§1395m. Special payment rules for particular items and services
(a) Payment for durable medical equipment
(1) General rule for payment
(A) In general
With respect to a covered item (as defined in paragraph (13)) for which payment is determined under this subsection, payment shall be made in the frequency specified in paragraphs (2) through (7) and in an amount equal to 80 percent of the payment basis described in subparagraph (B).
(B) Payment basis
The payment basis described in this subparagraph is the lesser of-
(i) the actual charge for the item, or
(ii) the payment amount recognized under paragraphs (2) through (7) of this subsection for the item;
except that clause (i) shall not apply if the covered item is furnished by a public home health agency (or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low income) free of charge or at nominal charges to the public.
(C) Exclusive payment rule
This subsection shall constitute the exclusive provision of this subchapter for payment for covered items under this part or under part A of this subchapter to a home health agency.
(D) Reduction in fee schedules for certain items
With respect to a seat-lift chair or transcutaneous electrical nerve stimulator furnished on or after April 1, 1990, the Secretary shall reduce the payment amount applied under subparagraph (B)(ii) for such an item by 15 percent, and, in the case of a transcutaneous electrical nerve stimulator furnished on or after January 1, 1991, the Secretary shall further reduce such payment amount (as previously reduced) by 45 percent.
(2) Payment for inexpensive and other routinely purchased durable medical equipment
(A) In general
Payment for an item of durable medical equipment (as defined in paragraph (13))-
(i) the purchase price of which does not exceed $150,
(ii) which the Secretary determines is acquired at least 75 percent of the time by purchase, or
(iii) which is an accessory used in conjunction with a nebulizer, aspirator, or a ventilator excluded under paragraph (3)(A),
shall be made on a rental basis or in a lump-sum amount for the purchase of the item. The payment amount recognized for purchase or rental of such equipment is the amount specified in subparagraph (B) for purchase or rental, except that the total amount of payments with respect to an item may not exceed the payment amount specified in subparagraph (B) with respect to the purchase of the item.
(B) Payment amount
For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to the purchase or rental of an item furnished in a carrier service area-
(i) in 1989 and in 1990 is the average reasonable charge in the area for the purchase or rental, respectively, of the item for the 12-month period ending on June 30, 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987;
(ii) in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991;
(iii) in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and
(iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year.
(C) Computation of local payment amount and national limited payment amount
For purposes of subparagraph (B)-
(i) the local payment amount for an item or device for a year is equal to-
(I) for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the covered item update for 1991, and
(II) for 1992, 1993, and 1994, the amount determined under this clause for the preceding year increased by the covered item update for the year; and
(ii) the national limited payment amount for an item or device for a year is equal to-
(I) for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item,
(II) for 1992 and 1993, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year,
(III) for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and
(IV) for each subsequent year, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year.
(3) Payment for items requiring frequent and substantial servicing
(A) In general
Payment for a covered item (such as IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or intermittent assist devices with continuous airway pressure devices) for which there must be frequent and substantial servicing in order to avoid risk to the patient's health shall be made on a monthly basis for the rental of the item and the amount recognized is the amount specified in subparagraph (B).
(B) Payment amount
For purposes of subparagraph (A), the amount specified in this subparagraph, with respect to an item or device furnished in a carrier service area-
(i) in 1989 and in 1990 is the average reasonable charge in the area for the rental of the item or device for the 12-month period ending with June 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987;
(ii) in 1991 is the sum of (I) 67 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(I) for 1991, and (II) 33 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1991;
(iii) in 1992 is the sum of (I) 33 percent of the local payment amount for the item or device computed under subparagraph (C)(i)(II) for 1992, and (II) 67 percent of the national limited payment amount for the item or device computed under subparagraph (C)(ii) for 1992; and
(iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under subparagraph (C)(ii) for that year.
(C) Computation of local payment amount and national limited payment amount
For purposes of subparagraph (B)-
(i) the local payment amount for an item or device for a year is equal to-
(I) for 1991, the amount specified in subparagraph (B)(i) for 1990 increased by the covered item update for 1991, and
(II) for 1992, 1993, and 1994, the amount determined under this clause for the preceding year increased by the covered item update for the year; and
(ii) the national limited payment amount for an item or device for a year is equal to-
(I) for 1991, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the weighted average of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the weighted average of all local payment amounts determined under such clause for such item,
(II) for 1992 and 1993, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year,
(III) for 1994, the local payment amount determined under clause (i) for such item or device for that year, except that the national limited payment amount may not exceed 100 percent of the median of all local payment amounts determined under such clause for such item for that year and may not be less than 85 percent of the median of all local payment amounts determined under such clause for such item or device for that year, and
(IV) for each subsequent year, the amount determined under this clause for the preceding year increased by the covered item update for such subsequent year.
