SUBCHAPTER II—GENERAL POWERS AND DUTIES
Subchapter Referred to in Other Sections
This subchapter is referred to in title 8 section 1613.
Part A—Research and Investigations
§241. Research and investigations generally
(a) Authority of Secretary
The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to—
(1) collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities;
(2) make available research facilities of the Service to appropriate public authorities, and to health officials and scientists engaged in special study;
(3) make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects and make, upon recommendation of the advisory council to the appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research;
(4) secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad;
(5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons not otherwise eligible for such treatment;
(6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical methods to experiments, studies, and surveys in health and medical fields;
(7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under
(8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers necessary or appropriate to carry out the purposes of this section.
The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(b) Testing for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects; consultation
(1) The Secretary shall conduct and may support through grants and contracts studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the Secretary shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.
(2)(A) The Secretary shall establish a comprehensive program of research into the biological effects of low-level ionizing radiation under which program the Secretary shall conduct such research and may support such research by others through grants and contracts.
(B) The Secretary shall conduct a comprehensive review of Federal programs of research on the biological effects of ionizing radiation.
(3) The Secretary shall conduct and may support through grants and contracts research and studies on human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and on the maintenance and promotion of health, and programs for the dissemination of information respecting human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of these activities as are performed by the different divisions within the Department of Health and Human Services and shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct and support such activities for such entity.
(4) The Secretary shall publish a biennial report which contains—
(A) a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing in the United States are exposed;
(B) information concerning the nature of such exposure and the estimated number of persons exposed to such substances;
(C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance; and
(D) a description of (i) each request received during the year involved—
(I) from a Federal agency outside the Department of Health and Human Services for the Secretary, or
(II) from an entity within the Department of Health and Human Services to any other entity within the Department,
to conduct research into, or testing for, the carcinogenicity of substances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity, respectively, have responded to each such request.
(5) The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research, or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts.
(c) Diseases not significantly occurring in United States
The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.
(d) Protection of privacy of individuals who are research subjects
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.
(July 1, 1944, ch. 373, title III, §301,
Amendments
1993—Subsec. (b)(4).
1988—Subsec. (d).
1986—Subsec. (a)(3).
Subsec. (c).
1985—Subsec. (a)(3).
Subsec. (a)(8).
1978—
1976—Subsecs. (c), (h).
1974—Subsec. (c).
Subsec. (d).
Subsecs. (e), (f).
Subsec. (g).
Subsecs. (h), (i).
1972—Subsecs. (d), (i).
1971—Subsecs. (d), (i).
1970—Subsec. (d).
Subsec. (h).
1967—Subsec. (h).
1965—Subsecs. (h), (i).
1962—Subsec. (d).
1960—Subsec. (d).
1956—Subsecs. (g), (h). Act July 3, 1956, added subsec. (g) and redesignated former subsec. (g) as (h).
1948—Subsec. (d). Acts June 16, 1948, §4(e), and June 24, 1948, §4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (d). Act June 25, 1948, continued in basic legislation the authority to purchase penicillin and other antibiotic compounds for use in research projects.
Subsec. (g). Acts June 16, 1948, §4(f), and June 24, 1948, §4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
1946—Subsec. (d). Act July 3, 1946, made the National Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of grants-in-aid for research projects with respect to mental health.
Subsec. (g). Act July 3, 1946, gave National Advisory Health Council the right to make recommendations to carry out purposes of this section.
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a)(7), and "Department of Health and Human Services" substituted for "Department of Health, Education, and Welfare" in subsec. (b)(1), (3), and (4)(D)(I), (II), pursuant to section 509(b) of
Effective Date of 1978 Amendment
Sections 261 and 262 of
Effective Date of 1974 Amendment
Section 104(b) of
Effective Date of 1972 Amendment
Amendment by
Effective Date of 1971 Amendment
Amendment by
Coordination of Data Surveys and Reports
Female Genital Mutilation
"(a) Congress finds that—
"(1) the practice of female genital mutilation is carried out by members of certain cultural and religious groups within the United States; and
"(2) the practice of female genital mutilation often results in the occurrence of physical and psychological health effects that harm the women involved.
"(b) The Secretary of Health and Human Services shall do the following:
"(1) Compile data on the number of females living in the United States who have been subjected to female genital mutilation (whether in the United States or in their countries of origin), including a specification of the number of girls under the age of 18 who have been subjected to such mutilation.
"(2) Identify communities in the United States that practice female genital mutilation, and design and carry out outreach activities to educate individuals in the communities on the physical and psychological health effects of such practice. Such outreach activities shall be designed and implemented in collaboration with representatives of the ethnic groups practicing such mutilation and with representatives of organizations with expertise in preventing such practice.
"(3) Develop recommendations for the education of students of schools of medicine and osteopathic medicine regarding female genital mutilation and complications arising from such mutilation. Such recommendations shall be disseminated to such schools.
"(c) For purposes of this section the term 'female genital mutilation' means the removal or infibulation (or both) of the whole or part of the clitoris, the labia minor, or the labia major.
"(d) The Secretary of Health and Human Services shall commence carrying out this section not later than 90 days after the date of enactment of this Act [Apr. 26, 1996]."
Sentinel Disease Concept Study
Section 1910 of
Study of Thyroid Morbidity for Hanford, Washington
Section 161 of
National Commission on Sleep Disorders Research
Section 162 of
Research With Respect to Health Resources and Services Administration
Section 632 of
Continuing Care for Psychiatric Patients in Former Clinical Research Center at National Institute on Drug Abuse
Analysis of Thyroid Cancer; Creation and Publication of Radioepidemiological Tables
"(a) In carrying out section 301 of the Public Health Service Act [this section], the Secretary of Health and Human Services shall—
"(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131;
"(2) conduct scientific research and prepare analyses necessary to develop valid and credible methods to estimate the thyroid doses of Iodine 131 that are received by individuals from nuclear bomb fallout;
"(3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric nuclear bomb tests; and
"(4) prepare and transmit to the Congress within one year after the date of enactment of this Act [Jan. 4, 1983] a report with respect to the activities conducted in carrying out paragraphs (1), (2), and (3).
"(b)(1) Within one year after the date of enactment of this Act [Jan. 4, 1983], the Secretary of Health and Human Services shall devise and publish radioepidemiological tables that estimate the likelihood that persons who have or have had any of the radiation related cancers and who have received specific doses prior to the onset of such disease developed cancer as a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from 1 millirad to 1,000 rads in terms of sex, age at time of exposure, time from exposure to the onset of the cancer in question, and such other categories as the Secretary, after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation shall be calculated and displayed as a single percentage figure.
"(2) At the time the Secretary of Health and Human Services publishes the tables pursuant to paragraph (1), such Secretary shall also publish—
"(A) for the tables of each radiation related cancer, an evaluation which will assess the credibility, validity, and degree of certainty associated with such tables; and
"(B) a compilation of the formulas that yielded the probabilities of causation listed in such tables. Such formulas shall be published in such a manner and together with information necessary to determine the probability of causation of any individual who has or has had a radiation related cancer and has received any given dose.
"(3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from the best available data that are most applicable to the United States, and shall be devised in accordance with the best available scientific procedures and expertise. The Secretary of Health and Human Services shall update these tables and formulas every four years, or whenever he deems it necessary to insure that they continue to represent the best available scientific data and expertise."
Termination of Advisory Committees
Section Referred to in Other Sections
This section is referred to in
§242. Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States
(a) In carrying out the purposes of
(b) The Surgeon General shall cooperate with States for the purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the States the benefit of his experience in the care, treatment, and rehabilitation of narcotic addicts to the end that each State may be encouraged to provide adequate facilities and methods for the care and treatment of its narcotic addicts.
(July 1, 1944, ch. 373, title III, §302,
References in Text
The Controlled Substances Act, referred to in subsec. (a), is title II of
The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of
Amendments
1970—Subsec. (a).
Effective Date of 1970 Amendment
Amendment by
Savings Provision
Amendment by
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Marihuana and Health Reporting
§242a. Repealed. Pub. L. 106–310, div. B, title XXXII, §3201(b)(1), Oct. 17, 2000, 114 Stat. 1190
Section, act July 1, 1944, ch. 373, title III, §303, as added July 3, 1946, ch. 538, §7(c),
§242b. General authority respecting research, evaluations, and demonstrations in health statistics, health services, and health care technology
(a) Scope of activities
The Secretary may, through the Agency for Healthcare Research and Quality or the National Center for Health Statistics, or using National Research Service Awards or other appropriate authorities, undertake and support training programs to provide for an expanded and continuing supply of individuals qualified to perform the research, evaluation, and demonstration projects set forth in
(b) Additional authority; scope of activities
To implement subsection (a) of this section and
(1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the physical resources of such Department, provide technical assistance and advice, make grants to public and nonprofit private entities and individuals, and, when appropriate, enter into contracts with public and private entities and individuals.
(2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and treatment at such facilities.
(3) Secure, from time to time and for such periods as the Secretary deems advisable but in accordance with
(4) Acquire, construct, improve, repair, operate, and maintain laboratory, research, and other necessary facilities and equipment, and such other real or personal property (including patents) as the Secretary deems necessary; and acquire, without regard to
(c) Coordination of activities through units of Department
(1) The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical and epidemiological activities, and all research, evaluations, and demonstrations respecting the assessment of health care technology undertaken and supported through units of the Department of Health and Human Services. To the maximum extent feasible such coordination shall be carried out through the Agency for Healthcare Research and Quality and the National Center for Health Statistics.
(2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health statistical and (where appropriate) epidemiological activities, and the research, evaluations, and demonstrations respecting the assessment of health care technology authorized by this chapter through the Agency for Healthcare Research and Quality and the National Center for Health Statistics.
(July 1, 1944, ch. 373, title III, §304, as added July 28, 1955, ch. 417, §3,
References in Text
Amendments
1999—Subsecs. (a), (c).
1993—Subsec. (d).
1989—Subsec. (a).
Subsec. (b).
Subsec. (c)(1), (2).
1984—Subsec. (a)(1).
Subsec. (a)(3).
Subsec. (c)(1), (2).
1981—Subsec. (a)(3).
Subsecs. (b)(1), (c)(1).
Subsec. (d)(1).
Subsec. (d)(3).
1979—Subsec. (b)(1), (3).
Subsec. (d).
1978—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b)(1).
Subsec. (b)(3).
Subsec. (c).
Subsec. (d).
1974—
1973—Subsec. (c)(1).
1970—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b).
Subsecs. (c), (d).
1967—
1956—Act Aug. 2, 1956, changed heading of section 304 of act July 1, 1944 from "Grants for special projects in mental health" to "Mental health study grants". Section heading has been changed for purposes of codification.
Effective Date of 1970 Amendments
Section 201(d) of
Section 401(b)(1) of
Effective Date of 1956 Amendment
Amendment of section by act Aug. 2, 1956, effective July 1, 1956, see section 503 of act Aug. 2, 1956.
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Model Standards With Respect to Preventive Health Services in Communities
Transfer of Equipment
Congressional Declaration of Purpose
Section 2 of Joint Res. July 28, 1955, provides a Congressional statement of the critical need for an analysis and reevaluation of the human and economic problems of mental illness and of the resources, methods, and practices utilized in diagnosing, treating, caring for, and rehabilitating the mentally ill, both within and outside of institutions, as might lead to the development of recommendations for such better utilization of those resources or such improvements on and new developments in methods of diagnosis, treatment, care, and rehabilitation as give promise of resulting in a marked reduction in the incidence or duration of mental illness and, in consequence, a lessening of the appalling emotional and financial drain on the families of those afflicted or on the economic resources of the States and of the Nation and a declaration of the policy to promote mental health and to help solve the complex and the interrelated problems posed by mental illness by encouraging the undertaking of nongovernmental, multidisciplinary research into and reevaluation of all aspects of our resources, methods, and practices for diagnosing, treating, caring for, and rehabilitating the mentally ill, including research aimed at the prevention of mental illness.
Children's Emotional Illness Study; Program Grants; Conditions; Definitions; Appropriations; Terms of Grant
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§242c. Repealed. Pub. L. 101–239, title VI, §6103(d)(1)(A), Dec. 19, 1989, 103 Stat. 2205
Section, act July 1, 1944, ch. 373, title III, §305, as added July 3, 1956, ch. 510, §3,
Termination of National Center for Health Services Research and Health Care Technology Assessment
Section 6103(d)(1)(A) of
Transitional and Savings Provisions for Pub. L. 101–239
For provision transferring personnel of Department of Health and Human Services employed on Dec. 19, 1989, in connection with functions vested in Administrator for Health Care Policy and Research pursuant to amendments made by section 6103 of
§242d. Transferred
Codification
Section, act July 1, 1944, ch. 373, title III, §306, as added Aug. 2, 1956, ch. 871, title I, §101,
§242e. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section, act July 1, 1944, ch. 373, title III, §307, as added Aug. 2, 1956, ch. 871, title II, §201,
§§242f to 242j. Transferred
Codification
Section 242f, act July 1, 1944, ch. 373, title III, §308, as added July 12, 1960,
Section 242g, act July 1, 1944, ch. 373, title III, §309, as added Sept. 8, 1960,
Section 242h, act July 1, 1944, ch. 373, title III, §310, as added Sept. 25, 1962,
Section 242i, act July 1, 1944, ch. 373, title III, §310A, as added Oct. 30, 1970,
Section 242j, act July 1, 1944, ch. 373, title III, §310B, as added Oct. 30, 1970,
§242k. National Center for Health Statistics
(a) Establishment; appointment of Director; statistical and epidemiological activities
There is established in the Department of Health and Human Services the National Center for Health Statistics (hereinafter in this section referred to as the "Center") which shall be under the direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the Center, shall conduct and support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States.
(b) Duties
In carrying out subsection (a) of this section, the Secretary, acting through the Center,
(1) shall collect statistics on—
(A) the extent and nature of illness and disability of the population of the United States (or of any groupings of the people included in the population), including life expectancy, the incidence of various acute and chronic illnesses, and infant and maternal morbidity and mortality,
(B) the impact of illness and disability of the population on the economy of the United States and on other aspects of the well-being of its population (or of such groupings),
(C) environmental, social, and other health hazards,
(D) determinants of health,
(E) health resources, including physicians, dentists, nurses, and other health professionals by specialty and type of practice and the supply of services by hospitals, extended care facilities, home health agencies, and other health institutions,
(F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types of practice of the health professionals providing such services, and (ii) services of hospitals, extended care facilities, home health agencies, and other institutions,
(G) health care costs and financing, including the trends in health care prices and cost, the sources of payments for health care services, and Federal, State, and local governmental expenditures for health care services, and
(H) family formation, growth, and dissolution;
(2) shall undertake and support (by grant or contract) research, demonstrations, and evaluations respecting new or improved methods for obtaining current data on the matters referred to in paragraph (1);
(3) may undertake and support (by grant or contract) epidemiological research, demonstrations, and evaluations on the matters referred to in paragraph (1); and
(4) may collect, furnish, tabulate, and analyze statistics, and prepare studies, on matters referred to in paragraph (1) upon request of public and nonprofit private entities under arrangements under which the entities will pay the cost of the service provided.
Amounts appropriated to the Secretary from payments made under arrangements made under paragraph (4) shall be available to the Secretary for obligation until expended.
(c) Statistical and epidemiological compilations and surveys
The Center shall furnish such special statistical and epidemiological compilations and surveys as the Committee on Labor and Human Resources and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives may request. Such statistical and epidemiological compilations and surveys shall not be made subject to the payment of the actual or estimated cost of the preparation of such compilations and surveys.
(d) Technical aid to States and localities
To insure comparability and reliability of health statistics, the Secretary shall, through the Center, provide adequate technical assistance to assist State and local jurisdictions in the development of model laws dealing with issues of confidentiality and comparability of data.
(e) Cooperative Health Statistics System
For the purpose of producing comparable and uniform health information and statistics, there is established the Cooperative Health Statistics System. The Secretary, acting through the Center, shall—
(1) coordinate the activities of Federal agencies involved in the design and implementation of the System;
(2) undertake and support (by grant or contract) research, development, demonstrations, and evaluations respecting the System;
(3) make grants to and enter into contracts with State and local health agencies to assist them in meeting the costs of data collection and other activities carried out under the System; and
(4) review the statistical activities of the Department of Health and Human Services to assure that they are consistent with the System.
States participating in the System shall designate a State agency to administer or be responsible for the administration of the statistical activities within the State under the System. The Secretary, acting through the Center, shall prescribe guidelines to assure that statistical activities within States participating in the system 1 produce uniform and timely data and assure appropriate access to such data.
(f) Federal-State cooperation
To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate and consult with the Departments of Commerce and Labor and any other interested Federal departments or agencies and with State and local health departments and agencies. For such purpose he shall utilize insofar as possible the services or facilities of any agency of the Federal Government and, without regard to
(g) Collection of health data; data collection forms
To secure uniformity in the registration and collection of mortality, morbidity, and other health data, the Secretary shall prepare and distribute suitable and necessary forms for the collection and compilation of such data.
(h) Registration area records
(1) There shall be an annual collection of data from the records of births, deaths, marriages, and divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data on ethnic and racial populations, including subpopulations of Hispanics, Asian Americans, and Pacific Islanders with significant representation in the State or registration area. Each State or registration area shall be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such data.
(2) There shall be an annual collection of data from a statistically valid sample concerning the general health, illness, and disability status of the civilian noninstitutionalized population. Specific topics to be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations, and the relationship between demographic and socioeconomic characteristics and health characteristics.
(i) Technical assistance in effective use of statistics
The Center may provide to public and nonprofit private entities technical assistance in the effective use in such activities of statistics collected or compiled by the Center.
(j) Coordination of health statistical and epidemiological activities
In carrying out the requirements of
(1) establishing standardized means for the collection of health information and statistics under laws administered by the Secretary;
(2) developing, in consultation with the National Committee on Vital and Health Statistics, and maintaining the minimum sets of data needed on a continuing basis to fulfill the collection requirements of subsection (b)(1) of this section;
(3) after consultation with the National Committee on Vital and Health Statistics, establishing standards to assure the quality of health statistical and epidemiological data collection, processing, and analysis;
(4) in the case of proposed health data collections of the Department which are required to be reviewed by the Director of the Office of Management and Budget under section 3509 2 of title 44, reviewing such proposed collections to determine whether they conform with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3), and if any such proposed collection is found not to be in conformance, by taking such action as may be necessary to assure that it will conform to such sets of data and standards, and
(5) periodically reviewing ongoing health data collections of the Department, subject to review under such section 3509,2 to determine if the collections are being conducted in accordance with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is found not to be in conformance, by taking such action as may be necessary to assure that the collection will conform to such sets of data and standards not later than the ninetieth day after the date of the completion of the review of the collection.
(k) National Committee on Vital and Health Statistics; establishment; membership; term of office; compensation; functions; consultations of Secretary with Committee and professional advisory groups
(1) There is established in the Office of the Secretary a committee to be known as the National Committee on Vital and Health Statistics (hereinafter in this subsection referred to as the "Committee") which shall consist of 18 members.
(2) The members of the Committee shall be appointed from among persons who have distinguished themselves in the fields of health statistics, electronic interchange of health care information, privacy and security of electronic information, population-based public health, purchasing or financing health care services, integrated computerized health information systems, health services research, consumer interests in health information, health data standards, epidemiology, and the provision of health services. Members of the Committee shall be appointed for terms of 4 years.
(3) Of the members of the Committee—
(A) 1 shall be appointed, not later than 60 days after August 21, 1996, by the Speaker of the House of Representatives after consultation with the Minority Leader of the House of Representatives;
(B) 1 shall be appointed, not later than 60 days after August 21, 1996, by the President pro tempore of the Senate after consultation with the Minority Leader of the Senate; and
(C) 16 shall be appointed by the Secretary.
(4) Members of the Committee shall be compensated in accordance with
(5) The Committee—
(A) shall assist and advise the Secretary—
(i) to delineate statistical problems bearing on health and health services which are of national or international interest;
(ii) to stimulate studies of such problems by other organizations and agencies whenever possible or to make investigations of such problems through subcommittees;
(iii) to determine, approve, and revise the terms, definitions, classifications, and guidelines for assessing health status and health services, their distribution and costs, for use (I) within the Department of Health and Human Services, (II) by all programs administered or funded by the Secretary, including the Federal-State-local cooperative health statistics system referred to in subsection (e) of this section, and (III) to the extent possible as determined by the head of the agency involved, by the Department of Veterans Affairs, the Department of Defense, and other Federal agencies concerned with health and health services;
(iv) with respect to the design of and approval of health statistical and health information systems concerned with the collection, processing, and tabulation of health statistics within the Department of Health and Human Services, with respect to the Cooperative Health Statistics System established under subsection (e) of this section, and with respect to the standardized means for the collection of health information and statistics to be established by the Secretary under subsection (j)(1) of this section;
(v) to review and comment on findings and proposals developed by other organizations and agencies and to make recommendations for their adoption or implementation by local, State, national, or international agencies;
(vi) to cooperate with national committees of other countries and with the World Health Organization and other national agencies in the studies of problems of mutual interest;
(vii) to issue an annual report on the state of the Nation's health, its health services, their costs and distributions, and to make proposals for improvement of the Nation's health statistics and health information systems; and
(viii) in complying with the requirements imposed on the Secretary under part C of title XI of the Social Security Act [
(B) shall study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information;
(C) shall report to the Secretary not later than 4 years after August 21, 1996, recommendations and legislative proposals for such standards and electronic exchange; and
(D) shall be responsible generally for advising the Secretary and the Congress on the status of the implementation of part C of title XI of the Social Security Act [
(6) In carrying out health statistical activities under this part, the Secretary shall consult with, and seek the advice of, the Committee and other appropriate professional advisory groups.
(7) Not later than 1 year after August 21, 1996, and annually thereafter, the Committee shall submit to the Congress, and make public, a report regarding the implementation of part C of title XI of the Social Security Act [
(A) The extent to which persons required to comply with part C of title XI of the Social Security Act are cooperating in implementing the standards adopted under such part.
(B) The extent to which such entities are meeting the security standards adopted under such part and the types of penalties assessed for noncompliance with such standards.
(C) Whether the Federal and State Governments are receiving information of sufficient quality to meet their responsibilities under such part.
(D) Any problems that exist with respect to implementation of such part.
(E) The extent to which timetables under such part are being met.
(l) Data specific to particular ethnic and racial populations
In carrying out this section, the Secretary, acting through the Center, shall collect and analyze adequate health data that is specific to particular ethnic and racial populations, including data collected under national health surveys. Activities carried out under this subsection shall be in addition to any activities carried out under subsection (m) of this section.
(m) Grants for assembly and analysis of data on ethnic and racial populations
(1) The Secretary, acting through the Center, may make grants to public and nonprofit private entities for—
(A) the conduct of special surveys or studies on the health of ethnic and racial populations or subpopulations;
(B) analysis of data on ethnic and racial populations and subpopulations; and
(C) research on improving methods for developing statistics on ethnic and racial populations and subpopulations.
(2) The Secretary, acting through the Center, may provide technical assistance, standards, and methodologies to grantees supported by this subsection in order to maximize the data quality and comparability with other studies.
(3) Provisions of
(4)(A) Subject to subparagraph (B), the Secretary, acting through the Center, shall collect data on Hispanics and major Hispanic subpopulation groups and American Indians, and for developing special area population studies on major Asian American and Pacific Islander populations.
(B) The provisions of subparagraph (A) shall be effective with respect to a fiscal year only to the extent that funds are appropriated pursuant to paragraph (3) of subsection (n) of this section, and only if the amounts appropriated for such fiscal year pursuant to each of paragraphs (1) and (2) of subsection (n) of this section equal or exceed the amounts so appropriated for fiscal year 1997.
(n) Authorization of appropriations
(1) For health statistical and epidemiological activities undertaken or supported under subsections (a) through (l) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 2003.
(2) For activities authorized in paragraphs (1) through (3) of subsection (m) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. Of such amounts, the Secretary shall use not more than 10 percent for administration and for activities described in subsection (m)(2) of this section.
(3) For activities authorized in subsection (m)(4) of this section, there are authorized to be appropriated $1,000,000 for fiscal year 1998, and such sums as may be necessary for each of the fiscal years 1999 through 2002.
(July 1, 1944, ch. 373, title III, §306, as added
References in Text
The Social Security Act, referred to in subsec. (k)(5)(A)(viii), (D), (7), is act Aug. 14, 1935, ch. 531,
Prior Provisions
Provisions similar to those comprising subsec. (g) of this section were contained in section 313 of act July 1, 1944, ch. 373, title III,
Provisions similar to those comprising subsec. (h) of this section were contained in section 312a of act July 1, 1944, ch. 373, title III, as added Aug. 31, 1954, ch. 1158, §2,
Amendments
1998—Subsec. (m)(4).
Subsec. (n)(1).
Subsec. (n)(2).
Subsec. (n)(3).
1996—Subsec. (k)(1).
Subsec. (k)(2).
Subsec. (k)(3), (4).
Subsec. (k)(5).
Subsec. (k)(6).
Subsec. (k)(7).
1993—Subsec. (c).
Subsec. (g).
Subsec. (i).
Subsec. (k)(2).
Subsec. (l).
Subsec. (m).
Subsecs. (n), (o).
1991—Subsec. (k)(4)(C).
1990—Subsec. (h).
Subsecs. (m) to (o).
1989—Subsec. (a).
Subsec. (b).
Subsec. (m).
1987—Subsec. (a).
Subsec. (k)(1).
Subsec. (k)(2)(A).
Subsec. (k)(2)(B).
"(i) five shall be appointed for terms of one year,
"(ii) five shall be appointed for terms of two years, and
"(iii) five shall be appointed for terms of three years,
as designated by the Secretary at the time of appointment. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed only for the remainder of such term. A member may serve after the expiration of his term until his successor has taken office."
1983—Subsec. (l)(2)(D).
Subsec. (l)(2)(E) to (G).
1981—Subsec. (a).
Subsec. (c).
Subsec. (e).
Subsecs. (j), (k)(4)(C), (D).
Subsec. (l)(2).
1978—Subsec. (b).
Subsec. (c).
Subsec. (e).
Subsec. (f).
Subsecs. (i), (j).
Subsec. (k).
Subsec. (l).
Change of Name
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 1990 Amendment
Section 12 of
Effective Date of 1987 Amendment
Section 105(b) of
Money Received by Center From Reimbursements, Interagency Agreements, and Sale of Data Tapes To Remain Available Until Expended
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be capitalized.
2 See References in Text note below.
§242l. International cooperation
(a) Cooperative endeavors; statement of purpose
For the purpose of advancing the status of the health sciences in the United States (and thereby the health of the American people), the Secretary may participate with other countries in cooperative endeavors in biomedical research, health care technology, and the health services research and statistical activities authorized by
(b) Authority of Secretary; building construction prohibition
In connection with the cooperative endeavors authorized by subsection (a) of this section, the Secretary may—
(1) make such use of resources offered by participating foreign countries as he may find necessary and appropriate;
(2) establish and maintain fellowships in the United States and in participating foreign countries;
(3) make grants to public institutions or agencies and to nonprofit private institutions or agencies in the United States and in participating foreign countries for the purpose of establishing and maintaining the fellowships authorized by paragraph (2);
(4) make grants or loans of equipment and materials, for use by public or nonprofit institutions or agencies, or by individuals, in participating foreign countries;
(5) participate and otherwise cooperate in any international meetings, conferences, or other activities concerned with biomedical research, health services research, health statistics, or health care technology;
(6) facilitate the interchange between the United States and participating foreign countries, and among participating foreign countries, of research scientists and experts who are engaged in experiments or programs of biomedical research, health services research, health statistical activities, or health care technology activities, and in carrying out such purpose may pay per diem compensation, subsistence, and travel for such scientists and experts when away from their places of residence at rates not to exceed those provided in section 5703(b) 1 of title 5 for persons in the Government service employed intermittently;
(7) procure, in accordance with
(8) enter into contracts with individuals for the provision of services (as defined in section 104 of part 37 of title 48, Code of Federal Regulations (48 CFR 37.104)) in participating foreign countries, which individuals may not be deemed employees of the United States for any purpose.
The Secretary may not, in the exercise of his authority under this section, provide financial assistance for the construction of any facility in any foreign country.
(c) Benefits for overseas assignees
The Secretary may provide to personnel appointed or assigned by the Secretary to serve abroad, allowances and benefits similar to those provided under
(July 1, 1944, ch. 373, title III, §307, formerly §308, as added
References in Text
The Foreign Service Act of 1990, referred to in subsec. (c), probably means the Foreign Service Act of 1980, which is
Codification
Section was formerly classified to
Prior Provisions
A prior section 307 of act July 1, 1944, was classified to
Amendments
1993—Subsec. (c).
1992—Subsec. (b)(8).
1989—Subsec. (a).
1981—Subsec. (a).
Subsec. (b).
1974—
International Health Study
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§242m. General provisions respecting effectiveness, efficiency, and quality of health services
(a) Reports to Congress and President; preparation; review by Office of Management and Budget
(1) Not later than March 15 of each year, the Secretary shall submit to the President and Congress the following reports:
(A) A report on health care costs and financing. Such report shall include a description and analysis of the statistics collected under
(B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the statistics collected under
(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
(D) A report on the health of the Nation's people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
(2) The reports required in paragraph (1) shall be prepared through the National Center for Health Statistics.
(3) The Office of Management and Budget may review any report required by paragraph (1) of this subsection before its submission to Congress, but the Office may not revise any such report or delay its submission beyond the date prescribed for its submission, and may submit to Congress its comments respecting any such report.
(b) Grants or contracts; applications, submittal; application peer review group, findings and recommendations; necessity of favorable recommendation; appointments
(1) No grant or contract may be made under
(2)(A) Each application submitted for a grant or contract under
(B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report its finding and recommendations respecting the application to the Secretary, acting through the Director of the National Center for Health Statistics, in such form and manner as the Secretary shall by regulation prescribe. The Secretary may not approve an application described in such subparagraph unless a peer review group has recommended the application for approval.
(C) The Secretary, acting through the Director of the National Center for Health Statistics, shall make appointments to the peer review groups required in subparagraph (A) from among persons who are not officers or employees of the United States and who possess appropriate technical and scientific qualifications, except that peer review groups regarding grants under
(c) Development and dissemination of statistics
The Secretary shall take such action as may be necessary to assure that statistics developed under
(d) Information; publication restrictions
No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under
(e) Payment procedures; advances or reimbursement; installments; conditions; reductions
(1) Payments of any grant or under any contract under
(2) The amounts otherwise payable to any person under a grant or contract made under
(A) amounts equal to the fair market value of any equipment or supplies furnished to such person by the Secretary for the purpose of carrying out the project with respect to which such grant or contract is made, and
(B) amounts equal to the pay, allowances, traveling expenses, and related personnel expenses attributable to the performance of services by an officer or employee of the Government in connection with such project, if such officer or employee was assigned or detailed by the Secretary to perform such services,
but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as the case may be.
(f) Contracts without regard to section 3324 of title 31 and section 5 of title 41
Contracts may be entered into under
(July 1, 1944, ch. 373, title III, §308, as added
Prior Provisions
Provisions similar to those comprising subsec. (e) of this section were contained in subsec. (a)(3) of section 304 of act July 1, 1944, ch. 373, title III, as added July 28, 1955, ch. 417, §3,
Amendments
1998—Subsec. (b)(2)(A), (C).
1993—Subsec. (a)(1).
"(i) the administration of
"(ii) the current state and progress of health services research, health statistics, and health care technology."
Subsec. (a)(2).
Subsec. (c).
Subsec. (f).
Subsec. (g).
"(A) publish, make available and disseminate, promptly in understandable form and on as broad a basis as practicable, the results of health services research, demonstrations, and evaluations undertaken and supported under
"(B) make available to the public data developed in such research, demonstrations, and evaluations; and
"(C) provide indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of information on health services research, demonstrations, and evaluations in health care delivery to public and private entities and individuals engaged in the improvement of health care delivery and the general public; and undertake programs to develop new or improved methods for making such information available."
Subsec. (h).
"(1) Except where the Secretary determines that unusual circumstances make a larger percentage necessary in order to effectuate the purposes of
"(2) Laborers and mechanics employed by contractors and subcontractors in the construction of such a facility shall be paid wages at rates not less than those prevailing on similar work in the locality, as determined by the Secretary of Labor in accordance with the Act of March 3, 1931 (
"(3) Such grants and contracts shall be subject to such additional requirements as the Secretary may by regulation prescribe."
1990—Subsec. (b)(2)(A).
Subsec. (b)(2)(C).
Subsec. (b)(3).
1989—
Subsec. (a)(1)(A)(i).
Subsec. (a)(2).
Subsec. (b)(1).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(2)(C).
Subsec. (b)(3).
Subsec. (d).
Subsec. (e)(1), (2).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (h)(1).
Subsec. (i).
1988—Subsec. (b)(2)(A).
1987—Subsec. (a)(1), (2).
"(1) Not later than December 1 of each year, the Secretary shall make a report to Congress respecting (A) the administration of sections 242b, 242c, 242k, and 242l and
"(2) The Secretary, acting through the National Center for Health Services Research and the National Center for Health Statistics, shall assemble and submit to the President and the Congress not later than December 1 of each year the following reports:
"(A) A report on health care costs and financing. Such report shall include a description and analysis of the statistics collected under
"(B) A report on health resources. Such report shall include a description and analysis, by geographic area, of the statistics collected under
"(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
"(D) A report on the health of the Nation's people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
Subsec. (a)(3).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (i).
1984—Subsec. (i)(1).
Subsec. (i)(2).
1983—Subsec. (d).
1981—Subsec. (a)(2).
Subsec. (b)(2).
Subsec. (d)(2).
Subsec. (i)(1).
Subsec. (i)(2).
1978—Subsec. (a)(1).
Subsec. (b)(1).
Subsec. (d).
Subsecs. (e), (f), (g)(2), (h)(1).
Subsec. (i)(1).
Subsec. (i)(2).
1977—Subsec. (i)(1).
Subsec. (i)(2).
1976—Subsec. (a).
Effective Date of 1998 Amendment
Effective Date of 1988 Amendment
Section 2600 of
Effective Date of 1987 Amendment
Section 106(c) of
Mine Workers Study; Report Completed and Submitted No Later Than 30 Months After November 9, 1978
Section 10 of
Authorization of Appropriations for Fiscal Year Ending June 30, 1977
Section 107(b) of
Section Referred to in Other Sections
This section is referred to in
§242n. Repealed. Pub. L. 101–239, title VI, §6103(d)(1)(B), Dec. 19, 1989, 103 Stat. 2205
Section, act July 1, 1944, ch. 373, title III, §309, as added Nov. 9, 1978,
Termination of Council on Health Care Technology
Section 6103(d)(1)(B) of
Transitional and Savings Provisions for Pub. L. 101–239
For provision transferring personnel of Department of Health and Human Services employed on Dec. 19, 1989, in connection with functions vested in Administrator for Health Care Policy and Research pursuant to amendments made by section 6103 of
§242o. Health conferences; publication of health educational information
(a) A conference of the health authorities in and among the several States shall be called annually by the Secretary. Whenever in his opinion the interests of the public health would be promoted by a conference, the Secretary may invite as many of such health authorities and officials of other State or local public or private agencies, institutions, or organizations to confer as he deems necessary or proper. Upon the application of health authorities of five or more States it shall be the duty of the Secretary to call a conference of all State health authorities joining in the request. Each State represented at any conference shall be entitled to a single vote. Whenever at any such conference matters relating to mental health are to be discussed, the mental health authorities of the respective States shall be invited to attend.
(b) From time to time the Secretary shall issue information related to public health, in the form of publications or otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United States and other countries and other pertinent health information for the use of persons and institutions concerned with health services.
(July 1, 1944, ch. 373, title III, §310, formerly §§309, 310, as added
Codification
Subsec. (a) of this section consists of former section 309 of act July 1, 1944, prior to the renumbering of that section as section 310(a) by
Prior Provisions
A prior section 310 of act July 1, 1944, was renumbered section 329, and was classified to
Provisions similar to those comprising subsec. (a) of this section were contained in section 312 of act July 1, 1944, ch. 373, title III,
Provisions similar to those comprising subsec. (b) of this section were contained in section 315 of act July 1, 1944, ch. 373, title III,
§242p. National disease prevention data profile
(a) The Secretary, acting through the National Center for Health Statistics, shall submit to Congress on March 15, 1990, and on March 15 of every third year thereafter, a national disease prevention data profile in order to provide a data base for the effective implementation of this Act and to increase public awareness of the prevalence, incidence, and any trends in the preventable causes of death and disability in the United States. Such profile shall include at a minimum—
(1) mortality rates for preventable diseases;
(2) morbidity rates associated with preventable diseases;
(3) the physical determinants of health of the population of the United States and the relationship between these determinants of health and the incidence and prevalence of preventable causes of death and disability; and
(4) the behavioral determinants of health of the population of the United States including, but not limited to, smoking, nutritional and dietary habits, exercise, and alcohol consumption, and the relationship between these determinants of health and the incidence and prevalence of preventable causes of death and disability.
(b) In preparing the profile required by subsection (a) of this section, the Secretary, acting through the National Center for Health Statistics, shall comply with all relevant provisions of
(
References in Text
This Act, referred to in subsec. (a), is
Codification
Section was enacted as part of the Health Services and Centers Amendments of 1978, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1987—Subsec. (a).
Effective Date of 1987 Amendment
Amendment by
§242q. Task Force on Aging Research; establishment and duties
(a) Establishment
The Secretary of Health and Human Services shall establish a Task Force on Aging Research.
(b) Duties
With respect to aging research (as defined in
(1) make recommendations to the Secretary specifying the particular projects of research, or the particular categories of research, that should be conducted or supported by the Secretary;
(2) of the projects specified under paragraph (1), make recommendations to the Secretary of the projects that should be given priority in the provision of funds; and
(3) make recommendations to the Secretary of the amount of funds that should be appropriated for such research.
(c) Provision of information to public
The Task Force may make available to health professionals, and to other members of the public, information regarding the research described in subsection (b) of this section.
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§242q–1. Membership
(a) Composition
The Task Force shall be composed of—
(1) the Assistant Secretary for Health;
(2) the Surgeon General of the Public Health Service;
(3) the Assistant Secretary for Planning and Evaluation;
(4) the Director of the National Institute on Aging, and the Directors of such other agencies of the National Institutes of Health as the Secretary determines to be appropriate;
(5) the Commissioner of the Administration on Aging;
(6) the Commissioner of Food and Drugs;
(7) the Under Secretary for Health of the Department of Veterans Affairs;
(8) the Administrator of the the 1 Substance Abuse and Mental Health Services Administration;
(9) the Administrator of the Health Care Financing Administration;
(10) the Commissioner of Social Security;
(11) the Director of the Agency for Healthcare Research and Quality;
(12) two Members of the House of Representatives appointed by the Speaker of the House in consultation with the Minority Leader, and two members of the Senate appointed by the Majority Leader in consultation with the Minority Leader, not more than one of whom from each body shall be members of the same political party; and
(13) three members of the general public, to be appointed by the Secretary, that shall include one representative each from—
(A) a nonprofit group representing older Americans;
(B) a private voluntary health organization concerned with the health problems affecting older Americans; and
(C) a nonprofit organization concerned with research related to the health and independence of older Americans.
(b) Chair
The Secretary, acting through either the Assistant Secretary for Health or the Director of the National Institute on Aging, shall serve as the Chair of the Task Force.
(c) Quorum
A majority of the members of the Task Force shall constitute a quorum, and a lesser number may hold hearings.
(d) Meetings
The Task Force shall meet periodically at the call of the Chair, but in no event less than twice each year.
(e) Compensation and expenses
(1) Compensation
Members of the Task Force who are not regular full-time employees of the United States Government shall, while attending meetings and conferences of the Task Force or otherwise engaged in the business of the Task Force (including traveltime), be entitled to receive compensation at a rate fixed by the Secretary, but not exceeding the rate specified at the time of such service under GS–18 of the General Schedules established under
(2) Expenses
While away from their homes or regular places of business on the business of the Task Force, members of such Task Force may be allowed travel expenses, including per diem in lieu of subsistence, as is authorized under
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1999—Subsec. (a)(11).
1992—Subsec. (a)(7).
Subsec. (a)(8).
Effective Date of 1992 Amendment
Amendment by
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
Section Referred to in Other Sections
This section is referred to in
§242q–2. Administrative staff and support
The Secretary, acting through either the Assistant Secretary for Health or the Director of the National Institute on Aging, shall appoint an Executive Secretary for the Task Force and shall provide the Task Force with such administrative staff and support as may be necessary to enable the Task Force to carry out subsections (b) and (c) of
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§242q–3. Reports
(a) In general
Not later than 1 year after November 15, 1990, and annually thereafter, the Task Force shall prepare and submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report providing the recommendations required in
(b) Availability to public
The Task Force may make available to the public copies of the reports required in subsection (a) of this section.
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
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
Section Referred to in Other Sections
This section is referred to in
§242q–4. Definitions
For purposes of
(1) Aging research
(A) The term "aging research" means research on the aging process and on the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause. Such research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders, and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals.
(B) For purposes of subparagraph (A), the term "independence", with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision.
(2) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(3) Task Force
The term "Task Force" means the Task Force on Aging Research established under
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§242q–5. Authorization of appropriations
For the purpose of carrying out
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
Part B—Federal-State Cooperation
§243. General grant of authority for cooperation
(a) Enforcement of quarantine regulations; prevention of communicable diseases
The Secretary is authorized to accept from State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this chapter which such authorities may be able and willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and suppression of communicable diseases and with respect to other public health matters, shall cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations, and shall advise the several States on matters relating to the preservation and improvement of the public health.
(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees
The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence.
(c) Development of plan to control epidemics and meet emergencies or problems resulting from disasters; cooperative planning; temporary assistance; reimbursement of United States
(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may enter into agreements providing for the cooperative planning between the Service and public and private community health programs and agencies to cope with health problems (including epidemics and health emergencies).
(2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance provided under this paragraph as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such reimbursement is received.
(July 1, 1944, ch. 373, title III, §311,
Amendments
1985—Subsec. (c)(1).
1983—Subsec. (c)(2).
1981—Subsec. (a).
Subsec. (b).
1976—Subsec. (b).
Subsec. (c).
1970—Subsecs. (a), (b).
1967—Subsec. (c).
1966—
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1966 Amendment
Section 5(a) of
Section 5(b) of
Training of Private Persons Subject to Reimbursement or Advances to Appropriations
Section Referred to in Other Sections
This section is referred to in
§244. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section, acts July 1, 1944, ch. 373, title III, §312,
§244–1. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, §312, formerly §306, as added Aug. 2, 1956, ch. 871, title I, §101,
Effective Date of Repeal
Section 503(c) of
§§244a, 245. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section 244a, act July 1, 1944, ch. 373, title III, §312a, as added Aug. 31, 1954, ch. 1158, §2,
Section 245, acts July 1, 1944, ch. 373, title III, §313,
§245a. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, §313, formerly §309, as added Sept. 8, 1960,
Effective Date of Repeal
Repeal effective Oct. 1, 1977, see section 503(c) of
§246. Grants and services to States
(a) Comprehensive health planning and services
(1) In order to assist the States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized during the period beginning July 1, 1966, and ending June 30, 1973, to make grants to States which have submitted, and had approved by the Secretary, State plans for comprehensive State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972, $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974.
(2) In order to be approved for purposes of this subsection, a State plan for comprehensive State health planning must—
(A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental agency, as the sole agency for administering or supervising the administration of the State's health planning functions under the plan;
(B) provide for the establishment of a State health planning council, which shall include representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities of such Department which are located in such State) and nongovernmental organizations and groups concerned with health (including representation of the regional medical program or programs included in whole or in part within the State), and of consumers of health services, to advise such State agency in carrying out its functions under the plan, and a majority of the membership of such council shall consist of representatives of consumers of health services;
(C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the Secretary, are designed to provide for comprehensive State planning for health services (both public and private and including home health care), including the facilities and persons required for the provision of such services, to meet the health needs of the people of the State and including environmental considerations as they relate to public health;
(D) provide for encouraging cooperative efforts among governmental or nongovernmental agencies, organizations and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such agencies, organizations, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and rehabilitation;
(E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise be made available by the State for the purpose of comprehensive health planning and not to supplant such non-Federal funds;
(F) provide such methods of administration (including methods relating to the establishment and maintenance of personnel standards on a merit basis, except that the Secretary shall exercise no authority with respect to the selection, tenure of office, and compensation of any individual employed in accordance with such methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
(G) provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of such reports;
(H) provide that the State agency will from time to time, but not less often than annually, review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan developed in accordance with criteria established by the Secretary after consultation with the State which will meet the needs of the State for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State agency furnishing such assistance will periodically review the program (developed pursuant to clause (i)) of each health care facility in the State and recommend appropriate modification thereof;
(J) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for funds paid to the State under this subsection; and
(K) contain such additional information and assurances as the Secretary may find necessary to carry out the purposes of this subsection.
(3)(A) From the sums appropriated for such purpose for each fiscal year, the several States shall be entitled to allotments determined, in accordance with regulations, on the basis of the population and the per capita income of the respective States; except that no such allotment to any State for any fiscal year shall be less than 1 per centum of the sum appropriated for such fiscal year pursuant to paragraph (1). Any such allotment to a State for a fiscal year shall remain available for obligation by the State, in accordance with the provisions of this subsection and the State's plan approved thereunder, until the close of the succeeding fiscal year.
(B) The amount of any allotment to a State under subparagraph (A) for any fiscal year which the Secretary determines will not be required by the State, during the period for which it is available, for the purposes for which allotted shall be available for reallotment by the Secretary from time to time, on such date or dates as he may fix, to other States with respect to which such a determination has not been made, in proportion to the original allotments to such States under subparagraph (A) for such fiscal year, but with such proportionate amount for any of such other States being reduced to the extent it exceeds the sum the Secretary estimates such State needs and will be able to use during such period; and the total of such reductions shall be similarly reallotted among the States whose proportionate amounts were not so reduced. Any amount so reallotted to a State from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of its allotment under subparagraph (A) for such fiscal year.
(4) From each State's allotment for a fiscal year under this subsection, the State shall from time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved under this subsection. Such payments shall be made on the basis of estimates by the Secretary of the sums the State will need in order to perform the planning under its approved State plan under this subsection, but with such adjustments as may be necessary to take account of previously made underpayments or overpayments. The "Federal share" for any State for purposes of this subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per centum of such cost.
(b) Project grants for areawide health planning; authorization of appropriations; prerequisites for grants; application; contents
(1)(A) The Secretary is authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make, with the approval of the State agency administering or supervising the administration of the State plan approved under subsection (a) of this section, project grants to any other public or nonprofit private agency or organization (but with appropriate representation of the interests of local government where the recipient of the grant is not a local government or combination thereof or an agency of such government or combination) to cover not to exceed 75 per centum of the costs of projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other local area plans for coordination of existing and planned health services, including the facilities and persons required for provision of such services; and including the provision of such services through home health care; except that in the case of project grants made in any State prior to July 1, 1968, approval of such State agency shall be required only if such State has such a State plan in effect at the time of such grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization to develop or revise health plans for an area unless the Secretary determines that such agency or organization provides means for appropriate representation of the interests of the hospitals, other health care facilities, and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for the fiscal year ending June 30, 1974.
(B) Project grants may be made by the Secretary under subparagraph (A) to the State agency administering or supervising the administration of the State plan approved under subsection (a) of this section with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region or area has been filed by any other agency or organization qualified to receive such a grant, and (ii) such State agency certifies, and the Secretary finds, that ample opportunity has been afforded to qualified agencies and organizations to file application for such a grant with respect to such region or area and that it is improbable that, in the foreseeable future, any agency or organization which is qualified for such a grant will file application therefor.
(2)(A) In order to be approved under this subsection, an application for a grant under this subsection must contain or be supported by reasonable assurances that there has been or will be established, in or for the area with respect to which such grant is sought, an areawide health planning council. The membership of such council shall include representatives of public, voluntary, and nonprofit private agencies, institutions, and organizations concerned with health (including representatives of the interests of local government of the regional medical program for such area, and of consumers of health services). A majority of the members of such council shall consist of representatives of consumers of health services.
(B) In addition, an application for a grant under this subsection must contain or be supported by reasonable assurances that the areawide health planning agency has made provision for assisting health care facilities in its area to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan which will meet the needs of the State and the area for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner.
(c) Project grants for training, studies, and demonstrations; authorization of appropriations
The Secretary is also authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make grants to any public or nonprofit private agency, institution, or other organization to cover all or any part of the cost of projects for training, studies, or demonstrations looking toward the development of improved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30, 1969, $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000 for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and $4,700,000 for the fiscal year ending June 30, 1974.
(July 1, 1944, ch. 373, title III, §314,
Amendments
1991—Subsec. (a)(2)(B).
1985—Subsec. (g).
1981—Subsec. (d).
1980—Subsec. (g).
1979—Subsec. (d)(2)(C)(ii).
Subsec. (d)(4)(A).
Subsec. (g)(2)(D)(iv).
1978—Subsec. (d).
Subsec. (d)(7)(A).
Subsec. (d)(7)(B).
Subsec. (f).
Subsec. (g).
1977—Subsec. (d)(7)(A).
Subsec. (d)(7)(B).
1976—Subsec. (g)(4)(B).
1975—Subsec. (d).
Subsec. (e).
1973—Subsec. (a)(1).
Subsec. (b)(1)(A).
Subsec. (c).
Subsec. (d)(1).
Subsec. (e).
1972—Subsec. (d)(2)(K).
1971—Subsec. (f).
1970—
Subsec. (a)(1).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(2)(C).
Subsec. (d)(2)(K).
Subsec. (d)(2)(L).
Subsec. (e).
1967—Subsec. (a)(1).
Subsec. (a)(2)(I) to (K).
Subsec. (a)(4).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(5).
Subsec. (d)(7).
Subsec. (e).
Subsec. (f)(5).
Subsec. (f)(6), (8).
Subsec. (g)(4)(B).
1966—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsecs. (h) to (m).
1965—Subsec. (c).
1962—Subsec. (l).
1961—Subsec. (c).
Subsec. (m).
1958—Subsec. (c).
1956—Subsec. (l). Act Aug. 1, 1956, added subsec. (l).
1948—Subsec. (e). Act June 16, 1948, §5(a), added subsec. (e) to provide for community programs of heart disease control. Former subsec. (e) redesignated (f).
Subsec. (f). Act June 16, 1948, §5(a), (b), redesignated former subsec. (e) as (f) and inserted proviso relating to determination and certification of amounts to be paid under subsec. (e). Former subsec. (f) redesignated (g).
Subsec. (g). Act June 16, 1948, §5(a), (c), redesignated former subsec. (f) as (g) and brought subsecs. (e) and (f)(1) within the provisions of this subsection. Former subsec. (g) redesignated (h).
Subsec. (h). Act June 16, 1948, §5(a), (d), redesignated former subsec. (g) as (h) and made subsection applicable to agencies, institutions or other organizations specified in subsec. (f)(1). Former subsec. (h) redesignated (i).
Subsec. (i). Act June 16, 1948, §5(a), (e), redesignated former subsec. (h) as (i), made subsection applicable to subsec. (e), and made technical changes as a result of the renumbering of subsections. Former subsec. (i) redesignated (j).
Subsecs. (j), (k). Act June 16, 1948, §5(a), redesignated former subsecs. (i) and (j) as (j) and (k), respectively.
1946—Subsec. (c). Act July 3, 1946, increased annual appropriation from $20,000,000 to $30,000,000, and increased annual amount available to provide demonstrations and to train personnel for State and local health work from $2,000,000 to $3,000,000.
Subsec. (d). Act July 3, 1946, provided that Surgeon General shall give special consideration to the extent of the mental health problem as well as other special problems.
Subsecs. (f), (h), (i). Act July 3, 1946, provided that in matters relating to work in field of mental health Surgeon General shall deal with State mental health authorities where they differ from general health authorities.
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1980 Amendment
Section 107(d) of
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1978 Amendments
Section 201(b)(2) of
Section 403(b) of
Effective Date of 1975 Amendment
Section 102 of
Amendment by section 501(b) of
Effective Date of 1971 Amendment
Repeal of subsec. (f) of this section (less applicability to commissioned officers of the Public Health Service) by section 403(a) of
Effective Date of 1970 Amendments
Section 260(c)(2) of
Section 401(b)(1) of
Effective Date of 1967 Amendment
Section 2(d)(2), (f) of
Section 3(b) of
Effective Date of 1966 Amendment
Section 6 of
Effective Date of 1962 Amendment
Section 4(b) of
Effective and Termination Date of 1958 Amendment
Section 2 of
Effective Date of 1956 Amendment
Section 18 of act Aug. 1, 1956, provided that the amendment made by that section is effective July 1, 1956.
Repeals
The directory language of, but not the amendment made by,
Transfer of Functions
Functions, powers, and duties of Secretary of Health and Human Services under subsecs. (a)(2)(F) and (d)(2)(F) of this section, insofar as relates to the prescription of personnel standards on a merit basis, transferred to Office of Personnel Management, see
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Year 2000 Health Objectives Planning
Congressional Findings and Declaration
Section 201(b)(1) of
"(A) individual health status can be effectively and economically improved through an adequate investment in community public health programs and services;
"(B) the Federal Government and the States and their communities share in the financial responsibility for funding public health programs;
"(C) the Federal contribution to funds for public health programs should serve as an incentive to an additional investment by State and local governments;
"(D) existing categorical programs of Federal financial assistance to combat specific public health problems should be supplemented by a national program of stable generic support for such public health activities as the prevention and control of environmental health hazards, prevention and control of diseases, prevention and control of health problems of particularly vulnerable population groups, and development and regulation of health care facilities and health services delivery systems; and
"(E) the States and their communities, not the Federal Government, should have primary responsibility for identifying and measuring the impact of public health problems and the allocation of resources for their amelioration."
Section 2 of
"(a) The Congress declares that fulfillment of our national purpose depends on promoting and assuring the highest level of health attainable for every person, in an environment which contributes positively to healthful individual and family living; that attainment of this goal depends on an effective partnership, involving close intergovernmental collaboration, official and voluntary efforts, and participation of individuals and organizations; that Federal financial assistance must be directed to support the marshaling of all health resources—national, State, and local—to assure comprehensive health services of high quality for every person, but without interference with existing patterns of private professional practice of medicine, dentistry, and related healing arts.
"(b) To carry out such purpose, and recognizing the changing character of health problems, the Congress finds that comprehensive planning for health services, health manpower, and health facilities is essential at every level of government; that desirable administration requires strengthening the leadership and capacities of State health agencies; and that support of health services provided people in their communities should be broadened and made more flexible."
Section 2 of act July 3, 1956, provided that:
"(a) The Congress hereby finds and declares—
"(1) that the latest information on the number and relevant characteristics of persons in the country suffering from heart disease, cancer, diabetes, arthritis and rheumatism, and other diseases, injuries, and handicapping conditions is now seriously out of date; and
"(2) that periodic inventories providing reasonably current information on these matters are urgently needed for purposes such as (A) appraisal of the true state of health of our population (including both adults and children), (B) adequate planning of any programs to improve their health, (C) research in the field of chronic diseases, and (D) measurement of the numbers of persons in the working ages so disabled as to be unable to perform gainful work.
"(b) It is, therefore, the purpose of this Act [see Short Title of 1956 Amendment note set out under
Limitation on Grants-in-Aid to Schools of Public Health
Section 2 of
Grants to States To Provide for Vaccination Against Poliomyelitis
The Poliomyelitis Vaccination Assistance Act of 1955, act Aug. 12, 1955, ch. 863,
Applicability of Reorganization Plan No. 3 of 1966
Section 7 of
Section Referred to in Other Sections
This section is referred to in
§246a. Bureau of State Services management fund; establishment; advancements; availability
For the purpose of facilitating the economical and efficient conduct of operations in the Bureau of State Services which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the Bureau of State Services management fund. Such amounts as the Secretary may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by the Secretary: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.
(
Codification
Section was not enacted as part of the Public Health Service Act which comprises this chapter.
Amendments
1970—
§247. Omitted
Section, act July 1, 1944, ch. 373, title III, §315, as added Oct. 4, 1988,
Prior Provisions
A prior section 247, act July 1, 1944, ch. 373, title III, §315, as added Nov. 10, 1978,
Another prior section 247, acts July 1, 1944, ch. 373, title III, §315,
§247a. Family support groups for Alzheimer's disease patients
(a) Establishment; priorities
Subject to available appropriations, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emotional, and practical support to assist individuals with Alzheimer's disease or a related memory disorder and members of the families of such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
(1) university medical centers and other appropriate health care facilities which receive Federal funds from the Secretary and which conduct research on Alzheimer's disease or provide services to individuals with such disease; and
(2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
(b) National network to coordinate groups
The Secretary shall promote the establishment of a national network to coordinate the family support groups described in subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §316, as added
Prior Provisions
A prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Nov. 10, 1978,
Another prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Oct. 30, 1970,
Amendments
1993—Subsec. (c).
§247b. Project grants for preventive health services
(a) Grant authority
The Secretary may make grants to States, and in consultation with State health authorities, to political subdivisions of States and to other public entities to assist them in meeting the costs of establishing and maintaining preventive health service programs.
(b) Application
No grant may be made under subsection (a) of this section unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—
(1) a complete description of the type and extent of the program for which the applicant is seeking a grant under subsection (a) of this section;
(2) with respect to each such program (A) the amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program, (B) a description of the services provided by the applicant in such program in such period, (C) the amount of Federal funds needed by the applicant to continue providing such services in such program, and (D) if the applicant proposes changes in the provision of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such changes;
(3) assurances satisfactory to the Secretary that the program which will be provided with funds under a grant under subsection (a) of this section will be provided in a manner consistent with the State health plan in effect under section 300m–3(c) 1 of this title and in those cases where the applicant is a State, that such program will be provided, where appropriate, in a manner consistent with any plans in effect under an application approved under section 247 1 of this title;
(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal control and fund accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and accounting for funds received under grants under subsection (a) of this section;
(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or programs;
(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and keep such records and afford such access thereto as the Secretary may find necessary to assure the correctness of, and to verify, such reports;
(7) assurances satisfactory to the Secretary that the applicant will comply with any other conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary may by regulation prescribe.
(c) Approval; annual project review
(1) The Secretary shall not approve an application submitted under subsection (b) of this section for a grant for a program for which a grant was previously made under subsection (a) of this section unless the Secretary determines—
(A) the program for which the application was submitted is operating effectively to achieve its stated purpose,
(B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and
(C) the applicant will comply with the assurances provided with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant under subsection (a) of this section to determine if the program assisted by such grant is operating effectively to achieve its stated purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant.
(d) Amount of grant; payment
The amount of a grant under subsection (a) of this section shall be determined by the Secretary. Payments under such grants may be made in advance on the basis of estimates or by the way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(e) Reduction
The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may reduce the amount of such grant by—
(1) the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished the grant recipient, and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee,
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) of this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(f) Recordkeeping; audit authority
(1) Each recipient of a grant under subsection (a) of this section shall keep such records as the Secretary shall by regulation prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of grants under subsection (a) of this section that are pertinent to such grants.
(g) Use of grant funds; mandatory treatment prohibited
(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to a State or to an agency or a political subdivision of a State under provisions of Federal law (other than this section) and which are available for the conduct of preventive health service programs from being used in connection with programs assisted through grants under subsection (a) of this section.
(2) Nothing in this section shall be construed to require any State or any agency or political subdivision of a State to have a preventive health service program which would require any person, who objects to any treatment provided under such a program, to be treated or to have any child or ward treated under such program.
(h) Reports
The Secretary shall include, as part of the report required by
(i) Technical assistance
The Secretary may provide technical assistance to States, State health authorities, and other public entities in connection with the operation of their preventive health service programs.
(j) Authorization of appropriations
(1) Except for grants for immunization programs the authorization of appropriations for which are established in paragraph (2), for grants under subsections (a) and (k)(1) of this section for preventive health service programs to immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1998 through 2005. Not more than 10 percent of the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants under subsection (k)(1) of this section for such fiscal year.
(2) For grants under subsection (a) of this section for preventive health service programs for the provision without charge of immunizations with vaccines approved for use, and recommended for routine use, after October 1, 1997, there are authorized to be appropriated such sums as may be necessary.
(k) Additional grants to States, political subdivisions, and other public and nonprofit private entities
(1) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases that may be prevented through vaccination;
(B) demonstration projects for the prevention and control of such diseases;
(C) public information and education programs for the prevention and control of such diseases; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).
(2) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases and conditions;
(B) demonstration projects for the prevention and control of such diseases and conditions;
(C) public information and education programs for the prevention and control of such diseases and conditions; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases and conditions for health professionals (including allied health personnel).
(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at such time, and containing such information as the Secretary may by regulation prescribe.
(4) Subsections (d), (e), and (f) of this section shall apply to grants under this subsection in the same manner as such subsections apply to grants under subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §317, as added
References in Text
Amendments
2000—Subsec. (j)(1).
1998—Subsec. (j)(1).
Subsec. (j)(2).
1993—Subsec. (j).
Subsec. (k)(2).
"(A) research into the prevention, control, and elimination of tuberculosis, especially research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations;
"(B) demonstration projects for the prevention, control, and elimination of tuberculosis;
"(C) public information and education programs for prevention, control, and elimination of tuberculosis; and
"(D) education, training, and clinical skills improvement activities in the prevention, control, and elimination of tuberculosis for health professionals, including allied health personnel."
Subsec. (k)(3).
Subsec. (k)(4), (5).
Subsec. (l).
1990—Subsec. (j)(1)(A).
Subsec. (j)(1)(B).
Subsec. (j)(1)(C).
Subsec. (j)(2).
Subsec. (k)(2)(A) to (D).
Subsec. (l).
1987—Subsec. (j).
Subsec. (k).
1985—Subsec. (j).
1984—Subsec. (j)(1).
Subsec. (j)(2).
1981—Subsec. (a).
Subsec. (j).
1979—Subsec. (j)(4), (5).
1978—
Subsec. (g)(2).
1976—
Subsecs. (j) to (l).
1975—Subsec. (d)(3).
Subsec. (h)(1).
1974—Subsec. (a).
Subsec. (b)(2)(C).
Subsecs. (b)(3), (d)(1), (2), (3), (f)(1).
Subsec. (h)(1).
Subsec. (i).
1972—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
1970—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsecs. (f), (g).
1965—Subsec. (a).
Subsec. (b).
Subsec. (c).
Effective Date of 1978 Amendment
Section 202 of
Effective Date of 1976 Amendment
Section 202(a) of
Effective Date of 1975 Amendment
Section 608 of title VI of
Effective Date of 1972 Amendment
Section 102 of
Assistance of Administrator of Veterans' Affairs in Administration of National Swine Flu Immunization Program of 1976; Claims for Damages
Study by Secretary of Scope and Extent of Liability Arising Out of Immunization Program; Alternative Protective Approaches; Report to Congress
Section 3 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§247b–1. Screenings, referrals, and education regarding lead poisoning
(a) Authority for grants
(1) In general
Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and political subdivisions of States for the initiation and expansion of community programs designed—
(A) to provide, for infants and children—
(i) screening for elevated blood lead levels;
(ii) referral for treatment of such levels; and
(iii) referral for environmental intervention associated with such levels; and
(B) to provide education about childhood lead poisoning.
(2) Authority regarding certain entities
With respect to a geographic area with a need for activities authorized in paragraph (1), in any case in which neither the State nor the political subdivision in which such area is located has applied for a grant under paragraph (1), the Secretary may make a grant under such paragraph to any grantee under
(3) Provision of all services and activities through each grantee
In making grants under paragraph (1), the Secretary shall ensure that each of the activities described in such paragraph is provided through each grantee under such paragraph. The Secretary may authorize such a grantee to provide the services and activities directly, or through arrangements with other providers.
(b) Status as medicaid provider
(1) In general
Subject to paragraph (2), the Secretary may not make a grant under subsection (a) of this section unless, in the case of any service described in such subsection that is made available pursuant to the State plan approved under title XIX of the Social Security Act [
(A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation agreement and is qualified to receive such payments.
(2) Waiver regarding certain secondary agreements
(A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the provider does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits plan.
(B) A determination by the Secretary of whether a provider referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary donations regarding the provision of services to the public.
(c) Priority in making grants
In making grants under subsection (a) of this section, the Secretary shall give priority to applications for programs that will serve areas with a high incidence of elevated blood lead levels in infants and children.
(d) Grant application
No grant may be made under subsection (a) of this section, unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall prescribe and shall include each of the following:
(1) A complete description of the program which is to be provided by or through the applicant.
(2) Assurances satisfactory to the Secretary that the program to be provided under the grant applied for will include educational programs designed to—
(A) communicate to parents, educators, and local health officials the significance and prevalence of lead poisoning in infants and children (including the sources of lead exposure, the importance of screening young children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which the program is designed to detect and prevent; and
(B) communicate to health professionals and paraprofessionals updated knowledge concerning lead poisoning and research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning among all socioeconomic groupings; the benefits of expanded lead screening; and the therapeutic and other interventions available to prevent and combat lead poisoning in affected children and families).
(3) Assurances satisfactory to the Secretary that the applicant will report on a quarterly basis the number of infants and children screened for elevated blood lead levels, the number of infants and children who were found to have elevated blood lead levels, the number and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary that the applicant will make such reports respecting the program involved as the Secretary may require.
(5) Assurances satisfactory to the Secretary that the applicant will coordinate the activities carried out pursuant to subsection (a) of this section with related activities and services carried out in the State by grantees under title V or XIX of the Social Security Act [
(6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for any period will be so used as to supplement and, to the extent practical, increase the level of State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made available for the program for which the grant is to be made and will in no event supplant such State, local, and other non-Federal funds.
(7) Assurances satisfactory to the Secretary that the applicant will ensure complete and consistent reporting of all blood lead test results from laboratories and health care providers to State and local health departments in accordance with guidelines of the Centers for Disease Control and Prevention for standardized reporting as described in subsection (m) of this section.
(8) Such other information as the Secretary may prescribe.
(e) Relationship to services and activities under other programs
(1) In general
A recipient of a grant under subsection (a) of this section may not make payments from the grant for any service or activity to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service or activity—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(2) Applicability to certain secondary agreements for provision of services
Paragraph (1) shall not apply in the case of a provider through which a grantee under subsection (a) of this section provides services under such subsection if the Secretary has provided a waiver under subsection (b)(2) of this section regarding the provider.
(f) Method and amount of payment
The Secretary shall determine the amount of a grant made under subsection (a) of this section. Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants. Not more than 10 percent of any grant may be obligated for administrative costs.
(g) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may reduce the amount of such grant by—
(1) the fair market value of any supplies or equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) of this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(h) Records
Each recipient of a grant under subsection (a) of this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(i) Audit and examination of records
The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant under subsection (a) of this section, that are pertinent to such grant.
(j) Annual report
(1) In general
Not later than May 1 of each year, the Secretary shall submit to the Congress a report on the effectiveness during the preceding fiscal year of programs carried out with grants under subsection (a) of this section and of any programs that are carried out by the Secretary pursuant to subsection (l)(2) of this section.
(2) Certain requirements
Each report under paragraph (1) shall include, in addition to any other information that the Secretary may require, the following information:
(A) The number of infants and children screened.
(B) Demographic information on the population of infants and children screened, including the age and racial or ethnic status of such population.
(C) The number of screening sites.
(D) A description of the severity of the extent of the blood lead levels of the infants and children screened, expressed in categories of severity.
(E) The sources of payment for the screenings.
(F) The number of grantees that have established systems to ensure mandatory reporting of all blood lead tests from laboratories and health care providers to State and local health departments.
(G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if any, provided in the report under paragraph (1) preceding the report involved.
(k) Indian tribes
For purposes of this section, the term "political subdivision" includes Indian tribes.
(l) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2005.
(2) Allocation for other programs
Of the amounts appropriated under paragraph (1) for any fiscal year, the Secretary may reserve not more than 20 percent for carrying out programs regarding the activities described in subsection (a) of this section in addition to the program of grants established in such subsection.
(m) Guidelines for standardized reporting
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop national guidelines for the uniform reporting of all blood lead test results to State and local health departments.
(July 1, 1944, ch. 373, title III, §317A, as added
References in Text
The Social Security Act, referred to in subsecs. (b)(1) and (d)(5), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 247b–1,
Amendments
2000—Subsec. (d)(7), (8).
Subsec. (j)(2)(F), (G).
Subsec. (l)(1).
Subsec. (m).
1998—Subsec. (l)(1).
1993—Subsec. (l)(1).
