted in the manner provided in paragraph (3)(E) for different area wage levels; and
(II) for discharges in a fiscal year beginning on or after October 1, 2003, the national DRG prospective payment rate determined under paragraph (3)(D)(iii) for hospitals located in any area for such discharges, adjusted in the manner provided in paragraph (3)(E) for different area wage levels.
As used in this section, the term "subsection (d) Puerto Rico hospital" means a hospital that is located in Puerto Rico and that would be a subsection (d) hospital (as defined in paragraph (1)(B)) if it were located in one of the 50 States.
(B) The Secretary shall determine a Puerto Rico adjusted DRG prospective payment rate, for each inpatient hospital discharge in fiscal year 1988 involving inpatient hospital services of a subsection (d) Puerto Rico hospital for which payment may be made under part A of this subchapter. Such rate shall be determined for such hospitals located in urban or rural areas within Puerto Rico, as follows:
(i) The Secretary shall determine the target amount (as defined in subsection (b)(3)(A)) for the hospital for the cost reporting period beginning in fiscal year 1987 and increase such amount by prorating the applicable percentage increase (as defined in subsection (b)(3)(B)) to update the amount to the midpoint in fiscal year 1988.
(ii) The Secretary shall standardize the amount determined under clause (i) for each hospital by—
(I) excluding an estimate of indirect medical education costs,
(II) adjusting for variations among hospitals by area in the average hospital wage level,
(III) adjusting for variations in case mix among hospitals, and
(IV) excluding an estimate of the additional payments to certain subsection (d) Puerto Rico hospitals to be made under subparagraph (D)(iii) (relating to disproportionate share payments).
(iii) The Secretary shall compute a discharge weighted average of the standardized amounts determined under clause (ii) for all hospitals located in an urban area and for all hospitals located in a rural area (as such terms are defined in paragraph (2)(D)).
(iv) The Secretary shall reduce the average standardized amount by a proportion equal to the proportion (estimated by the Secretary) of the amount of payments under this paragraph which are additional payments described in subparagraph (D)(i) (relating to outlier payments).
(v) For each discharge classified within a diagnosis-related group for hospitals located in an urban or rural area, respectively, the Secretary shall establish a Puerto Rico DRG prospective payment rate equal to the product of—
(I) the average standardized amount (computed under clause (iii) and reduced under clause (iv)) for hospitals located in an urban or rural area, respectively, and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group.
(vi) The Secretary shall adjust the proportion (as estimated by the Secretary from time to time) of hospitals' costs which are attributable to wages and wage-related costs, of the Puerto Rico DRG prospective payment rate computed under clause (v) for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the Puerto Rican average hospital wage level.
(C) The Secretary shall determine a Puerto Rico adjusted DRG prospective payment rate, for each inpatient hospital discharge after fiscal year 1988 involving inpatient hospital services of a subsection (d) Puerto Rico hospital for which payment may be made under part A of this subchapter. Such rate shall be determined for hospitals located in urban or rural areas within Puerto Rico as follows:
(i)(I) For discharges in a fiscal year after fiscal year 1988 and before fiscal year 2004, the Secretary shall compute an average standardized amount for hospitals located in an urban area and for hospitals located in a rural area equal to the respective average standardized amount computed for the previous fiscal year under subparagraph (B)(iii) or under this clause, increased for fiscal year 1989 by the applicable percentage increase under subsection (b)(3)(B), and adjusted for subsequent fiscal years in accordance with the final determination of the Secretary under subsection (e)(4), and adjusted to reflect the most recent case-mix data available.
(II) For discharges occurring in a fiscal year (beginning with fiscal year 2004), the Secretary shall compute an average standardized amount for hospitals located in any area of Puerto Rico that is equal to the average standardized amount computed under subclause (I) for fiscal year 2003 for hospitals in a large urban area (or, beginning with fiscal year 2005, for all hospitals in the previous fiscal year) increased by the applicable percentage increase under subsection (b)(3)(B) for the fiscal year involved.
(ii) The Secretary shall reduce each of the average standardized amounts (or for fiscal year 2004 and thereafter, the average standardized amount) by a proportion equal to the proportion (estimated by the Secretary) of the amount of payments under this paragraph which are additional payments described in subparagraph (D)(i) (relating to outlier payments).
(iii) For each discharge classified within a diagnosis-related group for hospitals located in an urban or rural area, respectively, the Secretary shall establish a Puerto Rico DRG prospective payment rate equal to the product of—
(I) the average standardized amount (computed under clause (i) and reduced under clause (ii)), and
(II) the weighting factor (determined under paragraph (4)(B)) for that diagnosis-related group.
(iv)(I) The Secretary shall adjust the proportion (as estimated by the Secretary from time to time) of hospitals' costs which are attributable to wages and wage-related costs, of the Puerto Rico DRG prospective payment rate computed under clause (iii) for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the Puerto Rico average hospital wage level. The second and third sentences of paragraph (3)(E)(i) shall apply to subsection (d) Puerto Rico hospitals under this clause in the same manner as they apply to subsection (d) hospitals under such paragraph and, for purposes of this clause, any reference in such paragraph to a subsection (d) hospital is deemed a reference to a subsection (d) Puerto Rico hospital.
(II) For discharges occurring on or after October 1, 2004, the Secretary shall substitute "62 percent" for the proportion described in the first sentence of clause (i), unless the application of this subclause would result in lower payments to a hospital than would otherwise be made.
(D) The following provisions of paragraph (5) shall apply to subsection (d) Puerto Rico hospitals receiving payment under this paragraph in the same manner and to the extent as they apply to subsection (d) hospitals receiving payment under this subsection:
(i) Subparagraph (A) (relating to outlier payments).
(ii) Subparagraph (B) (relating to payments for indirect medical education costs), except that for this purpose the sum of the amount determined under subparagraph (A) of this paragraph and the amount paid to the hospital under clause (i) of this subparagraph shall be substituted for the sum referred to in paragraph (5)(B)(i)(I).
(iii) Subparagraph (F) (relating to disproportionate share payments), except that for this purpose the sum described in clause (ii) of this subparagraph shall be substituted for the sum referred to in paragraph (5)(F)(ii)(I).
(iv) Subparagraph (H) (relating to exceptions and adjustments).
(E) For purposes of subparagraph (A), for discharges occurring—
(i) on or after October 1, 1987, and before October 1, 1997, the applicable Puerto Rico percentage is 75 percent and the applicable Federal percentage is 25 percent;
(ii) on or after October 1, 1997, and before April 1, 2004, the applicable Puerto Rico percentage is 50 percent and the applicable Federal percentage is 50 percent;
(iii) on or after April 1, 2004, and before October 1, 2004, the applicable Puerto Rico percentage is 37.5 percent and the applicable Federal percentage is 62.5 percent;
(iv) on or after October 1, 2004, and before January 1, 2016, the applicable Puerto Rico percentage is 25 percent and the applicable Federal percentage is 75 percent; and
(v) on or after January 1, 2016, the applicable Puerto Rico percentage is 0 percent and the applicable Federal percentage is 100 percent.
(10)(A) There is hereby established the Medicare Geographic Classification Review Board (hereinafter in this paragraph referred to as the "Board").
(B)(i) The Board shall be composed of 5 members appointed by the Secretary without regard to the provisions of title 5, governing appointments in the competitive service. Two of such members shall be representative of subsection (d) hospitals located in a rural area under paragraph (2)(D). At least 1 member shall be knowledgeable in the field of analyzing costs with respect to the provision of inpatient hospital services.
(ii) The Secretary shall make initial appointments to the Board as provided in this paragraph within 180 days after December 19, 1989.
(C)(i) The Board shall consider the application of any subsection (d) hospital requesting that the Secretary change the hospital's geographic classification for purposes of determining for a fiscal year—
(I) the hospital's average standardized amount under paragraph (2)(D), or
(II) the factor used to adjust the DRG prospective payment rate for area differences in hospital wage levels that applies to such hospital under paragraph (3)(E).
(ii) A hospital requesting a change in geographic classification under clause (i) for a fiscal year shall submit its application to the Board not later than the first day of the 13-month period ending on September 30 of the preceding fiscal year.
(iii)(I) The Board shall render a decision on an application submitted under clause (i) not later than 180 days after the deadline referred to in clause (ii).
(II) Appeal of decisions of the Board shall be subject to the provisions of section 557b 7 of title 5. The Secretary shall issue a decision on such an appeal not later than 90 days after the date on which the appeal is filed. The decision of the Secretary shall be final and shall not be subject to judicial review.
(D)(i) The Secretary shall publish guidelines to be utilized by the Board in rendering decisions on applications submitted under this paragraph, and shall include in such guidelines the following:
(I) Guidelines for comparing wages, taking into account (to the extent the Secretary determines appropriate) occupational mix, in the area in which the hospital is classified and the area in which the hospital is applying to be classified.
(II) Guidelines for determining whether the county in which the hospital is located should be treated as being a part of a particular Metropolitan Statistical Area.
(III) Guidelines for considering information provided by an applicant with respect to the effects of the hospital's geographic classification on access to inpatient hospital services by medicare beneficiaries.
(IV) Guidelines for considering the appropriateness of the criteria used to define New England County Metropolitan Areas.
(ii) Notwithstanding clause (i), if the Secretary uses a method for making adjustments to the DRG prospective payment rate for area differences in hospital wage levels under paragraph (3)(E) that is not based on the use of Metropolitan Statistical Area classifications, the Secretary may revise the guidelines published under clause (i) to the extent such guidelines are used to determine the appropriateness of the geographic area in which the hospital is determined to be located for purposes of making such adjustments.
(iii) Under the guidelines published by the Secretary under clause (i), in the case of a hospital which has ever been classified by the Secretary as a rural referral center under paragraph (5)(C), the Board may not reject the application of the hospital under this paragraph on the basis of any comparison between the average hourly wage of the hospital and the average hourly wage of hospitals in the area in which it is located.
(iv) The Secretary shall publish the guidelines described in clause (i) by July 1, 1990.
(v) Any decision of the Board to reclassify a subsection (d) hospital for purposes of the adjustment factor described in subparagraph (C)(i)(II) for fiscal year 2001 or any fiscal year thereafter shall be effective for a period of 3 fiscal years, except that the Secretary shall establish procedures under which a subsection (d) hospital may elect to terminate such reclassification before the end of such period.
(vi) Such guidelines shall provide that, in making decisions on applications for reclassification for the purposes described in clause (v) for fiscal year 2003 and any succeeding fiscal year, the Board shall base any comparison of the average hourly wage for the hospital with the average hourly wage for hospitals in an area on—
(I) an average of the average hourly wage amount for the hospital from the most recently published hospital wage survey data of the Secretary (as of the date on which the hospital applies for reclassification) and such amount from each of the two immediately preceding surveys; and
(II) an average of the average hourly wage amount for hospitals in such area from the most recently published hospital wage survey data of the Secretary (as of the date on which the hospital applies for reclassification) and such amount from each of the two immediately preceding surveys.
(E)(i) The Board shall have full power and authority to make rules and establish procedures, not inconsistent with the provisions of this subchapter or regulations of the Secretary, which are necessary or appropriate to carry out the provisions of this paragraph. In the course of any hearing the Board may administer oaths and affirmations. The provisions of subsections (d) and (e) of
(ii) The Board is authorized to engage such technical assistance and to receive such information as may be required to carry out its functions, and the Secretary shall, in addition, make available to the Board such secretarial, clerical, and other assistance as the Board may require to carry out its functions.
(F)(i) Each member of the Board who is not an officer or employee of the Federal Government shall be compensated at a rate equal to the daily equivalent of the annual rate of basic pay prescribed for grade GS–18 of the General Schedule under
(ii) Members of the Board shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under subchapter I of
(11)
(A)
(B)
(C)
(D)
(12)
(A)
(B)
(i) The Secretary shall determine the empirical relationship for subsection (d) hospitals between the standardized cost-per-case for such hospitals and the total number of discharges of such hospitals and the amount of the additional incremental costs (if any) that are associated with such number of discharges.
(ii) The applicable percentage increase shall be determined based upon such relationship in a manner that reflects, based upon the number of such discharges for a subsection (d) hospital, such additional incremental costs.
(iii) In no case shall the applicable percentage increase exceed 25 percent.
(C)
(i)
(I) with respect to each of fiscal years 2005 through 2010, less than 800 discharges during the fiscal year;
(II) with respect to each of fiscal years 2011 through 2018, less than 1,600 discharges of individuals entitled to, or enrolled for, benefits under part A during the fiscal year or portion of fiscal year;
(III) with respect to each of fiscal years 2019 through 2024 and the portion of fiscal year 2025 beginning on October 1, 2024, and ending on December 31, 2024, less than 3,800 discharges during the fiscal year; and
(IV) with respect to the portion of fiscal year 2025 beginning on January 1, 2025, and ending on September 30, 2025, and fiscal year 2026 and each subsequent fiscal year, less than 800 discharges during the fiscal year.
(ii)
(iii)
(I) a subsection (d) hospital of the Indian Health Service (whether operated by such Service or by an Indian tribe or tribal organization (as those terms are defined in
(II) a subsection (d) hospital other than a hospital of the Indian Health Service meets the mileage criterion under clause (i) with respect to fiscal year 2011 or a succeeding fiscal year, the Secretary shall apply the policy described in the regulation at part 8 412.101(e) of title 42, Code of Federal Regulations (as in effect on March 23, 2018).
(D)
(i) with respect to each of fiscal years 2011 through 2018, with 200 or fewer discharges of individuals entitled to, or enrolled for, benefits under part A in the fiscal year or the portion of fiscal year to 0 percent for low-volume hospitals with greater than 1,600 discharges of such individuals in the fiscal year or the portion of fiscal year or portion of fiscal year; 9 and
(ii) with respect to each of fiscal years 2019 through 2024 and the portion of fiscal year 2025 beginning on October 1, 2024, and ending on December 31, 2024, with 500 or fewer discharges in the fiscal year to 0 percent for low-volume hospitals with greater than 3,800 discharges in the fiscal year.
(13)(A) In order to recognize commuting patterns among geographic areas, the Secretary shall establish a process through application or otherwise for an increase of the wage index applied under paragraph (3)(E) for subsection (d) hospitals located in a qualifying county described in subparagraph (B) in the amount computed under subparagraph (D) based on out-migration of hospital employees who reside in that county to any higher wage index area.
(B) The Secretary shall establish criteria for a qualifying county under this subparagraph based on the out-migration referred to in subparagraph (A) and differences in the area wage indices. Under such criteria the Secretary shall, utilizing such data as the Secretary determines to be appropriate, establish—
(i) a threshold percentage, established by the Secretary, of the weighted average of the area wage index or indices for the higher wage index areas involved;
(ii) a threshold (of not less than 10 percent) for minimum out-migration to a higher wage index area or areas; and
(iii) a requirement that the average hourly wage of the hospitals in the qualifying county equals or exceeds the average hourly wage of all the hospitals in the area in which the qualifying county is located.
(C) For purposes of this paragraph, the term "higher wage index area" means, with respect to a county, an area with a wage index that exceeds that of the county.
(D) The increase in the wage index under subparagraph (A) for a qualifying county shall be equal to the percentage of the hospital employees residing in the qualifying county who are employed in any higher wage index area multiplied by the sum of the products, for each higher wage index area of—
(i) the difference between—
(I) the wage index for such higher wage index area, and
(II) the wage index of the qualifying county; and
(ii) the number of hospital employees residing in the qualifying county who are employed in such higher wage index area divided by the total number of hospital employees residing in the qualifying county who are employed in any higher wage index area.
(E) The process under this paragraph may be based upon the process used by the Medicare Geographic Classification Review Board under paragraph (10). As the Secretary determines to be appropriate to carry out such process, the Secretary may require hospitals (including subsection (d) hospitals and other hospitals) and critical access hospitals, as required under
(F) A wage index increase under this paragraph shall be effective for a period of 3 fiscal years, except that the Secretary shall establish procedures under which a subsection (d) hospital may elect to waive the application of such wage index increase.
(G) A hospital in a county that has a wage index increase under this paragraph for a period and that has not waived the application of such an increase under subparagraph (F) is not eligible for reclassification under paragraph (8) or (10) during that period.
(H) Any increase in a wage index under this paragraph for a county shall not be taken into account for purposes of—
(i) computing the wage index for portions of the wage index area (not including the county) in which the county is located; or
(ii) applying any budget neutrality adjustment with respect to such index under paragraph (8)(D).
(I) The thresholds described in subparagraph (B), data on hospital employees used under this paragraph, and any determination of the Secretary under the process described in subparagraph (E) shall be final and shall not be subject to judicial review.
(e) Proportional adjustments in applicable percentage increases
(1)(A) For cost reporting periods of hospitals beginning in fiscal year 1984 or fiscal year 1985, the Secretary shall provide for such proportional adjustment in the applicable percentage increase (otherwise applicable to the periods under subsection (b)(3)(B)) as may be necessary to assure that—
(i) the aggregate payment amounts otherwise provided under subsection (d)(1)(A)(i)(I) for that fiscal year for operating costs of inpatient hospital services of hospitals (excluding payments made under
are not greater or less than—
(ii) the target percentage (as defined in subsection (d)(1)(C)) of the payment amounts which would have been payable for such services for those same hospitals for that fiscal year under this section under the law as in effect before April 20, 1983 (excluding payments made under
except that the adjustment made under this subparagraph shall apply only to subsection (d) hospitals and shall not apply for purposes of making computations under subsection (d)(2)(B)(ii) or subsection (d)(3)(A).
(B) For discharges occurring in fiscal year 1984 or fiscal year 1985, the Secretary shall provide under subsections (d)(2)(F) and (d)(3)(C) for such equal proportional adjustment in each of the average standardized amounts otherwise computed for that fiscal year as may be necessary to assure that—
(i) the aggregate payment amounts otherwise provided under subsection (d)(1)(A)(i)(II) and (d)(5) for that fiscal year for operating costs of inpatient hospital services of hospitals (excluding payments made under
are not greater or less than—
(ii) the DRG percentage (as defined in subsection (d)(1)(C)) of the payment amounts which would have been payable for such services for those same hospitals for that fiscal year under this section under the law as in effect before April 20, 1983 (excluding payments made under
(C) For discharges occurring in fiscal year 1988, the Secretary shall provide for such equal proportional adjustment in each of the average standardized amounts otherwise computed under subsection (d)(3) for that fiscal year as may be necessary to assure that—
(i) the aggregate payment amounts otherwise provided under subsections (d)(1)(A)(iii), (d)(5), and (d)(9) for that fiscal year for operating costs of inpatient hospital services of subsection (d) hospitals and subsection (d) Puerto Rico hospitals,
are not greater or less than—
(ii) the payment amounts that would have been payable for such services for those same hospitals for that fiscal year but for the enactment of the amendments made by section 9304 of the Omnibus Budget Reconciliation Act of 1986.
(2) Repealed.
(3) Repealed.
(4)(A) Taking into consideration the recommendations of the Commission, the Secretary shall recommend for each fiscal year (beginning with fiscal year 1988) an appropriate change factor for inpatient hospital services for discharges in that fiscal year which will take into account amounts necessary for the efficient and effective delivery of medically appropriate and necessary care of high quality. The appropriate change factor may be different for all large urban subsection (d) hospitals, other urban subsection (d) hospitals, urban subsection (d) Puerto Rico hospitals, rural subsection (d) hospitals, and rural subsection (d) Puerto Rico hospitals, and all other hospitals and units not paid under subsection (d), and may vary among such other hospitals and units.
(B) In addition to the recommendation made under subparagraph (A), the Secretary shall, taking into consideration the recommendations of the Commission under paragraph (2)(B), recommend for each fiscal year (beginning with fiscal year 1992) other appropriate changes in each existing reimbursement policy under this subchapter under which payments to an institution are based upon prospectively determined rates.
(5) The Secretary shall cause to have published in the Federal Register, not later than—
(A) the April 1 before each fiscal year (beginning with fiscal year 1986), the Secretary's proposed recommendations under paragraph (4) for that fiscal year for public comment, and
(B) the August 1 before such fiscal year after such consideration of public comment on the proposal as is feasible in the time available, the Secretary's final recommendations under such paragraph for that year.
The Secretary shall include in the publication referred to in subparagraph (A) for a fiscal year the report of the Commission's recommendations submitted under paragraph (3) for that fiscal year. To the extent that the Secretary's recommendations under paragraph (4) differ from the Commission's recommendations for that fiscal year, the Secretary shall include in the publication referred to in subparagraph (A) an explanation of the Secretary's grounds for not following the Commission's recommendations.
(f) Reporting of costs of hospitals receiving payments on basis of prospective rates
(1)(A) The Secretary shall maintain a system for the reporting of costs of hospitals receiving payments computed under subsection (d).
(B)(i) Subject to clause (ii), the Secretary shall place into effect a standardized electronic cost reporting format for hospitals under this subchapter.
(ii) The Secretary may delay or waive the implementation of such format in particular instances where such implementation would result in financial hardship (in particular with respect to hospitals with a small percentage of inpatients entitled to benefits under this subchapter).
(2) If the Secretary determines, based upon information supplied by a quality improvement organization under part B of subchapter XI, that a hospital, in order to circumvent the payment method established under subsection (b) or (d) of this section, has taken an action that results in the admission of individuals entitled to benefits under part A unnecessarily, unnecessary multiple admissions of the same such individuals, or other inappropriate medical or other practices with respect to such individuals, the Secretary may—
(A) deny payment (in whole or in part) under part A with respect to inpatient hospital services provided with respect to such an unnecessary admission (or subsequent admission of the same individual), or
(B) require the hospital to take other corrective action necessary to prevent or correct the inappropriate practice.
(3) The provisions of subsections (c) through (g) of
(g) Prospective payment for capital-related costs; return on equity capital for hospitals
(1)(A) Notwithstanding
(B) Such system—
(i) shall provide for (I) a payment on a per discharge basis, and (II) an appropriate weighting of such payment amount as relates to the classification of the discharge;
(ii) may provide for an adjustment to take into account variations in the relative costs of capital and construction for the different types of facilities or areas in which they are located;
(iii) may provide for such exceptions (including appropriate exceptions to reflect capital obligations) as the Secretary determines to be appropriate, and
(iv) may provide for suitable adjustment to reflect hospital occupancy rate.
(C) In this paragraph, the term "capital-related costs" has the meaning given such term by the Secretary under subsection (a)(4) as of September 30, 1987, and does not include a return on equity capital.
(2)(A) The Secretary shall provide that the amount which is allowable, with respect to reasonable costs of inpatient hospital services for which payment may be made under this subchapter, for a return on equity capital for hospitals shall, for cost reporting periods beginning on or after April 20, 1983, be equal to amounts otherwise allowable under regulations in effect on March 1, 1983, except that the rate of return to be recognized shall be equal to the applicable percentage (described in subparagraph (B)) of the average of the rates of interest, for each of the months any part of which is included in the reporting period, on obligations issued for purchase by the Federal Hospital Insurance Trust Fund.
(B) In this paragraph, the "applicable percentage" is—
(i) 75 percent, for cost reporting periods beginning during fiscal year 1987,
(ii) 50 percent, for cost reporting periods beginning during fiscal year 1988,
(iii) 25 percent, for cost reporting periods beginning during fiscal year 1989, and
(iv) 0 percent, for cost reporting periods beginning on or after October 1, 1989.
(3)(A) Except as provided in subparagraph (B), in determining the amount of the payments that may be made under this subchapter with respect to all the capital-related costs of inpatient hospital services of a subsection (d) hospital and a subsection (d) Puerto Rico hospital, the Secretary shall reduce the amounts of such payments otherwise established under this subchapter by—
(i) 3.5 percent for payments attributable to portions of cost reporting periods occurring during fiscal year 1987,
(ii) 7 percent for payments attributable to portions of cost reporting periods or discharges (as the case may be) occurring during fiscal year 1988 on or after October 1, 1987, and before January 1, 1988,
(iii) 12 percent for payments attributable to portions of cost reporting periods or discharges (as the case may be) in fiscal year 1988, occurring on or after January 1, 1988,
(iv) 15 percent for payments attributable to portions of cost reporting periods or discharges (as the case may be) occurring during fiscal year 1989, and
(v) 15 percent for payments attributable to portions of cost reporting periods or discharges (as the case may be) occurring during the period beginning January 1, 1990, and ending September 30, 1991.
(B) Subparagraph (A) shall not apply to payments with respect to the capital-related costs of any hospital that is a sole community hospital (as defined in subsection (d)(5)(D)(iii)) or a critical access hospital (as defined in
(4) In determining the amount of the payments that are attributable to portions of cost reporting periods occurring during fiscal years 1998 through 2002 and that may be made under this subchapter with respect to capital-related costs of inpatient hospital services of a hospital which is described in clause (i), (ii), or (iv) of subsection (d)(1)(B) or a unit described in the matter after clause (v) of such subsection, the Secretary shall reduce the amounts of such payments otherwise determined under this subchapter by 15 percent.
(h) Payments for direct graduate medical education costs
(1) Substitution of special payment rules
Notwithstanding
(2) Determination of hospital-specific approved FTE resident amounts
The Secretary shall determine, for each hospital with an approved medical residency training program, an approved FTE resident amount for each cost reporting period beginning on or after July 1, 1985, as follows:
(A) Determining allowable average cost per FTE resident in a hospital's base period
The Secretary shall determine, for the hospital's cost reporting period that began during fiscal year 1984, the average amount recognized as reasonable under this subchapter for direct graduate medical education costs of the hospital for each full-time-equivalent resident.
(B) Updating to the first cost reporting period
(i) In general
The Secretary shall update each average amount determined under subparagraph (A) by the percentage increase in the consumer price index during the 12-month cost reporting period described in such subparagraph.
(ii) Exception
The Secretary shall not perform an update under clause (i) in the case of a hospital if the hospital's reporting period, described in subparagraph (A), began on or after July 1, 1984, and before October 1, 1984.
(C) Amount for first cost reporting period
For the first cost reporting period of the hospital beginning on or after July 1, 1985, the approved FTE resident amount for the hospital is equal to the amount determined under subparagraph (B) increased by 1 percent.
(D) Amount for subsequent cost reporting periods
(i) In general
Except as provided in a subsequent clause, for each subsequent cost reporting period, the approved FTE resident amount for the hospital is equal to the approved FTE resident amount determined under this paragraph for the previous cost reporting period updated, through the midpoint of the period, by projecting the estimated percentage change in the consumer price index during the 12-month period ending at that midpoint, with appropriate adjustments to reflect previous under- or over-estimations under this subparagraph in the projected percentage change in the consumer price index.
(ii) Freeze in update for fiscal years 1994 and 1995
For cost reporting periods beginning during fiscal year 1994 or fiscal year 1995, the approved FTE resident amount for a hospital shall not be updated under clause (i) for a resident who is not a primary care resident (as defined in paragraph (5)(H)) or a resident enrolled in an approved medical residency training program in obstetrics and gynecology.
(iii) Floor for locality adjusted national average per resident amount
The approved FTE resident amount for a hospital for the cost reporting period beginning during fiscal year 2001 shall not be less than 70 percent, and for the cost reporting period beginning during fiscal year 2002 shall not be less than 85 percent, of the locality adjusted national average per resident amount computed under subparagraph (E) for the hospital and period.
(iv) Adjustment in rate of increase for hospitals with FTE approved amount above 140 percent of locality adjusted national average per resident amount
(I) Freeze for fiscal years 2001 and 2002 and 2004 through 2013
For a cost reporting period beginning during fiscal year 2001 or fiscal year 2002 or during the period beginning with fiscal year 2004 and ending with fiscal year 2013, if the approved FTE resident amount for a hospital for the preceding cost reporting period exceeds 140 percent of the locality adjusted national average per resident amount computed under subparagraph (E) for that hospital and period, subject to subclause (III), the approved FTE resident amount for the period involved shall be the same as the approved FTE resident amount for the hospital for such preceding cost reporting period.
(II) 2 percent decrease in update for fiscal years 2003, 2004, and 2005
For the cost reporting period beginning during fiscal year 2003, if the approved FTE resident amount for a hospital for the preceding cost reporting period exceeds 140 percent of the locality adjusted national average per resident amount computed under subparagraph (E) for that hospital and preceding period, the approved FTE resident amount for the period involved shall be updated in the manner described in subparagraph (D)(i) except that, subject to subclause (III), the consumer price index applied for a 12-month period shall be reduced (but not below zero) by 2 percentage points.
(III) No adjustment below 140 percent
In no case shall subclause (I) or (II) reduce an approved FTE resident amount for a hospital for a cost reporting period below 140 percent of the locality adjusted national average per resident amount computed under subparagraph (E) for such hospital and period.
(E) Determination of locality adjusted national average per resident amount
The Secretary shall determine a locality adjusted national average per resident amount with respect to a cost reporting period of a hospital beginning during a fiscal year as follows:
(i) Determining hospital single per resident amount
The Secretary shall compute for each hospital operating an approved graduate medical education program a single per resident amount equal to the average (weighted by number of full-time equivalent residents, as determined under paragraph (4)) of the primary care per resident amount and the non-primary care per resident amount computed under paragraph (2) for cost reporting periods ending during fiscal year 1997.
(ii) Standardizing per resident amounts
The Secretary shall compute a standardized per resident amount for each such hospital by dividing the single per resident amount computed under clause (i) by an average of the 3 geographic index values (weighted by the national average weight for each of the work, practice expense, and malpractice components) as applied under
(iii) Computing of weighted average
The Secretary shall compute the average of the standardized per resident amounts computed under clause (ii) for such hospitals, with the amount for each hospital weighted by the average number of full-time equivalent residents at such hospital (as determined under paragraph (4)).
(iv) Computing national average per resident amount
The Secretary shall compute the national average per resident amount, for a hospital's cost reporting period that begins during fiscal year 2001, equal to the weighted average computed under clause (iii) increased by the estimated percentage increase in the consumer price index for all urban consumers during the period beginning with the month that represents the midpoint of the cost reporting periods described in clause (i) and ending with the midpoint of the hospital's cost reporting period that begins during fiscal year 2001.
(v) Adjusting for locality
The Secretary shall compute the product of—
(I) the national average per resident amount computed under clause (iv) for the hospital, and
(II) the geographic index value average (described and applied under clause (ii)) for the fee schedule area in which the hospital is located.
(vi) Computing locality adjusted amount
The locality adjusted national per resident amount for a hospital for—
(I) the cost reporting period beginning during fiscal year 2001 is the product computed under clause (v); or
(II) each subsequent cost reporting period is equal to the locality adjusted national per resident amount for the hospital for the previous cost reporting period (as determined under this clause) updated, through the midpoint of the period, by projecting the estimated percentage change in the consumer price index for all urban consumers during the 12-month period ending at that midpoint.
(F) Treatment of certain hospitals
(i) In the case of a hospital that did not have an approved medical residency training program or was not participating in the program under this subchapter for a cost reporting period beginning during fiscal year 1984, the Secretary shall, for the first such period for which it has such a residency training program and is participating under this subchapter, provide for such approved FTE resident amount as the Secretary determines to be appropriate, based on approved FTE resident amounts for comparable programs.
(ii) In applying this subparagraph in the case of a hospital that trains residents and has not entered into a GME affiliation agreement (as defined by the Secretary for purposes of paragraph (4)(H)(ii)), on or after December 27, 2020, the Secretary shall not establish an FTE resident amount until such time as the Secretary determines that the hospital has trained at least 1.0 full-time-equivalent resident in an approved medical residency training program in a cost reporting period.
(iii) In applying this subparagraph for cost reporting periods beginning on or after December 27, 2020, in the case of a hospital that, as of such date, has an approved FTE resident amount based on the training in an approved medical residency program or programs of—
(I) less than 1.0 full-time-equivalent resident in any cost reporting period beginning before October 1, 1997, as determined by the Secretary; or
(II) no more than 3.0 full-time-equivalent residents in any cost reporting period beginning on or after October 1, 1997, and before December 27, 2020, as determined by the Secretary,
in lieu of such FTE resident amount the Secretary shall, in accordance with the methodology described in section 413.77(e) of title 42 of the Code of Federal Regulations (or any successor regulation), establish a new FTE resident amount if the hospital trains at least 1.0 full-time-equivalent resident (in the case of a hospital described in subclause (I)) or more than 3.0 full-time-equivalent residents (in the case of a hospital described in subclause (II)) in a cost reporting period beginning on or after such date and before the date that is 5 years after such date.
(iv) For purposes of carrying out this subparagraph for cost reporting periods beginning on or after December 27, 2020, a hospital shall report full-time-equivalent residents on its cost report for a cost reporting period if the hospital trains at least 1.0 full-time-equivalent residents 9 in an approved medical residency training program or programs in such period.
(v) As appropriate, the Secretary may consider information from any cost reporting period necessary to establish a new FTE resident amount as described in clause (iii).
(3) Hospital payment amount per resident
(A) In general
The payment amount, for a hospital cost reporting period beginning on or after July 1, 1985, is equal to the product of—
(i) the aggregate approved amount (as defined in subparagraph (B)) for that period, and
(ii) the hospital's medicare patient load (as defined in subparagraph (C)) for that period.
(B) Aggregate approved amount
As used in subparagraph (A), the term "aggregate approved amount" means, for a hospital cost reporting period, the product of—
(i) the hospital's approved FTE resident amount (determined under paragraph (2)) for that period, and
(ii) the weighted average number of full-time-equivalent residents (as determined under paragraph (4)) in the hospital's approved medical residency training programs in that period.
The Secretary shall reduce the aggregate approved amount to the extent payment is made under subsection (k) for residents included in the hospital's count of full-time equivalent residents.
(C) Medicare patient load
As used in subparagraph (A), the term "medicare patient load" means, with respect to a hospital's cost reporting period, the fraction of the total number of inpatient-bed-days (as established by the Secretary) during the period which are attributable to patients with respect to whom payment may be made under part A.
(D) Payment for managed care enrollees
(i) In general
For portions of cost reporting periods occurring on or after January 1, 1998, the Secretary shall provide for an additional payment amount under this subsection for services furnished to individuals who are enrolled under a risk-sharing contract with an eligible organization under
(I) the aggregate approved amount (as defined in subparagraph (B)) for that period; and
(II) the fraction of the total number of inpatient-bed days (as established by the Secretary) during the period which are attributable to such enrolled individuals.
(ii) Applicable percentage
For purposes of clause (i), the applicable percentage is—
(I) 20 percent in 1998,
(II) 40 percent in 1999,
(III) 60 percent in 2000,
(IV) 80 percent in 2001, and
(V) 100 percent in 2002 and subsequent years.
(iii) Proportional reduction for nursing and allied health education
The Secretary shall estimate a proportional adjustment in payments to all hospitals determined under clauses (i) and (ii) for portions of cost reporting periods beginning in a year (beginning with 2000) such that the proportional adjustment reduces payments in an amount for such year equal to the total additional payment amounts for nursing and allied health education determined under subsection (l) for portions of cost reporting periods occurring in that year. In applying the preceding sentence for each of 2010 through 2019, the Secretary shall not take into account any increase in the total amount of such additional payment amounts for such nursing and allied health education for portions of cost reporting periods occurring in the year pursuant to the application of paragraph (2)(B)(ii) of such subsection.
(iv) Special rule for hospitals under reimbursement system
The Secretary shall establish rules for the application of this subparagraph to a hospital reimbursed under a reimbursement system authorized under
(4) Determination of full-time-equivalent residents
(A) Rules
The Secretary shall establish rules consistent with this paragraph for the computation of the number of full-time-equivalent residents in an approved medical residency training program.
(B) Adjustment for part-year or part-time residents
Such rules shall take into account individuals who serve as residents for only a portion of a period with a hospital or simultaneously with more than one hospital.
(C) Weighting factors for certain residents
Subject to subparagraph (D), such rules shall provide, in calculating the number of full-time-equivalent residents in an approved residency program—
(i) before July 1, 1986, for each resident the weighting factor is 1.00,
(ii) on or after July 1, 1986, for a resident who is in the resident's initial residency period (as defined in paragraph (5)(F)), the weighting factor is 1.00,
(iii) on or after July 1, 1986, and before July 1, 1987, for a resident who is not in the resident's initial residency period (as defined in paragraph (5)(F)), the weighting factor is .75, and
(iv) on or after July 1, 1987, for a resident who is not in the resident's initial residency period (as defined in paragraph (5)(F)), the weighting factor is .50.
(D) Foreign medical graduates required to pass FMGEMS examination
(i) In general
Except as provided in clause (ii), such rules shall provide that, in the case of an individual who is a foreign medical graduate (as defined in paragraph (5)(D)), the individual shall not be counted as a resident on or after July 1, 1986, unless—
(I) the individual has passed the FMGEMS examination (as defined in paragraph (5)(E)), or
(II) the individual has previously received certification from, or has previously passed the examination of, the Educational Commission for Foreign Medical Graduates.
(ii) Transition for current FMGS
On or after July 1, 1986, but before July 1, 1987, in the case of a foreign medical graduate who—
(I) has served as a resident before July 1, 1986, and is serving as a resident after that date, but
(II) has not passed the FMGEMS examination or a previous examination of the Educational Commission for Foreign Medical Graduates before July 1, 1986,
the individual shall be counted as a resident at a rate equal to one-half of the rate at which the individual would otherwise be counted.
(E) Counting time spent in outpatient settings
Subject to subparagraphs (J) and (K), such rules shall provide that only time spent in activities relating to patient care shall be counted and that—
(i) effective for cost reporting periods beginning before July 1, 2010, all the time; 10 so spent by a resident under an approved medical residency training program shall be counted towards the determination of full-time equivalency, without regard to the setting in which the activities are performed, if the hospital incurs all, or substantially all, of the costs for the training program in that setting; and
(ii) effective for cost reporting periods beginning on or after July 1, 2010, all the time so spent by a resident shall be counted towards the determination of full-time equivalency, without regard to the setting in which the activities are performed, if a hospital incurs the costs of the stipends and fringe benefits of the resident during the time the resident spends in that setting. If more than one hospital incurs these costs, either directly or through a third party, such hospitals shall count a proportional share of the time, as determined by written agreement between the hospitals, that a resident spends training in that setting.
Any hospital claiming under this subparagraph for time spent in a nonprovider setting shall maintain and make available to the Secretary records regarding the amount of such time and such amount in comparison with amounts of such time in such base year as the Secretary shall specify.
(F) Limitation on number of residents in allopathic and osteopathic medicine
(i) In general
Such rules shall provide that for purposes of a cost reporting period beginning on or after October 1, 1997, subject to paragraphs (7), (8), (9), and (10), the total number of full-time equivalent residents before application of weighting factors (as determined under this paragraph) with respect to a hospital's approved medical residency training program in the fields of allopathic medicine and osteopathic medicine may not exceed the number (or, 130 percent of such number in the case of a hospital located in a rural area) of such full-time equivalent residents for the hospital's most recent cost reporting period ending on or before December 31, 1996.
(ii) Counting primary care residents on certain approved leaves of absence in base year FTE count
(I) In general
In determining the number of such full-time equivalent residents for a hospital's most recent cost reporting period ending on or before December 31, 1996, for purposes of clause (i), the Secretary shall count an individual to the extent that the individual would have been counted as a primary care resident for such period but for the fact that the individual, as determined by the Secretary, was on maternity or disability leave or a similar approved leave of absence.
(II) Limitation to 3 FTE residents for any hospital
The total number of individuals counted under subclause (I) for a hospital may not exceed 3 full-time equivalent residents.
(G) Counting interns and residents for FY 1998 and subsequent years
(i) In general
For cost reporting periods beginning during fiscal years beginning on or after October 1, 1997, subject to the limit described in subparagraph (F), the total number of full-time equivalent residents for determining a hospital's graduate medical education payment shall equal the average of the actual full-time equivalent resident counts for the cost reporting period and the preceding two cost reporting periods.
(ii) Adjustment for short periods
If any cost reporting period beginning on or after October 1, 1997, is not equal to twelve months, the Secretary shall make appropriate modifications to ensure that the average full-time equivalent resident counts pursuant to clause (i) are based on the equivalent of full twelve-month cost reporting periods.
(iii) Transition rule for 1998
In the case of a hospital's first cost reporting period beginning on or after October 1, 1997, clause (i) shall be applied by using the average for such period and the preceding cost reporting period.
(H) Special rules for application of subparagraphs (F) and (G)
(i) New facilities
(I) The Secretary shall, consistent with the principles of subparagraphs (F) and (G) and subject to paragraphs (7), (8), (9), and (10), prescribe rules for the application of such subparagraphs in the case of medical residency training programs established on or after January 1, 1995. In promulgating such rules for purposes of subparagraph (F), the Secretary shall give special consideration to facilities that meet the needs of underserved rural areas.
(II) In applying this clause in the case of a hospital that, on or after December 27, 2020, begins training residents in a new approved medical residency training program or programs (as defined by the Secretary), the Secretary shall not determine a limitation applicable to the hospital under subparagraph (F) until such time as the Secretary determines that the hospital has trained at least 1.0 full-time-equivalent resident in such new approved medical residency training program or programs in a cost reporting period.
(III) In applying this clause in the case of a hospital that, as of December 27, 2020, has a limitation under subparagraph (F), based on a cost reporting period beginning before October 1, 1997, of less than 1.0 full-time-equivalent resident, the Secretary shall adjust the limitation in the manner applicable to a new approved medical residency training program if the Secretary determines the hospital begins training at least 1.0 full-time-equivalent residents 9 in a program year beginning on or after such date and before the date that is 5 years after such date.
(IV) In applying this clause in the case of a hospital that, as of December 27, 2020, has a limitation under subparagraph (F), based on a cost reporting period beginning on or after October 1, 1997, and before such date, of no more than 3.0 full-time-equivalent residents, the Secretary shall adjust the limitation in the manner applicable to a new approved medical residency training program if the Secretary determines the hospital begins training more than 3.0 full-time-equivalent residents in a program year beginning on or after such date and before the date that is 5 years after such date.
(V) An adjustment to the limitation applicable to a hospital made pursuant to subclause (III) or (IV) shall be made in a manner consistent with the methodology, as appropriate, in section 413.79(e) of title 42, Code of Federal Regulations (or any successor regulation). As appropriate, the Secretary may consider information from any cost reporting periods necessary to make such an adjustment to the limitation.
(ii) Aggregation
The Secretary may prescribe rules which allow institutions which are members of the same affiliated group (as defined by the Secretary) to elect to apply the limitation of subparagraph (F) on an aggregate basis.
(iii) Data collection
The Secretary may require any entity that operates a medical residency training program and to which subparagraphs (F) and (G) apply to submit to the Secretary such additional information as the Secretary considers necessary to carry out such subparagraphs.
(iv) Training programs in rural areas
(I) Cost reporting periods beginning before October 1, 2022
For cost reporting periods beginning before October 1, 2022, in the case of a hospital that is not located in a rural area but establishes separately accredited approved medical residency training programs (or rural tracks) in a rural area or has an accredited training program with an integrated rural track, the Secretary shall adjust the limitation under subparagraph (F) in an appropriate manner insofar as it applies to such programs in such rural areas in order to encourage the training of physicians in rural areas.
(II) Cost reporting periods beginning on or after October 1, 2022
For cost reporting periods beginning on or after October 1, 2022, in the case of a hospital not located in a rural area that established or establishes a medical residency training program (or rural tracks) in a rural area or establishes an accredited program where greater than 50 percent of the program occurs in a rural area, the Secretary shall 11 consistent with the principles of subparagraphs (F) and (G) and subject to paragraphs (7) and (8), prescribe rules for the application of such subparagraphs with respect to such a program and, in accordance with such rules, adjust in an appropriate manner the limitation under subparagraph (F) for such hospital and each such hospital located in a rural area that participates in such a training.
(v) Special provider agreement
If an entity enters into a provider agreement pursuant to
(I) the limitation on the number of total full time equivalent residents under subparagraph (F) and clauses (v) and (vi)(I) of subsection (d)(5)(B) applicable to such provider shall be equal to the limitation applicable under such provisions to Provider No. 05–0578 for its cost reporting period ending on June 30, 2006; and
(II) the provisions of subparagraph (G) and subsection (d)(5)(B)(vi)(II) shall not be applicable to such provider for the first three cost reporting years in which such provider trains residents under any approved medical residency training program.
(vi) Redistribution of residency slots after a hospital closes
(I) In general
Subject to the succeeding provisions of this clause, the Secretary shall, by regulation, establish a process under which, in the case where a hospital (other than a hospital described in clause (v)) with an approved medical residency program closes on or after a date that is 2 years before March 23, 2010, the Secretary shall increase the otherwise applicable resident limit under this paragraph for other hospitals in accordance with this clause.
(II) Priority for hospitals in certain areas
Subject to the succeeding provisions of this clause, in determining for which hospitals the increase in the otherwise applicable resident limit is provided under such process, the Secretary shall distribute the increase to hospitals in the following priority order (with preference given within each category to hospitals that are members of the same affiliated group (as defined by the Secretary under clause (ii)) as the closed hospital):
(aa) First, to hospitals located in the same core-based statistical area as, or a core-based statistical area contiguous to, the hospital that closed.
(bb) Second, to hospitals located in the same State as the hospital that closed.
(cc) Third, to hospitals located in the same region of the country as the hospital that closed.
(dd) Fourth, only if the Secretary is not able to distribute the increase to hospitals described in item (cc), to qualifying hospitals in accordance with the provisions of paragraph (8).
(III) Requirement hospital likely to fill position within certain time period
The Secretary may only increase the otherwise applicable resident limit of a hospital under such process if the Secretary determines the hospital has demonstrated a likelihood of filling the positions made available under this clause within 3 years.
(IV) Limitation
The aggregate number of increases in the otherwise applicable resident limits for hospitals under this clause shall be equal to the number of resident positions in the approved medical residency programs that closed on or after the date described in subclause (I).
(V) Administration
(J) 12 Treatment of certain nonprovider and didactic activities
Such rules shall provide that all time spent by an intern or resident in an approved medical residency training program in a nonprovider setting that is primarily engaged in furnishing patient care (as defined in paragraph (5)(K)) in non-patient care activities, such as didactic conferences and seminars, but not including research not associated with the treatment or diagnosis of a particular patient, as such time and activities are defined by the Secretary, shall be counted toward the determination of full-time equivalency.
(K) Treatment of certain other activities
In determining the hospital's number of full-time equivalent residents for purposes of this subsection, all the time that is spent by an intern or resident in an approved medical residency training program on vacation, sick leave, or other approved leave, as such time is defined by the Secretary, and that does not prolong the total time the resident is participating in the approved program beyond the normal duration of the program shall be counted toward the determination of full-time equivalency.
(5) Definitions and special rules
As used in this subsection:
(A) Approved medical residency training program
The term "approved medical residency training program" means a residency or other postgraduate medical training program participation in which may be counted toward certification in a specialty or subspecialty and includes formal postgraduate training programs in geriatric medicine approved by the Secretary.
(B) Consumer price index
The term "consumer price index" refers to the Consumer Price Index for All Urban Consumers (United States city average), as published by the Secretary of Commerce.
(C) Direct graduate medical education costs
The term "direct graduate medical education costs" means direct costs of approved educational activities for approved medical residency training programs.
(D) Foreign medical graduate
The term "foreign medical graduate" means a resident who is not a graduate of—
(i) a school of medicine accredited by the Liaison Committee on Medical Education of the American Medical Association and the Association of American Medical Colleges (or approved by such Committee as meeting the standards necessary for such accreditation),
(ii) a school of osteopathy accredited by the American Osteopathic Association, or approved by such Association as meeting the standards necessary for such accreditation, or
(iii) a school of dentistry or podiatry which is accredited (or meets the standards for accreditation) by an organization recognized by the Secretary for such purpose.
(E) FMGEMS examination
The term "FMGEMS examination" means parts I and II of the Foreign Medical Graduate Examination in the Medical Sciences or any successor examination recognized by the Secretary for this purpose.
(F) Initial residency period
The term "initial residency period" means the period of board eligibility, except that—
(i) except as provided in clause (ii), in no case shall the initial period of residency exceed an aggregate period of formal training of more than five years for any individual, and
(ii) a period, of not more than two years, during which an individual is in a geriatric residency or fellowship program or a preventive medicine residency or fellowship program which meets such criteria as the Secretary may establish, shall be treated as part of the initial residency period, but shall not be counted against any limitation on the initial residency period.
Subject to subparagraph (G)(v), the initial residency period shall be determined, with respect to a resident, as of the time the resident enters the residency training program.
(G) Period of board eligibility
(i) General rule
Subject to clauses (ii), (iii), (iv), and (v), the term "period of board eligibility" means, for a resident, the minimum number of years of formal training necessary to satisfy the requirements for initial board eligibility in the particular specialty for which the resident is training.
(ii) Application of 1985–1986 directory
Except as provided in clause (iii), the period of board eligibility shall be such period specified in the 1985–1986 Directory of Residency Training Programs published by the Accreditation Council on Graduate Medical Education.
(iii) Changes in period of board eligibility
On or after July 1, 1989, if the Accreditation Council on Graduate Medical Education, in its Directory of Residency Training Programs—
(I) increases the minimum number of years of formal training necessary to satisfy the requirements for a specialty, above the period specified in its 1985–1986 Directory, the Secretary may increase the period of board eligibility for that specialty, but not to exceed the period of board eligibility specified in that later Directory, or
(II) decreases the minimum number of years of formal training necessary to satisfy the requirements for a specialty, below the period specified in its 1985–1986 Directory, the Secretary may decrease the period of board eligibility for that specialty, but not below the period of board eligibility specified in that later Directory.
(iv) Special rule for certain primary care combined residency programs
(I) In the case of a resident enrolled in a combined medical residency training program in which all of the individual programs (that are combined) are for training a primary care resident (as defined in subparagraph (H)), the period of board eligibility shall be the minimum number of years of formal training required to satisfy the requirements for initial board eligibility in the longest of the individual programs plus one additional year.
(II) A resident enrolled in a combined medical residency training program that includes an obstetrics and gynecology program shall qualify for the period of board eligibility under subclause (I) if the other programs such resident combines with such obstetrics and gynecology program are for training a primary care resident.
(v) Child neurology training programs
In the case of a resident enrolled in a child neurology residency training program, the period of board eligibility and the initial residency period shall be the period of board eligibility for pediatrics plus 2 years.
(H) Primary care resident
The term "primary care resident" means a resident enrolled in an approved medical residency training program in family medicine, general internal medicine, general pediatrics, preventive medicine, geriatric medicine, or osteopathic general practice.
(I) Resident
The term "resident" includes an intern or other participant in an approved medical residency training program.
(J) Adjustments for certain family practice residency programs
(i) In general
In the case of an approved medical residency training program (meeting the requirements of clause (ii)) of a hospital which received funds from the United States, a State, or a political subdivision of a State or an instrumentality of such a State or political subdivision (other than payments under this subchapter or a State plan under subchapter XIX) for the program during the cost reporting period that began during fiscal year 1984, the Secretary shall—
(I) provide for an average amount under paragraph (2)(A) that takes into account the Secretary's estimate of the amount that would have been recognized as reasonable under this subchapter if the hospital had not received such funds, and
(II) reduce the payment amount otherwise provided under this subsection in an amount equal to the proportion of such program funds received during the cost reporting period involved that is allocable to this subchapter.
(ii) Additional requirements
A hospital's approved medical residency program meets the requirements of this clause if—
(I) the program is limited to training for family and community medicine;
(II) the program is the only approved medical residency program of the hospital; and
(III) the average amount determined under paragraph (2)(A) for the hospital (as determined without regard to the increase in such amount described in clause (i)(I)) does not exceed $10,000.
(K) Nonprovider setting that is primarily engaged in furnishing patient care
The term "nonprovider setting that is primarily engaged in furnishing patient care" means a nonprovider setting in which the primary activity is the care and treatment of patients, as defined by the Secretary.
(6) Incentive payment under plans for voluntary reduction in number of residents
(A) In general
In the case of a voluntary residency reduction plan for which an application is approved under subparagraph (B), subject to subparagraph (F), each hospital which is part of the qualifying entity submitting the plan shall be paid an applicable hold harmless percentage (as specified in subparagraph (E)) of the sum of—
(i) the amount (if any) by which—
(I) the amount of payment which would have been made under this subsection if there had been a 5-percent reduction in the number of full-time equivalent residents in the approved medical education training programs of the hospital as of June 30, 1997, exceeds
(II) the amount of payment which is made under this subsection, taking into account the reduction in such number effected under the reduction plan; and
(ii) the amount of the reduction in payment under subsection (d)(5)(B) for the hospital that is attributable to the reduction in number of residents effected under the plan below 95 percent of the number of full-time equivalent residents in such programs of the hospital as of June 30, 1997.
The determination of the amounts under clauses (i) and (ii) for any year shall be made on the basis of the provisions of this subchapter in effect on the application deadline date for the first calendar year to which the reduction plan applies.
(B) Approval of plan applications
The Secretary may not approve the application of an qualifying entity unless—
(i) the application is submitted in a form and manner specified by the Secretary and by not later than November 1, 1999,13
(ii) the application provides for the operation of a plan for the reduction in the number of full-time equivalent residents in the approved medical residency training programs of the entity consistent with the requirements of subparagraph (D);
(iii) the entity elects in the application the period of residency training years (not greater than 5) over which the reduction will occur;
(iv) the entity will not reduce the proportion of its residents in primary care (to the total number of residents) below such proportion as in effect as of the applicable time described in subparagraph (D)(v); and
(v) the Secretary determines that the application and the entity and such plan meet such other requirements as the Secretary specifies in regulations.
(C) Qualifying entity
For purposes of this paragraph, any of the following may be a qualifying entity:
(i) Individual hospitals operating one or more approved medical residency training programs.
(ii) Two or more hospitals that operate such programs and apply for treatment under this paragraph as a single qualifying entity.
(iii) A qualifying consortium (as described in section 4628 of the Balanced Budget Act of 1997).
(D) Residency reduction requirements
(i) Individual hospital applicants
In the case of a qualifying entity described in subparagraph (C)(i), the number of full-time equivalent residents in all the approved medical residency training programs operated by or through the entity shall be reduced as follows:
(I) If the base number of residents exceeds 750 residents, by a number equal to at least 20 percent of such base number.
(II) Subject to subclause (IV), if the base number of residents exceeds 600 but is less than 750 residents, by 150 residents.
(III) Subject to subclause (IV), if the base number of residents does not exceed 600 residents, by a number equal to at least 25 percent of such base number.
(IV) In the case of a qualifying entity which is described in clause (v) and which elects treatment under this subclause, by a number equal to at least 20 percent of the base number.
(ii) Joint applicants
In the case of a qualifying entity described in subparagraph (C)(ii), the number of full-time equivalent residents in the aggregate for all the approved medical residency training programs operated by or through the entity shall be reduced as follows:
(I) Subject to subclause (II), by a number equal to at least 25 percent of the base number.
(II) In the case of such a qualifying entity which is described in clause (v) and which elects treatment under this subclause, by a number equal to at least 20 percent of the base number.
(iii) Consortia
In the case of a qualifying entity described in subparagraph (C)(iii), the number of full-time equivalent residents in the aggregate for all the approved medical residency training programs operated by or through the entity shall be reduced by a number equal to at least 20 percent of the base number.