(4) Payment for certain customized items
Payment with respect to a covered item that is uniquely constructed or substantially modified to meet the specific needs of an individual patient, and for that reason cannot be grouped with similar items for purposes of payment under this subchapter, shall be made in a lump-sum amount (A) for the purchase of the item in a payment amount based upon the carrier's individual consideration for that item, and (B) for the reasonable and necessary maintenance and servicing for parts and labor not covered by the supplier's or manufacturer's warranty, when necessary during the period of medical need, and the amount recognized for such maintenance and servicing shall be paid on a lump-sum, as needed basis based upon the carrier's individual consideration for that item.
(5) Payment for oxygen and oxygen equipment
(A) In general
Payment for oxygen and oxygen equipment shall be made on a monthly basis in the monthly payment amount recognized under paragraph (9) for oxygen and oxygen equipment (other than portable oxygen equipment), subject to subparagraphs (B), (C), and (E).
(B) Add-on for portable oxygen equipment
When portable oxygen equipment is used, but subject to subparagraph (D), the payment amount recognized under subparagraph (A) shall be increased by the monthly payment amount recognized under paragraph (9) for portable oxygen equipment.
(C) Volume adjustment
When the attending physician prescribes an oxygen flow rate-
(i) exceeding 4 liters per minute, the payment amount recognized under subparagraph (A), subject to subparagraph (D), shall be increased by 50 percent, or
(ii) of less than 1 liter per minute, the payment amount recognized under subparagraph (A) shall be decreased by 50 percent.
(D) Limit on adjustment
When portable oxygen equipment is used and the attending physician prescribes an oxygen flow rate exceeding 4 liters per minute, there shall only be an increase under either subparagraph (B) or (C), whichever increase is larger, and not under both such subparagraphs.
(E) Recertification for patients receiving home oxygen therapy
In the case of a patient receiving home oxygen therapy services who, at the time such services are initiated, has an initial arterial blood gas value at or above a partial pressure of 56 or an arterial oxygen saturation at or above 89 percent (or such other values, pressures, or criteria as the Secretary may specify) no payment may be made under this part for such services after the expiration of the 90-day period that begins on the date the patient first receives such services unless the patient's attending physician certifies that, on the basis of a follow-up test of the patient's arterial blood gas value or arterial oxygen saturation conducted during the final 30 days of such 90-day period, there is a medical need for the patient to continue to receive such services.
(6) Payment for other covered items (other than durable medical equipment)
Payment for other covered items (other than durable medical equipment and other covered items described in paragraph (3), (4), or (5)) shall be made in a lump-sum amount for the purchase of the item in the amount of the purchase price recognized under paragraph (8).
(7) Payment for other items of durable medical equipment
(A) In general
In the case of an item of durable medical equipment not described in paragraphs (2) through (6)-
(i) payment shall be made on a monthly basis for the rental of such item during the period of medical need (but payments under this clause may not extend over a period of continuous use of longer than 15 months, or, in the case of an item for which a purchase agreement has been entered into under clause (iii), a period of continuous use of longer than 13 months), and, subject to subparagraph (B), the amount recognized for each of the first 3 months of such period is 10 percent of the purchase price recognized under paragraph (8) with respect to the item, and for each of the remaining months of such period is 7.5 percent of such purchase price;
(ii) in the case of a power-driven wheelchair, at the time the supplier furnishes the item, the supplier shall offer the individual patient the option to purchase the item, and payment for such item shall be made on a lump-sum basis if the patient exercises such option;
(iii) during the 10th continuous month during which payment is made for the rental of an item under clause (i), the supplier of such item shall offer the individual patient the option to enter into a purchase agreement under which, if the patient notifies the supplier not later than 1 month after the supplier makes such offer that the patient agrees to accept such offer and exercise such option-
(I) the supplier shall transfer title to the item to the individual patient on the first day that begins after the 13th continuous month during which payment is made for the rental of the item under clause (i),
(II) after the supplier transfers title to the item under subclause (I), maintenance and servicing payments shall be made in accordance with clause (vi);
(iv) in the case of an item for which a purchase agreement has not been entered into under clause (ii) or clause (iii), during the first 6-month period of medical need that follows the period of medical need during which payment is made under clause (i), no payment shall be made for rental or maintenance and servicing of the item;
(v) in the case of an item for which a purchase agreement has not been entered into under clause (ii) or clause (iii), during the first month of each succeeding 6-month period of medical need, a maintenance and servicing payment may be made (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the particular type of durable medical equipment) and the amount recognized for each such 6-month period is the lower of (I) a reasonable and necessary maintenance and servicing fee or fees established by the Secretary, or (II) 10 percent of the total of the purchase price recognized under paragraph (8) with respect to the item; and
(vi) in the case of an item for which a purchase agreement has been entered into under clause (ii) or clause (iii), maintenance and servicing payments may be made (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the particular type of durable medical equipment), and such payments shall be in an amount established by the Secretary on the basis of reasonable charges in the locality for maintenance and servicing.