1992—
Development and Implementation of Effective Data Management by the Centers for Disease Control and Prevention
"(1)
"(A) assist with the improvement of data linkages between State and local health departments and between State health departments and the Centers for Disease Control and Prevention;
"(B) assist States with the development of flexible, comprehensive State-based data management systems for the surveillance of children with lead poisoning that have the capacity to contribute to a national data set;
"(C) assist with the improvement of the ability of State-based data management systems and federally-funded means-tested public benefit programs (including the special supplemental food program for women, infants and children (WIC) under section 17 of the Child Nutrition Act of 1966 (
"(D) assist States with the establishment of a capacity for assessing how many children enrolled in the Medicaid, WIC, early head start, and other federally-funded means-tested public benefit programs are being screened for lead poisoning at age-appropriate intervals;
"(E) use data obtained as result of activities under this section to formulate or revise existing lead blood screening and case management policies; and
"(F) establish performance measures for evaluating State and local implementation of the requirements and improvements described in subparagraphs (A) through (E).
"(2)
"(3)
1 See References in Text notes below.
§247b–2. Repealed. Pub. L. 97–35, title IX, §902(a), Aug. 13, 1981, 95 Stat. 559
Section,
Effective Date of Repeal
Repeal effective Oct. 1, 1981, see section 902(h) of
§247b–3. Education, technology assessment, and epidemiology regarding lead poisoning
(a) Prevention
(1) Public education
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out a program to educate health professionals and paraprofessionals and the general public on the prevention of lead poisoning in infants and children. In carrying out the program, the Secretary shall make available information concerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and secondary preventive measures that may be taken to prevent such poisoning.
(2) Interagency Task Force
(A) Not later than 6 months after October 27, 1992, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of Lead Poisoning (in this paragraph referred to as the "Task Force"). The Task Force shall coordinate the efforts of Federal agencies to prevent lead poisoning.
(B) The Task Force shall be composed of—
(i) the Secretary, who shall serve as the chair of the Task Force;
(ii) the Secretary of Housing and Urban Development;
(iii) the Administrator of the Environmental Protection Agency; and
(iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials respectively.
(C) The Task Force shall—
(i) review, evaluate, and coordinate current strategies and plans formulated by the officials serving as members of the Task Force, including—
(I) the plan of the Secretary of Health and Human Services entitled "Strategic Plan for the Elimination of Lead Poisoning", dated February 21, 1991;
(II) the plan of the Secretary of Housing and Urban Development entitled "Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing", dated December 7, 1990; and
(III) the strategy of the Administrator of the Environmental Protection Agency entitled "Strategy for Reducing Lead Exposures", dated February 21, 1991;
(ii) develop a unified implementation plan for programs that receive Federal financial assistance for activities related to the prevention of lead poisoning;
(iii) establish a mechanism for sharing and disseminating information among the agencies represented on the Task Force;
(iv) identify the most promising areas of research and education concerning lead poisoning;
(v) identify the practical and technological constraints to expanding lead poisoning prevention;
(vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and not later than May 1 of each year, submit to the Committee on Labor and Human Resources of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as a result of such review and that contains the recommendations of the Task Force on the programs and policies with respect to which the Task Force is established, including related budgetary recommendations; and
(vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning prevention activities of the Federal Government.
(b) Technology assessment and epidemiology
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts—
(1) provide for the development of improved, more cost-effective testing measures for detecting lead toxicity in children;
(2) provide for the development of improved methods of assessing the prevalence of lead poisoning, including such methods as may be necessary to conduct individual assessments for each State;
(3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and children, on the demographic characteristics of infants and children with such poisoning (including racial and ethnic status), and on the source of payment for treatment for such poisoning (including the extent to which insurance has paid for such treatment); and
(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in infants and children.
(July 1, 1944, ch. 373, title III, §317B, as added
Amendments
1993—
Change of Name
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
§247b–3a. Training and reports by the Health Resources and Services Administration
(a) Training
The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration and in collaboration with the Administrator of the Health Care Financing Administration and the Director of the Centers for Disease Control and Prevention, shall conduct education and training programs for physicians and other health care providers regarding childhood lead poisoning, current screening and treatment recommendations and requirements, and the scientific, medical, and public health basis for those policies.
(b) Report
The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, annually shall report to Congress on the number of children who received services through health centers established under
(c) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each 1 the fiscal years 2001 through 2005.
(
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
1 So in original. Probably should be followed by "of".
§247b–4. National Center on Birth Defects and Developmental Disabilities
(a) In general
(1) National Center
There is established within the Centers for Disease Control and Prevention a center to be known as the National Center on Birth Defects and Developmental Disabilities (referred to in this section as the "Center"), which shall be headed by a director appointed by the Director of the Centers for Disease Control and Prevention.
(2) General duties
The Secretary shall carry out programs—
(A) to collect, analyze, and make available data on birth defects and developmental disabilities (in a manner that facilitates compliance with subsection (d)(2) of this section), including data on the causes of such defects and disabilities and on the incidence and prevalence of such defects and disabilities;
(B) to operate regional centers for the conduct of applied epidemiological research on the prevention of such defects and disabilities; and
(C) to provide information and education to the public on the prevention of such defects and disabilities.
(3) Folic acid
The Secretary shall carry out
(4) Certain programs
(A) Transfers
All programs and functions described in subparagraph (B) are transferred to the Center, effective upon the expiration of the 180-day period beginning on October 17, 2000.
(B) Relevant programs
The programs and functions described in this subparagraph are all programs and functions that—
(i) relate to birth defects; folic acid; cerebral palsy; mental retardation; child development; newborn screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases, disorders, or conditions as determined 1 the Secretary; and
(ii) were carried out through the National Center for Environmental Health as of the day before October 17, 2000.
(C) Related transfers
Personnel employed in connection with the programs and functions specified in subparagraph (B), and amounts available for carrying out the programs and functions, are transferred to the Center, effective upon the expiration of the 180-day period beginning on October 17, 2000. Such transfer of amounts does not affect the period of availability of the amounts, or the availability of the amounts with respect to the purposes for which the amounts may be expended.
(b) Additional provisions regarding collection of data
(1) In general
In carrying out subsection (a)(2)(A) of this section, the Secretary—
(A) shall collect and analyze data by gender and by racial and ethnic group, including Hispanics, non-Hispanic whites, Blacks, Native Americans, Asian Americans, and Pacific Islanders;
(B) shall collect data under subparagraph (A) from birth certificates, death certificates, hospital records, and such other sources as the Secretary determines to be appropriate; and
(C) shall encourage States to establish or improve programs for the collection and analysis of epidemiological data on birth defects, and to make the data available.
(2) National clearinghouse
In carrying out subsection (a)(1) of this section, the Secretary shall establish and maintain a National Information Clearinghouse on Birth Defects to collect and disseminate to health professionals and the general public information on birth defects, including the prevention of such defects.
(c) Grants and contracts
(1) In general
In carrying out subsection (a) of this section, the Secretary may make grants to and enter into contracts with public and nonprofit private entities.
(2) Supplies and services in lieu of award funds
(A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(3) Application for award
The Secretary may make an award of a grant or contract under paragraph (1) only if an application for the award is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the purposes for which the award is to be made.
(d) Biennial report
Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
(1) contains information regarding the incidence and prevalence of birth defects and the extent to which birth defects have contributed to the incidence and prevalence of infant mortality;
(2) contains information under paragraph (1) that is specific to various racial and ethnic groups (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
(3) contains an assessment of the extent to which various approaches of preventing birth defects have been effective;
(4) describes the activities carried out under this section; and
(5) contains any recommendations of the Secretary regarding this section.
(e) Applicability of privacy laws
The provisions of this section shall be subject to the requirements of
(f) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $30,000,000 for fiscal year 1999, $40,000,000 for fiscal year 2000, and such sums as may be necessary for each of the fiscal years 2001 and 2002.
(July 1, 1944, ch. 373, title III, §317C, as added
Amendments
2000—
Subsec. (a).
Subsec. (b)(1).
1998—
1993—
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Congressional Findings
"(1) Birth defects are the leading cause of infant mortality, directly responsible for one out of every five infant deaths.
"(2) Thousands of the 150,000 infants born with a serious birth defect annually face a lifetime of chronic disability and illness.
"(3) Birth defects threaten the lives of infants of all racial and ethnic backgrounds. However, some conditions pose excess risks for certain populations. For example, compared to all infants born in the United States, Hispanic-American infants are more likely to be born with anencephaly spina bifida and other neural tube defects and African-American infants are more likely to be born with sickle-cell anemia.
"(4) Birth defects can be caused by exposure to environmental hazards, adverse health conditions during pregnancy, or genetic mutations. Prevention efforts are slowed by lack of information about the number and causes of birth defects. Outbreaks of birth defects may go undetected because surveillance and research efforts are underdeveloped and poorly coordinated.
"(5) Public awareness strategies, such as programs using folic acid vitamin supplements to prevent spina bifida and alcohol avoidance programs to prevent Fetal Alcohol Syndrome, are essential to prevent the heartache and costs associated with birth defects."
1 So in original. Probably should be followed by the word "by".
§247b–4a. Early detection, diagnosis, and interventions for newborns and infants with hearing loss
(a) Definitions
For the purposes of this section only, the following terms in this section are defined as follows:
(1) Hearing screening
Newborn and infant hearing screening consists of objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who, after rescreening, require further audiologic and medical evaluations.
(2) Audiologic evaluation
Audiologic evaluation consists of procedures to assess the status of the auditory system; to establish the site of the auditory disorder; the type and degree of hearing loss, and the potential effects of hearing loss on communication; and to identify appropriate treatment and referral options. Referral options should include linkage to State IDEA part C coordinating agencies or other appropriate agencies, medical evaluation, hearing aid/sensory aid assessment, audiologic rehabilitation treatment, national and local consumer, self-help, parent, and education organizations, and other family-centered services.
(3) Medical evaluation
Medical evaluation by a physician consists of key components including history, examination, and medical decision making focused on symptomatic and related body systems for the purpose of diagnosing the etiology of hearing loss and related physical conditions, and for identifying appropriate treatment and referral options.
(4) Medical intervention
Medical intervention is the process by which a physician provides medical diagnosis and direction for medical and/or surgical treatment options of hearing loss and/or related medical disorder associated with hearing loss.
(5) Audiologic rehabilitation
Audiologic rehabilitation (intervention) consists of procedures, techniques, and technologies to facilitate the receptive and expressive communication abilities of a child with hearing loss.
(6) Early intervention
Early intervention (e.g., nonmedical) means providing appropriate services for the child with hearing loss and ensuring that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, communication options and are given the opportunity to consider the full range of educational and program placements and options for their child.
(b) Purposes
The purposes of this section are to clarify the authority within the Public Health Service Act [
(1) All babies born in hospitals in the United States and its territories should have a hearing screening before leaving the birthing facility. Babies born in other countries and residing in the United States via immigration or adoption should have a hearing screening as early as possible.
(2) All babies who are not born in hospitals in the United States and its territories should have a hearing screening within the first 3 months of life.
(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for all newborns and infants suspected of having hearing loss to allow appropriate referral and provisions for audiologic rehabilitation, medical and early intervention before the age of 6 months.
(4) All newborn and infant hearing screening programs and systems should include a component for audiologic rehabilitation, medical and early intervention options that ensures linkage to any new and existing statewide systems of intervention and rehabilitative services for newborns and infants with hearing loss.
(5) Public policy in regard to newborn and infant hearing screening and intervention should be based on applied research and the recognition that newborns, infants, toddlers, and children who are deaf or hard-of-hearing have unique language, learning, and communication needs, and should be the result of consultation with pertinent public and private sectors.
(c) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
Under the existing authority of the Public Health Service Act [
(1) To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act [
(2) To collect data on statewide newborn and infant hearing screening, evaluation and intervention programs and systems that can be used for applied research, program evaluation and policy development.
(d) Technical assistance, data management, and applied research
(1) Centers for Disease Control and Prevention
Under the existing authority of the Public Health Service Act [
(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, and intervention programs and systems;
(B) to provide technical assistance on data collection and management;
(C) to study the costs and effectiveness of newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in order to answer issues of importance to State and national policymakers;
(D) to identify the causes and risk factors for congenital hearing loss;
(E) to study the effectiveness of newborn and infant hearing screening, audiologic and medical evaluations and intervention programs and systems by assessing the health, intellectual and social developmental, cognitive, and language status of these children at school age; and
(F) to promote the sharing of data regarding early hearing loss with State-based birth defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing loss.
(2) National Institutes of Health
Under the existing authority of the Public Health Service Act, the Director of the National Institutes of Health, acting through the Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of this section, continue a program of research and development on the efficacy of new screening techniques and technology, including clinical studies of screening methods, studies on efficacy of intervention, and related research.
(e) Coordination and collaboration
(1) In general
Under the existing authority of the Public Health Service Act [
(2) Policy development
Under the existing authority of the Public Health Service Act, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with the private sector, including consumer, medical and other health and education professional-based organizations, with respect to newborn and infant hearing screening, evaluation and intervention programs and systems.
(3) State early detection, diagnosis, and intervention programs and systems; data collection
Under the existing authority of the Public Health Service Act, the Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish newborn and infant hearing screening, evaluation and intervention programs and systems under subsection (c) of this section and to develop a data collection system under subsection (d) of this section.
(f) Rule of construction
Nothing in this section shall be construed to preempt any State law.
(g) Authorization of appropriations
(1) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
For the purpose of carrying out subsection (c) of this section under the existing authority of the Public Health Service Act [
(2) Technical assistance, data management, and applied research; Centers for Disease Control and Prevention
For the purpose of carrying out subsection (d)(1) of this section under the existing authority of the Public Health Service Act, there are authorized to the Centers for Disease Control and Prevention, appropriations in the amount of $5,000,000 for fiscal year 2000, $7,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal year 2002.
(3) Technical assistance, data management, and applied research; National Institute on Deafness and Other Communication Disorders
For the purpose of carrying out subsection (d)(2) of this section under the existing authority of the Public Health Service Act, there are authorized to the National Institute on Deafness and Other Communication Disorders appropriations for such sums as may be necessary for each of the fiscal years 2000 through 2002.
(
References in Text
The Public Health Service Act, referred to in subsecs. (b) to (e) and (g), is act July 1, 1944, ch. 373,
The Individuals with Disabilities Education Act, referred to in subsecs. (c)(1) and (e)(1), is title VI of
The Social Security Act, referred to in subsec. (e)(1), is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2000, and not as part of the Public Health Service Act which comprises this chapter.
§247b–4b. Developmental disabilities surveillance and research programs
(a) National autism and pervasive developmental disabilities surveillance program
(1) In general
The Secretary of Health and Human Services (in this section referred to as the "Secretary"), acting through the Director of the Centers for Disease Control and Prevention, may make awards of grants and cooperative agreements for the collection, analysis, and reporting of data on autism and pervasive developmental disabilities. In making such awards, the Secretary may provide direct technical assistance in lieu of cash.
(2) Eligibility
To be eligible to receive an award under paragraph (1) an entity shall be a public or nonprofit private entity (including health departments of States and political subdivisions of States, and including universities and other educational entities).
(b) Centers of excellence in autism and pervasive developmental disabilities epidemiology
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish not less than three regional centers of excellence in autism and pervasive developmental disabilities epidemiology for the purpose of collecting and analyzing information on the number, incidence, correlates, and causes of autism and related developmental disabilities.
(2) Recipients of awards for establishment of centers
Centers under paragraph (1) shall be established and operated through the awarding of grants or cooperative agreements to public or nonprofit private entities that conduct research, including health departments of States and political subdivisions of States, and including universities and other educational entities.
(3) Certain requirements
An award for a center under paragraph (1) may be made only if the entity involved submits to the Secretary an application containing such agreements and information as the Secretary may require, including an agreement that the center involved will operate in accordance with the following:
(A) The center will collect, analyze, and report autism and pervasive developmental disabilities data according to guidelines prescribed by the Director, after consultation with relevant State and local public health officials, private sector developmental disability researchers, and advocates for those with developmental disabilities.
(B) The center will assist with the development and coordination of State autism and pervasive developmental disabilities surveillance efforts within a region.
(C) The center will identify eligible cases and controls through its surveillance systems and conduct research into factors which may cause autism and related developmental disabilities.
(D) The center will develop or extend an area of special research expertise (including genetics, environmental exposure to contaminants, immunology, and other relevant research specialty areas).
(c) Clearinghouse
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out the following:
(1) The Secretary shall establish a clearinghouse within the Centers for Disease Control and Prevention for the collection and storage of data generated from the monitoring programs established by this title.1 Through the clearinghouse, such Centers shall serve as the coordinating agency for autism and pervasive developmental disabilities surveillance activities. The functions of such a clearinghouse shall include facilitating the coordination of research and policy development relating to the epidemiology of autism and other pervasive developmental disabilities.
(2) The Secretary shall coordinate the Federal response to requests for assistance from State health department officials regarding potential or alleged autism or developmental disability clusters.
(d) Definition
In this title,1 the term "State" means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands.
(e) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section.
(
References in Text
This title, referred to in subsecs. (c)(1) and (d), is title I of div. A of
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
Termination of Trust Territory of the Pacific Islands
For termination of Trust Territory of the Pacific Islands, see note set out preceding
1 See References in Text note below.
§247b–4c. Information and education
(a) In general
The Secretary shall establish and implement a program to provide information and education on autism to health professionals and the general public, including information and education on advances in the diagnosis and treatment of autism and training and continuing education through programs for scientists, physicians, and other health professionals who provide care for patients with autism.
(b) Stipends
The Secretary may use amounts made available under this section to provide stipends for health professionals who are enrolled in training programs under this section.
(c) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section.
(
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
§247b–4d. Inter-agency Autism Coordinating Committee
(a) Establishment
The Secretary shall establish a committee to be known as the "Autism Coordinating Committee" (in this section referred to as the "Committee") to coordinate all efforts within the Department of Health and Human Services concerning autism, including activities carried out through the National Institutes of Health and the Centers for Disease Control and Prevention under this title 1 (and the amendment made by this title).1
(b) Membership
(1) In general
The Committee shall be composed of the Directors of such national research institutes, of the Centers for Disease Control and Prevention, and of such other agencies and such other officials as the Secretary determines appropriate.
(2) Additional members
If determined appropriate by the Secretary, the Secretary may appoint to the Committee—
(A) parents or legal guardians of individuals with autism or other pervasive developmental disorders; and
(B) representatives of other governmental agencies that serve children with autism such as the Department of Education.
(c) Administrative support; terms of service; other provisions
The following shall apply with respect to the Committee:
(1) The Committee shall receive necessary and appropriate administrative support from the Department of Health and Human Services.
(2) Members of the Committee appointed under subsection (b)(2)(A) of this section shall serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed.
(3) The Committee shall meet not less than two times each year.
(
References in Text
This title, referred to in subsec. (a), is title I of div. A of
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
1 See References in Text note below.
§247b–4e. Report to Congress
Not later than January 1, 2001, and each January 1 thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress, a report concerning the implementation of this title 1 and the amendments made by this title.1
(
References in Text
This title, referred to in text, is title I of div. A of
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
1 See References in Text note below.
§247b–5. Preventive health measures with respect to prostate cancer
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs that may include the following:
(1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners regarding screening for prostate cancer.
(2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National Institutes of Health, the effectiveness of screening strategies for prostate cancer.
(3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the quality of life for men after prostrate 1 cancer screening and followup.
(4) To develop and disseminate public information and education programs for prostate cancer, including appropriate messages about the risks and benefits of prostate cancer screening for the general public, health care providers, policy makers and other appropriate individuals.
(5) To improve surveillance for prostate cancer.
(6) To address the needs of underserved and minority populations regarding prostate cancer.
(7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Preventive Services Task Force and shall seek input, where appropriate, from professional societies and other private and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—
(A) to screen men for prostate cancer as a preventive health measure;
(B) to provide appropriate referrals for the medical treatment of men who have been screened under subparagraph (A) and to ensure, to the extent practicable, the provision of appropriate followup services and support services such as case management;
(C) to establish mechanisms through which State and local health departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
(D) to improve, in consultation with the Health Resources and Services Administration, the education, training, and skills of health practitioners (including appropriate allied health professionals) in the detection and control of prostate cancer.
(8) To evaluate activities conducted under paragraphs (1) through (7) through appropriate surveillance or program monitoring activities.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such section, to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such contributions may be made directly or through donations from public or private entities.
(2) Determination of amount of non-Federal contribution
(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal contributions made by the applicant involved toward the purpose described in subsection (a) of this section for the 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such subsection.
(C) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act [
(c) Education on significance of early detection
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that, in carrying out subsection (a)(3) of this section, the applicant will carry out education programs to communicate to men, and to local health officials, the significance of the early detection of prostate cancer.
(d) Requirement of provision of all services by date certain
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees—
(1) to ensure that, initially and throughout the period during which amounts are received pursuant to the grant, not less than 60 percent of the grant is expended to provide each of the services or activities described in paragraphs (1) and (2) of such subsection;
(2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the services or activities described in such subsection is provided; and
(3) to ensure that not more than 40 percent of the grant is expended to provide the services or activities described in paragraphs (3) through (6) of such section.2
(e) Additional required agreements
(1) Priority for low-income men
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that low-income men, and men at risk of prostate cancer, will be given priority in the provision of services and activities pursuant to paragraphs (1) and (2) of such subsection.
(2) Limitation on imposition of fees for services
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(A) will be made according to a schedule of charges that is made available to the public;
(B) will be adjusted to reflect the income of the man involved; and
(C) will not be imposed on any man with an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(3) Relationship to items and services under other programs
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(4) Coordination with other prostate cancer programs
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that the services and activities funded through the grant will be coordinated with other Federal, State, and local prostate cancer programs.
(5) Limitation on administrative expenses
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that not more than 10 percent of the grant will be expended for administrative expenses with respect to the grant.
(6) Restrictions on use of grant
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that the grant will not be expended to provide inpatient hospital services for any individual.
(7) Records and audits
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that—
(A) the applicant will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the applicant under such section; 3 and
(B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of auditing the expenditures by the applicant of the grant.
(f) Reports to Secretary
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees to submit to the Secretary such reports as the Secretary may require with respect to the grant.
(g) Description of intended uses of grant
The Secretary may not make a grant under subsection (a) of this section unless—
(1) the applicant involved submits to the Secretary a description of the purposes for which the applicant intends to expend the grant;
(2) the description identifies the populations, areas, and localities in the applicant 4 with a need for the services or activities described in subsection (a) of this section;
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in which the services and activities will be coordinated with any similar services or activities of public or nonprivate entities; and
(4) the description provides assurances that the grant funds will be used in the most cost-effective manner.
(h) Requirement of submission of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary, the application contains the description of intended uses required in subsection (g) of this section, and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(i) Method and amount of payment
The Secretary shall determine the amount of a grant made under subsection (a) of this section. Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of the underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(j) Technical assistance and provision of supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to subsection (a) of this section. The Secretary may provide such technical assistance directly or through grants to, or contracts with, public and private entities.
(2) Provision of supplies and services in lieu of grant funds
(A) Upon the request of an applicant receiving a grant under subsection (a) of this section, the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out such section and, for such purpose, may detail to the applicant any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the grant under subsection (a) of this section to the applicant involved by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(k) "Units of local government" defined
For purposes of this section, the term "units of local government" includes Indian tribes.
(l) Authorization of appropriations
(1) In general
For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004.
(2) Allocation for technical assistance
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall reserve not more than 20 percent for carrying out subsection (j)(1) of this section.
(July 1, 1944, ch. 373, title III, §317D, as added
References in Text
The Social Security Act, referred to in subsec. (b)(2)(C), is act Aug. 14, 1935, ch. 531,
Amendments
2000—Subsec. (a).
"(1) to screen men for prostate cancer as a preventive health measure;
"(2) to provide appropriate referrals for medical treatment of men screened pursuant to paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up services;
"(3) to develop and disseminate public information and education programs for the detection and control of prostate cancer;
"(4) to improve the education, training, and skills of health professionals (including appropriate allied health professionals) in the detection and control of prostate cancer;
"(5) to establish mechanisms through which the States and such departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
"(6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or program monitoring activities."
Subsec. (l)(1).
1998—Subsec. (l)(1).
1993—
Subsec. (l)(1).
Effective Date of 1998 Amendment
Amendment by
1 So in original. Probably should be "prostate".
2 So in original. Probably should be "subsection."
3 So in original. Probably should be "subsection;".
4 So in original. Probably should be "application".
§247b–6. Preventive health services regarding tuberculosis
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions, and other public entities for preventive health service programs for the prevention, control, and elimination of tuberculosis.
(b) Research, demonstration projects, education, and training
With respect to the prevention, control, and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following:
(1) Research, with priority given to research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations.
(2) Demonstration projects.
(3) Public information and education programs.
(4) Education, training, and clinical skills improvement activities for health professionals, including allied health personnel and emergency response employees.
(5) Support of centers to carry out activities under paragraphs (1) through (4).
(6) Collaboration with international organizations and foreign countries in carrying out such activities.
(c) Cooperation with providers of primary health services
The Secretary may make a grant under subsection (a) or (b) of this section only if the applicant for the grant agrees that, in carrying out activities under the grant, the applicant will cooperate with public and nonprofit private providers of primary health services or substance abuse services, including entities receiving assistance under
(d) Application for grant
(1) In general
The Secretary may make a grant under subsection (a) or (b) of this section only if an application for the grant is submitted to the Secretary and the application, subject to paragraph (2), is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the subsection involved.
(2) Plan for prevention, control, and elimination
The Secretary may make a grant under subsection (a) of this section only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of tuberculosis in the geographic area with respect to which the grant is sought.
(e) Supplies and services in lieu of grant funds
(1) In general
Upon the request of a grantee under subsection (a) or (b) of this section, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out the subsection involved and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services.
(2) Corresponding reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(f) Advisory Council
(1) In general
The Secretary shall establish an advisory council to be known as the Advisory Council for the Elimination of Tuberculosis (in this subsection referred to as the "Council").
(2) General duties
The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary, the Assistant Secretary for Health, and the Director of the Centers for Disease Control and Prevention.
(3) Certain activities
With respect to the elimination of tuberculosis, the Council shall—
(A) in making recommendations under paragraph (2), make recommendations regarding policies, strategies, objectives, and priorities;
(B) address the development and application of new technologies; and
(C) review the extent to which progress has been made toward eliminating tuberculosis.
(4) Composition
The Secretary shall determine the size and composition of the Council, and the frequency and scope of official meetings of the Council.
(5) Staff, information, and other assistance
The Secretary shall provide to the Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council.
(g) Funding
(1) In general; allocation for emergency grants
(A) For the purpose of making grants under subsection (a) of this section, there are authorized to be appropriated $200,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2002.
(B) Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) of this section for any geographic area in which there is, relative to other areas, a substantial number of cases of tuberculosis or a substantial rate of increase in such cases.
(2) Research, demonstration projects, education, and training
For the purpose of carrying out subsection (b) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 2002.
(July 1, 1944, ch. 373, title III, §317E, as added
References in Text
Amendments
1998—Subsec. (g)(1)(A).
Subsec. (g)(1)(B).
Subsec. (g)(2).
Effective Date of 1998 Amendment
Amendment by section 401(b)(1) of
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 sections 3(2) and 14 of
1 See References in Text notes below.
§247b–7. Loan repayment program
(a) In general
(1) Authority
Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct prevention activities, as employees of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $35,000 of the principal and interest of the educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for Toxic Substances and Disease Registry for purposes of paragraph (1) for a period of not less than 3 years.
(b) Applicability of certain provisions
With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of this subchapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2002.
(d) Availability of appropriations
Amounts appropriated for a fiscal year for contracts under subsection (a) of this section shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.
(July 1, 1944, ch. 373, title III, §317F, as added
Amendments
1998—Subsec. (a)(1).
Subsec. (c).
Subsec. (d).
Section Referred to in Other Sections
This section is referred to in
§247b–8. Fellowship and training programs
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by such Centers to train individuals to develop skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in local, State, national, and international efforts toward the prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be administered through the use of either appointment or nonappointment procedures.
(July 1, 1944, ch. 373, title III, §317G, as added
Effective Date
Section 408(b)(2) of
§247b–9. Diabetes in children and youth
(a) Surveillance on juvenile diabetes
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a sentinel system to collect data on juvenile diabetes, including with respect to incidence and prevalence, and shall establish a national database for such data.
(b) Type 2 diabetes in youth
The Secretary shall implement a national public health effort to address type 2 diabetes in youth, including—
(1) enhancing surveillance systems and expanding research to better assess the prevalence and incidence of type 2 diabetes in youth and determine the extent to which type 2 diabetes is incorrectly diagnosed as type 1 diabetes among children; and
(2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia and improving existing glucometers that measure blood glucose.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317H, as added
§247b–10. Compilation of data on asthma
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and the quality of asthma management;
(2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and
(3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma nationally.
(b) Surveillance activities
The Director of the Centers for Disease Control and Prevention, acting through the representative of the Director on the National Asthma Education Prevention Program Coordinating Committee, shall, in carrying out subsection (a) of this section, provide an update on surveillance activities at each Committee meeting.
(c) Collaborative efforts
The activities described in subsection (a)(1) of this section may be conducted in collaboration with eligible entities awarded a grant under
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317I, as added
§247b–11. Effects of folic acid in prevention of birth defects
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and intensify programs (directly or through grants or contracts) for the following purposes:
(1) To provide education and training for health professionals and the general public for purposes of explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a dietary supplement that provides an appropriate level of folic acid.
(2) To conduct research with respect to such education and training, including identifying effective strategies for increasing the rate of consumption of folic acid by women of reproductive capacity.
(3) To conduct research to increase the understanding of the effects of folic acid in preventing birth defects, including understanding with respect to cleft lip, cleft palate, and heart defects.
(4) To provide for appropriate epidemiological activities regarding folic acid and birth defects, including epidemiological activities regarding neural tube defects.
(b) Consultations with States and private entities
In carrying out subsection (a) of this section, the Secretary shall consult with the States and with other appropriate public or private entities, including national nonprofit private organizations, health professionals, and providers of health insurance and health plans.
(c) Technical assistance
The Secretary may (directly or through grants or contracts) provide technical assistance to public and nonprofit private entities in carrying out the activities described in subsection (a) of this section.
(d) Evaluations
The Secretary shall (directly or through grants or contracts) provide for the evaluation of activities under subsection (a) of this section in order to determine the extent to which such activities have been effective in carrying out the purposes of the program under such subsection, including the effects on various demographic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge and attitudes on the consumption of folic acid and on blood folate levels. Such methods may include complete and timely monitoring of infants who are born with neural tube defects.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317J, as added
Section Referred to in Other Sections
This section is referred to in
§247b–12. Safe motherhood
(a) Surveillance
(1) Purpose
The purpose of this subsection is to develop surveillance systems at the local, State, and national level to better understand the burden of maternal complications and mortality and to decrease the disparities among population at risk of death and complications from pregnancy.
(2) Activities
For the purpose described in paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out the following activities:
(A) The Secretary may establish and implement a national surveillance program to identify and promote the investigation of deaths and severe complications that occur during pregnancy.
(B) The Secretary may expand the Pregnancy Risk Assessment Monitoring System to provide surveillance and collect data in each State.
(C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical support, financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health programs in each State.
(b) Prevention research
(1) Purpose
The purpose of this subsection is to provide the Secretary with the authority to further expand research concerning risk factors, prevention strategies, and the roles of the family, health care providers and the community in safe motherhood.
(2) Research
The Secretary may carry out activities to expand research relating to—
(A) encouraging preconception counseling, especially for at risk populations such as diabetics;
(B) the identification of critical components of prenatal delivery and postpartum care;
(C) the identification of outreach and support services, such as folic acid education, that are available for pregnant women;
(D) the identification of women who are at high risk for complications;
(E) preventing preterm delivery;
(F) preventing urinary tract infections;
(G) preventing unnecessary caesarean sections;
(H) an examination of the higher rates of maternal mortality among African American women;
(I) an examination of the relationship between domestic violence and maternal complications and mortality;
(J) preventing and reducing adverse health consequences that may result from smoking, alcohol and illegal drug use before, during and after pregnancy;
(K) preventing infections that cause maternal and infant complications; and
(L) other areas determined appropriate by the Secretary.
(c) Prevention programs
(1) In general
The Secretary may carry out activities to promote safe motherhood, including—
(A) public education campaigns on healthy pregnancies and the building of partnerships with outside organizations concerned about safe motherhood;
(B) education programs for physicians, nurses and other health care providers; and
(C) activities to promote community support services for pregnant women.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317K, as added
§247b–13. Prenatal and postnatal health
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out programs—
(1) to collect, analyze, and make available data on prenatal smoking, alcohol and illegal drug use, including data on the implications of such activities and on the incidence and prevalence of such activities and their implications;
(2) to conduct applied epidemiological research on the prevention of prenatal and postnatal smoking, alcohol and illegal drug use;
(3) to support, conduct, and evaluate the effectiveness of educational and cessation programs; and
(4) to provide information and education to the public on the prevention and implications of prenatal and postnatal smoking, alcohol and illegal drug use.
(b) Grants
In carrying out subsection (a) of this section, the Secretary may award grants to and enter into contracts with States, local governments, scientific and academic institutions, federally qualified health centers, and other public and nonprofit entities, and may provide technical and consultative assistance to such entities.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317L, as added
§247b–14. Oral health promotion and disease prevention
(a) Grants to increase resources for community water fluoridation
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and Indian tribes for the purpose of increasing the resources available for community water fluoridation.
(2) Use of funds
A State shall use amounts provided under a grant under paragraph (1)—
(A) to purchase fluoridation equipment;
(B) to train fluoridation engineers;
(C) to develop educational materials on the benefits of fluoridation; or
(D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.
(b) Community water fluoridation
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with the Director of the Indian Health Service, shall establish a demonstration project that is designed to assist rural water systems in successfully implementing the water fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled "Engineering and Administrative Recommendations for Water Fluoridation, 1995" (referred to in this subsection as the "EARWF").
(2) Requirements
(A) Collaboration
In collaborating under paragraph (1), the Directors referred to in such paragraph shall ensure that technical assistance and training are provided to tribal programs located in each of the 12 areas of the Indian Health Service. The Director of the Indian Health Service shall provide coordination and administrative support to tribes under this section.
(B) General use of funds
Amounts made available under paragraph (1) shall be used to assist small water systems in improving the effectiveness of water fluoridation and to meet the recommendations of the EARWF.
(C) Fluoridation specialists
(i) In general
In carrying out this subsection, the Secretary shall provide for the establishment of fluoridation specialist engineering positions in each of the Dental Clinical and Preventive Support Centers through which technical assistance and training will be provided to tribal water operators, tribal utility operators and other Indian Health Service personnel working directly with fluoridation projects.
(ii) Liaison
A fluoridation specialist shall serve as the principal technical liaison between the Indian Health Service and the Centers for Disease Control and Prevention with respect to engineering and fluoridation issues.
(iii) CDC
The Director of the Centers for Disease Control and Prevention shall appoint individuals to serve as the fluoridation specialists.
(D) Implementation
The project established under this subsection shall be planned, implemented and evaluated over the 5-year period beginning on the date on which funds are appropriated under this section and shall be designed to serve as a model for improving the effectiveness of water fluoridation systems of small rural communities.
(3) Evaluation
In conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary shall ensure that such evaluation includes—
(A) the measurement of changes in water fluoridation compliance levels resulting from assistance provided under this section;
(B) the identification of the administrative, technical and operational challenges that are unique to the fluoridation of small water systems;
(C) the development of a practical model that may be easily utilized by other tribal, State, county or local governments in improving the quality of water fluoridation with emphasis on small water systems; and
(D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the benefits of optimally fluoridated water.
(c) School-based dental sealant program
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with the Administrator of the Health Resources and Services Administration, may award grants to States and Indian tribes to provide for the development of school-based dental sealant programs to improve the access of children to sealants.
(2) Use of funds
A State shall use amounts received under a grant under paragraph (1) to provide funds to eligible school-based entities or to public elementary or secondary schools to enable such entities or schools to provide children with access to dental care and dental sealant services. Such services shall be provided by licensed dental health professionals in accordance with State practice licensing laws.
(3) Eligibility
To be eligible to receive funds under paragraph (1), an entity shall—
(A) prepare and submit to the State an application at such time, in such manner and containing such information as the State may require; and
(B) be a public elementary or secondary school—
(i) that is located in an urban area in which and 1 more than 50 percent of the student population is participating in Federal or State free or reduced meal programs; or
(ii) that is located in a rural area and, with respect to the school district in which the school is located, the district involved has a median income that is at or below 235 percent of the poverty line, as defined in
(d) Definitions
For purposes of this section, the term "Indian tribe" means an Indian tribe or tribal organization as defined in section 450b(b) and section 450b(c) 2 of title 25.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317M, as added
References in Text
1 So in original. The word "and" probably should not appear.
2 See References in Text note below.
§247b–14a. Identification of interventions that reduce the burden and transmission of oral, dental, and craniofacial diseases in high risk populations; development of approaches for pediatric oral and craniofacial assessment
(a) In general
The Secretary of Health and Human Services, through the Maternal and Child Health Bureau, the Indian Health Service, and in consultation with the National Institutes of Health and the Centers for Disease Control and Prevention, shall—
(1) support community-based research that is designed to improve understanding of the etiology, pathogenesis, diagnosis, prevention, and treatment of pediatric oral, dental, craniofacial diseases and conditions and their sequelae in high risk populations;
(2) support demonstrations of preventive interventions in high risk populations including nutrition, parenting, and feeding techniques; and
(3) develop clinical approaches to assess individual patients for the risk of pediatric dental disease.
(b) Compliance with State practice laws
Treatment and other services shall be provided pursuant to this section by licensed dental health professionals in accordance with State practice and licensing laws.
(c) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section for each 1 the fiscal years 2001 through 2005.
(
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
1 So in original. Probably should be followed by "of".
§247b–15. Surveillance and education regarding hepatitis C virus
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may (directly and through grants to public and nonprofit private entities) provide for programs to carry out the following:
(1) To cooperate with the States in implementing a national system to determine the incidence of hepatitis C virus infection (in this section referred to as "HCV infection") and to assist the States in determining the prevalence of such infection, including the reporting of chronic HCV cases.
(2) To identify, counsel, and offer testing to individuals who are at risk of HCV infection as a result of receiving blood transfusions prior to July 1992, or as a result of other risk factors.
(3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
(4) To develop and disseminate public information and education programs for the detection and control of HCV infection, with priority given to high risk populations as determined by the Secretary.
(5) To improve the education, training, and skills of health professionals in the detection and control of HCV infection, with priority given to pediatricians and other primary care physicians, and obstetricians and gynecologists.
(b) Laboratory procedures
The Secretary may (directly and through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding hepatitis C, including reducing variability in laboratory results on hepatitis C antibody and PCR testing.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317N, as added
Study and Demonstration Projects Regarding Cases of Hepatitis C Among Certain Emergency Response Employees
"(a)
"(1)
"(A) an estimate of the prevalence of hepatitis C among designated emergency response employees in the United States; and
"(B) the likely means through which such employees become infected with such disease in the course of performing their duties as such employees.
"(2)
"(3)
"(b)
"(1)
"(A) Training designated emergency response employees in minimizing the risk of infection with hepatitis C in performing their duties as such employees.
"(B) Testing such employees for infection with the disease.
"(C) Treating the employees for the disease.
"(2)
"(3)
"(4)
"(5)
"(A) a summary of evaluations under paragraph (4); and
"(B) the recommendations of the Secretary for administrative or legislative initiatives regarding the activities described in paragraph (1).
"(c)
§247b–16. Grants for lead poisoning related activities
(a) Authority to make grants
(1) In general
The Secretary shall make grants to States to support public health activities in States and localities where data suggests that at least 5 percent of preschool-age children have an elevated blood lead level through—
(A) effective, ongoing outreach and community education targeted to families most likely to be at risk for lead poisoning;
(B) individual family education activities that are designed to reduce ongoing exposures to lead for children with elevated blood lead levels, including through home visits and coordination with other programs designed to identify and treat children at risk for lead poisoning; and
(C) the development, coordination and implementation of community-based approaches for comprehensive lead poisoning prevention from surveillance to lead hazard control.
(2) State match
A State is not eligible for a grant under this section unless the State agrees to expend (through State or local funds) $1 for every $2 provided under the grant to carry out the activities described in paragraph (1).
(3) Application
To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require.
(b) Coordination with other children's programs
A State shall identify in the application for a grant under this section how the State will coordinate operations and activities under the grant with—
(1) other programs operated in the State that serve children with elevated blood lead levels, including any such programs operated under title V, XIX, or XXI of the Social Security Act [
(2) one or more of the following—
(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such Act [
(B) the head start program established under the Head Start Act (
(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under
(D) local public and private elementary or secondary schools; or
(E) public housing agencies, as defined in
(c) Performance measures
The Secretary shall establish needs indicators and performance measures to evaluate the activities carried out under grants awarded under this section. Such indicators shall be commensurate with national measures of maternal and child health programs and shall be developed in consultation with the Director of the Centers for Disease Control and Prevention.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317O, as added
References in Text
The Social Security Act, referred to in subsec. (b)(1), (2)(A), is act Aug. 14, 1935, ch. 531,
The Head Start Act, referred to in subsec. (b)(2)(B), is subchapter B (§§635–657) of
§247b–17. Human papillomavirus
(a) Surveillance
(1) In general
The Secretary, acting through the Centers for Disease Control and Prevention, shall—
(A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other special studies that would determine the prevalence in various age groups and populations of specific types of human papillomavirus (referred to in this section as "HPV") in different sites in various regions of the United States, through collection of special specimens for HPV using a variety of laboratory-based testing and diagnostic tools; and
(B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
(2) Report
The Secretary shall make a progress report to the Congress with respect to paragraph (1) no later than 1 year after the effective date of this section.
(b) Prevention activities; education program
(1) In general
The Secretary, acting through the Centers for Disease Control and Prevention, shall conduct prevention research on HPV, including—
(A) behavioral and other research on the impact of HPV-related diagnosis on individuals;
(B) formative research to assist with the development of educational messages and information for the public, for patients, and for their partners about HPV;
(C) surveys of physician and public knowledge, attitudes, and practices about genital HPV infection; and
(D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and disseminate educational materials for the public and health care providers regarding HPV and its impact and prevention.
(2) Report; final proposal
The Secretary shall make a progress report to the Congress with respect to paragraph (1) not later than 1 year after the effective date of this section, and shall develop a final report not later than 3 years after such effective date, including a detailed summary of the significant findings and problems and the best strategies to prevent future infections, based on available science.
(c) HPV education and prevention
(1) In general
The Secretary shall prepare and distribute educational materials for health care providers and the public that include information on HPV. Such materials shall address—
(A) modes of transmission;
(B) consequences of infection, including the link between HPV and cervical cancer;
(C) the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV; and
(D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cervical cancer purposes in preventing cervical cancer.
(2) Medically accurate information
Educational material under paragraph (1), and all other relevant educational and prevention materials prepared and printed from this date forward for the public and health care providers by the Secretary (including materials prepared through the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), or by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV shall contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address. Such requirement only applies to materials mass produced for the public and health care providers, and not to routine communications.
(July 1, 1944, ch. 373, title III, §317P, as added
References in Text
The effective date of this section, referred to in subsecs. (a)(2) and (b)(2), is the date of enactment of
§247c. Sexually transmitted diseases; prevention and control projects and programs
(a) Technical assistance to public and nonprofit private entities and scientific institutions
The Secretary may provide technical assistance to appropriate public and nonprofit private entities and to scientific institutions for their research in, and training and public health programs for, the prevention and control of sexually transmitted diseases.
(b) Research, demonstration, and public information and education projects
The Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity for—
(1) research into the prevention and control of sexually transmitted diseases;
(2) demonstration projects for the prevention and control of sexually transmitted diseases;
(3) public information and education programs for the prevention and control of such diseases; and
(4) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).
(c) Project grants to States
The Secretary is also authorized to make project grants to States and, in consultation with the State health authority, to political subdivisions of States, for—
(1) sexually transmitted diseases surveillance activities, including the reporting, screening, and followup of diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
(2) casefinding and case followup activities respecting sexually transmitted diseases, including contact tracing of infectious cases of sexually transmitted diseases and routine testing, including laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
(4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and control strategies and activities as may be prescribed by the Secretary.
(d) Grants for innovative, interdisciplinary approaches
The Secretary may make grants to States and political subdivisions of States for the development, implementation, and evaluation of innovative, interdisciplinary approaches to the prevention and control of sexually transmitted diseases.
(e) Authorization of appropriations; terms and conditions; payments; recordkeeping; audit; grant reduction; information disclosure
(1) For the purpose of making grants under subsections (b) through (d) of this section, there are authorized to be appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(3) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients of grants under this section that are pertinent to such grants.
(4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances, travel expenses, and any other costs in connection with the detail of an officer or employee of the United States to the recipient when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such recipient and for the purpose of carrying out the program with respect to which the grant under this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
(5) All information obtained in connection with the examination, care, or treatment of any individual under any program which is being carried out with a grant made under this section shall not, without such individual's consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a state or political subdivision of a State. Information derived from any such program may be disclosed—
(A) in summary, statistical, or other form; or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or provided care or treatment under such program is not disclosed.
(f) Consent of individuals
Nothing in this section shall be construed to require any State or any political subdivision of a State to have a sexually transmitted diseases program which would require any person, who objects to any treatment provided under such a program, to be treated under such a program.
(July 1, 1944, ch. 373, title III, §318, as added
Prior Provisions
A prior section 247c, act July 1, 1944, ch. 373 title III, §318, as added Aug. 18, 1964,
Amendments
1998—Subsec. (e).
Subsec. (e)(5).
Subsec. (f).
1993—Subsec. (b)(3).
Subsec. (c)(3).
Subsec. (d).
Subsec. (e).
Subsec. (e)(1).
Subsec. (e)(5).
1988—
Subsec. (d).
Subsec. (d)(1).
Subsecs. (e) to (g).
1984—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsecs. (f), (g).
1981—Subsec. (d)(1).
1979—Subsec. (b).
1978—Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (f).
Subsec. (g).
1976—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Effective Date of 1998 Amendment
Amendment by
Distribution of Information on Acquired Immune Deficiency Syndrome by Director of Centers for Disease Control to Every American Household
Congressional Findings and Declarations
Section 204(a) of
"(1) the number of reported cases of venereal disease persists in epidemic proportions in the United States;
"(2) the number of persons affected by venereal disease and reported to public health authorities is only a fraction of those actually affected;
"(3) the incidence of venereal disease continues to be particularly high among American youth, ages fifteen to twenty-nine, and among populations in metropolitan areas;
"(4) venereal disease accounts for severe permanent disabilities and sometimes death in newborns and causes reproductive dysfunction in women of childbearing age;
"(5) it is conservatively estimated that the public cost of health care for persons suffering from complications of venereal disease exceeds one-half billion dollars annually;
"(6) the number of trained Federal venereal disease prevention and control personnel has fallen to a dangerously inadequate level;
"(7) no vaccine for syphilis, gonorrhea, or any other venereal disease has yet been developed, nor does a blood test for the detection of asymptomatic gonorrhea in women exist, nor are safe and effective therapeutic agents available for some other venereal diseases;
"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup have all been found to be effective venereal disease prevention and control methodologies;
"(9) skilled and knowledgeable health care providers, informed and concerned individuals and active, well-coordinated voluntary groups are fundamental to venereal disease prevention and control;
"(10) biomedical research toward improved diagnostic and therapeutic tools is of singular importance to the elimination of venereal disease; and
"(11) an increasing number of sexually transmissible diseases besides syphilis and gonorrhea have become a public health hazard."
Section 203(a) of
"(1) the number of reported cases of venereal disease continues in epidemic proportions in the United States;
"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those actually infected;
"(3) the incidence of venereal disease is particularly high in the 15–29-year age group, and in metropolitan areas;
"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
"(5) the number of cases of congenital syphilis, a preventable disease, tends to parallel the incidence of syphilis in adults;
"(6) it is conservatively estimated that the public cost of care for persons suffering the complications of venereal disease exceed $80,000,000 annually;
"(7) medical researchers have no successful vaccine for syphilis or gonorrhea, and have no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females;
"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup activities have all been found to be effective disease intervention methodologies;
"(9) knowledgeable health providers and concerned individuals and groups are fundamental to venereal disease prevention and control;
"(10) biomedical research leading to the development of vaccines for syphilis and gonorrhea is of singular importance for the eventual eradication of these dreaded diseases; and
"(11) a variety of other sexually transmitted diseases, in addition to syphilis and gonorrhea, have become of public health significance."
Section 202 of
"(a) The Congress finds and declares that—
"(1) the number or reported cases of venereal disease has reached epidemic proportions in the United States;
"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those treated by physicians;
"(3) the incidence of venereal disease is particularly high among individuals in the 20–24 age group, and in metropolitan areas;
"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
"(5) the number of cases of congenital syphilis, a preventable disease, in infants under one year of age increased by 331/3 per centum between 1970 and 1971;
"(6) health education programs in schools and through the mass media may prevent a substantial portion of the venereal disease problem; and
"(7) medical authorities have no successful vaccine for syphilis or gonorrhea and no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females.
"(b) In order to preserve and protect the health and welfare of all citizens, it is the purpose of this Act [this chapter] to establish a national program for the prevention and control of venereal disease."
Section Referred to in Other Sections
This section is referred to in
§247c–1. Infertility and sexually transmitted diseases
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions of States, and other public or nonprofit private entities for the purpose of carrying out the activities described in subsection (c) of this section regarding any treatable sexually transmitted disease that can cause infertility in women if treatment is not received for the disease.
(b) Authority regarding individual diseases
With respect to diseases described in subsection (a) of this section, the Secretary shall, in making a grant under such subsection, specify the particular disease or diseases with respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved agrees to carry out this section only with respect to the disease or diseases so specified.
(c) Authorized activities
With respect to any sexually transmitted disease described in subsection (a) of this section, the activities referred to in such subsection are—
(1) screening women for the disease and for secondary conditions resulting from the disease, subject to compliance with criteria issued under subsection (f) of this section;
(2) providing treatment to women for the disease;
(3) providing counseling to women on the prevention and control of the disease (including, in the case of a woman with the disease, counseling on the benefits of locating and providing such counseling to any individual from whom the woman may have contracted the disease and any individual whom the woman may have exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services for women screened pursuant to paragraph (1), including referrals for evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;
(6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5), providing to the partner of the woman the services described in such paragraphs, as appropriate;
(7) providing outreach services to inform women of the availability of the services described in paragraphs (1) through (6);
(8) providing to the public information and education on the prevention and control of the disease, including disseminating such information; and
(9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3).
(d) Requirement of availability of all services through each grantee
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that each activity authorized in subsection (c) of this section will be available through the applicant. With respect to compliance with such agreement, the applicant may expend the grant to carry out any of the activities directly, and may expend the grant to enter into agreements with other public or nonprofit private entities under which the entities carry out the activities.
(e) Required providers regarding certain services
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that, in expending the grant to carry out activities authorized in subsection (c) of this section, the services described in paragraphs (1) through (7) of such subsection will be provided only through entities that are State or local health departments, grantees under
(f) Quality assurance regarding screening for diseases
For purposes of this section, the Secretary shall establish criteria for ensuring the quality of screening procedures for diseases described in subsection (a) of this section.
(g) Confidentiality
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees, subject to applicable law, to maintain the confidentiality of information on individuals with respect to activities carried out under subsection (c) of this section.
(h) Limitation on imposition of fees for services
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(1) will be made according to a schedule of charges that is made available to the public;
(2) will be adjusted to reflect the income of the individual involved; and
(3) will not be imposed on any individual with an income of less than 150 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(i) Limitations on certain expenditures
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that not less than 80 percent of the grant will be expended for the purpose of carrying out paragraphs (1) through (7) of subsection (c) of this section.
(j) Reports to Secretary
(1) Collection of data
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees, with respect to any disease selected under subsection (b) of this section for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a grant, a report providing—
(A) the incidence of the disease among the population of individuals served by the applicant;
(B) the number and demographic characteristics of individuals in such population;
(C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to which referrals have been made pursuant to subsection (c)(5) of this section;
(D) an assessment of the extent to which the activities carried pursuant to subsection (a) of this section have reduced the incidence of infertility in the geographic area involved; and
(E) such other information as the Secretary may require with respect to the project carried out with the grant.
(2) Utility and comparability of data
The Secretary shall carry out activities for the purpose of ensuring the utility and comparability of data collected pursuant to paragraph (1).
(k) Maintenance of effort
With respect to activities for which a grant under subsection (a) of this section is authorized to be expended, the Secretary may make such a grant only if the applicant involved agrees to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the average level of such expenditures maintained by the applicant for the 2-year period preceding the fiscal year for which the applicant is applying to receive such a grant.
(l) Requirement of application
(1) In general
The Secretary may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(2) Submission of plan for program of grantee
(A) In general
The Secretary may make a grant under subsection (a) of this section only if the applicant involved submits to the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a condition of receiving such a grant, including a specification of the entities through which activities authorized in subsection (c) of this section will be provided.
(B) Participation of certain entities
The Secretary may make a grant under subsection (a) of this section only if the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has been prepared in consultation with an appropriate number and variety of—
(i) representatives of entities in the geographic area involved that provide services for the prevention and control of sexually transmitted diseases, including programs to provide to the public information and education regarding such diseases; and
(ii) representatives of entities in such area that provide family planning services.
(m) Duration of grant
The period during which payments are made to an entity from a grant under subsection (a) of this section may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments in such year. The preceding sentence may not be construed to establish a limitation on the number of grants under such subsection that may be made to an entity.
(n) Technical assistance, and supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and technical assistance to grantees under subsection (a) of this section with respect to the planning, development, and operation of any program or service carried out under such subsection. The Secretary may provide such technical assistance directly or through grants or contracts.
(2) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may reduce the amount of such grant by—
(A) the fair market value of any supplies or equipment furnished the grant recipient; and
(B) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) of this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(o) Evaluations and reports by Secretary
(1) Evaluations
The Secretary shall, directly or through contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to subsection (a) of this section in order to determine the quality and effectiveness of the programs.
(2) Report to Congress
Not later than 1 year after the date on which amounts are first appropriated pursuant to subsection (q) of this section, and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report—
(A) summarizing the information provided to the Secretary in reports made pursuant to subsection (j)(1) of this section, including information on the incidence of sexually transmitted diseases described in subsection (a) of this section; and
(B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year.
(p) Coordination of Federal programs
The Secretary shall coordinate the program carried out under this section with any similar programs administered by the Secretary (including coordination between the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health).
(q) Authorization of appropriations
For the purpose of carrying out this section, other than subsections (o) and (r) of this section, there are authorized to be appropriated $25,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.
(r) Separate grants for research on delivery of services
(1) In general
The Secretary may make grants for the purpose of conducting research on the manner in which the delivery of services under subsection (a) of this section may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out programs substantially similar to programs carried out under such subsection.
(2) Authorization of appropriations
For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 through 1998.
(July 1, 1944, ch. 373, title III, §318A, as added
References in Text
Amendments
1993—
Subsec. (o)(2).
Subsec. (q).
Subsec. (r)(2).
Change of Name
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
1 See References in Text notes below.
§247c–2. Data collection regarding programs under subchapter XXIV
For the purpose of collecting and providing data for program planning and evaluation activities under subchapter XXIV of this chapter, there are authorized to be appropriated to the Secretary (acting through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are available for such purpose.
(July 1, 1944, ch. 373, title III, §318B, as added
Section Referred to in Other Sections
This section is referred to in
§247d. Public health emergencies
(a) Emergencies
If the Secretary determines, after consultation with such public health officials as may be necessary, that—
(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2).
(b) Public Health Emergency Fund
(1) In general
There is established in the Treasury a fund to be designated as the "Public Health Emergency Fund" to be made available to the Secretary without fiscal year limitation to carry out subsection (a) of this section only if a public health emergency has been declared by the Secretary under such subsection. There is authorized to be appropriated to the Fund such sums as may be necessary.
(2) Report
Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—
(A) the expenditures made from the Public Health Emergency Fund in such fiscal year; and
(B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.
(c) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(July 1, 1944, ch. 373, title III, §319, as added
Prior Provisions
A prior section 247d, act July 1, 1944, ch. 373, title III, §319, as added
Another prior section 247d, act July 1, 1944, ch. 373, title III, §319, formerly §310, as added Sept. 25, 1962,
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Section Referred to in Other Sections
This section is referred to in
§247d–1. National needs to combat threats to public health
(a) Capacities
(1) In general
Not later than 1 year after November 13, 2000, the Secretary, and such Administrators, Directors, or Commissioners, as may be appropriate, and in collaboration with State and local health officials, shall establish reasonable capacities that are appropriate for national, State, and local public health systems and the personnel or work forces of such systems. Such capacities shall be revised every 10 years, or more frequently as the Secretary determines to be necessary.
(2) Basis
The capacities established under paragraph (1) shall improve, enhance or expand the capacity of national, State and local public health agencies to detect and respond effectively to significant public health threats, including major outbreaks of infectious disease, pathogens resistant to antimicrobial agents and acts of bioterrorism. Such capacities may include the capacity to—
(A) recognize the clinical signs and epidemiological characteristic of significant outbreaks of infectious disease;
(B) identify disease-causing pathogens rapidly and accurately;
(C) develop and implement plans to provide medical care for persons infected with disease-causing agents and to provide preventive care as needed for individuals likely to be exposed to disease-causing agents;
(D) communicate information relevant to significant public health threats rapidly to local, State and national health agencies, and health care providers; or
(E) develop or implement policies to prevent the spread of infectious disease or antimicrobial resistance.
(b) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(c) Technical assistance
The Secretary shall provide technical assistance to the States to assist such States in fulfilling the requirements of this section.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section $4,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006.
(July 1, 1944, ch. 373, title III, §319A, as added
Section Referred to in Other Sections
This section is referred to in
§247d–2. Assessment of public health needs
(a) Program authorized
Not later than 1 year after November 13, 2000, and every 10 years thereafter, the Secretary shall award grants to States, or consortia of two or more States or political subdivisions of States, to perform, in collaboration with local public health agencies, an evaluation to determine the extent to which the States or local public health agencies can achieve the capacities applicable to State and local public health agencies described in subsection (a) of
(b) Procedure
(1) In general
A State, or a consortium of two or more States or political subdivisions of States, may contract with an outside entity to perform the evaluation described in subsection (a) of this section.
(2) Methods
To the extent practicable, the evaluation described in subsection (a) of this section shall be completed by using methods, to be developed by the Secretary in collaboration with State and local health officials, that facilitate the comparison of evaluations conducted by a State to those conducted by other States receiving funds under this section.
(c) Report
Not later than 1 year after the date on which a State, or a consortium of two or more States or political subdivisions of States, receives a grant under this subsection, such State, or a consortium of two or more States or political subdivisions of States, shall prepare and submit to the Secretary a report describing the results of the evaluation described in subsection (a) of this section with respect to such State, or consortia of two or more States or political subdivisions of States.
(d) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(e) Authorization of appropriations
There are authorized to be appropriated to carry out this section $45,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2003.
(July 1, 1944, ch. 373, title III, §319B, as added
Section Referred to in Other Sections
This section is referred to in
§247d–3. Grants to improve State and local public health agencies
(a) Program authorized
The Secretary shall award competitive grants to eligible entities to address core public health capacity needs using the capacities developed under
(b) Eligible entities
A State or political subdivision of a State, or a consortium of two or more States or political subdivisions of States, that has completed an evaluation under
(c) Use of funds
An eligible entity that receives a grant under subsection (a) of this section, may use funds received under such grant to—
(1) train public health personnel;
(2) develop, enhance, coordinate, or improve participation in an electronic network by which disease detection and public health related information can be rapidly shared among national, regional, State, and local public health agencies and health care providers;
(3) develop a plan for responding to public health emergencies, including significant outbreaks of infectious diseases or bioterrorism attacks, which is coordinated with the capacities of applicable national, State, and local health agencies and health care providers; and
(4) enhance laboratory capacity and facilities.
(d) Report
No later than January 1, 2005, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report that describes the activities carried out under this section and
(e) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(f) Authorization of appropriations
There are authorized to be appropriated to carry out this section $50,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006.
(July 1, 1944, ch. 373, title III, §319C, as added
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
§247d–4. Revitalizing the Centers for Disease Control and Prevention
(a) Findings
Congress finds that the Centers for Disease Control and Prevention have an essential role in defending against and combatting public health threats of the 21st century and requires secure and modern facilities that are sufficient to enable such Centers to conduct this important mission.
(b) Authorization of appropriations
For the purposes of achieving the mission of the Centers for Disease Control and Prevention described in subsection (a) of this section, for constructing new facilities and renovating existing facilities of such Centers, including laboratories, laboratory support buildings, health communication facilities, office buildings and other facilities and infrastructure, for better conducting the capacities described in
(July 1, 1944, ch. 373, title III, §319D, as added
§247d–5. Combating antimicrobial resistance
(a) Task force
(1) In general
The Secretary shall establish an Antimicrobial Resistance Task Force to provide advice and recommendations to the Secretary and coordinate Federal programs relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other organization in existence as of November 13, 2000, to serve as such a task force, if such committee, or other organization meets the requirements of this section.
(2) Members of task force
The task force described in paragraph (1) shall be composed of representatives from such Federal agencies, and shall seek input from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.
(3) Agenda
(A) In general
The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including—
(i) public health factors contributing to increasing antimicrobial resistance;
(ii) public health needs to detect and monitor antimicrobial resistance;
(iii) detection, prevention, and control strategies for resistant pathogens;
(iv) the need for improved information and data collection;
(v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and
(vi) any other issues which the Secretary determines are relevant to antimicrobial resistance.
(B) Detection and control
The Secretary, in consultation with the task force described in paragraph (1) and State and local public health officials, shall—
(i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and
(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.
(4) Meetings
The task force described under paragraph (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate.
(b) Research and development of new antimicrobial drugs and diagnostics
The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established under subsection (a) of this section, shall conduct and support research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—
(1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;
(2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;
(3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
(4) the sequencing of the genomes of priority pathogens as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a) of this section; and
(5) other relevant research areas.
(c) Education of medical and public health personnel
The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force described in subsection (a) of this section, professional organizations and societies, and such other public health officials as may be necessary, shall—
(1) develop and implement educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and
(3) develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens.
(d) Grants
(1) In general
The Secretary shall award competitive grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.
(2) Eligible entities
Eligible entities for grants under paragraph (1) shall be State or local public health agencies, Indian tribes or tribal organizations, or other public or private nonprofit entities.
(3) Use of funds
An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task force under subsection (a)(3) of this section, which may include activities that—
(A) provide training to enable such entity to identify patterns of resistance rapidly and accurately;
(B) develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and
(C) develop and implement policies to control the spread of antimicrobial resistance.
(e) Grants for demonstration programs
(1) In general
The Secretary shall award competitive grants to eligible entities to establish demonstration programs to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens.
(2) Eligible entities
Eligible entities for grants under paragraph (1) may include hospitals, clinics, institutions of long-term care, professional medical societies, or other public or private nonprofit entities.
(3) Technical assistance
The Secretary shall provide appropriate technical assistance to eligible entities that receive grants under paragraph (1).
(f) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(g) Authorization of appropriations
There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006.
(July 1, 1944, ch. 373, title III, §319E, as added
§247d–6. Public health countermeasures to a bioterrorist attack
(a) Working group on preparedness for acts of bioterrorism
The Secretary, in coordination with the Secretary of Defense, shall establish a joint interdepartmental working group on preparedness and readiness for the medical and public health effects of a bioterrorist attack on the civilian population. Such joint working group shall—
(1) coordinate research on pathogens likely to be used in a bioterrorist attack on the civilian population as well as therapies to treat such pathogens;
(2) coordinate research and development into equipment to detect pathogens likely to be used in a bioterrorist attack on the civilian population and protect against infection from such pathogens;
(3) develop shared standards for equipment to detect and to protect against infection from pathogens likely to be used in a bioterrorist attack on the civilian population; and
(4) coordinate the development, maintenance, and procedures for the release of, strategic reserves of vaccines, drugs, and medical supplies which may be needed rapidly after a bioterrorist attack upon the civilian population.
(b) Working group on the public health and medical consequences of bioterrorism
(1) In general
The Secretary, in collaboration with the Director of the Federal Emergency Management Agency, the Attorney General, and the Secretary of Agriculture, shall establish a joint interdepartmental working group to address the public health and medical consequences of a bioterrorist attack on the civilian population.
(2) Functions
Such working group shall—
(A) assess the priorities for and enhance the preparedness of public health institutions, providers of medical care, and other emergency service personnel to detect, diagnose, and respond to a bioterrorist attack; and
(B) in the recognition that medical and public health professionals are likely to provide much of the first response to such an attack, develop, coordinate, enhance, and assure the quality of joint planning and training programs that address the public health and medical consequences of a bioterrorist attack on the civilian population between—
(i) local firefighters, ambulance personnel, police and public security officers, or other emergency response personnel; and
(ii) hospitals, primary care facilities, and public health agencies.
(3) Working group membership
In establishing such working group, the Secretary shall act through the Assistant Secretary for Health and the Director of the Centers for Disease Control and Prevention.
(4) Coordination
The Secretary shall ensure coordination and communication between the working groups established in this subsection and subsection (a) of this section.
(c) Grants
(1) In general
The Secretary, in coordination with the working group established under subsection (b) of this section, shall, on a competitive basis and following scientific or technical review, award grants to or enter into cooperative agreements with eligible entities to enable such entities to increase their capacity to detect, diagnose, and respond to acts of bioterrorism upon the civilian population.
(2) Eligibility
To be an eligible entity under this subsection, such entity must be a State, political subdivision of a State, a consortium of two or more States or political subdivisions of States, or a hospital, clinic, or primary care facility.
(3) Use of funds
An entity that receives a grant under this subsection shall use such funds for activities that are consistent with the priorities identified by the working group under subsection (b) of this section, including—
(A) training health care professionals and public health personnel to enhance the ability of such personnel to recognize the symptoms and epidemiological characteristics of exposure to a potential bioweapon;
(B) addressing rapid and accurate identification of potential bioweapons;
(C) coordinating medical care for individuals exposed to bioweapons; and
(D) facilitating and coordinating rapid communication of data generated from a bioterrorist attack between national, State, and local health agencies, and health care providers.
(4) Coordination
The Secretary, in awarding grants under this subsection, shall—
(A) notify the Director of the Office of Justice Programs, and the Director of the National Domestic Preparedness Office annually as to the amount and status of grants awarded under this subsection; and
(B) coordinate grants awarded under this subsection with grants awarded by the Office of Emergency Preparedness and the Centers for Disease Control and Prevention for the purpose of improving the capacity of health care providers and public health agencies to respond to bioterrorist attacks on the civilian population.
(5) Activities
An entity that receives a grant under this subsection shall, to the greatest extent practicable, coordinate activities carried out with such funds with the activities of a local Metropolitan Medical Response System.
(d) Federal assistance
The Secretary shall ensure that the Department of Health and Human Services is able to provide such assistance as may be needed to State and local health agencies to enable such agencies to respond effectively to bioterrorist attacks.
(e) Education
The Secretary, in collaboration with members of the working group described in subsection (b) of this section, and professional organizations and societies, shall—
(1) develop and implement educational programs to instruct public health officials, medical professionals, and other personnel working in health care facilities in the recognition and care of victims of a bioterrorist attack; and
(2) develop and implement programs to train laboratory personnel in the recognition and identification of a potential bioweapon.
(f) Future resource development
The Secretary shall consult with the working group described in subsection (a) of this section, to develop priorities for and conduct research, investigations, experiments, demonstrations, and studies in the health sciences related to—
(1) the epidemiology and pathogenesis of potential bioweapons;
(2) the development of new vaccines or other therapeutics against pathogens likely to be used in a bioterrorist attack;
(3) the development of medical diagnostics to detect potential bioweapons; and
(4) other relevant research areas.
(g) General Accounting Office report
Not later than 180 days after November 13, 2000, the Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report that describes—
(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;
(2) the coordination of the activities described in paragraph (1);
(3) the amount of Federal funds authorized or appropriated for the activities described in paragraph (1); and
(4) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population.
(h) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(i) Authorization of appropriations
There are authorized to be appropriated to carry out this section $215,000,000 for fiscal year 2001, and such sums as may be necessary for each subsequent fiscal year through 2006.
(July 1, 1944, ch. 373, title III, §319F, as added
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
§247d–7. Demonstration program to enhance bioterrorism training, coordination, and readiness
(a) In general
The Secretary shall make grants to not more than three eligible entities to carry out demonstration programs to improve the detection of pathogens likely to be used in a bioterrorist attack, the development of plans and measures to respond to bioterrorist attacks, and the training of personnel involved with the various responsibilities and capabilities needed to respond to acts of bioterrorism upon the civilian population. Such awards shall be made on a competitive basis and pursuant to scientific and technical review.