(iv) Manner of reduction
The reductions specified under the preceding provisions of this subparagraph for a qualifying entity shall be below the base number of residents for that entity and shall be fully effective not later than the 5th residency training year in which the application under subparagraph (B) is effective.
(v) Entities providing assurance of increase in primary care residents
An entity is described in this clause if—
(I) the base number of residents for the entity is less than 750 or the entity is described in subparagraph (C)(ii); and
(II) the entity represents in its application under subparagraph (B) that it will increase the number of full-time equivalent residents in primary care by at least 20 percent (from such number included in the base number of residents) by not later than the 5th residency training year in which the application under subparagraph (B) is effective.
If a qualifying entity fails to comply with the representation described in subclause (II) by the end of such 5th residency training year, the entity shall be subject to repayment of all amounts paid under this paragraph, in accordance with procedures established to carry out subparagraph (F).
(vi) "Base number of residents" defined
For purposes of this paragraph, the term "base number of residents" means, with respect to a qualifying entity (or its participating hospitals) operating approved medical residency training programs, the number of full-time equivalent residents in such programs (before application of weighting factors) of the entity as of the most recent residency training year ending before June 30, 1997, or, if less, for any subsequent residency training year that ends before the date the entity makes application under this paragraph.
(E) Applicable hold harmless percentage
For purposes of subparagraph (A), the "applicable hold harmless percentage" for the—
(i) first and second residency training years in which the reduction plan is in effect, 100 percent,
(ii) third such year, 75 percent,
(iii) fourth such year, 50 percent, and
(iv) fifth such year, 25 percent.
(F) Penalty for noncompliance
(i) In general
No payment may be made under this paragraph to a hospital for a residency training year if the hospital has failed to reduce the number of full-time equivalent residents (in the manner required under subparagraph (D)) to the number agreed to by the Secretary and the qualifying entity in approving the application under this paragraph with respect to such year.
(ii) Increase in number of residents in subsequent years
If payments are made under this paragraph to a hospital, and if the hospital increases the number of full-time equivalent residents above the number of such residents permitted under the reduction plan as of the completion of the plan, then, as specified by the Secretary, the entity is liable for repayment to the Secretary of the total amounts paid under this paragraph to the entity.
(G) Treatment of rotating residents
In applying this paragraph, the Secretary shall establish rules regarding the counting of residents who are assigned to institutions the medical residency training programs in which are not covered under approved applications under this paragraph.
(7) Redistribution of unused resident positions
(A) Reduction in limit based on unused positions
(i) Programs subject to reduction
(I) In general
Except as provided in subclause (II), if a hospital's reference resident level (specified in clause (ii)) is less than the otherwise applicable resident limit (as defined in subparagraph (C)(ii)), effective for portions of cost reporting periods occurring on or after July 1, 2005, the otherwise applicable resident limit shall be reduced by 75 percent of the difference between such otherwise applicable resident limit and such reference resident level.
(II) Exception for small rural hospitals
This subparagraph shall not apply to a hospital located in a rural area (as defined in subsection (d)(2)(D)(ii)) with fewer than 250 acute care inpatient beds.
(ii) Reference resident level
(I) In general
Except as otherwise provided in subclauses (II) and (III), the reference resident level specified in this clause for a hospital is the resident level for the most recent cost reporting period of the hospital ending on or before September 30, 2002, for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.
(II) Use of most recent accounting period to recognize expansion of existing programs
If a hospital submits a timely request to increase its resident level due to an expansion of an existing residency training program that is not reflected on the most recent settled cost report, after audit and subject to the discretion of the Secretary, the reference resident level for such hospital is the resident level for the cost reporting period that includes July 1, 2003, as determined by the Secretary.
(III) Expansions under newly approved programs
Upon the timely request of a hospital, the Secretary shall adjust the reference resident level specified under subclause (I) or (II) to include the number of medical residents that were approved in an application for a medical residency training program that was approved by an appropriate accrediting organization (as determined by the Secretary) before January 1, 2002, but which was not in operation during the cost reporting period used under subclause (I) or (II), as the case may be, as determined by the Secretary.
(iii) Affiliation
The provisions of clause (i) shall be applied to hospitals which are members of the same affiliated group (as defined by the Secretary under paragraph (4)(H)(ii)) as of July 1, 2003.
(B) Redistribution
(i) In general
The Secretary is authorized to increase the otherwise applicable resident limit for each qualifying hospital that submits a timely application under this subparagraph by such number as the Secretary may approve for portions of cost reporting periods occurring on or after July 1, 2005. The aggregate number of increases in the otherwise applicable resident limits under this subparagraph may not exceed the Secretary's estimate of the aggregate reduction in such limits attributable to subparagraph (A).
(ii) Considerations in redistribution
In determining for which hospitals the increase in the otherwise applicable resident limit is provided under clause (i), the Secretary shall take into account the demonstrated likelihood of the hospital filling the positions within the first 3 cost reporting periods beginning on or after July 1, 2005, made available under this subparagraph, as determined by the Secretary.
(iii) Priority for rural and small urban areas
In determining for which hospitals and residency training programs an increase in the otherwise applicable resident limit is provided under clause (i), the Secretary shall distribute the increase to programs of hospitals located in the following priority order:
(I) First, to hospitals located in rural areas (as defined in subsection (d)(2)(D)(ii)).
(II) Second, to hospitals located in urban areas that are not large urban areas (as defined for purposes of subsection (d)).
(III) Third, to other hospitals in a State if the residency training program involved is in a specialty for which there are not other residency training programs in the State.
Increases of residency limits within the same priority category under this clause shall be determined by the Secretary.
(iv) Limitation
In no case shall more than 25 full-time equivalent additional residency positions be made available under this subparagraph with respect to any hospital.
(v) Application of locality adjusted national average per resident amount
With respect to additional residency positions in a hospital attributable to the increase provided under this subparagraph, notwithstanding any other provision of this subsection, the approved FTE resident amount is deemed to be equal to the locality adjusted national average per resident amount computed under paragraph (4)(E) for that hospital.
(vi) Construction
Nothing in this subparagraph shall be construed as permitting the redistribution of reductions in residency positions attributable to voluntary reduction programs under paragraph (6), under a demonstration project approved as of October 31, 2003, under the authority of section 402 of
(C) Resident level and limit defined
In this paragraph:
(i) Resident level
The term "resident level" means, with respect to a hospital, the total number of full-time equivalent residents, before the application of weighting factors (as determined under paragraph (4)), in the fields of allopathic and osteopathic medicine for the hospital.
(ii) Otherwise applicable resident limit
The term "otherwise applicable resident limit" means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph.
(D) Adjustment based on settled cost report
In the case of a hospital with a dual accredited osteopathic and allopathic family practice program for which—
(i) the otherwise applicable resident limit was reduced under subparagraph (A)(i)(I); and
(ii) such reduction was based on a reference resident level that was determined using a cost report and where a revised or corrected notice of program reimbursement was issued for such cost report between September 1, 2006 and September 15, 2006, whether as a result of an appeal or otherwise, and the reference resident level under such settled cost report is higher than the level used for the reduction under subparagraph (A)(i)(I);
the Secretary shall apply subparagraph (A)(i)(I) using the higher resident reference level and make any necessary adjustments to such reduction. Any such necessary adjustments shall be effective for portions of cost reporting periods occurring on or after July 1, 2005.
(E) Judicial review
There shall be no administrative or judicial review under
(8) Distribution of additional residency positions
(A) Reductions in limit based on unused positions
(i) In general
Except as provided in clause (ii), if a hospital's reference resident level (as defined in subparagraph (H)(i)) is less than the otherwise applicable resident limit (as defined in subparagraph (H)(iii)), effective for portions of cost reporting periods occurring on or after July 1, 2011, the otherwise applicable resident limit shall be reduced by 65 percent of the difference between such otherwise applicable resident limit and such reference resident level.
(ii) Exceptions
This subparagraph shall not apply to—
(I) a hospital located in a rural area (as defined in subsection (d)(2)(D)(ii)) with fewer than 250 acute care inpatient beds;
(II) a hospital that was part of a qualifying entity which had a voluntary residency reduction plan approved under paragraph (6)(B) or under the authority of section 402 of
(III) a hospital described in paragraph (4)(H)(v).
(B) Distribution
(i) In general
The Secretary shall increase the otherwise applicable resident limit for each qualifying hospital that submits an application under this subparagraph by such number as the Secretary may approve for portions of cost reporting periods occurring on or after July 1, 2011. The aggregate number of increases in the otherwise applicable resident limit under this subparagraph shall be equal to the aggregate reduction in such limits attributable to subparagraph (A) (as estimated by the Secretary).
(ii) Requirements
Subject to clause (iii), a hospital that receives an increase in the otherwise applicable resident limit under this subparagraph shall ensure, during the 5-year period beginning on the date of such increase, that—
(I) the number of full-time equivalent primary care residents, as defined in paragraph (5)(H) (as determined by the Secretary), excluding any additional positions under subclause (II), is not less than the average number of full-time equivalent primary care residents (as so determined) during the 3 most recent cost reporting periods ending prior to March 23, 2010; and
(II) not less than 75 percent of the positions attributable to such increase are in a primary care or general surgery residency (as determined by the Secretary).
The Secretary may determine whether a hospital has met the requirements under this clause during such 5-year period in such manner and at such time as the Secretary determines appropriate, including at the end of such 5-year period.
(iii) Redistribution of positions if hospital no longer meets certain requirements
In the case where the Secretary determines that a hospital described in clause (ii) does not meet either of the requirements under subclause (I) or (II) of such clause, the Secretary shall—
(I) reduce the otherwise applicable resident limit of the hospital by the amount by which such limit was increased under this paragraph; and
(II) provide for the distribution of positions attributable to such reduction in accordance with the requirements of this paragraph.
(C) Considerations in redistribution
In determining for which hospitals the increase in the otherwise applicable resident limit is provided under subparagraph (B), the Secretary shall take into account—
(i) the demonstration likelihood of the hospital filling the positions made available under this paragraph within the first 3 cost reporting periods beginning on or after July 1, 2011, as determined by the Secretary; and
(ii) whether the hospital has an accredited rural training track (as described in paragraph (4)(H)(iv)).
(D) Priority for certain areas
In determining for which hospitals the increase in the otherwise applicable resident limit is provided under subparagraph (B), subject to subparagraph (E), the Secretary shall distribute the increase to hospitals based on the following factors:
(i) Whether the hospital is located in a State with a resident-to-population ratio in the lowest quartile (as determined by the Secretary).
(ii) Whether the hospital is located in a State, a territory of the United States, or the District of Columbia that is among the top 10 States, territories, or Districts in terms of the ratio of—
(I) the total population of the State, territory, or District living in an area designated (under such section 332(a)(1)(A) 4) as a health professional shortage area (as of March 23, 2010); to
(II) the total population of the State, territory, or District (as determined by the Secretary based on the most recent available population data published by the Bureau of the Census).
(iii) Whether the hospital is located in a rural area (as defined in subsection (d)(2)(D)(ii)).
(E) Reservation of positions for certain hospitals
(i) In general
Subject to clause (ii), the Secretary shall reserve the positions available for distribution under this paragraph as follows:
(I) 70 percent of such positions for distribution to hospitals described in clause (i) of subparagraph (D).
(II) 30 percent of such positions for distribution to hospitals described in clause (ii) and (iii) of such subparagraph.
(ii) Exception if positions not redistributed by July 1, 2011
In the case where the Secretary does not distribute positions to hospitals in accordance with clause (i) by July 1, 2011, the Secretary shall distribute such positions to other hospitals in accordance with the considerations described in subparagraph (C) and the priority described in subparagraph (D).
(F) Limitation
A hospital may not receive more than 75 full-time equivalent additional residency positions under this paragraph.
(G) Application of per resident amounts for primary care and nonprimary care
With respect to additional residency positions in a hospital attributable to the increase provided under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for primary care and nonprimary care computed under paragraph (2)(D) for that hospital.
(H) Definitions
In this paragraph:
(i) Reference resident level
The term "reference resident level" means, with respect to a hospital, the highest resident level for any of the 3 most recent cost reporting periods (ending before March 23, 2010) of the hospital for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.
(ii) Resident level
The term "resident level" has the meaning given such term in paragraph (7)(C)(i).
(iii) Otherwise applicable resident limit
The term "otherwise applicable resident limit" means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph but taking into account paragraph (7)(A).
(I) Affiliation
The provisions of this paragraph shall be applied to hospitals which are members of the same affiliated group (as defined by the Secretary under paragraph (4)(H)(ii)) and the reference resident level for each such hospital shall be the reference resident level with respect to the cost reporting period that results in the smallest difference between the reference resident level and the otherwise applicable resident limit.
(9) Distribution of additional residency positions
(A) Additional residency positions
(i) In general
For fiscal year 2023, and for each succeeding fiscal year until the aggregate number of full-time equivalent residency positions distributed under this paragraph is equal to the aggregate number of such positions made available (as specified in clause (ii)(I)), the Secretary shall, subject to the succeeding provisions of this paragraph, increase the otherwise applicable resident limit for each qualifying hospital (as defined in subparagraph (F)) that submits a timely application under this subparagraph by such number as the Secretary may approve effective beginning July 1 of the fiscal year of the increase.
(ii) Number available for distribution
(I) Total number available
The aggregate number of such positions made available under this paragraph shall be equal to 1,000.
(II) Annual limit
The aggregate number of such positions so made available shall not exceed 200 for a fiscal year.
(iii) Process for distributing positions
(I) Rounds of applications
The Secretary shall initiate a separate round of applications for an increase under clause (i) for each fiscal year for which such an increase is to be provided.
(II) Timing
The Secretary shall notify hospitals of the number of positions distributed to the hospital under this paragraph as a result of an increase in the otherwise applicable resident limit by January 31 of the fiscal year of the increase. Such increase shall be effective beginning July 1 of such fiscal year.
(B) Distribution
For purposes of providing an increase in the otherwise applicable resident limit under subparagraph (A), the following shall apply:
(i) Considerations in distribution
In determining for which qualifying hospitals such an increase is provided under subparagraph (A), the Secretary shall take into account the demonstrated likelihood of the hospital filling the positions made available under this paragraph within the first 5 training years beginning after the date the increase would be effective, as determined by the Secretary.
(ii) Minimum distribution for certain categories of hospitals
With respect to the aggregate number of such positions available for distribution under this paragraph, the Secretary shall distribute not less than 10 percent of such aggregate number to each of the following categories of hospitals:
(I) Hospitals that are located in a rural area (as defined in subsection (d)(2)(D)) or are treated as being located in a rural area pursuant to subsection (d)(8)(E).
(II) Hospitals in which the reference resident level of the hospital (as specified in subparagraph (F)(iii)) is greater than the otherwise applicable resident limit.
(III) Hospitals in States with—
(aa) new medical schools that received "Candidate School" status from the Liaison Committee on Medical Education or that received "Pre-Accreditation" status from the American Osteopathic Association Commission on Osteopathic College Accreditation on or after January 1, 2000, and that have achieved or continue to progress toward "Full Accreditation" status (as such term is defined by the Liaison Committee on Medical Education) or toward "Accreditation" status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation); or
(bb) additional locations and branch campuses established on or after January 1, 2000, by medical schools with "Full Accreditation" status (as such term is defined by the Liaison Committee on Medical Education) or "Accreditation" status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation).
(IV) Hospitals that serve areas designated as health professional shortage areas under
(C) Limitations
(i) In general
A hospital may not receive more than 25 additional full-time equivalent residency positions under this paragraph.
(ii) Prohibition on distribution to hospitals without an increase agreement
No increase in the otherwise applicable resident limit of a hospital may be made under this paragraph unless such hospital agrees to increase the total number of full-time equivalent residency positions under the approved medical residency training program of such hospital by the number of such positions made available by such increase under this paragraph.
(D) Application of per resident amounts for primary care and nonprimary care
With respect to additional residency positions in a hospital attributable to the increase provided under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for primary care and nonprimary care computed under paragraph (2)(D) for that hospital.
(E) Permitting facilities to apply aggregation rules
The Secretary shall permit hospitals receiving additional residency positions attributable to the increase provided under this paragraph to, beginning in the fifth year after the effective date of such increase, apply such positions to the limitation amount under paragraph (4)(F) that may be aggregated pursuant to paragraph (4)(H) among members of the same affiliated group.
(F) Definitions
In this paragraph:
(i) Otherwise applicable resident limit
The term "otherwise applicable resident limit" means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph but taking into account paragraphs (7)(A), (7)(B), (8)(A), and (8)(B).
(ii) Qualifying hospital
The term "qualifying hospital" means a hospital described in any of subclauses (I) through (IV) of subparagraph (B)(ii).
(iii) Reference resident level
The term "reference resident level" means, with respect to a hospital, the resident level for the most recent cost reporting period of the hospital ending on or before December 27, 2020, for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.
(iv) Resident level
The term "resident level" has the meaning given such term in paragraph (7)(C)(i).
(10) Distribution of additional residency positions in psychiatry and psychiatry subspecialties
(A) Additional residency positions
(i) In general
For fiscal year 2026, the Secretary shall, subject to the succeeding provisions of this paragraph, increase the otherwise applicable resident limit for each qualifying hospital (as defined in subparagraph (F)) that submits a timely application under this subparagraph by such number as the Secretary may approve effective beginning July 1 of the fiscal year of the increase.
(ii) Number available for distribution
The aggregate number of such positions made available under this paragraph shall be equal to 200.
(iii) Distribution for psychiatry or psychiatry subspecialty residencies
At least 100 of the positions made available under this paragraph shall be distributed for a psychiatry or psychiatry subspecialty residency (as defined in subparagraph (F)).
(iv) Timing
The Secretary shall notify hospitals of the number of positions distributed to the hospital under this paragraph as a result of an increase in the otherwise applicable resident limit by January 31 of the fiscal year of the increase. Such increase shall be effective beginning July 1 of such fiscal year.
(B) Distribution
For purposes of providing an increase in the otherwise applicable resident limit under subparagraph (A), the following shall apply:
(i) Considerations in distribution
In determining for which qualifying hospitals such an increase is provided under subparagraph (A), the Secretary shall take into account the demonstrated likelihood of the hospital filling the positions made available under this paragraph within the first 5 training years beginning after the date the increase would be effective, as determined by the Secretary.
(ii) Minimum distribution for certain categories of hospitals
With respect to the aggregate number of such positions available for distribution under this paragraph, the Secretary shall distribute not less than 10 percent of such aggregate number to each of the following categories of hospitals:
(I) Hospitals that are located in a rural area (as defined in
(II) Hospitals in which the reference resident level of the hospital (as specified in subparagraph (F)(iii)) is greater than the otherwise applicable resident limit.
(III) Hospitals in States with—
(aa) new medical schools that received "Candidate School" status from the Liaison Committee on Medical Education or that received "Pre-Accreditation" status from the American Osteopathic Association Commission on Osteopathic College Accreditation on or after January 1, 2000, and that have achieved or continue to progress toward "Full Accreditation" status (as such term is defined by the Liaison Committee on Medical Education) or toward "Accreditation" status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation); or
(bb) additional locations and branch campuses established on or after January 1, 2000, by medical schools with "Full Accreditation" status (as such term is defined by the Liaison Committee on Medical Education) or "Accreditation" status (as such term is defined by the American Osteopathic Association Commission on Osteopathic College Accreditation).
(IV) Hospitals that serve areas designated as health professional shortage areas under
(iii) Pro rata application
The Secretary shall ensure that each qualifying hospital that submits a timely application under subparagraph (A) receives at least 1 (or a fraction of 1) of the positions made available under this paragraph before any qualifying hospital receives more than 1 of such positions.
(C) Requirements
(i) Limitation
A hospital may not receive more than 10 additional full-time equivalent residency positions under this paragraph.
(ii) Prohibition on distribution to hospitals without an increase agreement
No increase in the otherwise applicable resident limit of a hospital may be made under this paragraph unless such hospital agrees to increase the total number of full-time equivalent residency positions under the approved medical residency training program of such hospital by the number of such positions made available by such increase under this paragraph.
(iii) Requirement for hospitals to expand programs
If a hospital that receives an increase in the otherwise applicable resident limit under this paragraph would be eligible for an adjustment to the otherwise applicable resident limit for participation in a new medical residency training program under section 413.79(e)(3) of title 42, Code of Federal Regulations (or any successor regulation), the hospital shall ensure that any positions made available under this paragraph are used to expand an existing program of the hospital, and not for participation in a new medical residency training program.
(D) Application of per resident amounts for nonprimary care
With respect to additional residency positions in a hospital attributable to the increase provided under this paragraph, the approved FTE per resident amounts are deemed to be equal to the hospital per resident amounts for nonprimary care computed under paragraph (2)(D) for that hospital.
(E) Permitting facilities to apply aggregation rules
The Secretary shall permit hospitals receiving additional residency positions attributable to the increase provided under this paragraph to, beginning in the fifth year after the effective date of such increase, apply such positions to the limitation amount under paragraph (4)(F) that may be aggregated pursuant to paragraph (4)(H) among members of the same affiliated group.
(F) Definitions
In this paragraph:
(i) Otherwise applicable resident limit
The term "otherwise applicable resident limit" means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph but taking into account paragraphs (7)(A), (7)(B), (8)(A), (8)(B), and (9)(A).
(ii) Psychiatry or psychiatry subspecialty residency
The term "psychiatry or psychiatry subspecialty residency" means a residency in psychiatry as accredited by the Accreditation Council for Graduate Medical Education for the purpose of preventing, diagnosing, and treating mental health disorders.
(iii) Qualifying hospital
The term "qualifying hospital" means a hospital described in any of subclauses (I) through (IV) of subparagraph (B)(ii).
(iv) Reference resident level
The term "reference resident level" means, with respect to a hospital, the resident level for the most recent cost reporting period of the hospital ending on or before December 29, 2022, for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary.
(v) Resident level
The term "resident level" has the meaning given such term in paragraph (7)(C)(i).
(i) Avoiding duplicative payments to hospitals participating in rural demonstration programs
The Secretary shall reduce any payment amounts otherwise determined under this section to the extent necessary to avoid duplication of any payment made under section 4005(e) of the Omnibus Budget Reconciliation Act of 1987.
(j) Prospective payment for inpatient rehabilitation services
(1) Payment during transition period
(A) In general
Notwithstanding
(i) the TEFRA percentage (as defined in subparagraph (C)) of the amount that would have been paid under part A with respect to such costs if this subsection did not apply, and
(ii) the prospective payment percentage (as defined in subparagraph (C)) of the product of (I) the per unit payment rate established under this subsection for the fiscal year in which the payment unit of service occurs, and (II) the number of such payment units occurring in the cost reporting period.
(B) Fully implemented system
Notwithstanding
(C) TEFRA and prospective payment percentages specified
For purposes of subparagraph (A), for a cost reporting period beginning—
(i) on or after October 1, 2000, and before October 1, 2001, the "TEFRA percentage" is 662/3 percent and the "prospective payment percentage" is 331/3 percent; and
(ii) on or after October 1, 2001, and before October 1, 2002, the "TEFRA percentage" is 331/3 percent and the "prospective payment percentage" is 662/3 percent.
(D) Payment unit
For purposes of this subsection, the term "payment unit" means a discharge.
(E) Construction relating to transfer authority
Nothing in this subsection shall be construed as preventing the Secretary from providing for an adjustment to payments to take into account the early transfer of a patient from a rehabilitation facility to another site of care.
(F) Election to apply full prospective payment system
A rehabilitation facility may elect, not later than 30 days before its first cost reporting period for which the payment methodology under this subsection applies to the facility, to have payment made to the facility under this subsection under the provisions of subparagraph (B) (rather than subparagraph (A)) for each cost reporting period to which such payment methodology applies.
(2) Patient case mix groups
(A) Establishment
The Secretary shall establish—
(i) classes of patient discharges of rehabilitation facilities by functional-related groups (each in this subsection referred to as a "case mix group"), based on impairment, age, comorbidities, and functional capability of the patient and such other factors as the Secretary deems appropriate to improve the explanatory power of functional independence measure-function related groups; and
(ii) a method of classifying specific patients in rehabilitation facilities within these groups.
(B) Weighting factors
For each case mix group the Secretary shall assign an appropriate weighting which reflects the relative facility resources used with respect to patients classified within that group compared to patients classified within other groups.
(C) Adjustments for case mix
(i) In general
The Secretary shall from time to time adjust the classifications and weighting factors established under this paragraph as appropriate to reflect changes in treatment patterns, technology, case mix, number of payment units for which payment is made under this subchapter, and other factors which may affect the relative use of resources. Such adjustments shall be made in a manner so that changes in aggregate payments under the classification system are a result of real changes and are not a result of changes in coding that are unrelated to real changes in case mix.
(ii) Adjustment
Insofar as the Secretary determines that such adjustments for a previous fiscal year (or estimates that such adjustments for a future fiscal year) did (or are likely to) result in a change in aggregate payments under the classification system during the fiscal year that are a result of changes in the coding or classification of patients that do not reflect real changes in case mix, the Secretary shall adjust the per payment unit payment rate for subsequent years so as to eliminate the effect of such coding or classification changes.
(D) Data collection
The Secretary is authorized to require rehabilitation facilities that provide inpatient hospital services to submit such data as the Secretary deems necessary to establish and administer the prospective payment system under this subsection.
(3) Payment rate
(A) In general
The Secretary shall determine a prospective payment rate for each payment unit for which such rehabilitation facility is entitled to receive payment under this subchapter. Subject to subparagraph (B), such rate for payment units occurring during a fiscal year shall be based on the average payment per payment unit under this subchapter for inpatient operating and capital costs of rehabilitation facilities using the most recent data available (as estimated by the Secretary as of the date of establishment of the system) adjusted—
(i) by updating such per-payment-unit amount to the fiscal year involved by the weighted average of the applicable percentage increases provided under subsection (b)(3)(B)(ii) (for cost reporting periods beginning during the fiscal year) covering the period from the midpoint of the period for such data through the midpoint of fiscal year 2000 and by an increase factor (described in subparagraph (C)) specified by the Secretary for subsequent fiscal years up to the fiscal year involved;
(ii) by reducing such rates by a factor equal to the proportion of payments under this subsection (as estimated by the Secretary) based on prospective payment amounts which are additional payments described in paragraph (4) (relating to outlier and related payments);
(iii) for variations among rehabilitation facilities by area under paragraph (6);
(iv) by the weighting factors established under paragraph (2)(B); and
(v) by such other factors as the Secretary determines are necessary to properly reflect variations in necessary costs of treatment among rehabilitation facilities.
(B) Budget neutral rates
The Secretary shall establish the prospective payment amounts under this subsection for payment units during fiscal years 2001 and 2002 at levels such that, in the Secretary's estimation, the amount of total payments under this subsection for such fiscal years (including any payment adjustments pursuant to paragraphs (4) and (6) but not taking into account any payment adjustment resulting from an election permitted under paragraph (1)(F)) shall be equal to 98 percent for fiscal year 2001 and 100 percent for fiscal year 2002 of the amount of payments that would have been made under this subchapter during the fiscal years for operating and capital costs of rehabilitation facilities had this subsection not been enacted. In establishing such payment amounts, the Secretary shall consider the effects of the prospective payment system established under this subsection on the total number of payment units from rehabilitation facilities and other factors described in subparagraph (A).
(C) Increase factor
(i) In general
For purposes of this subsection for payment units in each fiscal year (beginning with fiscal year 2001), the Secretary shall establish an increase factor subject to clauses (ii) and (iii). Such factor shall be based on an appropriate percentage increase in a market basket of goods and services comprising services for which payment is made under this subsection, which may be the market basket percentage increase described in subsection (b)(3)(B)(iii). The increase factor to be applied under this subparagraph for each of fiscal years 2008 and 2009 shall be 0 percent.
(ii) Productivity and other adjustment
Subject to clause (iii), after establishing the increase factor described in clause (i) for a fiscal year, the Secretary shall reduce such increase factor—
(I) for fiscal year 2012 and each subsequent fiscal year, by the productivity adjustment described in subsection (b)(3)(B)(xi)(II); and
(II) for each of fiscal years 2010 through 2019, by the other adjustment described in subparagraph (D).
The application of this clause may result in the increase factor under this subparagraph being less than 0.0 for a fiscal year, and may result in payment rates under this subsection for a fiscal year being less than such payment rates for the preceding fiscal year.
(iii) Special rule for fiscal year 2018
The increase factor to be applied under this subparagraph for fiscal year 2018, after the application of clause (ii), shall be 1 percent.
(D) Other adjustment
For purposes of subparagraph (C)(ii)(II), the other adjustment described in this subparagraph is—
(i) for each of fiscal years 2010 and 2011, 0.25 percentage point;
(ii) for each of fiscal years 2012 and 2013, 0.1 percentage point;
(iii) for fiscal year 2014, 0.3 percentage point;
(iv) for each of fiscal years 2015 and 2016, 0.2 percentage point; and
(v) for each of fiscal years 2017, 2018, and 2019, 0.75 percentage point.
(4) Outlier and special payments
(A) Outliers
(i) In general
The Secretary may provide for an additional payment to a rehabilitation facility for patients in a case mix group, based upon the patient being classified as an outlier based on an unusual length of stay, costs, or other factors specified by the Secretary.
(ii) Payment based on marginal cost of care
The amount of such additional payment under clause (i) shall be determined by the Secretary and shall approximate the marginal cost of care beyond the cutoff point applicable under clause (i).
(iii) Total payments
The total amount of the additional payments made under this subparagraph for payment units in a fiscal year may not exceed 5 percent of the total payments projected or estimated to be made based on prospective payment rates for payment units in that year.
(B) Adjustment
The Secretary may provide for such adjustments to the payment amounts under this subsection as the Secretary deems appropriate to take into account the unique circumstances of rehabilitation facilities located in Alaska and Hawaii.
(5) Publication
The Secretary shall provide for publication in the Federal Register, on or before August 1 before each fiscal year (beginning with fiscal year 2001), of the classification and weighting factors for case mix groups under paragraph (2) for such fiscal year and a description of the methodology and data used in computing the prospective payment rates under this subsection for that fiscal year.
(6) Area wage adjustment
The Secretary shall adjust the proportion (as estimated by the Secretary from time to time) of rehabilitation facilities' costs which are attributable to wages and wage-related costs, of the prospective payment rates computed under paragraph (3) for area differences in wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the rehabilitation facility compared to the national average wage level for such facilities. Not later than October 1, 2001 (and at least every 36 months thereafter), the Secretary shall update the factor under the preceding sentence on the basis of information available to the Secretary (and updated as appropriate) of the wages and wage-related costs incurred in furnishing rehabilitation services. Any adjustments or updates made under this paragraph for a fiscal year shall be made in a manner that assures that the aggregated payments under this subsection in the fiscal year are not greater or less than those that would have been made in the year without such adjustment.
(7) Quality reporting
(A) Reduction in update for failure to report
(i) In general
For purposes of fiscal year 2014 and each subsequent fiscal year, in the case of a rehabilitation facility that does not submit data to the Secretary in accordance with subparagraphs (C) and (F) with respect to such a fiscal year, after determining the increase factor described in paragraph (3)(C), and after application of subparagraphs (C)(iii) and (D) of paragraph (3), the Secretary shall reduce such increase factor for payments for discharges occurring during such fiscal year by 2 percentage points.
(ii) Special rule
The application of this subparagraph may result in the increase factor described in paragraph (3)(C) being less than 0.0 for a fiscal year, and may result in payment rates under this subsection for a fiscal year being less than such payment rates for the preceding fiscal year.
(B) Noncumulative application
Any reduction under subparagraph (A) shall apply only with respect to the fiscal year involved and the Secretary shall not take into account such reduction in computing the payment amount under this subsection for a subsequent fiscal year.
(C) Submission of quality data
Subject to subparagraph (G), for fiscal year 2014 and each subsequent fiscal year, each rehabilitation facility shall submit to the Secretary data on quality measures specified under subparagraph (D). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
(D) Quality measures
(i) In general
Subject to clause (ii), any measure specified by the Secretary under this subparagraph must have been endorsed by the entity with a contract under
(ii) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(iii) Time frame
Not later than October 1, 2012, the Secretary shall publish the measures selected under this subparagraph that will be applicable with respect to fiscal year 2014.
(E) Public availability of data submitted
(i) In general
The Secretary shall establish procedures for making data submitted under subparagraph (C) and subparagraph (F)(i) available to the public. Such procedures shall ensure that a rehabilitation facility has the opportunity to review the data that is to be made public with respect to the facility prior to such data being made public. The Secretary shall report quality measures that relate to services furnished in inpatient settings in rehabilitation facilities on the Internet website of the Centers for Medicare & Medicaid Services.
(ii) Public recognition of rehabilitation innovation centers
Beginning not later than 18 months after January 5, 2023, the Secretary shall make publicly available on such Internet website, in addition to the information required to be reported on such website under clause (i), a list of all rehabilitation innovation centers, and shall update such list on such website not less frequently than biennially.
(iii) Rehabilitation innovation centers defined
For purposes of clause (ii), the term "rehabilitation innovation centers" means a rehabilitation facility that, as of the applicable date (as defined in clause (v)), is a rehabilitation facility described in clause (iv).
(iv) Rehabilitation facility described
(I) In general
Subject to subclause (II), a rehabilitation facility described in this clause is a rehabilitation facility that—
(aa) is classified as a rehabilitation facility under the IRF Rate Setting File for the Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019 (83 Fed. Reg. 38514), or any successor regulations that contain such information;
(bb) holds at least one Federal rehabilitation research and training designation for research projects on traumatic brain injury or spinal cord injury from the National Institute on Disability, Independent Living, and Rehabilitation Research at the Department of Health and Human Services, based on such data submitted to the Secretary by a facility, in a form, manner, and time frame specified by the Secretary;
(cc) submits to the Secretary a description of the clinical research enterprise of the facility and a summary of research activities of the facility that are supported by Federal agencies;
(dd) has a minimum Medicare estimated average weight per discharge of 1.20 for the most recent fiscal year for which such information is available according to the IRF Rate Setting File described in item (aa), or any successor regulations that contain such information; and
(ee) has a minimum teaching status of 0.075 for the most recent fiscal year for which such information is available according to the IRF Rate Setting File described in item (aa), or any successor regulations that contain such information.
(II) Waiver
The Secretary may, as determined appropriate, waive any of the requirements under items (aa) through (ee) of subclause (I).
(v) Applicable date defined
For purposes of clauses (iii) and (iv), the term "applicable date" means—
(I) with respect to the initial publication of a list under clause (ii), January 5, 2023; and
(II) with respect to the publication of an updated list under clause (ii), a date specified by the Secretary that is not more than one year prior to the date of such publication.
(vi) Implementation
Notwithstanding any other provision of law the Secretary may implement clauses (ii) through (v) by program instruction or otherwise.
(vii) Nonapplication of Paperwork Reduction Act
(F) Submission of additional data
(i) In general
For the fiscal year beginning on the specified application date (as defined in subsection (a)(2)(E) of
(ii) Standardized patient assessment data
For fiscal year 2019 and each subsequent fiscal year, in addition to such data described in clause (i), each rehabilitation facility shall submit to the Secretary standardized patient assessment data required under subsection (b)(1) of
(iii) Submission
Such data shall be submitted in the form and manner, and at the time, specified by the Secretary for purposes of this subparagraph.
(G) Non-duplication
To the extent data submitted under subparagraph (F) duplicates other data required to be submitted under subparagraph (C), the submission of such data under subparagraph (F) shall be in lieu of the submission of such data under subparagraph (C). The previous sentence shall not apply insofar as the Secretary determines it is necessary to avoid a delay in the implementation of
(8) Limitation on review
There shall be no administrative or judicial review under
(A) case mix groups, of the methodology for the classification of patients within such groups, and of the appropriate weighting factors thereof under paragraph (2),
(B) the prospective payment rates under paragraph (3),
(C) outlier and special payments under paragraph (4), and
(D) area wage adjustments under paragraph (6).
(k) Payment to nonhospital providers
(1) In general
For cost reporting periods beginning on or after October 1, 1997, the Secretary may establish rules for payment to qualified nonhospital providers for their direct costs of medical education, if those costs are incurred in the operation of an approved medical residency training program described in subsection (h). Such rules shall specify the amounts, form, and manner in which such payments will be made and the portion of such payments that will be made from each of the trust funds under this subchapter.
(2) Qualified nonhospital providers
For purposes of this subsection, the term "qualified nonhospital providers" means—
(A) a Federally 15 qualified health center, as defined in
(B) a rural health clinic, as defined in
(C) Medicare+Choice organizations; and
(D) such other providers (other than hospitals) as the Secretary determines to be appropriate.
(l) Payment for nursing and allied health education for managed care enrollees
(1) In general
For portions of cost reporting periods occurring in a year (beginning with 2000), the Secretary shall provide for an additional payment amount for any hospital that receives payments for the costs of approved educational activities for nurse and allied health professional training under
(2) Payment amount
The additional payment amount under this subsection for each hospital for portions of cost reporting periods occurring in a year shall be an amount specified by the Secretary in a manner consistent with the following:
(A) Determination of managed care enrollee payment ratio for graduate medical education payments
The Secretary shall estimate the ratio of payments for all hospitals for portions of cost reporting periods occurring in the year under subsection (h)(3)(D) to total direct graduate medical education payments estimated for such portions of periods under subsection (h)(3).
(B) Application to fee-for-service nursing and allied health education payments
(i) In general
Subject to clause (ii), such ratio shall be applied to the Secretary's estimate of total payments for nursing and allied health education determined under
(ii) Exception to annual limitation for each of 2010 through 2019
For each of 2010 through 2019, the limitation under clause (i) on the total amount of additional payments for nursing and allied health education to be distributed to hospitals under this subsection for portions of cost reporting periods occurring in the year shall not apply to such payments made in such year to those hospitals that, as of December 29, 2022, are operating a school of nursing, a school of allied health, or a school of nursing and allied health.
(C) Application to hospital
The amount of payment under this subsection to a hospital for portions of cost reporting periods occurring in a year is equal to the total amount of payments determined under subparagraph (B) for the year multiplied by the ratio of—
(i) the product of (I) the Secretary's estimate of the ratio of the amount of payments made under
(ii) the sum of the products determined under clause (i) for such cost reporting periods.
(m) Prospective payment for long-term care hospitals
(1) Reference to establishment and implementation of system
For provisions related to the establishment and implementation of a prospective payment system for payments under this subchapter for inpatient hospital services furnished by a long-term care hospital described in subsection (d)(1)(B)(iv), see section 123 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 and section 307(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000.
(2) Update for rate year 2008
In implementing the system described in paragraph (1) for discharges occurring during the rate year ending in 2008 for a hospital, the base rate for such discharges for the hospital shall be the same as the base rate for discharges for the hospital occurring during the rate year ending in 2007.
(3) Implementation for rate year 2010 and subsequent years
(A) In general
Subject to subparagraph (C), in implementing the system described in paragraph (1) for rate year 2010 and each subsequent rate year, any annual update to a standard Federal rate for discharges for the hospital during the rate year, shall be reduced—
(i) for rate year 2012 and each subsequent rate year, by the productivity adjustment described in subsection (b)(3)(B)(xi)(II); and
(ii) for each of rate years 2010 through 2019, by the other adjustment described in paragraph (4).
(B) Special rule
The application of this paragraph may result in such annual update being less than 0.0 for a rate year, and may result in payment rates under the system described in paragraph (1) for a rate year being less than such payment rates for the preceding rate year.
(C) Additional special rule
For fiscal year 2018, the annual update under subparagraph (A) for the fiscal year, after application of clauses (i) and (ii) of subparagraph (A), shall be 1 percent.
(4) Other adjustment
For purposes of paragraph (3)(A)(ii), the other adjustment described in this paragraph is—
(A) for rate year 2010, 0.25 percentage point;
(B) for rate year 2011, 0.50 percentage point;
(C) for each of the rate years beginning in 2012 and 2013, 0.1 percentage point;
(D) for rate year 2014, 0.3 percentage point;
(E) for each of rate years 2015 and 2016, 0.2 percentage point; and
(F) for each of rate years 2017, 2018, and 2019, 0.75 percentage point.
(5) Quality reporting
(A) Reduction in update for failure to report
(i) In general
Under the system described in paragraph (1), for rate year 2014 and each subsequent rate year, in the case of a long-term care hospital that does not submit data to the Secretary in accordance with subparagraphs (C) and (F) with respect to such a rate year, any annual update to a standard Federal rate for discharges for the hospital during the rate year, and after application of paragraph (3), shall be reduced by 2 percentage points.
(ii) Special rule
The application of this subparagraph may result in such annual update being less than 0.0 for a rate year, and may result in payment rates under the system described in paragraph (1) for a rate year being less than such payment rates for the preceding rate year.
(B) Noncumulative application
Any reduction under subparagraph (A) shall apply only with respect to the rate year involved and the Secretary shall not take into account such reduction in computing the payment amount under the system described in paragraph (1) for a subsequent rate year.
(C) Submission of quality data
Subject to subparagraph (G), for rate year 2014 and each subsequent rate year, each long-term care hospital shall submit to the Secretary data on quality measures specified under subparagraph (D). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
(D) Quality measures
(i) In general
Subject to clause (ii), any measure specified by the Secretary under this subparagraph must have been endorsed by the entity with a contract under
(ii) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(iii) Time frame
Not later than October 1, 2012, the Secretary shall publish the measures selected under this subparagraph that will be applicable with respect to rate year 2014.
(iv) Additional quality measures
Not later than October 1, 2015, the Secretary shall establish a functional status quality measure for change in mobility among inpatients requiring ventilator support.
(E) Public availability of data submitted
The Secretary shall establish procedures for making data submitted under subparagraph (C) and subparagraph (F)(i) available to the public. Such procedures shall ensure that a long-term care hospital has the opportunity to review the data that is to be made public with respect to the hospital prior to such data being made public. The Secretary shall report quality measures that relate to services furnished in inpatient settings in long-term care hospitals on the Internet website of the Centers for Medicare & Medicaid Services.
(F) Submission of additional data
(i) In general
For the rate year beginning on the specified application date (as defined in subsection (a)(2)(E) of
(ii) Standardized patient assessment data
For rate year 2019 and each subsequent rate year, in addition to such data described in clause (i), each long-term care hospital (other than a hospital classified under subsection (d)(1)(B)(vi)) shall submit to the Secretary standardized patient assessment data required under subsection (b)(1) of
(iii) Submission
Such data shall be submitted in the form and manner, and at the time, specified by the Secretary for purposes of this subparagraph.
(G) Non-duplication
To the extent data submitted under subparagraph (F) duplicates other data required to be submitted under subparagraph (C), the submission of such data under subparagraph (F) shall be in lieu of the submission of such data under subparagraph (C). The previous sentence shall not apply insofar as the Secretary determines it is necessary to avoid a delay in the implementation of
(6) Application of site neutral IPPS payment rate in certain cases
(A) General application of site neutral IPPS payment amount for discharges failing to meet applicable criteria
(i) In general
For a discharge in cost reporting periods beginning on or after October 1, 2015, except as provided in clause (ii) and subparagraphs (C), (E), (F), and (G), payment under this subchapter to a long-term care hospital for inpatient hospital services shall be made at the applicable site neutral payment rate (as defined in subparagraph (B)).
(ii) Exception for certain discharges meeting criteria
Clause (i) shall not apply (and payment shall be made to a long-term care hospital without regard to this paragraph) for a discharge if—
(I) the discharge meets the ICU criterion under clause (iii) or the ventilator criterion under clause (iv); and
(II) the discharge does not have a principal diagnosis relating to a psychiatric diagnosis or to rehabilitation.
(iii) Intensive care unit (ICU) criterion
(I) In general
The criterion specified in this clause (in this paragraph referred to as the "ICU criterion"), for a discharge from a long-term care hospital, is that the stay in the long-term care hospital ending with such discharge was immediately preceded by a discharge from a stay in a subsection (d) hospital that included at least 3 days in an intensive care unit (ICU), as determined by the Secretary.
(II) Determining ICU days
In determining intensive care unit days under subclause (I), the Secretary shall use data from revenue center codes 020x or 021x (or such successor codes as the Secretary may establish).
(iv) Ventilator criterion
The criterion specified in this clause (in this paragraph referred to as the "ventilator criterion"), for a discharge from a long-term care hospital, is that—
(I) the stay in the long-term care hospital ending with such discharge was immediately preceded by a discharge from a stay in a subsection (d) hospital; and
(II) the individual discharged was assigned to a Medicare-Severity-Long-Term-Care-Diagnosis-Related-Group (MS–LTC–DRG) based on the receipt of ventilator services of at least 96 hours.
(B) Applicable site neutral payment rate defined
(i) In general
In this paragraph, the term "applicable site neutral payment rate" means—
(I) for discharges in cost reporting periods beginning during fiscal years 2016 through 2019, the blended payment rate specified in clause (iii); and
(II) for discharges in cost reporting periods beginning during fiscal year 2020 or a subsequent fiscal year, the site neutral payment rate (as defined in clause (ii)).
(ii) Site neutral payment rate defined
Subject to clause (iv), in this paragraph, the term "site neutral payment rate" means the lower of—
(I) the IPPS comparable per diem amount determined under paragraph (d)(4) of section 412.529 of title 42, Code of Federal Regulations, including any applicable outlier payments under section 412.525 of such title; or
(II) 100 percent of the estimated cost for the services involved.
(iii) Blended payment rate
The blended payment rate specified in this clause, for a long-term care hospital for inpatient hospital services for a discharge, is comprised of—
(I) half of the site neutral payment rate (as defined in clause (ii)) for the discharge; and
(II) half of the payment rate that would otherwise be applicable to such discharge without regard to this paragraph, as determined by the Secretary.
(iv) Adjustment
For each of fiscal years 2018 through 2026, the amount that would otherwise apply under clause (ii)(I) for the year (determined without regard to this clause) shall be reduced by 4.6 percent.
(C) Limiting payment for all hospital discharges to site neutral payment rate for hospitals failing to meet applicable LTCH discharge thresholds
(i) Notice of LTCH discharge payment percentage
For cost reporting periods beginning during or after fiscal year 2016, the Secretary shall inform each long-term care hospital of its LTCH discharge payment percentage (as defined in clause (iv)) for such period.
(ii) Limitation
For cost reporting periods beginning during or after fiscal year 2020, if the Secretary determines for a long-term care hospital that its LTCH discharge payment percentage for the period is not at least 50 percent—
(I) the Secretary shall inform the hospital of such fact; and
(II) subject to clause (iii), for all discharges in the hospital in each succeeding cost reporting period, the payment amount under this subsection shall be the payment amount that would apply under subsection (d) for the discharge if the hospital were a subsection (d) hospital.
(iii) Process for reinstatement
The Secretary shall establish a process whereby a long-term care hospital may seek to and have the provisions of subclause (II) of clause (ii) discontinued with respect to that hospital.
(iv) LTCH discharge payment percentage
In this subparagraph, the term "LTCH discharge payment percentage" means, with respect to a long-term care hospital for a cost reporting period beginning during or after fiscal year 2020, the ratio (expressed as a percentage) of—
(I) the number of Medicare fee-for-service discharges for such hospital and period for which payment is not made at the site neutral payment rate, to
(II) the total number of Medicare fee-for-service discharges for such hospital and period.
(D) Inclusion of subsection (d) Puerto Rico hospitals
In this paragraph, any reference in this paragraph to a subsection (d) hospital shall be deemed to include a reference to a subsection (d) Puerto Rico hospital.
(E) Temporary exception for certain severe wound discharges from certain long-term care hospitals
(i) In general
In the case of a discharge occurring prior to January 1, 2017, subparagraph (A)(i) shall not apply (and payment shall be made to a long-term care hospital without regard to this paragraph) if such discharge—
(I) is from a long-term care hospital that is—
(aa) identified by the last sentence of subsection (d)(1)(B); and
(bb) located in a rural area (as defined in subsection (d)(2)(D)) or treated as being so located pursuant to subsection (d)(8)(E); and
(II) the individual discharged has a severe wound.
(ii) Severe wound defined
In this subparagraph, the term "severe wound" means a stage 3 wound, stage 4 wound, unstageable wound, non-healing surgical wound, infected wound, fistula, osteomyelitis, or wound with morbid obesity, as identified in the claim from the long-term care hospital.
(F) Temporary exception for certain spinal cord specialty hospitals
For discharges in cost reporting periods beginning during fiscal years 2018 and 2019, subparagraph (A)(i) shall not apply (and payment shall be made to a long-term care hospital without regard to this paragraph) if such discharge is from a long-term care hospital that meets each of the following requirements:
(i) Not-for-profit
The long-term care hospital was a not-for-profit long-term care hospital on June 1, 2014, as determined by cost report data.
(ii) Primarily providing treatment for catastrophic spinal cord or acquired brain injuries or other paralyzing neuromuscular conditions
Of the discharges in calendar year 2013 from the long-term care hospital for which payment was made under this section, at least 50 percent were classified under MS–LTCH–DRGs 28, 29, 52, 57, 551, 573, and 963.
(iii) Significant out-of-state admissions
(I) In general
The long-term care hospital discharged inpatients (including both individuals entitled to, or enrolled for, benefits under this subchapter and individuals not so entitled or enrolled) during fiscal year 2014 who had been admitted from at least 20 of the 50 States, determined by the States of residency of such inpatients and based on such data submitted by the hospital to the Secretary as the Secretary may require.
(II) Implementation
Notwithstanding any other provision of law, the Secretary may implement subclause (I) by program instruction or otherwise.
(III) Non-application of Paperwork Reduction Act
(G) Additional temporary exception for certain severe wound discharges from certain long-term care hospitals
(i) In general
For a discharge occurring in a cost reporting period beginning during fiscal year 2018, subparagraph (A)(i) shall not apply (and payment shall be made to a long-term care hospital without regard to this paragraph) if such discharge—
(I) is from a long-term care hospital identified by the last sentence of subsection (d)(1)(B);
(II) is classified under MS–LTCH–DRG 602, 603, 539, or 540; and
(III) is with respect to an individual treated by a long-term care hospital for a severe wound.
(ii) Severe wound defined
In this subparagraph, the term "severe wound" means a wound which is a stage 3 wound, stage 4 wound, unstageable wound, non-healing surgical wound, or fistula as identified in the claim from the long-term care hospital.
(iii) Wound defined
In this subparagraph, the term "wound" means an injury involving division of tissue or rupture of the integument or mucous membrane with exposure to the external environment.
(7) Treatment of high cost outlier payments
(A) Adjustment to the standard Federal payment rate for estimated high cost outlier payments
Under the system described in paragraph (1), for fiscal years beginning on or after October 1, 2017, the Secretary shall reduce the standard Federal payment rate as if the estimated aggregate amount of high cost outlier payments for standard Federal payment rate discharges for each such fiscal year would be equal to 8 percent of estimated aggregate payments for standard Federal payment rate discharges for each such fiscal year.
(B) Limitation on high cost outlier payment amounts
Notwithstanding subparagraph (A), the Secretary shall set the fixed loss amount for high cost outlier payments such that the estimated aggregate amount of high cost outlier payments made for standard Federal payment rate discharges for fiscal years beginning on or after October 1, 2017, shall be equal to 99.6875 percent of 8 percent of estimated aggregate payments for standard Federal payment rate discharges for each such fiscal year.
(C) Waiver of budget neutrality
Any reduction in payments resulting from the application of subparagraph (B) shall not be taken into account in applying any budget neutrality provision under such system.
(D) No effect on site neutral high cost outlier payment rate
This paragraph shall not apply with respect to the computation of the applicable site neutral payment rate under paragraph (6).
(n) Incentives for adoption and meaningful use of certified EHR technology
(1) In general
Subject to the succeeding provisions of this subsection, with respect to inpatient hospital services furnished by an eligible hospital during a payment year (as defined in paragraph (2)(G)), if the eligible hospital is a meaningful EHR user (as determined under paragraph (3)) for the EHR reporting period with respect to such year, in addition to the amount otherwise paid under this section, there also shall be paid to the eligible hospital, from the Federal Hospital Insurance Trust Fund established under
(2) Payment amount
(A) In general
Subject to the succeeding subparagraphs of this paragraph, the applicable amount specified in this subparagraph for an eligible hospital for a payment year is equal to the product of the following:
(i) Initial amount
The sum of—
(I) the base amount specified in subparagraph (B); plus
(II) the discharge related amount specified in subparagraph (C) for a 12-month period selected by the Secretary with respect to such payment year.
(ii) Medicare share
The Medicare share as specified in subparagraph (D) for the eligible hospital for a period selected by the Secretary with respect to such payment year.
(iii) Transition factor
The transition factor specified in subparagraph (E) for the eligible hospital for the payment year.
(B) Base amount
The base amount specified in this subparagraph is $2,000,000.
(C) Discharge related amount
The discharge related amount specified in this subparagraph for a 12-month period selected by the Secretary shall be determined as the sum of the amount, estimated based upon total discharges for the eligible hospital (regardless of any source of payment) for the period, for each discharge up to the 23,000th discharge as follows:
(i) For the first through 1,149th discharge, $0.
(ii) For the 1,150th through the 23,000th discharge, $200.
(iii) For any discharge greater than the 23,000th, $0.
(D) Medicare share
The Medicare share specified under this subparagraph for an eligible hospital for a period selected by the Secretary for a payment year is equal to the fraction—
(i) the numerator of which is the sum (for such period and with respect to the eligible hospital) of—
(I) the estimated number of inpatient-bed-days (as established by the Secretary) which are attributable to individuals with respect to whom payment may be made under part A; and
(II) the estimated number of inpatient-bed-days (as so established) which are attributable to individuals who are enrolled with a Medicare Advantage organization under part C; and
(ii) the denominator of which is the product of—
(I) the estimated total number of inpatient-bed-days with respect to the eligible hospital during such period; and
(II) the estimated total amount of the eligible hospital's charges during such period, not including any charges that are attributable to charity care (as such term is used for purposes of hospital cost reporting under this subchapter), divided by the estimated total amount of the hospital's charges during such period.
Insofar as the Secretary determines that data are not available on charity care necessary to calculate the portion of the formula specified in clause (ii)(II), the Secretary shall use data on uncompensated care and may adjust such data so as to be an appropriate proxy for charity care including a downward adjustment to eliminate bad debt data from uncompensated care data. In the absence of the data necessary, with respect to a hospital, for the Secretary to compute the amount described in clause (ii)(II), the amount under such clause shall be deemed to be 1. In the absence of data, with respect to a hospital, necessary to compute the amount described in clause (i)(II), the amount under such clause shall be deemed to be 0.
(E) Transition factor specified
(i) In general
Subject to clause (ii), the transition factor specified in this subparagraph for an eligible hospital for a payment year is as follows:
(I) For the first payment year for such hospital, 1.
(II) For the second payment year for such hospital, ¾.
(III) For the third payment year for such hospital, ½.
(IV) For the fourth payment year for such hospital, ¼.
(V) For any succeeding payment year for such hospital, 0.
(ii) Phase down for eligible hospitals first adopting EHR after 2013
If the first payment year for an eligible hospital is after 2013, then the transition factor specified in this subparagraph for a payment year for such hospital is the same as the amount specified in clause (i) for such payment year for an eligible hospital for which the first payment year is 2013. If the first payment year for an eligible hospital is after 2015 then the transition factor specified in this subparagraph for such hospital and for such year and any subsequent year shall be 0.