The Secretary shall determine the meaning of the term "continuous" in subparagraph (A).
(B) Range for rental amounts
(i) For 1989
For items furnished during 1989, the payment amount recognized under subparagraph (A)(i) shall not be more than 115 percent, and shall not be less than 85 percent, of the prevailing charge established for rental of the item in January 1987, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987.
(ii) For 1990
For items furnished during 1990, clause (i) shall apply in the same manner as it applies to items furnished during 1989.
(C) Replacement of items
(i) Establishment of reasonable useful lifetime
In accordance with clause (iii), the Secretary shall determine and establish a reasonable useful lifetime for items of durable medical equipment for which payment may be made under this paragraph.
(ii) Payment for replacement items
If the reasonable lifetime of such an item, as so established, has been reached during a continuous period of medical need, or the carrier determines that the item is lost or irreparably damaged, the patient may elect to have payment for an item serving as a replacement for such item made-
(I) on a monthly basis for the rental of the replacement item in accordance with subparagraph (A); or
(II) in the case of an item for which a purchase agreement has been entered into under subparagraph (A)(ii) or (A)(iii), in a lump-sum amount for the purchase of the item.
(iii) Length of reasonable useful lifetime
The reasonable useful lifetime of an item of durable medical equipment under this subparagraph shall be equal to 5 years, except that, if the Secretary determines that, on the basis of prior experience in making payments for such an item under this subchapter, a reasonable useful lifetime of 5 years is not appropriate with respect to a particular item, the Secretary shall establish an alternative reasonable lifetime for such item.
(8) Purchase price recognized for miscellaneous devices and items
For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for a covered item is the amount described in subparagraph (C) of this paragraph, determined as follows:
(A) Computation of local purchase price
Each carrier under section 1395u of this title shall compute a base local purchase price for the item as follows:
(i) The carrier shall compute a base local purchase price, for each item described-
(I) in paragraph (6) equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987, or
(II) in paragraph (7) equal to the average of the purchase prices on the claims submitted on an assignment-related basis for the unused item supplied during the 6-month period ending with December 1986.
(ii) The carrier shall compute a local purchase price, with respect to the furnishing of each particular item-
(I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987,
(II) in 1991, equal to the local purchase price computed under this clause for the previous year, increased by the covered item update for 1991, and decreased by the percentage by which the average of the reasonable charges for claims paid for all items described in paragraph (7) is lower than the average of the purchase prices submitted for such items during the final 9 months of 1988; 1 or
(III) in 1992, 1993, and 1994, equal to the local purchase price computed under this clause for the previous year increased by the covered item update for the year.
(B) Computation of national limited purchase price
With respect to the furnishing of a particular item in a year, the Secretary shall compute a national limited purchase price-
(i) for 1991, equal to the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local purchase prices for the item computed under such subparagraph for the year;
(ii) for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year;
(iii) for 1994, the local purchase price computed under subparagraph (A)(ii) for the item for the year, except that such national limited purchase price may not exceed 100 percent of the median of all local purchase prices computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local purchase prices computed under such subparagraph for the item for the year; and
(iv) for each subsequent year, equal to the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year.
(C) Purchase price recognized
For purposes of paragraphs (6) and (7), the amount that is recognized under this paragraph as the purchase price for each item furnished-
(i) in 1989 or 1990, is 100 percent of the local purchase price computed under subparagraph (A)(ii)(I);
(ii) in 1991, is the sum of (I) 67 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1991, and (II) 33 percent of the national limited purchase price computed under subparagraph (B) for 1991;
(iii) in 1992, is the sum of (I) 33 percent of the local purchase price computed under subparagraph (A)(ii)(III) for 1992, and (II) 67 percent of the national limited purchase price computed under subparagraph (B) for 1992; and
(iv) in 1993 or a subsequent year, is the national limited purchase price computed under subparagraph (B) for that year.