(b) Eligible entities
Eligible entities for grants under subsection (a) of this section are States, political subdivisions of States, and public or private non-profit organizations.
(c) Specific criteria
In making grants under subsection (a) of this section, the Secretary shall take into account the following factors:
(1) Whether the eligible entity involved is proximate to, and collaborates with, a major research university with expertise in scientific training, identification of biological agents, medicine, and life sciences.
(2) Whether the entity is proximate to, and collaborates with, a laboratory that has expertise in the identification of biological agents.
(3) Whether the entity demonstrates, in the application for the program, support and participation of State and local governments and research institutions in the conduct of the program.
(4) Whether the entity is proximate to, and collaborates with, or is, an academic medical center that has the capacity to serve an uninsured or underserved population, and is equipped to educate medical personnel.
(5) Such other factors as the Secretary determines to be appropriate.
(d) Duration of award
The period during which payments are made under a grant under subsection (a) of this section may not exceed 5 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments.
(e) Supplement not supplant
Grants under subsection (a) of this section shall be used to supplement, and not supplant, other Federal, State, or local public funds provided for the activities described in such subsection.
(f) General Accounting Office report
Not later than 180 days after the conclusion of the demonstration programs carried out under subsection (a) of this section, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and the Committee on Commerce and the Committee on Appropriations of the House of Representatives, a report that describes the ability of grantees under such subsection to detect pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such threats, and train personnel involved with the various responsibilities and capabilities needed to deal with bioterrorist threats.
(g) Authorization of appropriations
There is authorized to be appropriated to carry out this section $6,000,000 for fiscal year 2001, and such sums as may be necessary through fiscal year 2006.
(July 1, 1944, ch. 373, title III, §319G, as added
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
§247d–8. Coordinated program to improve pediatric oral health
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish a program to fund innovative oral health activities that improve the oral health of children under 6 years of age who are eligible for services provided under a Federal health program, to increase the utilization of dental services by such children, and to decrease the incidence of early childhood and baby bottle tooth decay.
(b) Grants
The Secretary shall award grants to or enter into contracts with public or private nonprofit schools of dentistry or accredited dental training institutions or programs, community dental programs, and programs operated by the Indian Health Service (including federally recognized Indian tribes that receive medical services from the Indian Health Service, urban Indian health programs funded under title V of the Indian Health Care Improvement Act [
(c) Distribution
In awarding grants under this section, the Secretary shall, to the extent practicable, ensure an equitable national geographic distribution of the grants, including areas of the United States where the incidence of early childhood caries is highest.
(d) Authorization of appropriations
There is authorized to be appropriated to carry out this section $10,000,000 for each 1 the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §320A, as added
References in Text
The Indian Health Care Improvement Act, referred to in subsec. (b), is
The Indian Self-Determination and Education Assistance Act, referred to in subsec. (b), is
Codification
Section 1603 of
1 So in original. Probably should be followed by "of".
Part C—Hospitals, Medical Examinations, and Medical Care
Amendments
1978—
1976—
§247e. Gillis W. Long Hansen's Disease Center
(a) Care and treatment
(1) At or through the Gillis W. Long Hansen's Disease Center (located in the State of Louisiana), the Secretary shall without charge provide short-term care and treatment, including outpatient care, for Hansen's disease and related complications to any person determined by the Secretary to be in need of such care and treatment. The Secretary may not at or through such Center provide long-term care for any such disease or complication.
(2) The Center referred to in paragraph (1) shall conduct training in the diagnosis and management of Hansen's disease and related complications, and shall conduct and promote the coordination of research (including clinical research), investigations, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of Hansen's disease and other mycobacterial diseases and complications related to such diseases.
(3) Paragraph (1) is subject to section 211 of the Department of Health and Human Services Appropriations Act, 1998.
(b) Additional sites authorized
In addition to the Center referred to in subsection (a) of this section, the Secretary may establish sites regarding persons with Hansen's disease. Each such site shall provide for the outpatient care and treatment for Hansen's disease and related complications to any person determined by the Secretary to be in need of such care and treatment.
(c) Agency designated by Secretary
The Secretary shall carry out subsections (a) and (b) of this section acting through an agency of the Service. For purposes of the preceding sentence, the agency designated by the Secretary shall carry out both activities relating to the provision of health services and activities relating to the conduct of research.
(d) Payments to Board of Health of Hawaii
The Secretary shall make payments to the Board of Health of the State of Hawaii for the care and treatment (including outpatient care) in its facilities of persons suffering from Hansen's disease at a rate determined by the Secretary. The rate shall be approximately equal to the operating cost per patient of such facilities, except that the rate may not exceed the comparable costs per patient with Hansen's disease for care and treatment provided by the Center referred to in subsection (a) of this section. Payments under this subsection are subject to the availability of appropriations for such purpose.
(July 1, 1944, ch. 373, title III, §320, formerly §331,
References in Text
Section 211 of the Department of Health and Human Services Appropriations Act, 1998, referred to in subsec. (a)(3), is section 211 of
Codification
Section was classified to
Amendments
1997—
1985—
Subsec. (a).
Subsec. (b).
1979—Subsec. (a).
1978—
1960—
1952—Act June 25, 1952, provided for payments to Hawaiian Board of Health for expenditures made by them in care and treatment of patients.
1948—Act June 25, 1948, authorized payment of travel expenses of indigent leper patients.
Effective Date of 1960 Amendment
Amendment by
Relocation of Gillis W. Long Hansen's Disease Center
Section 211(a)–(g) of
"(a) The Secretary of Health and Human Services may in accordance with this section provide for the relocation of the Federal facility known as the Gillis W. Long Hansen's Disease Center (located in the vicinity of Carville, in the State of Louisiana), including the relocation of the patients of the Center.
"(b)(1) Subject to paragraph (2), in relocating the Center the Secretary may on behalf of the United States transfer to the State of Louisiana, without charge, title to the real property and improvements that as of the date of the enactment of this Act [Nov. 13, 1997] constitute the Center. Such real property is a parcel consisting of approximately 330 acres. The exact acreage and legal description used for purposes of the transfer shall be in accordance with a survey satisfactory to the Secretary.
"(2) Any conveyance under paragraph (1) is not effective unless the deed or other instrument of conveyance contains the conditions specified in subsection (d); the instrument specifies that the United States and the State of Louisiana agree to such conditions; and the instrument specifies that, if the State engages in a material breach of the conditions, title to the real property and improvements involved reverts to the United States at the election of the Secretary.
"(c)(1) With respect to Federal equipment and other items of Federal personal property that are in use at the Center as of the date of the enactment of this Act [Nov. 13, 1997], the Secretary may, subject to paragraph (2), transfer to the State such items as the Secretary determines to be appropriate, if the Secretary makes the transfer under subsection (b).
"(2) A transfer of equipment or other items may be made under paragraph (1) only if the State agrees that, during the 30-year period beginning on the date on which the transfer under subsection (b) is made, the items will be used exclusively for purposes that promote the health or education of the public, except that the Secretary may authorize such exceptions as the Secretary determines to be appropriate.
"(d) For purposes of subsection (b)(2), the conditions specified in this subsection with respect to a transfer of title are the following:
"(1) During the 30-year period beginning on the date on which the transfer is made, the real property and improvements referred to in subsection (b)(1) (referred to in this subsection as the 'transferred property') will be used exclusively for purposes that promote the health or education of the public, with such incidental exceptions as the Secretary may approve.
"(2) For purposes of monitoring the extent to which the transferred property is being used in accordance with paragraph (1), the Secretary will have access to such documents as the Secretary determines to be necessary, and the Secretary may require the advance approval of the Secretary for such contracts, conveyances of real or personal property, or other transactions as the Secretary determines to be necessary.
"(3) The relocation of patients from the transferred property will be completed not later than 3 years after the date on which the transfer is made, except to the extent the Secretary determines that relocating particular patients is not feasible. During the period of relocation, the Secretary will have unrestricted access to the transferred property, and after such period will have such access as may be necessary with respect to the patients who pursuant to the preceding sentence are not relocated.
"(4)(A) With respect to projects to make repairs and energy-related improvements at the transferred property, the Secretary will provide for the completion of all such projects for which contracts have been awarded and appropriations have been made as of the date on which the transfer is made.
"(B) If upon completion of the projects referred to in subparagraph (A) there are any unobligated balances of amounts appropriated for the projects, and the sum of such balances is in excess of $100,000—
"(i) the Secretary will transfer the amount of such excess to the State; and
"(ii) the State will expend such amount for the purposes referred to in paragraph (1), which may include the renovation of facilities at the transferred property.
"(5)(A) The State will maintain the cemetery located on the transferred property, will permit individuals who were long-term-care patients of the Center to be buried at the cemetery, and will permit members of the public to visit the cemetery.
"(B) The State will permit the Center to maintain a museum on the transferred property, and will permit members of the public to visit the museum.
"(C) In the case of any waste products stored at the transferred property as of the date of the transfer, the Federal Government will after the transfer retain title to and responsibility for the products, and the State will not require that the Federal Government remove the products from the transferred property.
"(6) In the case of each individual who as of the date of the enactment of this Act [Nov. 13, 1997] is a Federal employee at the transferred property with facilities management or dietary duties:
"(A) The State will offer the individual an employment position with the State, the position with the State will have duties similar to the duties the individual performed in his or her most recent position at the transferred property, and the position with the State will provide compensation and benefits that are similar to the compensation and benefits provided for such most recent position, subject to the concurrence of the Governor of the State.
"(B) If the individual becomes an employee of the State pursuant to subparagraph (A), the State will make payments in accordance with subsection (e)(2)(B) (relating to disability), as applicable with respect to the individual.
"(7) The Federal Government may, consistent with the intended uses by the State of the transferred property, carry out at such property activities regarding at-risk youth.
"(8) Such additional conditions as the Secretary determines to be necessary to protect the interests of the United States.
"(e)(1) This subsection applies if the transfer under subsection (b) is made.
"(2) In the case of each individual who as of the date of the enactment of this Act [Nov. 13, 1997] is a Federal employee at the Center with facilities management or dietary duties, and who becomes an employee of the State pursuant to subsection (d)(6)(A):
"(A) The provisions of subchapter III of
"(i) the expiration of the 2-year period beginning on the date on which the transfer under subsection (b) is made; or
"(ii) the date on which the individual first meets all conditions for coverage under a State program for payments during retirement by reason of disability.
"(B) The payments to be made by the State pursuant to subsection (d)(6)(B) with respect to the individual are payments to the Civil Service Retirement and Disability Fund, if the individual is receiving Federal disability coverage pursuant to subparagraph (A). Such payments are to be made in a total amount equal to that portion of the normal-cost percentage (determined through the use of dynamic assumptions) of the basic pay of the individual that is allocable to such coverage and is paid for service performed during the period for which such coverage is in effect. Such amount is to be determined in accordance with
"(C) In the determination pursuant to subparagraph (A) of whether the individual is eligible for Federal disability coverage (during the applicable period of time under such subparagraph), service as an employee of the State after the date of the transfer under subsection (b) shall be counted toward the service requirement specified in the first sentence of section 8337(a) or 8451(a)(1)(A) of such title 5 (whichever is applicable).
"(3) In the case of each individual who as of the date of the enactment of this Act is a Federal employee with a position at the Center and is, for duty at the Center, receiving the pay differential under section 208(e) of the Public Health Service Act [
"(A) If as of the date of the transfer under subsection (b) the individual is eligible for an annuity under
"(B) If the individual is not eligible for such an annuity as of the date of the transfer under subsection (b) but subsequently does become eligible, then once the individual separates from the service and thereby becomes entitled to receive the annuity, the pay differential shall be included in the computation of the annuity if the individual separated from the service not later than the expiration of the 90-day period beginning on the date on which the individual first became eligible for the annuity.
"(C) For purposes of this paragraph, the individual is eligible for the annuity if the individual meets all conditions under such section 8336 or 8412 to be entitled to the annuity, except the condition that the individual be separated from the service.
"(4) With respect to individuals who as of the date of the enactment of this Act are Federal employees with positions at the Center and are not, for duty at the center, receiving the pay differential under section 208(e) of the Public Health Service Act [
"(A) During the calendar years 1997 and 1998, the Secretary may in accordance with this paragraph provide to any such individual a voluntary separation incentive payment. The purpose of such payments is to avoid or minimize the need for involuntary separations under a reduction in force with respect to the Center.
"(B) During calendar year 1997, any payment under subparagraph (A) shall be made under section 663 of the Treasury, Postal Service, and General Government Appropriations Act, 1997 (as contained in section 101(f) of division A of
"(C) During calendar year 1998, such section 663 applies with respect to payments under subparagraph (A) to the same extent and in the same manner as such section applied with respect to the payments during fiscal year 1997, and for purposes of this subparagraph, the reference in subsection (c)(2)(D) of such section 663 to December 31, 1997, is deemed to be a reference to December 31, 1998.
"(f) The following provisions apply if under subsection (a) the Secretary makes the decision to relocate the Center:
"(1) The site to which the Center is relocated shall be in the vicinity of Baton Rouge, in the State of Louisiana.
"(2) The facility involved shall continue to be designated as the Gillis W. Long Hansen's Disease Center.
"(3) The Secretary shall make reasonable efforts to inform the patients of the Center with respect to the planning and carrying out of the relocation.
"(4) In the case of each individual who as of October 1, 1996, was a patient of the Center and is considered by the Director of the Center to be a long-term-care patient (referred to in this subsection as an 'eligible patient'), the Secretary shall continue to provide for the long-term care of the eligible patient, without charge, for the remainder of the life of the patient.
"(5)(A) For purposes of paragraph (4), an eligible patient who is legally competent has the following options with respect to support and maintenance and other nonmedical expenses:
"(i) For the remainder of his or her life, the patient may reside at the Center.
"(ii) For the remainder of his or her life, the patient may receive payments each year at an annual rate of $33,000 (adjusted in accordance with subparagraphs (C) and (D)), and may not reside at the Center. Payments under this clause are in complete discharge of the obligation of the Federal Government under paragraph (4) for support and maintenance and other nonmedical expenses of the patient.
"(B) The choice by an eligible patient of the option under clause (i) of subparagraph (A) may at any time be revoked by the patient, and the patient may instead choose the option under clause (ii) of such subparagraph. The choice by an eligible patient of the option under such clause (ii) is irrevocable.
"(C) Payments under subparagraph (A)(ii) shall be made on a monthly basis, and shall be pro rated as applicable. In 1999 and each subsequent year, the monthly amount of such payments shall be increased by a percentage equal to any percentage increase taking effect under section 215(i) of the Social Security Act [
"(D) With respect to the provision of outpatient and inpatient medical care for Hansen's disease and related complications to an eligible patient:
"(i) The choice the patient makes under subparagraph (A) does not affect the responsibility of the Secretary for providing to the patient such care at or through the Center.
"(ii) If the patient chooses the option under subparagraph (A)(ii) and receives inpatient care at or through the Center, the Secretary may reduce the amount of payments under such subparagraph, except to the extent that reimbursement for the expenses of such care is available to the provider of the care through the program under title XVIII of the Social Security Act [
"(6) The Secretary shall provide to each eligible patient such information and time as may be necessary for the patient to make an informed decision regarding the options under paragraph (5)(A).
"(7) After the date of the enactment of this Act [Nov. 13, 1997], the Center may not provide long-term care for any individual who as of such date was not receiving such care as a patient of the Center.
"(8) If upon completion of the projects referred to in subsection (d)(4)(A) there are unobligated balances of amounts appropriated for the projects, such balances are available to the Secretary for expenses relating to the relocation of the Center, except that, if the sum of such balances is in excess of $100,000, such excess is available to the State in accordance with subsection (d)(4)(B). The amounts available to the Secretary pursuant to the preceding sentence are available until expended.
"(g) For purposes of this section:
"(1) The term 'Center' means the Gillis W. Long Hansen's Disease Center.
"(2) The term 'Secretary' means the Secretary of Health and Human Services.
"(3) The term 'State' means the State of Louisiana."
Section Referred to in Other Sections
This section is referred to in
§248. Control and management of hospitals; furnishing prosthetic and orthopedic devices; transfer of patients; disposal of articles produced by patients; disposal of money and effects of deceased patients; payment of burial expenses
The Surgeon General, pursuant to regulations, shall—
(a) Control, manage, and operate all institutions, hospitals, and stations of the Service, including minor repairs and maintenance, and provide for the care, treatment, and hospitalization of patients, including the furnishing of prosthetic and orthopedic devices; and from time to time, with the approval of the President, select suitable sites for and establish such additional institutions, hospitals, and stations in the States and possessions of the United States as in his judgment are necessary to enable the Service to discharge its functions and duties;
(b) Provide for the transfer of Public Health Service patients, in the care of attendants where necessary, between hospitals and stations operated by the Service or between such hospitals and stations and other hospitals and stations in which Public Health Service patients may be received, and the payment of expenses of such transfer;
(c) Provide for the disposal of articles produced by patients in the course of their curative treatment, either by allowing the patient to retain such articles or by selling them and depositing the money received therefor to the credit of the appropriation from which the materials for making the articles were purchased;
(d) Provide for the disposal of money and effects, in the custody of the hospitals or stations, of deceased patients; and
(e) Provide, to the extent the Surgeon General determines that other public or private funds are not available therefor, for the payment of expenses of preparing and transporting the remains of, or the payment of reasonable burial expenses for, any patient dying in a hospital or station.
(July 1, 1944, ch. 373, title III, §321,
Amendments
1978—Subsec. (a).
1948—Subsec. (a). Act June 25, 1948, §2(a), amended subsec. (a) generally, continuing authority of Service to furnish tobacco to patients being treated by it.
Subsec. (e). Act June 25, 1948, §2(b), added subsec. (e).
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§248a. Closing or transfer of hospitals; reduction of services; Congressional authorization required
(a) Except as provided in subsection (b) of this section, the Secretary of Health and Human Services shall take such action as may be necessary to assure that the hospitals of the Public Health Service, located in Seattle, Washington, Boston, Massachusetts, San Francisco, California, Galveston, Texas, New Orleans, Louisiana, Baltimore, Maryland, Staten Island, New York, and Norfolk, Virginia, shall continue—
(1) in operation as hospitals of the Public Health Service,
(2) to provide for all categories of individuals entitled or authorized to receive care and treatment at hospitals or other stations of the Public Health Service inpatient, outpatient, and other health care services in like manner as such services were provided on January 1, 1973, to such categories of individuals at the hospitals of the Public Health Service referred to in the matter preceding paragraph (1) and at a level and range at least as great as the level and range of such services which were provided (or authorized to be provided) by such hospitals on such date, and
(3) to conduct at such hospitals a level and range of other health-related activities (including training and research activities) which is not less than the level and range of such activities which were being conducted on January 1, 1973, at such hospitals.
(b)(1) The Secretary may—
(A) close or transfer control of a hospital of the Public Health Service to which subsection (a) of this section applies,
(B) reduce the level and range of health care services provided at such a hospital from the level and range required by subsection (a)(2) of this section or change the manner in which such services are provided at such a hospital from the manner required by such subsection, or
(C) reduce the level and range of the other health-related activities conducted at such hospital from the level and range required by subsection (a)(3) of this section,
if Congress by law (enacted after November 16, 1973) specifically authorizes such action.
(2) Any recommendation submitted to the Congress for legislation to authorize an action described in paragraph (1) with respect to a hospital of the Public Health Service shall be accompanied by a copy of the written, unqualified approval of the proposed action submitted to the Secretary by each (A) section 314(a) State health planning agency whose section 314(a) plan covers (in whole or in part) the area in which such hospital is located or which is served by such hospital, and (B) section 314(b) areawide health planning agency whose section 314(b) plan covers (in whole or in part) such area.
(3) For purposes of this subsection, the term "section 314(a) State health planning agency" means the agency of a State which administers or supervises the administration of a State's health planning functions under a State plan approved under section 314(a) of the Public Health Service Act (referred to in paragraph (2) as a "section 314(a) plan"); and the term "section 314(b) areawide health planning agency" means a public or nonprofit private agency or organization which has developed a comprehensive regional, metropolitan, or other local area plan or plans referred to in section 314(b) of that Act (referred to in paragraph (2) as a "section 314(b) plan").
(
References in Text
Section 314 of the Public Health Service Act, referred to in subsec. (b)(2), (3), is classified to
Codification
Section was enacted as part of the Department of Defense Appropriation Authorization Act, 1974, and not as part of the Public Health Service Act which comprises this chapter.
Prior Provisions
Provisions similar to those comprising this section were contained in
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a) pursuant to section 509(b) of
Section Referred to in Other Sections
This section is referred to in
§248b. Transfer or financial self-sufficiency of public health service hospitals and clinics
(a) Deadline for closure, transfer, or financial self-sufficiency
The Secretary of Health and Human Services (hereinafter in this subtitle referred to as the "Secretary") shall, in accordance with this section and notwithstanding
(b) Proposals for transfer or financial self-sufficiency
Not later than July 1, 1981, the Secretary shall notify each Service hospital and other station, and the chief executive officer of each State and of each locality in which such a hospital or other station is located, that the Secretary will accept proposals for the transfer of each such hospital and station from the Service to a public (including Federal) or nonprofit private entity or for the achievement of financial self-sufficiency of each such hospital and station not later than September 30, 1982. No such proposal shall be considered by the Secretary if it is submitted later than September 1, 1981.
(c) Evaluation of proposals
The Secretary shall evaluate promptly each proposal submitted under subsection (b) of this section with respect to a hospital or other station and determine, not later than September 30, 1981, whether or not under such proposal the hospital or station—
(1) will be maintained as a general health care facility providing a range of services to the population within its service area,
(2) will continue to make services available to existing patient populations, and
(3) has a reasonable expectation of financial viability and, in the case of a hospital or station that is not proposed to be transferred, of financial self-sufficiency.
Paragraph (1) shall not apply in the case of a proposal for the transfer of a discrete, minor, freestanding part of a hospital or station to a local public entity for the purpose of continuing the provision of services to refugees.
(d) Rejection or approval of proposal
(1) If the Secretary determines that a proposal for a hospital or other station does not meet the standards of subsection (c) of this section or if there is no proposal submitted under subsection (b) of this section with respect to a hospital or other station, the Secretary shall provide for the closure of the hospital or station by not later than October 31, 1981.
(2) If the Secretary determines that a proposal for a hospital or other station meets the standards of subsection (c) of this section, the Secretary shall take such steps, within the amounts available through appropriations, as may be necessary and proper—
(A) to operate (or participate or assist in the operation of) the hospital or station by the Service until the transfer is accomplished or financial self-sufficiency is achieved,
(B) to bring the hospital or station into compliance with applicable licensure, accreditation, and local medical practice standards, and
(C) to provide for such other legal, administrative, personnel, and financial arrangements (including allowing payments made with respect to services provided by the hospital or station to be made directly to that hospital or station) as may be necessary to effect a timely and orderly transfer of such hospital or station (including the land, building, and equipment thereof) from the Service, or for the financial self-sufficiency of the hospital or station, not later than September 30, 1982.
(e) Establishment of identifiable administrative unit
There is established, within the Office of the Assistant Secretary for Health of the Department of Health and Human Services, an identifiable administrative unit which shall have direct responsibility and authority for overseeing the activities under this section.
(f) Finding of financial self-sufficiency
For purposes of this section, a hospital or station cannot be found to be financially self-sufficient if the hospital or station is relying, in whole or in part, on direct appropriated funds for its continued operations.
(
References in Text
This subtitle, referred to in subsec. (a), is subtitle J of title IX of
Codification
Section was enacted as part of the Omnibus Budget Reconciliation Act of 1981, and not as part of the Public Health Service Act which comprises this chapter.
Congressional Findings and Declaration of Purpose
Section 985 of
"(a) Congress finds that—
"(1) because of national budgetary considerations, it has become necessary to terminate Federal appropriations for Public Health Service hospitals and clinics,
"(2) with proper planning and coordination, some of these hospitals and clinics could be transferred to State, local, or private control or become financially self-sufficient and continue to provide effective and efficient health care to individuals in the areas in which they are located,
"(3) a precipitous closure of these hospitals and clinics will preclude the possibility of such orderly transfer to entities which are willing and able to take over operations at such facilities and will cause unnecessary and costly hardships on the patients and staffs at such facilities and on the communities in which the facilities are located, and
"(4) it is in the national interest, consistent with sound budgetary considerations, to assist in the orderly and prompt transfer of such operations to State, local, or private operation or in the achievement of financial self-sufficiency where feasible.
"(b) The purposes of this subtitle [enacting this section, amending
"(1) to provide for the prompt and orderly closure by October 31, 1981, of Public Health Service hospitals and clinics which cannot reasonably be transferred to State, local, or private operation or become financially self-sufficient and for the transfer or achievement of financial self-sufficiency by September 30, 1982, of those hospitals and clinics which can be so transferred or which can achieve such financial self-sufficiency, and
"(2) to provide for transitional assistance for merchant seamen whose entitlement to receive free care through Public Health Service hospitals and clinics is repealed and who are hospitalized at the end of fiscal year 1981 and require continuing hospitalization."
§§248c, 248d. Repealed. Pub. L. 104–201, div. A, title VII, §727(a)(1), (2), Sept. 23, 1996, 110 Stat. 2596
Section 248c,
Section 248d,
Effective Date of Repeal
Repeal effective Oct. 1, 1997, see section 727(b) of
Equitable Implementation of Uniform Cost Sharing Requirements for Uniformed Services Treatment Facilities
Managed-Care Delivery and Reimbursement Model for the Uniformed Services Treatment Facilities
Section 718(c) of
§249. Medical care and treatment of quarantined and detained persons
(a) Persons entitled to treatment
Any person when detained in accordance with quarantine laws, or, at the request of the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for by the Public Health Service.
(b) Temporary treatment in emergency cases
Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in accordance with regulations of the Surgeon General, be admitted thereto for temporary treatment and care in case of emergency.
(c) Authorization for outside treatment
Persons whose care and treatment is authorized by subsection (a) of this section may, in accordance with regulations, receive such care and treatment at the expense of the Service from public or private medical or hospital facilities other than those of the Service, when authorized by the officer in charge of the station at which the application is made.
(July 1, 1944, ch. 373, title III, §322,
Amendments
1981—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsecs. (d), (e).
1967—Subsec. (a)(7).
1964—Subsec. (a)(8).
1948—Subsec. (e). Act June 25, 1948, permitted Service to provide for care and treatment of individuals detained in accordance with our quarantine laws.
Effective Date of 1981 Amendment
Section 986(c) of
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of all other officers of Department of Justice and functions of all agencies and employees of such Department transferred, with a few exceptions, to Attorney General, with power vested in him to authorize their performance or the performance of any of his functions by any of such officers, agencies, and employees, by sections 1 and 2 of Reorg. Plan No. 2 of 1950, eff. May 24, 1950, 15 F.R. 3173,
Continued Care for Merchant Seamen Hospitalized in Public Health Service Hospitals
Section 988 of
"(a) The Secretary shall provide, by contract or other arrangement with a Federal entity and without charge but subject to subsection (b), for the continuation of inpatient hospital services (and outpatient services related to the condition of hospitalization) to any individual who—
"(1) on September 30, 1981, is receiving inpatient hospital services at a Public Health Service hospital on the basis of the entitlement contained in section 322(a) of the Public Health Service Act (
"(2) requires continued hospitalization after such date for treatment of that condition (or requires outpatient services related to such condition), and
"(3) the Secretary determines has no other source of inpatient hospital services available for continued treatment of that condition.
"(b) Services may not be provided under subsection (a) to an individual after the earlier of—
"(1) September 30, 1982,
"(2) the end of the first 60-day consecutive period (beginning after September 30, 1981) during the entire period of which the individual is not an inpatient of a hospital.
"(c) Notwithstanding any other provision of law, the head of any Federal department or agency which provides, under other authority of law and through federal facilities, inpatient hospital services or outpatient services, or both, is authorized to provide inpatient hospital services (and related outpatient services) to individuals under contract or other arrangement with the Secretary pursuant to this section."
Foreign Seamen
Section 810(c), formerly §710(c), of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, §5,
Section Referred to in Other Sections
This section is referred to in
§250. Medical care and treatment of Federal prisoners
The Service shall supervise and furnish medical treatment and other necessary medical, psychiatric, and related technical and scientific services, authorized by
(July 1, 1944, ch. 373, title III, §323,
Codification
"
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
§250a. Transfer of appropriations
The Attorney General may transfer to the Health Resources and Services Administration such amounts as may be necessary for direct expenditures by that Administration for medical relief for inmates of Federal penal and correctional institutions.
(
Codification
Section was enacted as part of the appropriation act cited as the credit to this section, and not as part of the Public Health Service Act which comprises this chapter.
Section was formerly classified to
Prior Provisions
Provisions similar to those in this section were contained in the following prior appropriation acts:
June 20, 1956, ch. 414, title II,
July 7, 1955, ch. 279, title II,
§251. Medical examination and treatment of Federal employees; medical care at remote stations
(a) The Surgeon General is authorized to provide at institutions, hospitals, and station of the Service medical, surgical, and hospital services and supplies for persons entitled to treatment under subchapter I of
(1) employees of the Federal Government for retirement purposes;
(2) employees in the Federal classified service, and applicants for appointment, as requested by the Director of the Office of Personnel Management for the purpose of promoting health and efficiency;
(3) seamen for purposes of qualifying for certificates of service; and
(4) employees eligible for benefits under the Longshore and Harbor Workers' Compensation Act, as amended [
(b) The Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization and optometric care for Federal employees (as defined in
(July 1, 1944, ch. 373, title III, §324,
References in Text
The Longshore and Harbor Workers' Compensation Act, as amended, referred to in subsec. (a)(4), is act Mar. 4, 1927, ch. 509,
Codification
In subsec. (a), "subchapter I of
Amendments
1984—Subsec. (a)(4).
1983—Subsec. (a)(1).
1967—Subsec. (a).
Subsec. (b).
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1983 Amendment
Amendment by
Transfer of Functions
"Director of the Office of Personnel Management" substituted for "Civil Service Commission" in subsec. (a)(2), pursuant to Reorg. Plan No. 2 of 1978, §102, 43 F.R. 36037,
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
§252. Medical examination of aliens
The Surgeon General shall provide for making, at places within the United States or in other countries, such physical and mental examinations of aliens as are required by the immigration laws, subject to administrative regulations prescribed by the Attorney General and medical regulations prescribed by the Surgeon General with the approval of the Secretary.
(July 1, 1944, ch. 373, title III, §325,
References in Text
The immigration laws, referred to in text, are classified generally to Title 8, Aliens and Nationality. See, also,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§253. Medical services to Coast Guard, National Oceanic and Atmospheric Administration, and Public Health Service
(a) Persons entitled to medical services
Subject to regulations of the President—
(1) commissioned officers, chief warrant officers, warrant officers, cadets, and enlisted personnel of the Regular Coast Guard on active duty, including those on shore duty and those on detached duty; and Regular, and temporary members of the United States Coast Guard Reserve when on active duty;
(2) commissioned officers, ships' officers, and members of the crews of vessels of the National Oceanic and Atmospheric Administration on active duty, including those on shore duty and those on detached duty; and
(3) commissioned officers of the Regular or Reserve Corps of the Public Health Service on active duty;
shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service. The Surgeon General may detail commissioned officers for duty aboard vessels of the Coast Guard or the National Oceanic and Atmospheric Administration.
(b) Health care for involuntarily separated officers and dependents
(1) The Secretary may provide health care for an officer of the Regular or Reserve Corps involuntarily separated from the Service, and for any dependent of such officer, if—
(A) the officer or dependent was receiving health care at the expense of the Service at the time of separation; and
(B) the Secretary finds that the officer or dependent is unable to obtain appropriate insurance for the conditions for which the officer or dependent was receiving health care.
(2) Health care may be provided under paragraph (1) for a period of not more than one year from the date of separation of the officer from the Service.
(c) Examination of personnel of Service assigned to Coast Guard or National Oceanic and Atmospheric Administration
The Service shall provide all services referred to in subsection (a) of this section required by the Coast Guard or National Oceanic and Atmospheric Administration and shall perform all duties prescribed by statute in connection with the examinations to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, promotion and retirement, and officers of the Service assigned to duty on Coast Guard or National Oceanic and Atmospheric Administration vessels may extend aid to the crews of American vessels engaged in deep-sea fishing.
(July 1, 1944, ch. 373, title III, §326,
Amendments
1985—Subsec. (b).
1963—Subsec. (b).
Subsec. (c).
1960—Subsec. (a).
1956—Subsec. (b). Act June 7, 1956, repealed subsec. (b) except insofar as it related to dependent members of families of ships' officers and members of crews of vessels of Coast and Geodetic Survey.
Change of Name
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services Administration, and commissioned officers of Survey transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff. July 13, 1965, 30 F.R. 8819,
Effective Date of 1956 Amendment
Amendment by act June 7, 1956, effective six months after June 7, 1956, see section 307 of act June 7, 1956.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855
Section Referred to in Other Sections
This section is referred to in
§253a. Medical services to retired personnel of National Oceanic and Atmospheric Administration
(a) Eligibility
Subject to regulations of the President, retired ships' officers and retired members of the crews of vessels of the National Oceanic and Atmospheric Administration shall be entitled to medical, surgical, and dental treatment and hospitalization by the Public Health Service if the ships' officer or crew member, (1) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on July 19, 1963, whichever is later, and his employment as a vessel employee was continuous from that date until retirement, or (2) was retired as a vessel employee of the National Oceanic and Atmospheric Administration on or before July 1, 1963, or on July 19, 1963, whichever is later.
(b) Treatment of dependents of personnel
Subject to regulations of the President, dependent members of families (as defined in such regulations) of ships' officers and members of crews of vessels of the National Oceanic and Atmospheric Administration, whether such, ships' officers and members of crew are on active duty or retired, shall be furnished medical advice and outpatient treatment by the Public Health Service and, if suitable accommodations are available, they shall also be furnished hospitalization by the Public Health Service if the ships' officer or crew member (1) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on July 19, 1963, whichever is later, and his employment as a vessel employee has been continuous from that time, or (2) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on July 19, 1963, whichever is later, and his employment as a vessel employee was continuous from that time until retirement, or (3) was retired as a vessel employee of the National Oceanic and Atmospheric Administration on or before July 1, 1963, or on July 19, 1963, whichever is later. When dependent members of families are hospitalized, a per diem charge, at such uniform rate as may be prescribed from time to time for the hospitalization of dependents of members of the uniformed services at hospitals of the uniformed services pursuant to
(c) Identification
The National Oceanic and Atmospheric Administration shall furnish proper identification to those persons entitled to medical treatment under the provisions of this section.
(
Codification
Section was not enacted as part of the Public Health Service Act which comprises this chapter.
Amendments
1984—Subsec. (a).
Subsec. (b).
Change of Name
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services Administration, and commissioned officers of Survey transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff. July 13, 1965, 30 F.R. 8819,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Ex. Ord. No. 11160. Regulations Relating to Medical Care for Retired Personnel of Coast and Geodetic Survey [Now National Oceanic and Atmospheric Administration] and Their Dependents
Ex. Ord. No. 11160, July 6, 1964, 29 F.R. 9315, provided:
By virtue of the authority vested in me by the first section of the Act of July 19, 1963 (
(1) "Retired ships' officer and retired crew member" means a noncommissioned ships' officer or crew member of a vessel of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration] who either was on active duty as a vessel employee on July 19, 1963, and whose employment as such vessel employee was continuous from that date until the date of his retirement, or who had retired as a vessel employee on or before July 19, 1963.
(2) "Active duty ships' officer and active duty crew member" means a noncommissioned ships' officer or crew member on active duty as a vessel employee of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration] on July 19, 1963, and whose employment as such vessel employee has been continuous from that time.
(3) "Dependent members of families", with respect to active duty or retired ships' officers or crew members, means:
(A) the lawful wife;
(B) the unmarried legitimate child, including an adopted child or stepchild, who has not passed his twenty-first birthday; and
(C) the father or mother, if in fact dependent upon such active duty or retired ships' officer or crew member for over one-half of his or her support.
(4) "Relief stations" means Public Health Service outpatient clinics and outpatient offices.
(5) "Outpatient clinic" means a full-time outpatient medical facility, operated in Federally owned or leased space under the supervision of a commissioned medical officer or a full-time civil service medical officer (formerly known as a Second-Class Relief Station).
(6) "Outpatient office" means a part-time outpatient facility serving all classes of legal beneficiaries, located in other than Federal space, and in the charge of a local private physician under contract to the Service to provide medical care on an annual or fee basis (formerly known as a Third-Class Relief Station).
(1) Retired ships' officers and retired crew members of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration];
(2) Dependent members of families of persons described in paragraph (1) of this section;
(3) Dependent members of families of active duty ships' officers and crew members of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration].
(1) Medical, surgical, and dental treatment at hospitals, outpatient clinics, and outpatient offices of the Service, and hospitalization at hospitals of the Service. The Service will not be responsible for defraying the cost of hospitalization, medical services, and supplies procured elsewhere.
(2) Dental treatment shall be furnished to the extent that facilities and services at hospitals and outpatient clinics of the Service having full-time dental officers on duty are available to provide such treatment. At other Service facilities, dental treatment shall be limited to emergency measures necessary to relieve pain.
(b) For the purpose of this section—
(1) Medical advice and outpatient treatment may include such services and supplies as the Medical Officer in Charge may deem to be necessary for reasonable and adequate treatment.
(2) Hospitalization shall be furnished when, in the opinion of the Medical Officer in Charge, suitable accommodations are available and the condition of the patient is such as to require hospitalization. When hospitalization is authorized, it may include such services and supplies as the Medical Officer in Charge may deem to be necessary for reasonable and adequate treatment.
(c) Charges shall be made for hospitalization of dependent members of families at the same per diem rate as is prescribed for dependents of members of the uniformed services pursuant to
(d) Dental treatment may be furnished to the extent that facilities and services at hospitals and outpatient clinics of the Service having full-time dental officers are available to provide such treatment. Dental care will not be furnished under any circumstances in private facilities at the expense of the Service.
Lyndon B. Johnson.
§253b. Former Lighthouse Service employees; medical service eligibility
Subject to regulations of the President, lightkeepers, assistant lightkeepers, and officers and crews of vessels of the former Lighthouse Service, including any such persons who subsequent to June 30, 1939, were involuntarily assigned to other civilian duty in the Coast Guard, who were entitled to medical relief at hospitals and other stations of the Public Health Service prior to July 1, 1944, and who retired under the provisions of
(
Codification
Section was enacted as a part of Health Services Research, Health Statistics, and Medical Libraries Act of 1974, and also as a part of Health Services Research and Evaluation and Health Statistics Act of 1974, and not as a part of the Public Health Service Act which comprises this chapter.
Effective Date
Section 108(b) of
§254. Interdepartmental work
Nothing contained in this part shall affect the authority of the Service to furnish any materials, supplies, or equipment, or perform any work of services, requested in accordance with
(July 1, 1944, ch. 373, title III, §327,
Codification
"
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§254a. Sharing of medical care facilities and resources
(a) Definitions
For purposes of this section—
(1) the term "specialized health resources" means health care resources (whether equipment, space, or personnel) which, because of cost, limited availability, or unusual nature, are either unique in the health care community or are subject to maximum utilization only through mutual use;
(2) the term "hospital", unless otherwise specified, includes (in addition to other hospitals) any Federal hospital.
(b) Statement of purpose; agreements or arrangements; reciprocity; reimbursement; credits
For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide a professional environment therein which will help to attract and retain highly qualified and talented health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and hospitals and other health facilities in the health care community, and to promote the full utilization of hospitals and other health facilities and resources, the Secretary may—
(1) enter into agreements or arrangements with schools of medicine, schools of osteopathic medicine, and with other health professions schools, agencies, or institutions, for such interchange or cooperative use of facilities and services on a reciprocal or reimbursable basis, as will be of benefit to the training or research programs of the participating agencies; and
(2) enter into agreements or arrangements with hospitals and other health care facilities for the mutual use or the exchange of use of specialized health resources, and providing for reciprocal reimbursement.
Any reimbursement pursuant to any such agreement or arrangement shall be based on charges covering the reasonable cost of such utilization, including normal depreciation and amortization costs of equipment. Any proceeds to the Government under this subsection shall be credited to the applicable appropriation of the Public Health Service for the year in which such proceeds are received.
(July 1, 1944, ch. 373, title III, §327A, formerly §328, as added
Amendments
1988—Subsec. (b)(1).
Availability of Appropriations for Expenses of Sharing Medical Care Facilities and Resources
Similar provisions were contained in the following prior appropriation acts:
Part D—Primary Health Care
subpart i—health centers
Amendments
1996—
1978—
§254b. Health centers
(a) "Health center" defined
(1) In general
For purposes of this section, the term "health center" means an entity that serves a population that is medically underserved, or a special medically underserved population comprised of migratory and seasonal agricultural workers, the homeless, and residents of public housing, by providing, either through the staff and supporting resources of the center or through contracts or cooperative arrangements—
(A) required primary health services (as defined in subsection (b)(1) of this section); and
(B) as may be appropriate for particular centers, additional health services (as defined in subsection (b)(2) of this section) necessary for the adequate support of the primary health services required under subparagraph (A);
for all residents of the area served by the center (hereafter referred to in this section as the "catchment area").
(2) Limitation
The requirement in paragraph (1) to provide services for all residents within a catchment area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i) of this section.
(b) Definitions
For purposes of this section:
(1) Required primary health services
(A) In general
The term "required primary health services" means—
(i) basic health services which, for purposes of this section, shall consist of—
(I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gynecology that are furnished by physicians and where appropriate, physician assistants, nurse practitioners, and nurse midwives;
(II) diagnostic laboratory and radiologic services;
(III) preventive health services, including—
(aa) prenatal and perinatal services;
(bb) screening for breast and cervical cancer;
(cc) well-child services;
(dd) immunizations against vaccine-preventable diseases;
(ee) screenings for elevated blood lead levels, communicable diseases, and cholesterol;
(ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing correction and dental care;
(gg) voluntary family planning services; and
(hh) preventive dental services;
(IV) emergency medical services; and
(V) pharmaceutical services as may be appropriate for particular centers;
(ii) referrals to providers of medical services and other health-related services (including substance abuse and mental health services);
(iii) patient case management services (including counseling, referral, and follow-up services) and other services designed to assist health center patients in establishing eligibility for and gaining access to Federal, State, and local programs that provide or financially support the provision of medical, social, educational, or other related services;
(iv) services that enable individuals to use the services of the health center (including outreach and transportation services and, if a substantial number of the individuals in the population served by a center are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a predominant number of such individuals); and
(v) education of patients and the general population served by the health center regarding the availability and proper use of health services.
(B) Exception
With respect to a health center that receives a grant only under subsection (g) of this section, the Secretary, upon a showing of good cause, shall—
(i) waive the requirement that the center provide all required primary health services under this paragraph; and
(ii) approve, as appropriate, the provision of certain required primary health services only during certain periods of the year.
(2) Additional health services
The term "additional health services" means services that are not included as required primary health services and that are appropriate to meet the health needs of the population served by the health center involved. Such term may include—
(A) environmental health services, including—
(i) the detection and alleviation of unhealthful conditions associated with water supply;
(ii) sewage treatment;
(iii) solid waste disposal;
(iv) rodent and parasitic infestation;
(v) field sanitation;
(vi) housing; and
(vii) other environmental factors related to health; and
(B) in the case of health centers receiving grants under subsection (g) of this section, special occupation-related health services for migratory and seasonal agricultural workers, including—
(i) screening for and control of infectious diseases, including parasitic diseases; and
(ii) injury prevention programs, including prevention of exposure to unsafe levels of agricultural chemicals including pesticides.
(3) Medically underserved populations
(A) In general
The term "medically underserved population" means the population of an urban or rural area designated by the Secretary as an area with a shortage of personal health services or a population group designated by the Secretary as having a shortage of such services.
(B) Criteria
In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the specific shortages of personal health services of an area or population group. Such criteria shall—
(i) take into account comments received by the Secretary from the chief executive officer of a State and local officials in a State; and
(ii) include factors indicative of the health status of a population group or residents of an area, the ability of the residents of an area or of a population group to pay for health services and their accessibility to them, and the availability of health professionals to residents of an area or to a population group.
(C) Limitation
The Secretary may not designate a medically underserved population in a State or terminate the designation of such a population unless, prior to such designation or termination, the Secretary provides reasonable notice and opportunity for comment and consults with—
(i) the chief executive officer of such State;
(ii) local officials in such State; and
(iii) the organization, if any, which represents a majority of health centers in such State.
(D) Permissible designation
The Secretary may designate a medically underserved population that does not meet the criteria established under subparagraph (B) if the chief executive officer of the State in which such population is located and local officials of such State recommend the designation of such population based on unusual local conditions which are a barrier to access to or the availability of personal health services.
(c) Planning grants
(1) In general
(A) Centers
The Secretary may make grants to public and nonprofit private entities for projects to plan and develop health centers which will serve medically underserved populations. A project for which a grant may be made under this subsection may include the cost of the acquisition and lease of buildings and equipment (including the costs of amortizing the principal of, and paying the interest on, loans) and shall include—
(i) an assessment of the need that the population proposed to be served by the health center for which the project is undertaken has for required primary health services and additional health services;
(ii) the design of a health center program for such population based on such assessment;
(iii) efforts to secure, within the proposed catchment area of such center, financial and professional assistance and support for the project;
(iv) initiation and encouragement of continuing community involvement in the development and operation of the project; and
(v) proposed linkages between the center and other appropriate provider entities, such as health departments, local hospitals, and rural health clinics, to provide better coordinated, higher quality, and more cost-effective health care services.
(B) Comprehensive service delivery networks and plans
The Secretary may make grants to health centers that receive assistance under this section to enable the centers to plan and develop a network or plan for the provision of health services, which may include the provision of health services on a prepaid basis or through another managed care arrangement, to some or to all of the individuals which the centers serve. Such a grant may only be made for such a center if—
(i) the center has received grants under subsection (e)(1)(A) of this section for at least 2 consecutive years preceding the year of the grant under this subparagraph or has otherwise demonstrated, as required by the Secretary, that such center has been providing primary care services for at least the 2 consecutive years immediately preceding such year; and
(ii) the center provides assurances satisfactory to the Secretary that the provision of such services on a prepaid basis, or under another managed care arrangement, will not result in the diminution of the level or quality of health services provided to the medically underserved population served prior to the grant under this subparagraph.
Any such grant may include the acquisition and lease of buildings and equipment which may include data and information systems (including the costs of amortizing the principal of, and paying the interest on, loans), and providing training and technical assistance related to the provision of health services on a prepaid basis or under another managed care arrangement, and for other purposes that promote the development of managed care networks and plans.
(2) Limitation
Not more than two grants may be made under this subsection for the same project, except that upon a showing of good cause, the Secretary may make additional grant awards.
(d) Managed care loan guarantee program
(1) Establishment
(A) In general
The Secretary shall establish a program under which the Secretary may, in accordance with this subsection and to the extent that appropriations are provided in advance for such program, guarantee the principal and interest on loans made by non-Federal lenders to health centers funded under this section for the costs of developing and operating managed care networks or plans.
(B) Use of funds
Loan funds guaranteed under this subsection may be used—
(i) to establish reserves for the furnishing of services on a pre-paid basis; or
(ii) for costs incurred by the center or centers, otherwise permitted under this section, as the Secretary determines are necessary to enable a center or centers to develop, operate, and own the network or plan.
(C) Publication of guidance
Prior to considering an application submitted under this subsection, the Secretary shall publish guidelines to provide guidance on the implementation of this section. The Secretary shall make such guidelines available to the universe of parties affected under this subsection, distribute such guidelines to such parties upon the request of such parties, and provide a copy of such guidelines to the appropriate committees of Congress.
(2) Protection of financial interests
(A) In general
The Secretary may not approve a loan guarantee for a project under this subsection unless the Secretary determines that—
(i) the terms, conditions, security (if any), and schedule and amount of repayments with respect to the loan are sufficient to protect the financial interests of the United States and are otherwise reasonable, including a determination that the rate of interest does not exceed such percent per annum on the principal obligation outstanding as the Secretary determines to be reasonable, taking into account the range of interest rates prevailing in the private market for similar loans and the risks assumed by the United States, except that the Secretary may not require as security any center asset that is, or may be, needed by the center or centers involved to provide health services;
(ii) the loan would not be available on reasonable terms and conditions without the guarantee under this subsection; and
(iii) amounts appropriated for the program under this subsection are sufficient to provide loan guarantees under this subsection.
(B) Recovery of payments
(i) In general
The United States shall be entitled to recover from the applicant for a loan guarantee under this subsection the amount of any payment made pursuant to such guarantee, unless the Secretary for good cause waives such right of recovery (subject to appropriations remaining available to permit such a waiver) and, upon making any such payment, the United States shall be subrogated to all of the rights of the recipient of the payments with respect to which the guarantee was made. Amounts recovered under this clause shall be credited as reimbursements to the financing account of the program.
(ii) Modification of terms and conditions
To the extent permitted by clause (iii) and subject to the requirements of section 504(e) of the Credit Reform Act of 1990 (
(iii) Incontestability
Any loan guarantee made by the Secretary under this subsection shall be incontestable—
(I) in the hands of an applicant on whose behalf such guarantee is made unless the applicant engaged in fraud or misrepresentation in securing such guarantee; and
(II) as to any person (or successor in interest) who makes or contracts to make a loan to such applicant in reliance thereon unless such person (or successor in interest) engaged in fraud or misrepresentation in making or contracting to make such loan.
(iv) Further terms and conditions
Guarantees of loans under this subsection shall be subject to such further terms and conditions as the Secretary determines to be necessary to assure that the purposes of this section will be achieved.
(3) Loan origination fees
(A) In general
The Secretary shall collect a loan origination fee with respect to loans to be guaranteed under this subsection, except as provided in subparagraph (C).
(B) Amount
The amount of a loan origination fee collected by the Secretary under subparagraph (A) shall be equal to the estimated long term cost of the loan guarantees involved to the Federal Government (excluding administrative costs), calculated on a net present value basis, after taking into account any appropriations that may be made for the purpose of offsetting such costs, and in accordance with the criteria used to award loan guarantees under this subsection.
(C) Waiver
The Secretary may waive the loan origination fee for a health center applicant who demonstrates to the Secretary that the applicant will be unable to meet the conditions of the loan if the applicant incurs the additional cost of the fee.
(4) Defaults
(A) In general
Subject to the requirements of the Credit Reform Act of 1990 (
(B) Foreclosure
The Secretary may take such action, consistent with State law respecting foreclosure procedures and, with respect to reserves required for furnishing services on a prepaid basis, subject to the consent of the affected States, as the Secretary determines appropriate to protect the interest of the United States in the event of a default on a loan guaranteed under this subsection, except that the Secretary may only foreclose on assets offered as security (if any) in accordance with paragraph (2)(A)(i).
(5) Limitation
Not more than one loan guarantee may be made under this subsection for the same network or plan, except that upon a showing of good cause the Secretary may make additional loan guarantees.
(6) Annual report
Not later than April 1, 1998, and each April 1 thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress a report concerning loan guarantees provided under this subsection. Such report shall include—
(A) a description of the number, amount, and use of funds received under each loan guarantee provided under this subsection;
(B) a description of any defaults with respect to such loans and an analysis of the reasons for such defaults, if any; and
(C) a description of the steps that may have been taken by the Secretary to assist an entity in avoiding such a default.
(7) Program evaluation
Not later than June 30, 1999, the Secretary shall prepare and submit to the appropriate committees of Congress a report containing an evaluation of the program authorized under this subsection. Such evaluation shall include a recommendation with respect to whether or not the loan guarantee program under this subsection should be continued and, if so, any modifications that should be made to such program.
(8) Authorization of appropriations
There are authorized to be appropriated to carry out this subsection such sums as may be necessary.
(e) Operating grants
(1) Authority
(A) In general
The Secretary may make grants for the costs of the operation of public and nonprofit private health centers that provide health services to medically underserved populations.
(B) Entities that fail to meet certain requirements
The Secretary may make grants, for a period of not to exceed 2 years, for the costs of the operation of public and nonprofit private entities which provide health services to medically underserved populations but with respect to which the Secretary is unable to make each of the determinations required by subsection (j)(3) of this section.
(2) Use of funds
The costs for which a grant may be made under subparagraph (A) or (B) of paragraph (1) may include the costs of acquiring and leasing buildings and equipment (including the costs of amortizing the principal of, and paying interest on, loans), and the costs of providing training related to the provision of required primary health services and additional health services and to the management of health center programs.
(3) Construction
The Secretary may award grants which may be used to pay the costs associated with expanding and modernizing existing buildings or constructing new buildings (including the costs of amortizing the principal of, and paying the interest on, loans) for projects approved prior to October 1, 1996.
(4) Limitation
Not more than two grants may be made under subparagraph (B) of paragraph (1) for the same entity.
(5) Amount
(A) In general
The amount of any grant made in any fiscal year under paragraph (1) to a health center shall be determined by the Secretary, but may not exceed the amount by which the costs of operation of the center in such fiscal year exceed the total of—
(i) State, local, and other operational funding provided to the center; and
(ii) the fees, premiums, and third-party reimbursements, which the center may reasonably be expected to receive for its operations in such fiscal year.
(B) Payments
Payments under grants under subparagraph (A) or (B) of paragraph (1) shall be made in advance or by way of reimbursement and in such installments as the Secretary finds necessary and adjustments may be made for overpayments or underpayments.
(C) Use of nongrant funds
Nongrant funds described in clauses (i) and (ii) of subparagraph (A), including any such funds in excess of those originally expected, shall be used as permitted under this section, and may be used for such other purposes as are not specifically prohibited under this section if such use furthers the objectives of the project.
(f) Infant mortality grants
(1) In general
The Secretary may make grants to health centers for the purpose of assisting such centers in—
(A) providing comprehensive health care and support services for the reduction of—
(i) the incidence of infant mortality; and
(ii) morbidity among children who are less than 3 years of age; and
(B) developing and coordinating service and referral arrangements between health centers and other entities for the health management of pregnant women and children described in subparagraph (A).
(2) Priority
In making grants under this subsection the Secretary shall give priority to health centers providing services to any medically underserved population among which there is a substantial incidence of infant mortality or among which there is a significant increase in the incidence of infant mortality.
(3) Requirements
The Secretary may make a grant under this subsection only if the health center involved agrees that—
(A) the center will coordinate the provision of services under the grant to each of the recipients of the services;
(B) such services will be continuous for each such recipient;
(C) the center will provide follow-up services for individuals who are referred by the center for services described in paragraph (1);
(D) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health services (including prenatal care) with respect to the purpose described in this subsection; and
(E) the center will coordinate the provision of services with other maternal and child health providers operating in the catchment area.
(g) Migratory and seasonal agricultural workers
(1) In general
The Secretary may award grants for the purposes described in subsections (c), (e), and (f) of this section for the planning and delivery of services to a special medically underserved population comprised of—
(A) migratory agricultural workers, seasonal agricultural workers, and members of the families of such migratory and seasonal agricultural workers who are within a designated catchment area; and
(B) individuals who have previously been migratory agricultural workers but who no longer meet the requirements of subparagraph (A) of paragraph (3) because of age or disability and members of the families of such individuals who are within such catchment area.
(2) Environmental concerns
The Secretary may enter into grants or contracts under this subsection with public and private entities to—
(A) assist the States in the implementation and enforcement of acceptable environmental health standards, including enforcement of standards for sanitation in migratory agricultural worker labor camps, and applicable Federal and State pesticide control standards; and
(B) conduct projects and studies to assist the several States and entities which have received grants or contracts under this section in the assessment of problems related to camp and field sanitation, exposure to unsafe levels of agricultural chemicals including pesticides, and other environmental health hazards to which migratory agricultural workers and members of their families are exposed.
(3) Definitions
For purposes of this subsection:
(A) Migratory agricultural worker
The term "migratory agricultural worker" means an individual whose principal employment is in agriculture on a seasonal basis, who has been so employed within the last 24 months, and who establishes for the purposes of such employment a temporary abode.
(B) Seasonal agricultural worker
The term "seasonal agricultural worker" means an individual whose principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker.
(C) Agriculture
The term "agriculture" means farming in all its branches, including—
(i) cultivation and tillage of the soil;
(ii) the production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in or on, the land; and
(iii) any practice (including preparation and processing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in clause (ii).
(h) Homeless population
(1) In general
The Secretary may award grants for the purposes described in subsections (c), (e), and (f) of this section for the planning and delivery of services to a special medically underserved population comprised of homeless individuals, including grants for innovative programs that provide outreach and comprehensive primary health services to homeless children and children at risk of homelessness.
(2) Required services
In addition to required primary health services (as defined in subsection (b)(1) of this section), an entity that receives a grant under this subsection shall be required to provide substance abuse services as a condition of such grant.
(3) Supplement not supplant requirement
A grant awarded under this subsection shall be expended to supplement, and not supplant, the expenditures of the health center and the value of in kind contributions for the delivery of services to the population described in paragraph (1).
(4) Definitions
For purposes of this section:
(A) Homeless individual
The term "homeless individual" means an individual who lacks housing (without regard to whether the individual is a member of a family), including an individual whose primary residence during the night is a supervised public or private facility that provides temporary living accommodations and an individual who is a resident in transitional housing.
(B) Substance abuse
The term "substance abuse" has the same meaning given such term in
(C) Substance abuse services
The term "substance abuse services" includes detoxification and residential treatment for substance abuse provided in settings other than hospitals.
(i) Residents of public housing
(1) In general
The Secretary may award grants for the purposes described in subsections (c), (e), and (f) of this section for the planning and delivery of services to a special medically underserved population comprised of residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term in
(2) Supplement not supplant
A grant awarded under this subsection shall be expended to supplement, and not supplant, the expenditures of the health center and the value of in kind contributions for the delivery of services to the population described in paragraph (1).
(3) Consultation with residents
The Secretary may not make a grant under paragraph (1) unless, with respect to the residents of the public housing involved, the applicant for the grant—
(A) has consulted with the residents in the preparation of the application for the grant; and
(B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the program carried out with the grant.
(j) Applications
(1) Submission
No grant may be made under this section unless an application therefore is submitted to, and approved by, the Secretary. Such an application shall be submitted in such form and manner and shall contain such information as the Secretary shall prescribe.
(2) Description of need
An application for a grant under subparagraph (A) or (B) of subsection (e)(1) of this section for a health center shall include—
(A) a description of the need for health services in the catchment area of the center;
(B) a demonstration by the applicant that the area or the population group to be served by the applicant has a shortage of personal health services; and
(C) a demonstration that the center will be located so that it will provide services to the greatest number of individuals residing in the catchment area or included in such population group.
Such a demonstration shall be made on the basis of the criteria prescribed by the Secretary under subsection (b)(3) of this section or on any other criteria which the Secretary may prescribe to determine if the area or population group to be served by the applicant has a shortage of personal health services. In considering an application for a grant under subparagraph (A) or (B) of subsection (e)(1) of this section, the Secretary may require as a condition to the approval of such application an assurance that the applicant will provide any health service defined under paragraphs (1) and (2) of subsection (b) of this section that the Secretary finds is needed to meet specific health needs of the area to be served by the applicant. Such a finding shall be made in writing and a copy shall be provided to the applicant.
(3) Requirements
Except as provided in subsection (e)(1)(B) of this section, the Secretary may not approve an application for a grant under subparagraph (A) or (B) of subsection (e)(1) of this section unless the Secretary determines that the entity for which the application is submitted is a health center (within the meaning of subsection (a) of this section) and that—
(A) the required primary health services of the center will be available and accessible in the catchment area of the center promptly, as appropriate, and in a manner which assures continuity;
(B) the center has made and will continue to make every reasonable effort to establish and maintain collaborative relationships with other health care providers in the catchment area of the center;
(C) the center will have an ongoing quality improvement system that includes clinical services and management, and that maintains the confidentiality of patient records;
(D) the center will demonstrate its financial responsibility by the use of such accounting procedures and other requirements as may be prescribed by the Secretary;
(E) the center—
(i) has or will have a contractual or other arrangement with the agency of the State, in which it provides services, which administers or supervises the administration of a State plan approved under title XIX of the Social Security Act [
(ii) has made or will make every reasonable effort to enter into such an arrangement;
(F) the center has made or will make and will continue to make every reasonable effort to collect appropriate reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act [
(G) the center—
(i) has prepared a schedule of fees or payments for the provision of its services consistent with locally prevailing rates or charges and designed to cover its reasonable costs of operation and has prepared a corresponding schedule of discounts to be applied to the payment of such fees or payments, which discounts are adjusted on the basis of the patient's ability to pay;
(ii) has made and will continue to make every reasonable effort—
(I) to secure from patients payment for services in accordance with such schedules; and
(II) to collect reimbursement for health services to persons described in subparagraph (F) on the basis of the full amount of fees and payments for such services without application of any discount; and
(iii) has submitted to the Secretary such reports as the Secretary may require to determine compliance with this subparagraph;
(H) the center has established a governing board which except in the case of an entity operated by an Indian tribe or tribal or Indian organization under the Indian Self-Determination Act [
(i) is composed of individuals, a majority of whom are being served by the center and who, as a group, represent the individuals being served by the center;
(ii) meets at least once a month, selects the services to be provided by the center, schedules the hours during which such services will be provided, approves the center's annual budget, approves the selection of a director for the center, and, except in the case of a governing board of a public center (as defined in the second sentence of this paragraph), establishes general policies for the center; and
(iii) in the case of an application for a second or subsequent grant for a public center, has approved the application or if the governing body has not approved the application, the failure of the governing body to approve the application was unreasonable;
except that, upon a showing of good cause the Secretary shall waive, for the length of the project period, all or part of the requirements of this subparagraph in the case of a health center that receives a grant pursuant to subsection (g), (h), (i), or (p) of this section;
(I) the center has developed—
(i) an overall plan and budget that meets the requirements of the Secretary; and
(ii) an effective procedure for compiling and reporting to the Secretary such statistics and other information as the Secretary may require relating to—
(I) the costs of its operations;
(II) the patterns of use of its services;
(III) the availability, accessibility, and acceptability of its services; and
(IV) such other matters relating to operations of the applicant as the Secretary may require;
(J) the center will review periodically its catchment area to—
(i) ensure that the size of such area is such that the services to be provided through the center (including any satellite) are available and accessible to the residents of the area promptly and as appropriate;
(ii) ensure that the boundaries of such area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and Federal and State health and social service programs; and
(iii) ensure that the boundaries of such area eliminate, to the extent possible, barriers to access to the services of the center, including barriers resulting from the area's physical characteristics, its residential patterns, its economic and social grouping, and available transportation;
(K) in the case of a center which serves a population including a substantial proportion of individuals of limited English-speaking ability, the center has—
(i) developed a plan and made arrangements responsive to the needs of such population for providing services to the extent practicable in the language and cultural context most appropriate to such individuals; and
(ii) identified an individual on its staff who is fluent in both that language and in English and whose responsibilities shall include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences; and
(L) the center, has developed an ongoing referral relationship with one or more hospitals.
For purposes of subparagraph (H), the term "public center" means a health center funded (or to be funded) through a grant under this section to a public agency.
(4) Approval of new or expanded service applications
The Secretary shall approve applications for grants under subparagraph (A) or (B) of subsection (e)(1) of this section for health centers which—
(A) have not received a previous grant under such subsection; or
(B) have applied for such a grant to expand their services;
in such a manner that the ratio of the medically underserved populations in rural areas which may be expected to use the services provided by such centers to the medically underserved populations in urban areas which may be expected to use the services provided by such centers is not less than two to three or greater than three to two.
(k) Technical and other assistance
The Secretary may provide (either through the Department of Health and Human Services or by grant or contract) all necessary technical and other nonfinancial assistance (including fiscal and program management assistance and training in such management) to any public or private nonprofit entity to assist entities in developing plans for, or operating as, health centers, and in meeting the requirements of subsection (j)(2) of this section.
(l) Authorization of appropriations
(1) In general
For the purpose of carrying out this section, in addition to the amounts authorized to be appropriated under subsection (d) of this section, there are authorized to be appropriated $802,124,000 for fiscal year 1997, and such sums as may be necessary for each of the fiscal years 1998 through 2001.
(2) Special provisions
(A) Public centers
The Secretary may not expend in any fiscal year, for grants under this section to public centers (as defined in the second sentence of subsection (j)(3) of this section) the governing boards of which (as described in subsection (j)(3)(G)(ii) 1 of this section) do not establish general policies for such centers, an amount which exceeds 5 percent of the amounts appropriated under this section for that fiscal year. For purposes of applying the preceding sentence, the term "public centers" shall not include health centers that receive grants pursuant to subsection (h) or (i) of this section.
(B) Distribution of grants
(i) Fiscal year 1997
For fiscal year 1997, the Secretary, in awarding grants under this section shall ensure that the amounts made available under each of subsections (g), (h), and (i) of this section in such fiscal year bears the same relationship to the total amount appropriated for such fiscal year under paragraph (1) as the amounts appropriated for fiscal year 1996 under each of
(ii) Fiscal years 1998 and 1999
For each of the fiscal years 1998 and 1999, the Secretary, in awarding grants under this section shall ensure that the proportion of the amounts made available under each of subsections (g), (h), and (i) of this section is equal to the proportion of amounts made available under each such subsection for the previous fiscal year, as such amounts relate to the total amounts appropriated for the previous fiscal year involved, increased or decreased by not more than 10 percent.
(3) Funding report
The Secretary shall annually prepare and submit to the appropriate committees of Congress a report concerning the distribution of funds under this section that are provided to meet the health care needs of medically underserved populations, including the homeless, residents of public housing, and migratory and seasonal agricultural workers, and the appropriateness of the delivery systems involved in responding to the needs of the particular populations. Such report shall include an assessment of the relative health care access needs of the targeted populations and the rationale for any substantial changes in the distribution of funds.
(m) Memorandum of agreement
In carrying out this section, the Secretary may enter into a memorandum of agreement with a State. Such memorandum may include, where appropriate, provisions permitting such State to—
(1) analyze the need for primary health services for medically underserved populations within such State;
(2) assist in the planning and development of new health centers;
(3) review and comment upon annual program plans and budgets of health centers, including comments upon allocations of health care resources in the State;
(4) assist health centers in the development of clinical practices and fiscal and administrative systems through a technical assistance plan which is responsive to the requests of health centers; and
(5) share information and data relevant to the operation of new and existing health centers.
(n) Records
(1) In general
Each entity which receives a grant under subsection (e) of this section shall establish and maintain such records as the Secretary shall require.
(2) Availability
Each entity which is required to establish and maintain records under this subsection shall make such books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying or mechanical reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the authority to conduct such examination, copying, and reproduction.
(o) Delegation of authority
The Secretary may delegate the authority to administer the programs authorized by this section to any office, except that the authority to enter into, modify, or issue approvals with respect to grants or contracts may be delegated only within the central office of the Health Resources and Services Administration.
(p) Special consideration
In making grants under this section, the Secretary shall give special consideration to the unique needs of sparsely populated rural areas, including giving priority in the awarding of grants for new health centers under subsections (c) and (e) of this section, and the granting of waivers as appropriate and permitted under subsections (b)(1)(B)(i) and (j)(3)(G) 2 of this section.
(q) Audits
(1) In general
Each entity which receives a grant under this section shall provide for an independent annual financial audit of any books, accounts, financial records, files, and other papers and property which relate to the disposition or use of the funds received under such grant and such other funds received by or allocated to the project for which such grant was made. For purposes of assuring accurate, current, and complete disclosure of the disposition or use of the funds received, each such audit shall be conducted in accordance with generally accepted accounting principles. Each audit shall evaluate—
(A) the entity's implementation of the guidelines established by the Secretary respecting cost accounting,
(B) the processes used by the entity to meet the financial and program reporting requirements of the Secretary, and
(C) the billing and collection procedures of the entity and the relation of the procedures to its fee schedule and schedule of discounts and to the availability of health insurance and public programs to pay for the health services it provides.
A report of each such audit shall be filed with the Secretary at such time and in such manner as the Secretary may require.
(2) Records
Each entity which receives a grant under this section shall establish and maintain such records as the Secretary shall by regulation require to facilitate the audit required by paragraph (1). The Secretary may specify by regulation the form and manner in which such records shall be established and maintained.
(3) Availability of records
Each entity which is required to establish and maintain records or to provide for and 3 audit under this subsection shall make such books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying or mechanical reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the authority to conduct such examination, copying, and reproduction.
(4) Waiver
The Secretary may, under appropriate circumstances, waive the application of all or part of the requirements of this subsection with respect to an entity.