(F) Form of payment
The payment under this subsection for a payment year may be in the form of a single consolidated payment or in the form of such periodic installments as the Secretary may specify.
(G) Payment year defined
(i) In general
For purposes of this subsection, the term "payment year" means a fiscal year beginning with fiscal year 2011.
(ii) First, second, etc. payment year
The term "first payment year" means, with respect to inpatient hospital services furnished by an eligible hospital, the first fiscal year for which an incentive payment is made for such services under this subsection. The terms "second payment year", "third payment year", and "fourth payment year" mean, with respect to an eligible hospital, each successive year immediately following the first payment year for that hospital.
(3) Meaningful EHR user
(A) In general
For purposes of paragraph (1), an eligible hospital shall be treated as a meaningful EHR user for an EHR reporting period for a payment year (or, for purposes of subsection (b)(3)(B)(ix), for an EHR reporting period under such subsection for a fiscal year) if each of the following requirements are met:
(i) Meaningful use of certified EHR technology
The eligible hospital demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the hospital is using certified EHR technology in a meaningful manner.
(ii) Information exchange
The eligible hospital demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period such certified EHR technology is connected in a manner that provides, in accordance with law and standards applicable to the exchange of information, for the electronic exchange of health information to improve the quality of health care, such as promoting care coordination, and the hospital demonstrates (through a process specified by the Secretary, such as the use of an attestation) that the hospital has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of the certified EHR technology.
(iii) Reporting on measures using EHR
Subject to subparagraph (B)(ii) and using such certified EHR technology, the eligible hospital submits information for such period, in a form and manner specified by the Secretary, on such clinical quality measures and such other measures as selected by the Secretary under subparagraph (B)(i).
The Secretary shall seek to improve the use of electronic health records and health care quality over time.
(B) Reporting on measures
(i) Selection
The Secretary shall select measures for purposes of subparagraph (A)(iii) but only consistent with the following:
(I) The Secretary shall provide preference to clinical quality measures that have been selected for purposes of applying subsection (b)(3)(B)(viii) or that have been endorsed by the entity with a contract with the Secretary under
(II) Prior to any measure (other than a clinical quality measure that has been selected for purposes of applying subsection (b)(3)(B)(viii)) being selected under this subparagraph, the Secretary shall publish in the Federal Register such measure and provide for a period of public comment on such measure.
(ii) Limitations
The Secretary may not require the electronic reporting of information on clinical quality measures under subparagraph (A)(iii) unless the Secretary has the capacity to accept the information electronically, which may be on a pilot basis.
(iii) Coordination of reporting of information
In selecting such measures, and in establishing the form and manner for reporting measures under subparagraph (A)(iii), the Secretary shall seek to avoid redundant or duplicative reporting with reporting otherwise required, including reporting under subsection (b)(3)(B)(viii).
(C) Demonstration of meaningful use of certified EHR technology and information exchange
(i) In general
An eligible hospital may satisfy the demonstration requirement of clauses (i) and (ii) of subparagraph (A) through means specified by the Secretary, which may include—
(I) an attestation;
(II) the submission of claims with appropriate coding (such as a code indicating that inpatient care was documented using certified EHR technology);
(III) a survey response;
(IV) reporting under subparagraph (A)(iii); and
(V) other means specified by the Secretary.
(ii) Use of part D data
Notwithstanding
(4) Application
(A) Limitations on review
There shall be no administrative or judicial review under
(i) the methodology and standards for determining payment amounts under this subsection and payment adjustments under subsection (b)(3)(B)(ix), including selection of periods under paragraph (2) for determining, and making estimates or using proxies of, discharges under paragraph (2)(C) and inpatient-bed-days, hospital charges, charity charges, and Medicare share under paragraph (2)(D);
(ii) the methodology and standards for determining a meaningful EHR user under paragraph (3), including selection of measures under paragraph (3)(B), specification of the means of demonstrating meaningful EHR use under paragraph (3)(C), and the hardship exception under subsection (b)(3)(B)(ix)(II); and
(iii) the specification of EHR reporting periods under paragraph (6)(B) 16 and the selection of the form of payment under paragraph (2)(F).
(B) Posting on website
The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services, in an easily understandable format, a list of the names of the eligible hospitals that are meaningful EHR users under this subsection or subsection (b)(3)(B)(ix) (and a list of the names of critical access hospitals to which paragraph (3) or (4) of
(5) Certified EHR technology defined
The term "certified EHR technology" has the meaning given such term in
(6) Definitions
For purposes of this subsection:
(A) EHR reporting period
The term "EHR reporting period" means, with respect to a payment year, any period (or periods) as specified by the Secretary.
(B) Eligible hospital
The term "eligible hospital" means a hospital that is a subsection (d) hospital or a subsection (d) Puerto Rico hospital.
(o) Hospital value-based purchasing program
(1) Establishment
(A) In general
Subject to the succeeding provisions of this subsection, the Secretary shall establish a hospital value-based purchasing program (in this subsection referred to as the "Program") under which value-based incentive payments are made in a fiscal year to hospitals that meet the performance standards under paragraph (3) for the performance period for such fiscal year (as established under paragraph (4)).
(B) Program to begin in fiscal year 2013
The Program shall apply to payments for discharges occurring on or after October 1, 2012.
(C) Applicability of Program to hospitals
(i) In general
For purposes of this subsection, subject to clause (ii), the term "hospital" means a subsection (d) hospital (as defined in subsection (d)(1)(B)).
(ii) Exclusions
The term "hospital" shall not include, with respect to a fiscal year, a hospital—
(I) that is subject to the payment reduction under subsection (b)(3)(B)(viii)(I) for such fiscal year;
(II) for which, during the performance period for such fiscal year, the Secretary has cited deficiencies that pose immediate jeopardy to the health or safety of patients;
(III) for which there are not a minimum number (as determined by the Secretary) of measures that apply to the hospital for the performance period for such fiscal year; or
(IV) for which there are not a minimum number (as determined by the Secretary) of cases for the measures that apply to the hospital for the performance period for such fiscal year.
(iii) Independent analysis
For purposes of determining the minimum numbers under subclauses (III) and (IV) of clause (ii), the Secretary shall have conducted an independent analysis of what numbers are appropriate.
(iv) Exemption
In the case of a hospital that is paid under
(2) Measures
(A) In general
The Secretary shall select measures, other than measures of readmissions, for purposes of the Program. Such measures shall be selected from the measures specified under subsection (b)(3)(B)(viii).
(B) Requirements
(i) For fiscal year 2013
For value-based incentive payments made with respect to discharges occurring during fiscal year 2013, the Secretary shall ensure the following:
(I) Conditions or procedures
Measures are selected under subparagraph (A) that cover at least the following 5 specific conditions or procedures:
(aa) Acute myocardial infarction (AMI).
(bb) Heart failure.
(cc) Pneumonia.
(dd) Surgeries, as measured by the Surgical Care Improvement Project (formerly referred to as "Surgical Infection Prevention" for discharges occurring before July 2006).
(ee) Healthcare-associated infections, as measured by the prevention metrics and targets established in the HHS Action Plan to Prevent Healthcare-Associated Infections (or any successor plan) of the Department of Health and Human Services.
(II) HCAHPS
Measures selected under subparagraph (A) shall be related to the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS).
(ii) Inclusion of efficiency measures
For value-based incentive payments made with respect to discharges occurring during fiscal year 2014 or a subsequent fiscal year, the Secretary shall ensure that measures selected under subparagraph (A) include efficiency measures, including measures of "Medicare spending per beneficiary". Such measures shall be adjusted for factors such as age, sex, race, severity of illness, and other factors that the Secretary determines appropriate.
(iii) HCAHPS pain questions
The Secretary may not include under subparagraph (A) a measure that is based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 or 2019 about communication by hospital staff with an individual about the individual's pain.
(C) Limitations
(i) Time requirement for prior reporting and notice
The Secretary may not select a measure under subparagraph (A) for use under the Program with respect to a performance period for a fiscal year (as established under paragraph (4)) unless such measure has been specified under subsection (b)(3)(B)(viii) and included on the Hospital Compare Internet website for at least 1 year prior to the beginning of such performance period.
(ii) Measure not applicable unless hospital furnishes services appropriate to the measure
A measure selected under subparagraph (A) shall not apply to a hospital if such hospital does not furnish services appropriate to such measure.
(D) Replacing measures
Subclause (VI) of subsection (b)(3)(B)(viii) shall apply to measures selected under subparagraph (A) in the same manner as such subclause applies to measures selected under such subsection.
(3) Performance standards
(A) Establishment
The Secretary shall establish performance standards with respect to measures selected under paragraph (2) for a performance period for a fiscal year (as established under paragraph (4)).
(B) Achievement and improvement
The performance standards established under subparagraph (A) shall include levels of achievement and improvement.
(C) Timing
The Secretary shall establish and announce the performance standards under subparagraph (A) not later than 60 days prior to the beginning of the performance period for the fiscal year involved.
(D) Considerations in establishing standards
In establishing performance standards with respect to measures under this paragraph, the Secretary shall take into account appropriate factors, such as—
(i) practical experience with the measures involved, including whether a significant proportion of hospitals failed to meet the performance standard during previous performance periods;
(ii) historical performance standards;
(iii) improvement rates; and
(iv) the opportunity for continued improvement.
(4) Performance period
For purposes of the Program, the Secretary shall establish the performance period for a fiscal year. Such performance period shall begin and end prior to the beginning of such fiscal year.
(5) Hospital performance score
(A) In general
Subject to subparagraph (B), the Secretary shall develop a methodology for assessing the total performance of each hospital based on performance standards with respect to the measures selected under paragraph (2) for a performance period (as established under paragraph (4)). Using such methodology, the Secretary shall provide for an assessment (in this subsection referred to as the "hospital performance score") for each hospital for each performance period.
(B) Application
(i) Appropriate distribution
The Secretary shall ensure that the application of the methodology developed under subparagraph (A) results in an appropriate distribution of value-based incentive payments under paragraph (6) among hospitals achieving different levels of hospital performance scores, with hospitals achieving the highest hospital performance scores receiving the largest value-based incentive payments.
(ii) Higher of achievement or improvement
The methodology developed under subparagraph (A) shall provide that the hospital performance score is determined using the higher of its achievement or improvement score for each measure.
(iii) Weights
The methodology developed under subparagraph (A) shall provide for the assignment of weights for categories of measures as the Secretary determines appropriate.
(iv) No minimum performance standard
The Secretary shall not set a minimum performance standard in determining the hospital performance score for any hospital.
(v) Reflection of measures applicable to the hospital
The hospital performance score for a hospital shall reflect the measures that apply to the hospital.
(6) Calculation of value-based incentive payments
(A) In general
In the case of a hospital that the Secretary determines meets (or exceeds) the performance standards under paragraph (3) for the performance period for a fiscal year (as established under paragraph (4)), the Secretary shall increase the base operating DRG payment amount (as defined in paragraph (7)(D)), as determined after application of paragraph (7)(B)(i), for a hospital for each discharge occurring in such fiscal year by the value-based incentive payment amount.
(B) Value-based incentive payment amount
The value-based incentive payment amount for each discharge of a hospital in a fiscal year shall be equal to the product of—
(i) the base operating DRG payment amount (as defined in paragraph (7)(D)) for the discharge for the hospital for such fiscal year; and
(ii) the value-based incentive payment percentage specified under subparagraph (C) for the hospital for such fiscal year.
(C) Value-based incentive payment percentage
(i) In general
The Secretary shall specify a value-based incentive payment percentage for a hospital for a fiscal year.
(ii) Requirements
In specifying the value-based incentive payment percentage for each hospital for a fiscal year under clause (i), the Secretary shall ensure that—
(I) such percentage is based on the hospital performance score of the hospital under paragraph (5); and
(II) the total amount of value-based incentive payments under this paragraph to all hospitals in such fiscal year is equal to the total amount available for value-based incentive payments for such fiscal year under paragraph (7)(A), as estimated by the Secretary.
(7) Funding for value-based incentive payments
(A) Amount
The total amount available for value-based incentive payments under paragraph (6) for all hospitals for a fiscal year shall be equal to the total amount of reduced payments for all hospitals under subparagraph (B) for such fiscal year, as estimated by the Secretary.
(B) Adjustment to payments
(i) In general
The Secretary shall reduce the base operating DRG payment amount (as defined in subparagraph (D)) for a hospital for each discharge in a fiscal year (beginning with fiscal year 2013) by an amount equal to the applicable percent (as defined in subparagraph (C)) of the base operating DRG payment amount for the discharge for the hospital for such fiscal year. The Secretary shall make such reductions for all hospitals in the fiscal year involved, regardless of whether or not the hospital has been determined by the Secretary to have earned a value-based incentive payment under paragraph (6) for such fiscal year.
(ii) No effect on other payments
Payments described in items (aa) and (bb) of subparagraph (D)(i)(II) for a hospital shall be determined as if this subsection had not been enacted.
(C) Applicable percent defined
For purposes of subparagraph (B), the term "applicable percent" means—
(i) with respect to fiscal year 2013, 1.0 percent;
(ii) with respect to fiscal year 2014, 1.25 percent;
(iii) with respect to fiscal year 2015, 1.5 percent;
(iv) with respect to fiscal year 2016, 1.75 percent; and
(v) with respect to fiscal year 2017 and succeeding fiscal years, 2 percent.
(D) Base operating DRG payment amount defined
(i) In general
Except as provided in clause (ii), in this subsection, the term "base operating DRG payment amount" means, with respect to a hospital for a fiscal year—
(I) the payment amount that would otherwise be made under subsection (d) (determined without regard to subsection (q)) for a discharge if this subsection did not apply; reduced by
(II) any portion of such payment amount that is attributable to—
(aa) payments under paragraphs (5)(A), (5)(B), (5)(F), and (12) of subsection (d); and
(bb) such other payments under subsection (d) determined appropriate by the Secretary.
(ii) Special rules for certain hospitals
(I) Sole community hospitals and medicare-dependent, small rural hospitals
In the case of a medicare-dependent, small rural hospital (with respect to discharges occurring during fiscal year 2012 and 2013) or a sole community hospital, in applying subparagraph (A)(i), the payment amount that would otherwise be made under subsection (d) shall be determined without regard to subparagraphs (I) and (L) of subsection (b)(3) and subparagraphs (D) and (G) of subsection (d)(5).
(II) Hospitals paid under section 1395f
In the case of a hospital that is paid under
(8) Announcement of net result of adjustments
Under the Program, the Secretary shall, not later than 60 days prior to the fiscal year involved, inform each hospital of the adjustments to payments to the hospital for discharges occurring in such fiscal year under paragraphs (6) and (7)(B)(i).
(9) No effect in subsequent fiscal years
The value-based incentive payment under paragraph (6) and the payment reduction under paragraph (7)(B)(i) shall each apply only with respect to the fiscal year involved, and the Secretary shall not take into account such value-based incentive payment or payment reduction in making payments to a hospital under this section in a subsequent fiscal year.
(10) Public reporting
(A) Hospital specific information
(i) In general
The Secretary shall make information available to the public regarding the performance of individual hospitals under the Program, including—
(I) the performance of the hospital with respect to each measure that applies to the hospital;
(II) the performance of the hospital with respect to each condition or procedure; and
(III) the hospital performance score assessing the total performance of the hospital.
(ii) Opportunity to review and submit corrections
The Secretary shall ensure that a hospital has the opportunity to review, and submit corrections for, the information to be made public with respect to the hospital under clause (i) prior to such information being made public.
(iii) Website
Such information shall be posted on the Hospital Compare Internet website in an easily understandable format.
(B) Aggregate information
The Secretary shall periodically post on the Hospital Compare Internet website aggregate information on the Program, including—
(i) the number of hospitals receiving value-based incentive payments under paragraph (6) and the range and total amount of such value-based incentive payments; and
(ii) the number of hospitals receiving less than the maximum value-based incentive payment available to the hospital for the fiscal year involved and the range and amount of such payments.
(11) Implementation
(A) Appeals
The Secretary shall establish a process by which hospitals may appeal the calculation of a hospital's performance assessment with respect to the performance standards established under paragraph (3)(A) and the hospital performance score under paragraph (5). The Secretary shall ensure that such process provides for resolution of such appeals in a timely manner.
(B) Limitation on review
Except as provided in subparagraph (A), there shall be no administrative or judicial review under
(i) The methodology used to determine the amount of the value-based incentive payment under paragraph (6) and the determination of such amount.
(ii) The determination of the amount of funding available for such value-based incentive payments under paragraph (7)(A) and the payment reduction under paragraph (7)(B)(i).
(iii) The establishment of the performance standards under paragraph (3) and the performance period under paragraph (4).
(iv) The measures specified under subsection (b)(3)(B)(viii) and the measures selected under paragraph (2).
(v) The methodology developed under paragraph (5) that is used to calculate hospital performance scores and the calculation of such scores.
(vi) The validation methodology specified in subsection (b)(3)(B)(viii)(XI).
(C) Consultation with small hospitals
The Secretary shall consult with small rural and urban hospitals on the application of the Program to such hospitals.
(12) Promulgation of regulations
The Secretary shall promulgate regulations to carry out the Program, including the selection of measures under paragraph (2), the methodology developed under paragraph (5) that is used to calculate hospital performance scores, and the methodology used to determine the amount of value-based incentive payments under paragraph (6).
(p) Adjustment to hospital payments for hospital acquired conditions
(1) In general
In order to provide an incentive for applicable hospitals to reduce hospital acquired conditions under this subchapter, with respect to discharges from an applicable hospital occurring during fiscal year 2015 or a subsequent fiscal year, the amount of payment under this section or
(2) Applicable hospitals
(A) In general
For purposes of this subsection, the term "applicable hospital" means a subsection (d) hospital that meets the criteria described in subparagraph (B).
(B) Criteria described
(i) In general
The criteria described in this subparagraph, with respect to a subsection (d) hospital, is that the subsection (d) hospital is in the top quartile of all subsection (d) hospitals, relative to the national average, of hospital acquired conditions during the applicable period, as determined by the Secretary.
(ii) Risk adjustment
In carrying out clause (i), the Secretary shall establish and apply an appropriate risk adjustment methodology.
(C) Exemption
In the case of a hospital that is paid under
(3) Hospital acquired conditions
For purposes of this subsection, the term "hospital acquired condition" means a condition identified for purposes of subsection (d)(4)(D)(iv) and any other condition determined appropriate by the Secretary that an individual acquires during a stay in an applicable hospital, as determined by the Secretary.
(4) Applicable period
In this subsection, the term "applicable period" means, with respect to a fiscal year, a period specified by the Secretary.
(5) Reporting to hospitals
Prior to fiscal year 2015 and each subsequent fiscal year, the Secretary shall provide confidential reports to applicable hospitals with respect to hospital acquired conditions of the applicable hospital during the applicable period.
(6) Reporting hospital specific information
(A) In general
The Secretary shall make information available to the public regarding hospital acquired conditions of each applicable hospital.
(B) Opportunity to review and submit corrections
The Secretary shall ensure that an applicable hospital has the opportunity to review, and submit corrections for, the information to be made public with respect to the hospital under subparagraph (A) prior to such information being made public.
(C) Website
Such information shall be posted on the Hospital Compare Internet website in an easily understandable format.
(7) Limitations on review
There shall be no administrative or judicial review under
(A) The criteria described in paragraph (2)(A).
(B) The specification of hospital acquired conditions under paragraph (3).
(C) The specification of the applicable period under paragraph (4).
(D) The provision of reports to applicable hospitals under paragraph (5) and the information made available to the public under paragraph (6).
(q) Hospital readmissions reduction program
(1) In general
With respect to payment for discharges from an applicable hospital (as defined in paragraph (5)(C)) occurring during a fiscal year beginning on or after October 1, 2012, in order to account for excess readmissions in the hospital, the Secretary shall make payments (in addition to the payments described in paragraph (2)(A)(ii)) for such a discharge to such hospital under subsection (d) (or
(A) the base operating DRG payment amount (as defined in paragraph (2)) for the discharge; and
(B) the adjustment factor (described in paragraph (3)(A)) for the hospital for the fiscal year.
(2) Base operating DRG payment amount defined
(A) In general
Except as provided in subparagraph (B), in this subsection, the term "base operating DRG payment amount" means, with respect to a hospital for a fiscal year—
(i) the payment amount that would otherwise be made under subsection (d) (determined without regard to subsection (o)) for a discharge if this subsection did not apply; reduced by
(ii) any portion of such payment amount that is attributable to payments under paragraphs (5)(A), (5)(B), (5)(F), and (12) of subsection (d).
(B) Special rules for certain hospitals
(i) Sole community hospitals and medicare-dependent, small rural hospitals
In the case of a medicare-dependent, small rural hospital (with respect to discharges occurring during fiscal years 2012 and 2013) or a sole community hospital, in applying subparagraph (A)(i), the payment amount that would otherwise be made under subsection (d) shall be determined without regard to subparagraphs (I) and (L) of subsection (b)(3) and subparagraphs (D) and (G) of subsection (d)(5).
(ii) Hospitals paid under section 1395f of this title
In the case of a hospital that is paid under
(3) Adjustment factor
(A) In general
For purposes of paragraph (1), subject to subparagraph (D), the adjustment factor under this paragraph for an applicable hospital for a fiscal year is equal to the greater of—
(i) the ratio described in subparagraph (B) for the hospital for the applicable period (as defined in paragraph (5)(D)) for such fiscal year; or
(ii) the floor adjustment factor specified in subparagraph (C).
(B) Ratio
The ratio described in this subparagraph for a hospital for an applicable period is equal to 1 minus the ratio of—
(i) the aggregate payments for excess readmissions (as defined in paragraph (4)(A)) with respect to an applicable hospital for the applicable period; and
(ii) the aggregate payments for all discharges (as defined in paragraph (4)(B)) with respect to such applicable hospital for such applicable period.
(C) Floor adjustment factor
For purposes of subparagraph (A), the floor adjustment factor specified in this subparagraph for—
(i) fiscal year 2013 is 0.99;
(ii) fiscal year 2014 is 0.98; or
(iii) fiscal year 2015 and subsequent fiscal years is 0.97.
(D) Transitional adjustment for dual eligibles
(i) In general
In determining a hospital's adjustment factor under this paragraph for purposes of making payments for discharges occurring during and after fiscal year 2019, and before the application of clause (i) of subparagraph (E), the Secretary shall assign hospitals to groups (as defined by the Secretary under clause (ii)) and apply the applicable provisions of this subsection using a methodology in a manner that allows for separate comparison of hospitals within each such group, as determined by the Secretary.
(ii) Defining groups
For purposes of this subparagraph, the Secretary shall define groups of hospitals, based on their overall proportion, of the inpatients who are entitled to, or enrolled for, benefits under part A, and who are full-benefit dual eligible individuals (as defined in
(iii) Minimizing reporting burden on hospitals
In carrying out this subparagraph, the Secretary shall not impose any additional reporting requirements on hospitals.
(iv) Budget neutral design methodology
The Secretary shall design the methodology to implement this subparagraph so that the estimated total amount of reductions in payments under this subsection equals the estimated total amount of reductions in payments that would otherwise occur under this subsection if this subparagraph did not apply.
(E) Changes in risk adjustment
(i) Consideration of recommendations in IMPACT reports
The Secretary may take into account the studies conducted and the recommendations made by the Secretary under section 2(d)(1) of the IMPACT Act of 2014 (
(ii) Consideration of exclusion of patient cases based on V or other appropriate codes
In promulgating regulations to carry out this subsection with respect to discharges occurring after fiscal year 2018, the Secretary may consider the use of V or other ICD-related codes for removal of a readmission. The Secretary may consider modifying measures under this subsection to incorporate V or other ICD-related codes at the same time as other changes are being made under this subparagraph.
(iii) Removal of certain readmissions
In promulgating regulations to carry out this subsection, with respect to discharges occurring after fiscal year 2018, the Secretary may consider removal as a readmission of an admission that is classified within one or more of the following: transplants, end-stage renal disease, burns, trauma, psychosis, or substance abuse. The Secretary may consider modifying measures under this subsection to remove readmissions at the same time as other changes are being made under this subparagraph.
(4) Aggregate payments, excess readmission ratio defined
For purposes of this subsection:
(A) Aggregate payments for excess readmissions
The term "aggregate payments for excess readmissions" means, for a hospital for an applicable period, the sum, for applicable conditions (as defined in paragraph (5)(A)), of the product, for each applicable condition, of—
(i) the base operating DRG payment amount for such hospital for such applicable period for such condition;
(ii) the number of admissions for such condition for such hospital for such applicable period; and
(iii) the excess readmissions ratio (as defined in subparagraph (C)) for such hospital for such applicable period minus 1.
(B) Aggregate payments for all discharges
The term "aggregate payments for all discharges" means, for a hospital for an applicable period, the sum of the base operating DRG payment amounts for all discharges for all conditions from such hospital for such applicable period.
(C) Excess readmission ratio
(i) In general
Subject to clause (ii), the term "excess readmissions ratio" means, with respect to an applicable condition for a hospital for an applicable period, the ratio (but not less than 1.0) of—
(I) the risk adjusted readmissions based on actual readmissions, as determined consistent with a readmission measure methodology that has been endorsed under paragraph (5)(A)(ii)(I), for an applicable hospital for such condition with respect to such applicable period; to
(II) the risk adjusted expected readmissions (as determined consistent with such a methodology) for such hospital for such condition with respect to such applicable period.
(ii) Exclusion of certain readmissions
For purposes of clause (i), with respect to a hospital, excess readmissions shall not include readmissions for an applicable condition for which there are fewer than a minimum number (as determined by the Secretary) of discharges for such applicable condition for the applicable period and such hospital.
(5) Definitions
For purposes of this subsection:
(A) Applicable condition
The term "applicable condition" means, subject to subparagraph (B), a condition or procedure selected by the Secretary among conditions and procedures for which—
(i) readmissions (as defined in subparagraph (E)) that represent conditions or procedures that are high volume or high expenditures under this subchapter (or other criteria specified by the Secretary); and
(ii) measures of such readmissions—
(I) have been endorsed by the entity with a contract under
(II) such endorsed measures have exclusions for readmissions that are unrelated to the prior discharge (such as a planned readmission or transfer to another applicable hospital).
(B) Expansion of applicable conditions
Beginning with fiscal year 2015, the Secretary shall, to the extent practicable, expand the applicable conditions beyond the 3 conditions for which measures have been endorsed as described in subparagraph (A)(ii)(I) as of March 23, 2010, to the additional 4 conditions that have been identified by the Medicare Payment Advisory Commission in its report to Congress in June 2007 and to other conditions and procedures as determined appropriate by the Secretary. In expanding such applicable conditions, the Secretary shall seek the endorsement described in subparagraph (A)(ii)(I) but may apply such measures without such an endorsement in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(C) Applicable hospital
The term "applicable hospital" means a subsection (d) hospital or a hospital that is paid under
(D) Applicable period
The term "applicable period" means, with respect to a fiscal year, such period as the Secretary shall specify.
(E) Readmission
The term "readmission" means, in the case of an individual who is discharged from an applicable hospital, the admission of the individual to the same or another applicable hospital within a time period specified by the Secretary from the date of such discharge. Insofar as the discharge relates to an applicable condition for which there is an endorsed measure described in subparagraph (A)(ii)(I), such time period (such as 30 days) shall be consistent with the time period specified for such measure.
(6) Reporting hospital specific information
(A) In general
The Secretary shall make information available to the public regarding readmission rates of each subsection (d) hospital under the program.
(B) Opportunity to review and submit corrections
The Secretary shall ensure that a subsection (d) hospital has the opportunity to review, and submit corrections for, the information to be made public with respect to the hospital under subparagraph (A) prior to such information being made public.
(C) Website
Such information shall be posted on the Hospital Compare Internet website in an easily understandable format.
(7) Limitations on review
There shall be no administrative or judicial review under
(A) The determination of base operating DRG payment amounts.
(B) The methodology for determining the adjustment factor under paragraph (3), including excess readmissions ratio under paragraph (4)(C), aggregate payments for excess readmissions under paragraph (4)(A), and aggregate payments for all discharges under paragraph (4)(B), and applicable periods and applicable conditions under paragraph (5).
(C) The measures of readmissions as described in paragraph (5)(A)(ii).
(8) Readmission rates for all patients
(A) Calculation of readmission
The Secretary shall calculate readmission rates for all patients (as defined in subparagraph (D)) for a specified hospital (as defined in subparagraph (D)(ii)) for an applicable condition (as defined in paragraph (5)(B)) and other conditions deemed appropriate by the Secretary for an applicable period (as defined in paragraph (5)(D)) in the same manner as used to calculate such readmission rates for hospitals with respect to this subchapter and posted on the CMS Hospital Compare website.
(B) Posting of hospital specific all patient readmission rates
The Secretary shall make information on all patient readmission rates calculated under subparagraph (A) available on the CMS Hospital Compare website in a form and manner determined appropriate by the Secretary. The Secretary may also make other information determined appropriate by the Secretary available on such website.
(C) Hospital submission of all patient data
(i) Except as provided for in clause (ii), each specified hospital (as defined in subparagraph (D)(ii)) shall submit to the Secretary, in a form, manner and time specified by the Secretary, data and information determined necessary by the Secretary for the Secretary to calculate the all patient readmission rates described in subparagraph (A).
(ii) Instead of a specified hospital submitting to the Secretary the data and information described in clause (i), such data and information may be submitted to the Secretary, on behalf of such a specified hospital, by a state or an entity determined appropriate by the Secretary.
(D) Definitions
For purposes of this paragraph:
(i) The term "all patients" means patients who are treated on an inpatient basis and discharged from a specified hospital (as defined in clause (ii)).
(ii) The term "specified hospital" means a subsection (d) hospital, hospitals described in clauses (i) through (v) of subsection (d)(1)(B) and, as determined feasible and appropriate by the Secretary, other hospitals not otherwise described in this subparagraph.
(r) Adjustments to medicare DSH payments
(1) Empirically justified DSH payments
For fiscal year 2014 and each subsequent fiscal year, instead of the amount of disproportionate share hospital payment that would otherwise be made under subsection (d)(5)(F) to a subsection (d) hospital for the fiscal year, the Secretary shall pay to the subsection (d) hospital 25 percent of such amount (which represents the empirically justified amount for such payment, as determined by the Medicare Payment Advisory Commission in its March 2007 Report to the Congress).
(2) Additional payment
In addition to the payment made to a subsection (d) hospital under paragraph (1), for fiscal year 2014 and each subsequent fiscal year, the Secretary shall pay to such subsection (d) hospitals an additional amount equal to the product of the following factors:
(A) Factor one
A factor equal to the difference between—
(i) the aggregate amount of payments that would be made to subsection (d) hospitals under subsection (d)(5)(F) if this subsection did not apply for such fiscal year (as estimated by the Secretary); and
(ii) the aggregate amount of payments that are made to subsection (d) hospitals under paragraph (1) for such fiscal year (as so estimated).
(B) Factor two
(i) Fiscal years 2014, 2015, 2016, and 2017
For each of fiscal years 2014, 2015, 2016, and 2017, a factor equal to 1 minus the percent change in the percent of individuals under the age of 65 who are uninsured, as determined by comparing the percent of such individuals—
(I) who are uninsured in 2013, the last year before coverage expansion under the Patient Protection and Affordable Care Act (as calculated by the Secretary based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Health Care and Education Reconciliation Act of 2010 that, if determined in the affirmative, would clear such Act for enrollment); and
(II) who are uninsured in the most recent period for which data is available (as so calculated),
minus 0.1 percentage points for fiscal year 2014 and minus 0.2 percentage points for each of fiscal years 2015, 2016, and 2017.
(ii) 2018 and subsequent years
For fiscal year 2018 and each subsequent fiscal year, a factor equal to 1 minus the percent change in the percent of individuals who are uninsured, as determined by comparing the percent of individuals—
(I) who are uninsured in 2013 (as estimated by the Secretary, based on data from the Census Bureau or other sources the Secretary determines appropriate, and certified by the Chief Actuary of the Centers for Medicare & Medicaid Services); and
(II) who are uninsured in the most recent period for which data is available (as so estimated and certified),
minus 0.2 percentage points for each of fiscal years 2018 and 2019.
(C) Factor three
A factor equal to the percent, for each subsection (d) hospital, that represents the quotient of—
(i) the amount of uncompensated care for such hospital for a period selected by the Secretary (as estimated by the Secretary, based on appropriate data (including, in the case where the Secretary determines that alternative data is available which is a better proxy for the costs of subsection (d) hospitals for treating the uninsured, the use of such alternative data)); and
(ii) the aggregate amount of uncompensated care for all subsection (d) hospitals that receive a payment under this subsection for such period (as so estimated, based on such data).
(3) Limitations on review
There shall be no administrative or judicial review under
(A) Any estimate of the Secretary for purposes of determining the factors described in paragraph (2).
(B) Any period selected by the Secretary for such purposes.
(s) Prospective payment for psychiatric hospitals
(1) Reference to establishment and implementation of system
For provisions related to the establishment and implementation of a prospective payment system for payments under this subchapter for inpatient hospital services furnished by psychiatric hospitals (as described in clause (i) of subsection (d)(1)(B)) and psychiatric units (as described in the matter following clause (v) of such subsection), see section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999.
(2) Implementation for rate year beginning in 2010 and subsequent rate years
(A) In general
In implementing the system described in paragraph (1) for the rate year beginning in 2010 and any subsequent rate year, any update to a base rate for days during the rate year for a psychiatric hospital or unit, respectively, shall be reduced—
(i) for the rate year beginning in 2012 and each subsequent rate year, by the productivity adjustment described in subsection (b)(3)(B)(xi)(II); and
(ii) for each of the rate years beginning in 2010 through 2019, by the other adjustment described in paragraph (3).
(B) Special rule
The application of this paragraph may result in such update being less than 0.0 for a rate year, and may result in payment rates under the system described in paragraph (1) for a rate year being less than such payment rates for the preceding rate year.
(3) Other adjustment
For purposes of paragraph (2)(A)(ii), the other adjustment described in this paragraph is—
(A) for each of the rate years beginning in 2010 and 2011, 0.25 percentage point;
(B) for each of the rate years beginning in 2012 and 2013, 0.1 percentage point;
(C) for the rate year beginning in 2014, 0.3 percentage point;
(D) for each of the rate years beginning in 2015 and 2016, 0.2 percentage point; and
(E) for each of the rate years beginning in 2017, 2018, and 2019, 0.75 percentage point.
(4) Quality reporting
(A) Reduction in update for failure to report
(i) In general
Under the system described in paragraph (1), for rate year 2014 and each subsequent rate year, in the case of a psychiatric hospital or psychiatric unit that does not submit data to the Secretary in accordance with subparagraphs (C) and (E) with respect to such a rate year, any annual update to a standard Federal rate for discharges for the hospital during the rate year, and after application of paragraph (2), shall be reduced by 2 percentage points.
(ii) Special rule
The application of this subparagraph may result in such annual update being less than 0.0 for a rate year, and may result in payment rates under the system described in paragraph (1) for a rate year being less than such payment rates for the preceding rate year.
(B) Noncumulative application
Any reduction under subparagraph (A) shall apply only with respect to the rate year involved and the Secretary shall not take into account such reduction in computing the payment amount under the system described in paragraph (1) for a subsequent rate year.
(C) Submission of quality data
For rate year 2014 and each subsequent rate year, each psychiatric hospital and psychiatric unit shall submit to the Secretary data on quality measures specified under subparagraph (D). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph.
(D) Quality measures
(i) In general
Subject to clause (ii), any measure specified by the Secretary under this subparagraph must have been endorsed by the entity with a contract under
(ii) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(iii) Time frame
Not later than October 1, 2012, the Secretary shall publish the measures selected under this subparagraph that will be applicable with respect to rate year 2014.
(iv) Patients' perspective on care
Not later than for rate year 2031, the quality measures specified under this subparagraph shall include a quality measure of patients' perspective on care.
(E) Standardized patient assessment data
(i) In general
For rate year 2028 and each subsequent rate year, in addition to such data on the quality measures described in subparagraph (C), each psychiatric hospital and psychiatric unit shall submit to the Secretary, through the use of a standardized assessment instrument implemented under clause (iii), the standardized patient assessment data described in clause (ii). Such data shall be submitted with respect to admission and discharge of an individual (and may be submitted more frequently as the Secretary determines appropriate).
(ii) Standardized patient assessment data described
For purposes of clause (i), the standardized patient assessment data described in this clause, with respect to a psychiatric hospital or psychiatric unit, is data with respect to the following categories:
(I) Functional status, such as mobility and self-care at admission to a psychiatric hospital or unit and before discharge from a psychiatric hospital or unit.
(II) Cognitive function, such as ability to express ideas and to understand, and mental status, such as depression and dementia.
(III) Special services, treatments, and interventions for psychiatric conditions.
(IV) Medical conditions and co-morbidities, such as diabetes, congestive heart failure, and pressure ulcers.
(V) Impairments, such as incontinence and an impaired ability to hear, see, or swallow.
(VI) Other categories as determined appropriate by the Secretary.
(iii) Standardized assessment instrument
(I) In general
For purposes of clause (i), the Secretary shall implement a standardized assessment instrument that provides for the submission of standardized patient assessment data under this subchapter with respect to psychiatric hospitals and psychiatric units which enables comparison of such assessment data across all such hospitals and units to which such data are applicable.
(II) Funding
The Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under
(F) Public availability of data submitted
The Secretary shall establish procedures for making data submitted under subparagraphs (C) and (F) available to the public. Such procedures shall ensure that a psychiatric hospital and a psychiatric unit has the opportunity to review the data that is to be made public with respect to the hospital or unit prior to such data being made public. The Secretary shall report quality measures, including the quality measure of patients' perspective on care described in subparagraph (D)(iv), that relate to services furnished in inpatient settings in psychiatric hospitals and psychiatric units on the Internet website of the Centers for Medicare & Medicaid Services.
(5) Additional data and information
(A) In general
The Secretary shall collect data and information as the Secretary determines appropriate to revise payments under the system described in paragraph (1) for psychiatric hospitals and psychiatric units pursuant to subparagraph (D) and for other purposes as determined appropriate by the Secretary. The Secretary shall begin to collect such data by not later than October 1, 2023.
(B) Data and information
The data and information to be collected under subparagraph (A) may include—
(i) charges, including those related to ancillary services;
(ii) the required intensity of behavioral monitoring, such as cognitive deficit, suicide ideations, violent behavior, and need for physical restraint; and
(iii) interventions, such as detoxification services for substance abuse, dependence on respirator, total parenteral nutritional support, dependence on renal dialysis, and burn care.
(C) Method of collection
The Secretary may collect the additional data and information under subparagraph (A) on cost reports, on claims, or otherwise.
(D) Revisions to payment rates
(i) In general
Notwithstanding the preceding paragraphs of this subsection or section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, for rate year 2025 (and for any subsequent rate year, if determined appropriate by the Secretary), the Secretary shall, by regulation, implement revisions to the methodology for determining the payment rates under the system described in paragraph (1) for psychiatric hospitals and psychiatric units, as the Secretary determines to be appropriate. Such revisions may be based on a review of data and information collected under subparagraph (A).
(ii) Review
The Secretary may make revisions to the diagnosis-related group classifications, in accordance with subsection (d)(4)(C), to reflect nursing and staff resource use and costs involved in furnishing services at such hospitals and units, including considerations for patient complexity and prior admission to an inpatient psychiatric facility, which may be based on review of data and information collected under subparagraph (A), as the Secretary determines to be appropriate.
(iii) Budget neutrality
Revisions in payment implemented pursuant to clause (i) for a rate year shall result in the same estimated amount of aggregate expenditures under this subchapter for psychiatric hospitals and psychiatric units furnished in the rate year as would have been made under this subchapter for such care in such rate year if such revisions had not been implemented.
(6) Additional considerations for diagnosis-related group classifications
(A) In general
Notwithstanding the preceding paragraphs of this subsection (other than paragraph (5)) or section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, beginning not later than rate year 2031, in addition to any revisions pursuant to paragraph (5), the Secretary shall, by regulation, implement revisions to the methodology for determining the payment rates under the system described in paragraph (1) for psychiatric hospitals and psychiatric units, as the Secretary determines to be appropriate, to take into account the patient assessment data described in paragraph (4)(E)(ii).
(B) Budget neutrality
Revisions in payment implemented pursuant to subparagraph (A) for a rate year shall result in the same estimated amount of aggregate expenditures under this subchapter for psychiatric hospitals and psychiatric units furnished in the rate year as would have been made under this subchapter for such care in such rate year if such revisions had not been implemented.
(t) Relating similar inpatient and outpatient hospital services
(1) Development of HCPCS version of MS–DRG codes
Not later than January 1, 2018, the Secretary shall develop HCPCS versions for MS–DRGs that are similar to the ICD–10–PCS for such MS–DRGs such that, to the extent possible, the MS–DRG assignment shall be similar for a claim coded with the HCPCS version as an identical claim coded with a ICD–10–PCS code.
(2) Coverage of surgical MS–DRGs
In carrying out paragraph (1), the Secretary shall develop HCPCS versions of MS–DRG codes for not fewer than 10 surgical MS–DRGs.
(3) Publication and dissemination of the HCPCS versions of MS–DRGs
(A) In general
The Secretary shall develop a HCPCS MS–DRG definitions manual and software that is similar to the definitions manual and software for ICD–10–PCS codes for such MS–DRGs. The Secretary shall post the HCPCS MS–DRG definitions manual and software on the Internet website of the Centers for Medicare & Medicaid Services. The HCPCS MS–DRG definitions manual and software shall be in the public domain and available for use and redistribution without charge.
(B) Use of previous analysis done by MedPAC
In developing the HCPCS MS–DRG definitions manual and software under subparagraph (A), the Secretary shall consult with the Medicare Payment Advisory Commission and shall consider the analysis done by such Commission in translating outpatient surgical claims into inpatient surgical MS–DRGs in preparing
(4) Definition and reference
In this subsection:
(A) HCPCS
The term "HCPCS" means, with respect to hospital items and services, the code under the Healthcare Common Procedure Coding System (HCPCS) (or a successor code) for such items and services.
(B) ICD–10–PCS
The term "ICD–10–PCS" means the International Classification of Diseases, 10th Revision, Procedure Coding System, and includes any subsequent revision of such International Classification of Diseases, Procedure Coding System.
(Aug. 14, 1935, ch. 531, title XVIII, §1886, as added and amended
Editorial Notes
References in Text
Section 5001(b) of the Deficit Reduction Act of 2005, referred to in subsec. (b)(3)(B)(viii)(I), is section 5001(b) of
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsecs. (b)(3)(B)(viii)(IV) and (d)(2)(C)(i), is
The Internal Revenue Code of 1986, referred to in subsec. (b)(6), is classified generally to Title 26, Internal Revenue Code.
Section 222(a) of the Social Security Amendments of 1972, referred to in subsec. (c)(4)(B), is section 222(a) of
The effective date of such clause (vi), referred to in concluding provisions of subsec. (d)(1)(B), probably means the date of enactment of
Section 9104(a) of the Medicare and Medicaid Budget Reconciliation Amendments of 1985, referred to in subsec. (d)(2)(C)(i), is section 9104(a) of
Section 4621(a)(1) of the Balanced Budget Act of 1997, referred to in subsec. (d)(2)(C)(i), is section 4621(a)(1) of
Section 111 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, referred to in subsec. (d)(2)(C)(i), is section 1000(a)(6) [title I, §111] of
Section 302 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, referred to in subsec. (d)(2)(C)(i), is section 1(a)(6) [title III, §302] of
Section 6003(c) of the Omnibus Budget Reconciliation Act of 1989, referred to in subsec. (d)(2)(C)(iv), is section 6003(c) of
Section 4002(b) of the Omnibus Budget Reconciliation Act of 1990, referred to in subsec. (d)(2)(C)(iv), is section 4002(b) of
Section 303 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, referred to in subsec. (d)(2)(C)(iv), is section 1(a)(6) [title III, §303] of
Section 9104 of the Medicare and Medicaid Budget Reconciliation Amendments of 1985, referred to in subsec. (d)(3)(C)(ii), is section 9104 of
Section 4003(a)(1) of the Omnibus Budget Reconciliation Act of 1987, referred to in subsec. (d)(3)(C)(ii), is section 4003(a)(1) of
The Omnibus Budget Reconciliation Act of 1990, referred to in subsec. (d)(3)(C)(ii), is
The Patient Protection and Affordable Care Act, referred to in subsecs. (d)(3)(E)(i) and (r)(2)(B)(i)(I), is
Section 9831(a) of the American Rescue Plan Act of 2021, referred to in subsec. (d)(3)(E)(i), is section 9831(a) of
Section 9304 of the Omnibus Budget Reconciliation Act of 1986, referred to in subsec. (e)(1)(C)(ii), is section 9304 of
Section 4628 of the Balanced Budget Act of 1997, referred to in subsec. (h)(6)(C)(iii), is section 4628 of
Section 402 of
Such section 332(a)(1)(A), referred to in subsec. (h)(8)(D)(ii)(I), probably means section 332(a)(1)(A) of the Public Health Service Act, which is classified to
Section 4005(e) of the Omnibus Budget Reconciliation Act of 1987, referred to in subsec. (i), is section 4005(e) of
Section 123 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, referred to in subsec. (m)(1), is section 1000(a)(6) [title I, §123] of
Section 307(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, referred to in subsec. (m)(1), is section 1(a)(6) [title III, §307(b)] of
The Health Care and Education Reconciliation Act of 2010, referred to in subsec. (r)(2)(B)(i)(I), is
Section 124 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, referred to in subsec. (s)(1), (5)(D)(i), (6)(A), is section 1000(a)(6) [title I, §124] of
Amendments
2024—Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(C)(i)(III).
Subsec. (d)(12)(C)(i)(IV).
Subsec. (d)(12)(D).
Subsec. (d)(12)(D)(ii).
2023—Subsec. (j)(7)(E).
2022—Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(5)(B)(v).
Subsec. (d)(5)(B)(xii).
Subsec. (d)(5)(B)(xiii).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(C)(i)(III).
Subsec. (d)(12)(C)(i)(IV).
Subsec. (d)(12)(D).
Subsec. (d)(12)(D)(ii).
Subsec. (h)(3)(D)(iii).
Subsec. (h)(4)(F)(i).
Subsec. (h)(4)(H)(i)(I).
Subsec. (h)(7)(E).
Subsec. (h)(10).
Subsec. (l)(2)(B).
Subsec. (s)(4)(A)(i).
Subsec. (s)(4)(D)(iv).
Subsec. (s)(4)(E).
Subsec. (s)(4)(F).
Subsec. (s)(5).
Subsec. (s)(6).
2021—Subsec. (d)(3)(E)(i).
Subsec. (d)(3)(E)(iv).
2020—Subsec. (d)(4)(C)(iv).
Subsec. (d)(5)(B)(v).
Subsec. (d)(5)(B)(viii).
Subsec. (d)(5)(B)(x), (xi).
Subsec. (d)(5)(B)(xii).
Subsec. (h)(2)(F).
Subsec. (h)(4)(F)(i).
Subsec. (h)(4)(H)(i).
Subsec. (h)(4)(H)(iv).
Subsec. (h)(4)(H)(iv)(I).
Subsec. (h)(7)(E).
Subsec. (h)(9).
2019—Subsec. (a)(4).
Subsec. (d)(4)(C)(iii).
Subsec. (d)(5)(M).
2018—Subsec. (b)(3)(B)(viii)(XII).
Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(5)(G)(iv).
Subsec. (d)(5)(G)(iv)(I).
Subsec. (d)(5)(J)(ii)(IV), (V).
Subsec. (d)(5)(J)(iv).
Subsec. (d)(5)(J)(iv)(I).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(C)(ii).
Subsec. (d)(12)(C)(iii).
Subsec. (d)(12)(D).
"(i) with respect to each of fiscal years 2011 through 2018, with 200 or fewer"
for "hospitals with 200 or fewer", and "fiscal year or portion of fiscal year; and" for "fiscal year.", and added cl. (ii).
Subsec. (m)(6)(B)(i)(I).
Subsec. (m)(6)(B)(i)(II).
Subsec. (m)(6)(B)(ii).
Subsec. (m)(6)(B)(iv).
Subsec. (n)(3)(A).
Subsec. (o)(2)(B)(iii).
2016—Subsec. (b)(3)(B)(ix)(II).
Subsec. (d)(1)(B).
Subsec. (d)(1)(B)(iv).
Subsec. (d)(1)(B)(vi).
Subsec. (m)(5)(F)(i), (ii).
Subsec. (m)(6)(A)(i).
Subsec. (m)(6)(E)(i)(I)(aa).
Subsec. (m)(6)(F).
Subsec. (m)(6)(G).
Subsec. (m)(7).
Subsec. (q)(3)(A).
Subsec. (q)(3)(D), (E).
Subsec. (t).
2015—Subsec. (b)(3)(B)(ix)(I).
Subsec. (b)(3)(B)(ix)(II).
Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(9)(E)(iv).
Subsec. (d)(9)(E)(v).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(D).
Subsec. (j)(3)(C)(i).
Subsec. (j)(3)(C)(ii).
Subsec. (j)(3)(C)(iii).
Subsec. (j)(7)(A)(i).
Subsec. (m)(3)(A).
Subsec. (m)(3)(C).
Subsec. (m)(6)(A)(i).
Subsec. (m)(6)(E).
Subsec. (n)(3)(A)(ii).
Subsec. (n)(6)(B).
2014—Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(D).
Subsec. (j)(7)(A)(i).
Subsec. (j)(7)(C).
Subsec. (j)(7)(E).
Subsec. (j)(7)(F), (G).
Subsec. (m)(5)(A)(i).
Subsec. (m)(5)(C).
Subsec. (m)(5)(E).
Subsec. (m)(5)(F), (G).
Subsec. (m)(6)(C)(iv).
2013—Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(D).
Subsec. (m)(5)(D)(iv).
Subsec. (m)(6).
2011—Subsec. (f)(2).
2010—Subsec. (a)(4).
Subsec. (b)(3)(B)(i)(XX).
Subsec. (b)(3)(B)(viii)(I).
Subsec. (b)(3)(B)(viii)(II).
Subsec. (b)(3)(B)(viii)(V).
Subsec. (b)(3)(B)(viii)(VII).
Subsec. (b)(3)(B)(viii)(VIII) to (XI).
Subsec. (b)(3)(B)(ix)(I).
Subsec. (b)(3)(B)(x).
Subsec. (b)(3)(B)(xi), (xii).
Subsec. (b)(3)(B)(xii)(I).
Subsec. (b)(3)(B)(xii)(II).
Subsec. (b)(3)(B)(xii)(III).
Subsec. (b)(3)(B)(xii)(IV), (V).
Subsec. (b)(3)(B)(xiii).
"(I) the excess (if any) of—
"(aa) the total percentage of the non-elderly insured population for the preceding fiscal year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over
"(bb) the total percentage of the non-elderly insured population for such preceding fiscal year (as estimated by the Secretary); exceeds
"(II) 5 percentage points."
Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (d)(3)(E)(i).
Subsec. (d)(3)(E)(iii).
Subsec. (d)(5)(B)(iv).
Subsec. (d)(5)(B)(v).
Subsec. (d)(5)(B)(x).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(7)(C).
Subsec. (d)(12)(A).
Subsec. (d)(12)(B).
Subsec. (d)(12)(C)(i).
Subsec. (d)(12)(D).
Subsec. (h)(4)(E).
Subsec. (h)(4)(F)(i).
Subsec. (h)(4)(H)(i).
Subsec. (h)(4)(H)(vi).
Subsec. (h)(4)(J), (K).
Subsec. (h)(5)(K).
Subsec. (h)(7)(E).
Subsec. (h)(8).
Subsec. (h)(8)(I).
Subsec. (j)(3)(C).
Subsec. (j)(3)(D).
Subsec. (j)(3)(D)(i)(I).
Subsec. (j)(3)(D)(i)(II).
Subsec. (j)(3)(D)(i)(III).
Subsec. (j)(3)(D)(i)(IV), (V).
Subsec. (j)(3)(D)(ii).
"(I) the excess (if any) of—
"(aa) the total percentage of the non-elderly insured population for the preceding fiscal year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over
"(bb) the total percentage of the non-elderly insured population for such preceding fiscal year (as estimated by the Secretary); exceeds
"(II) 5 percentage points."
Subsec. (j)(7), (8).
Subsec. (m)(3), (4).
Subsec. (m)(4)(A).
Subsec. (m)(4)(A)(i).
Subsec. (m)(4)(A)(ii), (iii).
Subsec. (m)(4)(A)(iv).
Subsec. (m)(4)(A)(v), (vi).
Subsec. (m)(4)(B).
"(i) the excess (if any) of—
"(I) the total percentage of the non-elderly insured population for the preceding rate year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over
"(II) the total percentage of the non-elderly insured population for such preceding rate year (as estimated by the Secretary); exceeds
"(ii) 5 percentage points."
Subsec. (m)(4)(C) to (F).
Subsec. (m)(5).
Subsec. (o).
Subsec. (o)(2)(A).
Subsec. (p).
Subsec. (q).
Subsec. (q)(1).
Subsec. (r).
Subsec. (r)(1).
Subsec. (r)(2).
Subsec. (r)(2)(B)(i).
Subsec. (r)(2)(B)(i)(I).
Subsec. (r)(2)(B)(i)(II).
Subsec. (r)(2)(B)(ii).
Subsec. (s).
Subsec. (s)(3).
Subsec. (s)(3)(A)(i).
Subsec. (s)(3)(A)(ii).
Subsec. (s)(3)(A)(iii).
Subsec. (s)(3)(A)(iv), (v).
Subsec. (s)(3)(B).
"(i) the excess (if any) of—
"(I) the total percentage of the non-elderly insured population for the preceding rate year (based on the most recent estimates available from the Director of the Congressional Budget Office before a vote in either House on the Patient Protection and Affordable Care Act that, if determined in the affirmative, would clear such Act for enrollment); over
"(II) the total percentage of the non-elderly insured population for such preceding rate year (as estimated by the Secretary); exceeds
"(ii) 5 percentage points."
Subsec. (s)(4).
2009—Subsec. (b)(3)(B)(viii)(I).
Subsec. (b)(3)(B)(ix).
Subsec. (n).
2008—Subsec. (b)(3)(C).
Subsec. (b)(3)(I)(i).
Subsec. (b)(3)(L).
2007—Subsec. (h)(4)(H)(v).
Subsec. (h)(7)(D), (E).
Subsec. (j)(3)(C).
Subsec. (m).
2006—Subsec. (b)(3)(B)(i)(XIX).
Subsec. (b)(3)(B)(i)(XX).
Subsec. (b)(3)(B)(vii)(I).
Subsec. (b)(3)(B)(vii)(II).
Subsec. (b)(3)(B)(viii).
Subsec. (b)(3)(B)(viii)(III).
Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (b)(3)(K).
Subsec. (d)(4)(C)(iv).
Subsec. (d)(4)(D).
Subsec. (d)(5)(F)(vi).
Subsec. (d)(5)(F)(xiv)(II).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(7)(B).
Subsec. (e)(3).
2003—Subsec. (b)(3)(B)(i)(XIX), (XX).
Subsec. (b)(3)(B)(vii).
Subsec. (b)(3)(I)(i)(I).
Subsec. (b)(3)(I)(iii).
Subsec. (d)(2)(C)(i).