(9) Monthly payment amount recognized with respect to oxygen and oxygen equipment
For purposes of paragraph (5), the amount that is recognized under this paragraph for payment for oxygen and oxygen equipment is the monthly payment amount described in subparagraph (C) of this paragraph. Such amount shall be computed separately (i) for all items of oxygen and oxygen equipment (other than portable oxygen equipment) and (ii) for portable oxygen equipment (each such group referred to in this paragraph as an "item").
(A) Computation of local monthly payment rate
Each carrier under this section shall compute a base local payment rate for each item as follows:
(i) The carrier shall compute a base local average monthly payment rate per beneficiary as an amount equal to (I) the total reasonable charges for the item during the 12-month period ending with December 1986, divided by (II) the total number of months for all beneficiaries receiving the item in the area during the 12-month period for which the carrier made payment for the item under this subchapter.
(ii) The carrier shall compute a local average monthly payment rate for the item applicable-
(I) to 1989 and 1990, equal to 95 percent of the base local average monthly payment rate computed under clause (i) for the item increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with December 1987, or
(II) to 1991, 1992, 1993, and 1994, equal to the local average monthly payment rate computed under this clause for the item for the previous year increased by the covered item increase for the year.
(B) Computation of national limited monthly payment rate
With respect to the furnishing of an item in a year, the Secretary shall compute a national limited monthly payment rate equal to-
(i) for 1991, the local monthly payment rate computed under subparagraph (A)(ii)(II) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year, and may not be less than 85 percent of the weighted average of all local monthly payment rates computed for the item under such subparagraph for the year;
(ii) for 1992 and 1993, the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year;
(iii) for 1994, the local monthly payment rate computed under subparagraph (A)(ii) for the item for the year, except that such national limited monthly payment rate may not exceed 100 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year and may not be less than 85 percent of the median of all local monthly payment rates computed for the item under such subparagraph for the year; and
(iv) for each subsequent year, equal to the amount determined under this subparagraph for the preceding year increased by the covered item update for such subsequent year.
(C) Monthly payment amount recognized
For purposes of paragraph (5), the amount that is recognized under this paragraph as the base monthly payment amount for each item furnished-
(i) in 1989 and in 1990, is 100 percent of the local average monthly payment rate computed under subparagraph (A)(ii) for the item;
(ii) in 1991, is the sum of (I) 67 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1991, and (II) 33 percent of the national limited monthly payment rate computed under subparagraph (B)(i) for the item for 1991;
(iii) in 1992, is the sum of (I) 33 percent of the local average monthly payment rate computed under subparagraph (A)(ii)(II) for the item for 1992, and (II) 67 percent of the national limited monthly payment rate computed under subparagraph (B)(ii) for the item for 1992; and
(iv) in a subsequent year, is the national limited monthly payment rate computed under subparagraph (B) for the item for that year.
(10) Exceptions and adjustments
(A) Areas outside continental United States
Exceptions to the amounts recognized under the previous provisions of this subsection shall be made to take into account the unique circumstances of covered items furnished in Alaska, Hawaii, or Puerto Rico.
(B) Adjustment for inherent reasonableness
For covered items furnished on or after January 1, 1991, the Secretary is authorized to apply the provisions of paragraphs (8) and (9) (other than subparagraph (D)) of section 1395u(b) of this title to covered items and suppliers of such items and payments under this subsection as such provisions would otherwise apply to physicians' services and physicians and a reasonable charge under section 1395u(b) of this title but for the application of section 1395w–4(i)(3) of this title. In applying such provisions to payments for an item under this subsection, the Secretary shall make adjustments to the payment basis for the item described in paragraph (1)(B) if the Secretary determines (in accordance with such provisions and on the basis of prices and costs applicable at the time the item is furnished) that such payment basis is not inherently reasonable.
(C) Transcutaneous electrical nerve stimulator (TENS)
In order to permit an attending physician time to determine whether the purchase of a transcutaneous electrical nerve stimulator is medically appropriate for a particular patient, the Secretary may determine an appropriate payment amount for the initial rental of such item for a period of not more than 2 months. If such item is subsequently purchased, the payment amount with respect to such purchase is the payment amount determined under paragraph (2).