(July 1, 1944, ch. 373, title III, §330, as added
References in Text
The Credit Reform Act of 1990, referred to in subsec. (d)(4)(A), probably means the Federal Credit Reform Act of 1990, title V of
The Social Security Act, referred to in subsec. (j)(3)(E)(i), (F), is act Aug. 14, 1935, ch. 531,
The Indian Self-Determination Act, referred to in subsec. (j)(3)(H), is title I of
The Indian Health Care Improvement Act, referred to in subsec. (j)(3)(H), is
Codification
October 11, 1996, referred to in subsec. (l)(2)(B)(i), was in the original "the date of enactment of this section", which was translated as meaning the date of enactment of
Prior Provisions
A prior section 254a–1, act July 1, 1944, ch. 373, title III, §328, as added Nov. 10, 1978,
A prior section 254b, act July 1, 1944, ch. 373, title III, §329, formerly §310, as added Sept. 25, 1962,
Another prior section 254b, act July 1, 1944, ch. 373, title III, §329, as added Dec. 31, 1970,
A prior section 330 of act July 1, 1944, was classified to
Effective Date
Section effective Oct. 1, 1996, see section 5 of
Savings Provision for Current Grants, Contracts, and Cooperative Agreements
Section 3(b) of
Reference to Community, Migrant, Public Housing, or Homeless Health Center Considered Reference to Health Center
Section 4(c) of
Legislative Proposal for Changes Conforming to Pub. L. 104–299
Section 4(e) of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be subsection "(j)(3)(H)(ii)".
2 So in original. Probably should be a reference to subsection (j)(3)(H).
3 So in original. Probably should be "an".
§254c. Rural health outreach, network development, and telemedicine grant program
(a) Administration
The rural health services outreach demonstration grant program established under
(b) Grants
Under the program referred to in subsection (a) of this section, the Secretary, acting through the Director of the Office of Rural Health Policy, may award grants to expand access to, coordinate, restrain the cost of, and improve the quality of essential health care services, including preventive and emergency services, through the development of integrated health care delivery systems or networks in rural areas and regions.
(c) Eligible networks
(1) Outreach networks
To be eligible to receive a grant under this section, an entity shall—
(A) be a rural public or nonprofit private entity that is or represents a network or potential network that includes three or more health care providers or other entities that provide or support the delivery of health care services; and
(B) in consultation with the State office of rural health or other appropriate State entity, prepare and submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require, including—
(i) a description of the activities which the applicant intends to carry out using amounts provided under the grant;
(ii) a plan for continuing the project after Federal support is ended;
(iii) a description of the manner in which the activities funded under the grant will meet health care needs of underserved rural populations within the State; and
(iv) a description of how the local community or region to be served by the network or proposed network will be involved in the development and ongoing operations of the network.
(2) For-profit entities
An eligible network may include for-profit entities so long as the network grantee is a nonprofit entity.
(3) Telemedicine networks
(A) In general
An entity that is a health care provider and a member of an existing or proposed telemedicine network, or an entity that is a consortium of health care providers that are members of an existing or proposed telemedicine network shall be eligible for a grant under this section.
(B) Requirement
A telemedicine network referred to in subparagraph (A) shall, at a minimum, be composed of—
(i) a multispecialty entity that is located in an urban or rural area, which can provide 24-hour a day access to a range of specialty care; and
(ii) at least two rural health care facilities, which may include rural hospitals, rural physician offices, rural health clinics, rural community health clinics, and rural nursing homes.
(d) Preference
In awarding grants under this section, the Secretary shall give preference to applicant networks that include—
(1) a majority of the health care providers serving in the area or region to be served by the network;
(2) any federally qualified health centers, rural health clinics, and local public health departments serving in the area or region;
(3) outpatient mental health providers serving in the area or region; or
(4) appropriate social service providers, such as agencies on aging, school systems, and providers under the women, infants, and children program, to improve access to and coordination of health care services.
(e) Use of funds
(1) In general
Amounts provided under grants awarded under this section shall be used—
(A) for the planning and development of integrated self-sustaining health care networks; and
(B) for the initial provision of services.
(2) Expenditures in rural areas
(A) In general
In awarding a grant under this section, the Secretary shall ensure that not less than 50 percent of the grant award is expended in a rural area or to provide services to residents of rural areas.
(B) Telemedicine networks
An entity described in subsection (c)(3) of this section may not use in excess of—
(i) 40 percent of the amounts provided under a grant under this section to carry out activities under paragraph (3)(A)(iii); and
(ii) 20 percent of the amounts provided under a grant under this section to pay for the indirect costs associated with carrying out the purposes of such grant.
(3) Telemedicine networks
(A) In general
An entity described in subsection (c)(3) of this section, may use amounts provided under a grant under this section to—
(i) demonstrate the use of telemedicine in facilitating the development of rural health care networks and for improving access to health care services for rural citizens;
(ii) provide a baseline of information for a systematic evaluation of telemedicine systems serving rural areas;
(iii) purchase or lease and install equipment; and
(iv) operate the telemedicine system and evaluate the telemedicine system.
(B) Limitations
An entity described in subsection (c)(3) of this section, may not use amounts provided under a grant under this section—
(i) to build or acquire real property;
(ii) purchase or install transmission equipment (such as laying cable or telephone lines, microwave towers, satellite dishes, amplifiers, and digital switching equipment); or
(iii) for construction, except that such funds may be expended for minor renovations relating to the installation of equipment; 1
(f) Term of grants
Funding may not be provided to a network under this section for in excess of a 3-year period.
(g) Authorization of appropriations
For the purpose of carrying out this section there are authorized to be appropriated $36,000,000 for fiscal year 1997, and such sums as may be necessary for each of the fiscal years 1998 through 2001.
(July 1, 1944, ch. 373, title III, §330A, as added
Prior Provisions
A prior section 254c, act July 1, 1944, ch. 373, title III, §330, as added July 29, 1975,
Effective Date
Section effective Oct. 1, 1996, see section 5 of
Rural Access to Emergency Devices
"SEC. 411. SHORT TITLE.
"This subtitle may be cited as the 'Rural Access to Emergency Devices Act' or the 'Rural AED Act'.
"SEC. 412. FINDINGS.
"Congress makes the following findings:
"(1) Heart disease is the leading cause of death in the United States.
"(2) The American Heart Association estimates that 250,000 Americans die from sudden cardiac arrest each year.
"(3) A cardiac arrest victim's chance of survival drops 10 percent for every minute that passes before his or her heart is returned to normal rhythm.
"(4) Because most cardiac arrest victims are initially in ventricular fibrillation, and the only treatment for ventricular fibrillation is defibrillation, prompt access to defibrillation to return the heart to normal rhythm is essential.
"(5) Lifesaving technology, the automated external defibrillator, has been developed to allow trained lay rescuers to respond to cardiac arrest by using this simple device to shock the heart into normal rhythm.
"(6) Those people who are likely to be first on the scene of a cardiac arrest situation in many communities, particularly smaller and rural communities, lack sufficient numbers of automated external defibrillators to respond to cardiac arrest in a timely manner.
"(7) The American Heart Association estimates that more than 50,000 deaths could be prevented each year if defibrillators were more widely available to designated responders.
"(8) Legislation should be enacted to encourage greater public access to automated external defibrillators in communities across the United States.
"SEC. 413. GRANTS.
"(a)
"(b)
"(1) is composed of local emergency response entities such as community training facilities, local emergency responders, fire and rescue departments, police, community hospitals, and local non-profit entities and for-profit entities concerned about cardiac arrest survival rates;
"(2) evaluates the local community emergency response times to assess whether they meet the standards established by national public health organizations such as the American Heart Association and the American Red Cross; and
"(3) submits to the Secretary of Health and Human Services an application at such time, in such manner, and containing such information as the Secretary may require.
"(c)
"(1) to purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration; and
"(2) to provide defibrillator and basic life support training in automated external defibrillator usage through the American Heart Association, the American Red Cross, or other nationally recognized training courses.
"(d)
"(e)
Report on Telemedicine
"(1) identifies any factors that inhibit the expansion and accessibility of telemedicine services, including factors relating to telemedicine networks;
"(2) identifies any factors that, in addition to geographical isolation, should be used to determine which patients need or require access to telemedicine care;
"(3) determines the extent to which—
"(A) patients receiving telemedicine service have benefited from the services, and are satisfied with the treatment received pursuant to the services; and
"(B) the medical outcomes for such patients would have differed if telemedicine services had not been available to the patients;
"(4) determines the extent to which physicians involved with telemedicine services have been satisfied with the medical aspects of the services;
"(5) determines the extent to which primary care physicians are enhancing their medical knowledge and experience through the interaction with specialists provided by telemedicine consultations; and
"(6) identifies legal and medical issues relating to State licensing of health professionals that are presented by telemedicine services, and provides any recommendations of the Secretary for responding to such issues."
1 So in original. The semicolon probably should be a period.
§254c–1. Grants for health services for Pacific Islanders
(a) Grants
The Secretary of Health and Human Services (hereafter in this section referred to as the "Secretary") shall provide grants to, or enter into contracts with, public or private nonprofit agencies that have demonstrated experience in serving the health needs of Pacific Islanders living in the Territory of American Samoa, the Commonwealth of Northern Mariana Islands, the Territory of Guam, the Republic of the Marshall Islands, the Republic of Palau, and the Federated States of Micronesia.
(b) Use of grants or contracts
Grants or contracts made or entered into under subsection (a) of this section shall be used, among other items—
(1) to continue, as a priority, the medical officer training program in Pohnpei, Federated States of Micronesia;
(2) to improve the quality and availability of health and mental health services and systems, with an emphasis therein on preventive health services and health promotion programs and projects, including improved health data systems;
(3) to improve the quality and availability of health manpower, including programs and projects to train new and upgrade the skills of existing health professionals by—
(A) establishing dental officer, dental assistant, nurse practitioner, or nurse clinical specialist training programs;
(B) providing technical training of new auxiliary health workers;
(C) upgrading the training of currently employed health personnel in special areas of need;
(D) developing long-term plans for meeting health profession needs;
(E) developing or improving programs for faculty enhancement or post-doctoral training; and
(F) providing innovative health professions training initiatives (including scholarships) targeted toward ensuring that residents of the Pacific Basin attend and graduate from recognized health professional programs;
(4) to improve the quality of health services, including laboratory, x-ray, and pharmacy, provided in ambulatory and inpatient settings through quality assurance, standard setting, and other culturally appropriate means;
(5) to improve facility and equipment repair and maintenance systems;
(6) to improve alcohol, drug abuse, and mental health prevention and treatment services and systems;
(7) to improve local and regional health planning systems; and
(8) to improve basic local public health systems, with particular attention to primary care and services to those most in need.
No funds under subsection (b) of this section shall be used for capital construction.
(c) Advisory Council
The Secretary of Health and Human Services shall establish a "Pacific Health Advisory Council" which shall consist of 12 members and shall include—
(1) the Directors of the Health Departments for the entities identified in subsection (a) of this section; and
(2) 6 members, including a representative of the Rehabilitation Hospital of the Pacific, representing organizations in the State of Hawaii actively involved in the provision of health services or technical assistance to the entities identified in subsection (a) of this section. The Secretary shall solicit the advice of the Governor of the State of Hawaii in appointing the 5 Council members in addition to the representative of the Rehabilitation Hospital of the Pacific from the State of Hawaii.
The Secretary shall be responsible for providing sufficient staff support to the Council.
(d) Advisory Council functions
The Council shall meet at least annually to—
(1) recommend priority areas of need for funding by the Public Health Service under this section; and
(2) review progress in addressing priority areas and make recommendations to the Secretary for needed program modifications.
(e) Omitted
(f) Authorization of appropriation
There is authorized to be appropriated to carry out this section $10,000,000 for each of the fiscal years 1991 through 1993.
(
Codification
Section was enacted as part of the Disadvantaged Minority Health Improvement Act of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Subsec. (e) of this section, which required the Secretary, in consultation with the Council, to annually prepare and submit to appropriate committees of Congress a report describing the expenditure of funds authorized to be appropriated under this section, with any recommendations of the Secretary, terminated, effective May 15, 2000, pursuant to section 3003 of
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 sections 3(2) and 14 of
§254c–2. Special diabetes programs for type I diabetes
(a) In general
The Secretary, directly or through grants, shall provide for research into the prevention and cure of Type 1 I diabetes.
(b) Funding
(1) Transferred funds
Notwithstanding
(2) Appropriations
For the purpose of making grants under this section, there is appropriated, out of any funds in the Treasury not otherwise appropriated—
(A) $70,000,000 for each of fiscal years 2001 and 2002 (which shall be combined with amounts transferred under paragraph (1) for each such fiscal years); and
(B) $100,000,000 for fiscal year 2003.
(July 1, 1944, ch. 373, title III, §330B, as added
Amendments
2000—Subsec. (b).
1997—
Subsec. (a).
Effective Date of 1997 Amendment
Section 1604(f)(4) of
Report on Diabetes Grant Programs
Section 4923 of title IV of
"(a)
"(b)
"(1) an interim report on the evaluation conducted under subsection (a) not later than January 1, 2000, and
"(2) a final report on such evaluation not later than January 1, 2003."
1 So in original. Probably should not be capitalized.
§254c–3. Special diabetes programs for Indians
(a) In general
The Secretary shall make grants for providing services for the prevention and treatment of diabetes in accordance with subsection (b) of this section.
(b) Services through Indian health facilities
For purposes of subsection (a) of this section, services under such subsection are provided in accordance with this subsection if the services are provided through any of the following entities:
(1) The Indian Health Service.
(2) An Indian health program operated by an Indian tribe or tribal organization pursuant to a contract, grant, cooperative agreement, or compact with the Indian Health Service pursuant to the Indian Self-Determination Act [
(3) An urban Indian health program operated by an urban Indian organization pursuant to a grant or contract with the Indian Health Service pursuant to title V of the Indian Health Care Improvement Act [
(c) Funding
(1) Transferred funds
Notwithstanding
(2) Appropriations
For the purpose of making grants under this section, there is appropriated, out of any money in the Treasury not otherwise appropriated—
(A) $70,000,000 for each of fiscal years 2001 and 2002 (which shall be combined with amounts transferred under paragraph (1) for each such fiscal years); and
(B) $100,000,000 for fiscal year 2003.
(July 1, 1944, ch. 373, title III, §330C, as added
References in Text
The Indian Self-Determination Act, referred to in subsec. (b)(2), is title I of
The Indian Health Care Improvement Act, referred to in subsec. (b)(3), is
Amendments
2000—Subsec. (c).
1998—Subsec. (c).
§254c–4. Centers for strategies on facilitating utilization of preventive health services among various populations
(a) In general
The Secretary, acting through the appropriate agencies of the Public Health Service, shall make grants to public or nonprofit private entities for the establishment and operation of regional centers whose purpose is to develop, evaluate, and disseminate effective strategies, which utilize quality management measures, to assist public and private health care programs and providers in the appropriate utilization of preventive health care services by specific populations.
(b) Research and training
The activities carried out by a center under subsection (a) of this section may include establishing programs of research and training with respect to the purpose described in such subsection, including the development of curricula for training individuals in implementing the strategies developed under such subsection.
(c) Priority regarding infants and children
In carrying out the purpose described in subsection (a) of this section, the Secretary shall give priority to various populations of infants, young children, and their mothers.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2000 through 2004.
(July 1, 1944, ch. 373, title III, §330D, as added
§254c–5. Epilepsy; seizure disorder
(a) National public health campaign
(1) In general
The Secretary shall develop and implement public health surveillance, education, research, and intervention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children. Such projects may be carried out by the Secretary directly and through awards of grants or contracts to public or nonprofit private entities. The Secretary may directly or through such awards provide technical assistance with respect to the planning, development, and operation of such projects.
(2) Certain activities
Activities under paragraph (1) shall include—
(A) expanding current surveillance activities through existing monitoring systems and improving registries that maintain data on individuals with epilepsy, including children;
(B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
(C) implementing public and professional information and education programs regarding epilepsy, including initiatives which promote effective management of the disease through children's programs which are targeted to parents, schools, daycare providers, patients;
(D) undertaking educational efforts with the media, providers of health care, schools and others regarding stigmas and secondary disabilities related to epilepsy and seizures, and its effects on youth;
(E) utilizing and expanding partnerships with organizations with experience addressing the health and related needs of people with disabilities; and
(F) other activities the Secretary deems appropriate.
(3) Coordination of activities
The Secretary shall ensure that activities under this subsection are coordinated as appropriate with other agencies of the Public Health Service that carry out activities regarding epilepsy and seizure.
(b) Seizure disorder; demonstration projects in medically underserved areas
(1) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants for the purpose of carrying out demonstration projects to improve access to health and other services regarding seizures to encourage early detection and treatment in children and others residing in medically underserved areas.
(2) Application for grant
A grant may not be awarded under paragraph (1) unless an application therefore is submitted to the Secretary and the Secretary approves such application. Such application shall be submitted in such form and manner and shall contain such information as the Secretary may prescribe.
(c) Definitions
For purposes of this section:
(1) The term "epilepsy" refers to a chronic and serious neurological condition characterized by excessive electrical discharges in the brain causing recurring seizures affecting all life activities. The Secretary may revise the definition of such term to the extent the Secretary determines necessary.
(2) The term "medically underserved" has the meaning applicable under
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §330E, as added
§254c–6. Certain services for pregnant women
(a) Infant adoption awareness
(1) In general
The Secretary shall make grants to national, regional, or local adoption organizations for the purpose of developing and implementing programs to train the designated staff of eligible health centers in providing adoption information and referrals to pregnant women on an equal basis with all other courses of action included in nondirective counseling to pregnant women.
(2) Best-practices guidelines
(A) In general
A condition for the receipt of a grant under paragraph (1) is that the adoption organization involved agree that, in providing training under such paragraph, the organization will follow the guidelines developed under subparagraph (B).
(B) Process for development of guidelines
(i) In general
The Secretary shall establish and supervise a process described in clause (ii) in which the participants are—
(I) an appropriate number and variety of adoption organizations that, as a group, have expertise in all models of adoption practice and that represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
(II) affected public health entities.
(ii) Description of process
The process referred to in clause (i) is a process in which the participants described in such clause collaborate to develop best-practices guidelines on the provision of adoption information and referrals to pregnant women on an equal basis with all other courses of action included in nondirective counseling to pregnant women.
(iii) Date certain for development
The Secretary shall ensure that the guidelines described in clause (ii) are developed not later than 180 days after October 17, 2000.
(C) Relation to authority for grants
The Secretary may not make any grant under paragraph (1) before the date on which the guidelines under subparagraph (B) are developed.
(3) Use of grant
(A) In general
With respect to a grant under paragraph (1)—
(i) an adoption organization may expend the grant to carry out the programs directly or through grants to or contracts with other adoption organizations;
(ii) the purposes for which the adoption organization expends the grant may include the development of a training curriculum, consistent with the guidelines developed under paragraph (2)(B); and
(iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing training for the designated staff of eligible health centers, such organization will make reasonable efforts to ensure that the individuals who provide the training are individuals who are knowledgeable in all elements of the adoption process and are experienced in providing adoption information and referrals in the geographic areas in which the eligible health centers are located, and that the designated staff receive the training in such areas.
(B) Rule of construction regarding training of trainers
With respect to individuals who under a grant under paragraph (1) provide training for the designated staff of eligible health centers (referred to in this subparagraph as "trainers"), subparagraph (A)(iii) may not be construed as establishing any limitation regarding the geographic area in which the trainers receive instruction in being such trainers. A trainer may receive such instruction in a different geographic area than the area in which the trainer trains (or will train) the designated staff of eligible health centers.
(4) Adoption organizations; eligible health centers; other definitions
For purposes of this section:
(A) The term "adoption organization" means a national, regional, or local organization—
(i) among whose primary purposes are adoption;
(ii) that is knowledgeable in all elements of the adoption process and on providing adoption information and referrals to pregnant women; and
(iii) that is a nonprofit private entity.
(B) The term "designated staff", with respect to an eligible health center, means staff of the center who provide pregnancy or adoption information and referrals (or will provide such information and referrals after receiving training under a grant under paragraph (1)).
(C) The term "eligible health centers" means public and nonprofit private entities that provide health services to pregnant women.
(5) Training for certain eligible health centers
A condition for the receipt of a grant under paragraph (1) is that the adoption organization involved agree to make reasonable efforts to ensure that the eligible health centers with respect to which training under the grant is provided include—
(A) eligible health centers that receive grants under
(B) eligible health centers that receive grants under
(C) eligible health centers that receive grants under this chapter for the provision of services in schools.
(6) Participation of certain eligible health clinics
In the case of eligible health centers that receive grants under
(A) Within a reasonable period after the Secretary begins making grants under paragraph (1), the Secretary shall provide eligible health centers with complete information about the training available from organizations receiving grants under such paragraph. The Secretary shall make reasonable efforts to encourage eligible health centers to arrange for designated staff to participate in such training. Such efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective counseling to pregnant women.
(B) All costs of such centers in obtaining the training shall be reimbursed by the organization that provides the training, using grants under paragraph (1).
(C) Not later than 1 year after October 17, 2000, the Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which adoption information and referral, upon request, are provided by eligible health centers. Within a reasonable time after training under this section is initiated, the Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which adoption information and referral, upon request, are provided by eligible health centers in order to determine the effectiveness of such training and the extent to which such training complies with subsection (a)(1) of this section. In preparing the reports required by this subparagraph, the Secretary shall in no respect interpret the provisions of this section to allow any interference in the provider-patient relationship, any breach of patient confidentiality, or any monitoring or auditing of the counseling process or patient records which breaches patient confidentiality or reveals patient identity. The reports required by this subparagraph shall be conducted by the Secretary acting through the Administrator of the Health Resources and Services Administration and in collaboration with the Director of the Agency for Healthcare Research and Quality.
(b) Application for grant
The Secretary may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §330F, as added
§254c–7. Special needs adoption programs; public awareness campaign and other activities
(a) Special needs adoption awareness campaign
(1) In general
The Secretary shall, through making grants to nonprofit private entities, provide for the planning, development, and carrying out of a national campaign to provide information to the public regarding the adoption of children with special needs.
(2) Input on planning and development
In providing for the planning and development of the national campaign under paragraph (1), the Secretary shall provide for input from a number and variety of adoption organizations throughout the States in order that the full national diversity of interests among adoption organizations is represented in the planning and development of the campaign.
(3) Certain features
With respect to the national campaign under paragraph (1):
(A) The campaign shall be directed at various populations, taking into account as appropriate differences among geographic regions, and shall be carried out in the language and cultural context that is most appropriate to the population involved.
(B) The means through which the campaign may be carried out include—
(i) placing public service announcements on television, radio, and billboards; and
(ii) providing information through means that the Secretary determines will reach individuals who are most likely to adopt children with special needs.
(C) The campaign shall provide information on the subsidies and supports that are available to individuals regarding the adoption of children with special needs.
(D) The Secretary may provide that the placement of public service announcements, and the dissemination of brochures and other materials, is subject to review by the Secretary.
(4) Matching requirement
(A) In general
With respect to the costs of the activities to be carried out by an entity pursuant to paragraph (1), a condition for the receipt of a grant under such paragraph is that the entity agree to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs.
(B) Determination of amount contributed
Non-Federal contributions under subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions.
(b) National resources program
The Secretary shall (directly or through grant or contract) carry out a program that, through toll-free telecommunications, makes available to the public information regarding the adoption of children with special needs. Such information shall include the following:
(1) A list of national, State, and regional organizations that provide services regarding such adoptions, including exchanges and other information on communicating with the organizations. The list shall represent the full national diversity of adoption organizations.
(2) Information beneficial to individuals who adopt such children, including lists of support groups for adoptive parents and other postadoptive services.
(c) Other programs
With respect to the adoption of children with special needs, the Secretary shall make grants—
(1) to provide assistance to support groups for adoptive parents, adopted children, and siblings of adopted children; and
(2) to carry out studies to identify—
(A) the barriers to completion of the adoption process; and
(B) those components that lead to favorable long-term outcomes for families that adopt children with special needs.
(d) Application for grant
The Secretary may make an award of a grant or contract under this section only if an application for the award is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(e) Funding
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §330G, as added
§254c–8. Healthy start for infants
(a) In general
(1) Continuation and expansion of program
The Secretary, acting through the Administrator of the Health Resources and Services Administration, Maternal and Child Health Bureau, shall under authority of this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent years, carry out such program on a national basis.
(2) Definition
For purposes of paragraph (1), the term "Healthy Start Initiative" is a reference to the program that, as an initiative to reduce the rate of infant mortality and improve perinatal outcomes, makes grants for project areas with high annual rates of infant mortality and that, prior to the effective date of this section, was a demonstration program carried out under
(3) Additional grants
Effective upon increased funding beyond fiscal year 1999 for such Initiative, additional grants may be made to States to assist communities with technical assistance, replication of successful projects, and State policy formation to reduce infant and maternal mortality and morbidity.
(b) Requirements for making grants
In making grants under subsection (a) of this section, the Secretary shall require that applicants (in addition to meeting all eligibility criteria established by the Secretary) establish, for project areas under such subsection, community-based consortia of individuals and organizations (including agencies responsible for administering block grant programs under title V of the Social Security Act [
(c) Coordination
Recipients of grants under subsection (a) of this section shall coordinate their services and activities with the State agency or agencies that administer block grant programs under title V of the Social Security Act [
(d) Rule of construction
Except to the extent inconsistent with this section, this section may not be construed as affecting the authority of the Secretary to make modifications in the program carried out under subsection (a) of this section.
(e) Additional services for at-risk pregnant women and infants
(1) In general
The Secretary may make grants to conduct and support research and to provide additional health care services for pregnant women and infants, including grants to increase access to prenatal care, genetic counseling, ultrasound services, and fetal or other surgery.
(2) Eligible project area
The Secretary may make a grant under paragraph (1) only if the geographic area in which services under the grant will be provided is a geographic area in which a project under subsection (a) of this section is being carried out, and if the Secretary determines that the grant will add to or expand the level of health services available in such area to pregnant women and infants.
(3) Evaluation by General Accounting Office
(A) In general
During fiscal year 2004, the Comptroller General of the United States shall conduct an evaluation of activities under grants under paragraph (1) in order to determine whether the activities have been effective in serving the needs of pregnant women with respect to services described in such paragraph. The evaluation shall include an analysis of whether such activities have been effective in reducing the disparity in health status between the general population and individuals who are members of racial or ethnic minority groups. Not later than January 10, 2004, the Comptroller General shall submit to the Committee on Commerce in the House of Representatives, and to the Committee on Health, Education, Labor, and Pensions in the Senate, a report describing the findings of the evaluation.
(B) Relation to grants regarding additional services for at-risk pregnant women and infants
Before the date on which the evaluation under subparagraph (A) is submitted in accordance with such subparagraph—
(i) the Secretary shall ensure that there are not more than five grantees under paragraph (1); and
(ii) an entity is not eligible to receive grants under such paragraph unless the entity has substantial experience in providing the health services described in such paragraph.
(f) Funding
(1) General program
(A) Authorization of appropriations
For the purpose of carrying out this section (other than subsection (e) of this section), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(B) Allocations
(i) Program administration
Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for coordination, dissemination, technical assistance, and data activities that are determined by the Secretary to be appropriate for carrying out the program under this section.
(ii) Evaluation
Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 1 percent for evaluations of projects carried out under subsection (a) of this section. Each such evaluation shall include a determination of whether such projects have been effective in reducing the disparity in health status between the general population and individuals who are members of racial or ethnic minority groups.
(2) Additional services for at-risk pregnant women and infants
(A) Authorization of appropriations
For the purpose of carrying out subsection (e) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(B) Allocation for community-based mobile health units
Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary shall make available not less than 10 percent for providing services under subsection (e) of this section (including ultrasound services) through visits by mobile units to communities that are eligible for services under subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §330H, as added
References in Text
The effective date of this section, referred to in subsec. (a)(2), is the date of enactment of
The Social Security Act, referred to in subsecs. (b) and (c), is act Aug. 14, 1935, ch. 531,
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
§254c–9. Establishment of program of grants
(a) In general
The Secretary of Health and Human Services shall in accordance with
(b) Recipients of grants
A grant under subsection (a) of this section may be made to an entity only if the entity is a public or nonprofit private entity, which may include a State or local government; a public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, or homeless health center; or other appropriate public or nonprofit private entity.
(c) Certain activities
To the extent practicable and appropriate, the Secretary shall ensure that projects under subsection (a) of this section provide services for the diagnosis and disease management of lupus. Activities that the Secretary may authorize for such projects may also include the following:
(1) Delivering or enhancing outpatient, ambulatory, and home-based health and support services, including case management and comprehensive treatment services, for individuals with lupus; and delivering or enhancing support services for their families.
(2) Delivering or enhancing inpatient care management services that prevent unnecessary hospitalization or that expedite discharge, as medically appropriate, from inpatient facilities of individuals with lupus.
(3) Improving the quality, availability, and organization of health care and support services (including transportation services, attendant care, homemaker services, day or respite care, and providing counseling on financial assistance and insurance) for individuals with lupus and support services for their families.
(d) Integration with other programs
To the extent practicable and appropriate, the Secretary shall integrate the program under
(
Codification
Section was enacted as part of the Lupus Research and Care Amendments of 2000, and also as part of the Public Health Improvement Act, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§254c–10. Certain requirements
A grant may be made under
(1) Not more than 5 percent of the grant will be used for administration, accounting, reporting, and program oversight functions.
(2) The grant will be used to supplement and not supplant funds from other sources related to the treatment of lupus.
(3) The applicant will abide by any limitations deemed appropriate by the Secretary on any charges to individuals receiving services pursuant to the grant. As deemed appropriate by the Secretary, such limitations on charges may vary based on the financial circumstances of the individual receiving services.
(4) The grant will not be expended to make payment for services authorized under
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(5) The applicant will, at each site at which the applicant provides services under
(
Codification
Section was enacted as part of the Lupus Research and Care Amendments of 2000, and also as part of the Public Health Improvement Act, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§254c–11. Technical assistance
The Secretary may provide technical assistance to assist entities in complying with the requirements of
(
Codification
Section was enacted as part of the Lupus Research and Care Amendments of 2000, and also as part of the Public Health Improvement Act, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§254c–12. Definitions
For purposes of
(1) Official poverty line
The term "official poverty line" means the poverty line established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(2) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(
Codification
Section was enacted as part of the Lupus Research and Care Amendments of 2000, and also as part of the Public Health Improvement Act, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§254c–13. Authorization of appropriations
For the purpose of carrying out
(
Codification
Section was enacted as part of the Lupus Research and Care Amendments of 2000, and also as part of the Public Health Improvement Act, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
subpart ii—national health service corps program
Amendments
1976—
Subpart Referred to in Other Sections
This subpart is referred to in
§254d. National Health Service Corps
(a) Establishment; composition; purpose; definitions
(1) For the purpose of eliminating health manpower shortages in health professional shortage areas, there is established, within the Service, the National Health Service Corps, which shall consist of—
(A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate,
(B) such civilian employees of the United States as the Secretary may appoint, and
(C) such other individuals who are not employees of the United States.
(2) The Corps shall be utilized by the Secretary to provide primary health services in health professional shortage areas.
(3) For purposes of this subpart and subpart III:
(A) The term "Corps" means the National Health Service Corps.
(B) The term "Corps member" means each of the officers, employees, and individuals of which the Corps consists pursuant to paragraph (1).
(C) The term "health professional shortage area" has the meaning given such term in
(D) The term "primary health services" means health services regarding family medicine, internal medicine, pediatrics, obstetrics and gynecology, dentistry, or mental health, that are provided by physicians or other health professionals.
(b) Recruitment and fellowship programs
(1) The Secretary may conduct at schools of medicine, osteopathic medicine, dentistry, and, as appropriate, nursing and other schools of the health professions and at entities which train allied health personnel, recruiting programs for the Corps, the Scholarship Program, and the Loan Repayment Program. Such recruiting programs shall include efforts to recruit individuals who will serve in the Corps other than pursuant to obligated service under the Scholarship or Loan Repayment Program.
(2) In the case of physicians, dentists, certified nurse midwives, certified nurse practitioners, and physician assistants who have an interest and a commitment to providing primary health care, the Secretary may establish fellowship programs to enable such health professionals to gain exposure to and expertise in the delivery of primary health services in health professional shortage areas. To the maximum extent practicable, the Secretary shall ensure that any such programs are established in conjunction with accredited residency programs, and other training programs, regarding such health professions.
(c) Travel expenses; persons entitled; reimbursement; limitation
The Secretary may reimburse applicants for positions in the Corps (including individuals considering entering into a written agreement pursuant to
(d) Monthly pay adjustments of members directly engaged in delivery of health services in health professional shortage area; "monthly pay" defined; monthly pay adjustment of member with service obligation incurred under Scholarship Program or Loan Repayment Program; personnel system applicable
(1) The Secretary may, under regulations promulgated by the Secretary, adjust the monthly pay of each member of the Corps (other than a member described in subsection (a)(1)(C) of this section) who is directly engaged in the delivery of health services in a health professional shortage area as follows:
(A) During the first 36 months in which such a member is so engaged in the delivery of health services, his monthly pay may be increased by an amount which when added to the member's monthly pay and allowances will provide a monthly income competitive with the average monthly income from a practice of an individual who is a member of the profession of the Corps member, who has equivalent training, and who has been in practice for a period equivalent to the period during which the Corps member has been in practice.
(B) During the period beginning upon the expiration of the 36 months referred to in subparagraph (A) and ending with the month in which the member's monthly pay and allowances are equal to or exceed the monthly income he received for the last of such 36 months, the member may receive in addition to his monthly pay and allowances an amount which when added to such monthly pay and allowances equals the monthly income he received for such last month.
(C) For each month in which a member is directly engaged in the delivery of health services in a health professional shortage area in accordance with an agreement with the Secretary entered into under section 294n(f)(1)(C) 1 of this title, under which the Secretary is obligated to make payments in accordance with section 294n(f)(2) 1 of this title, the amount of any monthly increase under subparagraph (A) or (B) with respect to such member shall be decreased by an amount equal to one-twelfth of the amount which the Secretary is obligated to pay upon the completion of the year of practice in which such month occurs.
For purposes of subparagraphs (A) and (B), the term "monthly pay" includes special pay received under
(2) In the case of a member of the Corps who is directly engaged in the delivery of health services in a health professional shortage area in accordance with a service obligation incurred under the Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may be made for such a member only upon satisfactory completion of such service obligation, and the first 36 months of such member's being so engaged in the delivery of health services shall, for purposes of paragraph (1)(A), be deemed to begin upon such satisfactory completion.
(3) A member of the Corps described in subparagraph (C) of subsection (a)(1) of this section shall when assigned to an entity under
(e) Employment ceiling of Department not affected by Corps members
Corps members assigned under
(f) Assignment of personnel provisions inapplicable to members whose service obligation incurred under Scholarship Program or Loan Repayment Program
(g) Conversion from Corps member to commissioned officer; retirement credits
(1) The Secretary shall, by rule, prescribe conversion provisions applicable to any individual who, within a year after completion of service as a member of the Corps described in subsection (a)(1)(C) of this section, becomes a commissioned officer in the Regular or Reserve Corps of the Service.
(2) The rules prescribed under paragraph (1) shall provide that in applying the appropriate provisions of this chapter which relate to retirement, any individual who becomes such an officer shall be entitled to have credit for any period of service as a member of the Corps described in subsection (a)(1)(C) of this section.
(h) Effective administration of program
The Secretary shall ensure that adequate staff is provided to the Service with respect to effectively administering the program for the Corps.
(i) Definitions
For the purposes of this subpart and subpart III:
(1) The term "Department" means the Department of Health and Human Services.
(2) The term "Loan Repayment Program" means the National Health Service Corps Loan Repayment Program established under
(3) The term "Scholarship Program" means the National Health Service Corps Scholarship Program established under
(4) The term "State" includes, in addition to the several States, only the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands.
(July 1, 1944, ch. 373, title III, §331, as added
References in Text
Amendments
1990—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(1)(A).
Subsecs. (d)(2), (e).
Subsec. (h).
"(1) give priority to meeting the needs of the Indian Health Service and the needs of health programs or facilities operated by tribes or tribal organizations under the Indian Self-Determination Act (
"(2) provide special consideration to the homeless populations who do not have access to primary health care services."
Subsec. (i).
1988—Subsec. (b).
1987—Subsec. (b).
Subsec. (c).
Subsecs. (d)(2), (f).
Subsec. (h).
Subsec. (i).
1981—Subsec. (a)(1).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (g).
Subsec. (h).
Effective Date of 1990 Amendment
Section 501 of
Termination of Trust Territory of the Pacific Islands
For termination of Trust Territory of the Pacific Islands, see note set out preceding
Special Report on Present and Future Direction of National Health Service Corps; Submission to Congress Not Later Than February 1, 1979
Effective Date; Other Provisions: Health Manpower Shortage Area; Approval of Applications for Assignment of Corps Personnel; Assignment Period, Commencement; Credit for Months of Prior Health Care and Services for Additional Pay Benefit; National Advisory Council on the National Health Service Corps, Continuation of Council and Appointment of Members
Section 407(c) of
"(1) The amendment made by subsections (a) and (b) [enacting this subpart and repealing
"(2)(A) Any area for which a designation under section 329(b) of the Public Health Service Act (as in effect on September 30, 1977) [former
"(B) The assignment period (within the meaning of such section 334) [
"(C) In the case of any physician or dentist member of the Corps who was providing health care and services on September 30, 1977, under an assignment made under section 329(b) of such Act (as in effect on September 30, 1977) [former
"(3) The amendment made by subsection (b) which established an Advisory Council previously established under section 329 of the Public Health Service Act [former
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254e. Health professional shortage areas
(a) Designation by Secretary; removal from areas designated; "medical facility" defined
(1) For purposes of this subpart the term "health professional shortage area" means (A) an area in an urban or rural area (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the delivery of health services) which the Secretary determines has a health manpower shortage and which is not reasonably accessible to an adequately served area, (B) a population group which the Secretary determines has such a shortage, or (C) a public or nonprofit private medical facility or other public facility which the Secretary determines has such a shortage. The Secretary shall not remove an area from the areas determined to be health professional shortage areas under subparagraph (A) of the preceding sentence until the Secretary has afforded interested persons and groups in such area an opportunity to provide data and information in support of the designation as a health professional shortage area or a population group described in subparagraph (B) of such sentence or a facility described in subparagraph (C) of such sentence, and has made a determination on the basis of the data and information submitted by such persons and groups and other data and information available to the Secretary.
(2) For purposes of this subsection, the term "medical facility" means a facility for the delivery of health services and includes—
(A) a hospital, State mental hospital, public health center, outpatient medical facility, rehabilitation facility, facility for long-term care, community mental health center, migrant health center, facility operated by a city or county health department, and community health center;
(B) such a facility of a State correctional institution or of the Indian Health Service, and a health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act [
(C) such a facility used in connection with the delivery of health services under
(D) a Federal medical facility.
(3) Homeless individuals (as defined in section 256(r) 1 of this title) may be a population group under paragraph (1).
(b) Criteria for designation of health professional shortage areas; promulgation of regulations
The Secretary shall establish by regulation criteria for the designation of areas, population groups, medical facilities, and other public facilities, in the States, as health professional shortage areas. In establishing such criteria, the Secretary shall take into consideration the following:
(1) The ratio of available health manpower to the number of individuals in an area or population group, or served by a medical facility or other public facility under consideration for designation.
(2) Indicators of a need, notwithstanding the supply of health manpower, for health services for the individuals in an area or population group or served by a medical facility or other public facility under consideration for designation, with special consideration to indicators of—
(A) infant mortality,
(B) access to health services,
(C) health status, and
(D) ability to pay for health services.
(3) The percentage of physicians serving an area, population group, medical facility, or other public facility under consideration for designation who are employed by hospitals and who are graduates of foreign medical schools.
(c) Considerations in determination of designation
In determining whether to make a designation, the Secretary shall take into consideration the following:
(1) The recommendations of the Governor of each State in which the area, population group, medical facility, or other public facility under consideration for designation is in whole or part located.
(2) The extent to which individuals who are (A) residents of the area, members of the population group, or patients in the medical facility or other public facility under consideration for designation, and (B) entitled to have payment made for medical services under title XVIII or XIX of the Social Security Act [
(d) Designation; publication of descriptive lists
(1) In accordance with the criteria established under subsection (b) of this section and the considerations listed in subsection (c) of this section the Secretary shall designate health professional shortage areas in the States, publish a descriptive list of the areas, population groups, medical facilities, and other public facilities so designated, and at least annually review and, as necessary, revise such designations.
(2) For purposes of paragraph (1), a complete descriptive list shall be published in the Federal Register not later than July 1 of 1991 and each subsequent year.
(e) Notice of proposed designation of areas and facilities; time for comment
(1) Prior to the designation of a public facility, including a Federal medical facility, as a health professional shortage area, the Secretary shall give written notice of such proposed designation to the chief administrative officer of such facility and request comments within 30 days with respect to such designation.
(2) Prior to the designation of a health professional shortage area under this section, the Secretary shall, to the extent practicable, give written notice of the proposed designation of such area to appropriate public or private nonprofit entities which are located or have a demonstrated interest in such area and request comments from such entities with respect to the proposed designation of such area.
(f) Notice of designation
The Secretary shall give written notice of the designation of a health professional shortage area, not later than 60 days from the date of such designation, to—
(1) the Governor of each State in which the area, population group, medical facility, or other public facility so designated is in whole or part located; and
(2) appropriate public or nonprofit private entities which are located or which have a demonstrated interest in the area so designated.
(g) Recommendations to Secretary
Any person may recommend to the Secretary the designation of an area, population group, medical facility, or other public facility as a health professional shortage area.
(h) Public information programs in designated areas
The Secretary may conduct such information programs in areas, among population groups, and in medical facilities and other public facilities designated under this section as health professional shortage areas as may be necessary to inform public and nonprofit private entities which are located or have a demonstrated interest in such areas of the assistance available under this subchapter by virtue of the designation of such areas.
(July 1, 1944, ch. 373, title III, §332, as added
References in Text
The Indian Self-Determination Act, referred to in subsec. (a)(2)(B), is title I of
The Social Security Act, referred to in subsec. (c)(2), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 332 of act July 1, 1944, was renumbered section 340, and was classified to
Amendments
1990—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (b).
Subsec. (c).
"(A) The recommendations of each health systems agency (designated under
"(B) The recommendations of the State health planning and development agency (designated under
Subsec. (d).
Subsec. (e).
Subsec. (f).
"(A) each health systems agency (designated under
"(B) the State health planning and development agency of the State (designated under
Subsecs. (g), (h).
1988—Subsec. (a)(3).
1987—Subsec. (a)(1).
Subsec. (a)(3).
Subsec. (b)(2)(D).
1981—Subsec. (a)(1)(A).
Subsec. (a)(2)(C).
Subsec. (e).
Subsec. (h).
1979—Subsec. (a)(2)(C).
1977—Subsec. (c)(3).
Effective Date of 1988 Amendments
Section 631 of title VI of
Section 831 of title VIII of
Effective Date of 1981 Amendment
Amendment by section 986(b)(4) of
Effective Date of 1977 Amendment
Section 7(e)(1) of
Reference to Community, Migrant, Public Housing, or Homeless Health Center Considered Reference to Health Center
Reference to community health center, migrant health center, public housing health center, or homeless health center, considered reference to health center, see section 4(c) of
Evaluation of Criteria Used To Designate Health Manpower Shortage Areas; Report to Congress
Section 2702(c) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254f. Corps personnel
(a) Conditions necessary for assignment of Corps personnel to area; contents of application for assignment; assignment to particular facility; approval of applications
(1) The Secretary may assign members of the Corps to provide, under regulations promulgated by the Secretary, health services in or to a health professional shortage area during the assignment period (specified in the agreement described in
(A) a public or nonprofit private entity, which is located or has a demonstrated interest in such area makes application to the Secretary for such assignment;
(B) such application has been approved by the Secretary;
(C) an agreement has been entered into between the entity which has applied and the Secretary, in accordance with
(D) the Secretary has (i) conducted an evaluation of the need and demand for health manpower for the area, the intended use of Corps members to be assigned to the area, community support for the assignment of Corps members to the area, the area's efforts to secure health manpower for the area, and the fiscal management capability of the entity to which Corps members would be assigned and (ii) on the basis of such evaluation has determined that—
(I) there is a need and demand for health manpower for the area;
(II) there has been appropriate and efficient use of any Corps members assigned to the entity for the area;
(III) there is general community support for the assignment of Corps members to the entity;
(IV) the area has made unsuccessful efforts to secure health manpower for the area; and
(V) there is a reasonable prospect of sound fiscal management, including efficient collection of fee-for-service, third-party, and other appropriate funds, by the entity with respect to Corps members assigned to such entity.
An application for assignment of a Corps member to a health professional shortage area shall include a demonstration by the applicant that the area or population group to be served by the applicant has a shortage of personal health services and that the Corps member will be located so that the member will provide services to the greatest number of persons residing in such area or included in such population group. Such a demonstration shall be made on the basis of the criteria prescribed by the Secretary under
(2) Corps members may be assigned to a Federal health care facility, but only upon the request of the head of the department or agency of which such facility is a part.
(3) In approving applications for assignment of members of the Corps the Secretary shall not discriminate against applications from entities which are not receiving Federal financial assistance under this chapter.
(b) Corps member income assurances; grants respecting sufficiency of financial resources
(1) The Secretary may not approve an application for the assignment of a member of the Corps described in subparagraph (C) of
(2)(A) If in approving an application of an entity for the assignment of a member of the Corps described in subparagraph (C) of
(B) The amount of any grant under subparagraph (A) shall be determined by the Secretary. Payments under such a grant may be made in advance or by way of reimbursement, and at such intervals and on such conditions, as the Secretary finds necessary. No grant may be made unless an application therefor is submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such information, as the Secretary shall by regulation prescribe.
(c) Assignment of members without regard to ability of area to pay for services
The Secretary shall assign Corps members to entities in health professional shortage areas without regard to the ability of the individuals in such areas, population groups, medical facilities, or other public facilities to pay for such services.
(d) Entities entitled to aid; forms of assistance; coordination of efforts; agreements for assignment of Corps members; qualified entity
(1) The Secretary may provide technical assistance to a public or nonprofit private entity which is located in a health professional shortage area and which desires to make an application under this section for assignment of a Corps member to such area. Assistance provided under this paragraph may include assistance to an entity in (A) analyzing the potential use of health professions personnel in defined health services delivery areas by the residents of such areas, (B) determining the need for such personnel in such areas, (C) determining the extent to which such areas will have a financial base to support the practice of such personnel and the extent to which additional financial resources are needed to adequately support the practice, and (D) determining the types of inpatient and other health services that should be provided by such personnel in such areas.
(2) The Secretary may provide, to public and nonprofit private entities which are located in a health professional shortage area to which area a Corps member has been assigned, technical assistance to assist in the retention of such member in such area after the completion of such member's assignment to the area.
(3) The Secretary may provide, to health professional shortage areas to which no Corps member has been assigned, (A) technical assistance to assist in the recruitment of health manpower for such areas, and (B) current information on public and private programs which provide assistance in the securing of health manpower.
(4)(A) The Secretary shall undertake to demonstrate the improvements that can be made in the assignment of members of the Corps to health professional shortage areas and in the delivery of health care by Corps members in such areas through coordination with States, political subdivisions of States, agencies of States and political subdivisions, and other public and nonprofit private entities which have expertise in the planning, development, and operation of centers for the delivery of primary health care. In carrying out this subparagraph, the Secretary shall enter into agreements with qualified entities which provide that if—
(i) the entity places in effect a program for the planning, development, and operation of centers for the delivery of primary health care in health professional shortage areas which reasonably addresses the need for such care in such areas, and
(ii) under the program the entity will perform the functions described in subparagraph (B),
the Secretary will assign under this section members of the Corps in accordance with the program.
(B) For purposes of subparagraph (A), the term "qualified entity" means a State, political subdivision of a State, an agency of a State or political subdivision, or other public or nonprofit private entity operating solely within one State, which the Secretary determines is able—
(i) to analyze the potential use of health professions personnel in defined health services delivery areas by the residents of such areas;
(ii) to determine the need for such personnel in such areas and to recruit, select, and retain health professions personnel (including members of the National Health Service Corps) to meet such need;
(iii) to determine the extent to which such areas will have a financial base to support the practice of such personnel and the extent to which additional financial resources are needed to adequately support the practice;
(iv) to determine the types of inpatient and other health services that should be provided by such personnel in such areas;
(v) to assist such personnel in the development of their clinical practice and fee schedules and in the management of their practice;
(vi) to assist in the planning and development of facilities for the delivery of primary health care; and
(vii) to assist in establishing the governing bodies of centers for the delivery of such care and to assist such bodies in defining and carrying out their responsibilities.
(e) Practice within State by Corps member
Notwithstanding any other law, any member of the Corps licensed to practice medicine, osteopathic medicine, dentistry, or any other health profession in any State shall, while serving in the Corps, be allowed to practice such profession in any State.
(July 1, 1944, ch. 373, title III, §333, as added
Amendments
1990—Subsec. (a)(1).
Subsec. (a)(1)(D)(ii)(II).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
Subsecs. (j), (k).
1988—Subsec. (i).
1987—Subsec. (j).
Subsec. (k).
1981—Subsec. (a).
Subsec. (c).
Subsecs. (d) to (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
Effective Date of 1981 Amendment
Section 2703(d) of
Section Referred to in Other Sections
This section is referred to in
§254f–1. Priorities in assignment of Corps personnel
(a) In general
In approving applications made under
(1) give priority to any such application that—
(A) is made regarding the provision of primary health services to a health professional shortage area with the greatest such shortage, as determined in accordance with subsection (b) of this section; and
(B) is made by an entity that—
(i) serves a health professional shortage area described in subparagraph (A);
(ii) coordinates the delivery of primary health services with related health and social services;
(iii) has a documented record of sound fiscal management; and
(iv) will experience a negative impact on its capacity to provide primary health services if a Corps member is not assigned to the entity;
(2) with respect to the geographic area in which the health professional shortage area is located, take into consideration the willingness of individuals in the geographic area, and of the appropriate governmental agencies or health entities in the area, to assist and cooperate with the Corps in providing effective primary health services; and
(3) take into consideration comments of medical, osteopathic, dental, or other health professional societies whose members deliver services to the health professional shortage area, or if no such societies exist, comments of physicians, dentists, or other health professionals delivering services to the area.
(b) Exclusive factors for determining greatest shortages
In making a determination under subsection (a)(1)(A) of this section of the health professional shortage areas with the greatest such shortages, the Secretary may consider only the following factors:
(1) The ratio of available health manpower to the number of individuals in the area or population group involved, or served by the medical facility or other public facility involved.
(2) Indicators of need as follows:
(A) The rate of low birthweight births.
(B) The rate of infant mortality.
(C) The rate of poverty.
(D) Access to primary health services, taking into account the distance to such services.
(c) Establishment of criteria for determining priorities
(1) In general
The Secretary shall establish criteria specifying the manner in which the Secretary makes a determination under subsection (a)(1)(A) of this section of the health professional shortage areas with the greatest such shortages. Such criteria shall specify the manner in which the factors described in subsection (b) of this section are implemented regarding such a determination.
(2) Publication of criteria
The criteria required in paragraph (1) shall be published in the Federal Register not later than July 1, 1991. Any revisions made in the criteria by the Secretary shall be effective upon publication in the Federal Register.
(d) Notifications regarding priorities
(1) Preparation of list for applicable period
For the purpose of carrying out paragraph (2), the Secretary shall prepare a list of health professional shortage areas that are receiving priority under subsection (a)(1) of this section in the assignment of Corps members for the period applicable under subsection (f) of this section. Such list—
(A) shall include a specification, for each such health professional shortage area, of the entities for which the Secretary has provided an authorization to receive assignments of Corps members in the event that Corps members are available for the assignments; and
(B) shall, of the entities for which an authorization described in subparagraph (A) has been provided, specify—
(i) the entities provided such an authorization for the assignment of Corps members who are participating in the Scholarship Program;
(ii) the entities provided such an authorization for the assignment of Corps members who are participating in the Loan Repayment Program; and
(iii) the entities provided such an authorization for the assignment of Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs.
The Secretary may set forth such specifications by medical specialty.
(2) Notification of affected parties
(A) Not later than 30 days after the preparation of each list under paragraph (1), the Secretary shall notify entities specified for purposes of subparagraph (A) of such paragraph of the fact that the entities have been provided an authorization to receive assignments of Corps members in the event that Corps members are available for the assignments.
(B) In the case of individuals with respect to whom a period of obligated service under the Scholarship Program will begin during the period under subsection (f) of this section for which a list under paragraph (1) is prepared, the Secretary shall, not later than 30 days after the preparation of each such list, provide to such individuals the names of each of the entities specified for purposes of paragraph (1)(B)(i) that is appropriate to the medical specialty of the individuals.
(3) Revisions in list
If the Secretary makes a revision in a list under paragraph (1) during the period under subsection (f) of this section to which the list is applicable, and the revision alters the status of an entity with respect to the list, the Secretary shall notify the entity of the effect on the entity of the revision. Such notification shall be provided not later than 30 days after the date on which the revision is made.
(e) Limitation on number of entities offered as assignment choices in Scholarship Program
(1) Determination of available Corps members
The Secretary shall determine the number of participants in the Scholarship Program who are available for assignments under
(2) Availability of 500 or fewer members
If the number of participants for purposes of paragraph (1) is less than 500, the Secretary shall limit the number of entities specified under subsection (d)(1)(B)(i) of this section to the lesser of—
(A) 500 such entities; and
(B) a number of such entities constituting 300 percent of the number of such participants available for assignment under
(3) Availability of more than 500 members
If the number of participants for purposes of paragraph (1) is equal to or greater than 500, the Secretary shall determine the number of entities to be specified under subsection (d)(1)(B)(i) of this section, subject to ensuring that assignments of such participants are made to 500 entities that serve health professional shortage areas that have chronic difficulty in recruiting and retaining health professionals to provide primary health services.
(4) Adjustment in base number
The number 500, as used for purposes of paragraphs (2) and (3), may by regulation be adjusted by the Secretary to a greater or a lesser number.
(f) Applicable period regarding priorities
(1) In general
With respect to determinations under subsection (a)(1) of this section of the applications that are to be given priority regarding the assignment of Corps members, the Secretary shall make such a determination not less than once each fiscal year. The first determination shall be made not later than July 1 of the year preceding the year in which the period of obligated service begins. If the Secretary revises the determination before July 1 of the following year, the revised determination shall be applicable with respect to assignments of Corps members made during the period beginning on the date of the issuance of the revised determination and ending on July 1 of such year.
(2) Date certain for preparation of notification list
A list under subsection (d)(1) of this section shall be prepared for each of the periods decribed 1 in paragraph (1). Each such list shall be prepared not later than the date on which a determination of priorities under such paragraph is required to be made for the period involved.
(July 1, 1944, ch. 373, title III, §333A, as added and amended
Amendments
1990—
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "described".
§254g. Cost sharing
(a) Charges for services; collection of payments; payment to United States; calculation of payments; annual report
The Secretary shall require, as a condition to the approval of an application under
(1) the entity shall be responsible for charging, in accordance with subsection (d) of this section, for health services provided by Corps members assigned to the entity;
(2) the entity shall take such action as may be reasonable for the collection of payments for such health services, including, if a Federal agency, an agency of a State or local government, or other third party would be responsible for all or part of the cost of such health services if it had not been provided by Corps members under this subpart, the collection, on a fee-for-service or other basis, from such agency or third party, the portion of such cost for which it would be so responsible (and in determining the amount of such cost which such agency or third party would be responsible, the health services provided by Corps members shall be considered as being provided by private practitioners);
(3) the entity, if not a small health center, shall pay to the United States, as prescribed by the Secretary in each calendar quarter (or other period as may be specified in the agreement) during which any Corps member is assigned to such entity, the sum of—
(A) an amount calculated by the Secretary to reflect the average salary (including amounts paid in accordance with
(B) that portion of an amount calculated by the Secretary to reflect the average amount paid under the Scholarship Program or the Loan Repayment Program to or on behalf of comparable Corps members that bears the same ratio to the calculated amount as the number of days of service provided by the member during that quarter (or other period) bears to the number of days in his period of obligated service under the Scholarship Program or the Loan Repayment Program; and
(C) if such entity received a loan under
(4) the entity, if a small health center, shall pay to the United States, in each calendar quarter (or other period as may be specified in the agreement) during which any Corps member is assigned to such entity, an amount determined by the Secretary in accordance with subsection (f) of this section; and
(5) the entity shall prepare and submit to the Secretary an annual report, in such form and manner, as the Secretary may require.
(b) Waiver of payment; use of funds
(1) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of the requirement of subsection (a)(3) of this section for an entity which is not a small health center if he determines that the entity is financially unable to meet such requirement or if he determines that compliance with such requirement would unreasonably limit the ability of the entity to provide for the adequate support of the provision of health services by Corps members.
(2) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of the requirement of subsection (a)(3) of this section for any entity which is not a small health center and which is located in a health professional shortage area in which a significant percentage of the individuals are elderly, living in poverty, or have other characteristics which indicate an inability to repay, in whole or in part, the amounts required in subsection (a)(3) of this section.
(3) In the event that the Secretary grants a waiver under paragraph (1) or (2), and does not, pursuant to paragraph (5), require payment by the entity in the amount described in subsection (f)(1) of this section, the entity shall be required to use the total amount of funds collected by such entity in accordance with subsection (a)(2) of this section for the improvement of the capability of such entity to deliver health services to the individuals in, or served by, the health professional shortage area.
(4) In determining whether to grant a waiver under paragraph (1) or (2), the Secretary shall not discriminate against a public entity.
(5)(A) If the Secretary determines that an entity which is not a small health center is eligible for a waiver under paragraph (1) or (2), the Secretary may waive the application of subsection (a)(3) of this section for such entity and require such entity to make payment in an amount equal to the amount described in subsection (f)(1) of this section that would be payable by such entity if such entity were a small health center.
(B) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of the requirement of subparagraph (A) for any entity if the Secretary determines that the entity is financially unable to meet such requirement or that compliance with such requirement would unreasonably limit the ability of the entity to provide for the adequate support of the provision of health services by Corps members. Funds which would be paid to the United States but for a waiver under this subparagraph shall be used by an entity to—
(i) expand or improve its provision of health services;
(ii) increase the number of individuals served;
(iii) renovate or modernize facilities for its provision of health services;
(iv) improve the administration of its health service programs; or
(v) to establish a financial reserve to assure its ability to continue providing health services.
(c) Excess funds
The excess (if any) of the amount of funds collected by an entity which is not a small health center in accordance with subsection (a)(2) of this section over the amount paid to the United States in accordance with subsection (a)(3) of this section or subsection (b)(5)(A) of this section shall be used by the entity to expand and improve the provision of health services to the individuals in the health professional shortage area for which the entity submitted an application or to recruit and retain health manpower to provide health services for such individuals.
(d) Charge for services; reduced rate; no charge
Any person who receives health services provided by a Corps member under this subpart shall be charged for such services on a fee-for-service or other basis, at a rate approved by the Secretary, pursuant to regulations. Such rate shall be computed in such a way as to permit the recovery of the value of such services, except that if such person is determined under regulations of the Secretary to be unable to pay such charge, the Secretary shall provide for the furnishing of such services at a reduced rate or without charge.
(e) Deposit of funds in Treasury as miscellaneous receipts; appropriations unaffected
Funds received by the Secretary under an agreement entered into under this section shall be deposited in the Treasury as miscellaneous receipts and shall be disregarded in determining the amounts of appropriations to be requested and the amounts to be made available from appropriations made under
(f) Small health centers
(1) An entity which is a small health center shall pay to the United States, as prescribed by the Secretary in each calendar quarter (or other period as may be specified in the agreement) during which any Corps member is assigned to such entity, an amount equal to the amount (prorated for a calendar quarter or other period) by which the revenues that the center may reasonably expect to receive during an annual period for the provision of health services exceeds the costs that the center may reasonably expect to incur in the provision of such services, except that the amount that an entity shall pay to the United States under this paragraph shall not exceed the amount such entity would pay to the United States under paragraph (3) of subsection (a) of this section if such paragraph applied to such entity.
(2)(A) To determine for purposes of paragraph (1) the revenues and costs which an entity that is a small health center may reasonably be expected to receive and incur in an annual period for the provision of health services, the entity shall submit to the Secretary before the beginning of such period a proposed budget which—
(i) describes the primary and supplemental health services (as defined in section 254c 2 of this title) which are needed by the area the entity serves in such period; and
(ii) states the revenues and costs which the entity expects to receive and incur in providing such health services in such period.
(B) From the submission under subparagraph (A) and other information available to the Secretary, the Secretary shall determine—
(i) the primary and supplemental health services (as defined in section 254c 2 of this title) needed in the area the entity serves;
(ii) the fees, premiums, third party reimbursements, and other revenues the entity making the submission may reasonably expect to receive from the provision of such services; and
(iii) the costs which the entity may reasonably expect to incur in providing such services.
The revenues and costs determined by the Secretary shall be the revenues and costs used in making the determination under paragraph (1).
(C)(i) A determination under subparagraph (B) regarding the revenues and costs of an entity in an annual period shall be made by the Secretary utilizing criteria specific to the entity and shall be made without regard to whether the entity is making progress toward collecting sufficient revenues to provide an adequate level of primary health services without the assignment of Corps members.
(ii) In making a determination referred to in clause (i)—
(I) the Secretary may consider whether the proposed budget submitted under subparagraph (A) provides a reasonable estimate regarding the revenues and costs of the entity; and
(II) may not consider the reasonableness of the amount of revenues collected, or the amount of costs incurred by the entity, except to the extent necessary to ensure that the entity is operating in good faith and is operating efficiently with respect to fiscal matters within the control of the entity.
(iii) A determination of whether an entity is eligible for a waiver under paragraph (3) shall be made by the Secretary without regard to the revenues and costs determined by the Secretary under subparagraph (B).
(iv) A determination of whether an entity is a small health center shall be made by the Secretary without regard to the revenues and costs determined by the Secretary under subparagraph (B).
(3) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of paragraph (1) for an entity which is a small health center if the Secretary determines that the entity needs all or part of the amounts otherwise payable under such paragraph to—
(A) expand or improve its provision of health services;
(B) increase the number of individuals served;
(C) renovate or modernize facilities for its provision of health services;
(D) improve the administration of its health service programs; or
(E) establish a financial reserve to assure its ability to continue providing health services.
(4) The excess (if any) of the amount of funds collected by an entity which is a small health center in accordance with subsection (a)(2) of this section over the amount paid to the United States in accordance with paragraph (1) of this subsection shall be used by the center for the purposes set out in subparagraphs (A) through (E) of paragraph (3) of this subsection or to recruit and retain health manpower to provide health services to the individuals in the health professional shortage area for which the entity submitted an application.
(5) For purposes of this section, the term "small health center" means an entity other than—
(A) a hospital (or part of a hospital);
(B) a public entity; or
(C) an entity that is receiving a grant under section 254b 2 of this title or section 254c 2 of this title, except that such term includes an entity whose grant is less than the total of the amounts, calculated on an annual basis, specified in subparagraphs (A) and (B) of subsection (a)(3) of this section.
(July 1, 1944, ch. 373, title III, §334, as added
References in Text
Amendments
1990—Subsecs. (b)(2), (3), (c).
Subsec. (f)(2)(C).
Subsec. (f)(4).
1987—Subsec. (a)(3)(B).
1983—Subsec. (a)(3).
Subsec. (a)(4), (5).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(5).
Subsec. (c).
Subsec. (f).
1981—Subsec. (a).
Subsec. (b)(4).
Subsec. (e).
Effective Date of 1983 Amendment
Section 4 of
Congressional Findings
Section 2 of
"(1) rural health clinics are an important part of America's health care delivery system;
"(2) National Health Service Corps personnel assigned to rural health clinics located in health manpower shortage areas have provided valuable and needed staffing help for such clinics;
"(3) rural health clinics receiving assistance from National Health Service Corps personnel should be expected to reimburse the Federal Government for a reasonable share of the costs of such personnel; and
"(4) the criteria which should be applied to reimbursement by such clinics for use of such personnel should be a fair and equitable one which reflects the needs of such clinics and the populations served by such clinics, as well as the value of the services rendered by such personnel."
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 See References in Text note below.
§254h. Provision of health services by Corps members
(a) Means of delivery of services; cooperation with other health care providers
In providing health services in a health professional shortage area, Corps members shall utilize the techniques, facilities, and organizational forms most appropriate for the area, population group, medical facility, or other public facility, and shall, to the maximum extent feasible, provide such services (1) to all individuals in, or served by, such health professional shortage area regardless of their ability to pay for the services, and (2) in a manner which is cooperative with other health care providers serving such health professional shortage area.
(b) Utilization of existing health facilities; lease, acquisition, and use of equipment and supplies; permanent and temporary professional services
(1) Notwithstanding any other provision of law, the Secretary may (A) to the maximum extent feasible make such arrangements as he determines necessary to enable Corps members to utilize the health facilities in or serving the health professional shortage area in providing health services; (B) make such arrangements as he determines are necessary for the use of equipment and supplies of the Service and for the lease or acquisition of other equipment and supplies; and (C) secure the permanent or temporary services of physicians, dentists, nurses, administrators, and other health personnel. If there are no health facilities in or serving such area, the Secretary may arrange to have Corps members provide health services in the nearest health facilities of the Service or may lease or otherwise provide facilities in or serving such area for the provision of health services.
(2) If the individuals in or served by a health professional shortage area are being served (as determined under regulations of the Secretary) by a hospital or other health care delivery facility of the Service, the Secretary may, in addition to such other arrangements as he may make under paragraph (1), arrange for the utilization of such hospital or facility by Corps members in providing health services, but only to the extent that such utilization will not impair the delivery of health services and treatment through such hospital or facility to individuals who are entitled to health services and treatment through such hospital or facility.
(c) Loan; purposes; limitations
The Secretary may make one loan to any entity with an approved application under
(d) Property and equipment disposal; fair market value; sale at less than full market value
Upon the expiration of the assignment of all Corps members to a health professional shortage area, the Secretary may (notwithstanding any other provision of law) sell, to any appropriate local entity, equipment and other property of the United States utilized by such members in providing health services. Sales made under this subsection shall be made at the fair market value (as determined by the Secretary) of the equipment or such other property; except that the Secretary may make such sales for a lesser value to an appropriate local entity, if he determines that the entity is financially unable to pay the full market value.
(e) Admitting privileges denied to Corps member by hospital; notice and hearing; denial of Federal funds for violation; "hospital" defined
(1)(A) It shall be unlawful for any hospital to deny an authorized Corps member admitting privileges when such Corps member otherwise meets the professional qualifications established by the hospital for granting such privileges and agrees to abide by the published bylaws of the hospital and the published bylaws, rules, and regulations of its medical staff.
(B) Any hospital which is found by the Secretary, after notice and an opportunity for a hearing on the record, to have violated this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to be eligible to receive any Federal funds under this chapter or under titles XVIII or XIX of the Social Security Act [
(2) For purposes of this subsection, the term "hospital" includes a State or local public hospital, a private profit hospital, a private nonprofit hospital, a general or special hospital, and any other type of hospital (excluding a hospital owned or operated by an agency of the Federal Government), and any related facilities.
(July 1, 1944, ch. 373, title III, §335, as added
References in Text
The Social Security Act, referred to in subsec. (e)(1)(B), is act Aug. 14, 1935, ch. 531,
Amendments
1990—Subsecs. (a), (b)(1)(A), (2), (d).
Subsec. (e)(1)(A).
1981—Subsec. (a)(2).
Subsec. (c)(4).
Section Referred to in Other Sections
This section is referred to in
§254h–1. Facilitation of effective provision of Corps services
(a) Consideration of individual characteristics of members in making assignments
In making an assignment of a Corps member to an entity that has had an application approved under
(b) Counseling on service in Corps
(1) In general
The Secretary shall, subject to paragraph (3), offer appropriate counseling on service in the Corps to individuals during the period of membership in the Corps, particularly during the initial period of each assignment.
(2) Career advisor regarding obligated service
(A) In the case of individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, counseling under paragraph (1) shall include appropriate counseling on matters particular to such obligated service. The Secretary shall ensure that career advisors for providing such counseling are available to such individuals throughout the period of participation in the Scholarship or Loan Repayment Program.
(B) With respect to the Scholarship Program, counseling under paragraph (1) shall include counseling individuals during the period in which the individuals are pursuing an educational degree in the health profession involved, including counseling to prepare the individual for service in the Corps.
(3) Extent of counseling services
With respect to individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, this subsection shall be carried out regarding such individuals throughout the period of obligated service (and, additionally, throughout the period specified in paragraph (2)(B), in the case of the Scholarship Program). With respect to Corps members generally, this subsection shall be carried out to the extent practicable.