Subsec. (d)(2)(C)(iv).
Subsec. (d)(3).
Subsec. (d)(3)(A)(iii).
Subsec. (d)(3)(A)(iv).
Subsec. (d)(3)(D).
Subsec. (d)(3)(D)(i).
Subsec. (d)(3)(D)(i)(II).
Subsec. (d)(3)(D)(ii).
Subsec. (d)(3)(D)(ii)(II).
Subsec. (d)(3)(D)(iii).
Subsec. (d)(3)(E).
Subsec. (d)(5)(B)(ii).
Subsec. (d)(5)(B)(ii)(VI).
Subsec. (d)(5)(B)(ii)(VII).
Subsec. (d)(5)(B)(ii)(VIII) to (XII).
Subsec. (d)(5)(B)(v).
Subsec. (d)(5)(B)(ix).
Subsec. (d)(5)(F)(iv)(II) to (VI).
Subsec. (d)(5)(F)(viii).
Subsec. (d)(5)(F)(x) to (xiii).
Subsec. (d)(5)(F)(xiv).
Subsec. (d)(5)(K)(i).
Subsec. (d)(5)(K)(ii)(I).
Subsec. (d)(5)(K)(ii)(III).
Subsec. (d)(5)(K)(vii).
Subsec. (d)(5)(K)(viii).
Subsec. (d)(5)(K)(ix).
Subsec. (d)(7)(A).
Subsec. (d)(9)(A).
"(I) the national adjusted DRG prospective payment rate (determined under paragraph (3)(D)) for hospitals located in a large urban area,
"(II) such rate for hospitals located in other urban areas, and
"(III) such rate for hospitals located in a rural area,
for such discharges, adjusted in the manner provided in paragraph (3)(E) for different area wage levels. As used in this section, the term 'subsection (d) Puerto Rico hospital' means a hospital that is located in Puerto Rico and that would be a subsection (d) hospital (as defined in paragraph (1)(B)) if it were located in one of the fifty States."
Subsec. (d)(9)(A)(i).
Subsec. (d)(9)(A)(ii).
Subsec. (d)(9)(C)(i).
Subsec. (d)(9)(C)(ii).
Subsec. (d)(9)(C)(iii)(I).
Subsec. (d)(9)(C)(iv).
Subsec. (d)(9)(E).
Subsec. (d)(12).
Subsec. (d)(13).
Subsec. (g)(3)(B).
Subsec. (h)(2)(D)(iv)(I).
Subsec. (h)(2)(D)(iv)(II).
Subsec. (h)(3)(D)(ii)(III).
Subsec. (h)(4)(F)(i).
Subsec. (h)(4)(H)(i).
Subsec. (h)(7).
2000—Subsec. (b)(3)(B)(i)(XVI).
Subsec. (b)(3)(B)(i)(XVII).
Subsec. (b)(3)(B)(i)(XVIII).
Subsec. (b)(3)(B)(i)(XIX).
Subsec. (b)(3)(H)(ii)(III).
Subsec. (b)(3)(I)(i).
Subsec. (b)(3)(I)(i)(I).
Subsec. (b)(3)(I)(i)(II), (III).
Subsec. (b)(3)(J).
Subsec. (d)(1)(B)(v)(III).
Subsec. (d)(1)(E).
Subsec. (d)(2)(C)(i).
Subsec. (d)(2)(C)(iv).
Subsec. (d)(3)(A)(vi).
Subsec. (d)(3)(E).
Subsec. (d)(4)(C)(i).
Subsec. (d)(5)(B).
Subsec. (d)(5)(B)(ii)(V).
Subsec. (d)(5)(B)(ii)(VI).
Subsec. (d)(5)(B)(ii)(VII).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(iv)(II).
Subsec. (d)(5)(F)(iv)(III).
Subsec. (d)(5)(F)(iv)(IV).
Subsec. (d)(5)(F)(iv)(V).
Subsec. (d)(5)(F)(iv)(VI).
Subsec. (d)(5)(F)(v)(II).
Subsec. (d)(5)(F)(v)(III).
Subsec. (d)(5)(F)(v)(IV).
Subsec. (d)(5)(F)(ix)(III).
Subsec. (d)(5)(F)(ix)(IV).
Subsec. (d)(5)(F)(x).
Subsec. (d)(5)(F)(xi).
Subsec. (d)(5)(F)(xii).
Subsec. (d)(5)(F)(xiii).
Subsec. (d)(5)(G)(iv)(IV).
Subsec. (d)(5)(K), (L).
Subsec. (d)(10)(D)(v), (vi).
Subsec. (h)(2)(D)(iii).
Subsec. (j)(1)(A).
Subsec. (j)(1)(B).
Subsec. (j)(1)(F).
Subsec. (j)(3)(B).
Subsec. (l)(2)(C).
1999—Subsec. (b)(1).
Subsec. (b)(2)(A).
Subsec. (b)(2)(E).
Subsec. (b)(3)(B)(i)(XVI) to (XVIII).
Subsec. (b)(3)(B)(ii)(VI).
Subsec. (b)(3)(B)(ii)(VII).
Subsec. (b)(3)(C).
Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (b)(3)(H)(i) to (iii).
Subsec. (b)(3)(I).
Subsec. (b)(4)(A)(i).
Subsec. (b)(7)(A)(i)(II).
Subsec. (d)(2)(C)(i).
Subsec. (d)(5)(B)(ii)(V), (VI).
Subsec. (d)(5)(B)(v).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(ix)(III).
Subsec. (d)(5)(F)(ix)(IV).
Subsec. (d)(5)(F)(ix)(V), (VI).
Subsec. (d)(5)(G)(i).
Subsec. (d)(5)(G)(ii)(II).
Subsec. (d)(8)(B).
Subsec. (d)(8)(E).
Subsec. (d)(9)(A)(ii).
Subsec. (g)(1)(A).
Subsec. (h)(2)(D)(i).
Subsec. (h)(2)(D)(ii).
Subsec. (h)(2)(D)(iii), (iv).
Subsec. (h)(2)(E), (F).
Subsec. (h)(3)(D)(i).
Subsec. (h)(3)(D)(iii), (iv).
Subsec. (h)(4)(F).
Subsec. (h)(4)(F)(i).
Subsec. (h)(4)(H)(iv).
Subsec. (h)(5)(F).
Subsec. (h)(5)(G)(i).
Subsec. (h)(5)(G)(v).
Subsec. (j)(1)(D).
Subsec. (j)(1)(E).
Subsec. (j)(2)(A)(i).
Subsec. (l).
1997—Subsec. (b)(1).
Subsec. (b)(1)(A).
"(i) 50 percent of the amount by which the target amount exceeds the amount of the operating costs, or
"(ii) 5 percent of the target amount,
whichever is less; or".
Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(2).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(i).
Subsec. (b)(3)(B)(i)(XIII) to (XVII).
Subsec. (b)(3)(B)(ii)(VI) to (VIII).
Subsec. (b)(3)(B)(vi).
Subsec. (b)(3)(D).
Subsec. (b)(3)(D)(iv).
Subsec. (b)(3)(F), (G).
Subsec. (b)(3)(H).
Subsec. (b)(4)(A)(i).
Subsec. (b)(4)(A)(ii).
Subsec. (b)(7).
Subsec. (d)(1)(B).
Subsec. (d)(1)(B)(iv).
Subsec. (d)(1)(B)(v).
Subsec. (d)(1)(E).
Subsec. (d)(2)(C)(i).
Subsec. (d)(5)(A)(ii).
Subsec. (d)(5)(B)(i)(I).
Subsec. (d)(5)(B)(ii).
Subsec. (d)(5)(B)(iv).
Subsec. (d)(5)(B)(v) to (viii).
Subsec. (d)(5)(D)(iii)(III).
Subsec. (d)(5)(D)(v).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(ii).
Subsec. (d)(5)(F)(ii)(I).
Subsec. (d)(5)(F)(ix).
Subsec. (d)(5)(G)(i), (ii)(II).
Subsec. (d)(5)(I)(ii).
Subsec. (d)(5)(J).
Subsec. (d)(6).
Subsec. (d)(9)(A).
Subsec. (d)(9)(A)(i).
Subsec. (d)(9)(A)(ii).
Subsec. (d)(10)(C)(ii).
Subsec. (d)(10)(D)(iii), (iv).
Subsec. (d)(11).
Subsec. (e)(2).
Subsec. (e)(3).
Subsec. (e)(5)(A).
Subsec. (e)(5)(B).
Subsec. (e)(6).
Subsec. (g)(1)(A).
Subsec. (g)(3)(B).
Subsec. (g)(4).
Subsec. (h)(3)(B).
Subsec. (h)(3)(D).
Subsec. (h)(4)(F) to (H).
Subsec. (h)(5)(G).
Subsec. (h)(6).
Subsec. (j).
Subsec. (k).
1994—Subsec. (a)(4).
Subsec. (b)(3)(B)(iv)(II).
Subsec. (b)(3)(D).
Subsec. (d)(3)(A)(iii).
Subsec. (d)(5)(B)(ii).
Subsec. (d)(5)(D)(iii)(III).
Subsec. (d)(5)(D)(v).
Subsec. (d)(5)(G)(ii)(I).
Subsec. (d)(5)(I).
Subsec. (d)(8)(C)(iv).
Subsec. (d)(8)(C)(v).
Subsec. (d)(10)(C)(i)(II).
Subsec. (d)(10)(D)(i)(I).
Subsec. (d)(10)(D)(ii), (iii).
Subsec. (e)(6)(B).
Subsec. (h)(5)(E).
1993—Subsec. (b)(3)(B)(i)(IX).
Subsec. (b)(3)(B)(i)(X).
Subsec. (b)(3)(B)(i)(XI).
Subsec. (b)(3)(B)(i)(XII), (XIII).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(B)(ii)(III) to (VI).
Subsec. (b)(3)(B)(iv).
Subsec. (b)(3)(B)(v).
Subsec. (b)(3)(C)(i)(II).
Subsec. (b)(3)(C)(ii).
Subsec. (b)(3)(C)(iii), (iv).
Subsec. (b)(3)(D)(ii).
Subsec. (b)(3)(D)(iii).
Subsec. (b)(4)(A).
Subsec. (d)(1)(A)(iii).
Subsec. (d)(5)(A)(i).
Subsec. (d)(5)(A)(ii).
Subsec. (d)(5)(A)(iii).
Subsec. (d)(5)(A)(v), (vi).
Subsec. (d)(5)(B)(iv).
Subsec. (d)(5)(G)(i).
"(I) an amount based on 100 percent of the hospital's target amount for the cost reporting period, as defined in subsection (b)(3)(D) of this section, or
"(II) the amount determined under paragraph (1)(A)(iii),
whichever results in the greater payment to the hospital." to reflect the probable intent of Congress.
Subsec. (d)(5)(G)(ii) to (iv).
Subsec. (d)(8)(C)(iv).
Subsec. (g)(1)(A).
Subsec. (h)(2)(D).
Subsec. (h)(5)(F).
Subsec. (h)(5)(F)(ii).
Subsec. (h)(5)(H), (I).
Subsec. (h)(5)(J).
1990—Subsec. (a)(4).
Subsec. (b)(1)(B)(ii).
Subsec. (b)(3)(B)(i)(V).
Subsec. (b)(3)(B)(i)(VI).
Subsec. (b)(3)(B)(i)(VII).
Subsec. (b)(3)(B)(i)(VIII).
Subsec. (b)(3)(B)(i)(IX).
Subsec. (b)(3)(B)(i)(X).
Subsec. (b)(3)(B)(i)(XI).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(C)(ii), (D)(ii).
Subsec. (b)(4)(A).
Subsec. (b)(4)(B), (C).
Subsec. (c)(4).
Subsec. (d)(1)(A)(iii).
Subsec. (d)(2)(C)(iv).
Subsec. (d)(3)(A)(ii).
Subsec. (d)(3)(A)(iii) to (v).
Subsec. (d)(3)(B).
Subsec. (d)(3)(C)(ii).
"(I) on or after October 1, 1986, and before October 1, 1995, of an amount equal to the estimated reduction in the payment amounts under paragraph (5)(B) that would have resulted from the enactment of the amendments made by section 9104 of the Medicare and Medicaid Budget Reconciliation Amendments of 1985 and by section 4003(a)(1) of the Omnibus Budget Reconciliation Act of 1987 if the factor described in clause (ii)(II) of paragraph (5)(B) were applied for discharges occurring during such period instead of the factor described in clause (ii)(I) of that paragraph, and
"(II) on or after October 1, 1995, of an amount equal to the estimated reduction in the payment amounts under paragraph (5)(B) for those discharges that has resulted from the enactment of the amendments made by section 9104 of the Medicare and Medicaid Budget Reconciliation Amendments of 1985 and by section 4003(a)(1) of the Omnibus Budget Reconciliation Act of 1987."
Subsec. (d)(3)(D)(i).
Subsec. (d)(3)(D)(i)(I).
Subsec. (d)(3)(D)(ii).
Subsec. (d)(4)(D).
Subsec. (d)(5)(B)(ii).
"(I) on or after May 1, 1986, and before October 1, 1995, is equal to 1.89×((1+r).405−1), or
"(II) on or after October 1, 1995, is equal to 1.43×((1+r).5795−1),
where 'r' is the ratio of the hospital's full-time equivalent interns and residents to beds."
Subsec. (d)(5)(D)(iii).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(iii).
Subsec. (d)(5)(F)(vii)(I).
Subsec. (d)(5)(F)(vii)(II).
Subsec. (d)(8)(C)(i).
Subsec. (d)(8)(C)(i)(II).
Subsec. (d)(8)(C)(ii) to (iv).
"(I) reduces the wage index for the urban area within which the county or counties is reclassified by 1 percentage point or less (as applied under this subsection), the Secretary, in calculating such wage index under this subsection, shall exclude those counties so reclassified, or
"(II) reduces the wage index for the urban area within which the county or counties is reclassified by more than 1 percentage point (as applied under this subsection), the Secretary shall calculate and apply such wage index under this subsection separately to hospitals located in such urban area (excluding all the hospitals so reclassified) and to hospitals located in the counties so reclassified (as if each affected county were a separate area)."
Subsec. (d)(8)(D).
Subsec. (d)(10)(A).
Subsec. (d)(10)(B)(i).
Subsec. (d)(10)(B)(ii).
Subsec. (d)(10)(C)(iii)(II).
Subsec. (e)(2).
Subsec. (e)(2)(A).
Subsec. (e)(3)(A).
Subsec. (e)(4).
Subsec. (e)(5).
Subsec. (e)(6)(G).
Subsec. (g)(1)(A).
Subsec. (g)(3)(A)(v).
Subsec. (g)(3)(B).
1989—Subsec. (a)(4).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B)(i)(V), (VI).
Subsec. (b)(3)(B)(ii).
Subsec. (b)(3)(C).
Subsec. (b)(3)(D).
Subsec. (b)(3)(E).
Subsec. (b)(4)(A).
Subsec. (c)(4).
Subsec. (d)(1)(B)(v).
Subsec. (d)(3)(E).
Subsec. (d)(4)(C).
Subsec. (d)(5)(C).
Subsec. (d)(5)(D).
Subsec. (d)(5)(D)(iii)(III).
Subsec. (d)(5)(D)(v).
Subsec. (d)(5)(E).
Subsec. (d)(5)(F)(iii).
Subsec. (d)(5)(F)(iv)(I).
Subsec. (d)(5)(F)(iv)(III).
Subsec. (d)(5)(F)(iv)(IV) to (VI).
Subsec. (d)(5)(F)(v)(II) to (IV).
Subsec. (d)(5)(F)(vii).
Subsec. (d)(5)(F)(viii).
Subsec. (d)(5)(G).
Subsec. (d)(5)(H).
Subsec. (d)(5)(I).
Subsec. (d)(8)(C).
"(i) If the application of subparagraph (B) or a decision of the Medicare Geographic Classification Review Board or the Secretary under paragraph (10),, [sic] by treating hospitals located in a rural county or counties as being located in an urban area, reduces the wage index for that urban area (as applied under this subsection), the Secretary shall calculate and apply such wage index under this subsection separately to hospitals located in such urban area (excluding all the hospitals so treated) and to the hospitals so treated (as if each affected rural county were a separate urban area). If the application of subparagraph (B) or a decision of the Medicare Geographic Classification Review Board or the Secretary under paragraph (10),, [sic] by treating the hospitals located in a rural county or counties as not being located in the rural area in a State, reduces the wage index for that rural area (as applied under this subsection), the Secretary shall calculate and apply such wage index under this subsection as if the hospitals so treated had not been excluded from calculation of the wage index for that rural area.
"(ii) Clause (i) shall only apply to discharges occurring on or after October 1, 1989, and before October 1, 1991."
Subsec. (d)(8)(C)(i).
Subsec. (d)(8)(C)(iv).
Subsec. (d)(8)(D).
Subsec. (d)(9)(B)(ii)(IV).
Subsec. (d)(9)(D)(iii).
Subsec. (d)(9)(D)(iv).
Subsec. (d)(9)(D)(v).
Subsec. (d)(10).
Subsec. (g)(3)(A)(iv).
Subsec. (g)(3)(A)(v).
Subsec. (g)(3)(B).
Subsec. (i).
1988—Subsec. (b)(3)(B)(i)(III).
Subsec. (b)(3)(B)(i)(IV).
Subsec. (b)(3)(B)(i)(V).
Subsec. (d)(1)(A)(iii).
Subsec. (d)(2)(C)(i).
Subsec. (d)(2)(C)(iv).
Subsec. (d)(2)(D).
Subsec. (d)(3)(A).
Subsec. (d)(3)(A)(i).
Subsec. (d)(3)(A)(ii).
Subsec. (d)(3)(C)(ii).
Subsec. (d)(3)(C)(ii)(I), (II).
Subsec. (d)(3)(C)(iii).
Subsec. (d)(5)(B)(ii)(I), (II).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(vi)(I).
Subsec. (d)(8).
Subsec. (d)(8)(B).
"(i) the rural county would otherwise be considered part of an urban area but for the fact that the rural county does not meet the standard relating to the rate of commutation between the rural county and the central county or counties of any adjacent urban area; and
"(ii) either (I) the number of residents of the rural county who commute for employment to the central county or counties of any adjacent urban area is equal to at least 15 percent of the number of residents of the rural county who are employed, or (II) the sum of the number of residents of the rural county who commute for employment to the central county or counties of any adjacent urban area and the number of residents of any adjacent urban area who commute for employment to the rural county is at least equal to 20 percent of the number of residents of the rural county who are employed."
Subsec. (d)(8)(C).
Subsec. (d)(8)(D).
Subsec. (d)(9)(C)(iv).
Subsec. (e)(6)(B).
Subsec. (f)(1)(A).
Subsec. (f)(1)(B).
Subsec. (g)(3)(A)(ii) to (iv).
Subsec. (g)(3)(A)(iv).
1987—Subsec. (a)(4).
Subsec. (b)(3)(B)(i).
Subsec. (b)(3)(B)(i)(II).
Subsec. (b)(3)(B)(i)(III) to (V).
Subsec. (b)(3)(B)(ii), (iii).
Subsec. (d)(1)(A)(iii).
Subsec. (d)(2)(C)(iv).
Subsec. (d)(2)(D).
Subsec. (d)(3).
Subsec. (d)(3)(A)(i).
Subsec. (d)(3)(C)(ii).
Subsec. (d)(3)(C)(iii).
Subsec. (d)(3)(D).
Subsec. (d)(3)(D)(i).
Subsec. (d)(3)(E).
Subsec. (d)(5)(B)(ii).
Subsec. (d)(5)(C)(i)(I).
Subsec. (d)(5)(C)(i)(II).
Subsec. (d)(5)(C)(ii).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(i)(II).
Subsec. (d)(5)(F)(iii).
Subsec. (d)(5)(F)(iv)(I).
Subsec. (d)(5)(F)(vi)(I).
Subsec. (d)(8).
Subsec. (d)(9)(A)(ii).
Subsec. (d)(9)(B).
Subsec. (d)(9)(C)(iv).
Subsec. (e)(3)(B).
Subsec. (e)(4).
Subsec. (e)(5).
Subsec. (e)(6)(B).
Subsec. (e)(6)(D).
Subsec. (f)(1)(A).
Subsec. (f)(1)(B).
Subsec. (f)(3).
Subsec. (g)(1).
Subsec. (g)(3)(A)(ii) to (iv).
Subsec. (g)(3)(C).
"(i) notwithstanding any other provision of this subchapter, for the continuation of payment under the reasonable cost methodology described in
"(ii) in the design of such payment system that the aggregate payment amounts under this subchapter for such other capital-related costs for payments attributable to portions of cost reporting periods occurring during fiscal year 1988 and fiscal year 1989 shall approximate the aggregate payment amount under this subchapter that would have been made (taking into account the provisions of subparagraphs (A) and (B)) during that fiscal year but for the inclusion of such costs by the Secretary."
Subsec. (h)(4)(C).
1986—Subsec. (a)(4).
Subsec. (b)(3)(B).
Subsec. (b)(3)(B)(i)(II).
Subsec. (b)(6).
Subsec. (c)(7).
Subsec. (d)(1)(A).
Subsec. (d)(1)(C).
Subsec. (d)(1)(D).
Subsec. (d)(2)(C)(i).
Subsec. (d)(2)(C)(iv).
Subsec. (d)(3)(A).
Subsec. (d)(3)(B).
Subsec. (d)(3)(C).
Subsec. (d)(3)(C)(ii).
"(I) the sum of the additional payment amounts under paragraph (5)(B) (relating to indirect costs of medical education) if the indirect teaching adjustment factor were equal to 1.159r (as 'r' is defined in paragraph (5)(B)(ii)), and
"(II) that sum using the factor specified in paragraph (5)(B)(ii)(II)."
Subsec. (d)(3)(C)(iii).
Subsec. (d)(3)(D)(i)(I), (ii)(I).
Subsec. (d)(4)(C).
Subsec. (d)(5)(B).
Subsec. (d)(5)(B)(ii).
Subsec. (d)(5)(C)(i).
Subsec. (d)(5)(C)(i)(I).
Subsec. (d)(5)(C)(ii).
Subsec. (d)(5)(E).
Subsec. (d)(5)(F).
Subsec. (d)(5)(F)(i).
Subsec. (d)(5)(F)(iv)(I).
Subsec. (d)(5)(F)(iv)(III).
Subsec. (d)(5)(F)(v).
Subsec. (d)(5)(F)(vi)(I).
Subsec. (d)(9).
Subsec. (e)(1)(C).
Subsec. (e)(3).
Subsec. (e)(3)(A).
Subsec. (e)(4).
Subsec. (e)(5).
Subsec. (e)(5)(A).
Subsec. (e)(6)(A).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(2)(B).
Subsec. (g)(3).
Subsec. (g)(3)(A).
Subsec. (h).
Subsec. (h)(2)(C).
Subsec. (h)(4)(D).
Subsec. (h)(4)(E).
Subsec. (h)(5)(B).
1984—Subsec. (a)(2)(B).
Subsec. (a)(4).
Subsec. (b)(3)(A)(ii).
Subsec. (b)(3)(B).
Subsec. (c)(4)(A).
Subsec. (d)(2)(D).
Subsec. (d)(3)(D)(i)(I).
Subsec. (d)(5)(B).
Subsec. (d)(5)(C)(i).
Subsec. (d)(5)(E).
Subsec. (d)(8).
Subsec. (e)(2).
Subsec. (e)(5).
Subsec. (e)(5)(A).
Subsec. (e)(6)(C).
Subsec. (e)(6)(C)(i).
Subsec. (e)(6)(C)(iii).
Subsec. (e)(6)(D).
Subsec. (e)(6)(J).
1983—Subsec. (a)(1)(D).
Subsec. (a)(4).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3)(B).
Subsec. (b)(6).
Subsec. (b)(6)(C).
Subsec. (c)(1).
Subsec. (c)(3)(A).
Subsec. (c)(3)(B).
Subsec. (c)(4) to (6).
Subsec. (d).
Subsecs. (e) to (g).
1982—Subsec. (d).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2022 Amendment
Effective Date of 2020 Amendment
Effective Date of 2015 Amendment
Amendment by section 106(b)(2)(B) of
Effective Date of 2014 Amendment
Effective Date of 2011 Amendment
Amendment by
Effective Date of 2010 Amendment
"(1)
"(2) GME.—Section 1886(h)(4)(J) of the Social Security Act [
"(3) IME.—Section 1886(d)(5)(B)(x)(III) of the Social Security Act [
Effective Date of 2007 Amendment
Effective Date of 2006 Amendment
Amendment by section 109(a)(2) of
Amendment by section 205(b)(1) of
Effective Date of 2003 Amendment
"(1)
"(2)
"(A) the Secretary shall automatically reconsider the application as an application for fiscal year 2005 under the amendments made by this section; and
"(B) the maximum time period otherwise permitted for such classification of the service or technology shall be extended by 12 months."
Effective Date of 2000 Amendment
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §321(b), (e), (f), (h), (k)(15)–(17)] of
Amendment by section 1000(a)(6) [title IV, §401(a)] of
"(A) DGME.—The amendments made by paragraph (1) [amending this section] apply to cost reporting periods that begin on or after the date of the enactment of this Act [Nov. 29, 1999].
"(B) IME.—The amendment made by paragraph (2) [amending this section] applies to discharges occurring in cost reporting periods that begin on or after such date of enactment."
"(A) DGME.—The amendment made by paragraph (1) [amending this section] applies to cost reporting periods beginning on or after April 1, 2000.
"(B) IME.—The amendment made by paragraph (2) [amending this section] applies to discharges occurring on or after April 1, 2000."
"(A) payments to hospitals under section 1886(h) of the Social Security Act (
"(B) payments to hospitals under section 1886(d)(5)(B)(v) of such Act (
Effective Date of 1997 Amendment
Amendment by section 4022(b) of
Amendment by section 4201(c)(1), (4) of
Effective Date of 1994 Amendment
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
"(1) in the case of any services provided during the day immediately preceding the date of a patient's admission (without regard to whether the services are related to the admission), to services furnished on or after the date of the enactment of this Act [Nov. 5, 1990] and before October 1, 1991;
"(2) in the case of diagnostic services (including clinical diagnostic laboratory tests), to services furnished on or after January 1, 1991; and
"(3) in the case of any other services, to services furnished on or after October 1, 1991."
Effective Date of 1989 Amendment
"(A) in the case of a hospital classified by the Secretary of Health and Human Services as a hospital involved extensively in treatment for or research on cancer under section 1886(d)(5)(I) of the Social Security Act [
"(B) in the case of a hospital that is not described in subparagraph (A), such amendments shall apply with respect to portions of cost reporting periods or discharges occurring during and after fiscal year 1987 for purposes of section 1886(g) of the Social Security Act [
"(C) such amendments shall take effect 30 days after the date of the enactment of this Act for purposes of determining the eligibility of a hospital to receive periodic interim payments under section 1815(e)(2) of the Social Security Act [
[
Effective Date of 1988 Amendment
Amendment by section 1018(r)(1) of
Amendment by
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
"(1)
"(A) the amendments made by subsections (a) and (c) [amending this section] shall apply to payments made under section 1886(d)(1)(A)(iii) of the Social Security Act [
"(B) for discharges occurring on or after October 1, 1988, the applicable percentage increase (described in section 1886(b)(3)(B) of such Act [
"(2)
"(A) the amendment made by subsections (a) and (c) [amending this section] shall apply to payments under section 1886(d)(1)(A)(ii)(I) of the Social Security Act made on the basis of discharges occurring during a cost reporting period of a hospital, for the hospital's cost reporting period beginning on or after October 1, 1987;
"(B) notwithstanding subparagraph (A), for cost reporting period beginning during fiscal year 1988, the applicable percentage increase (as defined in section 1886(b)(3)(B) of such Act [
"(i) first 51 days of the cost reporting period shall be 0 percent,
"(ii) next 132 days of such period shall be 2.7 percent, and
"(iii) remainder of such period of the cost reporting period shall be the applicable percentage increase (as so defined, as amended by subsection (a)); and
"(C) for cost reporting periods beginning on or after October 1, 1988, the applicable percentage increase (as so defined) with respect to the previous cost reporting period shall be deemed to have been the applicable percentage increase (as so defined, as amended by subsection (a)).
"(3)
"(A) the amendments made by subsection (e) [amending this section] shall apply to cost reporting periods beginning on or after October 1, 1987;
"(B) notwithstanding subparagraph (A), for the hospital's cost reporting period beginning during fiscal year 1988, payment under title XVIII of the Social Security Act [
"(C) for cost reporting periods beginning on or after October 1, 1988, the applicable percentage increase (as so defined) with respect to the cost reporting period beginning during fiscal year 1988 shall be deemed to have been 2.7 percent.
"(4)
"(5)
"(6)
Amendment by
Effective Date of 1986 Amendment
Amendment by section 1895(b)(3), (9) of
"(i) Subject to clause (ii), the amendments made by subparagraph (A) [amending this section] shall apply to payments for discharges occurring on or after October 1, 1986.
"(ii) An appeal for classification of a rural hospital as a regional referral center, pursuant to the amendments made by subparagraph (A), which is filed before January 1, 1987, and which is approved shall be effective with respect to discharges occurring on or after October 1, 1986."
Amendment by section 9320(g) of
"(1)
"(A) the amendment made by subsection (b) [amending this section] shall apply to payments made under section 1886(d)(1)(A) of such Act [
"(B) for discharges occurring on or after October 1, 1986, the applicable percentage increase (described in section 1886(b)(3)(B) [
"(2)
"(A) the amendment made by subsection (b) [amending this section] shall apply to payments under section 1886(d)(1)(A) of the Social Security Act [
"(B) notwithstanding subparagraph (A), for the cost reporting period beginning during fiscal year 1986, the applicable percentage increase (as defined in section 1886(b)(3)(B) of such Act [
"(i) first 7 months of the cost reporting period shall be 0 percent, and
"(ii) for the remaining 5 months of the cost reporting period shall be ½ percent; and
"(C) for cost reporting periods beginning on or after October 1, 1986, the applicable percentage increase (as so defined) with respect to the previous cost reporting period shall be deemed to have been ½ percent.
"(3)
"(A) the amendment made by subsection (b) [amending this section] shall apply to cost reporting periods beginning on or after October 1, 1985;
"(B) notwithstanding subparagraph (A), for the hospital's cost reporting period beginning during fiscal year 1986, payment under title XVIII of the Social Security Act [
"(C) for cost reporting periods beginning on or after October 1, 1986, the applicable percentage increase (as so defined) with respect to the cost reporting period beginning during fiscal year 1986 shall be deemed to have been ½ percent.
"(4)
"(1)
"(2)
"(A) to cost reporting periods beginning on or after October 1, 1985, but
"(B) notwithstanding subparagraph (A), for a hospital's cost reporting period beginning during fiscal year 1986, for purposes of section 1886(d)(1)(A) of the Social Security Act [
"(i) during the first 7 months of the period the 'target percentage' is 50 percent and the 'DRG percentage' is 50 percent, and
"(ii) during the remaining 5 months of the period the 'target percentage' is 45 percent and the 'DRG percentage' is 55 percent.
"(3)
"(4)
"(A) Notwithstanding any other provision of this subsection, the amendments made by this section [amending this section] shall not apply to payments with respect to the operating costs of inpatient hospital services (as defined in section 1886(a)(4) of the Social Security Act [
"(B) Notwithstanding any other provision of law, for a cost reporting period beginning during fiscal year 1986 of a subsection (d) hospital to which the amendments made by this section [amending this section] do not apply, for purposes of section 1886(d)(1)(A) of of [sic] Social Security Act [
"(i) during the first 7 months of the period the 'target percentage' is 50 percent and the 'DRG percentage' is 50 percent, and
"(ii) during the remaining 5 months of the period the 'target percentage' is 25 percent and the 'DRG percentage' is 75 percent.
"(C) Notwithstanding any other provision of law, for purposes of section 1886(d)(1)(D) of such Act [
"(1) Except as provided in paragraph (2), the amendments made by this section [amending this section] shall apply to discharges occurring on or after May 1, 1986.
"(2) The amendments made by this section shall not first be applied to discharges occurring as of a date unless, for discharges occurring on that date, the amendments made by section 9105 [amending this section] are also being applied."
Effective and Termination Dates of 1984 Amendment
Amendment by
"(1) Except as provided in paragraph (2), the amendments made by subsections (b) and (c) [amending this section] shall be effective with respect to cost reporting periods beginning on or after October 1, 1983, and the amendment made by subsection (a) [amending this section] shall be effective with respect to cost reporting periods beginning on or after October 1, 1984.
"(2) The amendment made by subsection (b) [amending this section] shall not apply so as to reduce any payment under section 1886(d) of the Social Security Act [
Amendment by section 2313(a), (b), (d) of
Amendment by section 2354(b)(42)–(44) of
Effective Date of 1983 Amendment
"(a)(1) Except as provided in section 602(l) [amending
"(2) Section 1866(a)(1)(F) of the Social Security Act [
"(b) The Secretary shall make an appropriate reduction in the payment amount under section 1886(d) of the Social Security Act [
"(c)(1) The Secretary shall cause to be published in the Federal Register a notice of the interim final DRG prospective payment rates established under subsection (d) of section 1886 of the Social Security Act [
"(2) A modification under paragraph (1) that reduces a prospective payment rate shall apply only to discharges occurring after 30 days after the date the notice of the modification is published in the Federal Register.
"(3) Rules to implement the amendments made by this title [amending this section and
Amendment by
Effective Date
Regulations
Construction of 2010 Amendment
Transfer of Functions
Prospective Payment Assessment Commission (ProPAC) was terminated and its assets and staff transferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of
Implementation of Amendment by Pub. L. 118–42
Implementation of Amendment by Pub. L. 117–328
Implementation of Amendment by Pub. L. 117–229
Implementation of Amendment by Pub. L. 117–180
Implementation of Amendment by Pub. L. 116–136
Increasing Access to Post-Acute Care During Emergency Period
"(a)
"(b)
"(1)
"(2)
Application of Change in Medicare Classification for Certain Hospitals
"(1)
"(A) Payment for inpatient operating costs shall be made on a reasonable cost basis in the manner provided in section 412.526(c)(3) of title 42, Code of Federal Regulations (as in effect on January 1, 2015) and in any subsequent modifications.
"(B) Payment for capital costs shall be made in the manner provided by section 412.526(c)(4) of title 42, Code of Federal Regulations (as in effect on such date).
"(C) Claims for payment for Medicare beneficiaries who are discharged on or after January 1, 2017, shall be processed as claims which are paid on a reasonable cost basis as described in section 412.526(c) of title 42, Code of Federal Regulations (as in effect on such date).
"(2)
Implementation of Amendment by Pub. L. 114–113
Calculation of Length of Stay Excluding Cases Paid on a Site Neutral Basis
"(A)
"(B)
[
Review of Treatment of Certain LTCHs
"(1)
"(2)
Special Rule for Fiscal Year 2011 and Adjustment for Certain Hospitals in Fiscal Year 2011
"(2)
"(A)
"(B)
"(3)
"(A)
"(i) a reclassification of its wage index for purposes of such section was extended pursuant to the amendment made by paragraph (1); and
"(ii) the wage index applicable for such hospital for the period beginning on October 1, 2010, and ending on March 31, 2011, was lower than for the period beginning on April 1, 2011, and ending on September 30, 2011, by reason of the application of paragraph (2)(B);
"the Secretary shall pay such hospital an additional payment that reflects the difference between the wage index for such periods.
"(B)
Similar provisions were contained in
No Reopening of Previously Bundled Claims
"(1)
"(2)
Implementation of Amendment by Pub. L. 111–192
Payment for Qualifying Hospitals
"(a)
"(b)
"(c)
"(d)
Value-Based Purchasing Demonstration Programs
"(1)
"(A)
"(i)
"(ii)
"(iii)
"(B)
"(C)
"(D)
"(i) recommendations on the establishment of a permanent value-based purchasing program under the Medicare program for critical access hospitals with respect to inpatient critical access hospital services; and
"(ii) recommendations for such other legislation and administrative action as the Secretary determines appropriate.
"(2)
"(A)
"(i)
"(ii)
"(iii)
"(iv)
"(B)
"(C)
"(D)
"(i) recommendations on the establishment of a permanent value-based purchasing program under the Medicare program for applicable hospitals with respect to inpatient hospital services; and
"(ii) recommendations for such other legislation and administrative action as the Secretary determines appropriate."
Reforming the Medicare Hospital Wage Index System
"(b)
"(1)
"(2)
"(A) uses Bureau of Labor Statistics data, or other data or methodologies, to calculate relative wages for each geographic area involved;
"(B) minimizes wage index adjustments between and within metropolitan statistical areas and statewide rural areas;
"(C) includes methods to minimize the volatility of wage index adjustments that result from implementation of policy, while maintaining budget neutrality in applying such adjustments;
"(D) takes into account the effect that implementation of the system would have on health care providers and on each region of the country;
"(E) addresses issues related to occupational mix, such as staffing practices and ratios, and any evidence on the effect on quality of care or patient safety as a result of the implementation of the system; and
"(F) provides for a transition.
"(3)
"(c)
Application of Budget Neutrality on a National Basis in the Calculation of the Medicare Hospital Wage Index Floor
Effect on Temporary FTE Cap Adjustments
Graduate Nurse Education Demonstration
"(a)
"(1)
"(A)
"(B)
"(C)
"(2)
"(A)
"(B)
"(3)
"(4)
"(b)
"(1) the obligations of the eligible partners with respect to the provision of qualified training; and
"(2) the obligation of the eligible hospital to reimburse such eligible partners applicable (in a timely manner) for the costs of such qualified training attributable to partner.
"(c)
"(1) The growth in the number of advanced practice registered nurses with respect to a specific base year as a result of the demonstration.
"(2) The growth for each of the specialties described in subparagraphs (A) through (D) of subsection (e)(1).
"(3) The costs to the Medicare program under title XVIII of the Social Security Act as a result of the demonstration.
"(4) Other items the Secretary determines appropriate and relevant.
"(d)
"(1)
"(2)
"(3)
"(e)
"(1)
"(A) A clinical nurse specialist (as defined in subsection (aa)(5) of section 1861 of the Social Security Act (
"(B) A nurse practitioner (as defined in such subsection).
"(C) A certified registered nurse anesthetist (as defined in subsection (bb)(2) of such section).
"(D) A certified nurse-midwife (as defined in subsection (gg)(2) of such section).
"(2)
"(3)
"(4)
"(5)
"(A) 1 or more applicable schools of nursing; and
"(B) 2 or more applicable non-hospital community-based care settings.
"(6)
"(A) An applicable non-hospital community-based care setting.
"(B) An applicable school of nursing.
"(7)
"(A)
"(i) that provides an advanced practice registered nurse with the clinical skills necessary to provide primary care, preventive care, transitional care, chronic care management, and other services appropriate for individuals entitled to, or enrolled for, benefits under part A of title XVIII of the Social Security Act [
"(ii) subject to subparagraph (B), at least half of which is provided in a non-hospital community-based care setting.
"(B)
"(8)
Payment for Long-Term Care Hospital Services
"(1)
"(A) through June 30, 2016, and for discharges occurring on or after October 1, 2016, and before October 1, 2017, section 412.536 of title 42, Code of Federal Regulations, or any similar provision, to freestanding long-term care hospitals or to a long-term care hospital, or satellite facility, that as of December 29, 2007, was co-located with an entity that is a provider-based, off-campus location of a subsection (d) hospital which did not provide services payable under section 1886(d) of the Social Security Act [
"(B) such section or section 412.534 of title 42, Code of Federal Regulations, or any similar provisions, to a long-term care hospital identified by the amendment made by section 4417(a) of the Balanced Budget Act of 1997 (
"(2)
"(A)
"(B)
"(i)
"(ii)
"(C)
"(3)
"(4)
[
Moratorium on the Establishment of Long-Term Care Hospitals, Long-Term Care Satellite Facilities and on the Increase of Long-Term Care Hospital Beds in Existing Long-Term Care Hospitals or Satellite Facilities
"(1)
"(A) subject to paragraph (2), on the establishment and classification of a long-term care hospital or satellite facility, other than an existing long-term care hospital or facility; and
"(B) subject to paragraph (3), on an increase of long-term care hospital beds in existing long-term care hospitals or satellite facilities.
"(2)
"(A) began its qualifying period for payment as a long-term care hospital under section 412.23(e) of title 42, Code of Federal Regulations, on or before the date of the enactment of this Act;
"(B) has a binding written agreement with an outside, unrelated party for the actual construction, renovation, lease, or demolition for a long-term care hospital, and has expended, before the date of the enactment of this Act, at least 10 percent of the estimated cost of the project (or, if less, $2,500,000); or
"(C) has obtained an approved certificate of need in a State where one is required on or before the date of the enactment of this Act.
"(3)
"(A)
"(i) is located in a State where there is only one other long-term care hospital; and
"(ii) requests an increase in beds following the closure or the decrease in the number of beds of another long-term care hospital in the State.
"(B)
"(4)
"(5)
"(6)
"(7)
"(A) began its qualifying period for payment as a long-term care hospital under section 412.23(e) of title 42, Code of Federal Regulations, on or before the date of enactment of this paragraph [Apr. 1, 2014];
"(B) has a binding written agreement as of the date of the enactment of this paragraph with an outside, unrelated party for the actual construction, renovation, lease, or demolition for a long-term care hospital, and has expended, before such date of enactment, at least 10 percent of the estimated cost of the project (or, if less, $2,500,000); or
"(C) has obtained an approved certificate of need in a State where one is required on or before such date of enactment."
[
[For effective date of amendment by
Expanded Review of Medical Necessity
"(1)
"(2)
"(A) provide for a statistically valid and representative sample of admissions of such individuals sufficient to provide results at a 95 percent confidence interval; and
"(B) guarantee that at least 75 percent of overpayments received by long-term care hospitals for medically unnecessary admissions and continued stays of individuals in long-term care hospitals will be identified and recovered and that related days of care will not be counted toward the length of stay requirement contained in section 1886(d)(1)(B)(iv) of the Social Security Act (
"(3)
"(4)
"(A)
"(B)
"(5)
Extending Certain Medicare Hospital Wage Index Reclassifications
"(2)
"(3)
Correction of Application of Wage Index During Tax Relief and Health Care Act Extension
"(1) a reclassification of its wage index for purposes of such section was extended for the period beginning on April 1, 2007, and ending on September 30, 2007, pursuant to subsection (a) of section 106 of division B of the Tax Relief and Health Care Act of 2006 [
"(2) the wage index applicable for such hospital during such period was lower than the wage index applicable for such hospital during the period beginning on October 1, 2006, and ending on March 31, 2007,
the Secretary [of Health and Human Services] shall apply the higher wage index that was applicable for such hospital during the period beginning on October 1, 2006, and ending on March 31, 2007, for the entire fiscal year 2007. If the Secretary determines that the application of the preceding sentence to a hospital will result in a hospital being owed additional reimbursement, the Secretary shall make such payments within 90 days after the settlement of the applicable cost report."
Correction of Mid-Year Reclassification Expiration
[
["(b)
["(1)
["(2)
["(c)
["(1)
[
["(b)
["(1)
["(2)
["(c)
Plan for Hospital Value Based Purchasing Program
"(1)
"(2)
"(A) The on-going development, selection, and modification process for measures of quality and efficiency in hospital inpatient settings.
"(B) The reporting, collection, and validation of quality data.
"(C) The structure of value based payment adjustments, including the determination of thresholds or improvements in quality that would substantiate a payment adjustment, the size of such payments, and the sources of funding for the value based payments.
"(D) The disclosure of information on hospital performance.
In developing such a plan, the Secretary shall consult with relevant affected parties and shall consider experience with such demonstrations that are relevant to the value based purchasing program under this subsection."
Extended Phase-In of the Inpatient Rehabilitation Facility Classification Criteria
"(a)
"(b)
"(c) IRF
[
Medicare Demonstration Projects To Permit Gainsharing Arrangements
"(a)
"(b)
"(1)
"(2)
"(A) is submitted to the Secretary prior to implementation of the project; and
"(B) includes a plan outlining how the project will achieve improvements in quality and efficiency.
"(3)
"(4)
"(5)
"(6)
"(c)
"(1)
"(A) remuneration for purposes of section 1128B of the Social Security Act (
"(B) a payment intended to induce a physician to reduce or limit services to a patient entitled to benefits under Medicare or a State plan approved under title XIX of such Act [
"(C) a financial relationship for purposes of section 1877 of such Act (
"(2)
"(d)
"(1)
"(2)
"(3)
"(e)
"(1)
"(2)
"(3)
"(4)
"(f)
"(1)
"(2)
"(g)
"(1)
"(2)
"(3)
"(4)
"(5)
More Frequent Update in Weights Used in Hospital Market Basket
"(a)
"(b)
Rural Community Hospital Demonstration Program
"(a)
"(1)
"(2)
"(3)
"(4)
"(5)
"(6)
"(b)
"(1)
"(A) for discharges occurring in the first cost reporting period beginning on or after the implementation of the demonstration program, the reasonable costs of providing such services; and
"(B) for discharges occurring in a subsequent cost reporting period under the demonstration program, the lesser of—
"(i) the reasonable costs of providing such services in the cost reporting period involved; or
"(ii) the target amount (as defined in paragraph (2)), applicable to the cost reporting period involved.
"(2)
"(A) in the case of the second such cost reporting period for which this subsection is in effect, the reasonable costs of providing such covered inpatient hospital services as determined under paragraph (1)(A), and
"(B) in the case of a later cost reporting period, the target amount for the preceding 12-month cost reporting period,
increased by the applicable percentage increase (under clause (i) of section 1886(b)(3)(B) of the Social Security Act (
"(c)
"(1)
"(2)
"(d)
"(e)
"(f)
"(1)
"(A)
"(i) is located in a rural area (as defined in section 1886(d)(2)(D) of such Act (
"(ii) subject to subparagraph (B), has fewer than 51 acute care inpatient beds, as reported in its most recent cost report;
"(iii) makes available 24-hour emergency care services; and
"(iv) is not eligible for designation, or has not been designated, as a critical access hospital under section 1820 of the Social Security Act (
"(B)
"(2)
"(g)
"(1)
"(2)
"(3)
"(4)
"(A) shall provide for the continued participation of such rural community hospital in the demonstration program during the 15-year extension period unless the rural community hospital makes an election, in such form and manner as the Secretary may specify, to discontinue such participation; and
"(B) in calculating the amount of payment under subsection (b) to the rural community hospital for covered inpatient hospital services furnished by the hospital during each 5-year period in such 15-year extension period, shall substitute, under paragraph (1)(A) of such subsection—
"(i) the reasonable costs of providing such services for discharges occurring in the first cost reporting period beginning on or after the first day of each applicable 5-year period in the 15-year extension period, for
"(ii) the reasonable costs of providing such services for discharges occurring in the first cost reporting period beginning on or after the implementation of the demonstration program.
"(5)
"(A)
"(B)
"(6)
"(A)
"(B)
"(i) shall give priority to rural community hospitals located in one of the 20 States with the lowest population densities (as determined by the Secretary using the 2015 Statistical Abstract of the United States); and
"(ii) may consider—
"(I) closures of hospitals located in rural areas in the State in which the rural community hospital is located during the 5-year period immediately preceding the date of the enactment of this paragraph; and
"(II) the population density of the State in which the rural community hospital is located."
Applicability of Chapter 35 of Title 44
Report on Extension of Applications Under Redistribution Program
MedPAC Study on Rural Hospital Payment Adjustments
"(a)
"(b)
"(1)
"(2)
GAO Study and Report on Appropriateness of Payments Under the Prospective Payment System for Inpatient Hospital Services
"(1)
"(A) the appropriate level and distribution of payments in relation to costs under the prospective payment system under section 1886 of the Social Security Act (
"(B) whether there is a need to adjust such payments under such system to reflect legitimate differences in costs across different geographic areas, kinds of hospitals, and types of cases.
"(2)
Not Budget Neutral
One-Time Appeals Process for Hospital Wage Index Classification
"(a)
"(1)
"(2)
"(A) Such an appeal may be filed as soon as possible after the date of the enactment of this Act [Dec. 8, 2003] but shall be filed by not later than February 15, 2004.
"(B) Such an appeal shall be heard by the Medicare Geographic Reclassification Review Board.
"(C) There shall be no further administrative or judicial review of a decision of such Board.
"(3)
"(4)
"(b)
"(c)
"(1) does not qualify for a change in wage index classification under paragraph (8) or (10) of section 1886(d) of the Social Security Act (
"(2) meets such other criteria, such as quality, as the Secretary may specify by instruction or otherwise.
The Secretary may modify the wage comparison guidelines promulgated under section 1886(d)(10)(D) of such Act (
"(d)
"(e)
"(f)
"(g)
Exception to Initial Residency Period for Geriatric Residency or Fellowship Programs
"(a)
"(b)
Treatment of Volunteer Supervision
"(a)
"(b)
"(1)
"(2)
Furnishing Hospitals With Information To Compute DSH Formula
Special Rules for Payment for Fiscal Year 2001
"(1) for discharges occurring on or after October 1, 2000, and before April 1, 2001, shall be determined in accordance with subclause (XVI) of such section as in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(2) for discharges occurring on or after April 1, 2001, and before October 1, 2001, shall be equal to—
"(A) the market basket percentage increase plus 1.1 percentage points for hospitals (other than sole community hospitals) in all areas; and
"(B) the market basket percentage increase for sole community hospitals."
"(1) for discharges occurring on or after October 1, 2000, and before April 1, 2001, shall be adjusted as provided by clause (ix)(III) of such section as in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(2) for discharges occurring on or after April 1, 2001, and before October 1, 2001, shall, instead of being reduced by 3 percent as provided by clause (ix)(III) of such section as in effect after the date of the enactment of this Act, be reduced by 1 percent."
"(a)
"(1) Section 301(b)(2)(A) [set out as a note above] (relating to acute care hospital payment update).
"(2) Section 302(b) [set out as a note above] (relating to IME percentage adjustment).
"(3) Section 303(b)(2) [set out as a note above] (relating to DSH payments)."
Consideration of Price of Blood and Blood Products in Market Basket Index
MedPAC Study and Report Regarding Certain Hospital Costs
"(1)
"(A) any increased costs incurred by subsection (d) hospitals (as defined in paragraph (1)(B) of section 1886(d) of the Social Security Act (
"(i) complying with new blood safety measure requirements; and
"(ii) providing such services using new technologies;
"(B) the extent to which the prospective payment system for such services under such section provides adequate and timely recognition of such increased costs;
"(C) the prospects for (and to the extent practicable, the magnitude of) cost increases that hospitals will incur in providing such services that are attributable to complying with new blood safety measure requirements and providing such services using new technologies during the 10 years after the date of the enactment of this Act [Dec. 21, 2000]; and
"(D) the feasibility and advisability of establishing mechanisms under such payment system to provide for more timely and accurate recognition of such cost increases in the future.
"(2)
"(A) hospitals;
"(B) organizations involved in the collection, processing, and delivery of blood; and
"(C) organizations involved in the development of new blood safety technologies.
"(3)
Process To Permit Statewide Wage Index Calculation and Application
"(1)
"(2)
Collection of Information on Occupational Mix
"(A) the collection of data under paragraph (1) [set out above]; and
"(B) the measurement under the third sentence of section 1886(d)(3)(E) [
Payment for Inpatient Services of Psychiatric Hospitals
Expediting Recognition of New Technologies Into Inpatient PPS Coding System
"(1)
"(2)
Consultation Prior to Rulemaking
Special Payments To Maintain 6.5 Percent IME Payment for Fiscal Year 2000
"(1)
"(2)
Data Collection
"(1)
"(2)
Per Discharge Prospective Payment System for Long-Term Care Hospitals
"(1)
"(2)
"(a)
"(1)
"(2)
"(b)
"(c)
Per Diem Prospective Payment System for Psychiatric Hospitals
"(a)
"(1)
"(2)
"(3)
"(b)
"(c)
Study on Impact of Implementation of Prospective Payment System
"(1)
"(2)
MedPAC Study on Medicare Payment for Nonphysician Health Professional Clinical Training in Hospitals
"(a)
"(b)
Not Counting Against Numerical Limitation Certain Interns and Residents Transferred from a VA Residency Program That Loses Accreditation
"(1)
"(2)
"(A) participated in graduate medical education at a facility of the Department of Veterans Affairs;
"(B) was subsequently transferred on or after January 1, 1997, and before July 31, 1998, to a hospital that was not a Department of Veterans Affairs facility; and
"(C) was transferred because the approved medical residency program in which the resident or intern participated would lose accreditation by the Accreditation Council on Graduate Medical Education if such program continued to train residents at the Department of Veterans Affairs facility.
"(3)
"(A)
"(B)
GAO Study on Geographic Reclassification
"(a)
"(1) the magnitude of the effect of geographic reclassification on rural hospitals that are not reclassified;
"(2) whether the current thresholds used in geographic reclassification reclassify hospitals to the appropriate labor markets;
"(3) the effect of eliminating geographic reclassification through use of the occupational mix data;
"(4) the group reclassification policy;
"(5) changes in the number of reclassifications and the compositions of the groups;
"(6) the effect of State-specific budget neutrality compared to national budget neutrality; and
"(7) whether there are sufficient controls over the intermediary evaluation of the wage data reported by hospitals.
"(b)
Continuing Treatment of Previously Designated Centers
"(1)
"(2)
Hospital Geographic Reclassification Permitted for Purposes of Disproportionate Share Payment Adjustments
"(a)
"(b)
"(c)
Temporary Relief for Certain Non-Teaching, Non-DSH Hospitals
"(1)
"(A) beginning in fiscal year 1998 the amount of payment made to the hospital under section 1886(d) of the Social Security Act [
"(B) beginning in fiscal year 1999 the amount of payment made to the hospital under section 1886(d) of the Social Security Act for discharges occurring during such fiscal year only shall be increased as though the applicable percentage increase (otherwise applicable to discharges occurring during fiscal year 1999 under section 1886(b)(3)(B)(i)(XIV) of the Social Security Act (
Subparagraph (A) shall not apply in computing the increase under subparagraph (B) and neither subparagraph shall affect payment for discharges for any hospital occurring during a fiscal year after fiscal year 1999. Payment increases under this subsection for discharges occurring during a fiscal year are subject to settlement after the close of the fiscal year.
"(2)
"(A) that is described in paragraph (3) for such period;
"(B) that is located in a State in which the amount of the aggregate payments under section 1886(d) of such Act [
"(C) with respect to which the payments under section 1886(d) of such Act (
"(3)
"(A) is not receiving any additional payment amount described in section 1886(d)(5)(F) of such Act (
"(B) is not receiving any additional payment under section 1886(d)(5)(B) of such Act (
"(C) does not qualify for payment under section 1886(d)(5)(G) of such Act (
Formula for Additional Payment Amounts; Report
"(b)
"(1)
"(2)
"(A) establish a single threshold for costs incurred by hospitals in serving low-income patients, and
"(B) consider the costs described in paragraph (3).