(11) Improper billing and requirement of physician order
(A) Improper billing for certain rental items
Notwithstanding any other provision of this subchapter, a supplier of a covered item for which payment is made under this subsection and which is furnished on a rental basis shall continue to supply the item without charge (other than a charge provided under this subsection for the maintenance and servicing of the item) after rental payments may no longer be made under this subsection. If a supplier knowingly and willfully violates the previous sentence, the Secretary may apply sanctions against the supplier under section 1395u(j)(2) of this title in the same manner such sanctions may apply with respect to a physician.
(B) Requirement of physician order
The Secretary is authorized to require, for specified covered items, that payment may be made under this subsection with respect to the item only if a physician has communicated to the supplier, before delivery of the item, a written order for the item.
(12) Regional carriers
The Secretary may designate, by regulation under section 1395u of this title, one carrier for one or more entire regions to process all claims within the region for covered items under this section.
(13) "Covered item" defined
In this subsection, the term "covered item" means durable medical equipment (as defined in section 1395x(n) of this title), including such equipment described in section 1395x(m)(5) of this title).2
(14) Covered item update
In this subsection, the term "covered item update" means, with respect to a year-
(A) for 1991 and 1992, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year reduced by 1 percentage point; and
(B) for a subsequent year, the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year.
(15) Advance determinations of coverage for certain items
(A) Development of lists of items by Secretary
The Secretary may develop and periodically update a list of items for which payment may be made under this subsection that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization throughout a carrier's entire service area or a portion of such area.
(B) Development of lists of suppliers by Secretary
The Secretary may develop and periodically update a list of suppliers of items for which payment may be made under this subsection with respect to whom-
(i) the Secretary has found that a substantial number of claims for payment under this part for items furnished by the supplier have been denied on the basis of the application of section 1395y(a)(1) of this title; or
(ii) the Secretary has identified a pattern of overutilization resulting from the business practice of the supplier.
(C) Determinations of coverage in advance
A carrier shall determine in advance of delivery of an item whether payment for the item may not be made because the item is not covered or because of the application of section 1395y(a)(1) of this title if-
(i) the item is included on the list developed by the Secretary under subparagraph (A);
(ii) the item is furnished by a supplier included on the list developed by the Secretary under subparagraph (B); or
(iii) the item is a customized item (other than inexpensive items specified by the Secretary) and the patient to whom the item is to be furnished or the supplier requests that such advance determination be made.
(16) Repealed.
Pub. L. 103–432, title I, §131(a)(2), Oct. 31, 1994, 108 Stat. 4419
(17) Prohibition against unsolicited telephone contacts by suppliers
(A) In general
A supplier of a covered item under this subsection may not contact an individual enrolled under this part by telephone regarding the furnishing of a covered item to the individual unless 1 of the following applies:
(i) The individual has given written permission to the supplier to make contact by telephone regarding the furnishing of a covered item.
(ii) The supplier has furnished a covered item to the individual and the supplier is contacting the individual only regarding the furnishing of such covered item.
(iii) If the contact is regarding the furnishing of a covered item other than a covered item already furnished to the individual, the supplier has furnished at least 1 covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact.
(B) Prohibiting payment for items furnished subsequent to unsolicited contacts
If a supplier knowingly contacts an individual in violation of subparagraph (A), no payment may be made under this part for any item subsequently furnished to the individual by the supplier.
(C) Exclusion from program for suppliers engaging in pattern of unsolicited contacts
If a supplier knowingly contacts individuals in violation of subparagraph (A) to such an extent that the supplier's conduct establishes a pattern of contacts in violation of such subparagraph, the Secretary shall exclude the supplier from participation in the programs under this chapter, in accordance with the procedures set forth in subsections (c), (f), and (g) of section 1320a–7 of this title.
(18) Refund of amounts collected for certain disallowed items
(A) In general
If a nonparticipating supplier furnishes to an individual enrolled under this part a covered item for which no payment may be made under this part by reason of paragraph (17)(B), the supplier shall refund on a timely basis to the patient (and shall be liable to the patient for) any amounts collected from the patient for the item, unless-
(i) the supplier establishes that the supplier did not know and could not reasonably have been expected to know that payment may not be made for the item by reason of paragraph (17)(B), or
(ii) before the item was furnished, the patient was informed that payment under this part may not be made for that item and the patient has agreed to pay for that item.
(B) Sanctions
If a supplier knowingly and willfully fails to make refunds in violation of subparagraph (A), the Secretary may apply sanctions against the supplier in accordance with section 1395u(j)(2) of this title.