(c) Grants regarding preparation of students for practice
With respect to individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, the Secretary may make grants to, and enter into contracts with, public and nonprofit private entities (including health professions schools) for the conduct of programs designed to prepare such individuals for the effective provision of primary health services in the health manpower shortage areas to which the individuals are assigned.
(d) Assistance in establishing local professional relationships
The Secretary shall assist Corps members in establishing appropriate professional relationships between the Corps member involved and the health professions community of the geographic area with respect to which the member is assigned, including such relationships with hospitals, with health professions schools, with area health education centers under section 295g–1 1 of this title, with health education and training centers under such section, and with border health education and training centers under such section. Such assistance shall include assistance in obtaining faculty appointments at health professions schools.
(e) Temporary relief from Corps duties
(1) In general
The Secretary shall, subject to paragraph (4), provide assistance to Corps members in establishing arrangements through which Corps members may, as appropriate, be provided temporary relief from duties in the Corps in order to pursue continuing education in the health professions, to participate in exchange programs with teaching centers, to attend professional conferences, or to pursue other interests, including vacations.
(2) Assumption of duties of member
(A) Temporary relief under paragraph (1) may be provided only if the duties of the Corps member involved are assumed by another health professional. With respect to such temporary relief, the duties may be assumed by Corps members or by health professionals who are not Corps members, if the Secretary approves the professionals for such purpose. Any health professional so approved by the Secretary shall, during the period of providing such temporary relief, be deemed to be a Corps member for purposes of
(B) In carrying out paragraph (1), the Secretary shall provide for the formation and continued existence of a group of health professionals to provide temporary relief under such paragraph.
(3) Recruitment from general health professions community
In carrying out paragraph (1), the Secretary shall—
(A) encourage health professionals who are not Corps members to enter into arrangements under which the health professionals temporarily assume the duties of Corps members for purposes of paragraph (1); and
(B) with respect to the entities to which Corps members have been assigned under
(4) Limitation
In carrying out paragraph (1), the Secretary may not, except as provided in paragraph (5), obligate any amounts (other than for incidental expenses) for the purpose of—
(A) compensating a health professional who is not a Corps member for assuming the duties of a Corps member; or
(B) paying the costs of a vacation, or other interests that a Corps member may pursue during the period of temporary relief under such paragraph.
(5) Sole providers of health services
In the case of any Corps member who is the sole provider of health services in the geographic area involved, the Secretary may, from amounts appropriated under
(f) Determinations regarding effective service
In carrying out subsection (a) of this section and
(1) the characteristics of physicians, dentists, and other health professionals who are more likely to remain in practice in health manpower shortage areas after the completion of the period of service in the Corps;
(2) the characteristics of health manpower shortage areas, and of entities seeking assignments of Corps members, that are more likely to retain Corps members after the members have completed the period of service in the Corps; and
(3) the appropriate conditions for the assignment and utilization in health manpower shortage areas of certified nurse practitioners, certified nurse midwives, and physician assistants.
(July 1, 1944, ch. 373, title III, §336, as added
References in Text
Prior Provisions
A prior section 336 of act July 1, 1944, was renumbered section 336A by
Amendments
1990—
"(a) The Secretary may make grants to and enter into contracts with public and private nonprofit entities for the conduct of programs which are designed to prepare individuals subject to a service obligation under the National Health Service Corps Scholarship Program or Loan Repayment Program to effectively provide health services in the health manpower shortage area to which they are assigned.
"(b) No grant may be made or contract entered into under subsection (a) of this section unless an application therefor is submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such information, as the Secretary shall by regulation prescribe."
Subsec. (a).
1987—Subsec. (a).
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254i. Annual report to Congress; contents
The Secretary shall submit an annual report to Congress, and shall include in such report with respect to the previous calendar year—
(1) the number, identity, and priority of all health professional shortage areas designated in such year and the number of health professional shortage areas which the Secretary estimates will be designated in the subsequent year;
(2) the number of applications filed under
(3) the number and types of Corps members assigned in such year to health professional shortage areas, the number and types of additional Corps members which the Secretary estimates will be assigned to such areas in the subsequent year, and the need for additional members for the Corps;
(4) the recruitment efforts engaged in for the Corps in such year and the number of qualified individuals who applied for service in the Corps in such year;
(5) the number of patients seen and the number of patient visits recorded during such year with respect to each health professional shortage area to which a Corps member was assigned during such year;
(6) the number of Corps members who elected, and the number of Corps members who did not elect, to continue to provide health services in health professional shortage areas after termination of their service in the Corps and the reasons (as reported to the Secretary) of members who did not elect for not making such election;
(7) the results of evaluations and determinations made under
(8) the amount charged during such year for health services provided by Corps members, the amount which was collected in such year by entities in accordance with agreements under
(July 1, 1944, ch. 373, title III, §336A, formerly §336, as added
Amendments
1990—Pars. (1), (3), (5), (6).
1982—
Section Referred to in Other Sections
This section is referred to in
§254j. National Advisory Council on National Health Service Corps
(a) Establishment; appointment of members
There is established a council to be known as the National Advisory Council on the National Health Service Corps (hereinafter in this section referred to as the "Council"). The Council shall be composed of not more than 15 members appointed by the Secretary. The Council shall consult with, advise, and make recommendations to, the Secretary with respect to his responsibilities in carrying out this subpart (other than section 254r 1 of this title), and shall review and comment upon regulations promulgated by the Secretary under this subpart.
(b) Term of members; compensation; expenses
(1) Members of the Council shall be appointed for a term of three years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term. No member shall be removed, except for cause. Members may not be reappointed to the Council.
(2) Members of the Council (other than members who are officers or employees of the United States), while attending meetings or conferences thereof or otherwise serving on the business of the Council, shall be entitled to receive for each day (including traveltime) in which they are so serving compensation at a rate fixed by the Secretary (but not to exceed the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule); and while so serving away from their homes or regular places of business all members may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by
(c) Termination
Section 14 of the Federal Advisory Committee Act shall not apply with respect to the Council.
(July 1, 1944, ch. 373, title III, §337, as added
References in Text
Section 14 of the Federal Advisory Committee Act, referred to in subsec. (c), is section 14 of
Amendments
1993—Subsec. (b)(2).
1983—Subsec. (a).
1981—Subsec. (a).
Subsec. (b)(1).
1979—Subsec. (b)(2).
Termination of Advisory Committees
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
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254k. Authorization of appropriations
(a)(1) For the purpose of carrying out this subpart, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 2000.
(2) In the case of individuals who serve in the Corps other than pursuant to obligated service under the Scholarship or Loan Repayment Program, the Secretary each fiscal year shall, to the extent practicable, make assignments under
(b) An appropriation under an authorization under subsection (a) of this section for any fiscal year may be made at any time before that fiscal year and may be included in an Act making an appropriation under an authorization under subsection (a) of this section for another fiscal year; but no funds may be made available from any appropriation under such authorization for obligation under sections 254d through 254h, section 254i, and
(July 1, 1944, ch. 373, title III, §338, as added
Amendments
1990—Subsec. (a).
1987—Subsec. (a).
1981—Subsec. (a).
Subsec. (b).
1979—Subsec. (a).
1978—Subsec. (a).
Section Referred to in Other Sections
This section is referred to in
subpart iii—scholarship program and loan repayment program
Amendments
1987—
Subpart Referred to in Other Sections
This subpart is referred to in
§254l. National Health Service Corps Scholarship Program
(a) Establishment
The Secretary shall establish the National Health Service Corps Scholarship Program to assure, with respect to the provision of primary health services pursuant to
(1) an adequate supply of physicians, dentists, certified nurse midwives, certified nurse practitioners, and physician assistants; and
(2) if needed by the Corps, an adequate supply of other health professionals.
(b) Eligibility; application; written contract
To be eligible to participate in the Scholarship Program, an individual must—
(1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by the Secretary) educational institution in a State and (B) in a course of study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps;
(3) submit an application to participate in the Scholarship Program; and
(4) sign and submit to the Secretary, at the time of submittal of such application, a written contract (described in subsection (f) of this section) to accept payment of a scholarship and to serve (in accordance with this subpart) for the applicable period of obligated service in a health professional shortage area.
(c) Review and evaluation of information and forms by prospective applicant
(1) In disseminating application forms and contract forms to individuals desiring to participate in the Scholarship Program, the Secretary shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose contract is accepted) by the Secretary, including in the summary a clear explanation of the damages to which the United States is entitled under section 254o 1 of this title in the case of the individual's breach of the contract; and
(B) information respecting meeting a service obligation through private practice under an agreement under section 254n 1 of this title and such other information as may be necessary for the individual to understand the individual's prospective participation in the Scholarship Program and service in the Corps, including a statement of all factors considered in approving applications for participation in the Program and in making assignments for participants in the Program.
(2) The application form, contract form, and all other information furnished by the Secretary under this subpart shall be written in a manner calculated to be understood by the average individual applying to participate in the Scholarship Program. The Secretary shall make such application forms, contract forms, and other information available to individuals desiring to participate in the Scholarship Program on a date sufficiently early to insure that such individuals have adequate time to carefully review and evaluate such forms and information.
(3)(A) The Secretary shall distribute to health professions schools materials providing information on the Scholarship Program and shall encourage the schools to disseminate the materials to the students of the schools.
(B)(i) In the case of any health professional whose period of obligated service under the Scholarship Program is nearing completion, the Secretary shall encourage the individual to remain in a health professional shortage area and to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to private practice from obligated service under the Scholarship Program, the Secretary may provide assistance to the professional regarding such transition if the professional is remaining in a health professional shortage area and is continuing to provide primary health services.
(C) In the case of entities to which participants in the Scholarship Program are assigned under
(d) Factors considered in providing contracts; priorities
(1) Subject to
(A) the Secretary shall consider the extent of the demonstrated interest of the applicants for the contracts in providing primary health services; and
(B) may consider such other factors regarding the applicants as the Secretary determines to be relevant to selecting qualified individuals to participate in such Program.
(2) In providing contracts under the Scholarship Program, the Secretary shall give priority—
(A) first, to any application for such a contract submitted by an individual who has previously received a scholarship under this section or under section 294z 1 of this title;
(B) second, to any application for such a contract submitted by an individual who has characteristics that increase the probability that the individual will continue to serve in a health professional shortage area after the period of obligated service pursuant to subsection (f) of this section is completed; and
(C) third, subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a disadvantaged background.
(e) Commencement of participation in Scholarship Program; notice
(1) An individual becomes a participant in the Scholarship Program only upon the Secretary's approval of the individual's application submitted under subsection (b)(3) of this section and the Secretary's acceptance of the contract submitted by the individual under subsection (b)(4) of this section.
(2) The Secretary shall provide written notice to an individual promptly upon the Secretary's approving, under paragraph (1), of the individual's participation in the Scholarship Program.
(f) Written contract; contents
The written contract (referred to in this subpart) between the Secretary and an individual shall contain—
(1) an agreement that—
(A) subject to paragraph (2), the Secretary agrees (i) to provide the individual with a scholarship (described in subsection (g) of this section) in each such school year or years for a period of years (not to exceed four school years) determined by the individual, during which period the individual is pursuing a course of study described in subsection (b)(1)(B) of this section, and (ii) to accept (subject to the availability of appropriated funds for carrying out sections 254d through 254h and
(B) subject to paragraph (2), the individual agrees—
(i) to accept provision of such a scholarship to the individual;
(ii) to maintain enrollment in a course of study described in subsection (b)(1)(B) of this section until the individual completes the course of study;
(iii) while enrolled in such course of study, to maintain an acceptable level of academic standing (as determined under regulations of the Secretary by the educational institution offering such course of study); and
(iv) to serve for a time period (hereinafter in the subpart referred to as the "period of obligated service") equal to—
(I) one year for each school year for which the individual was provided a scholarship under the Scholarship Program, or
(II) two years,
whichever is greater, as a provider of primary health services in a health professional shortage area (designated under
(2) a provision that any financial obligation of the United States arising out of a contract entered into under this subpart and any obligation of the individual which is conditioned thereon, is contingent upon funds being appropriated for scholarships under this subpart and to carry out the purposes of sections 254d through 254h and
(3) a statement of the damages to which the United States is entitled, under section 254o 2 of this title, for the individual's breach of the contract; and
(4) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with the provisions of this subpart.
(g) Scholarship provisions; contract with educational institution; increase in monthly stipend
(1) A scholarship provided to a student for a school year under a written contract under the Scholarship Program shall consist of—
(A) payment to, or (in accordance with paragraph (2)) on behalf of, the student of the amount (except as provided in section 292k 2 of this title) of—
(i) the tuition of the student in such school year; and
(ii) all other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the student in such school year; and
(B) payment to the student of a stipend of $400 per month (adjusted in accordance with paragraph (3)) for each of the 12 consecutive months beginning with the first month of such school year.
(2) The Secretary may contract with an educational institution, in which a participant in the Scholarship Program is enrolled, for the payment to the educational institution of the amounts of tuition and other reasonable educational expenses described in paragraph (1)(A). Payment to such an educational institution may be made without regard to section 3324(a) and (b) of title 31.
(3) The amount of the monthly stipend, specified in paragraph (1)(B) and as previously adjusted (if at all) in accordance with this paragraph, shall be increased by the Secretary for each school year ending in a fiscal year beginning after September 30, 1978, by an amount (rounded to the next highest multiple of $1) equal to the amount of such stipend multiplied by the overall percentage (under
(h) Employment ceiling of Department unaffected
Notwithstanding any other provision of law, individuals who have entered into written contracts with the Secretary under this section, while undergoing academic training, shall not be counted against any employment ceiling affecting the Department.
(i) Omitted
(July 1, 1944, ch. 373, title III, §338A, formerly title VII, §751, as added
References in Text
Codification
In subsec. (g)(2), "section 3324(a) and (b) of title 31" substituted for "section 3648 of the Revised Statutes (
Subsec. (i) of this section, which required the Secretary to submit an annual report to Congress on the Scholarship Program, terminated, effective May 15, 2000, pursuant to section 3003 of
Section was formerly classified to
Amendments
1990—Subsec. (a).
Subsec. (b)(4).
Subsec. (c).
Subsec. (d).
"(1) first, to applications made (and contracts submitted) by individuals who have previously received scholarships under the Scholarship Program or under
"(2) second, to applications made (and contracts submitted)—
"(A) for the school year beginning in calendar year 1978, by individuals who are entering their first, second, or third year of study in a course of study or program described in subsection (b)(1)(B) of this section in such school year;
"(B) for the school year beginning in calendar year 1979, by individuals who are entering their first or second year of study in a course of study or program described in subsection (b)(1)(B) of this section in such school year; and
"(C) for each school year thereafter, by individuals who are entering their first year of study in a course of study or program described in subsection (b)(1)(B) of this section in such school year."
Subsec. (f)(1)(B)(iv).
Subsec. (g)(3).
Subsec. (i).
Subsec. (i)(4), (5).
Subsec. (i)(6).
1988—Subsec. (b)(1).
1985—Subsec. (g)(1).
1981—Subsec. (a).
Subsec. (c).
Subsec. (f).
Subsec. (j).
1979—Subsec. (g)(3).
1978—Subsec. (f).
Subsec. (i).
1977—Subsec. (d)(2).
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1985 Amendment
Section 228 of
"(a) Except as provided in subsection (b), this Act and the amendments and repeals made by this Act [enacting
"(b)(1) The amendments made by section 101(a) of this Act [amending
"(2) The amendments made by section 208(e) of this Act [amending
"(3) The amendment made by section 208(h) of this Act [amending
"(4) The provisions of section 746 of the Public Health Service Act (as added by the amendment made by section 209(h)(2) of this Act) [
"(5) The amendments made by section 209(j) of this Act [amending
"(6) The amendments made by section 213(a) of this Act [amending
Effective Date of 1977 Amendment
Section 5 of
Effective Date
Section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
Section 408(b)(2) of
"(A) Except as provided in subparagraphs (B) and (C), the amendment made by paragraph (1) of this subsection [enacting this section and
"(B) The provisions of section 225(f)(1) of the Public Health Service Act (as in effect on September 30, 1977) [former
"(C) If an individual received a scholarship under the Public Health and National Health Service Corps Scholarship Program for any school year beginning before the date of the enactment of this Act [Oct. 12, 1976], periods of internship or residency served by such individual in a facility of the National Health Service Corps or other facility of the Public Health Service shall be creditable in satisfying such individual's service obligation incurred under that Program for such scholarship or for any scholarship received under the National Health Service Corps Scholarship Program for any subsequent school year. If an individual received a scholarship under the Public Health and National Health Service Corps Program for the first time from appropriations for such Program for the fiscal year ending September 30, 1977, periods of internship or residency served by such individual in such a facility shall be creditable in satisfying such individual's service obligation incurred under that Program for such scholarship."
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 See References in Text note below.
§254l–1. National Health Service Corps Loan Repayment Program
(a) Establishment
The Secretary shall establish a program to be known as the National Health Service Corps Loan Repayment Program to assure, with respect to the provision of primary health services pursuant to
(1) an adequate supply of physicians, dentists, certified nurse midwives, certified nurse practitioners, and physician assistants; and
(2) if needed by the Corps, an adequate supply of other health professionals (including mental health professionals).
(b) Eligibility
To be eligible to participate in the Loan Repayment Program, an individual must—
(1)(A) must 1 have a degree in medicine, osteopathic medicine, dentistry, or other health profession, or be certified as a nurse midwife, nurse practioner,2 or physician assistant;
(B) be enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, behavioral and mental health, or other health profession; or
(C) be enrolled as a full-time student—
(i) in an accredited (as determined by the Secretary) educational institution in a State; and
(ii) in the final year of a course of a study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps; and
(3) submit to the Secretary an application for a contract described in subsection (f) of this section (relating to the payment by the Secretary of the educational loans of the individual in consideration of the individual serving for a period of obligated service).
(c) Information to be included with application and contract forms; understandability; availability
(1) Summary and information
In disseminating application forms and contract forms to individuals desiring to participate in the Loan Repayment Program, the Secretary shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose contract is accepted) by the Secretary, including in the summary a clear explanation of the damages to which the United States is entitled under
(B) information respecting meeting a service obligation through private practice under an agreement under
(2) Understandability
The application form, contract form, and all other information furnished by the Secretary under this subpart shall be written in a manner calculated to be understood by the average individual applying to participate in the Loan Repayment Program.
(3) Availability
The Secretary shall make such application forms, contract forms, and other information available to individuals desiring to participate in the Loan Repayment Program on a date sufficiently early to ensure that such individuals have adequate time to carefully review and evaluate such forms and information.
(4) Recruitment and retention
(A) The Secretary shall distribute to health professions schools materials providing information on the Loan Repayment Program and shall encourage the schools to disseminate the materials to the students of the schools.
(B)(i) In the case of any health professional whose period of obligated service under the Loan Repayment Program is nearing completion, the Secretary shall encourage the individual to remain in a health professional shortage area and to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to private practice from obligated service under the Loan Repayment Program, the Secretary may provide assistance to the professional regarding such transition if the professional is remaining in a health professional shortage area and is continuing to provide primary health services.
(C) In the case of entities to which participants in the Loan Repayment Program are assigned under
(d) Factors considered in providing contracts; priorities
(1) Subject to
(A) the Secretary shall consider the extent of the demonstrated interest of the applicants for the contracts in providing primary health services; and
(B) may consider such other factors regarding the applicants as the Secretary determines to be relevant to selecting qualified individuals to participate in such Program.
(2) In providing contracts under the Loan Repayment Program, the Secretary shall give priority—
(A) to any application for such a contract submitted by an individual whose training is in a health profession or specialty determined by the Secretary to be needed by the Corps;
(B) to any application for such a contract submitted by an individual who has (and whose spouse, if any, has) characteristics that increase the probability that the individual will continue to serve in a health professional shortage area after the period of obligated service pursuant to subsection (f) of this section is completed; and
(C) subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a disadvantaged background.
(e) Approval required for participation
(1) In general
An individual becomes a participant in the Loan Repayment Program only upon the Secretary and the individual entering into a written contract described in subsection (f) of this section.
(2) Repealed. Pub. L. 101–597, title II, §202(b)(2)(B), Nov. 16, 1990, 104 Stat. 3024
(f) Contents of contracts
The written contract (referred to in this subpart) between the Secretary and an individual shall contain—
(1) an agreement that—
(A) subject to paragraph (3), the Secretary agrees—
(i) to pay on behalf of the individual loans in accordance with subsection (g) of this section; and
(ii) to accept (subject to the availability of appropriated funds for carrying out
(B) subject to paragraph (3), the individual agrees—
(i) to accept loan payments on behalf of the individual;
(ii) in the case of an individual described in subsection (b)(1)(C) of this section, to maintain enrollment in a course of study or training described in such subsection until the individual completes the course of study or training;
(iii) in the case of an individual described in subsection (b)(1)(C) of this section, while enrolled in such course of study or training, to maintain an acceptable level of academic standing (as determined under regulations of the Secretary by the educational institution offering such course of study or training); and
(iv) to serve for a time period (hereinafter in this subpart referred to as the "period of obligated service") equal to 2 years or such longer period as the individual may agree to, as a provider of primary health services in a health professional shortage area (designated under
(2) a provision permitting the Secretary to extend for such longer additional periods, as the individual may agree to, the period of obligated service agreed to by the individual under paragraph (1)(B)(iv), including extensions resulting in an aggregate period of obligated service in excess of 4 years;
(3) a provision that any financial obligation of the United States arising out of a contract entered into under this subpart and any obligation of the individual that is conditioned thereon, is contingent on funds being appropriated for loan repayments under this subpart and to carry out the purposes of
(4) a statement of the damages to which the United States is entitled, under
(5) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with this subpart.
(g) Payments
(1) In general
A loan repayment provided for an individual under a written contract under the Loan Repayment Program shall consist of payment, in accordance with paragraph (2), on behalf of the individual of the principal, interest, and related expenses on government and commercial loans received by the individual regarding the undergraduate or graduate education of the individual (or both), which loans were made for—
(A) tuition expenses;
(B) all other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the individual; or
(C) reasonable living expenses as determined by the Secretary.
(2) Payments for years served
(A) In general
For each year of obligated service that an individual contracts to serve under subsection (f) of this section the Secretary may pay up to $35,000 on behalf of the individual for loans described in paragraph (1). In making a determination of the amount to pay for a year of such service by an individual, the Secretary shall consider the extent to which each such determination—
(i) affects the ability of the Secretary to maximize the number of contracts that can be provided under the Loan Repayment Program from the amounts appropriated for such contracts;
(ii) provides an incentive to serve in health professional shortage areas with the greatest such shortages; and
(iii) provides an incentive with respect to the health professional involved remaining in a health professional shortage area, and continuing to provide primary health services, after the completion of the period of obligated service under the Loan Repayment Program.
(B) Repayment schedule
Any arrangement made by the Secretary for the making of loan repayments in accordance with this subsection shall provide that any repayments for a year of obligated service shall be made no later than the end of the fiscal year in which the individual completes such year of service.
(3) Tax liability
For the purpose of providing reimbursements for tax liability resulting from payments under paragraph (2) on behalf of an individual—
(A) the Secretary shall, in addition to such payments, make payments to the individual in an amount equal to 39 percent of the total amount of loan repayments made for the taxable year involved; and
(B) may make such additional payments as the Secretary determines to be appropriate with respect to such purpose.
(4) Payment schedule
The Secretary may enter into an agreement with the holder of any loan for which payments are made under the Loan Repayment Program to establish a schedule for the making of such payments.
(h) Employment ceiling
Notwithstanding any other provision of law, individuals who have entered into written contracts with the Secretary under this section, while undergoing academic or other training, shall not be counted against any employment ceiling affecting the Department.
(July 1, 1944, ch. 373, title III, §338B, as added
Codification
Subsec. (i) of this section, which required the Secretary to submit not later than Mar. 1 of each year a report to Congress providing, with respect to the preceding fiscal year, information about the Loan Repayment Program, terminated, effective May 15, 2000, pursuant to section 3003 of
Prior Provisions
A prior section 338B of act July 1, 1944, was renumbered section 338C by section 201(2) of
Amendments
1998—Subsec. (b)(1)(B).
1990—Subsec. (a).
"(1) an adequate supply of trained physicians, dentists, and nurses for the Corps; and
"(2) if needed by the Corps, an adequate supply of podiatrists, optometrists, pharmacists, clinical psychologists, graduates of schools of veterinary medicine, graduates of schools of public health, graduates of programs in health administration, graduates of programs for the training of physician assistants, expanded function dental auxiliaries, and nurse practitioners (as defined in
Subsec. (b)(1).
"(A) be enrolled—
"(i) as a full-time student—
"(I) in an accredited (as determined by the Secretary) educational institution in a State; and
"(II) in the final year of a course of study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession; or
"(ii) in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession; or
"(B) have—
"(i) a degree in medicine, osteopathic medicine, dentistry, or other health profession;
"(ii) completed an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession in a State, except that the Secretary may waive the completion requirement of this clause for good cause; and
"(iii) a license to practice medicine, osteopathic medicine, dentistry, or other health profession in a State;".
Subsec. (b)(2) to (4).
"(3) submit an application to participate in the Loan Repayment Program; and
"(4) sign and submit to the Secretary, at the time of the submission of such application, a written contract (described in subsection (f) of this section) to accept repayment of educational loans and to serve (in accordance with this subpart) for the applicable period of obligated service in a health manpower shortage area."
Subsec. (c)(4).
Subsec. (d).
"(1) individuals whose training is in a health profession or specialty determined by the Secretary to be needed by the Corps; and
"(2) individuals who are committed to service in medically underserved areas."
Subsec. (e).
"(A) the Secretary's approving, under paragraph (1), of the individual's participation in the Loan Repayment Program; or
"(B) the Secretary's disapproving an individual's participation in such Program."
Subsec. (f)(1)(B)(ii), (iii).
Subsec. (f)(1)(B)(iv).
Subsec. (f)(2).
Subsec. (g)(1).
Subsec. (g)(2)(A).
Subsec. (g)(2)(B), (C).
Subsec. (g)(3).
Subsec. (i).
"(1) the number, and type of health profession training, of individuals receiving loan payments under the Loan Repayment Program;
"(2) the educational institution at which such individuals are receiving their training;
"(3) the number of applications filed under this section in the school year beginning in such year and in prior school years; and
"(4) the amount of loan payments made in the year reported on."
1988—Subsec. (b)(1).
Effective Date of 1990 Amendment
Section 202(g)(2) of
Regulations
Section 205 of title II of
Section Referred to in Other Sections
This section is referred to in
1 So in original. The word "must" probably should not appear.
2 So in original. Probably should be "practitioner,".
§254m. Obligated service under contract
(a) Service in full-time clinical practice
Except as provided in
(b) Notice to individual; information for informed decision; eligibility; notice to Secretary; qualification and appointment as commissioned officer; appointment as civilian member; designation of non-United States employee as member; deferment of obligated service
(1) If an individual is required under subsection (a) of this section to provide service as specified in
(A) as a member of the Corps who is a commissioned officer in the Regular or Reserve Corps of the Service or who is a civilian employee of the United States, or
(B) as a member of the Corps who is not such an officer or employee,
and shall notify such individual of such determination.
(2) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is a commissioned officer in the Service or a civilian employee of the United States, the Secretary shall, not later than sixty days before the date described in paragraph (5), provide such individual with sufficient information regarding the advantages and disadvantages of service as such a commissioned officer or civilian employee to enable the individual to make a decision on an informed basis. To be eligible to provide obligated service as a commissioned officer in the Service, an individual shall notify the Secretary, not later than thirty days before the date described in paragraph (5), of the individual's desire to provide such service as such an officer. If an individual qualifies for an appointment as such an officer, the Secretary shall, as soon as possible after the date described in paragraph (5), appoint the individual as a commissioned officer of the Regular or Reserve Corps of the Service and shall designate the individual as a member of the Corps.
(3) If an individual provided notice by the Secretary under paragraph (2) does not qualify for appointment as a commissioned officer in the Service, the Secretary shall, as soon as possible after the date described in paragraph (5), appoint such individual as a civilian employee of the United States and designate the individual as a member of the Corps.
(4) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is not an employee of the United States, the Secretary shall, as soon as possible after the date described in paragraph (5), designate such individual as a member of the Corps to provide such service.
(5)(A) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatry, or pharmacy, the date referred to in paragraphs (1) through (4) shall be the date on which the individual completes the training required for such degree, except that—
(i) at the request of such an individual with whom the Secretary has entered into a contract under
(ii) at the request of such an individual with whom the Secretary has entered into a contract under
(B)(i) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school of medicine, osteopathic medicine, or dentistry, the number of years referred to in subparagraph (A)(i) shall be 3 years.
(ii) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school of veterinary medicine, optometry, podiatry, or pharmacy, the number of years referred to in subparagraph (A)(i) shall be 1 year.
(C) No period of internship, residency, or other advanced clinical training shall be counted toward satisfying a period of obligated service under this subpart.
(D) In the case of the Scholarship Program, with respect to an individual receiving a degree from an institution other than a school referred to in subparagraph (A), the date referred to in paragraphs (1) through (4) shall be the date on which the individual completes the academic training of the individual leading to such degree.
(E) In the case of the Loan Repayment Program, if an individual is required to provide obligated service under such Program, the date referred to in paragraphs (1) through (4)—
(i) shall be the date determined under subparagraph (A), (B), or (D) in the case of an individual who is enrolled in the final year of a course of study;
(ii) shall, in the case of an individual who is enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession, be the date the individual completes such training program; and
(iii) shall, in the case of an individual who has a degree in medicine, osteopathic medicine, dentistry, or other health profession and who has completed graduate training, be the date the individual enters into an agreement with the Secretary under
(c) Obligated service period; commencement
An individual shall be considered to have begun serving a period of obligated service—
(1) on the date such individual is appointed as an officer in a Regular or Reserve Corps of the Service or is designated as a member of the Corps under subsection (b)(3) or (b)(4) of this section, or
(2) in the case of an individual who has entered into an agreement with the Secretary under
whichever is earlier.
(d) Assignment of personnel
The Secretary shall assign individuals performing obligated service in accordance with a written contract under the Scholarship Program to health professional shortage areas in accordance with sections 254d through 254h and
(e) Service under National Research Service Award program; credits against obligated service time
Notwithstanding any other provision of this subchapter, service of an individual under a National Research Service Award awarded under subparagraph (A) or (B) of section 288(a)(1) 1 of this title shall be counted against the period of obligated service which the individual is required to perform under the Scholarship Program or under section 234 2 of this title as in effect on September 30, 1977.
(July 1, 1944, ch. 373, title III, §338C, formerly title VII, §752, as added
References in Text
Codification
Section was formerly classified to
Prior Provisions
A prior section 338C of act July 1, 1944, was renumbered section 338D by section 201(2) of
Amendments
1990—Subsec. (d).
1988—Subsec. (b)(5).
1987—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(5).
Subsec. (c)(2).
1983—Subsec. (e).
1981—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
1979—Subsec. (b)(5)(A).
Subsec. (b)(5)(B).
1978—Subsec. (d).
Effective Date of 1981 Amendment
Section 2709(h) of
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Special Retention Pay for Regular or Reserve Officers for Period Officer Is Obligated Under This Section
Similar provisions were contained in the following prior appropriation acts:
Section Referred to in Other Sections
This section is referred to in
1 See Codification note below.
2 See References in Text note below.
§254n. Private practice
(a) Application for release of obligations; conditions
The Secretary shall, to the extent permitted by, and consistent with, the requirements of applicable State law, release an individual from all or part of his service obligation under
(1) in the case of an individual who received a scholarship under the Scholarship Program or a loan repayment under the Loan Repayment Program and who is performing obligated service as a member of the Corps in a health professional shortage area on the date of his application for such a release, in the health professional shortage area in which such individual is serving on such date or in the case of an individual for whom a loan payment was made under the Loan Repayment Program and who is performing obligated service as a member of the Corps in a health professional shortage area on the date of the application of the individual for such a release, in the health professional shortage area selected by the Secretary; or
(2) in the case of any other individual, in a health professional shortage area (designated under
(b) Written agreement; fee rates; ability to pay; health insurance; regulations; actions to ensure compliance
The written agreement described in subsection (a) of this section shall—
(1) provide that during the period of private practice by an individual pursuant to the agreement—
(A) any person who receives health services provided by the individual in connection with such practice will be charged for such services at the usual and customary rate prevailing in the area in which such services are provided, except that if such person is unable to pay such charge, such person shall be charged at a reduced rate or not charged any fee; and
(B) the individual in providing health services in connection with such practice (i) shall not discriminate against any person on the basis of such person's ability to pay for such services or because payment for the health services provided to such person will be made under the insurance program established under part A or B of title XVIII of the Social Security Act [
(2) contain such additional provisions as the Secretary may require to carry out the purposes of this section.
For purposes of paragraph (1)(A), the Secretary shall by regulation prescribe the method for determining a person's ability to pay a charge for health services and the method of determining the amount (if any) to be charged such person based on such ability. The Secretary shall take such action as may be appropriate to ensure that the conditions of the written agreement prescribed by this subsection are adhered to.
(c) Breach of service contract
If an individual breaches the contract entered into under
(d) Travel expenses
The Secretary may pay an individual who has entered into an agreement with the Secretary under subsection (a) of this section an amount to cover all or part of the individual's expenses reasonably incurred in transporting himself, his family, and his possessions to the location of his private clinical practice.
(e) Sale of equipment and supplies
Upon the expiration of the written agreement under subsection (a) of this section, the Secretary may (notwithstanding any other provision of law) sell to the individual who has entered into an agreement with the Secretary under subsection (a) of this section, equipment and other property of the United States utilized by such individual in providing health services. Sales made under this subsection shall be made at the fair market value (as determined by the Secretary) of the equipment or such other property, except that the Secretary may make such sales for a lesser value to the individual if he determines that the individual is financially unable to pay the full market value.
(f) Malpractice insurance
The Secretary may, out of appropriations authorized under
(1)(A) $10,000 in the first year of obligated service;
(B) $7,500 in the second year of obligated service;
(C) $5,000 in the third year of obligated service; and
(D) $2,500 in the fourth year of obligated service; or
(2) an amount determined by subtracting such individual's net income before taxes from the income the individual would have received as a member of the Corps for each such year of obligated service.
(g) Technical assistance
The Secretary shall, upon request, provide to each individual released from service obligation under this section technical assistance to assist such individual in fulfilling his or her agreement under this section.
(July 1, 1944, ch. 373, title III, §338D, formerly title VII, §753, as added
References in Text
The Social Security Act, referred to in subsec. (b)(1)(B), is act Aug. 14, 1935, ch. 531,
Codification
Section was formerly classified to
Prior Provisions
A prior section 338D of act July 1, 1944, was renumbered section 338E by section 201(2) of
Amendments
1990—Subsec. (a)(1), (2).
1987—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (e).
1981—Subsec. (a).
Subsec. (b)(1)(B).
Subsecs. (c) to (g).
1980—Subsec. (a).
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254o. Breach of scholarship contract or loan repayment contract
(a) Failure to maintain academic standing; dismissal from institution; voluntary termination; liability; failure to accept payment
(1) An individual who has entered into a written contract with the Secretary under
(A) fails to maintain an acceptable level of academic standing in the educational institution in which he is enrolled (such level determined by the educational institution under regulations of the Secretary),
(B) is dismissed from such educational institution for disciplinary reasons,
(C) voluntarily terminates the training in such an educational institution for which he is provided a scholarship under such contract, before the completion of such training, or
(D) fails to accept payment, or instructs the educational institution in which he is enrolled not to accept payment, in whole or in part, of a scholarship under such contract,
in lieu of any service obligation arising under such contract, shall be liable to the United States for the amount which has been paid to him, or on his behalf, under the contract.
(2) An individual who has entered into a written contract with the Secretary under
(A) in the case of an individual who is enrolled in the final year of a course of study, fails to maintain an acceptable level of academic standing in the educational institution in which such individual is enrolled (such level determined by the educational institution under regulations of the Secretary) or voluntarily terminates such enrollment or is dismissed from such educational institution before completion of such course of study; or
(B) in the case of an individual who is enrolled in a graduate training program, fails to complete such training program and does not receive a waiver from the Secretary under
in lieu of any service obligation arising under such contract shall be liable to the United States for the amount that has been paid on behalf of the individual under the contract.
(b) Failure to commence or complete service obligations; formula to determine liability; payment to United States; recovery of delinquent damages; disclosure to credit reporting agencies
(1)(A) Except as provided in paragraph (2), if an individual breaches his written contract by failing (for any reason not specified in subsection (a) of this section or section 254p(d) 1 of this title) either to begin such individual's service obligation under
t−s
A=3φ (——)
t
in which "A" is the amount the United States is entitled to recover, "φ" is the sum of the amounts paid under this subpart to or on behalf of the individual and the interest on such amounts which would be payable if at the time the amounts were paid they were loans bearing interest at the maximum legal prevailing rate, as determined by the Treasurer of the United States; "t" is the total number of months in the individual's period of obligated service; and "s" is the number of months of such period served by him in accordance with
(B)(i) Any amount of damages that the United States is entitled to recover under this subsection or under subsection (c) of this section shall, within the 1-year period beginning on the date of the breach of the written contract (or such longer period beginning on such date as specified by the Secretary), be paid to the United States. Amounts not paid within such period shall be subject to collection through deductions in Medicare payments pursuant to
(ii) If damages described in clause (i) are delinquent for 3 months, the Secretary shall, for the purpose of recovering such damages—
(I) utilize collection agencies contracted with by the Administrator of the General Services Administration; or
(II) enter into contracts for the recovery of such damages with collection agencies selected by the Secretary.
(iii) Each contract for recovering damages pursuant to this subsection shall provide that the contractor will, not less than once each 6 months, submit to the Secretary a status report on the success of the contractor in collecting such damages.
(iv) To the extent not otherwise prohibited by law, the Secretary shall disclose to all appropriate credit reporting agencies information relating to damages of more than $100 that are entitled to be recovered by the United States under this subsection and that are delinquent by more than 60 days or such longer period as is determined by the Secretary.
(2) If an individual is released under section 254n 1 of this title from a service obligation under section 234 1 of this title (as in effect on September 30, 1977) and if the individual does not meet the service obligation incurred under section 254n 1 of this title, subsection (f) of such section 234 1 of this title shall apply to such individual in lieu of paragraph (1) of this subsection.
(c) Failure to commence or complete service obligations for other reasons; determination of liability; payment to United States; waiver of recovery for extreme hardship or good cause shown
(1) If (for any reason not specified in subsection (a) of this section or section 254p(d) 1 of this title) an individual breaches the written contract of the individual under
(A) in the case of a contract for a 2-year period of obligated service—
(i) the total of the amounts paid by the United States under
(ii) an amount equal to the unserved obligation penalty;
(B) in the case of a contract for a period of obligated service of greater than 2 years, and the breach occurs before the end of the first 2 years of such period—
(i) the total of the amounts paid by the United States under
(ii) an amount equal to the unserved obligation penalty; and
(C) in the case of a contract for a period of obligated service of greater than 2 years, and the breach occurs after the first 2 years of such period—
(i) the total of the amounts paid by the United States under
(ii) if the individual breaching the contract failed to give the Secretary notice, that the individual intends to take action which constitutes a breach of the contract, at least 1 year (or such shorter period of time as the Secretary determines is adequate for finding a replacement) prior to the breach, $10,000.
(2) For purposes of paragraph (1), the term "unserved obligation penalty" means the amount equal to the product of the number of months of obligated service that were not completed by an individual, multiplied by $1,000, except that in any case in which the individual fails to serve 1 year, the unserved obligation penalty shall be equal to the full period of obligated service multiplied by $1,000.
(3) The Secretary may waive, in whole or in part, the rights of the United States to recover amounts under this section in any case of extreme hardship or other good cause shown, as determined by the Secretary.
(4) Damages that the United States is entitled to recover shall be paid in accordance with subsection (b)(1)(B) of this section.
(d) Cancellation of obligation upon death of individual; waiver or suspension of obligation for impossibility, hardship, or unconscionability; release of debt by discharge in bankruptcy, time limitations
(1) Any obligation of an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) for service or payment of damages shall be canceled upon the death of the individual.
(2) The Secretary shall by regulation provide for the partial or total waiver or suspension of any obligation of service or payment by an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) whenever compliance by the individual is impossible or would involve extreme hardship to the individual and if enforcement of such obligation with respect to any individual would be unconscionable.
(3)(A) Any obligation of an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) for payment of damages may be released by a discharge in bankruptcy under title 11 only if such discharge is granted after the expiration of the five-year period beginning on the first date that payment of such damages is required, and only if the bankruptcy court finds that nondischarge of the obligation would be unconscionable.
(B)(i) Subparagraph (A) shall apply to any financial obligation of an individual under the provision of law specified in clause (ii) to the same extent and in the same manner as such subparagraph applies to any obligation of an individual under the Scholarship or Loan Repayment Program (or contract thereunder) for payment of damages.
(ii) The provision of law referred to in clause (i) is subsection (f) of section 234 2 of this title, as in effect prior to the repeal of such section by section 408(b)(1) of
(July 1, 1944, ch. 373, title III, §338E, formerly title VII, §754, as added
References in Text
Codification
Section was formerly classified to
Prior Provisions
A prior section 338E of act July 1, 1944, was renumbered section 338F by
Amendments
1990—Subsec. (d)(3).
1988—Subsec. (b)(1)(B)(i).
1987—
Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(B)(i).
Subsec. (c).
Subsec. (d).
1983—Subsec. (b)(1).
1981—Subsec. (a).
Subsec. (b).
Subsecs. (c), (d).
1977—Subsec. (c).
Effective Date of 1990 Amendment
Section 203(b) of
Effective Date of 1988 Amendment
Except as specifically provided in section 411 of
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Special Repayment Provisions
Section 204 of
Existing Proceedings
Section 308(b) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 See References in Text note below.
§254o–1. Fund regarding use of amounts recovered for contract breach to replace services lost as result of breach
(a) Establishment of Fund
There is established in the Treasury of the United States a fund to be known as the National Health Service Corps Member Replacement Fund (hereafter in this section referred to as the "Fund"). The Fund shall consist of such amounts as may be appropriated under subsection (b) of this section to the Fund. Amounts appropriated for the Fund shall remain available until expended.
(b) Authorization of appropriations to Fund
For each fiscal year, there is authorized to be appropriated to the Fund an amount equal to the sum of—
(1) the amount collected during the preceding fiscal year by the Federal Government pursuant to the liability of individuals under
(2) the amount by which grants under
(3) the aggregate of the amount of interest accruing during the preceding fiscal year on obligations held in the Fund pursuant to subsection (d) of this section and the amount of proceeds from the sale or redemption of such obligations during such fiscal year.
(c) Use of Fund
(1) Payments to certain health facilities
Amounts in the Fund and available pursuant to appropriations Act may, subject to paragraph (2), be expended by the Secretary to make payments to any entity—
(A) to which a Corps member has been assigned under
(B) that has a need for a health professional to provide primary health services as a result of the Corps member having breached the contract entered into under
(2) Purpose of payments
An entity receiving payments pursuant to paragraph (1) may expend the payments to recruit and employ a health professional to provide primary health services to patients of the entity, or to enter into a contract with such a professional to provide the services to the patients.
(d) Investment
(1) In general
The Secretary of the Treasury shall invest such amounts of the Fund as such Secretary determines are not required to meet current withdrawals from the Fund. Such investments may be made only in interest-bearing obligations of the United States. For such purpose, such obligations may be acquired on original issue at the issue price, or by purchase of outstanding obligations at the market price.
(2) Sale of obligations
Any obligation acquired by the Fund may be sold by the Secretary of the Treasury at the market price.
(July 1, 1944, ch. 373, title III, §338F, as added
Prior Provisions
A prior section 338F of act July 1, 1944, was renumbered section 338G by
Another prior section 338F of act July 1, 1944, was renumbered section 338G by section 201(2) of
§254p. Special loans for former Corps members to enter private practice
(a) Persons entitled; conditions
The Secretary may, out of appropriations authorized under
(1) to engage in the private full-time clinical practice of the profession of the member in a health professional shortage area (designated under
(A) in the case of a Corps member who is required to complete a period of obligated service under this subpart, begins not later than 1 year after the date on which such individual completes such period of obligated service; and
(B) in the case of an individual who is not required to complete a period of obligated service under this subpart, begins at such time as the Secretary considers appropriate;
(2) to conduct such practice in accordance with
(3) to such additional conditions as the Secretary may require to carry out this section.
Such a loan shall be used to assist such individual in meeting the costs of beginning the practice of such individual's profession in accordance with such agreement, including the costs of acquiring equipment and renovating facilities for use in providing health services, and of hiring nurses and other personnel to assist in providing health services. Such loan may not be used for the purchase or construction of any building.
(b) Amount of loan; maximum interest rate
(1) The amount of a loan under subsection (a) of this section to an individual shall not exceed $25,000.
(2) The interest rate for any such loan shall not exceed an annual rate of 5 percent.
(c) Application for loan; submission and approval; interest rates and repayment terms
The Secretary may not make a loan under this section unless an application therefor has been submitted to, and approved by, the Secretary. The Secretary shall, by regulation, set interest rates and repayment terms for loans under this section.
(d) Breach of agreement; notice; determination of liability
If the Secretary determines that an individual has breached a written agreement entered into under subsection (a) of this section, he shall, as soon as practicable after making such determination, notify the individual of such determination. If within 60 days after the date of giving such notice, such individual is not practicing his profession in accordance with the agreement under such subsection and has not provided assurances satisfactory to the Secretary that he will not knowingly violate such agreement again, the United States shall be entitled to recover from such individual—
(1) in the case of an individual who has received a grant under this section (as in effect prior to October 1, 1984), an amount determined under
(2) in the case of an individual who has received a loan under this section, the full amount of the principal and interest owed by such individual under this section.
(July 1, 1944, ch. 373, title III, §338G, formerly title VII, §755, as added
Codification
Section was formerly classified to
Prior Provisions
A prior section 338G of act July 1, 1944, was renumbered section 338H by
Another prior section 338G of act July 1, 1944, was renumbered section 338I by section 201(1) of
Another prior section 338G of act July 1, 1944, was classified to
Amendments
1990—Subsec. (a)(1).
1987—Subsec. (a).
Subsec. (b).
"(1) $12,500 if the individual agrees to practice his profession in accordance with the agreement for a period of at least one year, but less than two years; or
"(2) $25,000 if the individual agrees to practice his profession in accordance with the agreement for a period of at least two years."
Subsec. (c).
Subsec. (d)(1).
1983—Subsec. (d)(1).
1981—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Section Referred to in Other Sections
This section is referred to in
§254q. Report and authorization of appropriations
(a) Omitted
(b) Funding
(1) Authorization of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $63,900,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 2000.
(2) Reservation of amounts
(A) Scholarships for new participants
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall obligate not less than 30 percent for the purpose of providing contracts for scholarships under this subpart to individuals who have not previously received such scholarships.
(B) Scholarships for first-year study in certain fields
With respect to certification as a nurse practitioner, nurse midwife, or physician assistant, the Secretary shall, of the amounts appropriated under paragraph (1) for a fiscal year, obligate not less than 10 percent for the purpose of providing contracts for scholarships under this subpart to individuals who are entering the first year of study in a course of study or program described in subsection 1 254l(b)(1)(B) of this title that leads to such a certification. Amounts obligated under this subparagraph shall be in addition to amounts obligated under subparagraph (A).
(July 1, 1944, ch. 373, title III, §338H, formerly §338G, as added
Prior Provisions
A prior section 254q, act July 1, 1944, ch. 373, title III, §338G, formerly title VII, §756, as added Oct. 12, 1976,
A prior section 338H of act July 1, 1944, was renumbered section 338I by
Codification
Subsec. (a) of this section, which required the Secretary to report annually to certain committees of Congress on plans related to meeting the National Health Service Corps' anticipated requirements for providers of health care, including the proposed number of scholarships under the Scholarship Program, the proposed number of loan repayments under the Loan Repayment Program, and the number of individuals who, without obligation under
Amendments
1990—Subsec. (a).
Subsec. (b).
1 So in original. Probably should be "section".
§254q–1. Grants to States for loan repayment programs
(a) In general
(1) Authority for grants
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to States for the purpose of assisting the States in operating programs described in paragraph (2) in order to provide for the increased availability of primary health services in health professional shortage areas.
(2) Loan repayment programs
The programs referred to in paragraph (1) are, subject to subsection (c) of this section, programs of entering into contracts under which the State involved agrees to pay all or part of the principal, interest, and related expenses of the educational loans of health professionals in consideration of the professionals agreeing to provide primary health services in health professional shortage areas.
(3) Direct administration by State agency
The Secretary may not make a grant under paragraph (1) unless the State involved agrees that the program operated with the grant will be administered directly by a State agency.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) of this section unless the State agrees that, with respect to the costs of making payments on behalf of individuals under contracts made pursuant to paragraph (2) of such subsection, the State will make available (directly or through donations from public or private entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $1 of Federal funds provided in the grant.
(2) Determination of amount of non-Federal contribution
In determining the amount of non-Federal contributions in cash that a State has provided pursuant to paragraph (1), the Secretary may not include any amounts provided to the State by the Federal Government.
(c) Coordination with Federal program
(1) Assignments for health professional shortage areas under Federal program
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that, in carrying out the program operated with the grant, the State will assign health professionals participating in the program only to public and nonprofit private entities located in and providing health services in health professional shortage areas.
(2) Remedies for breach of contracts
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such subsection will provide remedies for any breach of the contracts by the health professionals involved.
(3) Limitation regarding contract inducements
(A) Except as provided in subparagraph (B), the Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such subsection will not be provided on terms that are more favorable to health professionals than the most favorable terms that the Secretary is authorized to provide for contracts under the Loan Repayment Program under
(i) the annual amount of payments provided on behalf of the professionals regarding educational loans; and
(ii) the availability of remedies for any breach of the contracts by the health professionals involved.
(B) With respect to the limitation established in subparagraph (A) regarding the annual amount of payments that may be provided to a health professional under a contract provided by a State pursuant to subsection (a)(2) of this section, such limitation shall not apply with respect to a contract if—
(i) the excess of such annual payments above the maximum amount authorized in
(ii) the contract provides that the health professional involved will satisfy the requirement of obligated service under the contract solely through the provision of primary health services in a health professional shortage area that is receiving priority for purposes of
(d) Restrictions on use of funds
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the grant will not be expended—
(1) to conduct activities for which Federal funds are expended—
(A) within the State to provide technical or other nonfinancial assistance under subsection (f) of
(B) under a memorandum of agreement entered into with the State under subsection (h) of such section; or
(C) under a grant under
(2) for any purpose other than making payments on behalf of health professionals under contracts entered into pursuant to subsection (a)(2) of this section.
(e) Reports
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees—
(1) to submit to the Secretary reports providing the same types of information regarding the program operated pursuant to such subsection as reports submitted pursuant to subsection (i) 1 of
(2) to submit such a report not later than January 10 of each fiscal year immediately following any fiscal year for which the State has received such a grant.
(f) Requirement of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(g) Noncompliance
(1) In general
The Secretary may not make payments under subsection (a) of this section to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section.
(2) Reduction in grant relative to number of breached contracts
(A) Before making a grant under subsection (a) of this section to a State for a fiscal year, the Secretary shall determine the number of contracts provided by the State under paragraph (2) of such subsection with respect to which there has been an initial breach by the health professionals involved during the fiscal year preceding the fiscal year for which the State is applying to receive the grant.
(B) Subject to paragraph (3), in the case of a State with 1 or more initial breaches for purposes of subparagraph (A), the Secretary shall reduce the amount of a grant under subsection (a) of this section to the State for the fiscal year involved by an amount equal to the sum of the expenditures of Federal funds made regarding the contracts involved and an amount representing interest on the amount of such expenditures, determined with respect to each contract on the basis of the maximum legal rate prevailing for loans made during the time amounts were paid under the contract, as determined by the Treasurer of the United States.
(3) Waiver regarding reduction in grant
The Secretary may waive the requirement established in paragraph (2)(B) with respect to the initial breach of a contract if the Secretary determines that such breach by the health professional involved was attributable solely to the professional having a serious illness.
(h) "State" defined
For purposes of this section, the term "State" means each of the several States.
(i) Authorization of appropriations
(1) In general
For the purpose of making grants under subsection (a) of this section, there is authorized to be appropriated $10,000,000 for each of the fiscal years 1991 through 1995, and such sums as may be necessary for each of the fiscal years 1998 through 2002.
(2) Availability
Amounts appropriated under paragraph (1) shall remain available until expended.
(July 1, 1944, ch. 373, title III, §338I, formerly §338H, as added
References in Text
Subsection (i) of
Prior Provisions
A prior section 338I of act July 1, 1944, was classified to
Amendments
1998—Subsec. (i)(1).
1990—
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254r. Grants to States for operation of offices of rural health
(a) In general
The Secretary, acting through the Director of the Office of Rural Health Policy (established in
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees, with respect to the costs to be incurred by the State in carrying out the purpose described in such subsection, to provide non-Federal contributions toward such costs in an amount equal to—
(A) for the first fiscal year of payments under the grant, not less than $1 for each $3 of Federal funds provided in the grant;
(B) for any second fiscal year of such payments, not less than $1 for each $1 of Federal funds provided in the grant; and
(C) for any third fiscal year of such payments, not less than $3 for each $1 of Federal funds provided in the grant.
(2) Determination of amount of non-Federal contribution
(A) Subject to subparagraph (B), non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that—
(i) for the first fiscal year of payments under the grant, 100 percent or less of the non-Federal contributions required in paragraph (1) will be provided in the form of in-kind contributions;
(ii) for any second fiscal year of such payments, not more than 50 percent of such non-Federal contributions will be provided in the form of in-kind contributions; and
(iii) for any third fiscal year of such payments, such non-Federal contributions will be provided solely in the form of cash.
(c) Certain required activities
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that activities carried out by an office operated pursuant to such subsection will include—
(1) establishing and maintaining within the State a clearinghouse for collecting and disseminating information on—
(A) rural health care issues;
(B) research findings relating to rural health care; and
(C) innovative approaches to the delivery of health care in rural areas;
(2) coordinating the activities carried out in the State that relate to rural health care, including providing coordination for the purpose of avoiding redundancy in such activities; and
(3) identifying Federal and State programs regarding rural health, and providing technical assistance to public and nonprofit private entities regarding participation in such programs.
(d) Requirement regarding annual budget for office
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that, for any fiscal year for which the State receives such a grant, the office operated pursuant to subsection (a) of this section will be provided with an annual budget of not less than $50,000.
(e) Certain uses of funds
(1) Restrictions
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that—
(A) if research with respect to rural health is conducted pursuant to the grant, not more than 10 percent of the grant will be expended for such research; and
(B) the grant will not be expended—
(i) to provide health care (including providing cash payments regarding such care);
(ii) to conduct activities for which Federal funds are expended—
(I) within the State to provide technical and other nonfinancial assistance under subsection (f) of section 254c 1 of this title;
(II) under a memorandum of agreement entered into with the State under subsection (h) of such section; or
(III) under a grant under
(iii) to purchase medical equipment, to purchase ambulances, aircraft, or other vehicles, or to purchase major communications equipment;
(iv) to purchase or improve real property; or
(v) to carry out any activity regarding a certificate of need.
(2) Authorities
Activities for which a State may expend a grant under subsection (a) of this section include—
(A) paying the costs of establishing an office of rural health for purposes of subsection (a) of this section;
(B) subject to paragraph (1)(B)(ii)(III), paying the costs of any activity carried out with respect to recruiting and retaining health professionals to serve in rural areas of the State; and
(C) providing grants and contracts to public and nonprofit private entities to carry out activities authorized in this section.
(f) Reports
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees—
(1) to submit to the Secretary reports containing such information as the Secretary may require regarding activities carried out under this section by the State; and
(2) to submit such a report not later than January 10 of each fiscal year immediately following any fiscal year for which the State has received such a grant.
(g) Requirement of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(h) Noncompliance
The Secretary may not make payments under subsection (a) of this section to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section.
(i) "State" defined
For purposes of this section, the term "State" means each of the several States.
(j) Authorization of appropriations
(1) In general
For the purpose of making grants under subsection (a) of this section, there are authorized to be appropriated $3,000,000 for fiscal year 1991, $4,000,000 for fiscal year 1992, $3,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1998 through 2002.
(2) Availability
Amounts appropriated under paragraph (1) shall remain available until expended.
(k) Termination of program
No grant may be made under this section after the aggregate amounts appropriated under subsection (j)(1) of this section are equal to $36,000,000.
(July 1, 1944, ch. 373, title III, §338J, as added
References in Text
Prior Provisions
A prior section 254r, act July 1, 1944, ch. 373, title III, §338I, formerly title VII, §757, as added Aug. 1, 1977,
A prior section 338J of act July 1, 1944, was renumbered section 338K by
Amendments
1998—Subsec. (b)(1).
Subsec. (j)(1).
Subsec. (k).
Communications for Rural Health Providers
Similar provisions were contained in
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254s. Native Hawaiian Health Scholarships
(a) Eligibility
Subject to the availability of funds appropriated under the authority of subsection (d) of this section, the Secretary shall provide funds to Kamehameha Schools/Bishop Estate for the purpose of providing scholarship assistance to students who—
(1) meet the requirements of
(2) are Native Hawaiians.
(b) Terms and conditions
(1) The scholarship assistance provided under subsection (a) of this section shall be provided under the same terms and subject to the same conditions, regulations, and rules that apply to scholarship assistance provided under
(2) The Native Hawaiian Health Scholarship program shall not be administered by or through the Indian Health Service.
(c) "Native Hawaiian" defined
For purposes of this section, the term "Native Hawaiian" means any individual who is—
(1) a citizen of the United States,
(2) a resident of the State of Hawaii, and
(3) a descendant of the aboriginal people, who prior to 1778, occupied and exercised sovereignty in the area that now constitutes the State of Hawaii, as evidenced by—
(A) genealogical records,
(B) Kupuna (elders) or Kama'aina (long-term community residents) verification, or
(C) birth records of the State of Hawaii.
(d) Authorization of appropriations
There are authorized to be appropriated $1,800,000 for each of the fiscal years 1990, 1991, and 1992 for the purpose of funding the scholarship assistance provided under subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §338k, formerly §338J, as added
Amendments
1990—Subsec. (a).
"(1) meet the requirements of
"(2) are Native Hawaiians."
§254t. Demonstration grants to States for community scholarship programs
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to States for the purpose of carrying out demonstration programs to increase the availability of primary health care in urban and rural health manpower shortage areas through assisting community organizations of such areas in educating individuals to serve as health professionals in such areas.
(b) Certain requirements for States
(1) Minimum qualifications
The Secretary may not make a grant under subsection (a) of this section unless the State involved will, under any provision of this chapter other than subsection (a) of this section, receive 1 or more grants, cooperative agreements, or contracts for the fiscal year for which the State is applying pursuant to subsection (h) of this section to receive a grant under subsection (a) of this section.
(2) Administration of program
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the program carried out by the State with the grant will be administered directly by a single State agency.
(c) Grants by States to community organizations for provision of scholarship contracts
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees, subject to subsections (d) and (e) of this section, to carry out the purpose described in subsection (a) of this section only through operating a program in which the State makes grants to community organizations located in health manpower 1 shortage areas in order to assist the organizations with the costs of entering into contracts under which—
(1) the community organizations agree to provide scholarships to individuals for attendance at health professions schools; and
(2) the individuals agree to provide, in the health manpower shortage areas in which the community organizations are located, primary health care for—
(A) a number of years equal to the number of years for which the scholarships are provided, or for a period of 2 years, whichever period is greater; or
(B) such greater period of time as the individuals and the community organizations may agree.
(d) Requirement of State and local matching funds
(1) In general
With respect to the costs of providing any scholarship pursuant to subsection (c) of this section, the Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that—
(A) 40 percent of the costs of the scholarship will be paid from the grant made under subsection (a) of this section to the State; and
(B) 60 percent of such costs will be paid from non-Federal contributions made in cash by both the State and the community organization through which the scholarship is provided, subject to—
(i) the State making available through such contributions not less than 15 percent, nor more than 25 percent, of such costs; and
(ii) the community organization making available through such contributions not less than 35 percent, nor more than 45 percent, of such costs.
(2) Determination of amount of non-Federal contributions
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that, in determining the amount of non-Federal contributions that have been provided in cash for purposes of paragraph (1), the State will not include any amounts provided by the Federal Government to the State or community organization involved, or to any other entity.
(3) Use of donations
Non-Federal contributions required in paragraph (1) may be provided directly by the State and community organization involved, and may be provided through donations from public and private entities.
(e) Specifications regarding scholarship contract
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the State will make a grant to a community organization for a contract described in subsection (c) of this section only if—
(1) the individual who is to receive the scholarship under the contract is a resident of the health manpower shortage area in which the community organization is located;
(2) the individual is enrolled or accepted for enrollment as a full-time student in a health professions school that is approved by the Secretary for purposes of this section;
(3) the individual agrees to maintain an acceptable level of academic standing at the school (as determined by the school in accordance with regulations issued by the Secretary for purposes of
(4) the individual and the community organization agree that the scholarship provided pursuant to the contract—
(A) will be expended only for—
(i) tuition expenses, other reasonable educational expenses, and reasonable living expenses incurred in attendance at the school; and
(ii) payment to the individual of a monthly stipend of not more than the amount authorized for purposes of
(B) will not, for any year of such attendance for which the scholarship is provided, be in an amount exceeding the total amount required for the year for the purposes authorized in subparagraph (A);
(5) the individual agrees to meet the educational and licensure requirements necessary to be a physician, certified nurse practitioner, certified nurse midwife, or physician assistant; and
(6) the individual agrees that, in providing primary health care pursuant to the scholarship, the individual—
(A) will not, in the case of an individual seeking such care, discriminate against the individual on the basis of the ability of the individual to pay for such care or on the basis that payment for such care will be made pursuant to the program established in title XVIII of the Social Security Act [
(B) will accept assignment under section 1842(b)(3)(B)(ii) of the Social Security Act [
(f) Reports to Secretary
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees—
(1) for each fiscal year for which such a grant is received by the State, to submit to the Secretary a report—
(A) identifying the community organizations providing scholarships pursuant to subsection (c) of this section and the health manpower shortage areas in which the organizations are located;
(B) providing the names of individuals receiving the scholarships, the health professions in which the individuals will engage pursuant to the scholarships, the number of years of service the individuals are obligated to provide pursuant to the scholarships, and the extent of compliance with the contracts under subsection (c) of this section on the part of the individuals and the community organizations; and
(C) providing such information as the Secretary may determine to be necessary for carrying out this section; and
(2) to submit each such report not later than January 10 of the fiscal year immediately following the fiscal year for which the report is prepared.
(g) Estimates regarding allocations between urban and rural areas
The Secretary may not make a grant under subsection (a) of this section unless the State involved submits to the Secretary, as part of the application required in subsection (h) of this section, an estimate of the amount of the grant that will be expended regarding the provision of primary health care in urban health manpower shortage areas of the State, and an estimate of the amount of the grant that will be expended regarding the provision of such care in rural health manpower shortage areas of the State.
(h) Requirement of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(i) Noncompliance
(1) In general
The Secretary may not make payments under subsection (a) of this section to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section.
(2) Reduction in grant relative to number of breached contracts
(A) Before making a grant under subsection (a) of this section to a State for a fiscal year, the Secretary shall determine the number of contracts provided under subsection (c) of this section with respect to which there has been an initial breach by the community organizations or individuals involved during the fiscal year preceding the fiscal year for which the State is applying to receive the grant.
(B) In the case of a State with 1 or more initial breaches for purposes of subparagraph (A), the Secretary shall reduce the amount of a grant under subsection (a) of this section to the State for the fiscal year involved by an amount equal to the sum of—
(i) an amount equal to the expenditures of Federal funds made regarding the contracts involved; and
(ii) an amount representing interest on the amount of such expenditures, determined with respect to each contract on the basis of the maximum legal rate prevailing for loans made during the time amounts were paid under the contract, as determined by the Treasurer of the United States.
(C) If a State is not receiving a grant under subsection (a) of this section for a fiscal year for which a reduction under subparagraph (B) would have been made in the event that the State had received such a grant, the Secretary shall reduce the amount of payments due to the State under other grants, cooperative agreements, or contracts under this chapter by the amount specified in such subparagraph.
(D) With respect to contracts provided under subsection (c) of this section, the Secretary may carry out this paragraph on the basis of information submitted by the States involved, or on the basis of information collected through such other means as the Secretary determines to be appropriate.
(j) Reports to Congress
(1) In general
Each fiscal year the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report summarizing information received by the Secretary under subsection (f) of this section for the preceding fiscal year.
(2) Date for submission
With respect to a fiscal year, the report required in paragraph (1) shall be submitted for purposes of such paragraph by not later than the date on which the report required in section 254l(i) 2 of this title is required to be submitted for purposes of such section.
(k) Definitions
For purposes of this section:
(1) Community organization
The term "community organization" means a public or nonprofit private entity.
(2) Primary health care
The term "primary health care" means health services regarding family medicine, internal medicine, pediatrics, or obstetrics and gynecology, that are provided by physicians, certified nurse practitioners, certified nurse midwives, or physician assistants.
(3) State
The term "State" means each of the several States and the District of Columbia.
(l) Funding
(1) Authorization of appropriations
For the purpose of making grants under subsection (a) of this section, there are authorized to be appropriated $5,000,000 for fiscal year 1991, $10,000,000 for fiscal year 1992, and such sums as may be necessary for fiscal year 1993.
(2) Availability
Amounts appropriated under paragraph (1) shall remain available until expended.
(3) Allocations for rural areas
(A) In carrying out subsection (a) of this section, the Secretary shall, to the extent practicable, ensure that not less than 50 percent of the amounts appropriated under paragraph (1) are, in the aggregate, expended for making grants pursuant to subsection (c) of this section to community organizations that are located in rural health manpower shortage areas.
(B) Subparagraph (A) may not be construed to prohibit the Secretary from making grants under subsection (a) of this section to States in which no rural health manpower shortage areas are located.
(C) With respect to any fiscal year for which the Secretary is unable to comply with subparagraph (A), the Secretary shall, not later than April 1 of the subsequent fiscal year, submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report stating the fact of such noncompliance and an explanation of the reasons underlying such noncompliance.
(July 1, 1944, ch. 373, title III, §338L, as added
References in Text
The Social Security Act, referred to in subsec. (e)(6), is act Aug. 14, 1935, ch. 531,
Change of Name
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
1 So in original. Probably should be "professional".
2 See References in Text note below.
subpart iv—home health services
Amendments
1987—
1983—
1978—
§255. Home health services
(a) Purpose; authorization of grants and loans; considerations; conditions on loans; appropriations
(1) For the purpose of encouraging the establishment and initial operation of home health programs to provide home health services in areas in which such services are inadequate or not readily accessible, the Secretary may, in accordance with the provisions of this section, make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating such home health programs. Such grants and loans may include funds to provide training for paraprofessionals (including homemaker home health aides) to provide home health services.
(2) In making grants and loans under this subsection, the Secretary shall—
(A) consider the relative needs of the several States for home health services;
(B) give preference to areas in which a high percentage of the population proposed to be served is composed of individuals who are elderly, medically indigent, or disabled; and
(C) give special consideration to areas with inadequate means of transportation to obtain necessary health services.
(3)(A) No loan may be made to a proprietary entity under this section unless the application of such entity for such loan contains assurances satisfactory to the Secretary that—
(i) at the time the application is made the entity is fiscally sound;
(ii) the entity is unable to secure a loan for the project for which the application is submitted from non-Federal lenders at the rate of interest prevailing in the area in which the entity is located; and
(iii) during the period of the loan, such entity will remain fiscally sound.
(B) Loans under this section shall be made at an interest rate comparable to the rate of interest prevailing on the date the loan is made with respect to the marketable obligations of the United States of comparable maturities, adjusted to provide for administrative costs.
(4) Applications for grants and loans under this subsection shall be in such form and contain such information as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and loans under this subsection $5,000,000 for each of the fiscal years ending on September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and September 30, 1987.
(b) Grants and contracts for training programs for paraprofessionals; considerations; applications; appropriations
(1) The Secretary may make grants to and enter into contracts with public and private entities to assist them in developing appropriate training programs for paraprofessionals (including homemaker home health aides) to provide home health services.
(2) Any program established with a grant or contract under this subsection to train homemaker home health aides shall—
(A) extend for at least forty hours, and consist of classroom instruction and at least twenty hours (in the aggregate) of supervised clinical instruction directed toward preparing students to deliver home health services;
(B) be carried out under appropriate professional supervision and be designed to train students to maintain or enhance the personal care of an individual in his home in a manner which promotes the functional independence of the individual; and
(C) include training in—
(i) personal care services designed to assist an individual in the activities of daily living such as bathing, exercising, personal grooming, and getting in and out of bed; and
(ii) household care services such as maintaining a safe living environment, light housekeeping, and assisting in providing good nutrition (by the purchasing and preparation of food).