"(3) The costs described in this paragraph are as follows:
"(A) The costs incurred by the hospital during a period (as determined by the Secretary) of furnishing hospital services to individuals who are entitled to benefits under part A of title XVIII of the Social Security Act [
"(B) The costs incurred by the hospital during a period (as so determined) of furnishing hospital services to individuals who receive medical assistance under the State plan under title XIX of such Act [
"(c)
Geographic Reclassification for Certain Disproportionately Large Hospitals
"(a)
"(b)
"(1) the average hourly wage paid by the hospital is not less than 108 percent of the average hourly wage paid by all other hospitals located in the Metropolitan Statistical Area (or the New England County Metropolitan Area) in which the hospital is located;
"(2) not less than 40 percent of the adjusted uninflated wages paid by all hospitals located in such Area is attributable to wages paid by the hospital; and
"(3) the hospital submitted an application requesting reclassification for purposes of wage index under section 1886(d)(10)(C) of such Act (
Floor on Area Wage Index
"(a)
"(b)
"(c)
Report on Effect of Amendments by Pub. L. 105–33, §4415, on Psychiatric Hospitals
Treatment of Certain Cancer Hospitals; Payment
"(1)
"(2)
"(3)
"(1)
"(2)
"(A) the hospital's cost reporting period beginning during fiscal year 1990, or
"(B) pursuant to an election under 1886(b)(3)(G) of such Act (
"(3)
Report on Exceptions
Development of Proposal on Payments for Long-Term Care Hospitals
"(a)
"(1)
"(2)
"(A) may require such long-term care hospitals to submit such information to the Secretary as the Secretary may require to develop the proposal; and
"(B) shall consider several payment methodologies, including the feasibility of expanding the current diagnosis-related groups and prospective payment system established under section 1886(d) of the Social Security Act [
"(b)
Dissemination of Information on High Per Discharge Relative Values for In-Hospital Physicians' Services
"(a)
"(1)
"(A) the hospital-specific per discharge relative value under subsection (b); and
"(B) whether the hospital-specific relative value is projected to be excessive (as determined based on such value represented as a percentage of the median of hospital-specific per discharge relative values determined under subsection (b)).
"(2)
"(b)
"(1)
"(2)
"(A) the average per discharge relative value (as determined under section 1848(c)(2) of such Act [
"(B) the equivalent per discharge relative value (as determined under such section) for physicians' services furnished to inpatients of the hospital by interns and residents of the hospital during the second year preceding that calendar year, adjusted for variations in case-mix among hospitals, and in disproportionate share status and teaching status among hospitals (as determined by the Secretary under paragraph (3)).
The Secretary shall determine the equivalent relative value unit per discharge for interns and residents based on the best available data and may make such adjustment in the aggregate.
"(3)
"(c)
"(1)
"(2)
"(A) if (in accordance with requirements for hospitals established by the Joint Commission on Accreditation of Health Organizations)—
"(i) the individual is subject to bylaws, rules, and regulations established by the hospital to provide a framework for the self-governance of medical staff activities,
"(ii) subject to the bylaws, rules, and regulations, the individual has clinical privileges granted by the hospital's governing body, and
"(iii) under the clinical privileges, the individual may provide physicians' services independently within the scope of the individual's clinical privileges, or
"(B) if the physician provides at least one service to an individual entitled to benefits under this title in that hospital.
"(3)
"(4)
"(5)
"(6)
Incentive Payments Under Plans for Voluntary Reduction in Number of Residents; Relation to Demonstration Projects and Authority; Regulations
"(b)
"(1) Section 1886(h)(6) of the Social Security Act [
"(2) Effective May 27, 1997, the Secretary of Health and Human Services is not authorized to approve any demonstration project described in paragraph (3) for any residency training year beginning before July 1, 2006.
"(3) A demonstration project described in this paragraph is a project that primarily provides for additional payments under title XVIII of the Social Security Act [
"(c)
Demonstration Project on Use of Consortia
"(a)
"(b)
"(1) The consortium consists of a teaching hospital with one or more approved medical residency training programs and one or more of the following entities:
"(A) A school of allopathic medicine or osteopathic medicine.
"(B) Another teaching hospital, which may be a children's hospital.
"(C) A Federally qualified health center.
"(D) A medical group practice.
"(E) A managed care entity.
"(F) An entity furnishing outpatient services.
"(G) Such other entity as the Secretary determines to be appropriate.
"(2) The members of the consortium have agreed to participate in the programs of graduate medical education that are operated by the entities in the consortium.
"(3) With respect to the receipt by the consortium of payments made pursuant to this section, the members of the consortium have agreed on a method for allocating the payments among the members.
"(4) The consortium meets such additional requirements as the Secretary may establish.
"(c)
Recommendations on Long-Term Policies Regarding Teaching Hospitals and Graduate Medical Education
"(a)
"(1) Possible methodologies for making payments for graduate medical education and the selection of entities to receive such payments. Matters considered under this paragraph shall include—
"(A) issues regarding children's hospitals and approved medical residency training programs in pediatrics, and
"(B) whether and to what extent payments are being made (or should be made) for training in the nursing and other allied health professions.
"(2) Federal policies regarding international medical graduates.
"(3) The dependence of schools of medicine on service-generated income.
"(4) Whether and to what extent the needs of the United States regarding the supply of physicians, in the aggregate and in different specialties, will change during the 10-year period beginning on October 1, 1997, and whether and to what extent any such changes will have significant financial effects on teaching hospitals.
"(5) Methods for promoting an appropriate number, mix, and geographical distribution of health professionals.
"(b)
"(1) deans from allopathic and osteopathic schools of medicine;
"(2) chief executive officers (or equivalent administrative heads) from academic health centers, integrated health care systems, approved medical residency training programs, and teaching hospitals that sponsor approved medical residency training programs;
"(3) chairs of departments or divisions from allopathic and osteopathic schools of medicine, schools of dentistry, and approved medical residency training programs in oral surgery;
"(4) individuals with leadership experience from representative fields of non-physician health professionals;
"(5) individuals with substantial experience in the study of issues regarding the composition of the health care workforce of the United States; and
"(6) individuals with expertise in health care payment policies.
"(c)
Study of Hospital Overhead and Supervisory Physician Components of Direct Medical Education Costs
"(a)
"(1) variations among hospitals in the hospital overhead and supervisory physician components of their direct medical education costs taken into account under section 1886(h) of the Social Security Act [
"(2) the reasons for such variations.
"(b)
DRG Prospective Payment Rate Methodology; Transition Rule for Fiscal Year 1998
Hospital Payment Updates; Transition Rule for Fiscal Year 1998
Geographical Reclassification; Special Rule for Applications Received in Fiscal Year 1997
No Standardized Amount Adjustments for Fiscal Years 1992 or 1993
Extension of Regional Referral Center Classifications Through Fiscal Year 1994; Reclassification
"(1)
"(2)
"(A) notify such hospital of such failure to qualify,
"(B) provide an opportunity for such hospital to decline such reclassification, and
"(C) if the hospital—
"(i) declines such reclassification, administer the Social Security Act [
"(ii) fails to decline such reclassification, administer the Social Security Act without regard to paragraph (1).
"(3)
"(A)
"(B)
Hospitals Declining Urban Area Reclassifications; Retroactive Payments
"(2)
"(A) notify such hospital of such failure to qualify,
"(B) provide an opportunity for such hospital to decline such reclassification, and
"(C) if the hospital declines such reclassification, administer the Social Security Act [
"(3)
"(A)
"(B)
Adjustment in GME Base-Year Costs of Federal Insurance Contributions Act
"(1)
"(2)
"(3)
"(A) The 'base cost reporting period' for a hospital is the hospital's cost reporting period that began during fiscal year 1984.
"(B) The term 'FICA taxes' means, with respect to a hospital, the taxes under section 3111 of the Internal Revenue Code of 1986 [
Determination of Area Wage Index for Discharges Occurring January 1, 1991 to October 1, 1993
"(A) For purposes of section 1886(d)(3)(E) of the Social Security Act [
"(B) The Secretary shall apply the wage index described in subparagraph (A) without regard to a previous survey of wages and wage-related costs."
Study and Report on Relationship Between Non-Wage-Related Input Prices and Adjusted Average Standardized Amounts
Section 4002(e)(2) of
Deadline for Submission of Applications to Geographic Classification Review Board
Payments for Medical Education Costs
"(a)
"(1)
"(2)
"(3)
"(b)
"(1)
"(2)
"(A) the hospital claimed and was reimbursed for such costs during the most recent cost reporting period that ended on or before October 1, 1989;
"(B) the proportion of the hospital's total allowable costs that is attributable to the clinical training costs of the approved program, and allowable under (b)(1) during the cost reporting period does not exceed the proportion of total allowable costs that were attributable to the clinical training costs during the cost reporting period described in subparagraph (A);
"(C) the hospital receives a benefit for the support it furnishes to such program through the provision of clinical services by nursing or allied health students participating in such program; and
"(D) the costs incurred by the hospital for such program do not exceed the costs that would be incurred by the hospital if it operated the program itself.
"(3)
"(A)
"(B)
"(4)
"(5)
"(a)
"(1)
"(2)
"(3)
"(b)
"(1)
"(2)
"(A) the hospital claimed and was reimbursed for such costs during the most recent cost reporting period that ended on or before October 1, 1989;
"(B) the proportion of the hospital's total allowable costs that is attributable to the clinical training costs of the approved program, and allowable under (b)(1) during the cost reporting period does not exceed the proportion of total allowable costs that were attributable to clinical training costs during the cost reporting period described in subparagraph (A);
"(C) the hospital receives a benefit for the support it furnishes to such program through the provision of clinical services by nursing or allied health students participating in such program; and
"(D) the costs incurred by the hospital for such program do not exceed the costs that would be incurred by the hospital if it operated the program itself.
"(3)
"(A)
"(B)
"(4)
"(5)
Development of National Prospective Payment Rates for Current Non-PPS Hospitals
"(1)
"(A) take into consideration the need to provide for appropriate limits on increases in expenditures under the medicare program;
"(B) provide for adjustments to prospectively determined rates to account for changes in a hospital's case mix, severity of illness of patients, volume of cases, and the development of new technologies and standards of medical practice;
"(C) take into consideration the need to increase the payment otherwise made under such system in the case of services provided to patients whose length of stay or costs of treatment greatly exceed the length of stay or cost of treatment provided for under the applicable prospectively determined payment rate;
"(D) take into consideration the need to adjust payments under the system to take into account factors such as a disproportionate share of low-income patients, costs related to graduate medical education programs, differences in wages and wage-related costs among hospitals located in various geographic areas, and other factors the Secretary considers appropriate; and
"(E) provide for the appropriate allocation of operating and capital-related costs of hospitals not subject to the new prospective payment system and distinct units of such hospitals that would be paid under such system.
"(2)
"(B) By not later than June 1, 1992, the Prospective Payment Assessment Commission shall submit an analysis of and comments on the proposal developed under paragraph (1) to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives."
Guidance to Intermediaries and Hospitals
Freeze in Payments Under Part A of This Subchapter Through December 31, 1990
"(a)
"(1) The market basket percentage increase (described in section 1886(b)(3)(B)(iii) of the Social Security Act) shall be deemed to be 0 for discharges occurring during such period.
"(2) The percentage increase or decrease in the medical care expenditure category of the consumer price index applicable under section 1814(i)(2)(B) of such Act [
"(3) The area wage index applicable to a subsection (d) hospital under section 1886(d)(3)(E) of such Act shall be deemed to be the area wage index applicable to such hospital as of September 30, 1990.
"(4) The percentage change in the consumer price index applicable under section 1886(h)(2)(D) of such Act shall be deemed to be 0.
"(b)
Review of Hospital Regulations With Respect to Rural Hospitals
"(1)
"(2)
Prohibition on Cost Savings Policies Before Beginning of Fiscal Year
"(A) The Secretary may issue such a proposed regulation, instruction, or other policy with respect to the fiscal year before the May 15 preceding the beginning of the fiscal year.
"(B) The Secretary may issue such a final regulation, instruction, or other policy with respect to the fiscal year on or after October 15 of the fiscal year.
"(C) The Secretary may, at any time, issue such a proposed or final regulation, instruction, or other policy with respect to the fiscal year if required to implement specific provisions under statute."
Prohibition of Payment Cycle Changes
Extension of Area Wage Index
Adjustments Resulting From Extensions of Regional Floor on Standardized Amounts
Indexing of Future Applicable Percentage Increases
Continuation of Sole Community Hospital Designation for Current Sole Community Hospitals
Additional Payment Resulting From Corrections of Erroneously Determined Wage Index
"(A)
"(B)
"(i) the error resulted from the submission of erroneous data, except that a hospital is not eligible for such additional payment if it submitted such erroneous data;
"(ii) the error was made with respect to the survey of the 1984 wages and wage-related costs of hospitals in the United States conducted under section 1886(d)(3)(E) of the Social Security Act; and
"(iii) the correction of the error resulted in an adjustment to the area wage index of not less than 3 percentage points.
"(C)
Legislative Proposal Eliminating Separate Average Standardized Amounts
Determination and Recommendations of Payments for Costs of Administering Blood Clotting Factors to Individuals With Hemophilia
"(b)
"(c)
Publication of Instructions Relating to Exceptions and Adjustments in Target Amounts
Delay in Recoupment of Certain Nursing and Allied Education Costs
"(1) The Secretary of Health and Human Services (in this subsection referred to as the 'Secretary') shall not, before October 1, 1990, recoup from, or otherwise reduce or adjust payments under title XVIII of the Social Security Act [
"(2)(A) Before July 1, 1990, the Secretary shall issue regulations respecting payment of costs described in paragraph (1).
"(B) In issuing such regulations—
"(i) the Secretary shall allow a comment period of not less than 60 days,
"(ii) the Secretary shall consult with the Prospective Payment Assessment Commission, and
"(iii) any final rule shall not be effective prior to October 1, 1990, or 30 days after publication of the final rule in the Federal Register, whichever is later.
"(C) Such regulations shall specify—
"(i) the relationship required between an approved nursing or allied health education program and a hospital for the program's costs to be attributed to the hospital;
"(ii) the types of costs related to nursing or allied health education programs that are allowable by medicare;
"(iii) the distinction between costs of approved educational activities as recognized under section 1886(a)(3) of the Social Security Act [
"(iv) the treatment of other funding sources for the program."
Inner-City Hospital Triage Demonstration Project
"(a)
"(1) to train hospital personnel to operate and participate in the system; and
"(2) to provide services to patients who might otherwise be denied appropriate and prompt care.
"(b)
"(2) The amount of payment made under the demonstration project during a single year may not exceed $500,000."
Transition Adjustments to Target Amounts for Inpatient Hospital Services
Election of Personnel Policy for ProPAC Employees
Adjustments in Payments for Inpatient Hospital Services
"(1) PPS
"(2) PPS-
[Amendment of section 104(c) of
ProPAC Study
Clinic Hospital Wage Indices
Limitation on Amounts Paid in Fiscal Years 1988 and 1989
Study of Criteria for Classification of Hospitals as Rural Referral Centers; Report
Grant Program for Rural Health Care Transition
"(1) The Administrator of the Health Care Financing Administration, in consultation with the Assistant Secretary for Health (or a designee), shall establish a program of grants to assist eligible small rural hospitals and their communities in the planning and implementation of projects to modify the type and extent of services such hospitals provide in order to adjust for one or more of the following factors:
"(A) Changes in clinical practice patterns.
"(B) Changes in service populations.
"(C) Declining demand for acute-care inpatient hospital capacity.
"(D) Declining ability to provide appropriate staffing for inpatient hospitals.
"(E) Increasing demand for ambulatory and emergency services.
"(F) Increasing demand for appropriate integration of community health services.
"(G) The need for adequate access (including appropriate transportation) to emergency care and inpatient care in areas in which a significant number of underutilized hospital beds are being eliminated.
"(H) The Administrator shall submit a final report on the program to the Congress not later than 180 days after all projects receiving a grant under the program are completed.
Each demonstration project under this subsection shall demonstrate methods of strengthening the financial and managerial capability of the hospital involved to provide necessary services. Such methods may include programs of cooperation with other health care providers, of diversification in services furnished (including the provision of home health services), of physician recruitment, and of improved management systems. Grants under this paragraph may be used to provide instruction and consultation (and such other services as the Administrator determines appropriate) via telecommunications to physicians in such rural areas (within the meaning of section 1886(d)(2)(D) of the Social Security Act [
"(2) For purposes of this subsection, the term 'eligible small rural hospital' means any rural primary care hospital designated by the Secretary under section 1820(i)(2) of the Social Security Act [
"(A) is located in a rural area (as determined in accordance with subsection (d)),
"(B) has less than 100 beds, and
"(C) is not for profit.
"(3)(A) Any eligible small rural hospital that desires to modify the type or extent of health care services that it provides in order to adjust for one or more of the factors specified in paragraph (1) may submit an application to the Administrator and a copy of such application to the Governor of the State in which it is located. The application shall specify the nature of the project proposed by the hospital, the data and information on which the project is based, and a timetable (of not more than 24 months) for completion of the project. The application shall be submitted on or before a date specified by the Administrator and shall be in such form as the Administrator may require.
"(B) The Governor shall transmit to the Administrator, within a reasonable time after receiving a copy of an application pursuant to subparagraph (A), any comments with respect to the application that the Governor deems appropriate.
"(C) The Governor of a State may designate an appropriate State agency to receive and comment on applications submitted under subparagraph (A).
"(4) A hospital shall be considered to be located in a rural area for purposes of this subsection if it is treated as being located in a rural area for purposes of section 1886(d)(3)(D) of the Social Security Act [
"(5) In determining which hospitals making application under paragraph (3) will receive grants under this subsection, the Administrator shall take into account—
"(A) any comments received under paragraph (3)(B) with respect to a proposed project;
"(B) the effect that the project will have on—
"(i) reducing expenditures from the Federal Hospital Insurance Trust Fund,
"(ii) improving the access of medicare beneficiaries to health care of a reasonable quality;
"(C) the extent to which the proposal of the hospital, using appropriate data, demonstrates an understanding of—
"(i) the primary market or service area of the hospital, and
"(ii) the health care needs of the elderly and disabled that are not currently being met by providers in such market or area, and
"(D) the degree of coordination that may be expected between the proposed project and—
"(i) other local or regional health care providers, and
"(ii) community and government leaders,
as evidenced by the availability of support for the project (in cash or in kind) and other relevant factors.
"(6) A grant to a hospital under this subsection may not exceed $50,000 a year and may not exceed a term of 3 years.
"(7)(A) Except as provided in subparagraphs (B) and (C), a hospital receiving a grant under this subsection may use the grant for any of expenses incurred in planning and implementing the project with respect to which the grant is made.
"(B) A hospital receiving a grant under this subsection for a project may not use the grant to retire debt incurred with respect to any capital expenditure made prior to the date on which the project is initiated.
"(C) Not more than one-third of any grant made under this subsection may be expended for capital-related costs (as defined by the Secretary for purposes of section 1886(a)(4) of the Social Security Act [
"(D) A hospital may use a grant received under this subsection to develop a plan for converting itself to a rural primary care hospital (as described in section 1820 of the Social Security Act [
"(8)(A) A hospital receiving a grant under this section [amending this section and
"(B) The Administrator shall report to the Congress at least once every 12 months on the program of grants established under this subsection. The report shall assess the functioning and status of the program, shall evaluate the progress made toward achieving the purposes of the program, and shall include any recommendations the Secretary may deem appropriate with respect to the program. In preparing the report, the Secretary shall solicit and include the comments and recommendations of private and public entities with an interest in rural health care.
"(C) The Administrator shall submit a final report on the program to the Congress not later than 180 days after all projects receiving a grant under the program are completed.
"(9) For purposes of carrying out the program of grants under this subsection, there are authorized to be appropriated from the Federal Hospital Insurance Trust Fund $15,000,000 for fiscal year 1989, $25,000,000 for each of the fiscal years 1990, 1991, and 1992 and $30,000,000 for each of fiscal years 1993 through 1997."
[For termination, effective May 15, 2000, of provisions of law requiring submittal to Congress of any annual, semiannual, or other regular periodic report listed in House Document No. 103–7 (in which item 6 on page 100 identifies a reporting provision which, as subsequently amended, is contained in section 4005(e)(8)(B) of
[
[
[
Reporting Hospital Information
"(a)
"(b) [Amended subsec. (f) of this section and enacted provisions set out as an Effective Date of 1987 Amendment note above.]
"(c)
"(1) The Secretary of Health and Human Services shall provide for a demonstration project to develop, and determine the costs and benefits of establishing a uniform system for the reporting by medicare participating hospitals of balance sheet and information described in paragraph (2). In conducting the project, the Secretary shall require hospitals in at least 2 States, one of which maintains a uniform hospital reporting system, to report such information based on standard information established by the Secretary.
"(2) The information described in this paragraph is as follows:
"(A) Hospital discharges (classified by class of primary payer).
"(B) Patient days (classified by class of primary payer).
"(C) Licensed beds, staffed beds, and occupancy.
"(D) Inpatient charges and revenues (classified by class of primary payer).
"(E) Outpatient charges and revenues (classified by class of primary payer).
"(F) Inpatient and outpatient hospital expenses (by cost-center classified for operating and capital).
"(G) Reasonable costs.
"(H) Other income.
"(I) Bad debt and charity care.
"(J) Capital acquisitions.
"(K) Capital assets.
The Secretary shall develop a definition of 'outpatient visit' for purposes of reporting hospital information.
"(3) The Secretary shall develop the system under subsection (c) in a manner so as—
"(A) to facilitate the submittal of the information in the report in an electronic form, and
"(B) to be compatible with the needs of the medicare prospective payment system.
"(4) The Secretary shall prepare and submit, to the Prospective Payment Assessment Commission, the Comptroller General, the Committee on Ways and Means of the House of Representatives, and the Committee on Finance of the Senate, by not later than 45 days after the end of each calendar quarter, data collected under the system.
"(5) In paragraph (2):
"(A) The term 'bad debt and charity care' has such meaning as the Secretary establishes.
"(B) The term 'class' means, with respect to payers at least, the programs under this title XVIII of the Social Security Act [
"(6) The Secretary shall set aside at least a total of $3,000,000 for fiscal years 1988, 1989, and 1990 from existing research funds or from operations funds to develop the format, according to paragraph (1) and for data collection and analysis, but total funds shall not exceed $15,000,000.
"(7) The Comptroller General shall analyze the adequacy of the existing system for reporting of hospital information and the costs and benefits of data reporting under the demonstration system and will recommend improvements in hospital data collection and in analysis and display of data in support of policy making.
"(d)
Hospital Outlier Payments and Policy
"(1)
"(A)
"(B)
"(2)
"(A)
"(B)
"(3)
ProPAC Studies and Reports
"(1)
"(2)
"(3)
Special Rule for Urban Areas in New England
Rural Health Medical Education Demonstration Project
"(a)
"(b)
"(c)
"(A) two of such hospitals are located in rural counties of more than 2,700 square miles (one of which is east of the Mississippi River and one of which is west of such river); and
"(B) two of such hospitals are located in rural counties with (as determined by the Secretary) a severe shortage of physicians (one of which is east of the Mississippi River and one of which is west of such river).
"(2) The provisions of paragraph (1) shall not apply with respect to applications submitted as a result of amendments made by section 6216 of the Omnibus Budget Reconciliation Act of 1989 [
"(d)
"(1) with respect to subsection (d)(5)(B) of such section, any resident physician participating in the project under subsection (a) for any part of a year shall be treated as if he or she were working at the appropriate sponsoring hospital with an agreement under subsection (a) on September 1 of such year (and shall not be treated as if working at the small rural hospital); and
"(2) with respect to subsection (h) of such section, the payment amount permitted under such subsection for a sponsoring hospital with an agreement under subsection (a) shall be increased (for the duration of the project only) by an amount equal to the amount of any direct graduate medical education costs (as defined in paragraph (5) of such subsection (h)) incurred by such hospital in supervising the education and training activities under a project under subsection (a).
"(e)
"(f)
Prohibition on Policy by Secretary of Health and Human Services To Reduce Expenditures in Fiscal Years 1989, 1990, and 1991
Temporary Extension of Payment Policies for Inpatient Hospital Services
"(A)
"(B)
"(i)
"(I) during the extension period is the rate specified in subsection (d)(1)(D)(ii) of such section, or
"(II) after such period is the national adjusted prospective payment rate determined under subsection (d)(3) of such section.
"(ii)
"(C)
"(D)
"(E)
[Section 4002(f)(2) of
Freezing Certain Changes in Medicare Payment Regulations and Policies
"(1)
"(A) any final regulation that changes the policy with respect to payment under title XVIII of the Social Security Act [
"(B) any final regulation, instruction, or other policy change which is primarily intended to have the effect of slowing down claims processing, or delaying payment of claims, under such title; or
"(C) any final regulation that changes the policy under such title with respect to payment for a return on equity capital for outpatient hospital services.
The final regulation of the Health Care Financing Administration published on September 1, 1987 (52 Federal Register 32920) and relating to changes to the return on equity capital provisions for outpatient hospital services is void and of no effect.
"(2)
"(3)
Maintaining Current Outlier Policy in Fiscal Year 1987
"(A) the proportions under paragraph (3)(B) for hospitals located in urban and rural areas shall be established at such levels as produce the same total dollar reduction under such paragraph as if this section had not been enacted; and
"(B) the thresholds and standards used for making additional payments under paragraph (5) of such section shall be the same as those in effect as of October 1, 1986."
Extension of Regional Referral Center Classification
Budget-Neutral Implementation
Promulgation of New Rate
Miscellaneous Accounting Provision
"(1) had a cost reporting period beginning on September 28, 29, or 30 of 1985,
"(2) is located in a State in which inpatient hospital services were paid in fiscal year 1985 pursuant to a Statewide demonstration project under section 402 of the Social Security Amendments of 1967 [section 402 of
"(3) elects, by notice to the Secretary of Health and Human Services by not later than April 1, 1988, to have this subsection apply,
during the first 7 months of such cost reporting period the 'target percentage' shall be 75 percent and the 'DRG percentage' shall be 25 percent, and during the remaining 5 months of such period the 'target percentage' and the 'DRG percentage' shall each be 50 percent."
[Section 4008(e) of
Treatment of Capital-Related Regulations
"(1)
"(2)
"(3)
"(4)
Limitation on Authority To Issue Certain Final Regulations and Instructions Relating to Hospitals or Physicians
Study of Methodology for Area Wage Adjustment for Central Cities; Report to Congress
"(1) The Secretary of Health and Human Services, in consultation with the Prospective Payment Assessment Commission, shall collect information and shall develop one or more methodologies to permit the adjustment of the wage indices used for purposes of sections 1886(d)(2)(C)(ii), 1886(d)(2)(H), and 1886(d)(3)(E) of the Social Security Act [
"(2) The Secretary shall report to Congress on the information collected and the methodologies developed under paragraph (1) not later than May 1, 1987. The report shall include a recommendation as to the feasibility and desirability of implementing such methodologies."
Continuation of Medicare Reimbursement Waivers for Certain Hospitals Participating in Regional Hospital Reimbursement Demonstrations
"(a)
"(1) to substantially all non-Federal acute care hospitals (as defined by the Secretary) in the geographic area served by such system on January 1, 1985, and
"(2) to the review of at least 75 percent of—
"(A) all revenues or expenses in such geographic area for inpatient hospital services, and
"(B) revenues or expenses in such geographic area for inpatient hospital services provided under the State's plan approved under title XIX [
"(b)
"(c)
Information on Impact of PPS Payments on Hospitals
"(a)
"(b)
Special Rules for Implementation of Hospital Reimbursement
"(a)
"(b)
Appointment of Additional Members to Prospective Payment Assessment Commission
Studies by Secretary; GAO Study; Report on Uniformity of Approved FTE Resident Amounts; Study on Foreign Medical Graduates; Establishing Physician Identifier System; Paperwork Reduction
"(c)
"(A) the types and numbers of such programs, and number of students supported or trained under each program;
"(B) the fiscal and administrative relationships between the hospitals involved and the schools with which the programs and students are affiliated; and
"(C) the types and amounts of expenses of such programs for which reimbursement is made, and the financial and other contributions which accrue to the hospital as a consequence of having such programs.
The Secretary shall report the results of such study to the Committee on Finance of the Senate and the Committees on Ways and Means and Energy and Commerce of the House of Representatives prior to December 31, 1987.
"(2) The Secretary shall conduct a separate study of the advisability of continuing or terminating the exception under section 1886(h)(5)(F)(ii) of the Social Security Act [
"(d)
"(2) In carrying out such study, the Comptroller General may utilize a sample of hospital patients and any other data sources which he deems appropriate, and shall, to the extent feasible, control for differences in severity of illness levels, area wage levels, levels of physician reasonable charges for like services and procedures, and for other factors which could affect the comparability of patients and of payments between teaching and nonteaching settings and among teaching settings. The information obtained in the study shall be coordinated with the information obtained in conducting the study of teaching physicians' services under section 2307(c) of the Deficit Reduction Act of 1984 [section 2307(c) of
"(3) The Comptroller General shall report the results of the study to the committees described in subsection (c)(1) prior to December 31, 1987.
"(e)
"(f)
"(1) the types of services provided;
"(2) the cost of providing such services, relative to the cost of other physicians providing the services or other approaches to providing the services;
"(3) any deficiencies in the quality of the services provided, and methods of assuring the quality of such services; and
"(4) the impact on costs of and access to services if medicare payment for hospitals' costs of graduate medical education of foreign medical graduates were phased out.
"[(g) Repealed.
"(h)
Special Treatment of States Formerly Under Waiver
"(1) the Secretary of Health and Human Services shall permit the hospital to change the method by which it allocates administrative and general costs to the direct medical education cost centers to the method specified in the medicare cost report;
"(2) the Secretary may make appropriate adjustments in the regional adjusted DRG prospective payment rate (for the region in which the State is located), based on the assumption that all teaching hospitals in the State use the medicare cost report; and
"(3) the Secretary shall adjust the hospital-specific portion of payment under section 1886(d) of such Act [
The Secretary shall implement this subsection based on the best available data."
Moratorium on Laboratory Payment Demonstrations; Cooperation in Study; Report to Congress
"(a)
"(b)
Medicare Hospital and Physician Payment Provisions; Extension Period
"(a)
"(b)
"(c)
"(1)
"(2)
[Amendment of section 5 of
Definition of Hospital Serving Significantly Disproportionate Number of Low-Income Patients or Patients Entitled to Hospital Insurance Benefits for Aged and Disabled; Identification
"(1) develop and publish a definition of 'hospitals that serve a significantly disproportionate number of patients who have low income or are entitled to benefits under part A' of title XVIII of the Social Security Act [
"(2) identify those hospitals which meet such definition, and make such identity available to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate."
Prospective Payment Wage Index; Studies and Reports to Congress
"(a) The Secretary of Health and Human Services, in consultation with the Secretary of Labor, shall conduct a study to develop an appropriate index for purposes of adjusting payment amounts under section 1886(d) of the Social Security Act [
"(b) The Secretary shall adjust the payment amounts for hospitals for discharges occurring on or after May 1, 1986, to reflect the changes the Secretary has promulgated in final regulations (on September 3, 1985) relating to the hospital wage index under section 1886(d)(3)(E) of the Social Security Act [
"(c) The Secretary shall conduct a study and report to the Congress on proposed criteria under which, in the case of a hospital that demonstrates to the Secretary in a current fiscal year that the adjustment being made under paragraph (2)(H) or (3)(E) of section 1886(d) of the Social Security Act [
[
Different Treatment of Capital-Projects-Related Costs Before and After Implementation of System for Including Such Costs Under Prospectively Determined Payment Rate
New England Hospitals; Classification as Urban or Rural
Reports, Experiments, and Demonstration Projects Related to Inclusion in Prospective Payment Amounts of Inpatient Hospital Service Capital-Related Costs
Inapplicability of Coordination of Federal Information Policy to the Collection of Information
1 So in original. Probably should be followed by "percentage point".
2 So in original. The semicolon probably should be a comma.
3 So in original. The comma probably should not appear.
4 See References in Text note below.
5 So in original. Probably should be followed by a period.
6 So in original. Probably should be followed by "and".
7 So in original. Probably should be section "557(b)".
8 So in original. Probably should be "section".
10 So in original. The semicolon probably should not appear.
11 So in original. Probably should be followed by a comma.
12 So in original. No subpar. (I) has been enacted.
13 So in original. The comma probably should be a semicolon.
14 So in original. Probably should be followed by "paragraph (9),". See 2020 Amendment notes below.
15 So in original. Probably should not be capitalized.
16 So in original. Probably should be "(6)(A)".
§1395xx. Payment of provider-based physicians and payment under certain percentage arrangements
(a) Criteria; amount of payments
(1) The Secretary shall by regulation determine criteria for distinguishing those services (including inpatient and outpatient services) rendered in hospitals or skilled nursing facilities—
(A) which constitute professional medical services, which are personally rendered for an individual patient by a physician and which contribute to the diagnosis or treatment of an individual patient, and which may be reimbursed as physicians' services under part B, and
(B) which constitute professional services which are rendered for the general benefit to patients in a hospital or skilled nursing facility and which may be reimbursed only on a reasonable cost basis or on the bases described in
(2)(A) For purposes of cost reimbursement, the Secretary shall recognize as a reasonable cost of a hospital or skilled nursing facility only that portion of the costs attributable to services rendered by a physician in such hospital or facility which are services described in paragraph (1)(B), apportioned on the basis of the amount of time actually spent by such physician rendering such services.
(B) In determining the amount of the payments which may be made with respect to services described in paragraph (1)(B), after apportioning costs as required by subparagraph (A), the Secretary may not recognize as reasonable (in the efficient delivery of health services) such portion of the provider's costs for such services to the extent that such costs exceed the reasonable compensation equivalent for such services. The reasonable compensation equivalent for any service shall be established by the Secretary in regulations.
(C) The Secretary may, upon a showing by a hospital or facility that it is unable to recruit or maintain an adequate number of physicians for the hospital or facility on account of the reimbursement limits established under this subsection, grant exceptions to such reimbursement limits as may be necessary to allow such provider to provide a compensation level sufficient to provide adequate physician services in such hospital or facility.
(b) Prohibition of recognition of payments under certain percentage agreements
(1) Except as provided in paragraph (2), in the case of a provider of services which is paid under this subchapter on a reasonable cost basis, or other basis related to costs that are reasonable, and which has entered into a contract for the purpose of having services furnished for or on behalf of it, the Secretary may not include any cost incurred by the provider under the contract if the amount payable under the contract by the provider for that cost is determined on the basis of a percentage (or other proportion) of the provider's charges, revenues, or claim for reimbursement.
(2) Paragraph (1) shall not apply—
(A) to services furnished by a physician and described in subsection (a)(1)(B) and covered by regulations in effect under subsection (a), and
(B) under regulations established by the Secretary, where the amount involved under the percentage contract is reasonable and the contract—
(i) is a customary commercial business practice, or
(ii) provides incentives for the efficient and economical operation of the provider of services.
(Aug. 14, 1935, ch. 531, title XVIII, §1887, as added and amended
Editorial Notes
Amendments
1983—Subsec. (a)(1)(B).
1982—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 1983 Amendment
Amendment by
Effective Date of 1982 Amendment
"(1) The amendments made by this section [amending this section and
"(2) In the case of a contract with a provider of services entered into prior to the date of the enactment of this Act [Sept. 3, 1982], the amendment made by subsection (a) [amending this section] shall apply to payments under such contract (A) 30 days after the first date (after such date of enactment) the provider of services may unilaterally terminate the contract, or (B) one year after the date of the enactment of this Act, whichever is earlier."
Effective Date of Regulations
§1395yy. Payment to skilled nursing facilities for routine service costs
(a) Per diem limitations
The Secretary, in determining the amount of the payments which may be made under this subchapter with respect to routine service costs of extended care services shall not recognize as reasonable (in the efficient delivery of health services) per diem costs of such services to the extent that such per diem costs exceed the following per diem limits, except as otherwise provided in this section:
(1) With respect to freestanding skilled nursing facilities located in urban areas, the limit shall be equal to 112 percent of the mean per diem routine service costs for freestanding skilled nursing facilities located in urban areas.
(2) With respect to freestanding skilled nursing facilities located in rural areas, the limit shall be equal to 112 percent of the mean per diem routine service costs for freestanding skilled nursing facilities located in rural areas.
(3) With respect to hospital-based skilled nursing facilities located in urban areas, the limit shall be equal to the sum of the limit for freestanding skilled nursing facilities located in urban areas, plus 50 percent of the amount by which 112 percent of the mean per diem routine service costs for hospital-based skilled nursing facilities located in urban areas exceeds the limit for freestanding skilled nursing facilities located in urban areas.
(4) With respect to hospital-based skilled nursing facilities located in rural areas, the limit shall be equal to the sum of the limit for freestanding skilled nursing facilities located in rural areas, plus 50 percent of the amount by which 112 percent of the mean per diem routine service costs for hospital-based skilled nursing facilities located in rural areas exceeds the limit for freestanding skilled nursing facilities located in rural areas.
In applying this subsection the Secretary shall make appropriate adjustments to the labor related portion of the costs based upon an appropriate wage index, and shall, for cost reporting periods beginning on or after October 1, 1992, on or after October 1, 1995, and every 2 years thereafter, provide for an update to the per diem cost limits described in this subsection, except that the limits effective for cost reporting periods beginning on or after October 1, 1997, shall be based on the limits effective for cost reporting periods beginning on or after October 1, 1996.
(b) Excess overhead allocations for hospital-based facilities
With respect to a hospital-based skilled nursing facility, the Secretary may not recognize as reasonable the portion of the cost differences between hospital-based and freestanding skilled nursing facilities attributable to excess overhead allocations.
(c) Adjustments in limitations; publication of data
The Secretary may make adjustments in the limits set forth in subsection (a) with respect to any skilled nursing facility to the extent the Secretary deems appropriate, based upon case mix or circumstances beyond the control of the facility. The Secretary shall publish the data and criteria to be used for purposes of this subsection on an annual basis.
(d) Access to skilled nursing facilities
(1) Subject to subsection (e), any skilled nursing facility may choose to be paid under this subsection on the basis of a prospective payment for all routine service costs (including the costs of services required to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident eligible for benefits under this subchapter) and capital-related costs of extended care services provided in a cost reporting period if such facility had, in the preceding cost reporting period, fewer than 1,500 patient days with respect to which payments were made under this subchapter. Such prospective payment shall be in lieu of payments which would otherwise be made for routine service costs pursuant to
(2)(A) The amount of the payment under this section shall be determined on a per diem basis.
(B) Subject to the limitations of subparagraph (C), for skilled nursing facilities located—
(i) in an urban area, the amount shall be equal to 105 percent of the mean of the per diem reasonable routine service and capital-related costs of extended care services for skilled nursing facilities in urban areas within the same region, determined without regard to the limitations of subsection (a) and adjusted for different area wage levels, and
(ii) in a rural area the amount shall be equal to 105 percent of the mean of the per diem reasonable routine service and capital-related costs of extended care services for skilled nursing facilities in rural areas within the same region, determined without regard to the limitations of subsection (a) and adjusted for different area wage levels.
(C) The per diem amounts determined under subparagraph (B) shall not exceed the limit on routine service costs determined under subsection (a) with respect to the facility, adjusted to take into account average capital-related costs with respect to the type and location of the facility.
(3) For purposes of this subsection, urban and rural areas shall be determined in the same manner as for purposes of subsection (a), and the term "region" shall have the same meaning as under
(4) The Secretary shall establish the prospective payment amounts for cost reporting periods beginning in a fiscal year at least 90 days prior to the beginning of such fiscal year, on the basis of the most recent data available for a 12-month period. A skilled nursing facility must notify the Secretary of its intention to be paid pursuant to this subsection for a cost reporting period no later than 30 days before the beginning of that period.
(5) The Secretary shall provide for a simplified cost report to be filed by facilities being paid pursuant to this subsection, which shall require only the cost information necessary for determining prospective payment amounts pursuant to paragraph (2) and reasonable costs of ancillary services.
(6) In lieu of payment on a cost basis for ancillary services provided by a facility which is being paid pursuant to this subsection, the Secretary may pay for such ancillary services on a reasonable charge basis if the Secretary determines that such payment basis will provide an equitable level of reimbursement and will ease the reporting burden of the facility.
(7) In computing the rates of payment to be made under this subsection, there shall be taken into account the costs described in the last sentence of
(e) Prospective payment
(1) Payment provision
Notwithstanding any other provision of this subchapter, subject to paragraphs (7), (11), and (12), the amount of the payment for all costs (as defined in paragraph (2)(B)) of covered skilled nursing facility services (as defined in paragraph (2)(A)) for each day of such services furnished—
(A) in a cost reporting period during the transition period (as defined in paragraph (2)(E)), is equal to the sum of—
(i) the non-Federal percentage of the facility-specific per diem rate (computed under paragraph (3)), and
(ii) the Federal percentage of the adjusted Federal per diem rate (determined under paragraph (4)) applicable to the facility; and
(B) after the transition period is equal to the adjusted Federal per diem rate applicable to the facility.
(2) Definitions
For purposes of this subsection:
(A) Covered skilled nursing facility services
(i) In general
The term "covered skilled nursing facility services"—
(I) means post-hospital extended care services as defined in
(II) includes all items and services (other than items and services described in clauses (ii), (iii), and (iv)) for which payment may be made under part B and which are furnished to an individual who is a resident of a skilled nursing facility during the period in which the individual is provided covered post-hospital extended care services.
(ii) Services excluded
Services described in this clause are physicians' services, services described by clauses (i) and (ii) of
(iii) Exclusion of certain additional items and services
Items and services described in this clause are the following:
(I) Ambulance services furnished to an individual in conjunction with renal dialysis services described in
(II) Chemotherapy items (identified as of July 1, 1999, by HCPCS codes J9000–J9020; J9040–J9151; J9170–J9185; J9200–J9201; J9206–J9208; J9211; J9230–J9245; and J9265–J9600 (and as subsequently modified by the Secretary)) and any additional chemotherapy items identified by the Secretary.
(III) Chemotherapy administration services (identified as of July 1, 1999, by HCPCS codes 36260–36262; 36489; 36530–36535; 36640; 36823; and 96405–96542 (and as subsequently modified by the Secretary)) and any additional chemotherapy administration services identified by the Secretary.
(IV) Radioisotope services (identified as of July 1, 1999, by HCPCS codes 79030–79440 (and as subsequently modified by the Secretary)) and any additional radioisotope services identified by the Secretary.
(V) Customized prosthetic devices (commonly known as artificial limbs or components of artificial limbs) under the following HCPCS codes (as of July 1, 1999 (and as subsequently modified by the Secretary)), and any additional customized prosthetic devices identified by the Secretary, if delivered to an inpatient for use during the stay in the skilled nursing facility and intended to be used by the individual after discharge from the facility: L5050–L5340; L5500–L5611; L5613–L5986; L5988; L6050–L6370; L6400–L6880; L6920–L7274; and L7362–7366.
(VI) Blood clotting factors indicated for the treatment of patients with hemophilia and other bleeding disorders (identified as of July 1, 2020, by HCPCS codes J7170, J7175, J7177–J7183, J7185–J7190, J7192–J7195, J7198–J7203, J7205, J7207–J7211, and as subsequently modified by the Secretary) and items and services related to the furnishing of such factors under
(iv) Exclusion of certain rural health clinic and federally qualified health center services
Services described in this clause are—
(I) rural health clinic services (as defined in paragraph (1) of
(II) federally qualified health center services (as defined in paragraph (3) of such section);
that would be described in clause (ii) if such services were furnished by an individual not affiliated with a rural health clinic or a federally qualified health center.
(B) All costs
The term "all costs" means routine service costs, ancillary costs, and capital-related costs of covered skilled nursing facility services, but does not include costs associated with approved educational activities.
(C) Non-Federal percentage; Federal percentage
For—
(i) the first cost reporting period (as defined in subparagraph (D)) of a facility, the "non-Federal percentage" is 75 percent and the "Federal percentage" is 25 percent;
(ii) the next cost reporting period of such facility, the "non-Federal percentage" is 50 percent and the "Federal percentage" is 50 percent; and
(iii) the subsequent cost reporting period of such facility, the "non-Federal percentage" is 25 percent and the "Federal percentage" is 75 percent.
(D) First cost reporting period
The term "first cost reporting period" means, with respect to a skilled nursing facility, the first cost reporting period of the facility beginning on or after July 1, 1998.
(E) Transition period
(i) In general
The term "transition period" means, with respect to a skilled nursing facility, the 3 cost reporting periods of the facility beginning with the first cost reporting period.
(ii) Treatment of new skilled nursing facilities
In the case of a skilled nursing facility that first received payment for services under this subchapter on or after October 1, 1995, payment for such services shall be made under this subsection as if all services were furnished after the transition period.
(3) Determination of facility specific per diem rates
The Secretary shall determine a facility-specific per diem rate for each skilled nursing facility not described in paragraph (2)(E)(ii) for a cost reporting period as follows:
(A) Determining base payments
The Secretary shall determine, on a per diem basis, the total of—
(i) the allowable costs of extended care services for the facility for cost reporting periods beginning in fiscal year 1995, including costs associated with facilities described in subsection (d), with appropriate adjustments (as determined by the Secretary) to non-settled cost reports or, in the case of a facility participating in the Nursing Home Case-Mix and Quality Demonstration (RUGS–III), the RUGS–III rate received by the facility during the cost reporting period beginning in 1997, and
(ii) an estimate of the amounts that would be payable under part B (disregarding any applicable deductibles, coinsurance, and copayments) for covered skilled nursing facility services described in paragraph (2)(A)(i)(II) furnished during the applicable cost reporting period described in clause (i) to an individual who is a resident of the facility, regardless of whether or not the payment was made to the facility or to another entity.
In making appropriate adjustments under clause (i), the Secretary shall take into account exceptions and shall take into account exemptions but, with respect to exemptions, only to the extent that routine costs do not exceed 150 percent of the routine cost limits otherwise applicable but for the exemption.
(B) Update to first cost reporting period
The Secretary shall update the amount determined under subparagraph (A), for each cost reporting period after the applicable cost reporting period described in subparagraph (A)(i) and up to the first cost reporting period by a factor equal to the skilled nursing facility market basket percentage increase minus 1.0 percentage point.
(C) Updating to applicable cost reporting period
The Secretary shall update the amount determined under subparagraph (B) for each cost reporting period beginning with the first cost reporting period and up to and including the cost reporting period involved by a factor equal to the facility-specific update factor.
(D) Facility-specific update factor
For purposes of this paragraph, the "facility-specific update factor" for cost reporting periods beginning during—
(i) during each of fiscal years 1998 and 1999, is equal to the skilled nursing facility market basket percentage increase for such fiscal year minus 1 percentage point, and
(ii) during each subsequent fiscal year is equal to the skilled nursing facility market basket percentage increase for such fiscal year.
(4) Federal per diem rate
(A) Determination of historical per diem for facilities
For each skilled nursing facility that received payments for post-hospital extended care services during a cost reporting period beginning in fiscal year 1995 and that was subject to (and not exempted from) the per diem limits referred to in paragraph (1) or (2) of subsection (a) (and facilities described in subsection (d)), the Secretary shall estimate, on a per diem basis for such cost reporting period, the total of—
(i) the allowable costs of extended care services (excluding exceptions payments) for the facility for cost reporting periods beginning in 1995 with appropriate adjustments (as determined by the Secretary) to non-settled cost reports, and
(ii) an estimate of the amounts that would be payable under part B (disregarding any applicable deductibles, coinsurance, and copayments) for covered skilled nursing facility services described in paragraph (2)(A)(i)(II) furnished during such period to an individual who is a resident of the facility, regardless of whether or not the payment was made to the facility or to another entity.
(B) Update to first fiscal year
The Secretary shall update the amount determined under subparagraph (A), for each cost reporting period after the cost reporting period described in subparagraph (A)(i) and up to the first cost reporting period by a factor equal to the skilled nursing facility market basket percentage increase reduced (on an annualized basis) by 1 percentage point.
(C) Computation of standardized per diem rate
The Secretary shall standardize the amount updated under subparagraph (B) for each facility by—
(i) adjusting for variations among facilities by area in the average facility wage level per diem, and
(ii) adjusting for variations in case mix per diem among facilities.
(D) Computation of weighted average per diem rates
(i) All facilities
The Secretary shall compute a weighted average per diem rate for all facilities by computing an average of the standardized amounts computed under subparagraph (C), weighted for each facility by the number of days of extended care services furnished during the cost reporting period referred to in subparagraph (A).
(ii) Freestanding facilities
The Secretary shall compute a weighted average per diem rate for freestanding facilities by computing an average of the standardized amounts computed under subparagraph (C) only for such facilities, weighted for each facility by the number of days of extended care services furnished during the cost reporting period referred to in subparagraph (A).
(iii) Separate computation
The Secretary may compute and apply such averages separately for facilities located in urban and rural areas (as defined in
(E) Updating
(i) Initial period
For the initial period beginning on July 1, 1998, and ending on September 30, 1999, the Secretary shall compute for skilled nursing facilities an unadjusted Federal per diem rate equal to the average of the weighted average per diem rates computed under clauses (i) and (ii) of subparagraph (D), increased by skilled nursing facility market basket percentage change for such period minus 1 percentage point.
(ii) Subsequent fiscal years
The Secretary shall compute an unadjusted Federal per diem rate equal to the Federal per diem rate computed under this subparagraph—
(I) for fiscal year 2000, the rate computed for the initial period described in clause (i), increased by the skilled nursing facility market basket percentage change for the initial period minus 1 percentage point;
(II) for fiscal year 2001, the rate computed for the previous fiscal year increased by the skilled nursing facility market basket percentage change for the fiscal year;
(III) for each of fiscal years 2002 and 2003, the rate computed for the previous fiscal year increased by the skilled nursing facility market basket percentage change for the fiscal year involved minus 0.5 percentage points; and
(IV) for each subsequent fiscal year, the rate computed for the previous fiscal year increased by the skilled nursing facility market basket percentage change for the fiscal year involved.
(F) Adjustment for case mix creep
Insofar as the Secretary determines that the adjustments under subparagraph (G)(i) for a previous fiscal year (or estimates that such adjustments for a future fiscal year) did (or are likely to) result in a change in aggregate payments under this subsection during the fiscal year that are a result of changes in the coding or classification of residents that do not reflect real changes in case mix, the Secretary may adjust unadjusted Federal per diem rates for subsequent fiscal years so as to eliminate the effect of such coding or classification changes.
(G) Determination of Federal rate
The Secretary shall compute for each skilled nursing facility for each fiscal year (beginning with the initial period described in subparagraph (E)(i)) an adjusted Federal per diem rate equal to the unadjusted Federal per diem rate determined under subparagraph (E), as adjusted under subparagraph (F), and as further adjusted as follows:
(i) Adjustment for case mix
The Secretary shall provide for an appropriate adjustment to account for case mix. Such adjustment shall be based on a resident classification system, established by the Secretary, that accounts for the relative resource utilization of different patient types. The case mix adjustment shall be based on resident assessment data and other data that the Secretary considers appropriate.
(ii) Adjustment for geographic variations in labor costs
The Secretary shall adjust the portion of such per diem rate attributable to wages and wage-related costs for the area in which the facility is located compared to the national average of such costs using an appropriate wage index as determined by the Secretary. Such adjustment shall be done in a manner that does not result in aggregate payments under this subsection that are greater or less than those that would otherwise be made if such adjustment had not been made.
(iii) Adjustment for exclusion of certain additional items and services
The Secretary shall provide for an appropriate proportional reduction in payments so that beginning with fiscal year 2001, the aggregate amount of such reductions is equal to the aggregate increase in payments attributable to the exclusion effected under clause (iii) of paragraph (2)(A).
(H) Publication of information on per diem rates
The Secretary shall provide for publication in the Federal Register, before May 1, 1998 (with respect to fiscal period described in subparagraph (E)(i)) and before the August 1 preceding each succeeding fiscal year (with respect to that succeeding fiscal year), of—
(i) the unadjusted Federal per diem rates to be applied to days of covered skilled nursing facility services furnished during the fiscal year,
(ii) the case mix classification system to be applied under subparagraph (G)(i) with respect to such services during the fiscal year, and
(iii) the factors to be applied in making the area wage adjustment under subparagraph (G)(ii) with respect to such services.
(5) Skilled nursing facility market basket index and percentage
For purposes of this subsection:
(A) Skilled nursing facility market basket index
The Secretary shall establish a skilled nursing facility market basket index that reflects changes over time in the prices of an appropriate mix of goods and services included in covered skilled nursing facility services.
(B) Skilled nursing facility market basket percentage
(i) In general
Subject to clauses (ii), (iii), and (iv), the term "skilled nursing facility market basket percentage" means, for a fiscal year or other annual period and as calculated by the Secretary, the percentage change in the skilled nursing facility market basket index (established under subparagraph (A)) from the midpoint of the prior fiscal year (or period) to the midpoint of the fiscal year (or other period) involved.
(ii) Adjustment
For fiscal year 2012 and each subsequent fiscal year, subject to clauses (iii) and (iv), after determining the percentage described in clause (i), the Secretary shall reduce such percentage by the productivity adjustment described in
(iii) Special rule for fiscal year 2018
For fiscal year 2018 (or other similar annual period specified in clause (i)), the skilled nursing facility market basket percentage, after application of clause (ii), is equal to 1 percent.
(iv) Special rule for fiscal year 2019
For fiscal year 2019 (or other similar annual period specified in clause (i)), the skilled nursing facility market basket percentage, after application of clause (ii), is equal to 2.4 percent.
(6) Reporting of assessment and quality data
(A) Reduction in update for failure to report
(i) In general
For fiscal years beginning with fiscal year 2018, in the case of a skilled nursing facility that does not submit data, as applicable, in accordance with subclauses (II) and (III) of subparagraph (B)(i) with respect to such a fiscal year, after determining the percentage described in paragraph (5)(B)(i), and after application of clauses (ii) and (iii) of paragraph (5)(B), the Secretary shall reduce such percentage for payment rates during such fiscal year by 2 percentage points.
(ii) Special rule
The application of this subparagraph may result in the percentage described in paragraph (5)(B)(i), after application of clauses (ii) and (iii) of paragraph (5)(B), being less than 0.0 for a fiscal year, and may result in payment rates under this subsection for a fiscal year being less than such payment rates for the preceding fiscal year.
(iii) Noncumulative application
Any reduction under clause (i) shall apply only with respect to the fiscal year involved and the Secretary shall not take into account such reduction in computing the payment amount under this subsection for a subsequent fiscal year.
(B) Assessment and measure data
(i) In general
A skilled nursing facility, or a facility (other than a critical access hospital) described in paragraph (7)(B), shall submit to the Secretary, in a manner and within the timeframes prescribed by the Secretary—
(I) subject to clause (iii), the resident assessment data necessary to develop and implement the rates under this subsection;
(II) for fiscal years beginning on or after the specified application date (as defined in subsection (a)(2)(E) of
(III) for fiscal years beginning on or after October 1, 2018, standardized patient assessment data required under subsection (b)(1) of
(ii) Use of standard instrument
For purposes of meeting the requirement under clause (i), a skilled nursing facility, or a facility (other than a critical access hospital) described in paragraph (7)(B), may submit the resident assessment data required under
(iii) Non-duplication
To the extent data submitted under subclause (II) or (III) of clause (i) duplicates other data required to be submitted under clause (i)(I), the submission of such data under such a subclause shall be in lieu of the submission of such data under clause (i)(I). The previous sentence shall not apply insofar as the Secretary determines it is necessary to avoid a delay in the implementation of
(7) Treatment of medicare swing bed hospitals
(A) Transition
Subject to subparagraph (C), the Secretary shall determine an appropriate manner in which to apply this subsection to the facilities described in subparagraph (B) (other than critical access hospitals), taking into account the purposes of this subsection, and shall provide that at the end of the transition period (as defined in paragraph (2)(E)) such facilities shall be paid only under this subsection. Payment shall not be made under this subsection to such facilities for cost reporting periods beginning before such date (not earlier than July 1, 1999) as the Secretary specifies.