(C) Notice
Each carrier with a contract in effect under this part with respect to suppliers of covered items shall send any notice of denial of payment for covered items by reason of paragraph (17)(B) and for which payment is not requested on an assignment-related basis to the supplier and the patient involved.
(D) Timely basis defined
A refund under subparagraph (A) is considered to be on a timely basis only if-
(i) in the case of a supplier who does not request reconsideration or seek appeal on a timely basis, the refund is made within 30 days after the date the supplier receives a denial notice under subparagraph (C), or
(ii) in the case in which such a reconsideration or appeal is taken, the refund is made within 15 days after the date the supplier receives notice of an adverse determination on reconsideration or appeal.
(b) Fee schedules for radiologist services
(1) Development
The Secretary shall develop-
(A) a relative value scale to serve as the basis for the payment for radiologist services under this part, and
(B) using such scale and appropriate conversion factors and subject to subsection (c)(1)(A) of this section, fee schedules (on a regional, statewide, locality, or carrier service area basis) for payment for radiologist services under this part, to be implemented for such services furnished during 1989.
(2) Consultation
In carrying out paragraph (1), the Secretary shall regularly consult closely with the Physician Payment Review Commission, the American College of Radiology, and other organizations representing physicians or suppliers who furnish radiologist services and shall share with them the data and data analysis being used to make the determinations under paragraph (1), including data on variations in current medicare payments by geographic area, and by service and physician specialty.
(3) Considerations
In developing the relative value scale and fee schedules under paragraph (1), the Secretary-
(A) shall take into consideration variations in the cost of furnishing such services among geographic areas and among different sites where services are furnished, and
(B) may also take into consideration such other factors respecting the manner in which physicians in different specialties furnish such services as may be appropriate to assure that payment amounts are equitable and designed to promote effective and efficient provision of radiologist services by physicians in the different specialties.
(4) Savings
(A) Budget neutral fee schedules
The Secretary shall develop preliminary fee schedules for 1989, which are designed to result in the same amount of aggregate payments (net of any coinsurance and deductibles under sections 1395l(a)(1)(J) and 1395l(b) of this title) for radiologist services furnished in 1989 as would have been made if this subsection had not been enacted.
(B) Initial savings
The fee schedules established for payment purposes under this subsection for services furnished in 1989 shall be 97 percent of the amounts permitted under the preliminary fee schedules developed under subparagraph (A).
(C) 1990 fee schedules
For radiologist services (other than portable X-ray services) furnished under this part during 1990, after March 31 of such year, the conversion factors used under this subsection shall be 96 percent of the conversion factors that applied under this subsection as of December 31, 1989.
(D) 1991 fee schedules
For radiologist services (other than portable X-ray services) furnished under this part during 1991, the conversion factors used in a locality under this subsection shall, subject to clause (vii), be reduced to the adjusted conversion factor for the locality determined as follows:
(i) National weighted average conversion factor
The Secretary shall estimate the national weighted average of the conversion factors used under this subsection for services furnished during 1990 beginning on April 1, using the best available data.
(ii) Reduced national weighted average
The national weighted average estimated under clause (i) shall be reduced by 13 percent.
(iii) Computation of 1990 locality index relative to national average
The Secretary shall establish an index which reflects, for each locality, the ratio of the conversion factor used in the locality under this subsection to the national weighted average estimated under clause (i).
(iv) Adjusted conversion factor
The adjusted conversion factor for the professional or technical component of a service in a locality is the sum of ½ of the locally-adjusted amount determined under clause (v) and ½ of the GPCI-adjusted amount determined under clauses 3 (vi).
(v) Locally-adjusted amount
For purposes of clause (iv), the locally adjusted amount determined under this clause is the product of (I) the national weighted average conversion factor computed under clause (ii), and (II) the index value established under clause (iii) for the locality.
(vi) GPCI-adjusted amount
For purposes of clause (iv), the GPCI-adjusted amount determined under this clause is the sum of-
(I) the product of (a) the portion of the reduced national weighted average conversion factor computed under clause (ii) which is attributable to physician work and (b) the geographic work index value for the locality (specified in Addendum C to the Model Fee Schedule for Physician Services (published on September 4, 1990, 55 Federal Register pp. 36238–36243)); and
(II) the product of (a) the remaining portion of the reduced national weighted average conversion factor computed under clause (ii), and (b) the geographic practice cost index value specified in section 1395u(b)(14)(C)(iv) of this title for the locality.