(3) In making grants and entering into contracts under this subsection, special consideration shall be given to entities which establish or will establish programs to provide training for persons fifty years of age and older who wish to become paraprofessionals (including homemaker home health aides) to provide home health services.
(4) Applications for grants and contracts under this subsection shall be in such form and contain such information as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and contracts under this subsection $2,000,000 for each of the fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and September 30, 1987.
(c) Report to Congress with respect to grants and loans and training of personnel
The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
(1) the impact of grants made and contracts entered into under subsections (a) and (b) of this section (as such subsections were in effect prior to October 1, 1981);
(2) the need to continue grants and loans under subsections (a) and (b) of this section (as such subsections are in effect on the day after January 4, 1983); and
(3) the extent to which standards have been applied to the training of personnel who provide home health services.
(d) "Home health services" defined
For purposes of this section, the term "home health services" has the meaning prescribed for the term by
(July 1, 1944, ch. 373, title III, §339, as added
References in Text
Subsections (a) and (b) of this section (as such subsections were in effect prior to October 1, 1981), referred to in subsec. (c)(1), mean subsections (a) and (b) of
Prior Provisions
A prior section 255, act July 1, 1944, ch. 373, title III, §339, as added Nov. 10, 1978,
Another prior section 339 of act July 1, 1944, ch. 373, title III, formerly §331,
Amendments
1984—Subsecs. (a)(5), (b)(5).
Change of Name
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
Report to Congress Concerning Results of Studies Evaluating Home and Community Based Health Services; Studies of Reimbursement Methodologies; Investigation of Fraud; Demonstration Projects; Home Health Services, Defined
Section 6(b)–(f) of
subpart v—health services for the homeless
§256. Repealed. Pub. L. 104–299, §4(a)(3), Oct. 11, 1996, 110 Stat. 3645
Section, act July 1, 1944, ch. 373, title III, §340, as added July 22, 1987,
A prior section 256, act July 1, 1944, ch. 373, title III, §340, as added Nov. 10, 1978,
Another prior section 256, act July 1, 1944, ch. 373, title III, §340, formerly §332,
Effective Date of Repeal
Repeal effective Oct. 1, 1996, see section 5 of
subpart vi—health services for residents of public housing
§256a. Repealed. Pub. L. 104–299, §4(a)(3), Oct. 11, 1996, 110 Stat. 3645
Section, act July 1, 1944, ch. 373, title III, §340A, as added Nov. 6, 1990,
Prior Provisions
A prior section 256a, act July 1, 1944, ch. 373, title III, §340A, as added Nov. 10, 1978,
Effective Date of Repeal
Repeal effective Oct. 1, 1996, see section 5 of
subpart vii—drug pricing agreements
§256b. Limitation on prices of drugs purchased by covered entities
(a) Requirements for agreement with Secretary
(1) In general
The Secretary shall enter into an agreement with each manufacturer of covered drugs under which the amount required to be paid (taking into account any rebate or discount, as provided by the Secretary) to the manufacturer for covered drugs (other than drugs described in paragraph (3)) purchased by a covered entity on or after the first day of the first month that begins after November 4, 1992, does not exceed an amount equal to the average manufacturer price for the drug under title XIX of the Social Security Act [
(2) "Rebate percentage" defined
(A) In general
For a covered outpatient drug purchased in a calendar quarter, the "rebate percentage" is the amount (expressed as a percentage) equal to—
(i) the average total rebate required under section 1927(c) of the Social Security Act [
(ii) the average manufacturer price for such a unit of the drug during such quarter.
(B) Over the counter drugs
(i) In general
For purposes of subparagraph (A), in the case of over the counter drugs, the "rebate percentage" shall be determined as if the rebate required under section 1927(c) of the Social Security Act [
(ii) "Over the counter drug" defined
The term "over the counter drug" means a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to prescribe such drug under State law).
(3) Drugs provided under State medicaid plans
Drugs described in this paragraph are drugs purchased by the entity for which payment is made by the State under the State plan for medical assistance under title XIX of the Social Security Act [
(4) "Covered entity" defined
In this section, the term "covered entity" means an entity that meets the requirements described in paragraph (5) and is one of the following:
(A) A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act [
(B) An entity receiving a grant under section 256a 1 of this title.
(C) A family planning project receiving a grant or contract under
(D) An entity receiving a grant under subpart II 1 of part C of subchapter XXIV of this chapter (relating to categorical grants for outpatient early intervention services for HIV disease).
(E) A State-operated AIDS drug purchasing assistance program receiving financial assistance under subchapter XXIV of this chapter.
(F) A black lung clinic receiving funds under
(G) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the Social Security Act [
(H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988.
(I) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act [
(J) Any entity receiving assistance under subchapter XXIV of this chapter (other than a State or unit of local government or an entity described in subparagraph (D)), but only if the entity is certified by the Secretary pursuant to paragraph (7).
(K) An entity receiving funds under
(L) A subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act [
(i) is owned or operated by a unit of State or local government, is a public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government, or is a private non-profit hospital which has a contract with a State or local government to provide health care services to low income individuals who are not entitled to benefits under title XVIII of the Social Security Act [
(ii) for the most recent cost reporting period that ended before the calendar quarter involved, had a disproportionate share adjustment percentage (as determined under section 1886(d)(5)(F) of the Social Security Act [
(iii) does not obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.
(5) Requirements for covered entities
(A) Prohibiting duplicate discounts or rebates
(i) In general
A covered entity shall not request payment under title XIX of the Social Security Act [
(ii) Establishment of mechanism
The Secretary shall establish a mechanism to ensure that covered entities comply with clause (i). If the Secretary does not establish a mechanism within 12 months under the previous sentence, the requirements of section 1927(a)(5)(C) of the Social Security Act [
(B) Prohibiting resale of drugs
With respect to any covered outpatient drug that is subject to an agreement under this subsection, a covered entity shall not resell or otherwise transfer the drug to a person who is not a patient of the entity.
(C) Auditing
A covered entity shall permit the Secretary and the manufacturer of a covered outpatient drug that is subject to an agreement under this subsection with the entity (acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) to audit at the Secretary's or the manufacturer's expense the records of the entity that directly pertain to the entity's compliance with the requirements described in subparagraphs 2 (A) or (B) with respect to drugs of the manufacturer.
(D) Additional sanction for noncompliance
If the Secretary finds, after notice and hearing, that a covered entity is in violation of a requirement described in subparagraphs 2 (A) or (B), the covered entity shall be liable to the manufacturer of the covered outpatient drug that is the subject of the violation in an amount equal to the reduction in the price of the drug (as described in subparagraph (A)) provided under the agreement between the entity and the manufacturer under this paragraph.
(6) Treatment of distinct units of hospitals
In the case of a covered entity that is a distinct part of a hospital, the hospital shall not be considered a covered entity under this paragraph unless the hospital is otherwise a covered entity under this subsection.
(7) Certification of certain covered entities
(A) Development of process
Not later than 60 days after November 4, 1992, the Secretary shall develop and implement a process for the certification of entities described in subparagraphs (J) and (K) of paragraph (4).
(B) Inclusion of purchase information
The process developed under subparagraph (A) shall include a requirement that an entity applying for certification under this paragraph submit information to the Secretary concerning the amount such entity expended for covered outpatient drugs in the preceding year so as to assist the Secretary in evaluating the validity of the entity's subsequent purchases of covered outpatient drugs at discounted prices.
(C) Criteria
The Secretary shall make available to all manufacturers of covered outpatient drugs a description of the criteria for certification under this paragraph.
(D) List of purchasers and dispensers
The certification process developed by the Secretary under subparagraph (A) shall include procedures under which each State shall, not later than 30 days after the submission of the descriptions under subparagraph (C), prepare and submit a report to the Secretary that contains a list of entities described in subparagraphs (J) and (K) of paragraph (4) that are located in the State.
(E) Recertification
The Secretary shall require the recertification of entities certified pursuant to this paragraph on a not more frequent than annual basis, and shall require that such entities submit information to the Secretary to permit the Secretary to evaluate the validity of subsequent purchases by such entities in the same manner as that required under subparagraph (B).
(8) Development of prime vendor program
The Secretary shall establish a prime vendor program under which covered entities may enter into contracts with prime vendors for the distribution of covered outpatient drugs. If a covered entity obtains drugs directly from a manufacturer, the manufacturer shall be responsible for the costs of distribution.
(9) Notice to manufacturers
The Secretary shall notify manufacturers of covered outpatient drugs and single State agencies under section 1902(a)(5) of the Social Security Act [
(10) No prohibition on larger discount
Nothing in this subsection shall prohibit a manufacturer from charging a price for a drug that is lower than the maximum price that may be charged under paragraph (1).
(b) Other definitions
In this section, the terms "average manufacturer price", "covered outpatient drug", and "manufacturer" have the meaning given such terms in section 1927(k) of the Social Security Act [
(c) References to Social Security Act
Any reference in this section to a provision of the Social Security Act [
(d) Compliance with requirements
A manufacturer is deemed to meet the requirements of subsection (a) of this section if the manufacturer establishes to the satisfaction of the Secretary that the manufacturer would comply (and has offered to comply) with the provisions of this section (as in effect immediately after November 4, 1992), as applied by the Secretary, and would have entered into an agreement under this section (as such section was in effect at such time), but for a legislative change in this section (or the application of this section) after November 4, 1992.
(July 1, 1944, ch. 373, title III, §340B, as added
References in Text
The Social Security Act, referred to in subsecs. (a)(1), (3), (4)(L)(i), (5)(A)(i), and (c), is act Aug. 14, 1935, ch. 531,
Subpart II of part C of subchapter XXIV of this chapter, referred to in subsec. (a)(4)(D), was redesignated subpart I of part C of subchapter XXIV of this chapter by
The Native Hawaiian Health Care Act of 1988, referred to in subsec. (a)(4)(H), was
The Indian Health Care Improvement Act, referred to in subsec. (a)(4)(I), is
Codification
Another section 340B of act July 1, 1944, was renumbered section 340C and is classified to
Amendments
1993—
Study of Treatment of Certain Clinics as Covered Entities Eligible for Prescription Drug Discounts
Section 602(b) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 So in original. Probably should be "subparagraph".
subpart viii—bulk purchases of vaccines for certain programs
Amendments
1993—
§256c. Bulk purchases of vaccines for certain programs
(a) Agreements for purchases
(1) In general
Not later than 180 days after October 27, 1992, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administrator of the Health Resources and Services Administration, shall enter into negotiations with manufacturers of vaccines for the purpose of establishing and maintaining agreements under which entities described in paragraph (2) may purchase vaccines from the manufacturers at the prices specified in the agreements.
(2) Relevant entities
The entities referred to in paragraph (1) are entities that provide immunizations against vaccine-preventable diseases with assistance provided under
(b) Negotiation of prices
In carrying out subsection (a) of this section, the Secretary shall, to the extent practicable, ensure that the prices provided for in agreements under such subsection are comparable to the prices provided for in agreements negotiated by the Secretary on behalf of grantees under
(c) Authority of Secretary
In carrying out subsection (a) of this section, the Secretary, in the discretion of the Secretary, may enter into the agreements described in such subsection (and may decline to enter into such agreements), may modify such agreements, may extend such agreements, and may terminate such agreements.
(d) Rule of construction
This section may not be construed as requiring any State to reduce or terminate the supply of vaccines provided by the State to any of the entities described in subsection (a)(2) of this section.
(July 1, 1944, ch. 373, title III, §340C, formerly §340B, as added
Amendments
1996—Subsec. (a)(2).
Effective Date of 1996 Amendment
Amendment by
§256d. Breast and cervical cancer information
(a) In general
As a condition of receiving grants, cooperative agreements, or contracts under this chapter, each of the entities specified in subsection (c) of this section shall, to the extent determined to be appropriate by the Secretary, make available information concerning breast and cervical cancer.
(b) Certain authorities
In carrying out subsection (a) of this section, an entity specified in subsection (c) of this section—
(1) may make the information involved available to such individuals as the entity determines appropriate;
(2) may, as appropriate, provide information under subsection (a) of this section on the need for self-examination of the breasts and on the skills for such self-examinations;
(3) shall provide information under subsection (a) of this section in the language and cultural context most appropriate to the individuals to whom the information is provided; and
(4) shall refer such clients as the entities determine appropriate for breast and cervical cancer screening, treatment, or other appropriate services.
(c) Relevant entities
The entities specified in this subsection are the following:
(1) Entities receiving assistance under section 247b–7 1 of this title (relating to tuberculosis).
(2) Entities receiving assistance under
(3) Migrant health centers receiving assistance under section 254b 1 of this title.
(4) Community health centers receiving assistance under section 254c 1 of this title.
(5) Entities receiving assistance under section 256 1 of this title (relating to homeless individuals).
(6) Entities receiving assistance under section 256a 1 of this title (relating to health services for residents of public housing).
(7) Entities providing services with assistance under subchapter III–A of this chapter or subchapter XVII of this chapter.
(8) Entities receiving assistance under
(9) Entities receiving assistance under subchapter XXIV of this chapter (relating to services with respect to acquired immune deficiency syndrome).
(10) Non-Federal entities authorized under the Indian Self-Determination Act [
(July 1, 1944, ch. 373, title III, §340D, as added
References in Text
The Indian Self-Determination Act, referred to in subsec. (c)(10), is title I of
Amendments
2000—Subsec. (c)(1).
Reference to Community, Migrant, Public Housing, or Homeless Health Center Considered Reference to Health Center
Reference to community health center, migrant health center, public housing health center, or homeless health center, considered reference to health center, see section 4(c) of
1 See References in Text note below.
subpart ix—support of graduate medical education programs in children's hospitals
§256e. Program of payments to children's hospitals that operate graduate medical education programs
(a) Payments
The Secretary shall make two payments under this section to each children's hospital for each of fiscal years 2000 through 2005, one for the direct expenses and the other for indirect expenses associated with operating approved graduate medical residency training programs. The Secretary shall promulgate regulations pursuant to the rulemaking requirements of title 5 which shall govern payments made under this subpart.
(b) Amount of payments
(1) In general
Subject to paragraph (2), the amounts payable under this section to a children's hospital for an approved graduate medical residency training program for a fiscal year are each of the following amounts:
(A) Direct expense amount
The amount determined under subsection (c) of this section for direct expenses associated with operating approved graduate medical residency training programs.
(B) Indirect expense amount
The amount determined under subsection (d) of this section for indirect expenses associated with the treatment of more severely ill patients and the additional costs relating to teaching residents in such programs.
(2) Capped amount
(A) In general
The total of the payments made to children's hospitals under paragraph (1)(A) or paragraph (1)(B) in a fiscal year shall not exceed the funds appropriated under paragraph (1) or (2), respectively, of subsection (f) of this section for such payments for that fiscal year.
(B) Pro rata reductions of payments for direct expenses
If the Secretary determines that the amount of funds appropriated under subsection (f)(1) of this section for a fiscal year is insufficient to provide the total amount of payments otherwise due for such periods under paragraph (1)(A), the Secretary shall reduce the amounts so payable on a pro rata basis to reflect such shortfall.
(c) Amount of payment for direct graduate medical education
(1) In general
The amount determined under this subsection for payments to a children's hospital for direct graduate expenses relating to approved graduate medical residency training programs for a fiscal year is equal to the product of—
(A) the updated per resident amount for direct graduate medical education, as determined under paragraph (2); and
(B) the average number of full-time equivalent residents in the hospital's graduate approved medical residency training programs (as determined under
(2) Updated per resident amount for direct graduate medical education
The updated per resident amount for direct graduate medical education for a hospital for a fiscal year is an amount determined as follows:
(A) Determination of hospital single per resident amount
The Secretary shall compute for each hospital operating an approved graduate medical education program (regardless of whether or not it is a children's hospital) a single per resident amount equal to the average (weighted by number of full-time equivalent residents) of the primary care per resident amount and the non-primary care per resident amount computed under
(B) Determination of wage and non-wage-related proportion of the single per resident amount
The Secretary shall estimate the average proportion of the single per resident amounts computed under subparagraph (A) that is attributable to wages and wage-related costs.
(C) Standardizing per resident amounts
The Secretary shall establish a standardized per resident amount for each such hospital—
(i) by dividing the single per resident amount computed under subparagraph (A) into a wage-related portion and a non-wage-related portion by applying the proportion determined under subparagraph (B);
(ii) by dividing the wage-related portion by the factor applied under
(iii) by adding the non-wage-related portion to the amount computed under clause (ii).
(D) Determination of national average
The Secretary shall compute a national average per resident amount equal to the average of the standardized per resident amounts computed under subparagraph (C) for such hospitals, with the amount for each hospital weighted by the average number of full-time equivalent residents at such hospital.
(E) Application to individual hospitals
The Secretary shall compute for each such hospital that is a children's hospital a per resident amount—
(i) by dividing the national average per resident amount computed under subparagraph (D) into a wage-related portion and a non-wage-related portion by applying the proportion determined under subparagraph (B);
(ii) by multiplying the wage-related portion by the factor described in subparagraph (C)(ii) for the hospital's area; and
(iii) by adding the non-wage-related portion to the amount computed under clause (ii).
(F) Updating rate
The Secretary shall update such per resident amount for each such children's hospital by the estimated percentage increase in the consumer price index for all urban consumers during the period beginning October 1997 and ending with the midpoint of the Federal fiscal year for which payments are made.
(d) Amount of payment for indirect medical education
(1) In general
The amount determined under this subsection for payments to a children's hospital for indirect expenses associated with the treatment of more severely ill patients and the additional costs related to the teaching of residents for a fiscal year is equal to an amount determined appropriate by the Secretary.
(2) Factors
In determining the amount under paragraph (1), the Secretary shall—
(A) take into account variations in case mix among children's hospitals and the number of full-time equivalent residents in the hospitals' approved graduate medical residency training programs; and
(B) assure that the aggregate of the payments for indirect expenses associated with the treatment of more severely ill patients and the additional costs related to the teaching of residents under this section in a fiscal year are equal to the amount appropriated for such expenses for the fiscal year involved under subsection (f)(2) of this section.
(e) Making of payments
(1) Interim payments
The Secretary shall determine, before the beginning of each fiscal year involved for which payments may be made for a hospital under this section, the amounts of the payments for direct graduate medical education and indirect medical education for such fiscal year and shall (subject to paragraph (2)) make the payments of such amounts in 26 equal interim installments during such period. Such interim payments to each individual hospital shall be based on the number of residents reported in the hospital's most recently filed Medicare cost report prior to the application date for the Federal fiscal year for which the interim payment amounts are established. In the case of a hospital that does not report residents on a Medicare cost report, such interim payments shall be based on the number of residents trained during the hospital's most recently completed Medicare cost report filing period.
(2) Withholding
The Secretary shall withhold up to 25 percent from each interim installment for direct and indirect graduate medical education paid under paragraph (1). The Secretary shall withhold up to 25 percent from each interim installment for direct and indirect graduate medical education paid under paragraph (1) as necessary to ensure a hospital will not be overpaid on an interim basis.
(3) Reconciliation
Prior to the end of each fiscal year, the Secretary shall determine any changes to the number of residents reported by a hospital in the application of the hospital for the current fiscal year to determine the final amount payable to the hospital for the current fiscal year for both direct expense and indirect expense amounts. Based on such determination, the Secretary shall recoup any overpayments made to pay any balance due to the extent possible. The final amount so determined shall be considered a final intermediary determination for the purposes of
(f) Authorization of appropriations
(1) Direct graduate medical education
(A) In general
There are hereby authorized to be appropriated, out of any money in the Treasury not otherwise appropriated, for payments under subsection (b)(1)(A) of this section—
(i) for fiscal year 2000, $90,000,000;
(ii) for fiscal year 2001, $95,000,000; and
(iii) for each of the fiscal years 2002 through 2005, such sums as may be necessary.
(B) Carryover of excess
The amounts appropriated under subparagraph (A) for fiscal year 2000 shall remain available for obligation through the end of fiscal year 2001.
(2) Indirect medical education
There are hereby authorized to be appropriated, out of any money in the Treasury not otherwise appropriated, for payments under subsection (b)(1)(A) of this section—
(A) for fiscal year 2000, $190,000,000;
(B) for fiscal year 2001, $190,000,000; and
(C) for each of the fiscal years 2002 through 2005, such sums as may be necessary.
(g) Definitions
In this section:
(1) Approved graduate medical residency training program
The term "approved graduate medical residency training program" has the meaning given the term "approved medical residency training program" in
(2) Children's hospital
The term "children's hospital" means a hospital with a Medicare payment agreement and which is excluded from the Medicare inpatient prospective payment system pursuant to
(3) Direct graduate medical education costs
The term "direct graduate medical education costs" has the meaning given such term in
(July 1, 1944, ch. 373, title III, §340E, as added
References in Text
Amendments
2000—Subsec. (a).
Subsec. (c)(2)(F).
Subsec. (e)(1).
Subsec. (e)(2).
Subsec. (e)(3).
Subsec. (f)(1)(A)(iii).
Subsec. (f)(2)(C).
Subsec. (g)(2).
1 See References in Text note below.
Part E—Narcotic Addicts and Other Drug Abusers
§257. Repealed. Pub. L. 106–310, div. B, title XXXIV, §3405(a), Oct. 17, 2000, 114 Stat. 1221
Section, acts July 1, 1944, ch. 373, title III, §341,
§257a. Transferred
Codification
Section,
§258. Repealed. Pub. L. 106–310, div. B, title XXXIV, §3405(a), Oct. 17, 2000, 114 Stat. 1221
Section, acts July 1, 1944, ch. 373, title III, §342,
§258a. Transferred
Codification
Section, act July 8, 1947, ch. 210, title II, §201,
§§259 to 261a. Repealed. Pub. L. 106–310, div. B, title XXXIV, §3405(a), Oct. 17, 2000, 114 Stat. 1221
Section 259, acts July 1, 1944, ch. 373, title III, §343,
Section 260, acts July 1, 1944, ch. 373, title III, §344,
Section 260a, act July 1, 1944, ch. 373, title III, §345, as added May 8, 1954, ch. 195, §2,
Section 261, acts July 1, 1944, ch. 373, title III, §346, formerly §345,
Section 261a, act July 1, 1944, ch. 373, title III, §347, as added May 8, 1954, ch. 195, §4,
Part F—Licensing of Biological Products and Clinical Laboratories
subpart 1—biological products
§262. Regulation of biological products
(a) Biologics license
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c) of this section.
(3) The Secretary shall prescribe requirements under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1).
(b) Falsely labeling or marking package or container; altering label or mark
No person shall falsely label or mark any package or container of any biological product or alter any label or mark on the package or container of the biological product so as to falsify the label or mark.
(c) Inspection of establishment for propagation and preparation
Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the purpose, may during all reasonable hours enter and inspect any establishment for the propagation or manufacture and preparation of any biological product.
(d) Recall of product presenting imminent hazard; violations
(1) Upon a determination that a batch, lot, or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this paragraph shall be issued in accordance with
(2) Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year beginning 1 year after the effective date of this paragraph, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest 1/10 of 1 percent. For purposes of this paragraph, the term "base quarter", as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter.
(e) Interference with officers
No person shall interfere with any officer, agent, or employee of the Service in the performance of any duty imposed upon him by this section or by regulations made by authority thereof.
(f) Penalties for offenses
Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such fine and imprisonment, in the discretion of the court.
(g) Construction with other laws
Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act [
(h) Exportation of partially processed biological products
A partially processed biological product which—
(1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
(2) is not intended for sale in the United States; and
(3) is intended for further manufacture into final dosage form outside the United States,
shall be subject to no restriction on the export of the product under this chapter or the Federal Food, Drug, and Cosmetic Act [
(i) "Biological product" defined
In this section, the term "biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
(j) Application of Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act [
(July 1, 1944, ch. 373, title III, §351,
References in Text
The effective date of this paragraph, referred to in subsec. (d)(2), is the effective date of section 315 of
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (g), (h), and (j), is act June 25, 1938, ch. 675,
Amendments
1997—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (i).
Subsec. (j).
1996—Subsec. (h).
Subsec. (h)(1)(A).
1992—Subsec. (c).
1986—Subsec. (d).
Subsec. (h).
1970—Subsecs. (a) to (c).
1958—Subsec. (d).
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1986 Amendment
Section 105(b) of
Amendment by section 315 of
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
References to Secretary and Department of Health, Education, and Welfare substituted for references to Federal Security Administrator and Federal Security Agency, respectively, pursuant to Reorg. Plan No. 1 of 1953, §5, set out as a note under
Enhanced Penalties and Control of Biological Agents
"(a)
"(1) certain biological agents have the potential to pose a severe threat to public health and safety;
"(2) such biological agents can be used as weapons by individuals or organizations for the purpose of domestic or international terrorism or for other criminal purposes;
"(3) the transfer and possession of potentially hazardous biological agents should be regulated to protect public health and safety; and
"(4) efforts to protect the public from exposure to such agents should ensure that individuals and groups with legitimate objectives continue to have access to such agents for clinical and research purposes.
"(b)
"(c)
"(d)
"(1)
"(A)
"(B)
"(i) consider—
"(I) the effect on human health of exposure to the agent;
"(II) the degree of contagiousness of the agent and the methods by which the agent is transferred to humans;
"(III) the availability and effectiveness of immunizations to prevent and treatments for any illness resulting from infection by the agent; and
"(IV) any other criteria that the Secretary considers appropriate; and
"(ii) consult with scientific experts representing appropriate professional groups.
"(e)
"(1) the establishment and enforcement of safety procedures for the transfer of biological agents listed pursuant to subsection (d)(1), including measures to ensure—
"(A) proper training and appropriate skills to handle such agents; and
"(B) proper laboratory facilities to contain and dispose of such agents;
"(2) safeguards to prevent access to such agents for use in domestic or international terrorism or for any other criminal purpose;
"(3) the establishment of procedures to protect the public safety in the event of a transfer or potential transfer of a biological agent in violation of the safety procedures established under paragraph (1) or the safeguards established under paragraph (2); and
"(4) appropriate availability of biological agents for research, education, and other legitimate purposes.
"(f)
"(1) proposed rules not later than 60 days after the date of enactment of this Act [Apr. 24, 1996]; and
"(2) final rules not later than 120 days after the date of enactment of this Act.
"(g)
"(1) the term 'biological agent' has the same meaning as in
"(2) the term 'Secretary' means the Secretary of Health and Human Services."
Section Referred to in Other Sections
This section is referred to in
§263. Preparation of biological products by Service
(a) The Service may prepare for its own use any product described in
(b) The Service may prepare any product described in
(July 1, 1944, ch. 373, title III, §352,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
subpart 2—clinical laboratories
§263a. Certification of laboratories
(a) "Laboratory" or "clinical laboratory" defined
As used in this section, the term "laboratory" or "clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
(b) Certificate requirement
No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
(c) Issuance and renewal of certificates
(1) In general
The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d) of this section.
(2) Term
A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.
(d) Requirements for certificates
(1) In general
A laboratory may be issued a certificate or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e) of this section, the accreditation body which accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—
(I) the number and types of laboratory examinations and other procedures performed,
(II) the methodologies for laboratory examinations and other procedures employed, and
(III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(iii) that contains such other information as the Secretary may require to determine compliance with this section, and
the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months after the change was put into effect,
(B) the laboratory provides the Secretary—
(i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f) of this section, or
(ii) with proof of accreditation under subsection (e) of this section,
(C) the laboratory agrees to permit inspections by the Secretary under subsection (g) of this section,
(D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and
(E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business.
(2) Requirements for certificates of waiver
(A) In general
A laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if—
(i) the laboratory submits an application—
(I) in such form and manner as the Secretary shall prescribe,
(II) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(III) that contains such other information as the Secretary may reasonably require to determine compliance with this section, and
(ii) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require.
(B) Changes
If a laboratory makes changes in the examinations and other procedures performed by it only with respect to examinations and procedures which are described in paragraph (3), the laboratory shall report such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory proposes to make changes in the examinations and procedures performed by it such that the laboratory will perform an examination or procedure not described in paragraph (3), the laboratory shall report such change to the Secretary before the change takes effect.
(C) Effect
Subsections (f) and (g) of this section shall not apply to a laboratory to which has been issued a certificate of waiver.
(3) Examinations and procedures
The examinations and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that—
(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or
(B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.
(4) "Certificate" defined
As used in this section, the term "certificate" includes a certificate of waiver issued under paragraph (2).
(e) Accreditation
(1) In general
A laboratory may be accredited for purposes of obtaining a certificate if the laboratory—
(A) meets the standards of an approved accreditation body, and
(B) authorizes the accreditation body to submit to the Secretary (or such State agency as the Secretary may designate) such records or other information as the Secretary may require.
(2) Approval of accreditation bodies
(A) In general
The Secretary may approve a private nonprofit organization to be an accreditation body for the accreditation of laboratories if—
(i) using inspectors qualified to evaluate the methodologies used by the laboratories in performing laboratory examinations and other procedures, the accreditation body agrees to inspect a laboratory for purposes of accreditation with such frequency as determined by 1 Secretary,
(ii) the standards applied by the body in determining whether or not to accredit a laboratory are equal to or more stringent than the standards issued by the Secretary under subsection (f) of this section,
(iii) there is adequate provision for assuring that the standards of the accreditation body continue to be met by the laboratory,
(iv) in the case of any laboratory accredited by the body which has had its accreditation denied, suspended, withdrawn, or revoked or which has had any other action taken against it by the accrediting body, the accrediting body agrees to submit to the Secretary the name of such laboratory within 30 days of the action taken,
(v) the accreditation body agrees to notify the Secretary at least 30 days before it changes its standards, and
(vi) if the accreditation body has its approval withdrawn by the Secretary, the body agrees to notify each laboratory accredited by the body of the withdrawal within 10 days of the withdrawal.
(B) Criteria and procedures
The Secretary shall promulgate criteria and procedures for approving an accreditation body and for withdrawing such approval if the Secretary determines that the accreditation body does not meet the requirements of subparagraph (A).
(C) Effect of withdrawal of approval
If the Secretary withdraws the approval of an accreditation body under subparagraph (B), the certificate of any laboratory accredited by the body shall continue in effect for 60 days after the laboratory receives notification of the withdrawal of the approval, except that the Secretary may extend such period for a laboratory if it determines that the laboratory submitted an application for accreditation or a certificate in a timely manner after receipt of the notification of the withdrawal of approval. If an accreditation body withdraws or revokes the accreditation of a laboratory, the certificate of the laboratory shall continue in effect—
(i) for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or
(ii) until the effective date of any action taken by the Secretary under subsection (i) of this section.
(D) Evaluations
The Secretary shall evaluate annually the performance of each approved accreditation body by—
(i) inspecting under subsection (g) of this section a sufficient number of the laboratories accredited by such body to allow a reasonable estimate of the performance of such body, and
(ii) such other means as the Secretary determines appropriate.
(3) Omitted
(f) Standards
(1) In general
The Secretary shall issue standards to assure consistent performance by laboratories issued a certificate under this section of valid and reliable laboratory examinations and other procedures. Such standards shall require each laboratory issued a certificate under this section—
(A) to maintain a quality assurance and quality control program adequate and appropriate for the validity and reliability of the laboratory examinations and other procedures of the laboratory and to meet requirements relating to the proper collection, transportation, and storage of specimens and the reporting of results,
(B) to maintain records, equipment, and facilities necessary for the proper and effective operation of the laboratory,
(C) in performing and carrying out its laboratory examinations and other procedures, to use only personnel meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examinations and procedures within the laboratory, which qualifications shall take into consideration competency, training, experience, job performance, and education and which qualifications shall, as appropriate, be different on the basis of the type of examinations and procedures being performed by the laboratory and the risks and consequences of erroneous results associated with such examinations and procedures,
(D) to qualify under a proficiency testing program meeting the standards established by the Secretary under paragraph (3), and
(E) to meet such other requirements as the Secretary determines necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures.
(2) Considerations
In developing the standards to be issued under paragraph (1), the Secretary shall, within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration—
(A) the examinations and procedures performed and the methodologies employed,
(B) the degree of independent judgment involved,
(C) the amount of interpretation involved,
(D) the difficulty of the calculations involved,
(E) the calibration and quality control requirements of the instruments used,
(F) the type of training required to operate the instruments used in the methodology, and
(G) such other factors as the Secretary considers relevant.
(3) Proficiency testing program
(A) In general
The Secretary shall establish standards for the proficiency testing programs for laboratories issued a certificate under this section which are conducted by the Secretary, conducted by an organization approved under subparagraph (C), or conducted by an approved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for each examination and procedure conducted within a category of examinations or procedures for which it has received a certificate, except for examinations and procedures for which the Secretary has determined that a proficiency test cannot reasonably be developed. The testing shall be conducted on a quarterly basis, except where the Secretary determines for technical and scientific reasons that a particular examination or procedure may be tested less frequently (but not less often than twice per year).
(B) Criteria
The standards established under subparagraph (A) shall include uniform criteria for acceptable performance under a proficiency testing program, based on the available technology and the clinical relevance of the laboratory examination or other procedure subject to such program. The criteria shall be established for all examinations and procedures and shall be uniform for each examination and procedure. The standards shall also include a system for grading proficiency testing performance to determine whether a laboratory has performed acceptably for a particular quarter and acceptably for a particular examination or procedure or category of examination or procedure over a period of successive quarters.
(C) Approved proficiency testing programs
For the purpose of administering proficiency testing programs which meet the standards established under subparagraph (A), the Secretary shall approve a proficiency testing program offered by a private nonprofit organization or a State if the program meets the standards established under subparagraph (A) and the organization or State provides technical assistance to laboratories seeking to qualify under the program. The Secretary shall evaluate each program approved under this subparagraph annually to determine if the program continues to meet the standards established under subparagraph (A) and shall withdraw the approval of any program that no longer meets such standards.
(D) Onsite testing
The Secretary shall perform, or shall direct a program approved under subparagraph (C) to perform, onsite proficiency testing to assure compliance with the requirements of subsection (d)(5) of this section. The Secretary shall perform, on an onsite or other basis, proficiency testing to evaluate the performance of a proficiency testing program approved under subparagraph (C) and to assure quality performance by a laboratory.
(E) Training, technical assistance, and enhanced proficiency testing
The Secretary may, in lieu of or in addition to actions authorized under subsection (h), (i), or (j) of this section, require any laboratory which fails to perform acceptably on an individual examination and procedure or a category of examination and procedures—
(i) to undertake training and to obtain the necessary technical assistance to meet the requirements of the proficency 2 testing program,
(ii) to enroll in a program of enhanced proficiency testing, or
(iii) to undertake any combination of the training, technical assistance, or testing described in clauses (i) and (ii).
(F) Testing results
The Secretary shall establish a system to make the results of the proficiency testing programs subject to the standards established by the Secretary under subparagraph (A) available, on a reasonable basis, upon request of any person. The Secretary shall include with results made available under this subparagraph such explanatory information as may be appropriate to assist in the interpretation of such results.
(4) National standards for quality assurance in cytology services
(A) Establishment
The Secretary shall establish national standards for quality assurance in cytology services designed to assure consistent performance by laboratories of valid and reliable cytological services.
(B) Standards
The standards established under subparagraph (A) shall include—
(i) the maximum number of cytology slides that any individual may screen in a 24-hour period,
(ii) requirements that a clinical laboratory maintain a record of (I) the number of cytology slides screened during each 24-hour period by each individual who examines cytology slides for the laboratory, and (II) the number of hours devoted during each 24-hour period to screening cytology slides by such individual,
(iii) criteria for requiring rescreening of cytological preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II) focused rescreening of such preparations in high risk groups, and (III) for each abnormal cytological result, rescreening of all prior cytological specimens for the patient, if available,
(iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions,
(v) procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physicians of such slides,
(vi) requirements that all cytological screening be done on the premises of a laboratory that is certified under this section,
(vii) requirements for the retention of cytology slides by laboratories for such periods of time as the Secretary considers appropriate, and
(viii) standards requiring periodic inspection of cytology services by persons capable of evaluating the quality of cytology services.
(g) Inspections
(1) In general
The Secretary may, on an announced or unannounced basis, enter and inspect, during regular hours of operation, laboratories which have been issued a certificate under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials, records, and information that the Secretary determines have a bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the Secretary may copy any such material or require to it 3 be submitted to the Secretary. An inspection under this paragraph may be made only upon presenting identification to the owner, operator, or agent in charge of the laboratory being inspected.
(2) Compliance with requirements and standards
The Secretary shall conduct inspections of laboratories under paragraph (1) to determine their compliance with the requirements of subsection (d) of this section and the standards issued under subsection (f) of this section. Inspections of laboratories not accredited under subsection (e) of this section shall be conducted on a biennial basis or with such other frequency as the Secretary determines to be necessary to assure compliance with such requirements and standards. Inspections of laboratories accredited under subsection (e) of this section shall be conducted on such basis as the Secretary determines is necessary to assure compliance with such requirements and standards.
(h) Intermediate sanctions
(1) In general
If the Secretary determines that a laboratory which has been issued a certificate under this section no longer substantially meets the requirements for the issuance of a certificate, the Secretary may impose intermediate sanctions in lieu of the actions authorized by subsection (i) of this section.
(2) Types of sanctions
The intermediate sanctions which may be imposed under paragraph (1) shall consist of—
(A) directed plans of correction,
(B) civil money penalties in an amount not to exceed $10,000 for each violation listed in subsection (i)(1) of this section or for each day of substantial noncompliance with the requirements of this section,
(C) payment for the costs of onsite monitoring, or
(D) any combination of the actions described in subparagraphs (A), (B), and (C).
(3) Procedures
The Secretary shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under paragraph (1). Such procedures shall provide for notice to the laboratory and a reasonable opportunity to respond to the proposed sanction and appropriate procedures for appealing determinations relating to the imposition of intermediate sanctions 4
(i) Suspension, revocation, and limitation
(1) In general
Except as provided in paragraph (2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory—
(A) has been guilty of misrepresentation in obtaining the certificate,
(B) has performed or represented the laboratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examinations or other procedures authorized in the certificate,
(C) has failed to comply with the requirements of subsection (d) of this section or the standards prescribed by the Secretary under subsection (f) of this section,
(D) has failed to comply with reasonable requests of the Secretary for—
(i) any information or materials, or
(ii) work on materials,
that the Secretary concludes is necessary to determine the laboratory's continued eligibility for its certificate or continued compliance with the Secretary's standards under subsection (f) of this section,
(E) has refused a reasonable request of the Secretary, or any Federal officer or employee duly designated by the Secretary, for permission to inspect the laboratory and its operations and pertinent records during the hours the laboratory is in operation,
(F) has violated or aided and abetted in the violation of any provisions of this section or of any regulation promulgated thereunder, or
(G) has not complied with an intermediate sanction imposed under subsection (h) of this section.
(2) Action before a hearing
If the Secretary determines that—
(A) the failure of a laboratory to comply with the standards of the Secretary under subsection (f) of this section presents an imminent and serious risk to human health, or
(B) a laboratory has engaged in an action described in subparagraph (D) or (E) of paragraph (1),
the Secretary may suspend or limit the certificate of the laboratory before holding a hearing under paragraph (1) regarding such failure or refusal. The opportunity for a hearing shall be provided no later than 60 days from the effective date of the suspension or limitation. A suspension or limitation under this paragraph shall stay in effect until the decision of the Secretary made after the hearing under paragraph (1).
(3) Ineligibility to own or operate laboratories after revocation
No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section. The certificate of a laboratory which has been excluded from participation under the medicare program under title XVIII of the Social Security Act [
(4) Improper referrals
Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis shall have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h) of this section.
(j) Injunctions
Whenever the Secretary has reason to believe that continuation of any activity by a laboratory would constitute a significant hazard to the public health the Secretary may bring suit in the district court of the United States for the district in which such laboratory is situated to enjoin continuation of such activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity pending issuance of a final order under this subsection shall be granted without bond by such court.
(k) Judicial review
(1) Petition
Any laboratory which has had an intermediate sanction imposed under subsection (h) of this section or has had its certificate suspended, revoked, or limited under subsection (i) of this section may, at any time within 60 days after the date the action of the Secretary under subsection (i) or (h) of this section becomes final, file a petition with the United States court of appeals for the circuit wherein the laboratory has its principal place of business for judicial review of such action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary for that purpose. As soon as practicable after receipt of the copy, the Secretary shall file in the court the record on which the action of the Secretary is based, as provided in
(2) Additional evidence
If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal of such additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file such modified or new findings, and the recommendations of the Secretary, if any, for the modification or setting aside of his original action, with the return of such additional evidence.
(3) Judgment of court
Upon the filing of the petition referred to in paragraph (1), the court shall have jurisdiction to affirm the action, or to set it aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.
(4) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any such action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in
(l) Sanctions
Any person who intentionally violates any requirement of this section or any regulation promulgated thereunder shall be imprisoned for not more than one year or fined under title 18, or both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with title 18, or both.
(m) Fees
(1) Certificate fees
The Secretary shall require payment of fees for the issuance and renewal of certificates, except that the Secretary shall only require a nominal fee for the issuance and renewal of certificates of waiver.
(2) Additional fees
The Secretary shall require the payment of fees for inspections of laboratories which are not accredited and for the cost of performing proficiency testing on laboratories which do not participate in proficiency testing programs approved under subsection (f)(3)(C) of this section.
(3) Criteria
(A) Fees under paragraph (1)
Fees imposed under paragraph (1) shall be sufficient to cover the general costs of administering this section, including evaluating and monitoring proficiency testing programs approved under subsection (f) of this section and accrediting bodies and implementing and monitoring compliance with the requirements of this section.
(B) Fees under paragraph (2)
Fees imposed under paragraph (2) shall be sufficient to cover the cost of the Secretary in carrying out the inspections and proficiency testing described in paragraph (2).
(C) Fees imposed under paragraphs (1) and (2)
Fees imposed under paragraphs (1) and (2) shall vary by group or classification of laboratory, based on such considerations as the Secretary determines are relevant, which may include the dollar volume and scope of the testing being performed by the laboratories.
(n) Information
On April 1, 1990 and annually thereafter, the Secretary shall compile and make available to physicians and the general public information, based on the previous calendar year, which the Secretary determines is useful in evaluating the performance of a laboratory, including—
(1) a list of laboratories which have been convicted under Federal or State laws relating to fraud and abuse, false billings, or kickbacks,
(2) a list of laboratories—
(A) which have had their certificates revoked, suspended, or limited under subsection (i) of this section, or
(B) which have been the subject of a sanction under subsection (l) of this section,
together with a statement of the reasons for the revocation, suspension, limitation, or sanction,
(3) a list of laboratories subject to intermediate sanctions under subsection (h) of this section together with a statement of the reasons for the sanctions,
(4) a list of laboratories whose accreditation has been withdrawn or revoked together with a statement of the reasons for the withdrawal or revocation,
(5) a list of laboratories against which the Secretary has taken action under subsection (j) of this section together with a statement of the reasons for such action, and
(6) a list of laboratories which have been excluded from participation under title XVIII or XIX of the Social Security Act [
The information to be compiled under paragraphs (1) through (6) shall be information for the calendar year preceding the date the information is to be made available to the public and shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraphs.
(o) Delegation
In carrying out this section, the Secretary may, pursuant to agreement, use the services or facilities of any Federal or State or local public agency or nonprofit private organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as the Secretary may determine.
(p) State laws
(1) Except as provided in paragraph (2), nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with this section or with the regulations issued under this section.
(2) If a State enacts laws relating to matters covered by this section which provide for requirements equal to or more stringent than the requirements of this section or than the regulations issued under this section, the Secretary may exempt clinical laboratories in that State from compliance with this section.
(q) Consultations
In carrying out this section, the Secretary shall consult with appropriate private organizations and public agencies.
(July 1, 1944, ch. 373, title III, §353, as added
References in Text
The Social Security Act, referred to in subsecs. (i)(3) and (n)(6), is act Aug. 14, 1935, ch. 531,
Codification
Subsec. (e)(3) of this section, which required the Secretary to annually prepare and submit to certain committees of Congress a report describing the results of the evaluation conducted under subsec. (e)(2)(D) of this section, terminated, effective May 15, 2000, pursuant to section 3003 of
Amendments
1997—Subsec. (d)(3).
"(A) have been approved by the Food and Drug Administration for home use,
"(B) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or
"(C) the Secretary has determined pose no reasonable risk of harm to the patient if performed incorrectly."
1988—
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1988 Amendment; Exceptions; Continuing Applicability
Section 3 of
Effective Date
Section 5(b) of
Studies
Section 4 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "by the".
2 So in original. Probably should be "proficiency".
3 So in original. Probably should be "require it to".
4 So in original. Probably should be followed by a period.
§263a–1. Assisted reproductive technology programs
(a) In general
Effective 2 years after October 24, 1992, each assisted reproductive technology (as defined in section 263a–7 1 of this title) program shall annually report to the Secretary through the Centers for Disease Control—
(1) pregnancy success rates achieved by such program through each assisted reproductive technology, and
(2) the identity of each embryo laboratory (as defined in section 263a–7 1 of this title) used by such program and whether the laboratory is certified under
(b) Pregnancy success rates
(1) In general
For purposes of subsection (a)(1) of this section, the Secretary shall, in consultation with the organizations referenced in subsection (c) of this section, define pregnancy success rates and shall make public any proposed definition in such manner as to facilitate comment from any person (including any Federal or other public agency) during its development.
(2) Definition
In developing the definition of pregnancy success rates, the Secretary shall take into account the effect on success rates of age, diagnosis, and other significant factors and shall include in such rates—
(A) the basic live birth rate calculated for each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of pregnancies which result in live births by the number of ovarian stimulation procedures attempted by such program, and
(B) the live birth rate per successful oocyte retrieval procedure calculated for each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of pregnancies which result in live births by the number of successful oocyte retrieval procedures performed by such program.
(c) Consultation
In developing the definition under subsection (b) of this section, the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with assisted reproductive technologies.
(
References in Text
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section 9 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§263a–2. Certification of embryo laboratories
(a) In general
(1) Development
Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall develop a model program for the certification of embryo laboratories (referred to in this section as a "certification program") to be carried out by the States.
(2) Consultation
In developing the certification program under paragraph (1), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with the assisted reproductive technology programs.
(b) Distribution
The Secretary shall distribute a description of the certification program to—
(1) the Governor of each State,
(2) the presiding officers of each State legislature,
(3) the public health official of each State, and
(4) the official responsible in each State for the operation of the State's contract with the Secretary under
and shall encourage such officials to assist in the State adopting such program.
(c) Requirements
The certification program shall include the following requirements:
(1) Administration
The certification program shall be administered by the State and shall provide for the inspection and certification of embryo laboratories in the State by the State or by approved accreditation organizations.
(2) Application requirements
The certification program shall provide for the submission of an application to a State by an embryo laboratory for certification, in such form as may be specified by the State. Such an application shall include—
(A) assurances satisfactory to the State that the embryo laboratory will be operated in accordance with the standards under subsection (d) of this section,
(B) a report to the State identifying the assisted reproductive technology programs with which the laboratory is associated, and
(C) such other information as the State finds necessary.
An embryo laboratory which meets the requirements of
(d) Standards
The certification program shall include the following standards developed by the Secretary:
(1) A standard to assure consistent performance of procedures by each embryo laboratory certified under the certification program or by an approved accreditation organization in a State which has not adopted the certification program.
(2) A standard for a quality assurance and a quality control program to assure valid, reliable, and reproduceable 1 procedures in the laboratory.
(3) A standard for the maintenance of records (on a program by program basis) on laboratory tests and procedures performed, including the scientific basis of, and the methodology used for, the tests, procedures, and preparation of any standards or controls, criteria for acceptable and unacceptable outcomes, criteria for sample rejection, and procedures for safe sample disposal.
(4) A standard for the maintenance of written records on personnel and facilities necessary for proper and effective operation of the laboratory, schedules of preventive maintenance, function verification for equipment, and the release of such records to the State upon demand.
(5) A standard for the use of such personnel who meet such qualifications as the Secretary may develop.
(e) Certification under State programs
A State may qualify to adopt the certification program if the State has submitted an application to the Secretary to adopt such program and the Secretary has approved the application. Such an application shall include—
(1) assurances by the State satisfactory to the Secretary that the certification program within the State meets the requirements of this section,
(2) an agreement to make such reports as the Secretary may require, and
(3) information about any proposed use of accreditation organizations under subsection (g) 2 of this section.
(f) Use of accreditation organizations
A State which has adopted the certification program may use accreditation organizations approved under
(g) Inspections
(1) In general
A State which qualifies to adopt the certification program within the State shall conduct inspections in accordance with paragraph (2) to determine if laboratories in the State meet the requirements of such program. Such inspections shall be carried out by the State or by accreditation organizations used by the State under subsection (g) 2 of this section.
(2) Requirements
Inspections carried out under paragraph (1) shall—
(A) be periodic and unannounced, or
(B) be announced in such circumstances as the Secretary determines will not diminish the likelihood of discovering deficiencies in the operations of a laboratory.
Before making a determination under subparagraph (B), the Secretary shall make public, in such manner as to facilitate comment from any person (including any Federal or other public agency), a proposal indicating the circumstances under which announced inspections would be permitted.
(3) Results
The specific findings, including deficiencies, identified in an inspection carried out under paragraph (1) and any subsequent corrections to those deficiencies shall be announced and made available to the public upon request beginning no later than 60 days after the date of the inspection.
(h) Validation inspections
(1) In general
The Secretary may enter and inspect, during regular hours of operation, embryo laboratories—
(A) which have been certified by a State under the certification program, or
(B) which have been certified by an accreditation organization approved by the Secretary under
for the purpose of determining whether the laboratory is being operated in accordance with the standards in subsection (d) of this section.
(2) Access to facilities and records
In conducting an inspection of an embryo laboratory under paragraph (1), the Secretary shall have access to all facilities, equipment, materials, records, and information which the Secretary determines is necessary to determine if such laboratory is being operated in accordance with the standards in subsection (d) of this section. As part of such an inspection, the Secretary may copy any material, record, or information inspected or require it to be submitted to the Secretary. Such an inspection may be made only upon the presentation of identification to the owner, operator, or agent in charge of the laboratory being inspected.
(3) Failure to comply
If the Secretary determines as a result of an inspection under paragraph (1) that the embryo laboratory is not in compliance with the standards in subsection (d) of this section, the Secretary shall—
(A) notify the State in which the laboratory is located and, if appropriate, the accreditation organization which certified the laboratory,
(B) make available to the public the results of the inspection,
(C) conduct additional inspections of other embryo laboratories under paragraph (1) to determine if—
(i) such State in carrying out the certification program is reliably identifying the deficiencies of such laboratory, or
(ii) the accreditation organization which certified such laboratories is reliably identifying such deficencies,3 and
(D) if the Secretary determines—
(i) that such State in carrying out the certification program has not met the requirements applicable to such program, or
(ii) the accreditation organization which certified such laboratory has not met the requirements of
the Secretary may revoke the approval of the State certification program or revoke the approval of such accreditation organization.
(i) Limitation
(1) Secretary
In developing the certification program, the Secretary may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.
(2) State
In adopting the certification program, a State may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.
(j) Term
The term of a certification issued by a State or an accreditation organization in a State shall be prescribed by the Secretary in the certification program and shall be valid for a period of time to be defined by the Secretary through the public comment process described in subsection (h)(2) 4 of this section. The Secretary shall provide an application for recertification to be submitted at the time of changes in the ownership of a certified laboratory or changes in the administration of such a laboratory.
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "reproducible".
2 So in original. Probably should be subsection "(f)".
3 So in original. Probably should be "deficiencies,".
4 So in original. Probably should be subsection "(g)(2)".
§263a–3. Accreditation organizations
(a) Approval of accreditation organizations
Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall promulgate criteria and procedures for the approval of accreditation organizations to inspect and certify embryo laboratories. The procedures shall require an application to the Secretary by an accreditation organization for approval. An accreditation organization which has received such an approval—
(1) may be used by States in the certification program under
(2) may certify embryo laboratories in States which have not adopted such a certification program.
(b) Criteria and procedures
The criteria and procedures promulgated under subsection (a) of this section shall include—
(1) requirements for submission of such reports and the maintenance of such records as the Secretary or a State may require, and
(2) requirements for the conduct of inspections under section 263a–2(h) 1 of this title.
(c) Evaluations
The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—
(1) inspecting under section 263a–2(i) 2 of this title a sufficient number of embryo laboratories accredited by such an organization to allow a reasonable estimate of the performance of such organization, and
(2) such other means as the Secretary determines to be appropriate.
(d) Transition
If the Secretary revokes approval under section 263a–2(i)(3)(D) 3 of this title of an accreditation organization after an evaluation under subsection (c) of this section, the certification of any embryo laboratory accredited by the organization shall continue in effect for 60 days after the laboratory is notified by the Secretary of the withdrawal of approval, except that the Secretary may extend the period during which the certification shall remain in effect if the Secretary determines that the laboratory submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be section "263a–2(g)".
2 So in original. Probably should be section "263a–2(h)".
3 So in original. Probably should be section "263a–2(h)(3)(D)".
§263a–4. Certification revocation and suspension
(a) In general
A certification issued by a State or an accreditation organization for an embryo laboratory shall be revoked or suspended if the State or organization finds, on the basis of inspections and after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that the owner or operator or any employee of the laboratory—
(1) has been guilty of misrepresentation in obtaining the certification,
(2) has failed to comply with any standards under
(3) has refused a request of the State or accreditation organization for permission to inspect the laboratory, its operations, and records.
(b) Effect
If the certification of an embryo laboratory is revoked or suspended, the certification of the laboratory shall continue in effect for 60 days after the laboratory receives notice of the revocation or suspension. If the certification of an embryo laboratory is revoked or suspended, the laboratory may apply for recertification after one year after the date of the revocation or suspension.
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
§263a–5. Publication
The Secretary, through the Centers for Disease Control, shall not later than 3 years after October 24, 1992, and annually thereafter publish and distribute to the States and the public—
(1)(A) 1 pregnancy success rates reported to the Secretary under
(B) from information reported under
(i) the identity of each embryo laboratory in a State which has adopted the certification program under such program and whether such laboratory is certified under
(ii) the identity of each embryo laboratory in a State which has not adopted such certification program and which has been certified by an accreditation organization approved by the Secretary under
(iii) in the case of an embryo laboratory which is not certified under
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. No par. (2) has been enacted.
§263a–6. Fees
The Secretary may require the payment of fees for the purpose of, and in an amount sufficient to cover the cost of, administering
(
References in Text
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
§263a–7. Definitions
For purposes of
(1) Assisted reproductive technology
The term "assisted reproductive technology" means all treatments or procedures which include the handling of human oocytes or embryos, including in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, and such other specific technologies as the Secretary may include in this definition, after making public any proposed definition in such manner as to facilitate comment from any person (including any Federal or other public agency).
(2) Embryo laboratory
The term "embryo laboratory" means a facility in which human oocytes are subject to assisted reproductive technology treatment or procedures based on manipulation of oocytes or embryos which are subject to implantation.
(3) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(
References in Text
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
subpart 3—mammography facilities
Prior Provisions
A prior subpart 3 of part F of title III of the Public Health Service Act, comprising this subpart, was renumbered subchapter C of chapter V of the Federal Food, Drug, and Cosmetic Act, by
§263b. Certification of mammography facilities
(a) Definitions
As used in this section:
(1) Accreditation body
The term "accreditation body" means a body that has been approved by the Secretary under subsection (e)(1)(A) of this section to accredit mammography facilities.
(2) Certificate
The term "certificate" means the certificate described in subsection (b)(1) of this section.
(3) Facility
(A) In general
The term "facility" means a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility as determined by the Secretary, that conducts breast cancer screening or diagnosis through mammography activities. Such term does not include a facility of the Department of Veterans Affairs.
(B) Activities
For the purposes of this section, the activities of a facility include the operation of equipment to produce the mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation. Where procedures such as the film processing, or the interpretation of the mammogram are performed in a location different from where the mammogram is performed, the facility performing the mammogram shall be responsible for meeting the quality standards described in subsection (f) of this section.
(4) Inspection
The term "inspection" means an onsite evaluation of the facility by the Secretary, or State or local agency on behalf of the Secretary.
(5) Mammogram
The term "mammogram" means a radiographic image produced through mammography.
(6) Mammography
The term "mammography" means radiography of the breast.
(7) Survey
The term "survey" means an onsite physics consultation and evaluation performed by a medical physicist as described in subsection (f)(1)(E) of this section.
(8) Review physician
The term "review physician" means a physician as prescribed by the Secretary under subsection (f)(1)(D) of this section who meets such additional requirements as may be established by an accreditation body under subsection (e) of this section and approved by the Secretary to review clinical images under subsection (e)(1)(B)(i) of this section on behalf of the accreditation body.
(b) Certificate requirement
(1) Certificate
No facility may conduct an examination or procedure described in paragraph (2) involving mammography after October 1, 1994, unless the facility obtains—
(A) a certificate—
(i) that is issued, and, if applicable, renewed, by the Secretary in accordance with subsection (c)(1) of this section;
(ii) that is applicable to the examination or procedure to be conducted; and
(iii) that is displayed prominently in such facility; or
(B) a provisional certificate—
(i) that is issued by the Secretary in accordance with subsection (c)(2) of this section;
(ii) that is applicable to the examination or procedure to be conducted; and
(iii) that is displayed prominently in such facility.
The reference to a certificate in this section includes a provisional certificate.
(2) Examination or procedure
A facility shall obtain a certificate in order to—
(A) operate radiological equipment that is used to image the breast;
(B) provide for the interpretation of a mammogram produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed; and
(C) provide for the processing of film produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed.
(c) Issuance and renewal of certificates
(1) In general
The Secretary may issue or renew a certificate for a facility if the person or agent described in subsection (d)(1)(A) of this section meets the applicable requirements of subsection (d)(1) of this section with respect to the facility. The Secretary may issue or renew a certificate under this paragraph for not more than 3 years.
(2) Provisional certificate
The Secretary may issue a provisional certificate for an entity to enable the entity to qualify as a facility. The applicant for a provisional certificate shall meet the requirements of subsection (d)(1) of this section, except providing information required by clauses (iii) and (iv) of subsection (d)(1)(A) of this section. A provisional certificate may be in effect no longer than 6 months from the date it is issued, except that it may be extended once for a period of not more than 90 days if the owner, lessor, or agent of the facility demonstrates to the Secretary that without such extension access to mammography in the geographic area served by the facility would be significantly reduced and if the owner, lessor, or agent of the facility will describe in a report to the Secretary steps that will be taken to qualify the facility for certification under subsection (b)(1) of this section.
(d) Application for certificate
(1) Submission
The Secretary may issue or renew a certificate for a facility if—
(A) the person who owns or leases the facility or an authorized agent of the person, submits to the Secretary, in such form and manner as the Secretary shall prescribe, an application that contains at a minimum—
(i) a description of the manufacturer, model, and type of each x-ray machine, image receptor, and processor operated in the performance of mammography by the facility;
(ii) a description of the procedures currently used to provide mammography at the facility, including—
(I) the types of procedures performed and the number of such procedures performed in the prior 12 months;
(II) the methodologies for mammography; and
(III) the names and qualifications (educational background, training, and experience) of the personnel performing mammography and the physicians reading and interpreting the results from the procedures;
(iii) proof of on-site survey by a qualified medical physicist as described in subsection (f)(1)(E) of this section; and
(iv) proof of accreditation in such manner as the Secretary shall prescribe; and
(B) the person or agent submits to the Secretary—
(i) a satisfactory assurance that the facility will be operated in accordance with standards established by the Secretary under subsection (f) of this section to assure the safety and accuracy of mammography;
(ii) a satisfactory assurance that the facility will—
(I) permit inspections under subsection (g) of this section;
(II) make such records and information available, and submit such reports, to the Secretary as the Secretary may require; and
(III) update the information submitted under subparagraph (A) or assurances submitted under this subparagraph on a timely basis as required by the Secretary; and
(iii) such other information as the Secretary may require.
An applicant shall not be required to provide in an application under subparagraph (A) any information which the applicant has supplied to the accreditation body which accredited the applicant, except as required by the Secretary.
(2) Appeal
If the Secretary denies an application for the certification of a facility submitted under paragraph (1)(A), the Secretary shall provide the owner or lessor of the facility or the agent of the owner or lessor who submitted such application—
(A) a statement of the grounds on which the denial is based, and
(B) an opportunity for an appeal in accordance with the procedures set forth in regulations of the Secretary published at part 498 of title 42, Code of Federal Regulations.
(3) Effect of denial
If the application for the certification of a facility is denied, the facility may not operate unless the denial of the application is overturned at the conclusion of the administrative appeals process provided in the regulations referred to in paragraph (2)(B).
(e) Accreditation
(1) Approval of accreditation bodies
(A) In general
The Secretary may approve a private nonprofit organization or State agency to accredit facilities for purposes of subsection (d)(1)(A)(iv) of this section if the accreditation body meets the standards for accreditation established by the Secretary as described in subparagraph (B) and provides the assurances required by subparagraph (C).
(B) Standards
The Secretary shall establish standards for accreditation bodies, including—
(i) standards that require an accreditation body to perform—
(I) a review of clinical images from each facility accredited by such body not less often than every 3 years which review will be made by qualified review physicians; and
(II) a review of a random sample of clinical images from such facilities in each 3-year period beginning October 1, 1994, which review will be made by qualified review physicians;
(ii) standards that prohibit individuals conducting the reviews described in clause (i) from maintaining any relationship to the facility undergoing review which would constitute a conflict of interest;
(iii) standards that limit the imposition of fees for accreditation to reasonable amounts;
(iv) standards that require as a condition of accreditation that each facility undergo a survey at least annually by a medical physicist as described in subsection (f)(1)(E) of this section to ensure that the facility meets the standards described in subparagraphs (A) and (B) of subsection (f)(1) of this section;
(v) standards that require monitoring and evaluation of such survey, as prescribed by the Secretary;
(vi) standards that are equal to standards established under subsection (f) of this section which are relevant to accreditation as determined by the Secretary; and
(vii) such additional standards as the Secretary may require.
(C) Assurances
The accrediting body shall provide the Secretary satisfactory assurances that the body will—
(i) comply with the standards as described in subparagraph (B);
(ii) comply with the requirements described in paragraph (4);
(iii) submit to the Secretary the name of any facility for which the accreditation body denies, suspends, or revokes accreditation;
(iv) notify the Secretary in a timely manner before the accreditation body changes the standards of the body;
(v) notify each facility accredited by the accreditation body if the Secretary withdraws approval of the accreditation body under paragraph (2) in a timely manner; and
(vi) provide such other additional information as the Secretary may require.
(D) Regulations
Not later than 9 months after October 27, 1992, the Secretary shall promulgate regulations under which the Secretary may approve an accreditation body.
(2) Withdrawal of approval
(A) In general
The Secretary shall promulgate regulations under which the Secretary may withdraw the approval of an accreditation body if the Secretary determines that the accreditation body does not meet the standards under subparagraph (B) of paragraph (1), the requirements of clauses (i) through (vi) of subparagraph (C) of paragraph (1), or the requirements of paragraph (4).
(B) Effect of withdrawal
If the Secretary withdraws the approval of an accreditation body under subparagraph (A), the certificate of any facility accredited by the body shall continue in effect until the expiration of a reasonable period, as determined by the Secretary, for such facility to obtain another accreditation.
(3) Accreditation
To be accredited by an approved accreditation body a facility shall meet—
(A) the standards described in paragraph (1)(B) which the Secretary determines are applicable to the facility, and
(B) such other standards which the accreditation body may require.
(4) Compliance
To ensure that facilities accredited by an accreditation body will continue to meet the standards of the accreditation body, the accreditation body shall—
(A) make onsite visits on an annual basis of a sufficient number of the facilities accredited by the body to allow a reasonable estimate of the performance of the body; and
(B) take such additional measures as the Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be made after providing such notice as the Secretary may require.
(5) Revocation of accreditation
If an accreditation body revokes the accreditation of a facility, the certificate of the facility shall continue in effect until such time as may be determined by the Secretary.
(6) Evaluation and report
(A) Evaluation
The Secretary shall evaluate annually the performance of each approved accreditation body by—
(i) inspecting under subsection (g)(2) of this section a sufficient number of the facilities accredited by the body to allow a reasonable estimate of the performance of the body; and
(ii) such additional means as the Secretary determines to be appropriate.
(B) Report
The Secretary shall annually prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes the results of the evaluation conducted in accordance with subparagraph (A).
(f) Quality standards
(1) In general
The standards referred to in subsection (d)(1)(B)(i) of this section are standards established by the Secretary which include—
(A) standards that require establishment and maintenance of a quality assurance and quality control program at each facility that is adequate and appropriate to ensure the reliability, clarity, and accuracy of interpretation of mammograms and standards for appropriate radiation dose;
(B) standards that require use of radiological equipment specifically designed for mammography, including radiologic standards and standards for other equipment and materials used in conjunction with such equipment;
(C) a requirement that personnel who perform mammography—
(i)(I) be licensed by a State to perform radiological procedures; or
(II) be certified as qualified to perform radiological procedures by an organization described in paragraph (2)(A); and
(ii) during the 2-year period beginning October 1, 1994, meet training standards for personnel who perform mammography or meet experience requirements which shall at a minimum include 1 year of experience in the performance of mammography; and
(iii) upon the expiration of such 2-year period meet minimum training standards for personnel who perform mammograms;
(D) a requirement that mammograms be interpreted by a physician who is certified as qualified to interpret radiological procedures, including mammography—
(i)(I) by a board described in paragraph (2)(B); or
(II) by a program that complies with the standards described in paragraph (2)(C); and
(ii) who meets training and continuing medical education requirements as established by the Secretary;
(E) a requirement that individuals who survey mammography facilities be medical physicists—
(i) licensed or approved by a State to perform such surveys, reviews, or inspections for mammography facilities;
(ii) certified in diagnostic radiological physics or certified as qualified to perform such surveys by a board as described in paragraph (2)(D); or
(iii) in the first 5 years after October 27, 1992, who meet other criteria established by the Secretary which are comparable to the criteria described in clause (i) or (ii);
(F) a requirement that a medical physicist who is qualified in mammography as described in subparagraph (E) survey mammography equipment and oversee quality assurance practices at each facility;
(G) a requirement that—
(i) a facility that performs any mammogram—
(I) except as provided in subclause (II), maintain the mammogram in the permanent medical records of the patient for a period of not less than 5 years, or not less than 10 years if no subsequent mammograms of such patient are performed at the facility, or longer if mandated by State law; and
(II) upon the request of or on behalf of the patient, transfer the mammogram to a medical institution, to a physician of the patient, or to the patient directly; and
(ii)(I) a facility must assure the preparation of a written report of the results of any mammography examination signed by the interpreting physician;
(II) such written report shall be provided to the patient's physicians (if any);
(III) if such a physician is not available or if there is no such physician, the written report shall be sent directly to the patient; and
(IV) whether or not such a physician is available or there is no such physician, a summary of the written report shall be sent directly to the patient in terms easily understood by a lay person; and
(H) standards relating to special techniques for mammography of patients with breast implants.
Subparagraph (G) shall not be construed to limit a patient's access to the patient's medical records.
(2) Certification of personnel
The Secretary shall by regulation—
(A) specify organizations eligible to certify individuals to perform radiological procedures as required by paragraph (1)(C);
(B) specify boards eligible to certify physicians to interpret radiological procedures, including mammography, as required by paragraph (1)(D);
(C) establish standards for a program to certify physicians described in paragraph (1)(D); and
(D) specify boards eligible to certify medical physicists who are qualified to survey mammography equipment and to oversee quality assurance practices at mammography facilities.
(g) Inspections
(1) Annual inspections
(A) In general
The Secretary may enter and inspect facilities to determine compliance with the certification requirements under subsection (b) of this section and the standards established under subsection (f) of this section. The Secretary shall, if feasible, delegate to a State or local agency the authority to make such inspections.
(B) Identification
The Secretary, or State or local agency acting on behalf of the Secretary, may conduct inspections only on presenting identification to the owner, operator, or agent in charge of the facility to be inspected.
(C) Scope of inspection
In conducting inspections, the Secretary or State or local agency acting on behalf of the Secretary—
(i) shall have access to all equipment, materials, records, and information that the Secretary or State or local agency considers necessary to determine whether the facility is being operated in accordance with this section; and
(ii) may copy, or require the facility to submit to the Secretary or the State or local agency, any of the materials, records, or information.