(B) Facilities described
The facilities described in this subparagraph are facilities that have in effect an agreement described in
(C) Exemption from PPS of swing-bed services furnished in critical access hospitals
The prospective payment system established under this subsection shall not apply to services furnished by a critical access hospital pursuant to an agreement under
(8) Limitation on review
There shall be no administrative or judicial review under
(A) the establishment of Federal per diem rates under paragraph (4), including the computation of the standardized per diem rates under paragraph (4)(C), adjustments and corrections for case mix under paragraphs (4)(F) and (4)(G)(i), adjustments for variations in labor-related costs under paragraph (4)(G)(ii), and adjustments under paragraph (4)(G)(iii);
(B) the establishment of facility specific rates before July 1, 1999 (except any determination of costs paid under part A of this subchapter); and
(C) the establishment of transitional amounts under paragraph (7).
(9) Payment for certain services
In the case of an item or service furnished to a resident of a skilled nursing facility or a part of a facility that includes a skilled nursing facility (as determined under regulations) for which payment would (but for this paragraph) be made under part B in an amount determined in accordance with
(10) Required coding
No payment may be made under part B for items and services (other than services described in paragraph (2)(A)(ii)) furnished to an individual who is a resident of a skilled nursing facility or of a part of a facility that includes a skilled nursing facility (as determined under regulations), unless the claim for such payment includes a code (or codes) under a uniform coding system specified by the Secretary that identifies the items or services furnished.
(11) Permitting facilities to waive 3-year transition
Notwithstanding paragraph (1)(A), a facility may elect to have the amount of the payment for all costs of covered skilled nursing facility services for each day of such services furnished in cost reporting periods beginning no earlier than 30 days before the date of such election determined pursuant to paragraph (1)(B).
(12) Adjustment for residents with AIDS
(A) In general
Subject to subparagraph (B), in the case of a resident of a skilled nursing facility who is afflicted with acquired immune deficiency syndrome (AIDS), the per diem amount of payment otherwise applicable (determined without regard to any increase under section 101 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, or under section 314(a) of Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000), shall be increased by 128 percent to reflect increased costs associated with such residents.
(B) Sunset
Subparagraph (A) shall not apply on and after such date as the Secretary certifies that there is an appropriate adjustment in the case mix under paragraph (4)(G)(i) to compensate for the increased costs associated with residents described in such subparagraph.
(f) Reporting of direct care expenditures
(1) In general
For cost reports submitted under this subchapter for cost reporting periods beginning on or after the date that is 2 years after March 23, 2010, skilled nursing facilities shall separately report expenditures for wages and benefits for direct care staff (breaking out (at a minimum) registered nurses, licensed professional nurses, certified nurse assistants, and other medical and therapy staff).
(2) Modification of form
The Secretary, in consultation with private sector accountants experienced with Medicare and Medicaid nursing facility home cost reports, shall redesign such reports to meet the requirement of paragraph (1) not later than 1 year after March 23, 2010.
(3) Categorization by functional accounts
Not later than 30 months after March 23, 2010, the Secretary, working in consultation with the Medicare Payment Advisory Commission, the Medicaid and CHIP Payment and Access Commission, the Inspector General of the Department of Health and Human Services, and other expert parties the Secretary determines appropriate, shall take the expenditures listed on cost reports, as modified under paragraph (1), submitted by skilled nursing facilities and categorize such expenditures, regardless of any source of payment for such expenditures, for each skilled nursing facility into the following functional accounts on an annual basis:
(A) Spending on direct care services (including nursing, therapy, and medical services).
(B) Spending on indirect care (including housekeeping and dietary services).
(C) Capital assets (including building and land costs).
(D) Administrative services costs.
(4) Availability of information submitted
The Secretary shall establish procedures to make information on expenditures submitted under this subsection readily available to interested parties upon request, subject to such requirements as the Secretary may specify under the procedures established under this paragraph.
(g) Skilled nursing facility readmission measure
(1) Readmission measure
Not later than October 1, 2015, the Secretary shall specify a skilled nursing facility all-cause all-condition hospital readmission measure (or any successor to such a measure).
(2) Resource use measure
Not later than October 1, 2016, the Secretary shall specify a measure to reflect an all-condition risk-adjusted potentially preventable hospital readmission rate for skilled nursing facilities.
(3) Measure adjustments
When specifying the measures under paragraphs (1) and (2), the Secretary shall devise a methodology to achieve a high level of reliability and validity, especially for skilled nursing facilities with a low volume of readmissions.
(4) Pre-rulemaking process (measure application partnership process)
The application of the provisions of
(5) Feedback reports to skilled nursing facilities
Beginning October 1, 2016, and every quarter thereafter, the Secretary shall provide confidential feedback reports to skilled nursing facilities on the performance of such facilities with respect to a measure specified under paragraph (1) or (2).
(6) Public reporting of skilled nursing facilities
(A) In general
Subject to subparagraphs (B) and (C), the Secretary shall establish procedures for making available to the public by posting on the Nursing Home Compare Medicare website (or a successor website) described in
(B) Opportunity to review
The procedures under subparagraph (A) shall ensure that a skilled nursing facility has the opportunity to review and submit corrections to the information that is to be made public with respect to the facility prior to such information being made public.
(C) Timing
Such procedures shall provide that the information described in subparagraph (A) is made publicly available beginning not later than October 1, 2017.
(7) Non-application of Paperwork Reduction Act
(h) Skilled nursing facility value-based purchasing program
(1) Establishment
(A) In general
Subject to the succeeding provisions of this subsection, the Secretary shall establish a skilled nursing facility value-based purchasing program (in this subsection referred to as the "SNF VBP Program") under which value-based incentive payments are made in a fiscal year to skilled nursing facilities.
(B) Program to begin in fiscal year 2019
The SNF VBP Program shall apply to payments for services furnished on or after October 1, 2018.
(C) Exclusions
With respect to payments for services furnished on or after October 1, 2022, this subsection shall not apply to a facility for which there are not a minimum number (as determined by the Secretary) of—
(i) cases for the measures that apply to the facility for the performance period for the applicable fiscal year; or
(ii) measures that apply to the facility for the performance period for the applicable fiscal year.
(2) Application of measures
(A) In general
The Secretary—
(i) shall apply the measure specified under subsection (g)(1) for purposes of the SNF VBP Program; and
(ii) may, with respect to payments for services furnished on or after October 1, 2023, apply additional measures determined appropriate by the Secretary, which may include measures of functional status, patient safety, care coordination, or patient experience.
Subject to the succeeding sentence, in the case that the Secretary applies additional measures under clause (ii), the Secretary shall consider and apply, as appropriate, quality measures specified under
(B) Replacement
For purposes of the SNF VBP Program, the Secretary shall apply the measure specified under (g)(2) 1 instead of the measure specified under (g)(1) 1 as soon as practicable.
(3) Performance standards
(A) Establishment
The Secretary shall establish performance standards with respect to the measures applied under paragraph (2) for a performance period for a fiscal year.
(B) Higher of achievement and improvement
The performance standards established under subparagraph (A) shall include levels of achievement and improvement. In calculating the SNF performance score under paragraph (4), the Secretary shall use the higher of either improvement or achievement.
(C) Timing
The Secretary shall establish and announce the performance standards established under subparagraph (A) not later than 60 days prior to the beginning of the performance period for the fiscal year involved.
(4) SNF performance score
(A) In general
The Secretary shall develop a methodology for assessing the total performance of each skilled nursing facility based on performance standards established under paragraph (3) with respect to the measures applied under paragraph (2). Using such methodology, the Secretary shall provide for an assessment (in this subsection referred to as the "SNF performance score") for each skilled nursing facility for each such performance period.
(B) Ranking of SNF performance scores
The Secretary shall, for the performance period for each fiscal year, rank the SNF performance scores determined under subparagraph (A) from low to high.
(5) Calculation of value-based incentive payments
(A) In general
With respect to a skilled nursing facility, based on the ranking under paragraph (4)(B) for a performance period for a fiscal year, the Secretary shall increase the adjusted Federal per diem rate determined under subsection (e)(4)(G) otherwise applicable to such skilled nursing facility (and after application of paragraph (6)) for services furnished by such facility during such fiscal year by the value-based incentive payment amount under subparagraph (B).
(B) Value-based incentive payment amount
The value-based incentive payment amount for services furnished by a skilled nursing facility in a fiscal year shall be equal to the product of—
(i) the adjusted Federal per diem rate determined under subsection (e)(4)(G) otherwise applicable to such skilled nursing facility for such services furnished by the skilled nursing facility during such fiscal year; and
(ii) the value-based incentive payment percentage specified under subparagraph (C) for the skilled nursing facility for such fiscal year.
(C) Value-based incentive payment percentage
(i) In general
The Secretary shall specify a value-based incentive payment percentage for a skilled nursing facility for a fiscal year which may include a zero percentage.
(ii) Requirements
In specifying the value-based incentive payment percentage for each skilled nursing facility for a fiscal year under clause (i), the Secretary shall ensure that—
(I) such percentage is based on the SNF performance score of the skilled nursing facility provided under paragraph (4) for the performance period for such fiscal year;
(II) the application of all such percentages in such fiscal year results in an appropriate distribution of value-based incentive payments under subparagraph (B) such that—
(aa) skilled nursing facilities with the highest rankings under paragraph (4)(B) receive the highest value-based incentive payment amounts under subparagraph (B);
(bb) skilled nursing facilities with the lowest rankings under paragraph (4)(B) receive the lowest value-based incentive payment amounts under subparagraph (B); and
(cc) in the case of skilled nursing facilities in the lowest 40 percent of the ranking under paragraph (4)(B), the payment rate under subparagraph (A) for services furnished by such facility during such fiscal year shall be less than the payment rate for such services for such fiscal year that would otherwise apply under subsection (e)(4)(G) without application of this subsection; and
(III) the total amount of value-based incentive payments under this paragraph for all skilled nursing facilities in such fiscal year shall be greater than or equal to 50 percent, but not greater than 70 percent, of the total amount of the reductions to payments for such fiscal year under paragraph (6), as estimated by the Secretary.
(6) Funding for value-based incentive payments
(A) In general
The Secretary shall reduce the adjusted Federal per diem rate determined under subsection (e)(4)(G) otherwise applicable to a skilled nursing facility for services furnished by such facility during a fiscal year (beginning with fiscal year 2019) by the applicable percent (as defined in subparagraph (B)). The Secretary shall make such reductions for all skilled nursing facilities in the fiscal year involved, regardless of whether or not the skilled nursing facility has been determined by the Secretary to have earned a value-based incentive payment under paragraph (5) for such fiscal year.
(B) Applicable percent
For purposes of subparagraph (A), the term "applicable percent" means, with respect to fiscal year 2019 and succeeding fiscal years, 2 percent.
(7) Announcement of net result of adjustments
Under the SNF VBP Program, the Secretary shall, not later than 60 days prior to the fiscal year involved, inform each skilled nursing facility of the adjustments to payments to the skilled nursing facility for services furnished by such facility during the fiscal year under paragraphs (5) and (6).
(8) No effect in subsequent fiscal years
The value-based incentive payment under paragraph (5) and the payment reduction under paragraph (6) shall each apply only with respect to the fiscal year involved, and the Secretary shall not take into account such value-based incentive payment or payment reduction in making payments to a skilled nursing facility under this section in a subsequent fiscal year.
(9) Public reporting
(A) SNF specific information
The Secretary shall make available to the public, by posting on the Nursing Home Compare Medicare website (or a successor website) described in
(i) the SNF performance score of the skilled nursing facility for such fiscal year; and
(ii) the ranking of the skilled nursing facility under paragraph (4)(B) for the performance period for such fiscal year.
(B) Aggregate information
The Secretary shall periodically post on the Nursing Home Compare Medicare website (or a successor website) described in
(i) the range of SNF performance scores provided under paragraph (4)(A); and
(ii) the number of skilled nursing facilities receiving value-based incentive payments under paragraph (5) and the range and total amount of such value-based incentive payments.
(10) Limitation on review
There shall be no administrative or judicial review under
(A) The methodology used to determine the value-based incentive payment percentage and the amount of the value-based incentive payment under paragraph (5).
(B) The determination of the amount of funding available for such value-based incentive payments under paragraph (5)(C)(ii)(III) and the payment reduction under paragraph (6).
(C) The establishment of the performance standards under paragraph (3) and the performance period.
(D) The methodology developed under paragraph (4) that is used to calculate SNF performance scores and the calculation of such scores.
(E) The ranking determinations under paragraph (4)(B).
(11) Funding for program management
The Secretary shall provide for the one time transfer from the Federal Hospital Insurance Trust Fund established under
(A) for purposes of subsection (g)(2), $2,000,000; and
(B) for purposes of implementing this subsection, $10,000,000.
Such funds shall remain available until expended.
(12) Validation
(A) In general
The Secretary shall apply to the measures applied under this subsection and the data submitted under subsection (e)(6) a process to validate such measures and data, as appropriate, which may be similar to the process specified in
(B) Funding
For purposes of carrying out this paragraph, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund established under
(Aug. 14, 1935, ch. 531, title XVIII, §1888, as added
Editorial Notes
References in Text
Section 101 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, referred to in subsec. (e)(12)(A), is section 1000(a)(6) [title I, §101] of
Section 314(a) of Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, referred to in subsec. (e)(12)(A), is section 1(a)(6) [title III, §314(a)] of
Amendments
2022—Subsec. (e)(2)(A)(ii).
2020—Subsec. (e)(2)(A)(iii)(VI).
Subsec. (h)(1)(C).
Subsec. (h)(2)(A).
Subsec. (h)(3)(A), (4)(A).
Subsec. (h)(12).
2018—Subsec. (e)(5)(B)(i).
Subsec. (e)(5)(B)(ii).
Subsec. (e)(5)(B)(iv).
2015—Subsec. (e)(5)(B)(i).
Subsec. (e)(5)(B)(ii).
Subsec. (e)(5)(B)(iii).
Subsec. (e)(6)(A)(i), (ii).
2014—Subsec. (e)(6).
Subsec. (g).
Subsec. (h).
2010—Subsec. (e)(5)(B).
Subsec. (f).
2008—Subsec. (e)(2)(A)(ii).
2003—Subsec. (e)(2)(A)(i)(II).
Subsec. (e)(2)(A)(iv).
Subsec. (e)(12).
2000—Subsec. (e)(4)(E)(ii)(II).
Subsec. (e)(4)(E)(ii)(III).
Subsec. (e)(4)(E)(ii)(IV).
Subsec. (e)(7).
Subsec. (e)(7)(A).
Subsec. (e)(7)(B).
Subsec. (e)(7)(C).
1999—Subsec. (e)(1).
Subsec. (e)(2)(A)(i)(II).
Subsec. (e)(2)(A)(iii).
Subsec. (e)(3)(A)(i).
Subsec. (e)(3)(A)(ii).
Subsec. (e)(3)(B).
"(i)
"(ii)
Subsec. (e)(4)(E)(i).
Subsec. (e)(4)(E)(ii).
Subsec. (e)(4)(G)(iii).
Subsec. (e)(8)(A).
Subsec. (e)(8)(B).
Subsec. (e)(9).
Subsec. (e)(11).
Subsec. (e)(12).
1997—Subsec. (a).
Subsec. (d)(1).
Subsec. (e).
Subsec. (e)(2)(A)(ii).
Subsec. (e)(9), (10).
1993—Subsec. (a).
Subsec. (b).
1990—Subsec. (a).
Subsec. (d)(1).
1987—Subsec. (d)(7).
1986—Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (d)(1).
Subsec. (d)(4).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by
Effective Date of 2020 Amendment
Effective Date of 2008 Amendment
Amendment by
Effective Date of 2003 Amendment
Effective Date of 2000 Amendment
Amendment by section 1(a)(6) [title II, §203(a)] of
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §321(g)(1), (k)(18)] of
Effective Date of 1997 Amendment
Amendment by section 4432(a), (b)(3), (5)(H) of
Amendment by section 4511(a)(2)(E) of
Effective Date of 1993 Amendment
Effective Date of 1990 Amendment
Amendment by section 4008(h)(2)(A)(ii) of
Effective Date of 1987 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by section 9219(b)(1)(C) of
"(1) The amendment made by subsection (a) [amending this section] shall apply to cost reporting periods beginning on or after October 1, 1986.
"(2) The amendment made by subsection (b) [amending this section] shall become effective on the date of the enactment of this Act [Apr. 7, 1986]."
Effective Date
Study on Portable Diagnostic Ultrasound Services for Beneficiaries in Skilled Nursing Facilities
Special Rule for Payment for Fiscal Year 2001
"(1) for the period beginning on October 1, 2000, and ending on March 31, 2001, shall be the rate determined in accordance with the law as in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and
"(2) for the period beginning on April 1, 2001, and ending on September 30, 2001, shall be the rate that would have been determined under such section if 'plus 1 percentage point' had been substituted for 'minus 1 percentage point' under subclause (II) of such paragraph (as in effect on the day before the date of the enactment of this Act)."
GAO Report on Adequacy of SNF Payment Rates
HCFA Study of Classification Systems for SNF Residents
"(1)
"(2)
GAO Audit of Nursing Staff Ratios
"(1)
"(2)
Oversight
Establishment of Process for Geographic Reclassification
"(a)
"(b)
Report to Congress
Medical Review Process
Construction of Wage Index for Skilled Nursing Facilities
No Change in Limits on Per Diem Service Costs for Extended Care Services for Fiscal Years 1994 and 1995
No Change in Prospective Payments for Services Furnished During Fiscal Years 1994 and 1995
Prospective Payment System for Skilled Nursing Facility Services
"(1)
"(A) take into consideration the need to provide for appropriate limits on increases in expenditures under the medicare program without jeopardizing access to extended care services for individuals unable to care for themselves;
"(B) provide for adjustments to prospectively determined rates to account for changes in a facility's case mix, volume of cases, and the development of new technologies and standards of medical practice;
"(C) take into consideration the need to increase the payment otherwise made under such system in the case of services provided to patients whose length of stay or costs of treatment greatly exceed the length of stay or cost of treatment provided for under the applicable prospectively determined payment rate;
"(D) take into consideration the need to adjust payments under the system to take into account factors such as a disproportionate share of low-income patients, differences in wages and wage-related costs among facilities located in various geographic areas, and other factors the Secretary considers appropriate; and
"(E) take into consideration the appropriateness of classifying patients and payments upon functional disability, cognitive impairment, and other patient characteristics.
"(2)
"(B) By not later than September 1, 1991, the Secretary shall submit the proposal developed under paragraph (1) to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives.
"(C) By not later than March 1, 1992, the Prospective Payment Assessment Commission shall submit an analysis of and comments on the proposal developed under paragraph (1) to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives."
Use of More Recent Data Regarding Routine Service Costs of Skilled Nursing Facilities
1 So in original. Probably should be preceded by "subsection".
§1395zz. Provider education and technical assistance
(a) Coordination of education funding
The Secretary shall coordinate the educational activities provided through medicare contractors (as defined in subsection (g), including under
(b) Enhanced education and training
(1) Additional resources
There are authorized to be appropriated to the Secretary (in appropriate part from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund) such sums as may be necessary for fiscal years beginning with fiscal year 2005.
(2) Use
The funds made available under paragraph (1) shall be used to increase the conduct by medicare contractors of education and training of providers of services and suppliers regarding billing, coding, and other appropriate items and may also be used to improve the accuracy, consistency, and timeliness of contractor responses.
(c) Tailoring education and training activities for small providers or suppliers
(1) In general
Insofar as a medicare contractor conducts education and training activities, it shall tailor such activities to meet the special needs of small providers of services or suppliers (as defined in paragraph (2)). Such education and training activities for small providers of services and suppliers may include the provision of technical assistance (such as review of billing systems and internal controls to determine program compliance and to suggest more efficient and effective means of achieving such compliance).
(2) Small provider of services or supplier
In this subsection, the term "small provider of services or supplier" means—
(A) a provider of services with fewer than 25 full-time-equivalent employees; or
(B) a supplier with fewer than 10 full-time-equivalent employees.
(d) Internet websites; FAQs
The Secretary, and each medicare contractor insofar as it provides services (including claims processing) for providers of services or suppliers, shall maintain an Internet website which—
(1) provides answers in an easily accessible format to frequently asked questions, and
(2) includes other published materials of the contractor,
that relate to providers of services and suppliers under the programs under this subchapter (and subchapter XI insofar as it relates to such programs).
(e) Encouragement of participation in education program activities
A medicare contractor may not use a record of attendance at (or failure to attend) educational activities or other information gathered during an educational program conducted under this section or otherwise by the Secretary to select or track providers of services or suppliers for the purpose of conducting any type of audit or prepayment review.
(f) Construction
Nothing in this section or
(1) of the screens used for identifying claims that will be subject to medical review; or
(2) of information that would compromise pending law enforcement activities or reveal findings of law enforcement-related audits.
(g) Definitions
For purposes of this section, the term "medicare contractor" includes the following:
(1) A medicare administrative contractor with a contract under
(2) An eligible entity with a contract under
Such term does not include, with respect to activities of a specific provider of services or supplier an entity that has no authority under this subchapter or subchapter IX with respect to such activities and such provider of services or supplier.
(Aug. 14, 1935, ch. 531, title XVIII, §1889, as added and amended
Editorial Notes
Prior Provisions
A prior section 1395zz, act Aug. 14, 1935, ch. 531, title XVIII, §1889, as added Nov. 5, 1990,
Another prior section 1395zz, act Aug. 14, 1935, ch. 531, title XVIII, §1889, formerly §1833(f), as added Jan. 2, 1968,
Amendments
2003—Subsecs. (b), (c).
Subsec. (d).
Subsecs. (e) to (g).
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Effective Date
Small Provider Technical Assistance Demonstration Program
"(a)
"(1)
"(2)
"(A) evaluation and recommendations regarding billing and related systems; and
"(B) information and assistance regarding policies and procedures under the medicare program, including coding and reimbursement.
"(3)
"(A) a provider of services with fewer than 25 full-time-equivalent employees; or
"(B) a supplier with fewer than 10 full-time-equivalent employees.
"(b)
"(c)
"(d) GAO
"(e)
"(f)
§1395aaa. Contract with a consensus-based entity regarding performance measurement
(a) Contract
(1) In general
For purposes of activities conducted under this chapter, the Secretary shall identify and have in effect a contract with a consensus-based entity, such as the National Quality Forum, that meets the requirements described in subsection (c). Such contract shall provide that the entity will perform the duties described in subsection (b).
(2) Timing for first contract
As soon as practicable after July 15, 2008, the Secretary shall enter into the first contract under paragraph (1).
(3) Period of contract
A contract under paragraph (1) shall be for a period of 4 years (except as may be renewed after a subsequent bidding process).
(4) Competitive procedures
Competitive procedures (as defined in
(b) Duties
The duties described in this subsection are the following:
(1) Priority setting process
The entity shall synthesize evidence and convene key stakeholders to make recommendations, with respect to activities conducted under this chapter, on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In making such recommendations, the entity shall—
(A) ensure that priority is given to measures—
(i) that address the health care provided to patients with prevalent, high-cost chronic diseases;
(ii) with the greatest potential for improving the quality, efficiency, and patient-centeredness of health care; and
(iii) that may be implemented rapidly due to existing evidence, standards of care, or other reasons; and
(B) take into account measures that—
(i) may assist consumers and patients in making informed health care decisions;
(ii) address health disparities across groups and areas; and
(iii) address the continuum of care a patient receives, including services furnished by multiple health care providers or practitioners and across multiple settings.
(2) Endorsement of measures
The entity shall provide for the endorsement of standardized health care performance measures. The endorsement process under the preceding sentence shall consider whether a measure—
(A) is evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, and responsive to variations in patient characteristics, such as health status, language capabilities, race or ethnicity, and income level; and
(B) is consistent across types of health care providers, including hospitals and physicians.
(3) Maintenance of measures
The entity shall establish and implement a process to ensure that measures endorsed under paragraph (2) are updated (or retired if obsolete) as new evidence is developed.
(4) Removal of measures
The entity may provide input to the Secretary on quality and efficiency measures described in paragraph (7)(B) that could be considered for removal.
(5) Annual report to Congress and the Secretary; secretarial publication and comment
(A)1 Annual report
By not later than March 1 of each year (beginning with 2009), the entity shall submit to Congress and the Secretary a report containing the following:
(i) A description of—
(I) the implementation of quality measurement initiatives under this chapter and the coordination of such initiatives with quality initiatives implemented by other payers;
(II) the recommendations made under paragraph (1);
(III) the performance by the entity of the duties required under the contract entered into with the Secretary under subsection (a);
(IV) gaps in endorsed quality measures, which shall include measures that are within priority areas identified by the Secretary under the national strategy established under
(V) areas in which evidence is insufficient to support endorsement of quality measures in priority areas identified by the Secretary under the national strategy established under
(VI) the matters described in clauses (i) and (ii) of paragraph (7)(A).
(ii) An itemization of financial information for the fiscal year ending September 30 of the preceding year, including—
(I) annual revenues of the entity (including any government funding, private sector contributions, grants, membership revenues, and investment revenue);
(II) annual expenses of the entity (including grants paid, benefits paid, salaries or other compensation, fundraising expenses, and overhead costs); and
(III) a breakdown of the amount awarded per contracted task order and the specific projects funded in each task order assigned to the entity.
(iii) Any updates or modifications of internal policies and procedures of the entity as they relate to the duties of the entity under this section, including—
(I) specifically identifying any modifications to the disclosure of interests and conflicts of interests for committees, work groups, task forces, and advisory panels of the entity; and
(II) information on external stakeholder participation in the duties of the entity under this section (including complete rosters for all committees, work groups, task forces, and advisory panels funded through government contracts, descriptions of relevant interests and any conflicts of interest for members of all committees, work groups, task forces, and advisory panels, and the total percentage by health care sector of all convened committees, work groups, task forces, and advisory panels.2
(B) Secretarial review and publication of annual report
Not later than 6 months after receiving a report under subparagraph (A) for a year, the Secretary shall—
(i) review such report; and
(ii) publish such report in the Federal Register, together with any comments of the Secretary on such report.
(6) Review and endorsement of episode grouper under the physician feedback program
The entity shall provide for the review and, as appropriate, the endorsement of the episode grouper developed by the Secretary under
(7) Convening multi-stakeholder groups
(A) In general
The entity shall convene multi-stakeholder groups to provide input on—
(i) the selection of quality and efficiency measures described in subparagraph (B), from among—
(I) such measures that have been endorsed by the entity; and
(II) such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and
(ii) national priorities (as identified under
(B) Quality and efficiency measures
(i) In general
Subject to clause (ii), the quality and efficiency measures described in this subparagraph are quality and efficiency measures—
(I) for use pursuant to sections 1395f(i)(5)(D), 1395l(i)(7), 1395l(t)(17), 1395w–4(k)(2)(C), 1395cc(k)(3), 1395rr(h)(2)(A)(iii),3 1395ww(b)(3)(B)(viii), 1395ww(j)(7)(D), 1395ww(m)(5)(D), 1395ww(o)(2), 1395ww(s)(4)(D), and 1395fff(b)(3)(B)(v) of this title;
(II) for use in reporting performance information to the public; and
(III) for use in health care programs other than for use under this chapter.
(ii) Exclusion
Data sets (such as the outcome and assessment information set for home health services and the minimum data set for skilled nursing facility services) that are used for purposes of classification systems used in establishing payment rates under this subchapter shall not be quality and efficiency measures described in this subparagraph.
(C) Requirement for transparency in process
(i) In general
In convening multi-stakeholder groups under subparagraph (A) with respect to the selection of quality and efficiency measures, the entity shall provide for an open and transparent process for the activities conducted pursuant to such convening.
(ii) Selection of organizations participating in multi-stakeholder groups
The process described in clause (i) shall ensure that the selection of representatives comprising such groups provides for public nominations for, and the opportunity for public comment on, such selection.
(D) Multi-stakeholder group defined
In this paragraph, the term "multi-stakeholder group" means, with respect to a quality and efficiency measure, a voluntary collaborative of organizations representing a broad group of stakeholders interested in or affected by the use of such quality and efficiency measure.
(8) Transmission of multi-stakeholder input
Not later than February 1 of each year (beginning with 2012), the entity shall transmit to the Secretary the input of multi-stakeholder groups provided under paragraph (7).
(9) Prioritization of measure endorsement
The Secretary—
(A) during the period beginning on December 27, 2020, and ending on December 31, 2023, shall prioritize the endorsement of measures relating to maternal morbidity and mortality by the entity with a contract under subsection (a) in connection with endorsement of measures described in paragraph (2); and
(B) on and after January 1, 2024, may prioritize the endorsement of such measures by such entity.
(c) Requirements described
The requirements described in this subsection are the following:
(1) Private nonprofit
The entity is a private nonprofit entity governed by a board.
(2) Board membership
The members of the board of the entity include—
(A) representatives of health plans and health care providers and practitioners or representatives of groups representing such health plans and health care providers and practitioners;
(B) health care consumers or representatives of groups representing health care consumers; and
(C) representatives of purchasers and employers or representatives of groups representing purchasers or employers.
(3) Entity membership
The membership of the entity includes persons who have experience with—
(A) urban health care issues;
(B) safety net health care issues;
(C) rural and frontier health care issues; and
(D) health care quality and safety issues.
(4) Open and transparent
With respect to matters related to the contract with the Secretary under subsection (a), the entity conducts its business in an open and transparent manner and provides the opportunity for public comment on its activities.
(5) Voluntary consensus standards setting organization
The entity operates as a voluntary consensus standards setting organization as defined for purposes of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (
(6) Experience
The entity has at least 4 years of experience in establishing national consensus standards.
(7) Membership fees
If the entity requires a membership fee for participation in the functions of the entity, such fees shall be reasonable and adjusted based on the capacity of the potential member to pay the fee. In no case shall membership fees pose a barrier to the participation of individuals or groups with low or nominal resources to participate in the functions of the entity.
(d) Funding
(1) For purposes of carrying out this section, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under
(2) For purposes of carrying out this section and
(e) Annual report by Secretary to Congress
(1) In general
By not later than March 1 of each year (beginning with 2019), the Secretary shall submit to Congress a report containing the following:
(A) A comprehensive plan that identifies the quality measurement needs of programs and initiatives of the Secretary and provides a strategy for using the entity with a contract under subsection (a) and any other entity the Secretary has contracted with or may contract with to perform work associated with
(B) The amount of funding provided under subsection (d) for purposes of carrying out this section and
(C) With respect to the activities described under this section or
(D) Subject to paragraph (2)(B), a description of the activities for which the funds described in paragraph (2) were used, including task orders and activities assigned to the entity with a contract under subsection (a), activities performed by the Secretary, and task orders and activities assigned to any other entity the Secretary has contracted with to perform work related to carrying out
(E) Subject to paragraph (2)(B), the amount of funding described in paragraph (2) that has been obligated or expended for each of the activities described in paragraph (4).
(F) Subject to paragraph (2)(B), estimates for, and descriptions of, obligations and expenditures that the Secretary anticipates will be needed in the succeeding two year period to carry out each of the quality measurement activities required under this section and
(2) Additional requirements for reports
(A) Addressing GAO report
Each of the annual reports submitted in 2021 and 2022 pursuant to paragraph (1) shall also include the following:
(i) A comprehensive analysis detailing the ways in which the Centers for Medicare & Medicaid Services has addressed each of the recommendations set forth in the report by the Government Accountability Office (GAO–19–628) issued on September 19, 2019, and titled "Health Care Quality: CMS Could More Effectively Ensure Its Quality Measurement Activities Promote Its Objectives".
(ii) A detailed description of—
(I) any additional steps that the Centers for Medicare & Medicaid Services expects to take to address the findings and recommendations set forth in such report; and
(II) the anticipated timing for such steps.
(B) Ensuring detailed information
(i) In general
In the case of an annual report submitted in 2021 or a subsequent year pursuant to paragraph (1), the information required under—
(I) paragraph (1)(D) shall also include detailed information on each of the activities described in clause (ii);
(II) paragraph (1)(E) shall also include detailed information on the specific amounts obligated or expended on each of the activities described in clause (ii); and
(III) paragraph (1)(F) shall also include detailed information on the specific quality measurement activities required and future funding needed for each of the activities described in clause (ii).
(ii) Activities described
The activities described in this clause are the following:
(I) Measure selection activities.
(II) Measure development activities.
(III) Public reporting activities.
(IV) Education and outreach activities.
(f) Additional reporting by the Secretary to Congress
(1) In general
By not later than September 30 of each year (beginning with 2021), the Secretary shall submit to Congress a report on the amount of unobligated balances for appropriations relating to quality measurement. Such report shall include detailed plans on how the Secretary expects to expend such unobligated balances in the upcoming fiscal years.
(2) Separate report
The annual report required under paragraph (1) shall be separate from the annual report required under subsection (e).
(Aug. 14, 1935, ch. 531, title XVIII, §1890, as added
Editorial Notes
References in Text
Clause (iii) of
Section 12(d) of the National Technology Transfer and Advancement Act of 1995, referred to in subsec. (c)(5), is section 12(d) of
Codification
In subsec. (a)(4), "
Prior Provisions
A prior section 1395aaa, act Aug. 14, 1935, ch. 531, title XVIII, §1890, as added Aug. 18, 1987,
Amendments
2024—Subsec. (d)(2).
2020—Subsec. (b)(4).
Subsec. (b)(9).
Subsec. (d)(2).
Subsec. (e).
Subsec. (e)(1)(A).
Subsec. (e)(1)(D).
Subsec. (e)(1)(E).
Subsec. (e)(1)(F).
Subsec. (f).
2019—Subsec. (d)(2).
2018—Subsec. (b)(5)(A).
Subsec. (d)(2).
Subsec. (e).
2015—Subsec. (d)(2).
2014—Subsec. (d).
2013—Subsec. (b)(4).
Subsec. (d).
2010—Subsec. (b)(5)(A)(iv) to (vi).
Subsec. (b)(6).
Subsec. (b)(7).
Subsec. (b)(7)(B).
Subsec. (b)(7)(B)(i)(I).
Subsec. (b)(8).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Effective Date of 2019 Amendment
Effective Date of 2018 Amendment
1 See 2018 Amendment note below.
2 So in original. Probably should be "panels)."
3 See References in Text note below.
§1395aaa–1. Quality and efficiency measurement
(a) Multi-stakeholder group input into selection of quality and efficiency measures
The Secretary shall establish a pre-rulemaking process under which the following steps occur with respect to the selection of quality and efficiency measures described in
(1) Input
Pursuant to
(2) Public availability of measures considered for selection
Not later than December 1 of each year (beginning with 2011), the Secretary shall make available to the public a list of quality and efficiency measures described in
(3) Transmission of multi-stakeholder input
Pursuant to
(4) Consideration of multi-stakeholder input
The Secretary shall take into consideration the input from multi-stakeholder groups described in paragraph (1) in selecting quality and efficiency measures described in
(5) Rationale for use of quality and efficiency measures
The Secretary shall publish in the Federal Register the rationale for the use of any quality and efficiency measure described in
(6) Assessment of impact
Not later than March 1, 2012, and at least once every three years thereafter, the Secretary shall—
(A) conduct an assessment of the quality and efficiency impact of the use of endorsed measures described in
(B) make such assessment available to the public.
(b) Process for dissemination of measures used by the Secretary
(1) In general
The Secretary shall establish a process for disseminating quality and efficiency measures used by the Secretary. Such process shall include the following:
(A) The incorporation of such measures, where applicable, in workforce programs, training curricula, and any other means of dissemination determined appropriate by the Secretary.
(B) The dissemination of such quality and efficiency measures through the national strategy developed under
(2) Existing methods
To the extent practicable, the Secretary shall utilize and expand existing dissemination methods in disseminating quality and efficiency measures under the process established under paragraph (1).
(c) Review of quality and efficiency measures used by the Secretary
(1) In general
The Secretary shall—
(A) periodically (but in no case less often than once every 3 years) review quality and efficiency measures described in
(B) with respect to each such measure, determine whether to—
(i) maintain the use of such measure; or
(ii) phase out such measure.
(2) Considerations
In conducting the review under paragraph (1), the Secretary shall take steps to—
(A) seek to avoid duplication of measures used; and
(B) take into consideration current innovative methodologies and strategies for quality and efficiency improvement practices in the delivery of health care services that represent best practices for such quality and efficiency improvement and measures endorsed by the entity with a contract under
(d) Rule of construction
Nothing in this section shall preclude a State from using the quality and efficiency measures identified under
(e) Development of quality and efficiency measures
The Administrator of the Center for Medicare & Medicaid Services shall through contracts develop quality and efficiency measures (as determined appropriate by the Administrator) for use under this chapter. In developing such measures, the Administrator shall consult with the Director of the Agency for Healthcare Research and Quality.
(f) Hospital acquired conditions
The Secretary shall, to the extent practicable, publicly report on measures for hospital-acquired conditions that are currently utilized by the Centers for Medicare & Medicaid Services for the adjustment of the amount of payment to hospitals based on rates of hospital-acquired infections.
(g) Technical expert panel review of opioid and opioid use disorder quality measures
(1) In general
Not later than 180 days after October 24, 2018, the Secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders, including care, prevention, diagnosis, health outcomes, and treatment furnished to individuals with opioid use disorders. The Secretary may use the entity with a contract under
(2) Review and assessment
Not later than 1 year after the date the technical expert panel described in paragraph (1) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall—
(A) review quality measures that relate to opioids and opioid use disorders, including existing measures and those under development;
(B) identify gaps in areas of quality measurement that relate to opioids and opioid use disorders, and identify measure development priorities for such measure gaps; and
(C) make recommendations to the Secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System under
(3) Consideration of measures by Secretary
The Secretary shall consider—
(A) using opioid and opioid use disorder measures (including measures used under the Merit-Based Incentive Payment System under
(B) using opioid measures described in subparagraph (A), as applicable, in the quality reporting requirements for inpatient hospitals under
(4) Prioritization of measure development
The Secretary shall prioritize for measure development the gaps in quality measures identified under paragraph (2)(B).
(5) Prioritization of measure endorsement
The Secretary—
(A) during the period beginning on October 24, 2018, and ending on December 31, 2023, shall prioritize the endorsement of measures relating to opioids and opioid use disorders by the entity with a contract under subsection (a) of
(B) on and after January 1, 2024, may prioritize the endorsement of such measures by such entity.
(Aug. 14, 1935, ch. 531, title XVIII, §1890A, as added and amended
Editorial Notes
Amendments
2018—Subsec. (g).
2010—
Subsec. (e).
Subsec. (f).
§1395bbb. Conditions of participation for home health agencies; home health quality
(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual's plan of care; compliance with Federal, State, and local laws and regulations
The conditions of participation that a home health agency is required to meet under this subsection are as follows:
(1) The agency protects and promotes the rights of each individual under its care, including each of the following rights:
(A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual's well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment.
(B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances.
(C) The right to confidentiality of the clinical records described in
(D) The right to have one's property treated with respect.
(E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of—
(i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter,
(ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware,
(iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furnished by (or under arrangements with) the agency, and
(iv) any changes in the charges or items and services described in clause (i), (ii), or (iii).
(F) The right to be fully informed in writing (in advance of coming under the care of the agency) of the individual's rights and obligations under this subchapter.
(G) The right to be informed of the availability of the State home health agency hot-line established under
(2) The agency notifies the State entity responsible for the licensing or certification of the agency of a change in—
(A) the persons with an ownership or control interest (as defined in
(B) the persons who are officers, directors, agents, or managing employees (as defined in
(C) the corporation, association, or other company responsible for the management of the agency.
Such notice shall be given at the time of the change and shall include the identity of each new person or company described in the previous sentence.
(3)(A) The agency must not use as a home health aide (on a full-time, temporary, per diem, or other basis), any individual to provide items or services described in
(i) has completed a training and competency evaluation program, or a competency evaluation program, that meets the minimum standards established by the Secretary under subparagraph (D), and
(ii) is competent to provide such items and services.
For purposes of clause (i), an individual is not considered to have completed a training and competency evaluation program, or a competency evaluation program if, since the individual's most recent completion of such a program, there has been a continuous period of 24 consecutive months during none of which the individual provided items and services described in
(B)(i) The agency must provide, with respect to individuals used as a home health aide by the agency as of July 1, 1989, for a competency evaluation program (as described in subparagraph (A)(i)) and such preparation as may be necessary for the individual to complete such a program by January 1, 1990.
(ii) The agency must provide such regular performance review and regular in-service education as assures that individuals used to provide items and services described in
(C) The agency must not permit an individual, other than in a training and competency evaluation program that meets the minimum standards established by the Secretary under subparagraph (D), to provide items or services of a type for which the individual has not demonstrated competency.
(D)(i) The Secretary shall establish minimum standards for the programs described in subparagraph (A) by not later than October 1, 1988.
(ii) Such standards shall include the content of the curriculum, minimum hours of training, qualification of instructors, and procedures for determination of competency.
(iii) Such standards may permit approval of programs offered by or in home health agencies, as well as outside agencies (including employee organizations), and of programs in effect on December 22, 1987; except that they may not provide for the approval of a program offered by or in a home health agency which, within the previous 2 years—
(I) has been determined to be out of compliance with subparagraph (A), (B), or (C);
(II) has been subject to an extended (or partial extended) survey under subsection (c)(2)(D);
(III) has been assessed a civil money penalty described in subsection (f)(2)(A)(i) of not less than $5,000; or
(IV) has been subject to the remedies described in subsection (e)(1) or in clauses (ii) or (iii) of subsection (f)(2)(A).
(iv) Such standards shall permit a determination that an individual who has completed (before July 1, 1989) a training and competency evaluation program or a competency evaluation program shall be deemed for purposes of subparagraph (A) to have completed a program that is approved by the Secretary under the standards established under this subparagraph if the Secretary determines that, at the time the program was offered, the program met such standards.
(E) In this paragraph, the term "home health aide" means any individual who provides the items and services described in
(i) who is a licensed health professional (as defined in subparagraph (F)), or
(ii) who volunteers to provide such services without monetary compensation.
(F) In this paragraph, the term "licensed health professional" means a physician, physician assistant, nurse practitioner, physical, speech, or occupational therapist, physical or occupational therapy assistant, registered professional nurse, licensed practical nurse, or licensed or certified social worker.
(4) The agency includes an individual's plan of care required under
(5) The agency operates and provides services in compliance with all applicable Federal, State, and local laws and regulations (including the requirements of
(6) The agency complies with the requirement of
(b) Duty of Secretary
It is the duty and responsibility of the Secretary to assure that the conditions of participation and requirements specified in or pursuant to
(c) Surveys of home health agencies
(1) Any agreement entered into or renewed by the Secretary pursuant to
(2)(A) Except as provided in subparagraph (B), each home health agency shall be subject to a standard survey not later than 36 months after the date of the previous standard survey conducted under this paragraph. The Secretary shall establish a frequency for surveys of home health agencies within this 36-month interval commensurate with the need to assure the delivery of quality home health services.
(B) If not otherwise conducted under subparagraph (A), a standard survey (or an abbreviated standard survey) of an agency—
(i) may be conducted within 2 months of any change of ownership, administration, or management of the agency to determine whether the change has resulted in any decline in the quality of care furnished by the agency, and
(ii) shall be conducted within 2 months of when a significant number of complaints have been reported with respect to the agency to the Secretary, the State, the entity responsible for the licensing of the agency, the State or local agency responsible for maintaining a toll-free hotline and investigative unit (under
(C) A standard survey conducted under this paragraph with respect to a home health agency—
(i) shall include (to the extent practicable), for a case-mix stratified sample of individuals furnished items or services by the agency—
(I) visits to the homes of such individuals, but only with the consent of such individuals, for the purpose of evaluating (in accordance with a standardized reproducible assessment instrument (or instruments) approved by the Secretary under subsection (d)) the extent to which the quality and scope of items and services furnished by the agency attained and maintained the highest practicable functional capacity of each such individual as reflected in such individual's written plan of care required under
(II) a survey of the quality of care and services furnished by the agency as measured by indicators of medical, nursing, and rehabilitative care;
(ii) shall be based upon a protocol that is developed, tested, and validated by the Secretary not later than January 1, 1989; and
(iii) shall be conducted by an individual—
(I) who meets minimum qualifications established by the Secretary not later than July 1, 1989,
(II) who is not serving (or has not served within the previous 2 years) as a member of the staff of, or as a consultant to, the home health agency surveyed respecting compliance with the conditions of participation specified in or pursuant to
(III) who has no personal or familial financial interest in the home health agency surveyed.
(D) Each home health agency that is found, under a standard survey, to have provided substandard care shall be subject to an extended survey to review and identify the policies and procedures which produced such substandard care and to determine whether the agency has complied with the conditions of participation specified in or pursuant to
(E) Nothing in this paragraph shall be construed as requiring an extended (or partial extended) survey as a prerequisite to imposing a sanction against an agency under subsection (e) on the basis of the findings of a standard survey.
(d) Assessment process; reports to Congress
(1) Not later than January 1, 1989, the Secretary shall designate an assessment instrument (or instruments) for use by an agency in complying with subsection (c)(2)(C)(i)(I).
(2)(A) Not later than January 1, 1992, the Secretary shall—
(i) evaluate the assessment process,
(ii) report to Congress on the results of such evaluation, and
(iii) based on such evaluation, make such modifications in the assessment process as the Secretary determines are appropriate.
(B) The Secretary shall periodically update the evaluation conducted under subparagraph (A), report the results of such update to Congress, and, based on such update, make such modifications in the assessment process as the Secretary determines are appropriate.
(3) The Secretary shall provide for the comprehensive training of State and Federal surveyors in matters relating to the performance of standard and extended surveys under this section, including the use of any assessment instrument (or instruments) designated under paragraph (1).
(e) Enforcement
(1) If the Secretary determines on the basis of a standard, extended, or partial extended survey or otherwise, that a home health agency that is certified for participation under this subchapter is no longer in compliance with the requirements specified in or pursuant to
(2) If the Secretary determines on the basis of a standard, extended, or partial extended survey or otherwise, that a home health agency that is certified for participation under this subchapter is no longer in compliance with the requirements specified in or pursuant to
(3) If the Secretary determines that a home health agency that is certified for participation under this subchapter is in compliance with the requirements specified in or pursuant to
(4) The Secretary may continue payments under this subchapter with respect to a home health agency not in compliance with the requirements specified in or pursuant to
(A) the State or local survey agency finds that it is more appropriate to take alternative action to assure compliance of the agency with the requirements than to terminate the certification of the agency,
(B) the agency has submitted a plan and timetable for corrective action to the Secretary for approval and the Secretary approves the plan of corrective action, and
(C) the agency agrees to repay to the Federal Government payments received under this subparagraph if the corrective action is not taken in accordance with the approved plan and timetable.
The Secretary shall establish guidelines for approval of corrective actions requested by home health agencies under this subparagraph.
(f) Intermediate sanctions
(1) The Secretary shall develop and implement, by not later than April 1, 1989—
(A) a range of intermediate sanctions to apply to home health agencies under the conditions described in subsection (e), and
(B) appropriate procedures for appealing determinations relating to the imposition of such sanctions.
(2)(A) The intermediate sanctions developed under paragraph (1) shall include—
(i) civil money penalties in an amount not to exceed $10,000 for each day of noncompliance,
(ii) suspension of all or part of the payments to which a home health agency would otherwise be entitled under this subchapter with respect to items and services furnished by a home health agency on or after the date on which the Secretary determines that intermediate sanctions should be imposed pursuant to subsection (e)(2), and
(iii) the appointment of temporary management to oversee the operation of the home health agency and to protect and assure the health and safety of the individuals under the care of the agency while improvements are made in order to bring the agency into compliance with all the requirements specified in or pursuant to
The provisions of
(B) The sanctions specified in subparagraph (A) are in addition to sanctions otherwise available under State or Federal law and shall not be construed as limiting other remedies, including any remedy available to an individual at common law.
(C) A finding to suspend payment under subparagraph (A)(ii) shall terminate when the Secretary finds that the home health agency is in substantial compliance with all the requirements specified in or pursuant to
(3) The Secretary shall develop and implement, by not later than April 1, 1989, specific procedures with respect to the conditions under which each of the intermediate sanctions developed under paragraph (1) is to be applied, including the amount of any fines and the severity of each of these sanctions. Such procedures shall be designed so as to minimize the time between identification of deficiencies and imposition of these sanctions and shall provide for the imposition of incrementally more severe fines for repeated or uncorrected deficiencies.
(g) Payment on basis of location of service
A home health agency shall submit claims for payment for home health services under this subchapter only on the basis of the geographic location at which the service is furnished, as determined by the Secretary.
(Aug. 14, 1935, ch. 531, title XVIII, §1891, as added and amended
Editorial Notes
Amendments
2003—Subsec. (d)(1).
1997—Subsec. (g).
1996—Subsec. (c)(2)(A).
1990—Subsec. (a)(3)(D)(iii).
Subsec. (a)(6).
1988—Subsec. (a)(3)(A).
Subsec. (a)(3)(F).
Subsec. (a)(4) to (6).
Subsec. (c)(1).
Subsec. (d)(2)(A).
Subsecs. (e), (f).
Subsec. (f)(2)(A).
Subsec. (f)(2)(A)(i).
1987—Subsecs. (c), (d).
Subsecs. (e), (f).
Statutory Notes and Related Subsidiaries
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1990 Amendment
Amendment by section 4206(d)(2) of
"(i) had its participation terminated under title XVIII of the Social Security Act [
"(ii) was assessed a civil money penalty not less than $5,000 for deficiencies in applicable quality standards for home health agencies;
"(iii) was subject to suspension by the Secretary of all or part of the payments to which it would otherwise be entitled under such title;
"(iv) operated under a temporary management appointed to oversee the operation of the agency and to ensure the health and safety of the agency's patients; or
"(v) pursuant to State action, was closed or had its patients transferred."
Effective Date of 1988 Amendment
Amendment by
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Effective Date
Section applicable to home health agencies as of the first day of the 18th calendar month that begins after Dec. 22, 1987, except as otherwise provided, see section 4021(c) of
Treatment of Branch Offices; GAO Study on Supervision of Home Health Care Provided in Isolated Rural Areas
"(a)
"(1)
"(2)
"(b)
"(1)
"(2)
§1395ccc. Offset of payments to individuals to collect past-due obligations arising from breach of scholarship and loan contract
(a) In general
(1)(A) Subject to subparagraph (B), the Secretary shall enter into an agreement under this section with any individual who, by reason of a breach of a contract entered into by such individual pursuant to the National Health Service Corps Scholarship Program, the Physician Shortage Area Scholarship Program, or the Health Education Assistance Loan Program, owes a past-due obligation to the United States (as defined in subsection (b)).
(B) The Secretary shall not enter into an agreement with an individual under this section to the extent—
(i)(I) the individual has entered into a contract with the Secretary pursuant to section 204(a)(1) of the Public Health Service Amendments of 1987, and
(II) the individual has fulfilled or (as determined by the Secretary) is fulfilling the terms of such contract; or
(ii) the liability of the individual under such section 204(a)(1) has otherwise been relieved under such section; or
(iii) the individual is performing such physician's 1 service obligation under a forbearance agreement entered into with the Secretary under subpart II of part D of title III of the Public Health Service Act [
(2) The agreement under this section shall provide that—
(A) deductions shall be made from the amounts otherwise payable to the individual under this subchapter, in accordance with a formula and schedule agreed to by the Secretary and the individual, until such past-due obligation (and accrued interest) have been repaid;
(B) payment under this subchapter for services provided by such individual shall be made only on an assignment-related basis;
(C) if the individual does not provide services, for which payment would otherwise be made under this subchapter, of a sufficient quantity to maintain the offset collection according to the agreed upon formula and schedule—
(i) the Secretary shall immediately inform the Attorney General, and the Attorney General shall immediately commence an action to recover the full amount of the past-due obligation, and
(ii) subject to paragraph (4), the Secretary shall immediately exclude the individual from the program under this subchapter, until such time as the entire past-due obligation has been repaid.
(3) If the individual refuses to enter into an agreement or breaches any provision of the agreement—
(A) the Secretary shall immediately inform the Attorney General, and the Attorney General shall immediately commence an action to recover the full amount of the past-due obligation, and
(B) subject to paragraph (4), the Secretary shall immediately exclude the individual from the program under this subchapter, until such time as the entire past-due obligation has been repaid.
(4) The Secretary shall not exclude an individual pursuant to paragraph (2)(C)(ii) or paragraph (3)(B) if such individual is a sole community practitioner or sole source of essential specialized services in a community if a State requests that the individual not be excluded.
(b) Past-due obligation
For purposes of this section, a past-due obligation is any amount—
(1) owed by an individual to the United States by reason of a breach of a scholarship contract under section 338E of the Public Health Service Act [
(2) owed by an individual to the United States by reason of a loan covered by Federal loan insurance under subpart I 2 of part C of title VII of the Public Health Service Act and payment for which has not been cancelled, waived, or suspended by the Secretary under such subpart.
(c) Collection under this section shall not be exclusive
This section shall not preclude the United States from applying other provisions of law otherwise applicable to the collection of obligations owed to the United States, including (but not limited to) the use of tax refund offsets pursuant to
(d) Collection from providers and health maintenance organizations
(1) In the case of an individual who owes a past-due obligation, and who is an employee of, or affiliated by a medical services agreement with, a provider having an agreement under
(2) Deductions shall be in accordance with a formula and schedule agreed to by the Secretary, the individual and the provider, organization, or plan. The deductions shall be made from the amounts otherwise payable to the individual under this subchapter as long as the individual continues to be employed or affiliated by a medical services agreement.
(3) Such deduction shall not be made until 6 months after the Secretary notifies the provider, organization, or plan of the amount to be deducted and the particular physicians 3 to whom the deductions are attributable.
(4) A deduction made under this subsection shall relieve the individual of the obligation (to the extent of the amount collected) to the United States, but the provider, organization, or plan shall have a right of action to collect from such individual the amount deducted pursuant to this subsection (including accumulated interest).
(5) No deduction shall be made under this subsection if, within the 6-month period after notice is given to the provider, organization, or plan, the individual pays the past-due obligation, or ceases to be employed by the provider, organization, or plan.
(6) The Secretary shall also apply the provisions of this subsection in the case of an individual who is a member of a group practice, if such group practice submits bills under this program as a group, rather than by individual physicians.3
(e) Transfer from trust funds
Amounts equal to the amounts deducted pursuant to this section shall be transferred from the Trust Fund from which the payment to the individual, provider, or other entity would otherwise have been made, to the general fund in the Treasury, and shall be credited as payment of the past-due obligation of the individual from whom (or with respect to whom) the deduction was made.