In applying this clause with respect to the professional component of a service, 80 percent of the conversion factor shall be considered to be attributable to physician work and with respect to the technical component of the service, 0 percent shall be considered to be attributable to physician work.
(vii) Limits on conversion factor
The conversion factor to be applied to a locality to the professional or technical component of a service shall not be reduced under this subparagraph by more than 9.5 percent below the conversion factor applied in the locality under subparagraph (C) to such component, but in no case shall the conversion factor be less than 60 percent of the national weighted average of the conversion factors (computed under clause (i)).
(E) Rule for certain scanning services
In the case of the technical components of magnetic resonance imaging (MRI) services and computer assisted tomography (CAT) services furnished after December 31, 1990, the amount otherwise payable shall be reduced by 10 percent.
(F) Subsequent updating
For radiologist services furnished in subsequent years, the fee schedules shall be the schedules for the previous year updated by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for the year.
(G) Nonparticipating physicians and suppliers
Each fee schedule so established shall provide that the payment rate recognized for nonparticipating physicians and suppliers is equal to the appropriate percent (as defined in section 1395u(b)(4)(A)(iv) of this title) of the payment rate recognized for participating physicians and suppliers.
(5) Limiting charges of nonparticipating physicians and suppliers
(A) In general
In the case of radiologist services furnished after January 1, 1989, for which payment is made under a fee schedule under this subsection, if a nonparticipating physician or supplier furnishes the service to an individual entitled to benefits under this part, the physician or supplier may not charge the individual more than the limiting charge (as defined in subparagraph (B)).
(B) "Limiting charge" defined
In subparagraph (A), the term "limiting charge" means, with respect to a service furnished-
(i) in 1989, 125 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1),
(ii) in 1990, 120 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1), and
(iii) after 1990, 115 percent of the amount specified for the service in the appropriate fee schedule established under paragraph (1).
(C) Enforcement
If a physician or supplier knowingly and willfully bills in violation of subparagraph (A), the Secretary may apply sanctions against such physician or supplier in accordance with section 1395u(j)(2) of this title in the same manner as such sanctions may apply to a physician.
(6) "Radiologist services" defined
For the purposes of this subsection and section 1395l(a)(1)(J) of this title, the term "radiologist services" only includes radiology services performed by, or under the direction or supervision of, a physician-
(A) who is certified, or eligible to be certified, by the American Board of Radiology, or
(B) for whom radiology services account for at least 50 percent of the total amount of charges made under this part.
(c) Payments and standards for screening mammography
(1) In general
Notwithstanding any other provision of this part, with respect to expenses incurred for screening mammography (as defined in section 1395x(jj) of this title)-
(A) payment may be made only for screening mammography conducted consistent with the frequency permitted under paragraph (2);
(B) payment may be made only if the screening mammography is conducted by a facility that has a certificate (or provisional certificate) issued under section 263b of this title; and
(C) the amount of the payment under this part shall, subject to the deductible established under section 1395l(b) of this title, be equal to 80 percent of the least of-
(i) the actual charge for the screening,
(ii) the fee schedule established under subsection (b) of this section or the fee schedule established under section 1395w–4 of this title, whichever is applicable, with respect to both the professional and technical components of the screening mammography, or
(iii) the limit established under paragraph (3) for the screening mammography.
(2) Frequency covered
(A) In general
Subject to revision by the Secretary under subparagraph (B)-
(i) No payment may be made under this part for screening mammography performed on a woman under 35 years of age.
(ii) Payment may be made under this part for only 1 screening mammography performed on a woman over 34 years of age, but under 40 years of age.
(iii) In the case of a woman over 39 years of age, but under 50 years of age, who-
(I) is at a high risk of developing breast cancer (as determined pursuant to factors identified by the Secretary), payment may not be made under this part for a screening mammography performed within the 11 months following the month in which a previous screening mammography was performed, or
(II) is not at a high risk of developing breast cancer, payment may not be made under this part for a screening mammography performed within the 23 months following the month in which a previous screening mammography was performed.
(iv) In the case of a woman over 49 years of age, but under 65 years of age, payment may not be made under this part for screening mammography performed within 11 months following the month in which a previous screening mammography was performed.
(v) In the case of a woman over 64 years of age, payment may not be made for screening mammography performed within 23 months following the month in which a previous screening mammography was performed.
(B) Revision of frequency
(i) Review
The Secretary, in consultation with the Director of the National Cancer Institute, shall review periodically the appropriate frequency for performing screening mammography, based on age and such other factors as the Secretary believes to be pertinent.