(D) Qualifications of inspectors
Qualified individuals, as determined by the Secretary, shall conduct all inspections. The Secretary may request that a State or local agency acting on behalf of the Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal officer or employee to conduct inspections. The Secretary shall establish minimum qualifications and appropriate training for inspectors and criteria for certification of inspectors in order to inspect facilities for compliance with subsection (f) of this section.
(E) Frequency
The Secretary or State or local agency acting on behalf of the Secretary shall conduct inspections under this paragraph of each facility not less often than annually, subject to paragraph (6).
(F) Records and annual reports
The Secretary or a State or local agency acting on behalf of the Secretary which is responsible for inspecting mammography facilities shall maintain records of annual inspections required under this paragraph for a period as prescribed by the Secretary. Such a State or local agency shall annually prepare and submit to the Secretary a report concerning the inspections carried out under this paragraph. Such reports shall include a description of the facilities inspected and the results of such inspections.
(2) Inspection of accredited facilities
The Secretary shall inspect annually a sufficient number of the facilities accredited by an accreditation body to provide the Secretary with a reasonable estimate of the performance of such body.
(3) Inspection of facilities inspected by State or local agencies
The Secretary shall inspect annually facilities inspected by State or local agencies acting on behalf of the Secretary to assure a reasonable performance by such State or local agencies.
(4) Timing
The Secretary, or State or local agency, may conduct inspections under paragraphs (1), (2), and (3), during regular business hours or at a mutually agreeable time and after providing such notice as the Secretary may prescribe, except that the Secretary may waive such requirements if the continued performance of mammography at such facility threatens the public health.
(5) Limited reinspection
Nothing in this section limits the authority of the Secretary to conduct limited reinspections of facilities found not to be in compliance with this section.
(6) Demonstration program
(A) In general
The Secretary may establish a demonstration program under which inspections under paragraph (1) of selected facilities are conducted less frequently by the Secretary (or as applicable, by State or local agencies acting on behalf of the Secretary) than the interval specified in subparagraph (E) of such paragraph.
(B) Requirements
Any demonstration program under subparagraph (A) shall be carried out in accordance with the following:
(i) The program may not be implemented before April 1, 2001. Preparations for the program may be carried out prior to such date.
(ii) In carrying out the program, the Secretary may not select a facility for inclusion in the program unless the facility is substantially free of incidents of noncompliance with the standards under subsection (f) of this section. The Secretary may at any time provide that a facility will no longer be included in the program.
(iii) The number of facilities selected for inclusion in the program shall be sufficient to provide a statistically significant sample, subject to compliance with clause (ii).
(iv) Facilities that are selected for inclusion in the program shall be inspected at such intervals as the Secretary determines will reasonably ensure that the facilities are maintaining compliance with such standards.
(h) Sanctions
(1) In general
In order to promote voluntary compliance with this section, the Secretary may, in lieu of taking the actions authorized by subsection (i) of this section, impose one or more of the following sanctions:
(A) Directed plans of correction which afford a facility an opportunity to correct violations in a timely manner.
(B) Payment for the cost of onsite monitoring.
(2) Patient information
If the Secretary determines that the quality of mammography performed by a facility (whether or not certified pursuant to subsection (c) of this section) was so inconsistent with the quality standards established pursuant to subsection (f) of this section as to present a significant risk to individual or public health, the Secretary may require such facility to notify patients who received mammograms at such facility, and their referring physicians, of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial measures, and such other relevant information as the Secretary may require.
(3) Civil money penalties
The Secretary may assess civil money penalties in an amount not to exceed $10,000 for—
(A) failure to obtain a certificate as required by subsection (b) of this section,
(B) each failure by a facility to substantially comply with, or each day on which a facility fails to substantially comply with, the standards established under subsection (f) of this section or the requirements described in subclauses (I) through (III) of subsection (d)(1)(B)(ii) of this section,
(C) each failure to notify a patient of risk as required by the Secretary pursuant to paragraph (2), and
(D) each violation, or for each aiding and abetting in a violation of, any provision of, or regulation promulgated under, this section by an owner, operator, or any employee of a facility required to have a certificate.
(4) Procedures
The Secretary shall develop and implement procedures with respect to when and how each of the sanctions is to be imposed under paragraphs (1) through (3). Such procedures shall provide for notice to the owner or operator of the facility and a reasonable opportunity for the owner or operator to respond to the proposed sanctions and appropriate procedures for appealing determinations relating to the imposition of sanctions.
(i) Suspension and revocation
(1) In general
The certificate of a facility issued under subsection (c) of this section may be suspended or revoked if the Secretary finds, after providing, except as provided in paragraph (2), reasonable notice and an opportunity for a hearing to the owner or operator of the facility, that the owner, operator, or any employee of the facility—
(A) has been guilty of misrepresentation in obtaining the certificate;
(B) has failed to comply with the requirements of subsection (d)(1)(B)(ii)(III) of this section or the standards established by the Secretary under subsection (f) of this section;
(C) has failed to comply with reasonable requests of the Secretary (or of an accreditation body approved pursuant to subsection (e) of this section) for any record, information, report, or material that the Secretary (or such accreditation body or State carrying out certification program requirements pursuant to subsection (q) of this section) concludes is necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards established under subsection (f) of this section;
(D) has refused a reasonable request of the Secretary, any Federal officer or employee duly designated by the Secretary, or any State or local officer or employee duly designated by the State or local agency, for permission to inspect the facility or the operations and pertinent records of the facility in accordance with subsection (g) of this section;
(E) has violated or aided and abetted in the violation of any provision of, or regulation promulgated under, this section; or
(F) has failed to comply with a sanction imposed under subsection (h) of this section.
(2) Action before a hearing
(A) In general
The Secretary may suspend the certificate of the facility before holding a hearing required by paragraph (1) if the Secretary has reason to believe that the circumstance of the case will support one or more of the findings described in paragraph (1) and that—
(i) the failure or violation was intentional; or
(ii) the failure or violation presents a serious risk to human health.
(B) Hearing
If the Secretary suspends a certificate under subparagraph (A), the Secretary shall provide an opportunity for a hearing to the owner or operator of the facility not later than 60 days from the effective date of the suspension. The suspension shall remain in effect until the decision of the Secretary made after the hearing.
(3) Ineligibility to own or operate facilities after revocation
If the Secretary revokes the certificate of a facility on the basis of an act described in paragraph (1), no person who owned or operated the facility at the time of the act may, within 2 years of the revocation of the certificate, own or operate a facility that requires a certificate under this section.
(j) Injunctions
If the Secretary determines that—
(1) continuation of any activity related to the provision of mammography by a facility would constitute a serious risk to human health, the Secretary may bring suit in the district court of the United States for the district in which the facility is situated to enjoin continuation of the activity; and
(2) a facility is operating without a certificate as required by subsection (b) of this section, the Secretary may bring suit in the district court of the United States for the district in which the facility is situated to enjoin the operation of the facility.
Upon a proper showing, the district court shall grant a temporary injunction or restraining order against continuation of the activity or against operation of a facility, as the case may be, without requiring the Secretary to post a bond, pending issuance of a final order under this subsection.
(k) Judicial review
(1) Petition
If the Secretary imposes a sanction on a facility under subsection (h) of this section or suspends or revokes the certificate of a facility under subsection (i) of this section, the owner or operator of the facility may, not later than 60 days after the date the action of the Secretary becomes final, file a petition with the United States court of appeals for the circuit in which the facility is situated for judicial review of the action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary. As soon as practicable after receipt of the copy, the Secretary shall file in the court the record on which the action of the Secretary is based, as provided in
(2) Additional evidence
If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that the additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order the additional evidence (and evidence in rebuttal of the additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may determine to be proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file the modified or new findings, and the recommendations of the Secretary, if any, for the modification or setting aside of the original action of the Secretary with the return of the additional evidence.
(3) Judgment of court
Upon the filing of the petition referred to in paragraph (1), the court shall have jurisdiction to affirm the action, or to set the action aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.
(4) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in
(l) Information
(1) In general
Not later than October 1, 1996, and annually thereafter, the Secretary shall compile and make available to physicians and the general public information that the Secretary determines is useful in evaluating the performance of facilities, including a list of facilities—
(A) that have been convicted under Federal or State laws relating to fraud and abuse, false billings, or kickbacks;
(B) that have been subject to sanctions under subsection (h) of this section, together with a statement of the reasons for the sanctions;
(C) that have had certificates revoked or suspended under subsection (i) of this section, together with a statement of the reasons for the revocation or suspension;
(D) against which the Secretary has taken action under subsection (j) of this section, together with a statement of the reasons for the action;
(E) whose accreditation has been revoked, together with a statement of the reasons of the revocation;
(F) against which a State has taken adverse action; and
(G) that meets such other measures of performance as the Secretary may develop.
(2) Date
The information to be compiled under paragraph (1) shall be information for the calendar year preceding the date the information is to be made available to the public.
(3) Explanatory information
The information to be compiled under paragraph (1) shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraph.
(m) State laws
Nothing in this section shall be construed to limit the authority of any State to enact and enforce laws relating to the matters covered by this section that are at least as stringent as this section or the regulations issued under this section.
(n) National Advisory Committee
(1) Establishment
In carrying out this section, the Secretary shall establish an advisory committee to be known as the National Mammography Quality Assurance Advisory Committee (hereafter in this subsection referred to as the "Advisory Committee").
(2) Composition
The Advisory Committee shall be composed of not fewer than 13, nor more than 19 individuals, who are not officers or employees of the Federal Government. The Secretary shall make appointments to the Advisory Committee from among—
(A) physicians,
(B) practitioners, and
(C) other health professionals,
whose clinical practice, research specialization, or professional expertise include a significant focus on mammography. The Secretary shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mammography and at least 2 practicing physicians who provide mammography services.
(3) Functions and duties
The Advisory Committee shall—
(A) advise the Secretary on appropriate quality standards and regulations for mammography facilities;
(B) advise the Secretary on appropriate standards and regulations for accreditation bodies;
(C) advise the Secretary in the development of regulations with respect to sanctions;
(D) assist in developing procedures for monitoring compliance with standards under subsection (f) of this section;
(E) make recommendations and assist in the establishment of a mechanism to investigate consumer complaints;
(F) report on new developments concerning breast imaging that should be considered in the oversight of mammography facilities;
(G) determine whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determine the effects of personnel or other requirements of subsection (f) of this section on access to the services of such facilities in such areas;
(H) determine whether there will exist a sufficient number of medical physicists after October 1, 1999, to assure compliance with the requirements of subsection (f)(1)(E) of this section;
(I) determine the costs and benefits of compliance with the requirements of this section (including the requirements of regulations promulgated under this section); and
(J) perform other activities that the Secretary may require.
The Advisory Committee shall report the findings made under subparagraphs (G) and (I) to the Secretary and the Congress no later than October 1, 1993.
(4) Meetings
The Advisory Committee shall meet not less than quarterly for the first 3 years of the program and thereafter, at least biannually.
(5) Chairperson
The Secretary shall appoint a chairperson of the Advisory Committee.
(o) Consultations
In carrying out this section, the Secretary shall consult with appropriate Federal agencies within the Department of Health and Human Services for the purposes of developing standards, regulations, evaluations, and procedures for compliance and oversight.
(p) Breast cancer screening surveillance research grants
(1) Research
(A) Grants
The Secretary shall award grants to such entities as the Secretary may determine to be appropriate to establish surveillance systems in selected geographic areas to provide data to evaluate the functioning and effectiveness of breast cancer screening programs in the United States, including assessments of participation rates in screening mammography, diagnostic procedures, incidence of breast cancer, mode of detection (mammography screening or other methods), outcome and follow up information, and such related epidemiologic analyses that may improve early cancer detection and contribute to reduction in breast cancer mortality. Grants may be awarded for further research on breast cancer surveillance systems upon the Secretary's review of the evaluation of the program.
(B) Use of funds
Grants awarded under subparagraph (A) may be used—
(i) to study—
(I) methods to link mammography and clinical breast examination records with population-based cancer registry data;
(II) methods to provide diagnostic outcome data, or facilitate the communication of diagnostic outcome data, to radiology facilities for purposes of evaluating patterns of mammography interpretation; and
(III) mechanisms for limiting access and maintaining confidentiality of all stored data; and
(ii) to conduct pilot testing of the methods and mechanisms described in subclauses (I), (II), and (III) of clause (i) on a limited basis.
(C) Grant application
To be eligible to receive funds under this paragraph, an entity shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(D) Report
A recipient of a grant under this paragraph shall submit a report to the Secretary containing the results of the study and testing conducted under clauses (i) and (ii) of subparagraph (B), along with recommendations for methods of establishing a breast cancer screening surveillance system.
(2) Establishment
The Secretary shall establish a breast cancer screening surveillance system based on the recommendations contained in the report described in paragraph (1)(D).
(3) Standards and procedures
The Secretary shall establish standards and procedures for the operation of the breast cancer screening surveillance system, including procedures to maintain confidentiality of patient records.
(4) Information
The Secretary shall recruit facilities to provide to the breast cancer screening surveillance system relevant data that could help in the research of the causes, characteristics, and prevalence of, and potential treatments for, breast cancer and benign breast conditions, if the information may be disclosed under
(q) State program
(1) In general
The Secretary may, upon application, authorize a State—
(A) to carry out, subject to paragraph (2), the certification program requirements under subsections (b), (c), (d), (g)(1), (h), (i), and (j) of this section (including the requirements under regulations promulgated pursuant to such subsections), and
(B) to implement the standards established by the Secretary under subsection (f) of this section,
with respect to mammography facilities operating within the State.
(2) Approval
The Secretary may approve an application under paragraph (1) if the Secretary determines that—
(A) the State has enacted laws and issued regulations relating to mammography facilities which are the requirements of this section (including the requirements under regulations promulgated pursuant to such subsections), and
(B) the State has provided satisfactory assurances that the State—
(i) has the legal authority and qualified personnel necessary to enforce the requirements of and the regulations promulgated pursuant to this section (including the requirements under regulations promulgated pursuant to such subsections),
(ii) will devote adequate funds to the administration and enforcement of such requirements, and
(iii) will provide the Secretary with such information and reports as the Secretary may require.
(3) Authority of Secretary
In a State with an approved application—
(A) the Secretary shall carry out the Secretary's functions under subsections (e) and (f) of this section;
(B) the Secretary may take action under subsections (h), (i), and (j) of this section; and
(C) the Secretary shall conduct oversight functions under subsections (g)(2) and (g)(3) of this section.
(4) Withdrawal of approval
(A) In general
The Secretary may, after providing notice and opportunity for corrective action, withdraw the approval of a State's authority under paragraph (1) if the Secretary determines that the State does not meet the requirements of such paragraph. The Secretary shall promulgate regulations for the implementation of this subparagraph.
(B) Effect of withdrawal
If the Secretary withdraws the approval of a State under subparagraph (A), the certificate of any facility certified by the State shall continue in effect until the expiration of a reasonable period, as determined by the Secretary, for such facility to obtain certification by the Secretary.
(r) Funding
(1) Fees
(A) In general
The Secretary shall, in accordance with this paragraph assess and collect fees from persons described in subsection (d)(1)(A) of this section (other than persons who are governmental entities, as determined by the Secretary) to cover the costs of inspections conducted under subsection (g)(1) of this section by the Secretary or a State acting under a delegation under subparagraph (A) of such subsection. Fees may be assessed and collected under this paragraph only in such manner as would result in an aggregate amount of fees collected during any fiscal year which equals the aggregate amount of costs for such fiscal year for inspections of facilities of such persons under subsection (g)(1) of this section. A person's liability for fees shall be reasonably based on the proportion of the inspection costs which relate to such person.
(B) Deposit and appropriations
(i) Deposit and availability
Fees collected under subparagraph (A) shall be deposited as an offsetting collection to the appropriations for the Department of Health and Human Services as provided in appropriation Acts and shall remain available without fiscal year limitation.
(ii) Appropriations
Fees collected under subparagraph (A) shall be collected and available only to the extent provided in advance in appropriation Acts.
(2) Authorization of appropriations
There are authorized to be appropriated to carry out this section—
(A) to award research grants under subsection (p) of this section, such sums as may be necessary for each of the fiscal years 1993 through 2002; and
(B) for the Secretary to carry out other activities which are not supported by fees authorized and collected under paragraph (1), such sums as may be necessary for fiscal years 1993 through 2002.
(July 1, 1944, ch. 373, title III, §354, as added
Prior Provisions
A prior section 263b, act July 1, 1944, ch. 373, title III, §354, as added Oct. 18, 1968,
Sections 263c to 263n, act July 1, 1944, ch. 373, title III, §§355–360F, as added Oct. 18, 1968,
Amendments
1998—Subsec. (a)(4).
Subsec. (a)(8).
Subsec. (d)(2)(B).
Subsec. (e)(1)(B)(i)(I), (II).
Subsec. (e)(1)(B)(ii).
Subsec. (f)(1)(G)(i).
"(I) for a period of not less than 5 years, or not less than 10 years if no additional mammograms of such patient are performed at the facility, or longer if mandated by State law; or
"(II) until such time as the patient should request that the patient's medical records be forwarded to a medical institution or a physician of the patient;
whichever is longer; and".
Subsec. (f)(1)(G)(ii)(IV).
Subsec. (g)(1).
Subsec. (g)(1)(A).
Subsec. (g)(1)(E).
Subsec. (g)(3).
Subsec. (g)(4).
Subsec. (g)(6).
Subsec. (h)(2).
Subsec. (h)(3).
Subsec. (h)(4).
Subsec. (i)(1)(C).
Subsec. (i)(1)(D).
Subsec. (i)(2)(A).
"(i) the failure of a facility to comply with the standards established by the Secretary under subsection (f) of this section presents a serious risk to human health; or
"(ii) a facility has engaged in an action described in subparagraph (D) or (E) of paragraph (1)."
Subsec. (q)(4)(B).
Subsec. (r)(2)(A).
Subsec. (r)(2)(B).
Change of Name
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
Termination of Advisory Committees
Advisory committees 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 committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided for by law. See section 14 of
Regulations
"(1) under which the Secretary may approve accreditation bodies under section 354(e) of the Public Health Service Act (
"(2) establishing quality standards under section 354(f) of the Public Health Service Act (
Study
Section 3 of
Section Referred to in Other Sections
This section is referred to in
Part G—Quarantine and Inspection
Part Referred to in Other Sections
This part is referred to in
§264. Regulations to control communicable diseases
(a) Promulgation and enforcement by Surgeon General
The Surgeon General, with the approval of the Secretary, is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. For purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.
(b) Apprehension, detention, or conditional release of individuals
Regulations prescribed under this section shall not provide for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General.
(c) Application of regulations to persons entering from foreign countries
Except as provided in subsection (d) of this section, regulations prescribed under this section, insofar as they provide for the apprehension, detention, examination, or conditional release of individuals, shall be applicable only to individuals coming into a State or possession from a foreign country or a possession.
(d) Apprehension and examination of persons reasonably believed to be infected
On recommendation of the National Advisory Health Council, regulations prescribed under this section may provide for the apprehension and examination of any individual reasonably believed to be infected with a communicable disease in a communicable stage and (1) to be moving or about to move from a State to another State; or (2) to be a probable source of infection to individuals who, while infected with such disease in a communicable stage, will be moving from a State to another State. Such regulations may provide that if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of this subsection, the term "State" includes, in addition to the several States, only the District of Columbia.
(July 1, 1944, ch. 373, title III, §361,
Amendments
1976—Subsec. (d).
1960—Subsec. (c).
Effective Date of 1960 Amendment
Amendment by
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Ex. Ord. No. 12452. Revised List of Quarantinable Communicable Diseases
Ex. Ord. No. 12452, Dec. 22, 1983, 48 F.R. 56927, provided:
By the authority vested in me as President by the Constitution and laws of the United States of America, including
Ronald Reagan.
Section Referred to in Other Sections
This section is referred to in
§265. Suspension of entries and imports from designated places to prevent spread of communicable diseases
Whenever the Surgeon General determines that by reason of the existence of any communicable disease in a foreign country there is serious danger of the introduction of such disease into the United States, and that this danger is so increased by the introduction of persons or property from such country that a suspension of the right to introduce such persons and property is required in the interest of the public health, the Surgeon General, in accordance with regulations approved by the President, shall have the power to prohibit, in whole or in part, the introduction of persons and property from such countries or places as he shall designate in order to avert such danger, and for such period of time as he may deem necessary for such purpose.
(July 1, 1944, ch. 373, title III, §362,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
§266. Special quarantine powers in time of war
To protect the military and naval forces and war workers of the United States, in time of war, against any communicable disease specified in Executive orders as provided in subsection (b) of
(July 1, 1944, ch. 373, title III, §363,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Termination of War and Emergencies
Joint Res. July 25, 1947, ch. 327, §3,
Section Referred to in Other Sections
This section is referred to in
§267. Quarantine stations, grounds, and anchorages
(a) Control and management
Except as provided in title II of the Act of June 15, 1917, as amended [
(b) Hours of inspection
The Surgeon General shall establish the hours during which quarantine service shall be performed at each quarantine station, and, upon application by any interested party, may establish quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as, in his opinion, require such extended service. He may restrict the performance of quarantine inspection to hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of darkness. No vessel shall be required to undergo quarantine inspection during the hours of darkness, unless the quarantine officer at such quarantine station shall deem an immediate inspection necessary to protect the public health. Uniformity shall not be required in the hours during which quarantine inspection may be obtained at the various ports of the United States.
(c) Overtime pay for employees of Service
The Surgeon General shall fix a reasonable rate of extra compensation for overtime services of employees of the United States Public Health Service, Foreign Quarantine Division, performing overtime duties including the operation of vessels, in connection with the inspection or quarantine treatment of persons (passengers and crews), conveyances, or goods arriving by land, water, or air in the United States or any place subject to the jurisdiction thereof, hereinafter referred to as "employees of the Public Health Service", when required to be on duty between the hours of 6 o'clock postmeridian and 6 o'clock antemeridian (or between the hours of 7 o'clock postmeridian and 7 o'clock antemeridian at stations which have a declared workday of from 7 o'clock antemeridian to 7 o'clock postmeridian), or on Sundays or holidays, such rate, in lieu of compensation under any other provision of law, to be fixed at two times the basic hourly rate for each hour that the overtime extends beyond 6 o'clock (or 7 o'clock as the case may be) postmeridian, and two times the basic hourly rate for each overtime hour worked on Sundays or holidays. As used in this subsection, the term "basic hourly rate" shall mean the regular basic rate of pay which is applicable to such employees for work performed within their regular scheduled tour of duty.
(d) Payment of extra compensation to United States; bond or deposit to assure payment; deposit of moneys to credit of appropriation
(1) The said extra compensation shall be paid to the United States by the owner, agent, consignee, operator, or master or other person in charge of any conveyance, for whom, at his request, services as described in this subsection (hereinafter referred to as overtime service) are performed. If such employees have been ordered to report for duty and have so reported, and the requested services are not performed by reason of circumstances beyond the control of the employees concerned, such extra compensation shall be paid on the same basis as though the overtime services had actually been performed during the period between the time the employees were ordered to report for duty and did so report, and the time they were notified that their services would not be required, and in any case as though their services had continued for not less than one hour. The Surgeon General with the approval of the Secretary of Health and Human Services may prescribe regulations requiring the owner, agent, consignee, operator, or master or other person for whom the overtime services are performed to file a bond in such amounts and containing such conditions and with such sureties, or in lieu of a bond, to deposit money or obligations of the United States in such amount, as will assure the payment of charges under this subsection, which bond or deposit may cover one or more transactions or all transactions during a specified period: Provided, That no charges shall be made for services performed in connection with the inspection of (1) persons arriving by international highways, ferries, bridges, or tunnels, or the conveyances in which they arrive, or (2) persons arriving by aircraft or railroad trains, the operations of which are covered by published schedules, or the aircraft or trains in which they arrive, or (3) persons arriving by vessels operated between Canadian ports and ports on Puget Sound or operated on the Great Lakes and connecting waterways, the operations of which are covered by published schedules, or the vessels in which they arrive.
(2) Moneys collected under this subsection shall be deposited in the Treasury of the United States to the credit of the appropriation charged with the expense of the services, and the appropriations so credited shall be available for the payment of such compensation to the said employees for services so rendered.
(July 1, 1944, ch. 373, title III, §364,
Amendments
1958—Subsec. (c).
1957—Subsecs. (c), (d).
Transfer of Functions
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (d) pursuant to section 509(b) of
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§268. Quarantine duties of consular and other officers
(a) Any consular or medical officer of the United States, designated for such purpose by the Secretary, shall make reports to the Surgeon General, on such forms and at such intervals as the Surgeon General may prescribe, of the health conditions at the port or place at which such officer is stationed.
(b) It shall be the duty of the customs officers and of Coast Guard officers to aid in the enforcement of quarantine rules and regulations; but no additional compensation, except actual and necessary traveling expenses, shall be allowed any such officer by reason of such services.
(July 1, 1944, ch. 373, title III, §365,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Reference to Secretary of Health, Education, and Welfare substituted for reference to Federal Security Administrator pursuant to section 5 of Reorg. Plan No. 1, of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§269. Bills of health
(a) Detail of medical officer; conditions precedent to issuance; consular officer to receive fees
Except as otherwise prescribed in regulations, any vessel at any foreign port or place clearing or departing for any port or place in a State or possession shall be required to obtain from the consular officer of the United States or from the Public Health Service officer, or other medical officer of the United States designated by the Surgeon General, at the port or place of departure, a bill of health in duplicate, in the form prescribed by the Surgeon General. The President, from time to time, shall specify the ports at which a medical officer shall be stationed for this purpose. Such bill of health shall set forth the sanitary history and condition of said vessel, and shall state that it has in all respects complied with the regulations prescribed pursuant to subsection (c) of this section. Before granting such duplicate bill of health, such consular or medical officer shall be satisfied that the matters and things therein stated are true. The consular officer shall be entitled to demand and receive the fees for bills of health and such fees shall be established by regulation.
(b) Collectors of customs to receive originals; duplicate copies as part of ship's papers
Original bills of health shall be delivered to the collectors of customs at the port of entry. Duplicate copies of such bills of health shall be delivered at the time of inspection to quarantine officers at such port. The bills of health herein prescribed shall be considered as part of the ship's papers, and when duly certified to by the proper consular or other officer of the United States, over his official signature and seal, shall be accepted as evidence of the statements therein contained in any court of the United States.
(c) Regulations to secure sanitary conditions of vessels
The Surgeon General shall from time to time prescribe regulations, applicable to vessels referred to in subsection (a) of this section for the purpose of preventing the introduction into the States or possessions of the United States of any communicable disease by securing the best sanitary condition of such vessels, their cargoes, passengers, and crews. Such regulations shall be observed by such vessels prior to departure, during the course of the voyage, and also during inspection, disinfection, or other quarantine procedure upon arrival at any United States quarantine station.
(d) Vessels from ports near frontier
The provisions of subsections (a) and (b) of this section shall not apply to vessels plying between such foreign ports on or near the frontiers of the United States and ports of the United States as are designated by treaty.
(e) Compliance with regulations
It shall be unlawful for any vessel to enter any port in any State or possession of the United States to discharge its cargo, or land its passengers, except upon a certificate of the quarantine officer that regulations prescribed under subsection (c) of this section have in all respects been complied with by such officer, the vessel, and its master. The master of every such vessel shall deliver such certificate to the collector of customs at the port of entry, together with the original bill of health and other papers of the vessel. The certificate required by this subsection shall be procurable from the quarantine officer, upon arrival of the vessel at the quarantine station and satisfactory inspection thereof, at any time within which quarantine services are performed at such station.
(July 1, 1944, ch. 373, title III, §366,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
All offices of collector of customs, comptroller of customs, surveyor of customs, and appraiser of merchandise of Bureau of Customs of Department of the Treasury to which appointments were required to be made by the President with the advice and consent of the Senate ordered abolished, with such offices to be terminated not later than December 31, 1966, by Reorg. Plan No. 1, of 1965, eff. May 25, 1965, 30 F.R. 7035,
Section Referred to in Other Sections
This section is referred to in
§270. Quarantine regulations governing civil air navigation and civil aircraft
The Surgeon General is authorized to provide by regulations for the application to air navigation and aircraft of any of the provisions of
(July 1, 1944, ch. 373, title III, §367,
Abolition of Office of Surgeon General
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
§271. Penalties for violation of quarantine laws
(a) Penalties for persons violating quarantine laws
Any person who violates any regulation prescribed under
(b) Penalties for vessels violating quarantine laws
Any vessel which violates
(c) Remittance or mitigation of forfeitures
With the approval of the Secretary, the Surgeon General may, upon application therefor, remit or mitigate any forfeiture provided for under subsection (b) of this section, and he shall have authority to ascertain the facts upon all such applications.
(July 1, 1944, ch. 373, title III, §368,
Change of Name
Act June 25, 1948, eff. Sept. 1, 1948, substituted "United States attorney" for "United States district attorney". See
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§272. Administration of oaths by quarantine officers
Medical officers of the United States, when performing duties as quarantine officers at any port or place within the United States, are authorized to take declarations and administer oaths in matters pertaining to the administration of the quarantine laws and regulations of the United States.
(July 1, 1944, ch. 373, title III, §369,
Part H—Organ Transplants
Prior Provisions
A prior part H related to grants to Alaska for mental health, prior to the general revision of part H by
Another prior part H, entitled "National Library of Medicine", as added by act Aug. 3, 1956, ch. 907,
§273. Organ procurement organizations
(a) Grant authority of Secretary
(1) The Secretary may make grants for the planning of qualified organ procurement organizations described in subsection (b) of this section.
(2) The Secretary may make grants for the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations described in subsection (b) of this section.
(3) The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.
(b) Qualified organizations
(1) A qualified organ procurement organization for which grants may be made under subsection (a) of this section is an organization which, as determined by the Secretary, will carry out the functions described in paragraph (2) 1 and—
(A) is a nonprofit entity,
(B) has accounting and other fiscal procedures (as specified by the Secretary) necessary to assure the fiscal stability of the organization,
(C) has an agreement with the Secretary to be reimbursed under title XVIII of the Social Security Act [
(D) notwithstanding any other provision of law, has met the other requirements of this section and has been certified or recertified by the Secretary within the previous 4-year period as meeting the performance standards to be a qualified organ procurement organization through a process that either—
(i) granted certification or recertification within such 4-year period with such certification or recertification in effect as of January 1, 2000, and remaining in effect through the earlier of—
(I) January 1, 2002; or
(II) the completion of recertification under the requirements of clause (ii); or
(ii) is defined through regulations that are promulgated by the Secretary by not later than January 1, 2002, that—
(I) require recertifications of qualified organ procurement organizations not more frequently than once every 4 years;
(II) rely on outcome and process performance measures that are based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area of qualified organ procurement organizations;
(III) use multiple outcome measures as part of the certification process; and
(IV) provide for a qualified organ procurement organization to appeal a decertification to the Secretary on substantive and procedural grounds; 2
(E) has procedures to obtain payment for non-renal organs provided to transplant centers,
(F) has a defined service area that is of sufficient size to assure maximum effectiveness in the procurement and equitable distribution of organs, and that either includes an entire metropolitan statistical area (as specified by the Director of the Office of Management and Budget) or does not include any part of the area,
(G) has a director and such other staff, including the organ donation coordinators and organ procurement specialists necessary to effectively obtain organs from donors in its service area, and
(H) has a board of directors or an advisory board which—
(i) is composed of—
(I) members who represent hospital administrators, intensive care or emergency room personnel, tissue banks, and voluntary health associations in its service area,
(II) members who represent the public residing in such area,
(III) a physician with knowledge, experience, or skill in the field of histocompatability 3 or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility,
(IV) a physician with knowledge or skill in the field of neurology, and
(V) from each transplant center in its service area which has arrangements described in paragraph (2)(G) 1 with the organization, a member who is a surgeon who has practicing privileges in such center and who performs organ transplant surgery,
(ii) has the authority to recommend policies for the procurement of organs and the other functions described in paragraph (2),1 and
(iii) has no authority over any other activity of the organization.
(2)(A) Not later than 90 days after November 16, 1990, the Secretary shall publish in the Federal Register a notice of proposed rulemaking to establish criteria for determining whether an entity meets the requirement established in paragraph (1)(E).1
(B) Not later than 1 year after November 16, 1990, the Secretary shall publish in the Federal Register a final rule to establish the criteria described in subparagraph (A).
(3) An organ procurement organization shall—
(A) have effective agreements, to identify potential organ donors, with a substantial majority of the hospitals and other health care entities in its service area which have facilities for organ donations,
(B) conduct and participate in systematic efforts, including professional education, to acquire all useable organs from potential donors,
(C) arrange for the acquisition and preservation of donated organs and provide quality standards for the acquisition of organs which are consistent with the standards adopted by the Organ Procurement and Transplantation Network under
(D) arrange for the appropriate tissue typing of donated organs,
(E) have a system to allocate donated organs equitably among transplant patients according to established medical criteria,
(F) provide or arrange for the transportation of donated organs to transplant centers,
(G) have arrangements to coordinate its activities with transplant centers in its service area,
(H) participate in the Organ Procurement Transplantation Network established under
(I) have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all useable tissues are obtained from potential donors,
(J) evaluate annually the effectiveness of the organization in acquiring potentially available organs, and
(K) assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors.
(July 1, 1944, ch. 373, title III, §371, as added
References in Text
Paragraph (2), referred to in subsec. (b)(1), meaning paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by section 201(d)(1) of
The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531,
Paragraph (1)(E), referred to in subsec. (b)(2)(A), meaning paragraph (1)(E) of subsec. (b) of this section, was redesignated paragraph (1)(F) by section 701(c)(1) of
Prior Provisions
A prior section 273, act July 1, 1944, ch. 373, title III, §371, as added July 28, 1956, ch. 772, title II, §201,
A prior section 371 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
2000—Subsec. (b)(1)(D) to (H).
1990—
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b)(1)(E).
Subsec. (b)(1)(G)(i)(III).
Subsec. (b)(2), (3).
Subsec. (c).
1988—Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (a)(4)(C).
Subsec. (b)(1)(E).
Subsec. (b)(1)(G)(i)(III).
Subsec. (b)(2)(C).
Subsec. (b)(2)(E).
Subsec. (b)(2)(K).
Subsec. (c).
Effective Date of 1990 Amendment
Section 207 of title II of
Effective Date of 1988 Amendment
Section 402(c)(3) of
Short Title
For short title of
Severability
Section 301 of
Certification of Organ Procurement Organizations
"(1) Organ procurement organizations play an important role in the effort to increase organ donation in the United States.
"(2) The current process for the certification and recertification of organ procurement organizations conducted by the Department of Health and Human Services has created a level of uncertainty that is interfering with the effectiveness of organ procurement organizations in raising the level of organ donation.
"(3) The General Accounting Office, the Institute of Medicine, and the Harvard School of Public Health have identified substantial limitations in the organ procurement organization certification and recertification process and have recommended changes in that process.
"(4) The limitations in the recertification process include:
"(A) An exclusive reliance on population-based measures of performance that do not account for the potential in the population for organ donation and do not permit consideration of other outcome and process standards that would more accurately reflect the relative capability and performance of each organ procurement organization.
"(B) A lack of due process to appeal to the Secretary of Health and Human Services for recertification on either substantive or procedural grounds.
"(5) The Secretary of Health and Human Services has the authority under section 1138(b)(1)(A)(i) of the Social Security Act (
"(6) The Secretary of Health and Human Services can use the extended period described in paragraph (5) for recertification of all organ procurement organizations to—
"(A) develop improved performance measures that would reflect organ donor potential and interim outcomes, and to test these measures to ensure that they accurately measure performance differences among the organ procurement organizations; and
"(B) improve the overall certification process by incorporating process as well as outcome performance measures, and developing equitable processes for appeals."
Study Regarding Immunosuppressive Drugs
"(1)
"(2)
"(A) The costs of immunosuppressive drugs that are provided to children pursuant to organ transplants and to determine the extent to which health plans, health insurance and government programs cover such costs.
"(B) The extent of denial of organs to be released for transplant by coroners and medical examiners.
"(C) The special growth and developmental issues that children have pre- and post-organ transplantation.
"(D) Other issues that are particular to the special health and transplantation needs of children.
"(3)
Study on Hospital Agreements With Organ Procurement Agencies
Task Force on Organ Procurement and Transplantation
Bone Marrow Registry Demonstration and Study
Section 401 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 So in original. The semicolon probably should be a comma.
3 So in original. Probably should be "histocompatibility".
§274. Organ procurement and transplantation network
(a) Contract authority of Secretary; limitation; available appropriations
The Secretary shall by contract provide for the establishment and operation of an Organ Procurement and Transplantation Network which meets the requirements of subsection (b) of this section. The amount provided under such contract in any fiscal year may not exceed $2,000,000. Funds for such contracts shall be made available from funds available to the Public Health Service from appropriations for fiscal years beginning after fiscal year 1984.
(b) Functions
(1) The Organ Procurement and Transplantation Network shall carry out the functions described in paragraph (2) and shall—
(A) be a private nonprofit entity that has an expertise in organ procurement and transplantation, and
(B) have a board of directors—
(i) that includes representatives of organ procurement organizations (including organizations that have received grants under
(ii) that shall establish an executive committee and other committees, whose chairpersons shall be selected to ensure continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network shall—
(A) establish in one location or through regional centers—
(i) a national list of individuals who need organs, and
(ii) a national system, through the use of computers and in accordance with established medical criteria, to match organs and individuals included in the list, especially individuals whose immune system makes it difficult for them to receive organs,
(B) establish membership criteria and medical criteria for allocating organs and provide to members of the public an opportunity to comment with respect to such criteria,
(C) maintain a twenty-four-hour telephone service to facilitate matching organs with individuals included in the list,
(D) assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients,
(E) adopt and use standards of quality for the acquisition and transportation of donated organs, including standards for preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,
(F) prepare and distribute, on a regionalized basis (and, to the extent practicable, among regions or on a national basis), samples of blood sera from individuals who are included on the list and whose immune system makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such individuals with organ donors,
(G) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant centers,
(H) provide information to physicians and other health professionals regarding organ donation,
(I) collect, analyze, and publish data concerning organ donation and transplants,
(J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement and allocation,
(K) work actively to increase the supply of donated organs,
(L) submit to the Secretary an annual report containing information on the comparative costs and patient outcomes at each transplant center affiliated with the organ procurement and transplantation network,
(M) recognize the differences in health and in organ transplantation issues between children and adults throughout the system and adopt criteria, polices, and procedures that address the unique health care needs of children,
(N) carry out studies and demonstration projects for the purpose of improving procedures for organ donation procurement and allocation, including but not limited to projects to examine and attempt to increase transplantation among populations with special needs, including children and individuals who are members of racial or ethnic minority groups, and among populations with limited access to transportation, and
(O) provide that for purposes of this paragraph, the term "children" refers to individuals who are under the age of 18.
(c) Consideration of critical comments
The Secretary shall establish procedures for—
(1) receiving from interested persons critical comments relating to the manner in which the Organ Procurement and Transplantation Network is carrying out the duties of the Network under subsection (b) of this section; and
(2) the consideration by the Secretary of such critical comments.
(July 1, 1944, ch. 373, title III, §372, as added
Prior Provisions
A prior section 274, act July 1, 1944, ch. 373, title III, §372, as added July 28, 1956, ch. 772, title II, §201,
Another section 372 of act July 1, 1944, added by act Aug. 3, 1956, ch. 941, §1,
Amendments
2000—Subsec. (b)(2)(M) to(O).
1990—Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2)(D).
Subsec. (b)(2)(F).
Subsec. (b)(2)(K), (L).
1988—Subsec. (b)(2)(B), (C).
Subsec. (b)(2)(D).
Subsec. (b)(2)(E).
Subsec. (b)(2)(F).
Subsec. (b)(2)(G) to (I).
Subsec. (b)(2)(J).
Subsec. (c).
Effective Date of 1990 Amendment
Section 202(d) of
Section Referred to in Other Sections
This section is referred to in
§274a. Scientific registry
The Secretary shall, by grant or contract, develop and maintain a scientific registry of the recipients of organ transplants. The registry shall include such information respecting patients and transplant procedures as the Secretary deems necessary to an ongoing evaluation of the scientific and clinical status of organ transplantation. The Secretary shall prepare for inclusion in the report under
(July 1, 1944, ch. 373, title III, §373, as added
Prior Provisions
A prior section 373 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
1988—
Section Referred to in Other Sections
This section is referred to in
§274b. General provisions respecting grants and contracts
(a) Application requirement
No grant may be made under this part or contract entered into under
(b) Special considerations and priority; planning and establishment grants
(1) A grant for planning under
(2) Grants under
(3) Grants or contracts under
(c) Determination of grant amount; terms of payment; recordkeeping; access for purposes of audits and examination of records
(1) The Secretary shall determine the amount of a grant or contract made under
(2)(A) Each recipient of a grant or contract under
(B) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant or contract under
(d) "Transplant center" and "organ" defined
For purposes of this part:
(1) The term "transplant center" means a health care facility in which transplants of organs are performed.
(2) The term "organ" means the human kidney, liver, heart, lung, pancreas, and any other human organ (other than corneas and eyes) specified by the Secretary by regulation and for purposes of
(July 1, 1944, ch. 373, title III, §374, as added
Prior Provisions
A prior section 374 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—Subsec. (a).
Subsec. (b).
Subsec. (c).
1988—Subsec. (b)(3).
§274c. Administration
The Secretary shall designate and maintain an identifiable administrative unit in the Public Health Service to—
(1) administer this part and coordinate with the organ procurement activities under title XVIII of the Social Security Act [
(2) conduct a program of public information to inform the public of the need for organ donations,
(3) provide technical assistance to organ procurement organizations, the Organ Procurement and Transplantation Network established under
(4) provide information—
(i) to patients, their families, and their physicians about transplantation; and
(ii) to patients and their families about the resources available nationally and in each State, and the comparative costs and patient outcomes at each transplant center affiliated with the organ procurement and transplantation network, in order to assist the patients and families with the costs associated with transplantation.
(July 1, 1944, ch. 373, title III, §375, as added
References in Text
The Social Security Act, referred to in par. (1), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 375 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
Par. (3).
Par. (4).
1988—
§274d. Report
Not later than February 10 of 1991 and of each second year thereafter, the Secretary shall publish, and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.1 a report on the scientific and clinical status of organ transplantation. The Secretary shall consult with the Director of the National Institutes of Health and the Commissioner of the Food and Drug Administration in the preparation of the report.
(July 1, 1944, ch. 373, title III, §376, as added
Prior Provisions
A prior section 376 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
1988—
Change of Name
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
Section Referred to in Other Sections
This section is referred to in
1 So in original. The period probably should be a comma.
§274e. Prohibition of organ purchases
(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.
(b) Penalties
Any person who violates subsection (a) of this section shall be fined not more than $50,000 or imprisoned not more than five years, or both.
(c) Definitions
For purposes of subsection (a) of this section:
(1) The term "human organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
(2) The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.
(3) The term "interstate commerce" has the meaning prescribed for it by
(
Codification
Section was enacted as part of the National Organ Transplant Act, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1988—Subsec. (c)(1).
§274f. Study by General Accounting Office
(a) In general
The Comptroller General of the United States shall conduct a study for the purpose of determining—
(1) the extent to which the procurement and allocation of organs have been equitable, efficient, and effective;
(2) the problems encountered in the procurement and allocation; and
(3) the effect of State required-request laws.
(b) Report
Not later than January 7, 1992, the Comptroller General of the United States shall complete the study required in subsection (a) of this section and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the findings made as a result of the study.
(July 1, 1944, ch. 373, title III, §377, as added
Change of Name
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
§274g. Authorization of appropriations
For the purpose of carrying out this part, there are authorized to be appropriated $8,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §378, as added
Amendments
1998—
Part I—National Bone Marrow Donor Registry
Amendments
1990—
1985—
1970—
§274k. National Registry
(a) Establishment
The Secretary shall by contract establish and maintain a National Bone Marrow Donor Registry (referred to in this part as the "Registry") that has the purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow, and that meets the requirements of this section. The Registry shall be under the general supervision of the Secretary, and under the direction of a board of directors meeting the following requirements:
(1) Each member of the board shall serve for a term of 2 years, and each such member may serve as many as 3 consecutive 2-year terms, except that such limitations shall not apply to the Chair of the board (or the Chair-elect) or to the member of the board who most recently served as the Chair.
(2) A member of the board may continue to serve after the expiration of the term of such member until a successor is appointed.
(3) In order to ensure the continuity of the board, the board shall be appointed so that each year the terms of approximately one-third of the members of the board expire.
(4) The membership of the board shall include representatives of marrow donor centers and marrow transplant centers; recipients of a bone marrow transplant; persons who require or have required such a transplant; family members of such a recipient or family members of a patient who has requested the assistance of the Registry in searching for an unrelated donor of bone marrow; persons with expertise in the social sciences; and members of the general public; and in addition nonvoting representatives from the Naval Medical Research and Development Command and from the Division of Organ Transplantation of the Health Resources and Services Administration.
(b) Functions
The Registry shall—
(1) establish a system for finding marrow donors suitably matched to unrelated recipients for bone marrow transplantation;
(2) carry out a program for the recruitment of bone marrow donors in accordance with subsection (c) of this section, including with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed ancestry) in the enrollment of the Registry;
(3) carry out informational and educational activities in accordance with subsection (c) of this section;
(4) annually update information to account for changes in the status of individuals as potential donors of bone marrow;
(5) provide for a system of patient advocacy through the office established under subsection (d) of this section;
(6) provide case management services for any potential donor of bone marrow to whom the Registry has provided a notice that the potential donor may be suitably matched to a particular patient (which services shall be provided through a mechanism other than the system of patient advocacy under subsection (d) of this section), and conduct surveys of donors and potential donors to determine the extent of satisfaction with such services and to identify ways in which the services can be improved;
(7) with respect to searches for unrelated donors of bone marrow that are conducted through the system under paragraph (1), collect and analyze and publish data on the number and percentage of patients at each of the various stages of the search process, including data regarding the furthest stage reached; the number and percentage of patients who are unable to complete the search process, and the reasons underlying such circumstances; and comparisons of transplant centers regarding search and other costs that prior to transplantation are charged to patients by transplant centers; and
(8) support studies and demonstration projects for the purpose of increasing the number of individuals, especially minorities, who are willing to be marrow donors.
(c) Recruitment; priorities; information and education
(1) Recruitment; priorities
The Registry shall carry out a program for the recruitment of bone marrow donors. Such program shall identify populations that are underrepresented among potential donors enrolled with the Registry. In the case of populations that are identified under the preceding sentence:
(A) The Registry shall give priority to carrying out activities under this part to increase representation for such populations in order to enable a member of such a population, to the extent practicable, to have a probability of finding a suitable unrelated donor that is comparable to the probability that an individual who is not a member of an underrepresented population would have.
(B) The Registry shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be populations that have been identified for purposes of this paragraph, and shall carry out subparagraph (A) with respect to such populations.
(2) Information and education regarding recruitment; testing and enrollment
(A) In general
In carrying out the program under paragraph (1), the Registry shall carry out informational and educational activities for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll with the Registry potential donors. Such information and educational activities shall include the following:
(i) Making information available to the general public, including information describing the needs of patients with respect to donors of bone marrow.
(ii) Educating and providing information to individuals who are willing to serve as potential donors, including providing updates.
(iii) Training individuals in requesting individuals to serve as potential donors.
(B) Priorities
In carrying out informational and educational activities under subparagraph (A), the Registry shall give priority to recruiting individuals to serve as donors of bone marrow for populations that are identified under paragraph (1).
(3) Transplantation as treatment option
In addition to activities regarding recruitment, the program under paragraph (1) shall provide information to physicians, other health care professionals, and the public regarding the availability, as a potential treatment option, of receiving a transplant of bone marrow from an unrelated donor.
(d) Patient advocacy; case management
(1) In general
The Registry shall establish and maintain an office of patient advocacy (in this subsection referred to as the "Office").
(2) General functions
The Office shall meet the following requirements:
(A) The Office shall be headed by a director.
(B) The Office shall operate a system for patient advocacy, which shall be separate from mechanisms for donor advocacy, and which shall serve patients for whom the Registry is conducting, or has been requested to conduct, a search for an unrelated donor of bone marrow.
(C) In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the patient (or family members, physicians, or other individuals acting on behalf of the patient) individualized services with respect to efficiently utilizing the system under subsection (b)(1) of this section to conduct an ongoing search for a donor.
(D) In carrying out subparagraph (C), the Office shall monitor the system under subsection (b)(1) of this section to determine whether the search needs of the patient involved are being met, including with respect to the following:
(i) Periodically providing to the patient (or an individual acting on behalf of the patient) information regarding donors who are suitability matched to the patient, and other information regarding the progress being made in the search.
(ii) Informing the patient (or such other individual) if the search has been interrupted or discontinued.
(iii) Identifying and resolving problems in the search, to the extent practicable.
(E) In carrying out subparagraph (C), the Office shall monitor the system under subsection (b)(1) of this section to determine whether the Registry, donor centers, transplant centers, and other entities participating in the Registry program are complying with standards issued under subsection (e)(4) of this section for the system for patient advocacy under this subsection.
(F) The Office shall ensure that the following data are made available to patients:
(i) The resources available through the Registry.
(ii) A comparison of transplant centers regarding search and other costs that prior to transplantation are charged to patients by transplant centers.
(iii) A list of donor registries, transplant centers, and other entities that meet the applicable standards, criteria, and procedures under subsection (e) of this section.
(iv) The posttransplant outcomes for individual transplant centers.
(v) Such other information as the Registry determines to be appropriate.
(G) The Office shall conduct surveys of patients (or family members, physicians, or other individuals acting on behalf of patients) to determine the extent of satisfaction with the system for patient advocacy under this subsection, and to identify ways in which the system can be improved.
(3) Case management
(A) In general
In serving as an advocate for a patient under paragraph (2), the Office shall provide individualized case management services directly to the patient (or family members, physicians, or other individuals acting on behalf of the patient), including—
(i) individualized case assessment; and
(ii) the functions described in paragraph (2)(D) (relating to progress in the search process).
(B) Postsearch functions
In addition to the case management services described in paragraph (1) for patients, the Office may, on behalf of patients who have completed the search for an unrelated donor, provide information and education on the process of receiving a transplant of bone marrow, including the posttransplant process.
(e) Criteria, standards, and procedures
Not later than 180 days after November 16, 1990, the Secretary shall establish and enforce, for entities participating in the program, including the Registry, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers—
(1) quality standards and standards for tissue typing, obtaining the informed consent of donors, and providing patient advocacy;
(2) donor selection criteria, based on established medical criteria, to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases such as the viruses that cause hepatitis and the etiologic agent for Acquired Immune Deficiency Syndrome;
(3) procedures to ensure the proper collection and transportation of the marrow;
(4) standards for the system for patient advocacy operated under subsection (d) of this section, including standards requiring the provision of appropriate information (at the start of the search process and throughout the process) to patients and their families and physicians;
(5) standards that—
(A) require the establishment of a system of strict confidentiality of records relating to the identity, address, HLA type, and managing marrow donor center for marrow donors and potential marrow donors; and
(B) prescribe the purposes for which the records described in subparagraph (A) may be disclosed, and the circumstances and extent of the disclosure; and
(6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure the establishment of a method for integrating donor files, searches, and general procedures of the center or registry with the Registry.
(f) Comment procedures
The Secretary shall establish and provide information to the public on procedures, which may include establishment of a policy advisory committee, under which the Secretary shall receive and consider comments from interested persons relating to the manner in which the Registry is carrying out the duties of the Registry under subsection (b) of this section and complying with the criteria, standards, and procedures described in subsection (e) of this section.
(g) Consultation
The Secretary shall consult with the board of directors of the Registry and the bone marrow donor program of the Department of the Navy in developing policies affecting the Registry.
(h) Application
To be eligible to enter into a contract under this section, an entity shall submit to the Secretary and obtain approval of an application at such time, in such manner, and containing such information as the Secretary shall by regulation prescribe.
(i) Eligibility
Entities eligible to receive a contract under this section shall include private nonprofit entities.
(j) Records
(1) Recordkeeping
Each recipient of a contract or subcontract under subsection (a) of this section shall keep such records as the Secretary shall prescribe, including records that fully disclose the amount and disposition by the recipient of the proceeds of the contract, the total cost of the undertaking in connection with which the contract was made, and the amount of the portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) Examination of records
The Secretary and the Comptroller General of the United States shall have access to any books, documents, papers, and records of the recipient of a contract or subcontract entered into under this section that are pertinent to the contract, for the purpose of conducting audits and examinations.
(k) Penalties for disclosure
Any person who discloses the content of any record referred to in subsection (e)(5)(A) of this section without the prior written consent of the donor or potential donor with respect to whom the record is maintained, or in violation of the standards described in subsection (e)(5)(B) of this section, shall be imprisoned for not more than 2 years or fined in accordance with title 18, or both.
(l) Annual report regarding pretransplant costs
The Registry shall annually submit to the Secretary the data collected under subsection (b)(7) of this section on comparisons of transplant centers regarding search and other costs that prior to transplantation are charged to patients by transplant centers. The data shall be submitted to the Secretary through inclusion in the annual report required in
(July 1, 1944, ch. 373, title III, §379, as added
Amendments
1998—Subsec. (a).
Subsec. (b)(2) to (8).
"(2) establish a system for patient advocacy, separate from mechanisms for donor advocacy, that directly assists patients, their families, and their physicians in the search for an unrelated marrow donor;
"(3) increase the representation of individuals from racial and ethnic minority groups in the pool of potential donors for the Registry in order to enable an individual in a minority group, to the extent practicable, to have a comparable chance of finding a suitable unrelated donor as would an individual not in a minority group;
"(4) provide information to physicians, other health care professionals, and the public regarding bone marrow transplantation;
"(5) recruit potential bone marrow donors;
"(6) collect, analyze, and publish data concerning bone marrow donation and transplantation; and".
Subsecs. (c), (d).
Subsec. (e).
Subsec. (e)(4).
"(A) the resources available through the Registry;
"(B) all other marrow donor registries meeting the standards described in this paragraph; and
"(C) in the case of the Registry—
"(i) the comparative costs of all charges by marrow transplant centers incurred by patients prior to transplantation; and
"(ii) the success rates of individual marrow transplant centers;".
Subsec. (f).
Subsecs. (g) to (i).
Subsec. (j).
Subsec. (k).
Subsec. (l).
Effective Date of 1998 Amendment
Savings Provision
Section 102 of title I of
"(a)
"(b)
"(c)
Report of Inspector General; Plan Regarding Relationship Between Registry and Donor Centers
Study by General Accounting Office
"(a)
"(1) The extent to which, relative to the effective date of this Act [Oct. 1, 1998], such Registry has increased the representation of racial and ethnic minority groups (including persons of mixed ancestry) among potential donors of bone marrow who are enrolled with the Registry, and whether the extent of increase results in a level of representation that meets the standard established in subsection (c)(1)(A) of such section 379 [subsec. (c)(1)(A) of this section] (as added by section 2(c) of this Act).
"(2) The extent to which patients in need of a transplant of bone marrow from a biologically unrelated donor, and the physicians of such patients, have been utilizing the Registry in the search for such a donor.
"(3) The number of such patients for whom the Registry began a preliminary search but for whom the full search process was not completed, and the reasons underlying such circumstances.
"(4) The extent to which the plan required in section 2(b)(2) of this Act [set out as a note above] (relating to the relationship between the Registry and donor centers) has been implemented.
"(5) The extent to which the Registry, donor centers, donor registries, collection centers, transplant centers, and other appropriate entities have been complying with the standards, criteria, and procedures under subsection (e) of such section 379 [subsec. (e) of this section] (as redesignated by section 2(c) of this Act).
"(b)
Compliance With New Requirements for Office of Patient Advocacy
Section Referred to in Other Sections
This section is referred to in
§274l. Bone marrow scientific registry
(a) Establishment of recipient registry
The Secretary, acting through the Registry under
(b) Information
The scientific registry under subsection (a) of this section shall include information with respect to patients described in subsection (a) of this section, transplant procedures, and such other information as the Secretary determines to be appropriate to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of bone marrow from biologically unrelated donors.
(c) Annual report on patient outcomes
The Registry shall annually submit to the Secretary a report concerning patient outcomes with respect to each transplant center. Each such report shall use data collected and maintained by the scientific registry under subsection (a) of this section. Each such report shall in addition include the data required in
(July 1, 1944, ch. 373, title III, §379A, as added
Prior Provisions
A prior section 274l, act July 1, 1944, ch. 373, title III, §379A, as added
Effective Date
Section effective Oct. 1, 1998, see section 7 of
Section Referred to in Other Sections
This section is referred to in
§274m. Authorization of appropriations
For the purpose of carrying out this part, there are authorized to be appropriated $18,000,000 for fiscal year 1999, and such sums as may be necessary for each of the fiscal years 2000 through 2003.
(July 1, 1944, ch. 373, title III, §379B, as added
Effective Date
Section effective Oct. 1, 1998, see section 7 of
§275. Repealed. Pub. L. 103–43, title I, §121(a), June 10, 1993, 107 Stat. 133
Section, act July 1, 1944, ch. 373, title III, §381, as added Nov. 20, 1985,
A prior section 275, act July 1, 1944, ch. 373, title III, §381, formerly §371, as added Aug. 3, 1956, ch. 907, §1,
§§276 to 280a–1. Repealed. Pub. L. 99–158, §3(b), Nov. 20, 1985, 99 Stat. 879
Section 276, act July 1, 1944, ch. 373, title III, §382, formerly §372, as added Aug. 3, 1956, ch. 907, §1,
Section 277, act July 1, 1944, ch. 373, title III, §383, formerly §373, as added Aug. 3, 1956, ch. 907, §1,
Section 278, act July 1, 1944, ch. 373, title III, §384, formerly §374, as added Aug. 3, 1956, ch. 907, §1,
Section 279, act July 1, 1944, ch. 373, title III, §385, formerly §375, as added Aug. 3, 1956, ch. 907 §1,
Section 280, act July 1, 1944, ch. 373, title III, §386, formerly §376, as added Aug. 3, 1956, ch. 907, §1,
Section 280a, act July 1, 1944, ch. 373, title III, §387, formerly §377, as added Aug. 3, 1956, ch. 907, §1,
Section 280a–1, act July 1, 1944, ch. 373, title III, §388, formerly §378, as added Oct. 22, 1965,
Part J—Prevention and Control of Injuries
Amendments
1993—
1990—
Part Referred to in Other Sections
This part is referred to in
§280b. Research
(a) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall—
(1) conduct, and give assistance to public and nonprofit private entities, scientific institutions, and individuals engaged in the conduct of, research relating to the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation from injuries;
(2) make grants to, or enter into cooperative agreements or contracts with, public and nonprofit private entities (including academic institutions, hospitals, and laboratories) and individuals for the conduct of such research; and
(3) make grants to, or enter into cooperative agreements or contracts with, academic institutions for the purpose of providing training on the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation from injuries.
(b) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall collect and disseminate, through publications and other appropriate means, information concerning the practical applications of research conducted or assisted under subsection (a) of this section. In carrying out the preceding sentence, the Secretary shall disseminate such information to the public, including through elementary and secondary schools.
(July 1, 1944, ch. 373, title III, §391, as added
Prior Provisions
A prior section 280b, act July 1, 1944, ch. 373, title III, §390, as added Oct. 22, 1965,
A prior section 391 of act July 1, 1944, ch. 373, title III, as added Oct. 22, 1965,
Amendments
1993—Subsec. (b).
1992—
1990—Subsec. (a)(2).
Subsec. (a)(3).
Findings and Purposes
Section 2 of
"(a) The Congress finds and declares that:
"(1) Injury is one of the principal public health problems in America, and causes over 140,000 deaths per year.
"(2) Injury rates are particularly high for children and the elderly.
"(3) Injury causes 50 percent of all deaths for children over the age of one year and two-thirds of all deaths for children over the age of 15 years, and is the leading cause of death for individuals under the age of 44 years. Individuals over the age of 65 years have the highest fatality rates for many injuries.
"(4) Injury control has not been given high priority in the United States, and the research being conducted on injury control and the number of personnel involved in injury control activities are not adequate.
"(b) The purposes of this Act [enacting this part] are—
"(1) to promote research into the causes, diagnosis, treatment, prevention, and control of injuries and rehabilitation from injuries;
"(2) to promote cooperation between specialists in fields involved in injury research; and
"(3) to promote coordination between Federal, State, and local governments and public and private entities in order to achieve a reduction in deaths from injuries."
Section Referred to in Other Sections
This section is referred to in
§280b–1. Prevention and control activities
(a) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall—
(1) assist States and political subdivisions of States in activities for the prevention and control of injuries; and
(2) encourage regional activities between States designed to reduce injury rates.
(b) The Secretary, through the Director of the Centers for Disease Control and Prevention, may—
(1) enter into agreements between the Service and public and private community health agencies which provide for cooperative planning of activities to deal with problems relating to the prevention and control of injuries;
(2) work in cooperation with other Federal agencies, and with public and nonprofit private entities, to promote activities regarding the prevention and control of injuries; and
(3) make grants to States and, after consultation with State health agencies, to other public or nonprofit private entities for the purpose of carrying out demonstration projects for the prevention and control of injuries at sites that are not subject to the Occupational Safety and Health Act of 1970 [
(July 1, 1944, ch. 373, title III, §392, as added
References in Text
The Occupational Safety and Health Act of 1970, referred to in subsec. (b)(3), is
Prior Provisions
A prior section 280b–1, act July 1, 1944, ch. 373, title III, §391, as added Oct. 22, 1965,
A prior section 392 of act July 1, 1944, ch. 373, title III, as added Oct. 22, 1965,
Amendments
1993—
Subsec. (a)(1).
Subsec. (b)(1).
Subsec. (b)(2).
1992—
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
1990—Subsec. (b)(2).
Section Referred to in Other Sections
This section is referred to in
§280b–1a. Interpersonal violence within families and among acquaintances
(a) With respect to activities that are authorized in
(1) Collecting data relating to the incidence of such violence.
(2) Making grants to public and nonprofit private entities for the evaluation of programs whose purpose is to prevent such violence, including the evaluation of demonstration projects under paragraph (6).
(3) Making grants to public and nonprofit private entities for the conduct of research on identifying effective strategies for preventing such violence.
(4) Providing to the public information and education on such violence, including information and education to increase awareness of the public health consequences of such violence.
(5) Training health care providers as follows:
(A) To identify individuals whose medical conditions or statements indicate that the individuals are victims of such violence.
(B) To routinely determine, in examining patients, whether the medical conditions or statements of the patients so indicate.
(C) To refer individuals so identified to entities that provide services regarding such violence, including referrals for counseling, housing, legal services, and services of community organizations.
(6) Making grants to public and nonprofit private entities for demonstration projects with respect to such violence, including with respect to prevention.
(b) For purposes of this part, the term "interpersonal violence within families and among acquaintances" includes behavior commonly referred to as domestic violence, sexual assault, spousal abuse, woman battering, partner abuse, elder abuse, and acquaintance rape.
(July 1, 1944, ch. 373, title III, §393, as added
Prior Provisions
A prior section 393 of act July 1, 1944, was renumbered section 394 and is classified to
Another prior section 393 of act July 1, 1944, was renumbered section 394 and was classified to
§280b–1b. Prevention of traumatic brain injury
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out projects to reduce the incidence of traumatic brain injury. Such projects may be carried out by the Secretary directly or through awards of grants or contracts to public or nonprofit private entities. The Secretary may directly or through such awards provide technical assistance with respect to the planning, development, and operation of such projects.
(b) Certain activities
Activities under subsection (a) of this section may include—
(1) the conduct of research into identifying effective strategies for the prevention of traumatic brain injury;
(2) the implementation of public information and education programs for the prevention of such injury and for broadening the awareness of the public concerning the public health consequences of such injury; and
(3) the implementation of a national education and awareness campaign regarding such injury (in conjunction with the program of the Secretary regarding health-status goals for 2010, commonly referred to as Healthy People 2010), including—
(A) the national dissemination of information on—
(i) incidence and prevalence; and
(ii) information relating to traumatic brain injury and the sequelae of secondary conditions arising from traumatic brain injury upon discharge from hospitals and trauma centers; and
(B) the provision of information in primary care settings, including emergency rooms and trauma centers, concerning the availability of State level services and resources.
(c) Coordination of activities
The Secretary shall ensure that activities under this section are coordinated as appropriate with other agencies of the Public Health Service that carry out activities regarding traumatic brain injury.
(d) "Traumatic brain injury" defined
For purposes of this section, the term "traumatic brain injury" means an acquired injury to the brain. Such term does not include brain dysfunction caused by congenital or degenerative disorders, nor birth trauma, but may include brain injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the Secretary determines necessary, after consultation with States and other appropriate public or nonprofit private entities.
(July 1, 1944, ch. 373, title III, §393A, as added
Amendments
2000—Subsec. (b)(3).
Subsec. (d).
§280b–1c. Use of allotments for rape prevention education
(a) Permitted use
The Secretary, acting through the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, shall award targeted grants to States to be used for rape prevention and education programs conducted by rape crisis centers, State sexual assault coalitions, and other public and private nonprofit entities for—
(1) educational seminars;
(2) the operation of hotlines;
(3) training programs for professionals;
(4) the preparation of informational material;
(5) education and training programs for students and campus personnel designed to reduce the incidence of sexual assault at colleges and universities;
(6) education to increase awareness about drugs used to facilitate rapes or sexual assaults; and
(7) other efforts to increase awareness of the facts about, or to help prevent, sexual assault, including efforts to increase awareness in underserved communities and awareness among individuals with disabilities (as defined in
(b) Collection and dissemination of information on sexual assault
The Secretary shall, through the National Resource Center on Sexual Assault established under the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, provide resource information, policy, training, and technical assistance to Federal, State, local, and Indian tribal agencies, as well as to State sexual assault coalitions and local sexual assault programs and to other professionals and interested parties on issues relating to sexual assault, including maintenance of a central resource library in order to collect, prepare, analyze, and disseminate information and statistics and analyses thereof relating to the incidence and prevention of sexual assault.
(c) Authorization of appropriations
(1) In general
There is authorized to be appropriated to carry out this section $80,000,000 for each of fiscal years 2001 through 2005.
(2) National resource center allotment
Of the total amount made available under this subsection in each fiscal year, not more than the greater of $1,000,000 or 2 percent of such amount shall be available for allotment under subsection (b) of this section.
(d) Limitations
(1) Supplement not supplant
Amounts provided to States under this section shall be used to supplement and not supplant other Federal, State, and local public funds expended to provide services of the type described in subsection (a) of this section.
(2) Studies
A State may not use more than 2 percent of the amount received by the State under this section for each fiscal year for surveillance studies or prevalence studies.
(3) Administration
A State may not use more than 5 percent of the amount received by the State under this section for each fiscal year for administrative expenses.
(July 1, 1944, ch. 373, title III, §393B, as added
Codification
Another section 393B of act July 1, 1944, is classified to
§280b–1d. National program for traumatic brain injury registries
(a) 1 In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States or their designees to operate the State's traumatic brain injury registry, and to academic institutions to conduct applied research that will support the development of such registries, to collect data concerning—
(1) demographic information about each traumatic brain injury;
(2) information about the circumstances surrounding the injury event associated with each traumatic brain injury;
(3) administrative information about the source of the collected information, dates of hospitalization and treatment, and the date of injury; and
(4) information characterizing the clinical aspects of the traumatic brain injury, including the severity of the injury, outcomes of the injury, the types of treatments received, and the types of services utilized.
(July 1, 1944, ch. 373, title III, §393B, as added
Codification
Another section 393B of act July 1, 1944, is classified to
1 So in original. No subsec. (b) has been enacted.
§280b–2. General provisions
(a) Advisory committee
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish an advisory committee to advise the Secretary and such Director with respect to the prevention and control of injuries.
(b) Technical assistance
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may provide technical assistance to public and nonprofit private entities with respect to the planning, development, and operation of any program or service carried out pursuant to this part. The Secretary may provide such technical assistance directly or through grants or contracts.
(c) Biennial report
Not later than February 1 of 1995 and of every second year thereafter, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities carried out under this part during the preceding 2 fiscal years. Such report shall include a description of such activities that were carried out with respect to interpersonal violence within families and among acquaintances and with respect to rural areas.
(July 1, 1944, ch. 373, title III, §394, formerly §393, as added
Prior Provisions
A prior section 280b–2, act July 1, 1944, ch. 373, title III, §392, as added Oct. 22, 1965,
A prior section 394 of act July 1, 1944, was renumbered section 394A and is classified to
Amendments
1993—
"(1) information regarding the practical applications of research conducted pursuant to subsection (a) of
"(2) information on such activities regarding the prevention and control of injuries in rural areas, including information regarding injuries that are particular to rural areas."