(Aug. 14, 1935, ch. 531, title XVIII, §1892, as added
Editorial Notes
References in Text
Section 204(a)(1) of the Public Health Service Amendments of 1987, referred to in subsec. (a)(1)(B), is section 204(a)(1) of
The Public Health Service Act, referred to in subsecs. (a)(1)(B)(iii) and (b), is act July 1, 1944, ch. 373,
Amendments
1988—
Subsec. (a)(1)(A).
Subsec. (a)(1)(B).
Subsec. (a)(2)(A) to (C).
Subsec. (a)(2)(C)(ii).
Subsec. (a)(3).
Subsec. (a)(3)(B).
Subsec. (a)(4).
Subsec. (b).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (d)(1).
Subsec. (d)(2).
Subsec. (d)(4) to (6).
Subsec. (e).
Statutory Notes and Related Subsidiaries
Effective Date of 1988 Amendment
Amendment by
Except as specifically provided in section 411 of
Effective Date
1 So in original. Probably should be "individual's".
2 See References in Text note below.
3 So in original. Probably should be "individuals".
§1395ddd. Medicare Integrity Program
(a) Establishment of Program
There is hereby established the Medicare Integrity Program (in this section referred to as the "Program") under which the Secretary shall promote the integrity of the medicare program by entering into contracts in accordance with this section with eligible entities, or otherwise, to carry out the activities described in subsection (b).
(b) Activities described
The activities described in this subsection are as follows:
(1) Review of activities of providers of services or other individuals and entities furnishing items and services for which payment may be made under this subchapter (including skilled nursing facilities and home health agencies), including medical and utilization review and fraud review (employing similar standards, processes, and technologies used by private health plans, including equipment and software technologies which surpass the capability of the equipment and technologies used in the review of claims under this subchapter as of August 21, 1996).
(2) Audit of cost reports.
(3) Determinations as to whether payment should not be, or should not have been, made under this subchapter by reason of
(4) Education of providers of services, beneficiaries, and other persons with respect to payment integrity and benefit quality assurance issues.
(5) Developing (and periodically updating) a list of items of durable medical equipment in accordance with
(6) The Medicare-Medicaid Data Match Program in accordance with subsection (g).
(c) Eligibility of entities
An entity is eligible to enter into a contract under the Program to carry out any of the activities described in subsection (b) if—
(1) the entity has demonstrated capability to carry out such activities;
(2) in carrying out such activities, the entity agrees to cooperate with the Inspector General of the Department of Health and Human Services, the Attorney General, and other law enforcement agencies, as appropriate, in the investigation and deterrence of fraud and abuse in relation to this subchapter and in other cases arising out of such activities;
(3) the entity complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement;
(4) the entity agrees to provide the Secretary and the Inspector General of the Department of Health and Human Services with such performance statistics (including the number and amount of overpayments recovered, the number of fraud referrals, and the return on investment of such activities by the entity) as the Secretary or the Inspector General may request; and
(5) the entity meets such other requirements as the Secretary may impose.
In the case of the activity described in subsection (b)(5), an entity shall be deemed to be eligible to enter into a contract under the Program to carry out the activity if the entity is a carrier with a contract in effect under
(d) Process for entering into contracts
The Secretary shall enter into contracts under the Program in accordance with such procedures as the Secretary shall by regulation establish, except that such procedures shall include the following:
(1) Procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement.
(2) Competitive procedures to be used—
(A) when entering into new contracts under this section;
(B) when entering into contracts that may result in the elimination of responsibilities of an individual fiscal intermediary or carrier under section 202(b) of the Health Insurance Portability and Accountability Act of 1996; and
(C) at any other time considered appropriate by the Secretary,
except that the Secretary may continue to contract with entities that are carrying out the activities described in this section pursuant to agreements under
(3) Procedures under which a contract under this section may be renewed without regard to any provision of law requiring competition if the contractor has met or exceeded the performance requirements established in the current contract.
The Secretary may enter into such contracts without regard to final rules having been promulgated.
(e) Limitation on contractor liability
The Secretary shall by regulation provide for the limitation of a contractor's liability for actions taken to carry out a contract under the Program, and such regulation shall, to the extent the Secretary finds appropriate, employ the same or comparable standards and other substantive and procedural provisions as are contained in
(f) Recovery of overpayments
(1) Use of repayment plans
(A) In general
If the repayment, within 30 days by a provider of services or supplier, of an overpayment under this subchapter would constitute a hardship (as described in subparagraph (B)), subject to subparagraph (C), upon request of the provider of services or supplier the Secretary shall enter into a plan with the provider of services or supplier for the repayment (through offset or otherwise) of such overpayment over a period of at least 6 months but not longer than 3 years (or not longer than 5 years in the case of extreme hardship, as determined by the Secretary). Interest shall accrue on the balance through the period of repayment. Such plan shall meet terms and conditions determined to be appropriate by the Secretary.
(B) Hardship
(i) In general
For purposes of subparagraph (A), the repayment of an overpayment (or overpayments) within 30 days is deemed to constitute a hardship if—
(I) in the case of a provider of services that files cost reports, the aggregate amount of the overpayments exceeds 10 percent of the amount paid under this subchapter to the provider of services for the cost reporting period covered by the most recently submitted cost report; or
(II) in the case of another provider of services or supplier, the aggregate amount of the overpayments exceeds 10 percent of the amount paid under this subchapter to the provider of services or supplier for the previous calendar year.
(ii) Rule of application
The Secretary shall establish rules for the application of this subparagraph in the case of a provider of services or supplier that was not paid under this subchapter during the previous year or was paid under this subchapter only during a portion of that year.
(iii) Treatment of previous overpayments
If a provider of services or supplier has entered into a repayment plan under subparagraph (A) with respect to a specific overpayment amount, such payment amount under the repayment plan shall not be taken into account under clause (i) with respect to subsequent overpayment amounts.
(C) Exceptions
Subparagraph (A) shall not apply if—
(i) the Secretary has reason to suspect that the provider of services or supplier may file for bankruptcy or otherwise cease to do business or discontinue participation in the program under this subchapter; or
(ii) there is an indication of fraud or abuse committed against the program.
(D) Immediate collection if violation of repayment plan
If a provider of services or supplier fails to make a payment in accordance with a repayment plan under this paragraph, the Secretary may immediately seek to offset or otherwise recover the total balance outstanding (including applicable interest) under the repayment plan.
(E) Relation to no fault provision
Nothing in this paragraph shall be construed as affecting the application of
(2) Limitation on recoupment
(A) In general
In the case of a provider of services or supplier that is determined to have received an overpayment under this subchapter and that seeks a reconsideration by a qualified independent contractor on such determination under
(B) Collection with interest
Insofar as the determination on such appeal is against the provider of services or supplier, interest on the overpayment shall accrue on and after the date of the original notice of overpayment. Insofar as such determination against the provider of services or supplier is later reversed, the Secretary shall provide for repayment of the amount recouped plus interest at the same rate as would apply under the previous sentence for the period in which the amount was recouped.
(C) Medicare contractor defined
For purposes of this subsection, the term "medicare contractor" has the meaning given such term in
(3) Limitation on use of extrapolation
A medicare contractor may not use extrapolation to determine overpayment amounts to be recovered by recoupment, offset, or otherwise unless the Secretary determines that—
(A) there is a sustained or high level of payment error; or
(B) documented educational intervention has failed to correct the payment error.
There shall be no administrative or judicial review under
(4) Provision of supporting documentation
In the case of a provider of services or supplier with respect to which amounts were previously overpaid, a medicare contractor may request the periodic production of records or supporting documentation for a limited sample of submitted claims to ensure that the previous practice is not continuing.
(5) Consent settlement reforms
(A) In general
The Secretary may use a consent settlement (as defined in subparagraph (D)) to settle a projected overpayment.
(B) Opportunity to submit additional information before consent settlement offer
Before offering a provider of services or supplier a consent settlement, the Secretary shall—
(i) communicate to the provider of services or supplier—
(I) that, based on a review of the medical records requested by the Secretary, a preliminary evaluation of those records indicates that there would be an overpayment;
(II) the nature of the problems identified in such evaluation; and
(III) the steps that the provider of services or supplier should take to address the problems; and
(ii) provide for a 45-day period during which the provider of services or supplier may furnish additional information concerning the medical records for the claims that had been reviewed.
(C) Consent settlement offer
The Secretary shall review any additional information furnished by the provider of services or supplier under subparagraph (B)(ii). Taking into consideration such information, the Secretary shall determine if there still appears to be an overpayment. If so, the Secretary—
(i) shall provide notice of such determination to the provider of services or supplier, including an explanation of the reason for such determination; and
(ii) in order to resolve the overpayment, may offer the provider of services or supplier—
(I) the opportunity for a statistically valid random sample; or
(II) a consent settlement.
The opportunity provided under clause (ii)(I) does not waive any appeal rights with respect to the alleged overpayment involved.
(D) Consent settlement defined
For purposes of this paragraph, the term "consent settlement" means an agreement between the Secretary and a provider of services or supplier whereby both parties agree to settle a projected overpayment based on less than a statistically valid sample of claims and the provider of services or supplier agrees not to appeal the claims involved.
(6) Notice of over-utilization of codes
The Secretary shall establish, in consultation with organizations representing the classes of providers of services and suppliers, a process under which the Secretary provides for notice to classes of providers of services and suppliers served by the contractor in cases in which the contractor has identified that particular billing codes may be overutilized by that class of providers of services or suppliers under the programs under this subchapter (or provisions of subchapter XI insofar as they relate to such programs).
(7) Payment audits
(A) Written notice for post-payment audits
Subject to subparagraph (C), if a medicare contractor decides to conduct a post-payment audit of a provider of services or supplier under this subchapter, the contractor shall provide the provider of services or supplier with written notice (which may be in electronic form) of the intent to conduct such an audit.
(B) Explanation of findings for all audits
Subject to subparagraph (C), if a medicare contractor audits a provider of services or supplier under this subchapter, the contractor shall—
(i) give the provider of services or supplier a full review and explanation of the findings of the audit in a manner that is understandable to the provider of services or supplier and permits the development of an appropriate corrective action plan;
(ii) inform the provider of services or supplier of the appeal rights under this subchapter as well as consent settlement options (which are at the discretion of the Secretary);
(iii) give the provider of services or supplier an opportunity to provide additional information to the contractor; and
(iv) take into account information provided, on a timely basis, by the provider of services or supplier under clause (iii).
(C) Exception
Subparagraphs (A) and (B) shall not apply if the provision of notice or findings would compromise pending law enforcement activities, whether civil or criminal, or reveal findings of law enforcement-related audits.
(8) Standard methodology for probe sampling
The Secretary shall establish a standard methodology for medicare contractors to use in selecting a sample of claims for review in the case of an abnormal billing pattern.
(g) Medicare-Medicaid Data Match Program
(1) Expansion of Program
(A) In general
The Secretary shall enter into contracts with eligible entities or otherwise for the purpose of ensuring that, beginning with 2006, the Medicare-Medicaid Data Match Program (commonly referred to as the "Medi-Medi Program") is conducted with respect to the program established under this subchapter and State Medicaid programs under subchapter XIX for the purpose of—
(i) identifying program vulnerabilities in the program established under this subchapter and the Medicaid program established under subchapter XIX through the use of computer algorithms to review claims data to look for payment anomalies (including billing or billing patterns identified with respect to provider, service, time, or patient that appear to be suspect or otherwise implausible);
(ii) working with States, the Attorney General, and the Inspector General of the Department of Health and Human Services to coordinate appropriate actions to investigate and recover amounts with respect to suspect claims to protect the Federal and State share of expenditures under the Medicaid program under subchapter XIX, as well as the program established under this subchapter;
(iii) increasing the effectiveness and efficiency of both such programs through cost avoidance, savings, and recoupments of fraudulent, wasteful, or abusive expenditures; and
(iv) furthering the Secretary's design, development, installation, or enhancement of an automated data system architecture—
(I) to collect, integrate, and assess data for purposes of program integrity, program oversight, and administration, including the Medi-Medi Program; and
(II) that improves the coordination of requests for data from States.
(B) Reporting requirements
The Secretary shall make available in a timely manner any data and statistical information collected by the Medi-Medi Program to the Attorney General, the Director of the Federal Bureau of Investigation, the Inspector General of the Department of Health and Human Services, and the States (including a Medicaid fraud and abuse control unit described in
(2) Limited waiver authority
The Secretary shall waive only such requirements of this section and of subchapters XI and XIX as are necessary to carry out paragraph (1).
(3) Incentives for States
The Secretary shall study and, as appropriate, may specify incentives for States to work with the Secretary for the purposes described in paragraph (1)(A)(ii). The application of the previous sentence may include use of the waiver authority described in paragraph (2).
(h) Use of recovery audit contractors
(1) In general
Under the Program, the Secretary shall enter into contracts with recovery audit contractors in accordance with this subsection for the purpose of identifying underpayments and overpayments and recouping overpayments under this subchapter with respect to all services for which payment is made under this subchapter. Under the contracts—
(A) payment shall be made to such a contractor only from amounts recovered;
(B) from such amounts recovered, payment—
(i) shall be made on a contingent basis for collecting overpayments; and
(ii) may be made in such amounts as the Secretary may specify for identifying underpayments; and
(C) the Secretary shall retain a portion of the amounts recovered which shall be available to the program management account of the Centers for Medicare & Medicaid Services for purposes of activities conducted under the recovery audit program under this subsection.
(2) Disposition of remaining recoveries
The amounts recovered under such contracts that are not paid to the contractor under paragraph (1) or retained by the Secretary under paragraph (1)(C) or paragraph (10) shall be applied to reduce expenditures under this subchapter.
(3) Nationwide coverage
The Secretary shall enter into contracts under paragraph (1) in a manner so as to provide for activities in all States under such a contract by not later than January 1, 2010 (not later than December 31, 2010, in the case of contracts relating to payments made under part C or D).
(4) Audit and recovery periods
Each such contract shall provide that audit and recovery activities may be conducted during a fiscal year with respect to payments made under this subchapter—
(A) during such fiscal year; and
(B) retrospectively (for a period of not more than 4 fiscal years prior to such fiscal year).
(5) Waiver
The Secretary shall waive such provisions of this subchapter as may be necessary to provide for payment of recovery audit contractors under this subsection in accordance with paragraph (1).
(6) Qualifications of contractors
(A) In general
The Secretary may not enter into a contract under paragraph (1) with a recovery audit contractor unless the contractor has staff that has the appropriate clinical knowledge of, and experience with, the payment rules and regulations under this subchapter or the contractor has, or will contract with, another entity that has such knowledgeable and experienced staff.
(B) Ineligibility of certain contractors
The Secretary may not enter into a contract under paragraph (1) with a recovery audit contractor to the extent the contractor is a fiscal intermediary under
(C) Preference for entities with demonstrated proficiency
In awarding contracts to recovery audit contractors under paragraph (1), the Secretary shall give preference to those risk entities that the Secretary determines have demonstrated more than 3 years direct management experience and a proficiency for cost control or recovery audits with private insurers, health care providers, health plans, under the Medicaid program under subchapter XIX, or under this subchapter.
(7) Construction relating to conduct of investigation of fraud
A recovery of an overpayment to a individual or entity by a recovery audit contractor under this subsection shall not be construed to prohibit the Secretary or the Attorney General from investigating and prosecuting, if appropriate, allegations of fraud or abuse arising from such overpayment.
(8) Annual report
The Secretary shall annually submit to Congress a report on the use of recovery audit contractors under this subsection. Each such report shall include information on the performance of such contractors in identifying underpayments and overpayments and recouping overpayments, including an evaluation of the comparative performance of such contractors and savings to the program under this subchapter.
(9) Special rules relating to parts C and D
The Secretary shall enter into contracts under paragraph (1) to require recovery audit contractors to—
(A) ensure that each MA plan under part C has an anti-fraud plan in effect and to review the effectiveness of each such anti-fraud plan;
(B) ensure that each prescription drug plan under part D has an anti-fraud plan in effect and to review the effectiveness of each such anti-fraud plan;
(C) examine claims for reinsurance payments under
(D) review estimates submitted by prescription drug plans by private plans with respect to the enrollment of high cost beneficiaries (as defined by the Secretary) and to compare such estimates with the numbers of such beneficiaries actually enrolled by such plans.
(10) Use of certain recovered funds
(A) In general
After application of paragraph (1)(C), the Secretary shall retain a portion of the amounts recovered by recovery audit contractors for each year under this section which shall be available to the program management account of the Centers for Medicare & Medicaid Services for purposes of, subject to subparagraph (B), carrying out sections 1395l(z),1 1395m(l)(16), and 1395kk–1(a)(4)(G) of this title, carrying out section 514(b) of the Medicare Access and CHIP Reauthorization Act of 2015, and implementing strategies (such as claims processing edits) to help reduce the error rate of payments under this subchapter. The amounts retained under the preceding sentence shall not exceed an amount equal to 15 percent of the amounts recovered under this subsection, and shall remain available until expended.
(B) Limitation
Except for uses that support claims processing (including edits) or system functionality for detecting fraud, amounts retained under subparagraph (A) may not be used for technological-related infrastructure, capital investments, or information systems.
(C) No reduction in payments to recovery audit contractors
Nothing in subparagraph (A) shall reduce amounts available for payments to recovery audit contractors under this subsection.
(i) Evaluations and annual report
(1) Evaluations
The Secretary shall conduct evaluations of eligible entities which the Secretary contracts with under the Program not less frequently than every 3 years.
(2) Annual report
Not later than 180 days after the end of each fiscal year (beginning with fiscal year 2011), the Secretary shall submit a report to Congress which identifies—
(A) the use of funds, including funds transferred from the Federal Hospital Insurance Trust Fund under
(B) the effectiveness of the use of such funds.
(j) Expanding activities of Medicare drug integrity contractors (MEDICs)
(1) Access to information
Under contracts entered into under this section with Medicare drug integrity contractors (including any successor entity to a Medicare drug integrity contractor), the Secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies, prescription drug plans, MA–PD plans, and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in
(2) Requirement for acknowledgment of referrals
If a PDP sponsor or MA organization refers information to a contractor described in paragraph (1) in order for such contractor to assist in the determination described in such paragraph, the contractor shall—
(A) acknowledge to the sponsor or organization receipt of the referral; and
(B) in the case that any PDP sponsor or MA organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described in such paragraph, shall 2 inform such sponsor or organization of such determination on a date that is not later than 15 days after the date on which the sponsor or organization contacts the contractor.
(3) Making data available to other entities
(A) In general
For purposes of carrying out this subsection, subject to subparagraph (B), the Secretary shall authorize MEDICs to respond to requests for information from PDP sponsors and MA organizations, State prescription drug monitoring programs, and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud, waste, and abuse.
(B) HIPAA compliant information only
Information may only be disclosed by a MEDIC under subparagraph (A) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (
(Aug. 14, 1935, ch. 531, title XVIII, §1893, as added
Editorial Notes
References in Text
Section 202(b) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (d)(2)(B), is section 202(b) of
Section 514(b) of the Medicare Access and CHIP Reauthorization Act of 2015, referred to in subsec. (h)(10)(A), is section 514(b) of
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (j)(3)(B), is section 264(c) of
Amendments
2016—Subsec. (j).
2015—Subsec. (g)(1)(A).
Subsec. (g)(1)(A)(i).
Subsec. (g)(1)(A)(ii).
Subsec. (g)(1)(A)(iv).
Subsec. (g)(3).
Subsec. (h)(2).
Subsec. (h)(10).
2010—Subsec. (a).
Subsec. (c)(4), (5).
Subsec. (h)(1).
Subsec. (h)(2).
Subsec. (h)(3).
Subsec. (h)(4).
Subsec. (h)(9).
Subsec. (i).
2006—Subsec. (b)(6).
Subsec. (g).
Subsec. (h).
2003—Subsec. (a).
Subsec. (f).
Statutory Notes and Related Subsidiaries
Effective Date of 2016 Amendment
Amendment by
Effective Date of 2003 Amendment
"(1)
"(2)
"(3)
"(4)
"(5)
"(6)
"(7)
"(8)
Improving the Sharing of Data Between the Federal Government and State Medicaid Programs
"(a)
"(b)
"(c)
"(1)
"(2)
Extension of Two-Midnight Rule
"(a)
"(b)
"(c)
Access to Coordination of Benefits Contractor Database
1 See References in Text note below.
2 So in original. The word "shall" probably should not appear.
§1395eee. Payments to, and coverage of benefits under, programs of all-inclusive care for elderly (PACE)
(a) Receipt of benefits through enrollment in PACE program; definitions for PACE program related terms
(1) Benefits through enrollment in a PACE program
In accordance with this section, in the case of an individual who is entitled to benefits under part A or enrolled under part B and who is a PACE program eligible individual (as defined in paragraph (5)) with respect to a PACE program offered by a PACE provider under a PACE program agreement—
(A) the individual may enroll in the program under this section; and
(B) so long as the individual is so enrolled and in accordance with regulations—
(i) the individual shall receive benefits under this subchapter solely through such program; and
(ii) the PACE provider is entitled to payment under and in accordance with this section and such agreement for provision of such benefits.
(2) "PACE program" defined
For purposes of this section, the term "PACE program" means a program of all-inclusive care for the elderly that meets the following requirements:
(A) Operation
The entity operating the program is a PACE provider (as defined in paragraph (3)).
(B) Comprehensive benefits
The program provides comprehensive health care services to PACE program eligible individuals in accordance with the PACE program agreement and regulations under this section.
(C) Transition
In the case of an individual who is enrolled under the program under this section and whose enrollment ceases for any reason (including that the individual no longer qualifies as a PACE program eligible individual, the termination of a PACE program agreement, or otherwise), the program provides assistance to the individual in obtaining necessary transitional care through appropriate referrals and making the individual's medical records available to new providers.
(3) "PACE provider" defined
(A) In general
For purposes of this section, the term "PACE provider" means an entity that—
(i) subject to subparagraph (B), is (or is a distinct part of) a public entity or a private, nonprofit entity organized for charitable purposes under section 501(c)(3) of the Internal Revenue Code of 1986; and
(ii) has entered into a PACE program agreement with respect to its operation of a PACE program.
(B) Treatment of private, for-profit providers
Clause (i) of subparagraph (A) shall not apply—
(i) to entities subject to a demonstration project waiver under subsection (h); and
(ii) after the date the report under section 4804(b) of the Balanced Budget Act of 1997 is submitted, unless the Secretary determines that any of the findings described in subparagraph (A), (B), (C), or (D) of paragraph (2) of such section are true.
(4) "PACE program agreement" defined
For purposes of this section, the term "PACE program agreement" means, with respect to a PACE provider, an agreement, consistent with this section,
(5) "PACE program eligible individual" defined
For purposes of this section, the term "PACE program eligible individual" means, with respect to a PACE program, an individual who—
(A) is 55 years of age or older;
(B) subject to subsection (c)(4), is determined under subsection (c) to require the level of care required under the State medicaid plan for coverage of nursing facility services;
(C) resides in the service area of the PACE program; and
(D) meets such other eligibility conditions as may be imposed under the PACE program agreement for the program under subsection (e)(2)(A)(ii).
(6) "PACE protocol" defined
For purposes of this section, the term "PACE protocol" means the Protocol for the Program of All-inclusive Care for the Elderly (PACE), as published by On Lok, Inc., as of April 14, 1995, or any successor protocol that may be agreed upon between the Secretary and On Lok, Inc.
(7) "PACE demonstration waiver program" defined
For purposes of this section, the term "PACE demonstration waiver program" means a demonstration program under either of the following sections (as in effect before the date of their repeal):
(A) Section 603(c) of the Social Security Amendments of 1983 (
(B) Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986 (
(8) "State administering agency" defined
For purposes of this section, the term "State administering agency" means, with respect to the operation of a PACE program in a State, the agency of that State (which may be the single agency responsible for administration of the State plan under subchapter XIX in the State) responsible for administering PACE program agreements under this section and
(9) "Trial period" defined
(A) In general
For purposes of this section, the term "trial period" means, with respect to a PACE program operated by a PACE provider under a PACE program agreement, the first 3 contract years under such agreement with respect to such program.
(B) Treatment of entities previously operating PACE demonstration waiver programs
Each contract year (including a year occurring before the effective date of this section) during which an entity has operated a PACE demonstration waiver program shall be counted under subparagraph (A) as a contract year during which the entity operated a PACE program as a PACE provider under a PACE program agreement.
(10) "Regulations" defined
For purposes of this section, the term "regulations" refers to interim final or final regulations promulgated under subsection (f) to carry out this section and
(b) Scope of benefits; beneficiary safeguards
(1) In general
Under a PACE program agreement, a PACE provider shall—
(A) provide to PACE program eligible individuals enrolled with the provider, regardless of source of payment and directly or under contracts with other entities, at a minimum—
(i) all items and services covered under this subchapter (for individuals enrolled under this section) and all items and services covered under subchapter XIX, but without any limitation or condition as to amount, duration, or scope and without application of deductibles, copayments, coinsurance, or other cost-sharing that would otherwise apply under this subchapter or such subchapter, respectively; and
(ii) all additional items and services specified in regulations, based upon those required under the PACE protocol;
(B) provide such enrollees access to necessary covered items and services 24 hours per day, every day of the year;
(C) provide services to such enrollees through a comprehensive, multidisciplinary health and social services delivery system which integrates acute and long-term care services pursuant to regulations; and
(D) specify the covered items and services that will not be provided directly by the entity, and to arrange for delivery of those items and services through contracts meeting the requirements of regulations.
(2) Quality assurance; patient safeguards
The PACE program agreement shall require the PACE provider to have in effect at a minimum—
(A) a written plan of quality assurance and improvement, and procedures implementing such plan, in accordance with regulations; and
(B) written safeguards of the rights of enrolled participants (including a patient bill of rights and procedures for grievances and appeals) in accordance with regulations and with other requirements of this subchapter and Federal and State law that are designed for the protection of patients.
(3) Treatment of medicare services furnished by noncontract physicians and other entities
(A) Application of medicare advantage requirement with respect to medicare services furnished by noncontract physicians and other entities
(B) Reference to related provision for noncontract providers of services
For the provision relating to limitations on balance billing against PACE providers for services covered under this subchapter furnished by noncontract providers of services, see
(4) Reference to related provision for services covered under subchapter XIX but not under this subchapter
For provisions relating to limitations on payments to providers participating under the State plan under subchapter XIX that do not have a contract or other agreement with a PACE provider establishing payment amounts for services covered under such plan (but not under this subchapter) when such services are furnished to enrollees of that PACE provider, see
(c) Eligibility determinations
(1) In general
The determination of whether an individual is a PACE program eligible individual—
(A) shall be made under and in accordance with the PACE program agreement; and
(B) who is entitled to medical assistance under subchapter XIX, shall be made (or who is not so entitled, may be made) by the State administering agency.
(2) Condition
An individual is not a PACE program eligible individual (with respect to payment under this section) unless the individual's health status has been determined by the Secretary or the State administering agency, in accordance with regulations, to be comparable to the health status of individuals who have participated in the PACE demonstration waiver programs. Such determination shall be based upon information on health status and related indicators (such as medical diagnoses and measures of activities of daily living, instrumental activities of daily living, and cognitive impairment) that are part of a uniform minimum data set collected by PACE providers on potential PACE program eligible individuals.
(3) Annual eligibility recertifications
(A) In general
Subject to subparagraph (B), the determination described in subsection (a)(5)(B) for an individual shall be reevaluated at least annually.
(B) Exception
The requirement of annual reevaluation under subparagraph (A) may be waived during a period in accordance with regulations in those cases where the State administering agency determines that there is no reasonable expectation of improvement or significant change in an individual's condition during the period because of the severity of chronic condition, or degree of impairment of functional capacity of the individual involved.
(4) Continuation of eligibility
An individual who is a PACE program eligible individual may be deemed to continue to be such an individual notwithstanding a determination that the individual no longer meets the requirement of subsection (a)(5)(B) if, in accordance with regulations, in the absence of continued coverage under a PACE program the individual reasonably would be expected to meet such requirement within the succeeding 6-month period.
(5) Enrollment; disenrollment
(A) Voluntary disenrollment at any time
The enrollment and disenrollment of PACE program eligible individuals in a PACE program shall be pursuant to regulations and the PACE program agreement and shall permit enrollees to voluntarily disenroll without cause at any time.
(B) Limitations on disenrollment
(i) In general
Regulations promulgated by the Secretary under this section and
(I) for nonpayment of premiums (if applicable) on a timely basis; or
(II) for engaging in disruptive or threatening behavior, as defined in such regulations (developed in close consultation with State administering agencies).
(ii) No disenrollment for noncompliant behavior
Except as allowed under regulations promulgated to carry out clause (i)(II), a PACE program may not disenroll a PACE program eligible individual on the ground that the individual has engaged in noncompliant behavior if such behavior is related to a mental or physical condition of the individual. For purposes of the preceding sentence, the term "noncompliant behavior" includes repeated noncompliance with medical advice and repeated failure to appear for appointments.
(iii) Timely review of proposed nonvoluntary disenrollment
A proposed disenrollment, other than a voluntary disenrollment, shall be subject to timely review and final determination by the Secretary or by the State administering agency (as applicable), prior to the proposed disenrollment becoming effective.
(d) Payments to PACE providers on capitated basis
(1) In general
In the case of a PACE provider with a PACE program agreement under this section, except as provided in this subsection or by regulations, the Secretary shall make prospective monthly payments of a capitation amount for each PACE program eligible individual enrolled under the agreement under this section in the same manner and from the same sources as payments are made to a Medicare+Choice organization under
(2) Capitation amount
The capitation amount to be applied under this subsection for a provider for a contract year shall be an amount specified in the PACE program agreement for the year. Such amount shall be based upon payment rates established for purposes of payment under
(3) Capitation rates determined without regard to the phase-out of the indirect costs of medical education from the annual Medicare Advantage capitation rate
Capitation amounts under this subsection shall be determined without regard to the application of
(e) PACE program agreement
(1) Requirement
(A) In general
The Secretary, in close cooperation with the State administering agency, shall establish procedures for entering into, extending, and terminating PACE program agreements for the operation of PACE programs by entities that meet the requirements for a PACE provider under this section,
(B) Numerical limitation
(i) In general
The Secretary shall not permit the number of PACE providers with which agreements are in effect under this section or under section 9412(b) of the Omnibus Budget Reconciliation Act of 1986 to exceed—
(I) 40 as of August 5, 1997; or
(II) as of each succeeding anniversary of August 5, 1997, the numerical limitation under this subparagraph for the preceding year plus 20.
Subclause (II) shall apply without regard to the actual number of agreements in effect as of a previous anniversary date.
(ii) Treatment of certain private, for-profit providers
The numerical limitation in clause (i) shall not apply to a PACE provider that—
(I) is operating under a demonstration project waiver under subsection (h); or
(II) was operating under such a waiver and subsequently qualifies for PACE provider status pursuant to subsection (a)(3)(B)(ii).
(2) Service area and eligibility
(A) In general
A PACE program agreement for a PACE program—
(i) shall designate the service area of the program;
(ii) may provide additional requirements for individuals to qualify as PACE program eligible individuals with respect to the program;
(iii) shall be effective for a contract year, but may be extended for additional contract years in the absence of a notice by a party to terminate and is subject to termination by the Secretary and the State administering agency at any time for cause (as provided under the agreement);
(iv) shall require a PACE provider to meet all applicable State and local laws and requirements; and
(v) shall contain such additional terms and conditions as the parties may agree to, so long as such terms and conditions are consistent with this section and regulations.
(B) Service area overlap
In designating a service area under a PACE program agreement under subparagraph (A)(i), the Secretary (in consultation with the State administering agency) may exclude from designation an area that is already covered under another PACE program agreement, in order to avoid unnecessary duplication of services and avoid impairing the financial and service viability of an existing program.
(3) Data collection; development of outcome measures
(A) Data collection
(i) In general
Under a PACE program agreement, the PACE provider shall—
(I) collect data;
(II) maintain, and afford the Secretary and the State administering agency access to, the records relating to the program, including pertinent financial, medical, and personnel records; and
(III) make available to the Secretary and the State administering agency reports that the Secretary finds (in consultation with State administering agencies) necessary to monitor the operation, cost, and effectiveness of the PACE program under this section and
(ii) Requirements during trial period
During the first 3 years of operation of a PACE program (either under this section or under a PACE demonstration waiver program), the PACE provider shall provide such additional data as the Secretary specifies in regulations in order to perform the oversight required under paragraph (4)(A).
(B) Development of outcome measures
Under a PACE program agreement, the PACE provider, the Secretary, and the State administering agency shall jointly cooperate in the development and implementation of health status and quality of life outcome measures with respect to PACE program eligible individuals.
(4) Oversight
(A) Annual, close oversight during trial period
During the trial period (as defined in subsection (a)(9)) with respect to a PACE program operated by a PACE provider, the Secretary (in cooperation with the State administering agency) shall conduct a comprehensive annual review of the operation of the PACE program by the provider in order to assure compliance with the requirements of this section and regulations. Such a review shall include—
(i) an on-site visit to the program site;
(ii) comprehensive assessment of a provider's fiscal soundness;
(iii) comprehensive assessment of the provider's capacity to provide all PACE services to all enrolled participants;
(iv) detailed analysis of the entity's substantial compliance with all significant requirements of this section and regulations; and
(v) any other elements the Secretary or State administering agency considers necessary or appropriate.
(B) Continuing oversight
After the trial period, the Secretary (in cooperation with the State administering agency) shall continue to conduct such review of the operation of PACE providers and PACE programs as may be appropriate, taking into account the performance level of a provider and compliance of a provider with all significant requirements of this section and regulations.
(C) Disclosure
The results of reviews under this paragraph shall be reported promptly to the PACE provider, along with any recommendations for changes to the provider's program, and shall be made available to the public upon request.
(5) Termination of PACE provider agreements
(A) In general
Under regulations—
(i) the Secretary or a State administering agency may terminate a PACE program agreement for cause; and
(ii) a PACE provider may terminate an agreement after appropriate notice to the Secretary, the State agency, and enrollees.
(B) Causes for termination
In accordance with regulations establishing procedures for termination of PACE program agreements, the Secretary or a State administering agency may terminate a PACE program agreement with a PACE provider for, among other reasons, the fact that—
(i) the Secretary or State administering agency determines that—
(I) there are significant deficiencies in the quality of care provided to enrolled participants; or
(II) the provider has failed to comply substantially with conditions for a program or provider under this section or
(ii) the entity has failed to develop and successfully initiate, within 30 days of the date of the receipt of written notice of such a determination, a plan to correct the deficiencies, or has failed to continue implementation of such a plan.
(C) Termination and transition procedures
An entity whose PACE provider agreement is terminated under this paragraph shall implement the transition procedures required under subsection (a)(2)(C).
(6) Secretary's oversight; enforcement authority
(A) In general
Under regulations, if the Secretary determines (after consultation with the State administering agency) that a PACE provider is failing substantially to comply with the requirements of this section and regulations, the Secretary (and the State administering agency) may take any or all of the following actions:
(i) Condition the continuation of the PACE program agreement upon timely execution of a corrective action plan.
(ii) Withhold some or all further payments under the PACE program agreement under this section or
(iii) Terminate such agreement.
(B) Application of intermediate sanctions
Under regulations, the Secretary may provide for the application against a PACE provider of remedies described in section 1395w–27(g)(2) (or, for periods before January 1, 1999,
(7) Procedures for termination or imposition of sanctions
Under regulations, the provisions of
(8) Timely consideration of applications for PACE program provider status
In considering an application for PACE provider program status, the application shall be deemed approved unless the Secretary, within 90 days after the date of the submission of the application to the Secretary, either denies such request in writing or informs the applicant in writing with respect to any additional information that is needed in order to make a final determination with respect to the application. After the date the Secretary receives such additional information, the application shall be deemed approved unless the Secretary, within 90 days of such date, denies such request.
(f) Regulations
(1) In general
The Secretary shall issue interim final or final regulations to carry out this section and
(2) Use of PACE protocol
(A) In general
In issuing such regulations, the Secretary shall, to the extent consistent with the provisions of this section, incorporate the requirements applied to PACE demonstration waiver programs under the PACE protocol.
(B) Flexibility
In order to provide for reasonable flexibility in adapting the PACE service delivery model to the needs of particular organizations (such as those in rural areas or those that may determine it appropriate to use nonstaff physicians according to State licensing law requirements) under this section and
(i) The focus on frail elderly qualifying individuals who require the level of care provided in a nursing facility.
(ii) The delivery of comprehensive, integrated acute and long-term care services.
(iii) The interdisciplinary team approach to care management and service delivery.
(iv) Capitated, integrated financing that allows the provider to pool payments received from public and private programs and individuals.
(v) The assumption by the provider of full financial risk.
(C) Continuation of modifications or waivers of operational requirements under demonstration status
If a PACE program operating under demonstration authority has contractual or other operating arrangements which are not otherwise recognized in regulation and which were in effect on July 1, 2000, the Secretary (in close consultation with, and with the concurrence of, the State administering agency) shall permit any such program to continue such arrangements so long as such arrangements are found by the Secretary and the State to be reasonably consistent with the objectives of the PACE program.
(3) Application of certain additional beneficiary and program protections
(A) In general
In issuing such regulations and subject to subparagraph (B), the Secretary may apply with respect to PACE programs, providers, and agreements such requirements of part C (or, for periods before January 1, 1999,
(B) Considerations
In issuing such regulations, the Secretary shall—
(i) take into account the differences between populations served and benefits provided under this section and under part C (or, for periods before January 1, 1999,
(ii) not include any requirement that conflicts with carrying out PACE programs under this section; and
(iii) not include any requirement restricting the proportion of enrollees who are eligible for benefits under this subchapter or subchapter XIX.
(4) Construction
Nothing in this subsection shall be construed as preventing the Secretary from including in regulations provisions to ensure the health and safety of individuals enrolled in a PACE program under this section that are in addition to those otherwise provided under paragraphs (2) and (3).
(g) Waivers of requirements
With respect to carrying out a PACE program under this section, the following requirements of this subchapter (and regulations relating to such requirements) are waived and shall not apply:
(1)
(2)
(3)
(4)
(5) Paragraphs (1) and (9) of
(h) Demonstration project for for-profit entities
(1) In general
In order to demonstrate the operation of a PACE program by a private, for-profit entity, the Secretary (in close consultation with State administering agencies) shall grant waivers from the requirement under subsection (a)(3) that a PACE provider may not be a for-profit, private entity.
(2) Similar terms and conditions
(A) In general
Except as provided under subparagraph (B), and paragraph (1), the terms and conditions for operation of a PACE program by a provider under this subsection shall be the same as those for PACE providers that are nonprofit, private organizations.
(B) Numerical limitation
The number of programs for which waivers are granted under this subsection shall not exceed 10. Programs with waivers granted under this subsection shall not be counted against the numerical limitation specified in subsection (e)(1)(B).
(i) Miscellaneous provisions
Nothing in this section or
(Aug. 14, 1935, ch. 531, title XVIII, §1894, as added
Editorial Notes
References in Text
The Internal Revenue Code of 1986, referred to in subsec. (a)(3)(A)(i), is classified generally to Title 26, Internal Revenue Code.
Section 4804(b) of the Balanced Budget Act of 1997, referred to in subsec. (a)(3)(B)(ii), is section 4804(b) of
Section 603(c) of the Social Security Amendments of 1983, referred to in subsec. (a)(7)(A), is section 603(c) of
Section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985, referred to in subsec. (a)(7)(A), is section 9220 of
Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986, referred to in subsecs. (a)(7)(B) and (e)(1)(B)(i), is section 9412(b) of
For the effective date of this section, referred to in subsec. (a)(9)(B), see section 4803 of
Amendments
2010—Subsecs. (h) to (j).
"With respect to a PACE program under this section, the following provisions (and regulations relating to such provisions) shall not apply:
"(1)
"(2)
"(3)
"(4)
"(5)
See Effective Date of 2010 Amendment note below.
2008—Subsec. (d)(3).
2003—Subsec. (b)(3), (4).
2000—Subsec. (f)(2)(C).
Statutory Notes and Related Subsidiaries
Change of Name
References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of
Effective Date of 2010 Amendment
Repeal of section 3201 of
Effective Date of 2003 Amendment
Amendment by
Effective Date of 2000 Amendment
Rural PACE Provider Grant Program
"(a)
"(1) CMS.—The term 'CMS' means the Centers for Medicare & Medicaid Services.
"(2) PACE
"(3) PACE
"(4)
"(5)
"(6)
"(b)
"(1)
"(A)
"(B)
"(C)
"(D)
"(i) Feasibility analysis and planning.
"(ii) Interdisciplinary team development.
"(iii) Development of a provider network, including contract development.
"(iv) Development or adaptation of claims processing systems.
"(v) Preparation of special education and outreach efforts required for the PACE program.
"(vi) Development of expense reporting required for calculation of outlier payments or reconciliation processes.
"(vii) Development of any special quality of care or patient satisfaction data collection efforts.
"(viii) Establishment of a working capital fund to sustain fixed administrative, facility, or other fixed costs until the provider reaches sufficient enrollment size.
"(ix) Startup and development costs incurred prior to the approval of the rural PACE pilot site's PACE provider application by CMS.
"(x) Any other efforts determined by the rural PACE pilot site to be critical to its successful startup, as approved by the Secretary.
"(E)
"(i)
"(ii)
"(2)
"(A) outreach and education to State agencies and provider organizations interested in establishing PACE programs in rural areas; and
"(B) technical assistance necessary to support rural PACE pilot sites.
"(c)
"(1)
"(2)
"(3)
"(A)
"(i) If the services are provided under a contract between the pilot site and the provider, the payment rate specified under the contract.
"(ii) The payment rate established under the original Medicare fee-for-service program for such service.
"(iii) The amount actually paid for the services by the pilot site.
"(B)
"(3)[two pars. (3) have been enacted]
"(A)[no subpar. (B) has been enacted]
"(4)
"(A)
"(B)
"(C)
"(5)
"(6)
"(A) documentation of the costs incurred with respect to the participant;
"(B) a certification that the site has complied with the requirements under paragraph (4); and
"(C) such additional information as the Secretary may require.
"(7)
"(A)
"(B)
"(d)
"(e)
Flexibility in Exercising Waiver Authority
"(1) shall approve or deny a request for a modification or a waiver of provisions of the PACE protocol not later than 90 days after the date the Secretary receives the request; and
"(2) may exercise authority to modify or waive such provisions in a manner that responds promptly to the needs of PACE programs relating to areas of employment and the use of community-based primary care physicians."
Transition; Regulations
"(a)
"(b)
"(1)
"(A) in paragraph (1), by inserting before the period at the end the following: ', except that the Secretary shall grant waivers of such requirements to up to the applicable numerical limitation specified in sections 1894(e)(1)(B) and 1934(e)(1)(B) of the Social Security Act' [
"(B) in paragraph (2)—
"(i) in subparagraph (A), by striking ', including permitting the organization to assume progressively (over the initial 3-year period of the waiver) the full financial risk'; and
"(ii) in subparagraph (C), by adding at the end the following: 'In granting further extensions, an organization shall not be required to provide for reporting of information which is only required because of the demonstration nature of the project.'
"(2)
"(3)
"(c)
"(1)
"(A) first, to entities that are operating a PACE demonstration waiver program (as defined in sections 1894(a)(7) and 1934(a)(7) of such Act [
"(B) then to entities that have applied to operate such a program as of May 1, 1997.
"(2)
"(A) to any entities that have applied for such waivers under such section as of May 1, 1997; and
"(B) to any entity that, as of May 1, 1997, has formally contracted with a State to provide services for which payment is made on a capitated basis with an understanding that the entity was seeking to become a PACE provider.
"(3)
"(d)
"(1)
"(A) Section 603(c) of the Social Security Amendments of 1983 (
"(B) Section 9220 of the Consolidated Omnibus Budget Reconciliation Act of 1985 (
"(C) Section 9412(b) of the Omnibus Budget Reconciliation Act of 1986 (
"(2)
"(A)
"(B)
PACE Programs; Study and Reports
"(a)
"(1)
"(2)
"(b)
"(1)
"(2)
"(A) The number of covered lives enrolled with entities operating under demonstration project waivers under sections 1894(h) and 1934(h) of the Social Security Act is fewer than 800 (or such lesser number as the Secretary may find statistically sufficient to make determinations respecting findings described in the succeeding subparagraphs).
"(B) The population enrolled with such entities is less frail than the population enrolled with other PACE providers.
"(C) Access to or quality of care for individuals enrolled with such entities is lower than such access or quality for individuals enrolled with other PACE providers.
"(D) The application of such section has resulted in an increase in expenditures under the medicare or medicaid programs above the expenditures that would have been made if such section did not apply."
§1395fff. Prospective payment for home health services
(a) In general
Notwithstanding
(b) System of prospective payment for home health services
(1) In general
The Secretary shall establish under this subsection a prospective payment system for payment for all costs of home health services. Under the system under this subsection all services covered and paid on a reasonable cost basis under the medicare home health benefit as of August 5, 1997, including medical supplies, shall be paid for on the basis of a prospective payment amount determined under this subsection and applicable to the services involved. In implementing the system, the Secretary may provide for a transition (of not longer than 4 years) during which a portion of such payment is based on agency-specific costs, but only if such transition does not result in aggregate payments under this subchapter that exceed the aggregate payments that would be made if such a transition did not occur.
(2) Unit of payment
(A) In general
In defining a prospective payment amount under the system under this subsection, the Secretary shall consider an appropriate unit of service and the number, type, and duration of visits provided within that unit, potential changes in the mix of services provided within that unit and their cost, and a general system design that provides for continued access to quality services.
(B) 30-day unit of service
For purposes of implementing the prospective payment system with respect to home health units of service furnished during a year beginning with 2020, the Secretary shall apply a 30-day unit of service as the unit of service applied under this paragraph.
(3) Payment basis
(A) Initial basis
(i) In general
Under such system the Secretary shall provide for computation of a standard prospective payment amount (or amounts) as follows:
(I) Such amount (or amounts) shall initially be based on the most current audited cost report data available to the Secretary and shall be computed in a manner so that the total amounts payable under the system for the 12-month period beginning on the date the Secretary implements the system shall be equal to the total amount that would have been made if the system had not been in effect and if
(II) For the 12-month period beginning after the period described in subclause (I), such amount (or amounts) shall be equal to the amount (or amounts) determined under subclause (I), updated under subparagraph (B).
(III) Subject to clause (iii), for periods beginning after the period described in subclause (II), such amount (or amounts) shall be equal to the amount (or amounts) that would have been determined under subclause (I) that would have been made for fiscal year 2001 if the system had not been in effect and if
Each such amount shall be standardized in a manner that eliminates the effect of variations in relative case mix and area wage adjustments among different home health agencies in a budget neutral manner consistent with the case mix and wage level adjustments provided under paragraph (4)(A). Under the system, the Secretary may recognize regional differences or differences based upon whether or not the services or agency are in an urbanized area.
(ii) Reduction
The reduction described in this clause is a reduction by 15 percent in the cost limits and per beneficiary limits described in
(iii) Adjustment for 2014 and subsequent years
(I) In general
Subject to subclause (II), for 2014 and subsequent years, the amount (or amounts) that would otherwise be applicable under clause (i)(III) shall be adjusted by a percentage determined appropriate by the Secretary to reflect such factors as changes in the number of visits in an episode, the mix of services in an episode, the level of intensity of services in an episode, the average cost of providing care per episode, and other factors that the Secretary considers to be relevant. In conducting the analysis under the preceding sentence, the Secretary may consider differences between hospital-based and freestanding agencies, between for-profit and nonprofit agencies, and between the resource costs of urban and rural agencies. Such adjustment shall be made before the update under subparagraph (B) is applied for the year.
(II) Transition
The Secretary shall provide for a 4-year phase-in (in equal increments) of the adjustment under subclause (I), with such adjustment being fully implemented for 2017. During each year of such phase-in, the amount of any adjustment under subclause (I) for the year may not exceed 3.5 percent of the amount (or amounts) applicable under clause (i)(III) as of March 23, 2010.
(iv) Budget neutrality for 2020
With respect to payments for home health units of service furnished that end during the 12-month period beginning January 1, 2020, the Secretary shall calculate a standard prospective payment amount (or amounts) for 30-day units of service (as described in paragraph (2)(B)) for the prospective payment system under this subsection. Such standard prospective payment amount (or amounts) shall be calculated in a manner such that the estimated aggregate amount of expenditures under the system during such period with application of paragraph (2)(B) is equal to the estimated aggregate amount of expenditures that otherwise would have been made under the system during such period if paragraph (2)(B) had not been enacted. The previous sentence shall be applied before (and not affect the application of) paragraph (3)(B). In calculating such amount (or amounts), the Secretary shall make assumptions about behavior changes that could occur as a result of the implementation of paragraph (2)(B) and the case-mix adjustment factors established under paragraph (4)(B) and shall provide a description of such assumptions in the notice and comment rulemaking used to implement this clause.
(B) Annual update
(i) In general
The standard prospective payment amount (or amounts) shall be adjusted for fiscal year 2002 and for fiscal year 2003 and for each subsequent year (beginning with 2004) in a prospective manner specified by the Secretary by the home health applicable increase percentage (as defined in clause (ii)) applicable to the fiscal year or year involved.
(ii) Home health applicable increase percentage
For purposes of this subparagraph, the term "home health applicable increase percentage" means, with respect to—
(I) each of fiscal years 2002 and 2003, the home health market basket percentage increase (as defined in clause (iii)) minus 1.1 percentage points;
(II) for 1 the last calendar quarter of 2003 and the first calendar quarter of 2004, the home health market basket percentage increase;
(III) the last 3 calendar quarters of 2004, and all of 2005 2 the home health market basket percentage increase minus 0.8 percentage points;
(IV) 2006, 0 percent; and
(V) any subsequent year, subject to clauses (v) and (vi), the home health market basket percentage increase.
(iii) Home health market basket percentage increase
For purposes of this subsection, the term "home health market basket percentage increase" means, with respect to a fiscal year or year, a percentage (estimated by the Secretary before the beginning of the fiscal year or year) determined and applied with respect to the mix of goods and services included in home health services in the same manner as the market basket percentage increase under
(iv) Adjustment for case mix changes
Insofar as the Secretary determines that the adjustments under paragraph (4)(A)(i) for a previous fiscal year or year (or estimates that such adjustments for a future fiscal year or year) did (or are likely to) result in a change in aggregate payments under this subsection during the fiscal year or year that are a result of changes in the coding or classification of different units of services that do not reflect real changes in case mix, the Secretary may adjust the standard prospective payment amount (or amounts) under paragraph (3) for subsequent fiscal years or years so as to eliminate the effect of such coding or classification changes.
(v) Adjustment if quality data not submitted
(I) Adjustment
For purposes of clause (ii)(V), for 2007 and each subsequent year, in the case of a home health agency that does not submit data to the Secretary in accordance with subclauses (II) and (IV) with respect to such a year, the home health market basket percentage increase applicable under such clause for such year shall be reduced by 2 percentage points. Such reduction shall apply only with respect to the year involved, and the Secretary shall not take into account such reduction in computing the prospective payment amount under this section for a subsequent year, and the Medicare Payment Advisory Commission shall carry out the requirements under section 5201(d) of the Deficit Reduction Act of 2005.
(II) Submission of quality data
Subject to subclause (V), for 2007 and each subsequent year, each home health agency shall submit to the Secretary such data that the Secretary determines are appropriate for the measurement of health care quality. Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this clause.
(III) Public availability of data submitted
The Secretary shall establish procedures for making data submitted under subclause (II) and subclause (IV)(aa) available to the public. Such procedures shall ensure that a home health agency has the opportunity to review the data that is to be made public with respect to the agency prior to such data being made public.
(IV) Submission of additional data
(aa) In general
For the year beginning on the specified application date (as defined in subsection (a)(2)(E) of
(bb) Standardized patient assessment data
For 2019 and each subsequent year, in addition to such data described in item (aa), each home health agency shall submit to the Secretary standardized patient assessment data required under subsection (b)(1) of
(cc) Submission
Data shall be submitted under items (aa) and (bb) in the form and manner, and at the time, specified by the Secretary for purposes of this clause.
(V) Non-duplication
To the extent data submitted under subclause (IV) duplicates other data required to be submitted under subclause (II), the submission of such data under subclause (IV) shall be in lieu of the submission of such data under subclause (II). The previous sentence shall not apply insofar as the Secretary determines it is necessary to avoid a delay in the implementation of
(vi) Adjustments
After determining the home health market basket percentage increase under clause (iii), and after application of clause (v), the Secretary shall reduce such percentage—
(I) for 2015 and each subsequent year (except 2018 and 2020), by the productivity adjustment described in
(II) for each of 2011, 2012, and 2013, by 1 percentage point.
The application of this clause may result in the home health market basket percentage increase under clause (iii) being less than 0.0 for a year, and may result in payment rates under the system under this subsection for a year being less than such payment rates for the preceding year.
(C) Adjustment for outliers
The Secretary shall reduce the standard prospective payment amount (or amounts) under this paragraph applicable to home health services furnished during a period by such proportion as will result in an aggregate reduction in payments for the period equal to 5 percent of the total payments estimated to be made based on the prospective payment system under this subsection for the period.
(D) Behavior assumptions and adjustments
(i) In general
The Secretary shall annually determine the impact of differences between assumed behavior changes (as described in paragraph (3)(A)(iv)) and actual behavior changes on estimated aggregate expenditures under this subsection with respect to years beginning with 2020 and ending with 2026.
(ii) Permanent adjustments
The Secretary shall, at a time and in a manner determined appropriate, through notice and comment rulemaking, provide for one or more permanent increases or decreases to the standard prospective payment amount (or amounts) for applicable years, on a prospective basis, to offset for such increases or decreases in estimated aggregate expenditures (as determined under clause (i)).
(iii) Temporary adjustments for retrospective behavior
The Secretary shall, at a time and in a manner determined appropriate, through notice and comment rulemaking, provide for one or more temporary increases or decreases to the payment amount for a unit of home health services (as determined under paragraph (4)) for applicable years, on a prospective basis, to offset for such increases or decreases in estimated aggregate expenditures (as determined under clause (i)). Such a temporary increase or decrease shall apply only with respect to the year for which such temporary increase or decrease is made, and the Secretary shall not take into account such a temporary increase or decrease in computing such amount under this subsection for a subsequent year.
(4) Payment computation
(A) In general
The payment amount for a unit of home health services shall be the applicable standard prospective payment amount adjusted as follows:
(i) Case mix adjustment
The amount shall be adjusted by an appropriate case mix adjustment factor (established under subparagraph (B)).
(ii) Area wage adjustment
The portion of such amount that the Secretary estimates to be attributable to wages and wage-related costs shall be adjusted for geographic differences in such costs by an area wage adjustment factor (established under subparagraph (C)) for the area in which the services are furnished or such other area as the Secretary may specify.
(B) Establishment of case mix adjustment factors
(i) In general
The Secretary shall establish appropriate case mix adjustment factors for home health services in a manner that explains a significant amount of the variation in cost among different units of services.
(ii) Treatment of therapy thresholds
For 2020 and subsequent years, the Secretary shall eliminate the use of therapy thresholds (established by the Secretary) in case mix adjustment factors established under clause (i) for calculating payments under the prospective payment system under this subsection.
(C) Establishment of area wage adjustment factors
The Secretary shall establish area wage adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of home health services in a geographic area compared to the national average applicable level. Such factors may be the factors used by the Secretary for purposes of
(5) Outliers
(A) In general
Subject to subparagraph (B), the Secretary may provide for an addition or adjustment to the payment amount otherwise made in the case of outliers because of unusual variations in the type or amount of medically necessary care. The total amount of the additional payments or payment adjustments made under this paragraph with respect to a fiscal year or year may not exceed 2.5 percent of the total payments projected or estimated to be made based on the prospective payment system under this subsection in that year.
(B) Program specific outlier cap
The estimated total amount of additional payments or payment adjustments made under subparagraph (A) with respect to a home health agency for a year (beginning with 2011) may not exceed an amount equal to 10 percent of the estimated total amount of payments made under this section (without regard to this paragraph) with respect to the home health agency for the year.
(6) Proration of prospective payment amounts
If a beneficiary elects to transfer to, or receive services from, another home health agency within the period covered by the prospective payment amount, the payment shall be prorated between the home health agencies involved.
(c) Requirements for payment information
With respect to home health services furnished on or after October 1, 1998, no claim for such a service may be paid under this subchapter unless—
(1) the claim has the unique identifier for the physician 2 the nurse practitioner or clinical nurse specialist (as those terms are defined in
(2) in the case of a service visit described in paragraph (1), (2), (3), or (4) of
(3) in the case of home health services furnished on or after January 1, 2019, the claim contains the code for the county (or equivalent area) in which the home health service was furnished.
(d) Limitation on review
There shall be no administrative or judicial review under
(1) the establishment of a transition period under subsection (b)(1);
(2) the definition and application of payment units under subsection (b)(2);
(3) the computation of initial standard prospective payment amounts under subsection (b)(3)(A) (including the reduction described in clause (ii) of such subsection);
(4) the establishment of the adjustment for outliers under subsection (b)(3)(C);
(5) the establishment of case mix and area wage adjustments under subsection (b)(4); and
(6) the establishment of any adjustments for outliers under subsection (b)(5).
(e) Construction related to home health services
(1) Telecommunications
Nothing in this section shall be construed as preventing a home health agency furnishing a home health unit of service for which payment is made under the prospective payment system established by this section for such units of service from furnishing services via a telecommunication system if such services—
(A) do not substitute for in-person home health services ordered as part of a plan of care certified by a physician 2 a nurse practitioner or clinical nurse specialist, or a physician assistant pursuant to
(B) are not considered a home health visit for purposes of eligibility or payment under this subchapter.
(2) Rule of construction regarding requirement for certification
Nothing in this section shall be construed as waiving the requirement for a certification under
(Aug. 14, 1935, ch. 531, title XVIII, §1895, as added
Editorial Notes
References in Text
Section 5201(d) of the Deficit Reduction Act of 2005, referred to in subsec. (b)(3)(B)(v)(I), is section 5201(d) of title V of
Amendments
2020—Subsec. (c)(1).
Subsec. (e)(1)(A).
Subsec. (e)(2).
2018—Subsec. (b)(2).
Subsec. (b)(3)(A)(iv).
Subsec. (b)(3)(B)(iii).
Subsec. (b)(3)(B)(vi)(I).
Subsec. (b)(3)(D).
Subsec. (b)(4)(B).
Subsec. (c)(3).
2015—Subsec. (b)(3)(B)(iii).
Subsec. (b)(3)(B)(vi)(I).
2014—Subsec. (b)(3)(B)(v)(I).
Subsec. (b)(3)(B)(v)(II).
Subsec. (b)(3)(B)(v)(III).
Subsec. (b)(3)(B)(v)(IV), (V).
2010—Subsec. (b)(3)(A)(i)(III).
Subsec. (b)(3)(A)(iii).
Subsec. (b)(3)(B)(ii)(V).
Subsec. (b)(3)(B)(vi).
Subsec. (b)(3)(B)(vi)(II).
Subsec. (b)(3)(C).
Subsec. (b)(5).
2006—Subsec. (b)(3)(B)(ii)(III).
Subsec. (b)(3)(B)(ii)(IV).
Subsec. (b)(3)(B)(ii)(V).
Subsec. (b)(3)(B)(v).
2003—Subsec. (b)(3)(B)(i).
Subsec. (b)(3)(B)(ii)(I).
Subsec. (b)(3)(B)(ii)(II).
Subsec. (b)(3)(B)(ii)(III).
Subsec. (b)(3)(B)(ii)(IV).
Subsec. (b)(3)(B)(iii).
Subsec. (b)(3)(B)(iv).
Subsec. (b)(5).
2000—Subsec. (b)(3)(A)(i)(II).
Subsec. (b)(3)(A)(i)(III).
Subsec. (b)(3)(B)(iv).
Subsec. (e).
1999—Subsec. (b)(1).
Subsec. (b)(3)(A)(i).
Subsec. (b)(3)(A)(i)(I).
Subsec. (b)(3)(A)(i)(II).
Subsec. (b)(3)(B)(ii)(I).
1998—Subsec. (a).
Subsec. (b)(3)(A)(i).
Subsec. (b)(3)(A)(ii).
Subsec. (b)(3)(B)(i).
Subsec. (b)(3)(B)(ii), (iii).
Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment
Secretary of Health and Human Services to prescribe regulations to apply the amendments made by
Effective Date of 2000 Amendment
Effective Date of 1999 Amendment
Amendment by section 1000(a)(6) [title III, §303(b)] of
Amendment by section 1000(a)(6) [title III, §321(k)(19)] of
Effective Date
Increasing Transparency for Home Health Payments Under the Medicare Program
"(a)
"(1) Electronic data files showing the Centers for Medicare & Medicaid Services simulation of 60-day episodes under the home health prospective payment system in effect prior to the Patient Driven Groupings Model using data from 30-day periods paid under such Model, if such data are used in determining payment adjustments under clauses (ii) or (iii) of such section 1895(b)(3)(D).
"(2) To the extent practicable, a description of actual behavior changes, as described in clause (i) of such section 1895(b)(3)(D), including behavior changes as a result of the implementation of sections 1895(b)(2)(B) and 1895(b)(4)(B) of the Social Security Act (
"(b)
"(1)
"(2)
"(c)
Study and Report on the Development of Home Health Payment Revisions in Order To Ensure Access to Care and Payment for Severity of Illness
"(1)
"(A) Methods to potentially revise the home health prospective payment system under section 1895 of the Social Security Act (
"(i) payment adjustments for services that may involve additional or fewer resources;
"(ii) changes to reflect resources involved with providing home health services to low-income Medicare beneficiaries or Medicare beneficiaries residing in medically underserved areas;
"(iii) ways outlier payments might be revised to reflect costs of treating Medicare beneficiaries with high levels of severity of illness; and
"(iv) other issues determined appropriate by the Secretary.
"(B) Operational issues involved with potential implementation of potential revisions to the home health payment system, including impacts for both home health agencies and administrative and systems issues for the Centers for Medicare & Medicaid Services, and any possible payment vulnerabilities associated with implementing potential revisions.
"(C) Whether additional research might be needed.
"(D) Other items determined appropriate by the Secretary.
"(2)
"(A) population density and relative patient access to care;
"(B) variations in service costs for providing care to individuals who are dually eligible under the Medicare and Medicaid programs;
"(C) the presence of severe or chronic diseases, which might be measured by multiple, discontinuous home health episodes;
"(D) poverty status, such as evidenced by the receipt of Supplemental Security Income under title XVI of the Social Security Act [
"(E) other factors determined appropriate by the Secretary.
"(3)
"(4)
"(5)
"(A)
"(B)
"(C)
"(i) shall not apply to payments for home health services under title XVIII [
"(ii) shall not be taken into account in calculating the payment amounts applicable for such services after such period.
"(D)
"(E)
"(F)
"(i) provide for an evaluation of the project; and
"(ii) submit to Congress, by a date specified by the Secretary, a report on the project.
"(G)
Temporary Increase for Home Health Services Furnished in a Rural Area
"(a)
"(b)
"(1)
"(A) is in the highest quartile of all counties (or equivalent areas) based on the number of Medicare home health episodes furnished per 100 individuals who are entitled to, or enrolled for, benefits under part A of title XVIII of the Social Security Act [
"(i) in the case of episodes and visits ending during 2019, by 1.5 percent; and
"(ii) in the case of episodes and visits ending during 2020, by 0.5 percent;
"(B) has a population density of 6 individuals or fewer per square mile of land area and is not described in subparagraph (A)—
"(i) in the case of episodes and visits ending during 2019, by 4 percent;
"(ii) in the case of episodes and visits ending during 2020, by 3 percent;
"(iii) in the case of episodes and visits ending during 2021, by 2 percent;
"(iv) in the case of episodes and visits ending during 2022, by 1 percent; and
"(v) in the case of episodes and visits ending during 2023, by 1 percent; and
"(C) is not described in either subparagraph (A) or (B)—
"(i) in the case of episodes and visits ending during 2019, by 3 percent;
"(ii) in the case of episodes and visits ending during 2020, by 2 percent; and
"(iii) in the case of episodes and visits ending during 2021, by 1 percent.
"(2)
"(A)
"(B)
"(i) The Secretary shall use data from 2015.
"(ii) The Secretary shall exclude data from the territories (and the territories shall not be described in such paragraph).
"(iii) The Secretary may exclude data from counties (or equivalent areas) in rural areas with a low volume of home health episodes (and if data is so excluded with respect to a county (or equivalent area), such county (or equivalent area) shall not be described in such paragraph).
"(C)
"(3)
"(c)
"(d)
"(1) shall not apply to episodes and visits ending after such period; and
"(2) shall not be taken into account in calculating the payment amounts applicable for episodes and visits occurring after such period."
Demonstration Project for Medical Adult Day-Care Services
"(a)
"(b)
"(1)
"(2)
"(c)
"(d)
"(e)
"(f)
"(g)
"(h)
"(1) An analysis of the patient outcomes and costs of furnishing care to the medicare beneficiaries participating in the project as compared to such outcomes and costs to beneficiaries receiving only home health services for the same health conditions.
"(2) Such recommendations regarding the extension, expansion, or termination of the project as the Secretary determines appropriate.
"(i)
"(1)
"(2)
"(A) has been licensed or certified by a State to furnish medical adult day-care services in the State for a continuous 2-year period;
"(B) is engaged in providing skilled nursing services and other therapeutic services directly or under arrangement with a home health agency;
"(C) is licensed and certified by the State in which it operates or meets such standards established by the Secretary to assure quality of care and such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the facility; and
"(D) provides medical adult day-care services.
"(3)
"(A) home health service items and services described in paragraphs (1) through (7) of section 1861(m) [probably means section 1861(m) of the Social Security Act,
"(B) a program of supervised activities furnished in a group setting in the facility that—
"(i) meet such criteria as the Secretary determines appropriate; and
"(ii) is designed to promote physical and mental health of the individuals; and
"(C) such other services as the Secretary may specify.
"(4)
Temporary Suspension of Oasis Requirement for Collection of Data on Non-Medicare and Non-Medicaid Patients
"(a)
"(b)
"(1) begins on the date of the enactment of this Act [Dec. 8, 2003]; and
"(2) ends on the last day of the second month beginning after the date as of which the Secretary has published final regulations regarding the collection and use by the Centers for Medicare & Medicaid Services of non-medicare/medicaid OASIS information following the submission of the report required under subsection (c).
"(c)
"(1)
"(A) whether there are unique benefits from the analysis of such information that cannot be derived from other information available to, or collected by, such agencies; and
"(B) the value of collecting such information by small home health agencies compared to the administrative burden related to such collection.
In conducting the study the Secretary shall obtain recommendations from quality assessment experts in the use of such information and the necessity of small, as well as large, home health agencies collecting such information.
"(2)
"(d)
MedPAC Study on Medicare Margins of Home Health Agencies
"(a)
"(b)
Special Rule for Payment for Fiscal Year 2001 Based on Adjusted Prospective Payment Amounts
"(1)
"(A) with respect to episodes and visits ending on or after October 1, 2000, and before April 1, 2001, use the final standardized and budget neutral prospective payment amounts for 60-day episodes and standardized average per visit amounts for fiscal year 2001 as published by the Secretary in the Federal Register on July 3, 2000 (65 Fed. Reg. 41128–41214); and
"(B) with respect to episodes and visits ending on or after April 1, 2001, and before October 1, 2001, use such amounts increased by 2.2 percent.
"(2)
Temporary Two-Month Periodic Interim Payment
"(a)
"(b)
"(1) notifies the Secretary that such agency does not want to receive such payment;
"(2) is not receiving payments pursuant to section 405.371 of title 42, Code of Federal Regulations;
"(3) is excluded from the medicare program under title XI of the Social Security Act [
"(4) no longer has a provider agreement under section 1866 of such Act (
"(5) is no longer in business; or
"(6) is subject to a court order providing for the withholding of medicare payments under title XVIII of such Act [
Temporary Increase for Home Health Services Furnished in a Rural Area
"(a) 24
"(b)
Clarification of Application of Temporary Payment Increases for 2001
"(1)
"(2)
Adjustment To Reflect Administrative Costs Not Included in the Interim Payment System; GAO Report on Costs of Compliance With Oasis Data Collection Requirements
"(a)
"(1)
"(2)
"(A)
"(B)
"(3)
"(4)
"(A)
"(B)
"(C)
"(b)
"(1)
"(A)
"(B)
"(i) An assessment of the costs incurred by medicare home health agencies in complying with such data collection requirement.
"(ii) An analysis of the effect of such data collection requirement on the privacy interests of patients from whom data is collected.
"(C)
"(2)
"(A)
"(B)
Report to Congress on Need for Reductions
Study and Report to Congress Regarding Exemption of Rural Agencies and Populations From Inclusion in Home Health Prospective Payment System
"(a)
"(b)
Case Mix System Development
Case Mix System; Submission of Data
Prospective Payment System Contingency
Reports to Congress Regarding Home Health Cost Containment
"(a)
"(b)
1 So in original. The word "for" probably should not appear.
2 So in original. Probably should be followed by a comma.
§1395ggg. Omitted
Editorial Notes
Codification
Section, act Aug. 14, 1935, ch. 531, title XVIII, §1896, as added
§1395hhh. Health care infrastructure improvement program
(a) Establishment
The Secretary shall establish a loan program that provides loans to qualifying hospitals for payment of the capital costs of projects described in subsection (d).
(b) Application
No loan may be provided under this section to a qualifying hospital except pursuant to an application that is submitted and approved in a time, manner, and form specified by the Secretary. A loan under this section shall be on such terms and conditions and meet such requirements as the Secretary determines appropriate.
(c) Selection criteria
(1) In general
The Secretary shall establish criteria for selecting among qualifying hospitals that apply for a loan under this section. Such criteria shall consider the extent to which the project for which loan is sought is nationally or regionally significant, in terms of expanding or improving the health care infrastructure of the United States or the region or in terms of the medical benefit that the project will have.
(2) Qualifying hospital defined
For purposes of this section, the term "qualifying hospital" means a hospital or an entity described in paragraph (3) that—
(A) is engaged in research in the causes, prevention, and treatment of cancer; and
(B) is designated as a cancer center for the National Cancer Institute or is designated by the State legislature as the official cancer institute of the State and such designation by the State legislature occurred prior to December 8, 2003.
(3) Entity described
An entity described in this paragraph is an entity that—
(A) is described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code;
(B) has at least 1 existing memorandum of understanding or affiliation agreement with a hospital located in the State in which the entity is located; and
(C) retains clinical outpatient treatment for cancer on site as well as lab research and education and outreach for cancer in the same facility.
(d) Projects
A project described in this subsection is a project of a qualifying hospital that is designed to improve the health care infrastructure of the hospital, including construction, renovation, or other capital improvements.
(e) State and local permits
The provision of a loan under this section with respect to a project shall not—
(1) relieve any recipient of the loan of any obligation to obtain any required State or local permit or approval with respect to the project;
(2) limit the right of any unit of State or local government to approve or regulate any rate of return on private equity invested in the project; or
(3) otherwise supersede any State or local law (including any regulation) applicable to the construction or operation of the project.
(f) Forgiveness of indebtedness
The Secretary may forgive a loan provided to a qualifying hospital under this section under terms and conditions that are analogous to the loan forgiveness provision for student loans under part D of title IV of the Higher Education Act of 1965 (
(A) an outreach program for cancer prevention, early diagnosis, and treatment that provides services to a substantial majority of the residents of a State or region, including residents of rural areas;
(B) an outreach program for cancer prevention, early diagnosis, and treatment that provides services to multiple Indian tribes; and
(C)(i) unique research resources (such as population databases); or
(ii) an affiliation with an entity that has unique research resources.
(g) Funding
(1) In general
There are appropriated, out of amounts in the Treasury not otherwise appropriated, to carry out this section, $200,000,000, to remain available during the period beginning on July 1, 2004, and ending on September 30, 2008.
(2) Administrative costs
From funds made available under paragraph (1), the Secretary may use, for the administration of this section, not more than $2,000,000 for each of fiscal years 2004 through 2008.
(3) Availability
Amounts appropriated under this section shall be available for obligation on July 1, 2004.
(h) Report to Congress
Not later than 4 years after December 8, 2003, the Secretary shall submit to Congress a report on the projects for which loans are provided under this section and a recommendation as to whether the Congress should authorize the Secretary to continue loans under this section beyond fiscal year 2008.
(i) Limitation on review
There shall be no administrative or judicial review of any determination made by the Secretary under this section.
(Aug. 14, 1935, ch. 531, title XVIII, §1897, as added
Editorial Notes
References in Text
The Internal Revenue Code of 1986, referred to in subsec. (c)(3)(A), is classified generally to Title 26, Internal Revenue Code.
The Higher Education Act of 1965, referred to in subsec. (f), is
Amendments
2005—Subsec. (c)(2).
Subsec. (c)(2)(B).
Subsec. (c)(3).
Subsec. (i).
Statutory Notes and Related Subsidiaries
Effective Date of 2005 Amendment
§1395iii. Medicare Improvement Fund
(a) Establishment
The Secretary shall establish under this subchapter a Medicare Improvement Fund (in this section referred to as the "Fund") which shall be available to the Secretary to make improvements under the original Medicare fee-for-service program under parts A and B for individuals entitled to, or enrolled for, benefits under part 1 or enrolled under part B including adjustments to payments for items and services furnished by providers of services and suppliers under such original Medicare fee-for-service program.
(b) Funding
(1) In general
There shall be available to the Fund, for expenditures from the Fund for services furnished during and after fiscal year 2022, $0.
(2) Payment from Trust Funds
The amount specified under paragraph (1) shall be available to the Fund, as expenditures are made from the Fund, from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund in such proportion as the Secretary determines appropriate.
(3) Funding limitation
Amounts in the Fund shall be available in advance of appropriations but only if the total amount obligated from the Fund does not exceed the amount available to the Fund under paragraph (1). The Secretary may obligate funds from the Fund only if the Secretary determines (and the Chief Actuary of the Centers for Medicare & Medicaid Services and the appropriate budget officer certify) that there are available in the Fund sufficient amounts to cover all such obligations incurred consistent with the previous sentence.
(4) No effect on payments in subsequent years
In the case that expenditures from the Fund are applied to, or otherwise affect, a payment rate for an item or service under this subchapter for a year, the payment rate for such item or service shall be computed for a subsequent year as if such application or effect had never occurred.
(Aug. 14, 1935, ch. 531, title XVIII, §1898, as added
Editorial Notes
Amendments
2024—Subsec. (b)(1).
2023—Subsec. (b)(1).
2022—Subsec. (b)(1).
2021—Subsec. (b)(1).
2020—Subsec. (b)(1).
2018—Subsec. (b)(1).
2017—Subsec. (b)(1).
2016—Subsec. (b)(1).
2015—Subsec. (b)(1).
2014—
Subsec. (a).
Subsec. (b)(1).
"(A) fiscal year 2014, $0; and
"(B) fiscal year 2015, $0."
Subsec. (b)(2).
2013—Subsec. (b)(1).
"(A) fiscal year 2014, $0;
"(B) fiscal year 2015, $275,000,000; and
"(C) fiscal year 2020 and each subsequent fiscal year, the Secretary's estimate, as of July 1 of the fiscal year, of the aggregate reduction in expenditures under this subchapter during the preceding fiscal year directly resulting from the reduction in payment amounts under
2010—Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
2009—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B), (C).
Subsec. (b)(4).
2008—Subsec. (b)(1).
Statutory Notes and Related Subsidiaries
Effective Date of 2016 Amendment
Amendment by
§1395jjj. Shared savings program
(a) Establishment
(1) 1 In general
Not later than January 1, 2012, the Secretary shall establish a shared savings program (in this section referred to as the "program") that promotes accountability for a patient population and coordinates items and services under parts A and B, and encourages investment in infrastructure and redesigned care processes for high quality and efficient service delivery. Under such program—
(A) groups of providers of services and suppliers meeting criteria specified by the Secretary may work together to manage and coordinate care for Medicare fee-for-service beneficiaries through an accountable care organization (referred to in this section as an "ACO"); and
(B) ACOs that meet quality performance standards established by the Secretary are eligible to receive payments for shared savings under subsection (d)(2).
(b) Eligible ACOs
(1) In general
Subject to the succeeding provisions of this subsection, as determined appropriate by the Secretary, the following groups of providers of services and suppliers which have established a mechanism for shared governance are eligible to participate as ACOs under the program under this section:
(A) ACO professionals in group practice arrangements.
(B) Networks of individual practices of ACO professionals.
(C) Partnerships or joint venture arrangements between hospitals and ACO professionals.
(D) Hospitals employing ACO professionals.
(E) Such other groups of providers of services and suppliers as the Secretary determines appropriate.
(2) Requirements
An ACO shall meet the following requirements:
(A) The ACO shall be willing to become accountable for the quality, cost, and overall care of the Medicare fee-for-service beneficiaries assigned to it.
(B) The ACO shall enter into an agreement with the Secretary to participate in the program for not less than a 3-year period (referred to in this section as the "agreement period").
(C) The ACO shall have a formal legal structure that would allow the organization to receive and distribute payments for shared savings under subsection (d)(2) to participating providers of services and suppliers.
(D) The ACO shall include primary care ACO professionals that are sufficient for the number of Medicare fee-for-service beneficiaries assigned to the ACO under subsection (c). At a minimum, the ACO shall have at least 5,000 such beneficiaries assigned to it under subsection (c) in order to be eligible to participate in the ACO program.
(E) The ACO shall provide the Secretary with such information regarding ACO professionals participating in the ACO as the Secretary determines necessary to support the assignment of Medicare fee-for-service beneficiaries to an ACO, the implementation of quality and other reporting requirements under paragraph (3), and the determination of payments for shared savings under subsection (d)(2).
(F) The ACO shall have in place a leadership and management structure that includes clinical and administrative systems.
(G) The ACO shall define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care, such as through the use of telehealth, remote patient monitoring, and other such enabling technologies.
(H) The ACO shall demonstrate to the Secretary that it meets patient-centeredness criteria specified by the Secretary, such as the use of patient and caregiver assessments or the use of individualized care plans.
(I) An ACO that seeks to operate an ACO Beneficiary Incentive Program pursuant to subsection (m) shall apply to the Secretary at such time, in such manner, and with such information as the Secretary may require.
(3) Quality and other reporting requirements
(A) In general
The Secretary shall determine appropriate measures to assess the quality of care furnished by the ACO, such as measures of—
(i) clinical processes and outcomes;
(ii) patient and, where practicable, caregiver experience of care; and
(iii) utilization (such as rates of hospital admissions for ambulatory care sensitive conditions).
(B) Reporting requirements
An ACO shall submit data in a form and manner specified by the Secretary on measures the Secretary determines necessary for the ACO to report in order to evaluate the quality of care furnished by the ACO. Such data may include care transitions across health care settings, including hospital discharge planning and post-hospital discharge follow-up by ACO professionals, as the Secretary determines appropriate.
(C) Quality performance standards
The Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs. The Secretary shall seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing such quality of care.
(D) Other reporting requirements
The Secretary may, as the Secretary determines appropriate, incorporate reporting requirements and incentive payments related to the physician quality reporting initiative (PQRI) under
(4) No duplication in participation in shared savings programs
A provider of services or supplier that participates in any of the following shall not be eligible to participate in an ACO under this section:
(A) A model tested or expanded under
(B) The independence at home medical practice pilot program under
(c) Assignment of Medicare fee-for-service beneficiaries to ACOs
(1) In general
Subject to paragraph (2), the Secretary shall determine an appropriate method to assign Medicare fee-for-service beneficiaries to an ACO based on their utilization of—
(A) in the case of performance years beginning on or after April 1, 2012, primary care services provided under this subchapter by an ACO professional described in subsection (h)(1)(A); and
(B) in the case of performance years beginning on or after January 1, 2019, services provided under this subchapter by a Federally qualified health center or rural health clinic (as those terms are defined in
(2) Providing flexibility
(A) Choice of prospective assignment
For each agreement period (effective for agreements entered into or renewed on or after January 1, 2020), in the case where an ACO established under the program is in a Track that provides for the retrospective assignment of Medicare fee-for-service beneficiaries to the ACO, the Secretary shall permit the ACO to choose to have Medicare fee-for-service beneficiaries assigned prospectively, rather than retrospectively, to the ACO for an agreement period.
(B) Assignment based on voluntary identification by medicare fee-for-service beneficiaries
(i) In general
For performance year 2018 and each subsequent performance year, if a system is available for electronic designation, the Secretary shall permit a Medicare fee-for-service beneficiary to voluntarily identify an ACO professional as the primary care provider of the beneficiary for purposes of assigning such beneficiary to an ACO, as determined by the Secretary.
(ii) Notification process
The Secretary shall establish a process under which a Medicare fee-for-service beneficiary is—
(I) notified of their ability to make an identification described in clause (i); and
(II) informed of the process by which they may make and change such identification.
(iii) Superseding claims-based assignment
A voluntary identification by a Medicare fee-for-service beneficiary under this subparagraph shall supersede any claims-based assignment otherwise determined by the Secretary.
(d) Payments and treatment of savings
(1) Payments
(A) In general
Under the program, subject to paragraph (3), payments shall continue to be made to providers of services and suppliers participating in an ACO under the original Medicare fee-for-service program under parts A and B in the same manner as they would otherwise be made except that a participating ACO is eligible to receive payment for shared savings under paragraph (2) if—
(i) the ACO meets quality performance standards established by the Secretary under subsection (b)(3); and
(ii) the ACO meets the requirement under subparagraph (B)(i).
(B) Savings requirement and benchmark
(i) Determining savings
In each year of the agreement period, an ACO shall be eligible to receive payment for shared savings under paragraph (2) only if the estimated average per capita Medicare expenditures under the ACO for Medicare fee-for-service beneficiaries for parts A and B services, adjusted for beneficiary characteristics, is at least the percent specified by the Secretary below the applicable benchmark under clause (ii). The Secretary shall determine the appropriate percent described in the preceding sentence to account for normal variation in expenditures under this subchapter, based upon the number of Medicare fee-for-service beneficiaries assigned to an ACO.
(ii) Establish and update benchmark
The Secretary shall estimate a benchmark for each agreement period for each ACO using the most recent available 3 years of per-beneficiary expenditures for parts A and B services for Medicare fee-for-service beneficiaries assigned to the ACO. Such benchmark shall be adjusted for beneficiary characteristics and such other factors as the Secretary determines appropriate and updated by the projected absolute amount of growth in national per capita expenditures for parts A and B services under the original Medicare fee-for-service program, as estimated by the Secretary. Such benchmark shall be reset at the start of each agreement period.
(2) Payments for shared savings
Subject to performance with respect to the quality performance standards established by the Secretary under subsection (b)(3), if an ACO meets the requirements under paragraph (1), a percent (as determined appropriate by the Secretary) of the difference between such estimated average per capita Medicare expenditures in a year, adjusted for beneficiary characteristics, under the ACO and such benchmark for the ACO may be paid to the ACO as shared savings and the remainder of such difference shall be retained by the program under this subchapter. The Secretary shall establish limits on the total amount of shared savings that may be paid to an ACO under this paragraph.
(3) Monitoring avoidance of at-risk patients
If the Secretary determines that an ACO has taken steps to avoid patients at risk in order to reduce the likelihood of increasing costs to the ACO the Secretary may impose an appropriate sanction on the ACO, including termination from the program.
(4) Termination
The Secretary may terminate an agreement with an ACO if it does not meet the quality performance standards established by the Secretary under subsection (b)(3).
(e) Administration
(f) Waiver authority
The Secretary may waive such requirements of
(g) Limitations on review
There shall be no administrative or judicial review under
(1) the specification of criteria under subsection (a)(1)(B);
(2) the assessment of the quality of care furnished by an ACO and the establishment of performance standards under subsection (b)(3);
(3) the assignment of Medicare fee-for-service beneficiaries to an ACO under subsection (c);
(4) the determination of whether an ACO is eligible for shared savings under subsection (d)(2) and the amount of such shared savings, including the determination of the estimated average per capita Medicare expenditures under the ACO for Medicare fee-for-service beneficiaries assigned to the ACO and the average benchmark for the ACO under subsection (d)(1)(B);
(5) the percent of shared savings specified by the Secretary under subsection (d)(2) and any limit on the total amount of shared savings established by the Secretary under such subsection; and
(6) the termination of an ACO under subsection (d)(4) or of an ACO Beneficiary Incentive Program under subsections (b)(2)(I) and (m).
(h) Definitions
In this section:
(1) ACO professional
The term "ACO professional" means—
(A) a physician (as defined in
(B) a practitioner described in
(2) Hospital
The term "hospital" means a subsection (d) hospital (as defined in
(3) Medicare fee-for-service beneficiary
The term "Medicare fee-for-service beneficiary" means an individual who is enrolled in the original Medicare fee-for-service program under parts A and B and is not enrolled in an MA plan under part C, an eligible organization under
(i) Option to use other payment models
(1) In general
If the Secretary determines appropriate, the Secretary may use any of the payment models described in paragraph (2) or (3) for making payments under the program rather than the payment model described in subsection (d).
(2) Partial capitation model
(A) In general
Subject to subparagraph (B), a model described in this paragraph is a partial capitation model in which an ACO is at financial risk for some, but not all, of the items and services covered under parts A and B, such as at risk for some or all physicians' services or all items and services under part B. The Secretary may limit a partial capitation model to ACOs that are highly integrated systems of care and to ACOs capable of bearing risk, as determined to be appropriate by the Secretary.
(B) No additional program expenditures
Payments to an ACO for items and services under this subchapter for beneficiaries for a year under the partial capitation model shall be established in a manner that does not result in spending more for such ACO for such beneficiaries than would otherwise be expended for such ACO for such beneficiaries for such year if the model were not implemented, as estimated by the Secretary.
(3) Other payment models
(A) In general
Subject to subparagraph (B), a model described in this paragraph is any payment model that the Secretary determines will improve the quality and efficiency of items and services furnished under this subchapter.
(B) No additional program expenditures
Subparagraph (B) of paragraph (2) shall apply to a payment model under subparagraph (A) in a similar manner as such subparagraph (B) applies to the payment model under paragraph (2).
(j) Involvement in private payer and other third party arrangements
The Secretary may give preference to ACOs who are participating in similar arrangements with other payers.
(k) Treatment of physician group practice demonstration
During the period beginning on March 23, 2010, and ending on the date the program is established, the Secretary may enter into an agreement with an ACO under the demonstration under
(l) Providing ACOs the ability to expand the use of telehealth services
(1) In general
In the case of telehealth services for which payment would otherwise be made under this subchapter furnished on or after January 1, 2020, for purposes of this subsection only, the following shall apply with respect to such services furnished by a physician or practitioner participating in an applicable ACO (as defined in paragraph (2)) to a Medicare fee-for-service beneficiary assigned to the applicable ACO:
(A) Inclusion of home as originating site
Subject to paragraph (3), the home of a beneficiary shall be treated as an originating site described in
(B) No application of geographic limitation
The geographic limitation under
(2) Definitions
In this subsection:
(A) Applicable ACO
The term "applicable ACO" means an ACO participating in a model tested or expanded under
(i) that operates under a two-sided model—
(I) described in section 425.600(a) of title 42, Code of Federal Regulations; or
(II) tested or expanded under
(ii) for which Medicare fee-for-service beneficiaries are assigned to the ACO using a prospective assignment method, as determined appropriate by the Secretary.
(B) Home
The term "home" means, with respect to a Medicare fee-for-service beneficiary, the place of residence used as the home of the beneficiary.
(3) Telehealth services received in the home
In the case of telehealth services described in paragraph (1) where the home of a Medicare fee-for-service beneficiary is the originating site, the following shall apply:
(A) No facility fee
There shall be no facility fee paid to the originating site under
(B) Exclusion of certain services
No payment may be made for such services that are inappropriate to furnish in the home setting such as services that are typically furnished in inpatient settings such as a hospital.
(m) Authority to provide incentive payments to beneficiaries with respect to qualifying primary care services
(1) Program
(A) In general
In order to encourage Medicare fee-for-service beneficiaries to obtain medically necessary primary care services, an ACO participating under this section under a payment model described in clause (i) or (ii) of paragraph (2)(B) may apply to establish an ACO Beneficiary Incentive Program to provide incentive payments to such beneficiaries who are furnished qualifying services in accordance with this subsection. The Secretary shall permit such an ACO to establish such a program at the Secretary's discretion and subject to such requirements, including program integrity requirements, as the Secretary determines necessary.
(B) Implementation
The Secretary shall implement this subsection on a date determined appropriate by the Secretary. Such date shall be no earlier than January 1, 2019, and no later than January 1, 2020.
(2) Conduct of program
(A) Duration
Subject to subparagraph (H), an ACO Beneficiary Incentive Program established under this subsection shall be conducted for such period (of not less than 1 year) as the Secretary may approve.
(B) Scope
An ACO Beneficiary Incentive Program established under this subsection shall provide incentive payments to all of the following Medicare fee-for-service beneficiaries who are furnished qualifying services by the ACO:
(i) With respect to the Track 2 and Track 3 payment models described in section 425.600(a) of title 42, Code of Federal Regulations (or in any successor regulation), Medicare fee-for-service beneficiaries who are preliminarily prospectively or prospectively assigned (or otherwise assigned, as determined by the Secretary) to the ACO.
(ii) With respect to any future payment models involving two-sided risk, Medicare fee-for-service beneficiaries who are assigned to the ACO, as determined by the Secretary.
(C) Qualifying service
For purposes of this subsection, a qualifying service is a primary care service, as defined in section 425.20 of title 42, Code of Federal Regulations (or in any successor regulation), with respect to which coinsurance applies under part B, furnished through an ACO by—
(i) an ACO professional described in subsection (h)(1)(A) who has a primary care specialty designation included in the definition of primary care physician under section 425.20 of title 42, Code of Federal Regulations (or any successor regulation);
(ii) an ACO professional described in subsection (h)(1)(B); or
(iii) a Federally qualified health center or rural health clinic (as such terms are defined in
(D) Incentive payments
An incentive payment made by an ACO pursuant to an ACO Beneficiary Incentive Program established under this subsection shall be—
(i) in an amount up to $20, with such maximum amount updated annually by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year;
(ii) in the same amount for each Medicare fee-for-service beneficiary described in clause (i) or (ii) of subparagraph (B) without regard to enrollment of such a beneficiary in a medicare supplemental policy (described in
(iii) made for each qualifying service furnished to such a beneficiary described in clause (i) or (ii) of subparagraph (B) during a period specified by the Secretary; and
(iv) made no later than 30 days after a qualifying service is furnished to such a beneficiary described in clause (i) or (ii) of subparagraph (B).
(E) No separate payments from the Secretary
The Secretary shall not make any separate payment to an ACO for the costs, including incentive payments, of carrying out an ACO Beneficiary Incentive Program established under this subsection. Nothing in this subparagraph shall be construed as prohibiting an ACO from using shared savings received under this section to carry out an ACO Beneficiary Incentive Program.
(F) No application to shared savings calculation
Incentive payments made by an ACO under this subsection shall be disregarded for purposes of calculating benchmarks, estimated average per capita Medicare expenditures, and shared savings under this section.
(G) Reporting requirements
An ACO conducting an ACO Beneficiary Incentive Program under this subsection shall, at such times and in such format as the Secretary may require, report to the Secretary such information and retain such documentation as the Secretary may require, including the amount and frequency of incentive payments made and the number of Medicare fee-for-service beneficiaries receiving such payments.
(H) Termination
The Secretary may terminate an ACO Beneficiary Incentive Program established under this subsection at any time for reasons determined appropriate by the Secretary.
(3) Exclusion of incentive payments
Any payment made under an ACO Beneficiary Incentive Program established under this subsection shall not be considered income or resources or otherwise taken into account for purposes of—
(A) determining eligibility for benefits or assistance (or the amount or extent of benefits or assistance) under any Federal program or under any State or local program financed in whole or in part with Federal funds; or
(B) any Federal or State laws relating to taxation.
(Aug. 14, 1935, ch. 531, title XVIII, §1899, as added and amended
Editorial Notes
Amendments
2018—Subsec. (b)(2)(I).
Subsec. (c).
Subsec. (e).
Subsec. (g)(6).
Subsec. (l).
Subsec. (m).
2016—Subsec. (c).
2010—Subsecs. (i) to (k).
Statutory Notes and Related Subsidiaries
Study and Report
"(1)
"(A)
"(B)
"(2)
1 So in original. No par. (2) has been enacted.
§1395kkk. Repealed. Pub. L. 115–123, div. E, title XI, §52001(a), Feb. 9, 2018, 132 Stat. 298
Section, Aug. 14, 1935, ch. 531, title XVIII, §1899A, as added and amended
Statutory Notes and Related Subsidiaries
Change of Name
Construction
§1395kkk–1. Repealed. Pub. L. 115–123, div. E, title XI, §52001(b)(2), Feb. 9, 2018, 132 Stat. 298
Section,
§1395lll. Standardized post-acute care (PAC) assessment data for quality, payment, and discharge planning
(a) Requirement for standardized assessment data
(1) In general
The Secretary shall—
(A) require under the applicable reporting provisions post-acute care providers (as defined in paragraph (2)(A)) to report—
(i) standardized patient assessment data in accordance with subsection (b);
(ii) data on quality measures under subsection (c)(1); and
(iii) data on resource use and other measures under subsection (d)(1);
(B) require data described in subparagraph (A) to be standardized and interoperable so as to allow for the exchange of such data among such post-acute care providers and other providers and the use by such providers of such data that has been so exchanged, including by using common standards and definitions, in order to provide access to longitudinal information for such providers to facilitate coordinated care and improved Medicare beneficiary outcomes; and
(C) in accordance with subsections (b)(1) and (c)(2), modify PAC assessment instruments (as defined in paragraph (2)(B)) applicable to post-acute care providers to—
(i) provide for the submission of standardized patient assessment data under this subchapter with respect to such providers; and
(ii) enable comparison of such assessment data across all such providers to whom such data are applicable.
(2) Definitions
For purposes of this section:
(A) Post-acute care (PAC) provider
The terms "post-acute care provider" and "PAC provider" mean—
(i) a home health agency;
(ii) a skilled nursing facility;
(iii) an inpatient rehabilitation facility; and
(iv) a long-term care hospital (other than a hospital classified under
(B) PAC assessment instrument
The term "PAC assessment instrument" means—
(i) in the case of home health agencies, the instrument used for purposes of reporting and assessment with respect to the Outcome and Assessment Information Set (OASIS), as described in sections 484.55 and 484.250 of title 42, the Code of Federal Regulations, or any successor regulation, or any other instrument used with respect to home health agencies for such purposes;
(ii) in the case of skilled nursing facilities, the resident's assessment under
(iii) in the case of inpatient rehabilitation facilities, any Medicare beneficiary assessment instrument established by the Secretary for purposes of
(iv) in the case of long-term care hospitals, the Medicare beneficiary assessment instrument used with respect to such hospitals for the collection of data elements necessary to calculate quality measures as described in the August 18, 2011, Federal Register (76 Fed. Reg. 51754–51755), including for purposes of
(C) Applicable reporting provision
The term "applicable reporting provision" means—
(i) for home health agencies,
(ii) for skilled nursing facilities,
(iii) for inpatient rehabilitation facilities,
(iv) for long-term care hospitals,
(D) PAC payment system
The term "PAC payment system" means—
(i) with respect to a home health agency, the prospective payment system under
(ii) with respect to a skilled nursing facility, the prospective payment system under
(iii) with respect to an inpatient rehabilitation facility, the prospective payment system under
(iv) with respect to a long-term care hospital, the prospective payment system under
(E) Specified application date
The term "specified application date" means the following:
(i) Quality measures
In the case of quality measures under subsection (c)(1)—
(I) with respect to the domain described in subsection (c)(1)(A) (relating to functional status, cognitive function, and changes in function and cognitive function)—
(aa) for PAC providers described in clauses (ii) and (iii) of paragraph (2)(A), October 1, 2016;
(bb) for PAC providers described in clause (iv) of such paragraph, October 1, 2018; and
(cc) for PAC providers described in clause (i) of such paragraph, January 1, 2019;
(II) with respect to the domain described in subsection (c)(1)(B) (relating to skin integrity and changes in skin integrity)—
(aa) for PAC providers described in clauses (ii), (iii), and (iv) of paragraph (2)(A), October 1, 2016; and
(bb) for PAC providers described in clause (i) of such paragraph, January 1, 2017;
(III) with respect to the domain described in subsection (c)(1)(C) (relating to medication reconciliation)—
(aa) for PAC providers described in clause (i) of such paragraph, January 1, 2017; and
(bb) for PAC providers described in clauses (ii), (iii), and (iv) of such paragraph, October 1, 2018;
(IV) with respect to the domain described in subsection (c)(1)(D) (relating to incidence of major falls)—
(aa) for PAC providers described in clauses (ii), (iii), and (iv) of paragraph (2)(A), October 1, 2016; and
(bb) for PAC providers described in clause (i) of such paragraph, January 1, 2019; and
(V) with respect to the domain described in subsection (c)(1)(E) (relating to accurately communicating the existence of and providing for the transfer of health information and care preferences)—
(aa) for PAC providers described in clauses (ii), (iii), and (iv) of paragraph (2)(A), October 1, 2018; and
(bb) for PAC providers described in clause (i) of such paragraph, January 1, 2019.
(ii) Resource use and other measures
In the case of resource use and other measures under subsection (d)(1)—
(I) for PAC providers described in clauses (ii), (iii), and (iv) of paragraph (2)(A), October 1, 2016; and
(II) for PAC providers described in clause (i) of such paragraph, January 1, 2017.
(F) Medicare beneficiary
The term "Medicare beneficiary" means an individual entitled to benefits under part A or, as appropriate, enrolled for benefits under part B.
(b) Standardized patient assessment data
(1) Requirement for reporting assessment data
(A) In general
Beginning not later than October 1, 2018, for PAC providers described in clauses (ii), (iii), and (iv) of subsection (a)(2)(A) and January 1, 2019, for PAC providers described in clause (i) of such subsection, the Secretary shall require PAC providers to submit to the Secretary, under the applicable reporting provisions and through the use of PAC assessment instruments, the standardized patient assessment data described in subparagraph (B). The Secretary shall require such data be submitted with respect to admission and discharge of an individual (and may be submitted more frequently as the Secretary deems appropriate).
(B) Standardized patient assessment data described
For purposes of subparagraph (A), the standardized patient assessment data described in this subparagraph is data required for at least the quality measures described in subsection (c)(1) and that is with respect to the following categories:
(i) Functional status, such as mobility and self care at admission to a PAC provider and before discharge from a PAC provider.
(ii) Cognitive function, such as ability to express ideas and to understand, and mental status, such as depression and dementia.
(iii) Special services, treatments, and interventions, such as need for ventilator use, dialysis, chemotherapy, central line placement, and total parenteral nutrition.
(iv) Medical conditions and co-morbidities, such as diabetes, congestive heart failure, and pressure ulcers.
(v) Impairments, such as incontinence and an impaired ability to hear, see, or swallow.
(vi) Other categories deemed necessary and appropriate by the Secretary.
(2) Alignment of claims data with standardized patient assessment data
To the extent practicable, not later than October 1, 2018, for PAC providers described in clauses (ii), (iii), and (iv) of subsection (a)(2)(A), and January 1, 2019, for PAC providers described in clause (i) of such subsection, the Secretary shall match claims data with assessment data pursuant to this section for purposes of assessing prior service use and concurrent service use, such as antecedent hospital or PAC provider use, and may use such matched data for such other uses as the Secretary determines appropriate.
(3) Replacement of certain existing data
In the case of patient assessment data being used with respect to a PAC assessment instrument that duplicates or overlaps with standardized patient assessment data within a category described in paragraph (1), the Secretary shall, as soon as practicable, revise or replace such existing data with the standardized data.
(4) Clarification
Standardized patient assessment data submitted pursuant to this subsection shall not be used to require individuals to be provided post-acute care by a specific type of PAC provider in order for such care to be eligible for payment under this subchapter.
(c) Quality measures
(1) Requirement for reporting quality measures
Not later than the specified application date, as applicable to measures and PAC providers, the Secretary shall specify quality measures on which PAC providers are required under the applicable reporting provisions to submit standardized patient assessment data described in subsection (b)(1) and other necessary data specified by the Secretary. Such measures shall be with respect to at least the following domains:
(A) Functional status, cognitive function, and changes in function and cognitive function.
(B) Skin integrity and changes in skin integrity.
(C) Medication reconciliation.
(D) Incidence of major falls.
(E) Accurately communicating the existence of and providing for the transfer of health information and care preferences of an individual to the individual, family caregiver of the individual, and providers of services furnishing items and services to the individual, when the individual transitions—
(i) from a hospital or critical access hospital to another applicable setting, including a PAC provider or the home of the individual; or
(ii) from a PAC provider to another applicable setting, including a different PAC provider, a hospital, a critical access hospital, or the home of the individual.
(2) Reporting through PAC assessment instruments
(A) In general
To the extent possible, the Secretary shall require such reporting by a PAC provider of quality measures under paragraph (1) through the use of a PAC assessment instrument and shall modify such PAC assessment instrument as necessary to enable the use of such instrument with respect to such quality measures.
(B) Limitation
The Secretary may not make significant modifications to a PAC assessment instrument more than once per calendar year or fiscal year, as applicable, unless the Secretary publishes in the Federal Register a justification for such significant modification.
(3) Adjustments
(A) In general
The Secretary shall consider applying adjustments to the quality measures under this subsection taking into consideration the studies under section 2(d) of the IMPACT Act of 2014.
(B) Risk adjustment
Such quality measures shall be risk adjusted, as determined appropriate by the Secretary.
(d) Resource use and other measures
(1) Requirement for resource use and other measures
Not later than the specified application date, as applicable to measures and PAC providers, the Secretary shall specify resource use and other measures on which PAC providers are required under the applicable reporting provisions to submit any necessary data specified by the Secretary, which may include standardized assessment data in addition to claims data. Such measures shall be with respect to at least the following domains:
(A) Resource use measures, including total estimated Medicare spending per beneficiary.
(B) Discharge to community.
(C) Measures to reflect all-condition risk-adjusted potentially preventable hospital readmission rates.
(2) Aligning methodology adjustments for resource use measures
(A) Period of time
With respect to the period of time used for calculating measures under paragraph (1)(A), the Secretary shall, to the extent the Secretary determines appropriate, align resource use with the methodology used for purposes of
(B) Geographic and other adjustments
The Secretary shall standardize measures with respect to the domain described in paragraph (1)(A) for geographic payment rate differences and payment differentials (and other adjustments, as applicable) consistent with the methodology published in the Federal Register on August 18, 2011 (76 Fed. Reg. 51624 through 51626), or any subsequent modifications made to the methodology.
(C) Medicare spending per beneficiary
The Secretary shall adjust, as appropriate, measures with respect to the domain described in paragraph (1)(A) for the factors applied under
(3) Adjustments
(A) In general
The Secretary shall consider applying adjustments to the resource use and other measures specified under this subsection with respect to the domain described in paragraph (1)(A), taking into consideration the studies under section 2(d) of the IMPACT Act of 2014.
(B) Risk adjustment
Such resource use and other measures shall be risk adjusted, as determined appropriate by the Secretary.
(e) Measurement implementation phases; selection of quality measures and resource use and other measures
(1) Measurement implementation phases
In the case of quality measures specified under subsection (c)(1) and resource use and other measures specified under subsection (d)(1), the provisions of this section shall be implemented in accordance with the following phases:
(A) Initial implementation phase
The initial implementation phase, with respect to such a measure, shall, in accordance with subsections (c) and (d), as applicable, consist of—
(i) measure specification, including informing the public of the measure's numerator, denominator, exclusions, and any other aspects the Secretary determines necessary;
(ii) data collection, including, in the case of quality measures, requiring PAC providers to report data elements needed to calculate such a measure; and
(iii) data analysis, including, in the case of resource use and other measures, the use of claims data to calculate such a measure.
(B) Second implementation phase
The second implementation phase, with respect to such a measure, shall consist of the provision of feedback reports to PAC providers, in accordance with subsection (f).
(C) Third implementation phase
The third implementation phase, with respect to such a measure, shall consist of public reporting of PAC providers' performance on such measure in accordance with subsection (g).
(2) Consensus-based entity
(A) In general
Subject to subparagraph (B), each measure specified by the Secretary under this section shall be endorsed by the entity with a contract under
(B) Exception
In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under
(3) Treatment of application of pre-rulemaking process (measure applications partnership process)
(A) In general
Subject to subparagraph (B), the provisions of
(B) Exceptions
(i) Expedited procedures
For purposes of satisfying subparagraph (A), the Secretary may use expedited procedures, such as ad-hoc reviews, as necessary, in the case of a quality measure specified under subsection (c) or a resource use or other measure specified in subsection (d) required with respect to data submissions under the applicable reporting provisions during the 1-year period before the specified application date applicable to such a measure and provider involved.
(ii) Option to waive provisions
The Secretary may waive the application of the provisions of
(f) Feedback reports to PAC providers
(1) In general
Beginning one year after the specified application date, as applicable to PAC providers and quality measures and resource use and other measures under this section, the Secretary shall provide confidential feedback reports to such PAC providers on the performance of such providers with respect to such measures required under the applicable provisions.
(2) Frequency
To the extent feasible, the Secretary shall provide feedback reports described in paragraph (1) not less frequently than on a quarterly basis. Notwithstanding the previous sentence, with respect to measures described in such paragraph that are reported on an annual basis, the Secretary may provide such feedback reports on an annual basis.
(g) Public reporting of PAC provider performance
(1) In general
Subject to the succeeding paragraphs of this subsection, the Secretary shall provide for public reporting of PAC provider performance on quality measures under subsection (c)(1) and the resource use and other measures under subsection (d)(1), including by establishing procedures for making available to the public information regarding the performance of individual PAC providers with respect to such measures.
(2) Opportunity to review
The procedures under paragraph (1) shall ensure, including through a process consistent with the process applied under
(3) Timing
Such procedures shall provide that the data and information described in paragraph (1), with respect to a measure and PAC provider, is made publicly available beginning not later than two years after the specified application date applicable to such a measure and provider.
(4) Coordination with existing programs
Such procedures shall provide that data and information described in paragraph (1) with respect to quality measures and resource use and other measures under subsections (c)(1) and (d)(1) shall be made publicly available consistent with the following provisions:
(A) In the case of home health agencies,
(B) In the case of skilled nursing facilities,
(C) In the case of inpatient rehabilitation facilities,
(D) In the case of long-term care hospitals,
(h) Removing, suspending, or adding measures
(1) In general
The Secretary may remove, suspend, or add a quality measure or resource use or other measure described in subsection (c)(1) or (d)(1), so long as, subject to paragraph (2), the Secretary publishes in the Federal Register (with a notice and comment period) a justification for such removal, suspension, or addition.
(2) Exception
In the case of such a quality measure or resource use or other measure for which there is a reason to believe that the continued collection of such measure raises potential safety concerns or would cause other unintended consequences, the Secretary may promptly suspend or remove such measure and satisfy paragraph (1) by publishing in the Federal Register a justification for such suspension or removal in the next rulemaking cycle following such suspension or removal.
(i) Use of standardized assessment data, quality measures, and resource use and other measures to inform discharge planning and incorporate patient preference
(1) In general
Not later than January 1, 2016, and periodically thereafter (but not less frequently than once every 5 years), the Secretary shall promulgate regulations to modify conditions of participation and subsequent interpretive guidance applicable to PAC providers, hospitals, and critical access hospitals. Such regulations and interpretive guidance shall require such providers to take into account quality, resource use, and other measures under the applicable reporting provisions (which, as available, shall include measures specified under subsections (c) and (d), and other relevant measures) in the discharge planning process. Specifically, such regulations and interpretive guidance shall address the settings to which a patient may be discharged in order to assist subsection (d) hospitals, critical access hospitals, hospitals described in
(A) treatment preferences of patients; and
(B) goals of care of patients.
(2) Discharge planning
All requirements applied pursuant to paragraph (1) shall be used to help inform and mandate the discharge planning process.
(3) Clarification
Such regulations shall not require an individual to be provided post-acute care by a specific type of PAC provider in order for such care to be eligible for payment under this subchapter.
(j) Stakeholder input
Before the initial rulemaking process to implement this section, the Secretary shall allow for stakeholder input, such as through town halls, open door forums, and mail-box submissions.
(k) Funding
For purposes of carrying out this section, the Secretary shall provide for the transfer to the Centers for Medicare & Medicaid Services Program Management Account, from the Federal Hospital Insurance Trust Fund under
(l) Limitation
There shall be no administrative or judicial review under
(m) Non-application of Paperwork Reduction Act
(Aug. 14, 1935, ch. 531, title XVIII, §1899B, as added
Editorial Notes
References in Text
Section 2(d) of the IMPACT Act of 2014, referred to in subsecs. (c)(3)(A) and (d)(3)(A), is section 2(d) of
Amendments
2016—Subsec. (a)(2)(A)(iv).
Statutory Notes and Related Subsidiaries
Permitting Occupational Therapists To Conduct the Initial Assessment Visit and Complete the Comprehensive Assessment With Respect to Certain Rehabilitation Services for Home Health Agencies Under the Medicare Program
"(1) does not initially include skilled nursing care;
"(2) includes occupational therapy; and
"(3) includes physical therapy or speech language pathology."
Improving Payment Accuracy Under the PAC Payment Systems and Other Medicare Payment Systems
"(1)
"(A)
"(i)
"(ii)
"(B)
"(i)
"(ii)
"(C)
"(D)
"(i) obtain access to the necessary data (if such data is not already being collected) on such factors, including recommendations on how to address barriers to the Centers in accessing such data; and
"(ii) account for such factors—
"(I) in quality measures, resource use measures, and other measures under title XVIII of the Social Security Act (including such measures specified under subsections (c) and (d) of section 1899B of such Act [
"(II) in determining payment adjustments based on such measures in other applicable provisions of such title.
"(E)
"(2)
"(A)
"(i) assess appropriate adjustments to quality measures, resource use measures, and other measures under title XVIII of the Social Security Act (
"(ii) assess and implement appropriate adjustments to payments under such title based on measures described in clause (i).
"(B)
"(C)
"(D)
"(3)