1992—
1990—
Change of Name
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
Termination of Advisory Committees
Advisory committees 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 committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 14 of
§280b–3. Authorization of appropriations
For the purpose of carrying out this part, there are authorized to be appropriated $50,000,000 for fiscal year 1994, such sums as may be necessary for each of the fiscal years 1995 through 1998, and such sums as may be necessary for each of the fiscal years 2001 through 2005..1
(July 1, 1944, ch. 373, title III, §394A, formerly §394, as added
Prior Provisions
A prior section 280b–3, act July 1, 1944, ch. 373, title III, §393, as added Oct. 22, 1965,
Prior sections 280b–4 to 280b–11 were repealed by
Section 280b–4, act July 1, 1944, ch. 373, title III, §393, formerly §394, as added Oct. 22, 1965,
Section 280b–5, act July 1, 1944, ch. 373, title III, §394, formerly §395, as added Oct. 22, 1965,
Section 280b–6, act July 1, 1944, ch. 373, title III, §396, as added Oct. 22, 1965,
Section 280b–7, act July 1, 1944, ch. 373, title III, §395, formerly §397, as added Oct. 22, 1965,
Section 280b–8, act July 1, 1944, ch. 373, title III, §396, formerly §398, as added Oct. 22, 1965,
Section 280b–9, act July 1, 1944, ch. 373, title III, §397, formerly §399, as added Oct. 22, 1965,
Section 280b–10, act July 1, 1944, ch. 373, title III, §398, formerly §399a, as added Oct. 22, 1965,
Section 280b–11, act July 1, 1944, ch. 373, title III, §399, formerly §399b, as added Oct. 22, 1965,
A prior section 280b–12, act July 1, 1944, ch. 373, title III, §399b, as added Mar. 13, 1970,
Amendments
2000—
1993—
1990—
Part K—Health Care Services in the Home
Amendments
1993—
1990—
Prior Provisions
A prior part K, added
subpart i—grants for demonstration projects
§280c. Establishment of program
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make not less than 5, and not more than 20, grants to States for the purpose of assisting grantees in carrying out demonstration projects—
(1) to identify low-income individuals who can avoid institutionalization or prolonged hospitalization if skilled medical services, skilled nursing care services, homemaker or home health aide services, or personal care services are provided in the homes of the individuals;
(2) to pay the costs of the provision of such services in the homes of such individuals; and
(3) to coordinate the provision by public and private entities of such services, and other long-term care services, in the homes of such individuals.
(b) Requirement with respect to age of recipients of services
The Secretary may not make a grant under subsection (a) of this section to a State unless the State agrees to ensure that—
(1) not less than 25 percent of the grant is expended to provide services under such subsection to individuals who are not less than 65 years of age; and
(2) of the portion of the grant reserved by the State for purposes of complying with paragraph (1), not less than 10 percent is expended to provide such services to individuals who are not less than 85 years of age.
(c) Relationship to items and services under other programs
A State may not make payments from a grant under subsection (a) of this section for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services on a prepaid basis.
(July 1, 1944, ch. 373, title III, §395, as added
Prior Provisions
A prior section 280C, act July 1, 1944, ch. 373, title III, §399A, formerly §399c, as added Dec. 29, 1973,
A prior section 395 of act July 1, 1944, ch. 373, title III, formerly §397, as added Oct. 22, 1965,
Amendments
1991—Subsec. (a)(1).
1990—Subsec. (a).
Subsec. (a)(1).
Subsec. (b).
Effective Date
Part effective Oct. 1, 1987, see section 701(a) of
Short Title
For short title of title VI of
Section Referred to in Other Sections
This section is referred to in
§280c–1. Limitation on duration of grant and requirement of matching funds
(a) Limitation on duration of grant
The period during which payments are made to a State from a grant under
(b) Requirement of matching funds
(1)(A) For the first year of payments to a State from a grant under
(B) For the second year of such payments to a State, the Secretary may not make such payments in an amount exceeding 65 percent of the costs of such services.
(C) For the third year of such payments to a State, the Secretary may not make such payments in an amount exceeding 55 percent of the costs of such services.
(2) The Secretary may not make a grant under
(A) for the first year of payments to the State from the grant, not less than $25 (in cash or in kind under subsection (c) of this section) for each $75 of Federal funds provided in the grant;
(B) for the second year of such payments to the State, not less than $35 (in cash or in kind under subsection (c) of this section) for each $65 of such Federal funds; and
(C) for the third year of such payments to the State, not less than $45 (in cash or in kind under subsection (c) of this section) for each $55 of such Federal funds.
(c) Determination of amount of non-Federal contribution
Non-Federal contributions required in subsection (b) of this section may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(July 1, 1944, ch. 373, title III, §396, as added
Prior Provisions
A prior section 396 of act July 1, 1944, ch. 373, title III, formerly §398, as added Oct. 22, 1965,
§280c–2. General provisions
(a) Limitation on administrative expenses
The Secretary may not make a grant under
(b) Description of intended use of grant
The Secretary may not make a grant under
(1) the State submits to the Secretary a description of the purposes for which the State intends to expend the grant; and
(2) such description provides information relating to the programs and activities to be supported and services to be provided, including—
(A) the number of individuals who will receive services pursuant to
(B) a description of the manner in which such programs and activities will be coordinated with any similar programs and activities of public and private entities.
(c) Requirement of application
The Secretary may not make a grant under
(1) contain the description of intended expenditures required in subsection (b) of this section;
(2) with respect to carrying out the purpose for which the grant is to be made, provide assurances of compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such manner, and contain such information and agreements as the Secretary determines to be necessary to carry out this subpart.
(d) Evaluations and report by Secretary
The Secretary shall—
(1) provide for an evaluation of each demonstration project for which a grant is made under
(2) not later than 6 months after the completion of such evaluations, submit to the Congress a report describing the findings made as a result of the evaluations.
(e) Authorizations of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $5,000,000 for each of the fiscal years 1988 through 1990, $7,500,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §397, as added
Prior Provisions
A prior section 397 of act July 1, 1944, ch. 373, title III, formerly §399, as added Oct. 22, 1965,
Amendments
1990—Subsec. (e).
subpart ii—grants for demonstration projects with respect to alzheimer's disease
§280c–3. Establishment of program
(a) In general
The Secretary shall make grants to States for the purpose of assisting grantees in carrying out demonstration projects for planning, establishing, and operating programs—
(1) to coordinate the development and operation with public and private organizations of diagnostic, treatment, care management, respite care, legal counseling, and education services provided within the State to individuals with Alzheimer's disease or related disorders and to the families and care providers of such individuals;
(2) to provide home health care, personal care, day care, companion services, short-term care in health facilities, and other respite care to individuals with Alzheimer's disease or related disorders who are living in single family homes or in congregate settings;
(3) to improve the access of such individuals to home-based or community-based long-term care services (subject to the services being provided by entities that were providing such services in the State involved as of October 1, 1995), particularly such individuals who are members of racial or ethnic minority groups, who have limited proficiency in speaking the English language, or who live in rural areas; and
(4) to provide to health care providers, to individuals with Alzheimer's disease or related disorders, to the families of such individuals, to organizations established for such individuals and such families, and to the general public, information with respect to—
(A) diagnostic services, treatment services, and related services available to such individuals and to the families of such individuals;
(B) sources of assistance in obtaining such services, including assistance under entitlement programs; and
(C) the legal rights of such individuals and such families.
(b) Requirement with respect to certain expenditures
The Secretary may not make a grant under subsection (a) of this section to a State unless the State agrees to expend not less than 50 percent of the grant for the provision of services described in subsection (a)(2) of this section.
(c) Relationship to items and services under other programs
A State may not make payments from a grant under subsection (a) of this section for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services on a prepaid basis.
(July 1, 1944, ch. 373, title III, §398, as added
Prior Provisions
A prior section 398 of act July 1, 1944, ch. 373, title III, formerly §399a, as added Oct. 22, 1965,
Amendments
1998—Subsec. (a).
Subsec. (a)(2).
Subsec. (a)(3), (4).
1990—Subsec. (a).
Subsec. (a)(1).
Section Referred to in Other Sections
This section is referred to in
§280c–4. Requirement of matching funds
(a) Requirement of matching funds
(1)(A) For the first year of payments to a State from a grant under
(B) For the second year of such payments to a State, the Secretary may not make such payments in an amount exceeding 65 percent of the costs of such services.
(C) For the third or subsequent year of such payments to a State, the Secretary may not make such payments in an amount exceeding 55 percent of the costs of such services.
(2) The Secretary may not make a grant under
(A) for the first year of payments to the State from the grant, not less than $25 (in cash or in kind under subsection (c) of this section) for each $75 of Federal funds provided in the grant;
(B) for the second year of such payments to the State, not less than $35 (in cash or in kind under subsection (c) of this section) for each $65 of such Federal funds; and
(C) for the third or subsequent year of such payments to the State, not less than $45 (in cash or in kind under subsection (c) of this section) for each $55 of such Federal funds.
(b) Determination of amount of non-Federal contribution
Non-Federal contributions required in subsection (b) of this section may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(July 1, 1944, ch. 373, title III, §398A, formerly §399, as added
Amendments
1998—
Subsec. (a).
Subsecs. (b), (c).
§280c–5. General provisions
(a) Limitation on administrative expenses
The Secretary may not make a grant under
(b) Description of intended use of grant
The Secretary may not make a grant under
(1) the State submits to the Secretary a description of the purposes for which the State intends to expend the grant; and
(2) such description provides information relating to the programs and activities to be supported and services to be provided, including—
(A) the number of individuals who will receive services pursuant to
(B) a description of the manner in which such programs and activities will be coordinated with any similar programs and activities of public and private entities.
(c) Requirement of application
The Secretary may not make a grant under
(1) contain the description of intended expenditures required in subsection (b) of this section;
(2) with respect to carrying out the purpose for which the grant is to be made, provide assurances of compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such manner, and contain such information and agreements as the Secretary determines to be necessary to carry out this subpart.
(d) Evaluations and report by Secretary
The Secretary shall—
(1) provide for an evaluation of each demonstration project for which a grant is made under
(2) not later than 6 months after the completion of such evaluations, submit to the Congress a report describing the findings made as a result of the evaluations.
(e) Authorizations of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $5,000,000 for each of the fiscal years 1988 through 1990, $7,500,000 for fiscal year 1991, such sums as may be necessary for each of the fiscal years 1992 and 1993, $8,000,000 for fiscal year 1998, and such sums as may be necessary for each of the fiscal years 1999 through 2002.
(July 1, 1944, ch. 373, title III, §398B, formerly §399A, as added
Amendments
1998—Subsec. (e).
1990—Subsec. (e).
subpart iii—grants for home visiting services for at-risk families
§280c–6. Projects to improve maternal, infant, and child health
(a) In general
(1) Establishment of program
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants to eligible entities to pay the Federal share of the cost of providing the services specified in subsection (b) of this section to families in which a member is—
(A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
(B) a child less than 3 years of age—
(i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or neglect; or
(ii) who has been prenatally exposed to maternal substance abuse.
(2) Minimum period of awards; administrative consultations
(A) The Secretary shall award grants under paragraph (1) for periods of at least three years.
(B) The Administrator of the Administration for Children, Youth, and Families and the Director of the National Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines and funding priorities under this section.
(3) Requirement of status as medicaid provider
(A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the case of any service under such paragraph that is covered in the State plan approved under title XIX of the Social Security Act [
(i) the entity involved will provide the service directly, and the entity has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the entity will enter into an agreement with an organization under which the organization will provide the service, and the organization has entered into such a participation agreement and is qualified to receive such payments.
(B)(i) In the case of an organization making an agreement under subparagraph (A)(ii) regarding the provision of services under paragraph (1), the requirement established in such subparagraph regarding a participation agreement shall be waived by the Secretary if the organization does not, in providing health or mental health services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(ii) A determination by the Secretary of whether an organization referred to in clause (i) meets the criteria for a waiver under such clause shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the public.
(b) Home visiting services for eligible families
With respect to an eligible family, each of the following services shall, directly or through arrangement with other public or nonprofit private entities, be available (as applicable to the family member involved) in each project operated with a grant under subsection (a) of this section:
(1) Prenatal and postnatal health care.
(2) Primary health care for the children, including developmental assessments.
(3) Education for the parents concerning infant care and child development, including the development and utilization of parent and teacher resource networks and other family resource and support networks where such networks are available.
(4) Upon the request of a parent, providing the education described in paragraph (3) to other individuals who have responsibility for caring for the children.
(5) Education for the parents concerning behaviors that adversely affect health.
(6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and nutrition services and other assistance, including services and other assistance under maternal and child health programs; the special supplemental nutrition program for women, infants, and children;
(c) Considerations in making grants
In awarding grants under subsection (a) of this section, the Secretary shall take into consideration—
(1) the ability of the entity involved to provide, either directly or through linkages, a broad range of preventive and primary health care services and related social, family support, and developmental services;
(2) different combinations of professional and lay home visitors utilized within programs that are reflective of the identified service needs and characteristics of target populations;
(3) the extent to which the population to be targeted has limited access to health care, and related social, family support, and developmental services; and
(4) whether such grants are equitably distributed among urban and rural settings and whether entities serving Native American communities are represented among the grantees.
(d) Federal share
With respect to the costs of carrying out a project under subsection (a) of this section, a grant under such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non-Federal funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
(e) Rule of construction regarding at-risk births
For purposes of subsection (a)(1) of this section, a pregnant woman shall be considered to be at risk of delivering an infant with a health or developmental complication if during the pregnancy the woman—
(1) lacks appropriate access to, or information concerning, early and routine prenatal care;
(2) lacks the transportation necessary to gain access to the services described in subsection (b) of this section;
(3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize health and related social services;
(4) is fearful of accessing substance abuse services or child and family support services; or
(5) is a minor with a low income.
(f) Delivery of services and case management
(1) Case management model
Home visiting services provided under this section shall be delivered according to a case management model, and a registered nurse, licensed social worker, or other licensed health care professional with experience and expertise in providing health and related social services in home and community settings shall be assigned as the case manager for individual cases under such model.
(2) Case manager
A case manager assigned under paragraph (1) shall have primary responsibility for coordinating and overseeing the development of a plan for each family that is to receive home visiting services under this section, and for coordinating the delivery of such services provided through appropriate personnel.
(3) Appropriate personnel
In determining which personnel shall be utilized in the delivery of services, the case manager shall consider—
(A) the stated objective of the project to be operated with the grant, as determined after considering identified gaps in the current service delivery system; and
(B) the nature of the needs of the family to be served, as determined at the initial assessment of the family that is conducted by the case manager, and through follow-up contacts by other providers of home visiting services.
(4) Family service plan
A case manager, in consultation with a team established in accordance with paragraph (5) for the family involved, shall develop a plan for the family following the initial visit to the home of the family. Such plan shall reflect—
(A) an assessment of the health and related social service needs of the family;
(B) a structured plan for the delivery of home visiting services to meet the identified needs of the family;
(C) the frequency with which such services are to be provided to the family;
(D) ongoing revisions made as the needs of family members change; and
(E) the continuing voluntary participation of the family in the plan.
(5) Home visiting services team
The team to be consulted under paragraph (4) on behalf of a family shall include, as appropriate, other nursing professionals, physician assistants, social workers, child welfare professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be required by the mother or child.
(g) Outreach
Each grantee under subsection (a) of this section shall provide outreach and casefinding services to inform eligible families of the availability of home visiting services from the project.
(h) Confidentiality
In accordance with applicable State law, an entity receiving a grant under subsection (a) of this section shall maintain confidentiality with respect to services provided to families under this section.
(i) Certain assurances
The Secretary may award a grant under subsection (a) of this section only if the entity involved provides assurances satisfactory to the Secretary that—
(1) the entity will provide home visiting services with reasonable frequency—
(A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches at least 2 years of age; and
(B) to other eligible families, for at least 2 years; and
(2) the entity will coordinate with public health and related social service agencies to prevent duplication of effort and improve the delivery of comprehensive health and related social services.
(j) Submission to Secretary of certain information
The Secretary may award a grant under subsection (a) of this section only if the entity involved submits to the Secretary—
(1) a description of the population to be targeted for home visiting services and methods of outreach and casefinding for identifying eligible families, including the use of lay home visitors where appropriate;
(2) a description of the types and qualifications of home visitors used by the entity and the process by which the entity will provide continuing training and sufficient support to the home visitors; and
(3) such other information as the Secretary determines to be appropriate.
(k) Limitation regarding administrative expenses
Not more than 10 percent of a grant under subsection (a) of this section may be expended for administrative expenses with respect to the grant. The costs of training individuals to serve in the project involved are not subject to the preceding sentence.
(l) Restrictions on use of grant
To be eligible to receive a grant under this section, an entity must agree that the grant will not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private entity.
(m) Reports to Secretary
To be eligible to receive a grant under this section, an entity must agree to submit an annual report on the services provided under this section to the Secretary in such manner and containing such information as the Secretary by regulation requires. At a minimum, the entity shall report information concerning eligible families, including—
(1) the characteristics of the families and children receiving services under this section;
(2) the usage, nature, and location of the provider, of preventive health services, including prenatal, primary infant, and child health care;
(3) the incidence of low birthweight and premature infants;
(4) the length of hospital stays for pre- and post-partum women and their children;
(5) the incidence of substantiated child abuse and neglect for all children within participating families;
(6) the number of emergency room visits for routine health care;
(7) the source of payment for health care services and the extent to which the utilization of health care services, other than routine screening and medical care, available to the individuals under the program established under title XIX of the Social Security Act [
(8) the number and type of referrals made for health and related social services, including alcohol and drug treatment services, and the utilization of such services provided by the grantee; and
(9) the incidence of developmental disabilities.
(n) Requirement of application
The Secretary may make a grant under subsection (a) of this section only if—
(1) an application for the grant is submitted to the Secretary;
(2) the application contains the agreements and assurances required in this section, and the information required in subsection (j) of this section;
(3) the application contains evidence that the preparation of the application has been coordinated with the State agencies responsible for maternal and child health and child welfare, and coordinated with services provided under part H 1 of the Individuals with Disabilities Education Act; and
(4) the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(o) Peer review
(1) Requirement
In making determinations for awarding grants under subsection (a) of this section, the Secretary shall rely on the recommendations of the peer review panel established under paragraph (2).
(2) Composition
The Secretary shall establish a review panel to make recommendations under paragraph (1) that shall be composed of—
(A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of community-based primary health services; and
(B) representatives of relevant Federal agencies, including the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, the Administration for Children, Youth, and Families, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
(p) Evaluations
(1) In general
The Secretary shall, directly or through contracts with public or private entities—
(A) conduct evaluations to determine the effectiveness of projects under subsection (a) of this section in reducing the incidence of children born with health or developmental complications, the incidence among children less than 3 years of age of such complications, and the incidence of child abuse and neglect; and
(B) not less than once during each 3-year period, prepare and submit to the appropriate committees of Congress a report concerning the results of such evaluations.
(2) Contents
The evaluations conducted under paragraph (1) shall—
(A) include a summary of the data contained in the annual reports submitted under subsection (m) of this section;
(B) assess the relative effectiveness of projects under subsection (a) of this section in urban and rural areas, and among programs utilizing differing combinations of professionals and trained home visitors recruited from the community to meet the needs of defined target service populations; and
(C) make further recommendations necessary or desirable to increase the effectiveness of such projects.
(q) Definitions
For purposes of this section:
(1) The term "eligible entity" includes public and nonprofit private entities that provide health or related social services, including community-based organizations, visiting nurse organizations, hospitals, local health departments, community health centers, Native Hawaiian health centers, nurse managed clinics, family service agencies, child welfare agencies, developmental service providers, family resource and support programs, and resource mothers projects.
(2) The term "eligible family" means a family described in subsection (a) of this section.
(3) The term "health or developmental complication", with respect to a child, means—
(A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low birthweight, and prenatal exposure to maternal substance abuse;
(B) a condition arising from a condition described in subparagraph (A);
(C) a physical disability or delay; and
(D) a developmental disability or delay.
(4) The term "home visiting services" means the services specified in subsection (b) of this section, provided at the residence of the eligible family involved or provided pursuant to arrangements made for the family (including arrangements for services in community settings).
(5) The term "home visitors" means providers of home visiting services.
(r) Authorization of appropriations
For the purpose of carrying out this section, there is authorized to be appropriated $30,000,000 for each of the fiscal years 1993 and 1994.
(July 1, 1944, ch. 373, title III, §399, as added
References in Text
The Social Security Act, referred to in subsecs. (a)(3)(A), (b)(6), and (m)(7), is act Aug. 14, 1935, ch. 531,
The Individuals with Disabilities Education Act, referred to in subsec. (n)(3), is title VI of
Prior Provisions
A prior section 399 of act July 1, 1944, was renumbered section 398A by section 502(1) of
Another prior section 399 of act July 1, 1944, ch. 373, title III, formerly §399b, as added Oct. 22, 1965,
Amendments
1994—Subsec. (b)(6).
Effective Date of 1994 Amendment
Amendment by
Effective Date
Section effective July 10, 1992, with programs making awards providing financial assistance in fiscal year 1993 and subsequent years effective for awards made on or after Oct. 1, 1992, see section 801(b), (d)(1) of
Reference to Community, Migrant, Public Housing, or Homeless Health Center Considered Reference to Health Center
Reference to community health center, migrant health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of
Purpose
Section 501 of title V of
"(1) to increase the use of, and to provide information on the availability of early, continuous and comprehensive prenatal care;
"(2) to reduce the incidence of infant mortality and of infants born prematurely, with low birthweight, or with other impairments including those associated with maternal substance abuse;
"(3) for pregnant women and mothers of children below the age of 3 whose children have experienced or are at risk of experiencing a health or developmental complication, to provide assistance in obtaining health and related social services necessary to meet the special needs of the women and their children;
"(4) to assist, when requested, women who are pregnant and at-risk for poor birth outcomes, or who have young children and are abusing alcohol or other drugs, in obtaining appropriate treatment; and
"(5) to reduce the incidence of child abuse and neglect."
1 See References in Text note below.
Part L—[Repealed]
Amendments
2000—
1993—
1990—
§280d. Transferred
Codification
Section, act July 1, 1944, ch. 373, title III, §399D, as added
§280d–11. Transferred
Codification
Section, act July 1, 1944, ch. 373, title III, §399F, as added
Part M—National Program of Cancer Registries
§280e. National program of cancer registries
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control, may make grants to States, or may make grants or enter into contracts with academic or nonprofit organizations designated by the State to operate the State's cancer registry in lieu of making a grant directly to the State, to support the operation of population-based, statewide cancer registries in order to collect, for each form of in-situ and invasive cancer (with the exception of basal cell and squamous cell carcinoma of the skin), data concerning—
(1) demographic information about each case of cancer;
(2) information on the industrial or occupational history of the individuals with the cancers, to the extent such information is available from the same record;
(3) administrative information, including date of diagnosis and source of information;
(4) pathological data characterizing the cancer, including the cancer site, stage of disease (pursuant to Staging Guide), incidence, and type of treatment; and
(5) other elements determined appropriate by the Secretary.
(b) Matching funds
(1) In general
The Secretary may make a grant under subsection (a) of this section only if the State, or the academic or nonprofit private organization designated by the State to operate the cancer registry of the State, involved agrees, with respect to the costs of the program, to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs or $1 for every $3 of Federal funds provided in the grant.
(2) Determination of amount of non-Federal contribution; maintenance of effort
(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) With respect to a State in which the purpose described in subsection (a) of this section is to be carried out, the Secretary, in making a determination of the amount of non-Federal contributions provided under paragraph (1), may include only such contributions as are in excess of the amount of such contributions made by the State toward the collection of data on cancer for the fiscal year preceding the first year for which a grant under subsection (a) of this section is made with respect to the State. The Secretary may decrease the amount of non-Federal contributions that otherwise would have been required by this subsection in those cases in which the State can demonstrate that decreasing such amount is appropriate because of financial hardship.
(c) Eligibility for grants
(1) In general
No grant shall be made by the Secretary under subsection (a) of this section unless an application has been submitted to, and approved by, the Secretary. Such application shall be in such form, submitted in such a manner, and be accompanied by such information, as the Secretary may specify. No such application may be approved unless it contains assurances that the applicant will use the funds provided only for the purposes specified in the approved application and in accordance with the requirements of this section, that the application will establish such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement and accounting of Federal funds paid to the applicant under subsection (a) of this section, and that the applicant will comply with the peer review requirements under
(2) Assurances
Each applicant, prior to receiving Federal funds under subsection (a) of this section, shall provide assurances satisfactory to the Secretary that the applicant will—
(A) provide for the establishment of a registry in accordance with subsection (a) of this section;
(B) comply with appropriate standards of completeness, timeliness, and quality of population-based cancer registry data;
(C) provide for the annual publication of reports of cancer data under subsection (a) of this section; and
(D) provide for the authorization under State law of the statewide cancer registry, including promulgation of regulations providing—
(i) a means to assure complete reporting of cancer cases (as described in subsection (a) of this section) to the statewide cancer registry by hospitals or other facilities providing screening, diagnostic or therapeutic services to patients with respect to cancer;
(ii) a means to assure the complete reporting of cancer cases (as defined in subsection (a) of this section) to the statewide cancer registry by physicians, surgeons, and all other health care practitioners diagnosing or providing treatment for cancer patients, except for cases directly referred to or previously admitted to a hospital or other facility providing screening, diagnostic or therapeutic services to patients in that State and reported by those facilities;
(iii) a means for the statewide cancer registry to access all records of physicians and surgeons, hospitals, outpatient clinics, nursing homes, and all other facilities, individuals, or agencies providing such services to patients which would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified patient;
(iv) for the reporting of cancer case data to the statewide cancer registry in such a format, with such data elements, and in accordance with such standards of quality timeliness and completeness, as may be established by the Secretary;
(v) for the protection of the confidentiality of all cancer case data reported to the statewide cancer registry, including a prohibition on disclosure to any person of information reported to the statewide cancer registry that identifies, or could lead to the identification of, an individual cancer patient, except for disclosure to other State cancer registries and local and State health officers;
(vi) for a means by which confidential case data may in accordance with State law be disclosed to cancer researchers for the purposes of cancer prevention, control and research;
(vii) for the authorization or the conduct, by the statewide cancer registry or other persons and organizations, of studies utilizing statewide cancer registry data, including studies of the sources and causes of cancer, evaluations of the cost, quality, efficacy, and appropriateness of diagnostic, therapeutic, rehabilitative, and preventative services and programs relating to cancer, and any other clinical, epidemiological, or other cancer research; and
(viii) for protection for individuals complying with the law, including provisions specifying that no person shall be held liable in any civil action with respect to a cancer case report provided to the statewide cancer registry, or with respect to access to cancer case information provided to the statewide cancer registry.
(d) Relationship to certain programs
(1) In general
This section may not be construed to act as a replacement for or diminishment of the program carried out by the Director of the National Cancer Institute and designated by such Director as the Surveillance, Epidemiology, and End Results Program (SEER).
(2) Supplanting of activities
In areas where both such programs exist, the Secretary shall ensure that SEER support is not supplanted and that any additional activities are consistent with the guidelines provided for in subsection (c)(2)(C) and (D) of this section and are appropriately coordinated with the existing SEER program.
(3) Transfer of responsibility
The Secretary may not transfer administration responsibility for such SEER program from such Director.
(4) Coordination
To encourage the greatest possible efficiency and effectiveness of Federally supported efforts with respect to the activities described in this subsection, the Secretary shall take steps to assure the appropriate coordination of programs supported under this part with existing Federally supported cancer registry programs.
(e) Requirement regarding certain study on breast cancer
In the case of a grant under subsection (a) of this section to any State specified in subsection (b) of
(July 1, 1944, ch. 373, title III, §399B, formerly §399H, as added
Amendments
2000—Subsec. (e).
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Congressional Findings and Purpose
Section 2 of
"(a)
"(1) cancer control efforts, including prevention and early detection, are best addressed locally by State health departments that can identify unique needs;
"(2) cancer control programs and existing statewide population-based cancer registries have identified cancer incidence and cancer mortality rates that indicate the burden of cancer for Americans is substantial and varies widely by geographic location and by ethnicity;
"(3) statewide cancer incidence and cancer mortality data, can be used to identify cancer trends, patterns, and variation for directing cancer control intervention;
"(4) the American Association of Central Cancer Registries (AACCR) cites that of the 50 States, approximately 38 have established cancer registries, many are not statewide and 10 have no cancer registry; and
"(5) AACCR also cites that of the 50 States, 39 collect data on less than 100 percent of their population, and less than half have adequate resources for insuring minimum standards for quality and for completeness of case information.
"(b)
Section Referred to in Other Sections
This section is referred to in
§280e–1. Planning grants regarding registries
(a) In general
(1) States
The Secretary, acting through the Director of the Centers for Disease Control, may make grants to States for the purpose of developing plans that meet the assurances required by the Secretary under
(2) Other entities
For the purpose described in paragraph (1), the Secretary may make grants to public entities other than States and to nonprofit private entities. Such a grant may be made to an entity only if the State in which the purpose is to be carried out has certified that the State approves the entity as qualified to carry out the purpose.
(b) Application
The Secretary may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Secretary, the application contains the certification required in subsection (a)(2) of this section (if the application is for a grant under such subsection), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(July 1, 1944, ch. 373, title III, §399C, formerly §399I, as added
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Section Referred to in Other Sections
This section is referred to in
§280e–2. Technical assistance in operations of statewide cancer registries
The Secretary, acting through the Director of the Centers for Disease Control, may, directly or through grants and contracts, or both, provide technical assistance to the States in the establishment and operation of statewide registries, including assistance in the development of model legislation for statewide cancer registries and assistance in establishing a computerized reporting and data processing system.
(July 1, 1944, ch. 373, title III, §399D, formerly §399J, as added
Prior Provisions
A prior section 399D of act July 1, 1944, was renumbered section 519, and is classified to
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Section Referred to in Other Sections
This section is referred to in
§280e–3. Study in certain States to determine factors contributing to elevated breast cancer mortality rates
(a) In general
Subject to subsections (c) and (d) of this section, the Secretary, acting through the Director of the National Cancer Institute, shall conduct a study for the purpose of determining the factors contributing to the fact that breast cancer mortality rates in the States specified in subsection (b) of this section are elevated compared to rates in other States.
(b) Relevant States
The States referred to in subsection (a) of this section are Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and the District of Columbia.
(c) Cooperation of State
The Secretary may conduct the study required in subsection (a) of this section in a State only if the State agrees to cooperate with the Secretary in the conduct of the study, including providing information from any registry operated by the State pursuant to
(d) Planning, commencement, and duration
The Secretary shall, during each of the fiscal years 1993 and 1994, develop a plan for conducting the study required in subsection (a) of this section. The study shall be initiated by the Secretary not later than fiscal year 1994, and the collection of data under the study may continue through fiscal year 1998.
(e) Report
Not later than September 30, 1999, the Secretary shall complete the study required in subsection (a) of this section and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the findings and recommendations made as a result of the study.
(July 1, 1944, ch. 373, title III, §399E, formerly §399K, as added
Amendments
2000—Subsec. (c).
Change of Name
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
Potential Environmental and Other Risks Contributing to Incidence of Breast Cancer
Section Referred to in Other Sections
This section is referred to in
§280e–4. Authorization of appropriations
(a) Registries
For the purpose of carrying out this part, there are authorized to be appropriated $30,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2003. Of the amounts appropriated under the preceding sentence for any such fiscal year, the Secretary may obligate not more than 25 percent for carrying out
(b) Breast cancer study
Of the amounts appropriated for the National Cancer Institute under subpart 1 of part C of subchapter III of this chapter for any fiscal year in which the study required in
(July 1, 1944, ch. 373, title III, §399F, formerly §399L, as added
Prior Provisions
A prior section 399F of act July 1, 1944, was renumbered section 399G and is classified to
Amendments
2000—Subsec. (a).
Subsec. (b).
1998—Subsec. (a).
1993—Subsec. (a).
Part N—National Foundation for the Centers for Disease Control and Prevention
Codification
This part was formerly set out preceding part M of this subchapter.
§280e–11. Establishment and duties of Foundation
(a) In general
There shall be established in accordance with this section a nonprofit private corporation to be known as the National Foundation for the Centers for Disease Control and Prevention (in this part referred to as the "Foundation"). The Foundation shall not be an agency or instrumentality of the Federal Government, and officers, employees, and members of the board of the Foundation shall not be officers or employees of the Federal Government.
(b) Purpose of Foundation
The purpose of the Foundation shall be to support and carry out activities for the prevention and control of diseases, disorders, injuries, and disabilities, and for promotion of public health.
(c) Endowment fund
(1) In general
In carrying out subsection (b) of this section, the Foundation shall establish a fund for providing endowments for positions that are associated with the Centers for Disease Control and Prevention and dedicated to the purpose described in such subsection. Subject to subsection (f)(1)(B) of this section, the fund shall consist of such donations as may be provided by non-Federal entities and such non-Federal assets of the Foundation (including earnings of the Foundation and the fund) as the Foundation may elect to transfer to the fund.
(2) Authorized expenditures of fund
The provision of endowments under paragraph (1) shall be the exclusive function of the fund established under such paragraph. Such endowments may be expended only for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the positions, and for recruiting individuals to hold the positions endowed by the fund.
(d) Certain activities of Foundation
In carrying out subsection (b) of this section, the Foundation may provide for the following with respect to the purpose described in such subsection:
(1) Programs of fellowships for State and local public health officials to work and study in association with the Centers for Disease Control and Prevention.
(2) Programs of international arrangements to provide opportunities for public health officials of other countries to serve in public health capacities in the United States in association with the Centers for Disease Control and Prevention or elsewhere, or opportunities for employees of such Centers (or other public health officials in the United States) to serve in such capacities in other countries, or both.
(3) Studies, projects, and research (which may include applied research on the effectiveness of prevention activities, demonstration projects, and programs and projects involving international, Federal, State, and local governments).
(4) Forums for government officials and appropriate private entities to exchange information. Participants in such forums may include institutions of higher education and appropriate international organizations.
(5) Meetings, conferences, courses, and training workshops.
(6) Programs to improve the collection and analysis of data on the health status of various populations.
(7) Programs for writing, editing, printing, and publishing of books and other materials.
(8) Other activities to carry out the purpose described in subsection (b) of this section.
(e) General structure of Foundation; nonprofit status
(1) Board of directors
The Foundation shall have a board of directors (in this part referred to as the "Board"), which shall be established and conducted in accordance with subsection (f) of this section. The Board shall establish the general policies of the Foundation for carrying out subsection (b) of this section, including the establishment of the bylaws of the Foundation.
(2) Executive director
The Foundation shall have an executive director (in this part referred to as the "Director"), who shall be appointed by the Board, who shall serve at the pleasure of the Board, and for whom the Board shall establish the rate of compensation. Subject to compliance with the policies and bylaws established by the Board pursuant to paragraph (1), the Director shall be responsible for the daily operations of the Foundation in carrying out subsection (b) of this section.
(3) Nonprofit status
In carrying out subsection (b) of this section, the Board shall establish such policies and bylaws under paragraph (1), and the Director shall carry out such activities under paragraph (2), as may be necessary to ensure that the Foundation maintains status as an organization that—
(A) is described in subsection (c)(3) of
(B) is, under subsection (a) of such section, exempt from taxation.
(f) Board of directors
(1) Certain bylaws
(A) In establishing bylaws under subsection (e)(1) of this section, the Board shall ensure that the bylaws of the Foundation include bylaws for the following:
(i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation.
(ii) Policies, including ethical standards, for the acceptance and disposition of donations to the Foundation and for the disposition of the assets of the Foundation.
(iii) Policies for the conduct of the general operations of the Foundation.
(iv) Policies for writing, editing, printing, and publishing of books and other materials, and the acquisition of patents and licenses for devices and procedures developed by the Foundation.
(B) In establishing bylaws under subsection (e)(1) of this section, the Board shall ensure that the bylaws of the Foundation (and activities carried out under the bylaws) do not—
(i) reflect unfavorably upon the ability of the Foundation, or the Centers for Disease Control and Prevention, to carry out its responsibilities or official duties in a fair and objective manner; or
(ii) compromise, or appear to compromise, the integrity of any governmental program or any officer or employee involved in such program.
(2) Composition
(A) Subject to subparagraph (B), the Board shall be composed of 7 individuals, appointed in accordance with paragraph (4), who collectively possess education or experience appropriate for representing the general field of public health, the general field of international health, and the general public. Each such individual shall be a voting member of the Board.
(B) The Board may, through amendments to the bylaws of the Foundation, provide that the number of members of the Board shall be a greater number than the number specified in subparagraph (A).
(3) Chair
The Board shall, from among the members of the Board, designate an individual to serve as the chair of the Board (in this subsection referred to as the "Chair").
(4) Appointments, vacancies, and terms
Subject to subsection (j) of this section (regarding the initial membership of the Board), the following shall apply to the Board:
(A) Any vacancy in the membership of the Board shall be filled by appointment by the Board, after consideration of suggestions made by the Chair and the Director regarding the appointments. Any such vacancy shall be filled not later than the expiration of the 180-day period beginning on the date on which the vacancy occurs.
(B) The term of office of each member of the Board appointed under subparagraph (A) shall be 5 years. A member of the Board may continue to serve after the expiration of the term of the member until the expiration of the 180-day period beginning on the date on which the term of the member expires.
(C) A vacancy in the membership of the Board shall not affect the power of the Board to carry out the duties of the Board. If a member of the Board does not serve the full term applicable under subparagraph (B), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(5) Compensation
Members of the Board may not receive compensation for service on the Board. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board.
(g) Certain responsibilities of executive director
In carrying out subsection (e)(2) of this section, the Director shall carry out the following functions:
(1) Hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of the officers and employees.
(2) Accept and administer donations to the Foundation, and administer the assets of the Foundation.
(3) Establish a process for the selection of candidates for holding endowed positions under subsection (c) of this section.
(4) Enter into such financial agreements as are appropriate in carrying out the activities of the Foundation.
(5) Take such action as may be necessary to acquire patents and licenses for devices and procedures developed by the Foundation and the employees of the Foundation.
(6) Adopt, alter, and use a corporate seal, which shall be judicially noticed.
(7) Commence and respond to judicial proceedings in the name of the Foundation.
(8) Other functions that are appropriate in the determination of the Director.
(h) General provisions
(1) Authority for accepting funds
The Director of the Centers for Disease Control and Prevention may accept and utilize, on behalf of the Federal Government, any gift, donation, bequest, or devise of real or personal property from the Foundation for the purpose of aiding or facilitating the work of such Centers. Funds may be accepted and utilized by such Director under the preceding sentence without regard to whether the funds are designated as general-purpose funds or special-purpose funds.
(2) Authority for acceptance of voluntary services
(A) The Director of the Centers for Disease Control and Prevention may accept, on behalf of the Federal Government, any voluntary services provided to such Centers by the Foundation for the purpose of aiding or facilitating the work of such Centers. In the case of an individual, such Director may accept the services provided under the preceding sentence by the individual for not more than 2 years.
(B) The limitation established in subparagraph (A) regarding the period of time in which services may be accepted applies to each individual who is not an employee of the Federal Government and who serves in association with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation.
(3) Administrative control
No officer, employee, or member of the Board of the Foundation may exercise any administrative or managerial control over any Federal employee.
(4) Applicability of certain standards to non-Federal employees
In the case of any individual who is not an employee of the Federal Government and who serves in association with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation, the Foundation shall negotiate a memorandum of understanding with the individual and the Director of the Centers for Disease Control and Prevention specifying that the individual—
(A) shall be subject to the ethical and procedural standards regulating Federal employment, scientific investigation, and research findings (including publications and patents) that are required of individuals employed by the Centers for Disease Control and Prevention, including standards under this chapter, the Ethics in Government Act, and the Technology Transfer Act; 1 and
(B) shall be subject to such ethical and procedural standards under
(5) Financial conflicts of interest
Any individual who is an officer, employee, or member of the Board of the Foundation may not directly or indirectly participate in the consideration or determination by the Foundation of any question affecting—
(A) any direct or indirect financial interest of the individual; or
(B) any direct or indirect financial interest of any business organization or other entity of which the individual is an officer or employee or in which the individual has a direct or indirect financial interest.
(6) Audits; availability of records
The Foundation shall—
(A) provide for biennial audits of the financial condition of the Foundation; and
(B) make such audits, and all other records, documents, and other papers of the Foundation, available to the Secretary and the Comptroller General of the United States for examination or audit.
(7) Reports
(A) Not later than February 1 of each fiscal year, the Foundation shall publish a report describing the activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal year involved a comprehensive statement of the operations, activities, financial condition, and accomplishments of the Foundation.
(B) With respect to the financial condition of the Foundation, each report under subparagraph (A) shall include the source, and a description of, all gifts to the Foundation of real or personal property, and the source and amount of all gifts to the Foundation of money. Each such report shall include a specification of any restrictions on the purposes for which gifts to the Foundation may be used.
(C) The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy.
(8) Liaison from Centers for Disease Control and Prevention
The Director of the Centers for Disease Control and Prevention shall serve as the liaison representative of such Centers to the Board and the Foundation.
(i) Federal funding
(1) Authority for annual grants
(A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(i) for fiscal year 1993, make a grant to an entity described in subsection (j)(9) of this section (relating to the establishment of a committee to establish the Foundation);
(ii) for fiscal year 1994, make a grant to the committee established under such subsection, or if the Foundation has been established, to the Foundation; and
(iii) for fiscal year 1995 and each subsequent fiscal year, make a grant to the Foundation.
(B) A grant under subparagraph (A) may be expended—
(i) in the case of an entity receiving the grant under subparagraph (A)(i), only for the purpose of carrying out the duties established in subsection (j)(9) of this section for the entity;
(ii) in the case of the committee established under such subsection, only for the purpose of carrying out the duties established in subsection (j) of this section for the committee; and
(iii) in the case of the Foundation, only for the purpose of the administrative expenses of the Foundation.
(C) A grant under subparagraph (A) may not be expended to provide amounts for the fund established under subsection (c) of this section.
(D) For the purposes described in subparagraph (B)—
(i) any portion of the grant made under subparagraph (A)(i) for fiscal year 1993 that remains unobligated after the entity receiving the grant completes the duties established in subsection (j)(9) of this section for the entity shall be available to the committee established under such subsection; and
(ii) any portion of a grant under subparagraph (A) made for fiscal year 1993 or 1994 that remains unobligated after such committee completes the duties established in such subsection for the committee shall be available to the Foundation.
(2) Funding for grants
(A) For the purpose of grants under paragraph (1), there is authorized to be appropriated $500,000 for each fiscal year.
(B) For the purpose of grants under paragraph (1), the Secretary may for each fiscal year make available not more than $500,000 from the amounts appropriated for the fiscal year for the programs of the Department of Health and Human Services. Such amounts may be made available without regard to whether amounts have been appropriated under subparagraph (A).
(3) Certain restriction
If the Foundation receives Federal funds for the purpose of serving as a fiscal intermediary between Federal agencies, the Foundation may not receive such funds for the indirect costs of carrying out such purpose in an amount exceeding 10 percent of the direct costs of carrying out such purpose. The preceding sentence may not be construed as authorizing the expenditure of any grant under paragraph (1) for such purpose.
(j) Committee for establishment of Foundation
(1) In general
There shall be established in accordance with this subsection a committee to carry out the functions described in paragraph (2) (which committee is referred to in this subsection as the "Committee").
(2) Functions
The functions referred to in paragraph (1) for the Committee are as follows:
(A) To carry out such activities as may be necessary to incorporate the Foundation under the laws of the State involved, including serving as incorporators for the Foundation. Such activities shall include ensuring that the articles of incorporation for the Foundation require that the Foundation be established and operated in accordance with the applicable provisions of this part (or any successor to this part), including such provisions as may be in effect pursuant to amendments enacted after October 27, 1992.
(B) To ensure that the Foundation qualifies for and maintains the status described in subsection (e)(3) of this section (regarding taxation).
(C) To establish the general policies and initial bylaws of the Foundation, which bylaws shall include the bylaws described in subsections (e)(3) and (f)(1) of this section.
(D) To provide for the initial operation of the Foundation, including providing for quarters, equipment, and staff.
(E) To appoint the initial members of the Board in accordance with the requirements established in subsection (f)(2)(A) of this section for the composition of the Board, and in accordance with such other qualifications as the Committee may determine to be appropriate regarding such composition. Of the members so appointed—
(i) 2 shall be appointed to serve for a term of 3 years;
(ii) 2 shall be appointed to serve for a term of 4 years; and
(iii) 3 shall be appointed to serve for a term of 5 years.
(3) Completion of functions of Committee; initial meeting of Board
(A) The Committee shall complete the functions required in paragraph (1) not later than September 30, 1994. The Committee shall terminate upon the expiration of the 30-day period beginning on the date on which the Secretary determines that the functions have been completed.
(B) The initial meeting of the Board shall be held not later than November 1, 1994.
(4) Composition
The Committee shall be composed of 5 members, each of whom shall be a voting member. Of the members of the Committee—
(A) no fewer than 2 shall have broad, general experience in public health; and
(B) no fewer than 2 shall have broad, general experience in nonprofit private organizations (without regard to whether the individuals have experience in public health).
(5) Chair
The Committee shall, from among the members of the Committee, designate an individual to serve as the chair of the Committee.
(6) Terms; vacancies
The term of members of the Committee shall be for the duration of the Committee. A vacancy in the membership of the Committee shall not affect the power of the Committee to carry out the duties of the Committee. If a member of the Committee does not serve the full term, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(7) Compensation
Members of the Committee may not receive compensation for service on the Committee. Members of the Committee may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Committee.
(8) Committee support
The Director of the Centers for Disease Control and Prevention may, from amounts available to the Director for the general administration of such Centers, provide staff and financial support to assist the Committee with carrying out the functions described in paragraph (2). In providing such staff and support, the Director may both detail employees and contract for assistance.
(9) Grant for establishment of Committee
(A) With respect to a grant under paragraph (1)(A)(i) of subsection (i) of this section for fiscal year 1993, an entity described in this paragraph is a private nonprofit entity with significant experience in domestic and international issues of public health. Not later than 180 days after October 27, 1992, the Secretary shall make the grant to such an entity (subject to the availability of funds under paragraph (2) of such subsection).
(B) The grant referred to in subparagraph (A) may be made to an entity only if the entity agrees that—
(i) the entity will establish a committee that is composed in accordance with paragraph (4); and
(ii) the entity will not select an individual for membership on the Committee unless the individual agrees that the Committee will operate in accordance with each of the provisions of this subsection that relate to the operation of the Committee.
(C) The Secretary may make a grant referred to in subparagraph (A) only if the applicant for the grant makes an agreement that the grant will not be expended for any purpose other than carrying out subparagraph (B). Such a grant may be made only if an application for the grant is submitted to the Secretary containing such agreement, and the application is in such form, is made in such manner, and contains such other agreements and such assurances and information as the Secretary determines to be necessary to carry out this paragraph.
(July 1, 1944, ch. 373, title III, §399G, formerly §399F, as added
References in Text
The Ethics in Government Act, referred to in subsec. (h)(4)(A), probably means the Ethics in Government Act of 1978,
The Technology Transfer Act, referred to in subsec. (h)(4)(A), may mean the Federal Technology Transfer Act of 1986,
Codification
Section was formerly classified to
Prior Provisions
A prior section 399G of act July 1, 1944, was renumbered section 399H and is classified to
1 See References in Text note below.
Part O—Fetal Alcohol Syndrome Prevention and Services Program
§280f. Establishment of Fetal Alcohol Syndrome prevention and services program
(a) Fetal Alcohol Syndrome prevention, intervention and services delivery program
The Secretary shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention, intervention and services delivery program that shall include—
(1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
(A) educational programs targeting medical schools, social and other supportive services, educators and counselors and other service providers in all phases of childhood development, and other relevant service providers, concerning the prevention, identification, and provision of services for children, adolescents and adults with Fetal Alcohol Syndrome and Fetal Alcohol Effect;
(B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
(C) public and community awareness programs concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect; and
(D) strategies to coordinate information and services across affected community agencies, including agencies providing social services such as foster care, adoption, and social work, medical and mental health services, and agencies involved in education, vocational training and civil and criminal justice;
(2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate to—
(A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Effect; and
(B) develop effective prevention services and interventions for pregnant, alcohol-dependent women; and
(3) an applied research program concerning intervention and prevention to support and conduct service demonstration projects, clinical studies and other research models providing advocacy, educational and vocational training, counseling, medical and mental health, and other supportive services, as well as models that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
(b) Grants and technical assistance
The Secretary may award grants, cooperative agreements and contracts and provide technical assistance to eligible entities described in
(c) Dissemination of criteria
In carrying out this section, the Secretary shall develop a procedure for disseminating the Fetal Alcohol Syndrome and Fetal Alcohol Effect diagnostic criteria developed pursuant to section 705 of the ADAMHA Reorganization Act to health care providers, educators, social workers, child welfare workers, and other individuals.
(d) National Task Force
(1) In general
The Secretary shall establish a task force to be known as the National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect (referred to in this subsection as the "Task Force") to foster coordination among all governmental agencies, academic bodies and community groups that conduct or support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome and Fetal Alcohol Effect.
(2) Membership
The Task Force established pursuant to paragraph (1) shall—
(A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
(B) include the Chairperson of the Interagency Coordinating Committee on Fetal Alcohol Syndrome of the Department of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and representatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS Family Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic community, and Federal, State and local government agencies and offices.
(3) Functions
The Task Force shall—
(A) advise Federal, State and local programs and research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect, including programs and research concerning education and public awareness for relevant service providers, school-age children, women at-risk, and the general public, medical diagnosis, interventions for women at-risk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and beneficial services for individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect and their families;
(B) coordinate its efforts with the Interagency Coordinating Committee on Fetal Alcohol Syndrome of the Department of Health and Human Services; and
(C) report on a biennial basis to the Secretary and relevant committees of Congress on the current and planned activities of the participating agencies.
(4) Time for appointment
The members of the Task Force shall be appointed by the Secretary not later than 6 months after November 13, 1998.
(July 1, 1944, ch. 373, title III, §399H, formerly §399G, as added
References in Text
Section 705 of the ADAMHA Reorganization Act, referred to in subsec. (c), is section 705 of
Prior Provisions
A prior section 399H of act July 1, 1944, was renumbered section 399B and is classified to
Another prior section 399H of act July 1, 1944, was renumbered section 399I and is classified to
Amendments
2000—Subsec. (b).
Congressional Findings and Purpose
"(b)
"(1) Fetal Alcohol Syndrome is the leading preventable cause of mental retardation, and it is 100 percent preventable;
"(2) estimates on the number of children each year vary, but according to some researchers, up to 12,000 infants are born in the United States with Fetal Alcohol Syndrome, suffering irreversible physical and mental damage;
"(3) thousands more infants are born each year with Fetal Alcohol Effect, also known as Alcohol Related Neurobehavioral Disorder (ARND), a related and equally tragic syndrome;
"(4) children of women who use alcohol while pregnant have a significantly higher infant mortality rate (13.3 per 1,000) than children of those women who do not use alcohol (8.6 per 1,000);
"(5) Fetal Alcohol Syndrome and Fetal Alcohol Effect are national problems which can impact any child, family, or community, but their threat to American Indians and Alaska Natives is especially alarming;
"(6) in some American Indian communities, where alcohol dependency rates reach 50 percent and above, the chances of a newborn suffering Fetal Alcohol Syndrome or Fetal Alcohol Effect are up to 30 times greater than national averages;
"(7) in addition to the immeasurable toll on children and their families, Fetal Alcohol Syndrome and Fetal Alcohol Effect pose extraordinary financial costs to the Nation, including the costs of health care, education, foster care, job training, and general support services for affected individuals;
"(8) the total cost to the economy of Fetal Alcohol Syndrome was approximately $2,500,000,000 in 1995, and over a lifetime, health care costs for one Fetal Alcohol Syndrome child are estimated to be at least $1,400,000;
"(9) researchers have determined that the possibility of giving birth to a baby with Fetal Alcohol Syndrome or Fetal Alcohol Effect increases in proportion to the amount and frequency of alcohol consumed by a pregnant woman, and that stopping alcohol consumption at any point in the pregnancy reduces the emotional, physical, and mental consequences of alcohol exposure to the baby; and
"(10) though approximately 1 out of every 5 pregnant women drink alcohol during their pregnancy, we know of no safe dose of alcohol during pregnancy, or of any safe time to drink during pregnancy, thus, it is in the best interest of the Nation for the Federal Government to take an active role in encouraging all women to abstain from alcohol consumption during pregnancy.
"(c)
"(1) coordinate, support, and conduct national, State, and community-based public awareness, prevention, and education programs on Fetal Alcohol Syndrome and Fetal Alcohol Effect;
"(2) coordinate, support, and conduct prevention and intervention studies as well as epidemiologic research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
"(3) coordinate, support and conduct research and demonstration projects to develop effective developmental and behavioral interventions and programs that foster effective advocacy, educational and vocational training, appropriate therapies, counseling, medical and mental health, and other supportive services, as well as models that integrate or coordinate such services, aimed at the unique challenges facing individuals with Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families; and
"(4) foster coordination among all Federal, State and local agencies, and promote partnerships between research institutions and communities that conduct or support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, surveillance, prevention, and interventions and otherwise meet the general needs of populations already affected or at risk of being impacted by Fetal Alcohol Syndrome and Fetal Alcohol Effect."
Section Referred to in Other Sections
This section is referred to in
§280f–1. Eligibility
To be eligible to receive a grant, or enter into a cooperative agreement or contract under this part, an entity shall—
(1) be a State, Indian tribal government, local government, scientific or academic institution, or nonprofit organization; and
(2) prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may prescribe, including a description of the activities that the entity intends to carry out using amounts received under this part.
(July 1, 1944, ch. 373, title III, §399I, formerly §399H, as added
Prior Provisions
A prior section 399I of act July 1, 1944, was renumbered section 399C and is classified to
Another prior section 399I of act July 1, 1944, was renumbered section 399J and is classified to
Section Referred to in Other Sections
This section is referred to in
§280f–2. Authorization of appropriations
(a) In general
There are authorized to be appropriated to carry out this part, $27,000,000 for each of the fiscal years 1999 through 2003.
(b) Task Force
From amounts appropriated for a fiscal year under subsection (a) of this section, the Secretary may use not to exceed $2,000,000 of such amounts for the operations of the National Task Force under
(July 1, 1944, ch. 373, title III, §399J, formerly §399I, as added
Prior Provisions
A prior section 399J of act July 1, 1944, was renumbered section 399D and is classified to
Another prior section 399J of act July 1, 1944, was renumbered section 399K and is classified to
Amendments
2000—Subsec. (b).
§280f–3. Sunset provision
This part shall not apply on the date that is 7 years after the date on which all members of the National Task Force have been appointed under
(July 1, 1944, ch. 373, title III, §399K, formerly §399J, as added
Prior Provisions
A prior section 399K of act July 1, 1944, was renumbered section 399E and is classified to
Amendments
2000—
Part P—Additional Programs
§280g. Children's asthma treatment grants program
(a) Authority to make grants
(1) In general
In addition to any other payments made under this chapter or title V of the Social Security Act [
(A) To provide access to quality medical care for children who live in areas that have a high prevalence of asthma and who lack access to medical care.
(B) To provide on-site education to parents, children, health care providers, and medical teams to recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and prevent its exacerbations.
(C) To decrease preventable trips to the emergency room by making medication available to individuals who have not previously had access to treatment or education in the management of asthma.
(D) To provide other services, such as smoking cessation programs, home modification, and other direct and support services that ameliorate conditions that exacerbate or induce asthma.
(2) 1 Certain projects
In making grants under paragraph (1), the Secretary may make grants designed to develop and expand the following projects:
(A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the National Asthma Education and Prevention Program (through the National Heart, Lung and Blood Institute), including access to care and treatment for asthma in a community-based setting.
(B) Projects to fully equip mobile health care clinics that provide preventive asthma care including diagnosis, physical examinations, pharmacological therapy, skin testing, peak flow meter testing, and other asthma-related health care services.
(C) Projects to conduct validated asthma management education programs for patients with asthma and their families, including patient education regarding asthma management, family education on asthma management, and the distribution of materials, including displays and videos, to reinforce concepts presented by medical teams.
(2) 1 Award of grants
(A) Application
(i) In general
An eligible entity shall submit an application to the Secretary for a grant under this section in such form and manner as the Secretary may require.
(ii) Required information
An application submitted under this subparagraph shall include a plan for the use of funds awarded under the grant and such other information as the Secretary may require.
(B) Requirement
In awarding grants under this section, the Secretary shall give preference to eligible entities that demonstrate that the activities to be carried out under this section shall be in localities within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality or high rate of hospitalization or emergency room visits for asthma (relative to the average asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate a high prevalence of childhood asthma or high asthma-related mortality may include data from Federal, State, or local vital statistics, claims data under title XIX or XXI of the Social Security Act [
(3) Definition of eligible entity
For purposes of this section, the term "eligible entity" means a public or nonprofit private entity (including a State or political subdivision of a State), or a consortium of any of such entities.
(b) Coordination with other children's programs
An eligible entity shall identify in the plan submitted as part of an application for a grant under this section how the entity will coordinate operations and activities under the grant with—
(1) other programs operated in the State that serve children with asthma, including any such programs operated under title V, XIX, or XXI of the Social Security Act [
(2) one or more of the following—
(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such Act [
(B) the head start program established under the Head Start Act (
(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under
(D) local public and private elementary or secondary schools; or
(E) public housing agencies, as defined in
(c) Evaluation
An eligible entity that receives a grant under this section shall submit to the Secretary an evaluation of the operations and activities carried out under the grant that includes—
(1) a description of the health status outcomes of children assisted under the grant;
(2) an assessment of the utilization of asthma-related health care services as a result of activities carried out under the grant;
(3) the collection, analysis, and reporting of asthma data according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention; and
(4) such other information as the Secretary may require.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §399L, as added
References in Text
The Social Security Act, referred to in subsecs. (a)(1), (2)(B) and (b)(1), (2)(A), is act Aug. 14, 1935, ch. 531,
The Head Start Act, referred to in subsec. (b)(2)(B), is subchapter B (§§635–657) of
Prior Provisions
A prior section 399L of act July 1, 1944, was renumbered section 399F and is classified to
Section Referred to in Other Sections
This section is referred to in
1 So in original. Two pars. (2) have been enacted.
§280g–1. Early detection, diagnosis, and treatment regarding hearing loss in infants
(a) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to develop statewide newborn and infant hearing screening, evaluation and intervention programs and systems for the following purposes:
(1) To develop and monitor the efficacy of state-wide newborn and infant hearing screening, evaluation and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act [
(2) To collect data on statewide newborn and infant hearing screening, evaluation and intervention programs and systems that can be used for applied research, program evaluation and policy development.
(b) Technical assistance, data management, and applied research
(1) Centers for Disease Control and Prevention
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramural program and to conduct applied research related to newborn and infant hearing screening, evaluation and intervention programs and systems. The program shall develop standardized procedures for data management and program effectiveness and costs, such as—
(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, and intervention programs and systems;
(B) to provide technical assistance on data collection and management;
(C) to study the costs and effectiveness of newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in order to answer issues of importance to State and national policymakers;
(D) to identify the causes and risk factors for congenital hearing loss;
(E) to study the effectiveness of newborn and infant hearing screening, audiologic and medical evaluations and intervention programs and systems by assessing the health, intellectual and social developmental, cognitive, and language status of these children at school age; and
(F) to promote the sharing of data regarding early hearing loss with State-based birth defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing loss.
(2) National Institutes of Health
The Director of the National Institutes of Health, acting through the Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of this section, continue a program of research and development on the efficacy of new screening techniques and technology, including clinical studies of screening methods, studies on efficacy of intervention, and related research.
(c) Coordination and collaboration
(1) In general
In carrying out programs under this section, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall collaborate and consult with other Federal agencies; State and local agencies, including those responsible for early intervention services pursuant to title XIX of the Social Security Act [
(2) Policy development
The Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with the private sector, including consumer, medical and other health and education professional-based organizations, with respect to newborn and infant hearing screening, evaluation and intervention programs and systems.
(3) State early detection, diagnosis, and intervention programs and systems; data collection
The Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish newborn and infant hearing screening, evaluation and intervention programs and systems under subsection (a) of this section and to develop a data collection system under subsection (b) of this section.
(d) Rule of construction; religious accommodation
Nothing in this section shall be construed to preempt or prohibit any State law, including State laws which do not require the screening for hearing loss of newborn infants or young children of parents who object to the screening on the grounds that such screening conflicts with the parents' religious beliefs.
(e) Definitions
For purposes of this section:
(1) The term "audiologic evaluation" refers to procedures to assess the status of the auditory system; to establish the site of the auditory disorder; the type and degree of hearing loss, and the potential effects of hearing loss on communication; and to identify appropriate treatment and referral options. Referral options should include linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act [
(2) The terms "audiologic rehabilitation" and "audiologic intervention" refer to procedures, techniques, and technologies to facilitate the receptive and expressive communication abilities of a child with hearing loss.
(3) The term "early intervention" refers to providing appropriate services for the child with hearing loss, including nonmedical services, and ensuring that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, communication options and are given the opportunity to consider the full range of educational and program placements and options for their child.
(4) The term "medical evaluation by a physician" refers to key components including history, examination, and medical decision making focused on symptomatic and related body systems for the purpose of diagnosing the etiology of hearing loss and related physical conditions, and for identifying appropriate treatment and referral options.
(5) The term "medical intervention" refers to the process by which a physician provides medical diagnosis and direction for medical and/or surgical treatment options of hearing loss and/or related medical disorder associated with hearing loss.
(6) The term "newborn and infant hearing screening" refers to objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who, after rescreening, require further audiologic and medical evaluations.
(f) Authorization of appropriations
(1) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
For the purpose of carrying out subsection (a) of this section, there are authorized to be appropriated to the Health Resources and Services Administration such sums as may be necessary for fiscal year 2002.
(2) Technical assistance, data management, and applied research; Centers for Disease Control and Prevention
For the purpose of carrying out subsection (b)(1) of this section, there are authorized to be appropriated to the Centers for Disease Control and Prevention such sums as may be necessary for fiscal year 2002.
(3) Technical assistance, data management, and applied research; national institute on deafness and other communication disorders
For the purpose of carrying out subsection (b)(2) of this section, there are authorized to be appropriated to the National Institute on Deafness and Other Communication Disorders such sums as may be necessary for fiscal year 2002.
(July 1, 1944, ch. 373, title III, §399M, as added
References in Text
The Individuals with Disabilities Education Act, referred to in subsecs. (a)(1), (c)(1), and (e)(1), is title VI of
The Social Security Act, referred to in subsec. (c)(1), is act Aug. 14, 1935, ch. 531,
Purposes
"(1) All babies born in hospitals in the United States and its territories should have a hearing screening before leaving the birthing facility. Babies born in other countries and residing in the United States via immigration or adoption should have a hearing screening as early as possible.
"(2) All babies who are not born in hospitals in the United States and its territories should have a hearing screening within the first 3 months of life.
"(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for all newborns and infants suspected of having hearing loss to allow appropriate referral and provisions for audiologic rehabilitation, medical and early intervention before the age of 6 months.
"(4) All newborn and infant hearing screening programs and systems should include a component for audiologic rehabilitation, medical and early intervention options that ensures linkage to any new and existing state-wide systems of intervention and rehabilitative services for newborns and infants with hearing loss.
"(5) Public policy in regard to newborn and infant hearing screening and intervention should be based on applied research and the recognition that newborns, infants, toddlers, and children who are deaf or hard-of-hearing have unique language, learning, and communication needs, and should be the result of consultation with pertinent public and private sectors."
§280g–2. Childhood malignancies
(a) In general
The Secretary, acting as appropriate through the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall study environmental and other risk factors for childhood cancers (including skeletal malignancies, leukemias, malignant tumors of the central nervous system, lymphomas, soft tissue sarcomas, and other malignant neoplasms) and carry out projects to improve outcomes among children with childhood cancers and resultant secondary conditions, including limb loss, anemia, rehabilitation, and palliative care. Such projects shall be carried out by the Secretary directly and through awards of grants or contracts.
(b) Certain activities
Activities under subsection (a) of this section include—
(1) the expansion of current demographic data collection and population surveillance efforts to include childhood cancers nationally;
(2) the development of a uniform reporting system under which treating physicians, hospitals, clinics, and States report the diagnosis of childhood cancers, including relevant associated epidemiological data; and
(3) support for the National Limb Loss Information Center to address, in part, the primary and secondary needs of persons who experience childhood cancers in order to prevent or minimize the disabling nature of these cancers.
(c) Coordination of activities
The Secretary shall assure that activities under this section are coordinated as appropriate with other agencies of the Public Health Service that carry out activities focused on childhood cancers and limb loss.
(d) Definition
For purposes of this section, the term "childhood cancer" refers to a spectrum of different malignancies that vary by histology, site of disease, origin, race, sex, and age. The Secretary may for purposes of this section revise the definition of such term to the extent determined by the Secretary to be appropriate.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §399N, as added
Part Q—Programs To Improve the Health of Children
§280h. Grants to promote childhood nutrition and physical activity
(a) In general
The Secretary, acting though the Director of the Centers for Disease Control and Prevention, shall award competitive grants to States and political subdivisions of States for the development and implementation of State and community-based intervention programs to promote good nutrition and physical activity in children and adolescents.
(b) Eligibility
To be eligible to receive a grant under this section a State or political subdivision of a State shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a plan that describes—
(1) how the applicant proposes to develop a comprehensive program of school- and community-based approaches to encourage and promote good nutrition and appropriate levels of physical activity with respect to children or adolescents in local communities;
(2) the manner in which the applicant shall coordinate with appropriate State and local authorities, such as State and local school departments, State departments of health, chronic disease directors, State directors of programs under
(3) the manner in which the applicant will evaluate the effectiveness of the program carried out under this section.
(c) Use of funds
A State or political subdivision of a State shall use amount received under a grant under this section to—
(1) develop, implement, disseminate, and evaluate school- and community-based strategies in States to reduce inactivity and improve dietary choices among children and adolescents;
(2) expand opportunities for physical activity programs in school- and community-based settings; and
(3) develop, implement, and evaluate programs that promote good eating habits and physical activity including opportunities for children with cognitive and physical disabilities.
(d) Technical assistance
The Secretary may set-aside an amount not to exceed 10 percent of the amount appropriated for a fiscal year under subsection (h) of this section to permit the Director of the Centers for Disease Control and Prevention to—
(1) provide States and political subdivisions of States with technical support in the development and implementation of programs under this section; and
(2) disseminate information about effective strategies and interventions in preventing and treating obesity through the promotion of good nutrition and physical activity.
(e) Limitation on administrative costs
Not to exceed 10 percent of the amount of a grant awarded to the State or political subdivision under subsection (a) of this section for a fiscal year may be used by the State or political subdivision for administrative expenses.
(f) Term
A grant awarded under subsection (a) of this section shall be for a term of 3 years.
(g) Definition
In this section, the term "children and adolescents" means individuals who do not exceed 18 years of age.
(h) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §399W, as added
§280h–1. Applied research program
(a) In general
The Secretary, acting through the Centers for Disease Control and Prevention and in consultation with the Director of the National Institutes of Health, shall—
(1) conduct research to better understand the relationship between physical activity, diet, and health and factors that influence health-related behaviors;
(2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based interventions and by health professionals;
(3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
(4) conduct research to establish the prevalence, consequences, and costs of childhood obesity and its effects in adulthood;
(5) identify behaviors and risk factors that contribute to obesity;
(6) evaluate materials and programs to provide nutrition education to parents and teachers of children in child care or pre-school and the food service staff of such child care and pre-school entities; and
(7) evaluate materials and programs that are designed to educate and encourage physical activity in child care and pre-school facilities.
(b) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §399X, as added
§280h–2. Education campaign
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in collaboration with national, State, and local partners, physical activity organizations, nutrition experts, and health professional organizations, shall develop a national public campaign to promote and educate children and their parents concerning—
(1) the health risks associated with obesity, inactivity, and poor nutrition;
(2) ways in which to incorporate physical activity into daily living; and
(3) the benefits of good nutrition and strategies to improve eating habits.
(b) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §399Y, as added
§280h–3. Health professional education and training
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in collaboration with the Administrator of the Health Resources and Services Administration and the heads of other agencies, and in consultation with appropriate health professional associations, shall develop and carry out a program to educate and train health professionals in effective strategies to—
(1) better identify and assess patients with obesity or an eating disorder or patients at-risk of becoming obese or developing an eating disorder;
(2) counsel, refer, or treat patients with obesity or an eating disorder; and
(3) educate patients and their families about effective strategies to improve dietary habits and establish appropriate levels of physical activity.
(b) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §399Z, as added