(ii) Revision of frequency
The Secretary, taking into consideration the review made under clause (i), may revise from time to time the frequency with which screening mammography may be paid for under this subsection, but no such revision shall apply to screening mammography performed before January 1, 1992.
(3) Limit
(A) $55, indexed
Except as provided by the Secretary under subparagraph (B), the limit established under this paragraph-
(i) for screening mammography performed in 1991, is $55, and
(ii) for screening mammography performed in a subsequent year is the limit established under this paragraph for the preceding year increased by the percentage increase in the MEI for that subsequent year.
(B) Reduction of limit
The Secretary shall review from time to time the appropriateness of the amount of the limit established under this paragraph. The Secretary may, with respect to screening mammography performed in a year after 1992, reduce the amount of such limit as it applies nationally or in any area to the amount that the Secretary estimates is required to assure that screening mammography of an appropriate quality is readily and conveniently available during the year.
(C) Application of limit in hospital outpatient setting
The Secretary shall provide for an appropriate allocation of the limit established under this paragraph between professional and technical components in the case of hospital outpatient screening mammography (and comparable situations) where there is a claim for professional services separate from the claim for the radiologic procedure.
(4) Limiting charges of nonparticipating physicians
(A) In general
In the case of mammography screening performed on or after January 1, 1991, for which payment is made under this subsection, if a nonparticipating physician or supplier provides the screening to an individual entitled to benefits under this part, the physician or supplier may not charge the individual more than the limiting charge (as defined in subparagraph (B), or if less, as defined in subsection (b)(5)(B) of this section or as defined in section 1395w–4(g)(2) of this title).
(B) "Limiting charge" defined
In subparagraph (A), the term "limiting charge" means, with respect to screening mammography performed-
(i) in 1991, 125 percent of the limit established under paragraph (4),
(ii) in 1992, 120 percent of the limit established under paragraph (4), or
(iii) after 1992, 115 percent of the limit established under paragraph (4).
(C) Enforcement
If a physician or supplier knowing 4 and willfully imposes a charge in violation of subparagraph (A), the Secretary may apply sanctions against such physician or supplier in accordance with section 1395u(j)(2) of this title.
(d), (e) Repealed.
Pub. L. 101–234, title II, §201(a), Dec. 13, 1989, 103 Stat. 1981
(f) Reduction in payments for physician pathology services during 1991
(1) In general
For physician pathology services furnished under this part during 1991, the prevailing charges used in a locality under this part shall be 7 percent below the prevailing charges used in the locality under this part in 1990 after March 31.
(2) Limitation
The prevailing charge for the technical and professional components of an 5 physician pathology service furnished by a physician through an independent laboratory shall not be reduced pursuant to paragraph (1) to the extent that such reduction would reduce such prevailing charge below 115 percent of the prevailing charge for the professional component of such service when furnished by a hospital-based physician in the same locality. For purposes of the preceding sentence, an independent laboratory is a laboratory that is independent of a hospital and separate from the attending or consulting physicians' office.
(g) Payment for outpatient rural primary care hospital services
(1) In general
The amount of payment for outpatient rural primary care hospital services provided during a year before the prospective payment system described in paragraph (2) is in effect in a rural primary care hospital under this part shall be determined by one of the 2 following methods, as elected by the rural primary care hospital:
(A) Cost-based facility fee plus professional charges
(i) Facility fee
With respect to facility services, not including any services for which payment may be made under clause (ii), there shall be paid amounts equal to the amounts described in section 1395l(a)(2)(B) of this title (describing amounts paid for hospital outpatient services).
(ii) Reasonable charges for professional services
In electing treatment under this subparagraph, payment for professional medical services otherwise included within outpatient rural primary care hospital services shall be made under such other provisions of this part as would apply to payment for such services if they were not included in outpatient rural primary care hospital services.
(B) All-inclusive rate
With respect to both facility services and professional medical services, there shall be paid amounts equal to the costs which are reasonable and related to the cost of furnishing such services or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations, less the amount the hospital may charge as described in clause (i) of section 1395cc(a)(2)(A) of this title, but in no case may the payment for such services (other than for items and services described in section 1395x(s)(10)(A) of this title) exceed 80 percent of such costs.
The amount of payment shall be determined under either method without regard to the amount of the customary or other charge.
(2) Development and implementation of all inclusive, prospective payment system
Not later than January 1, 1996, the Secretary shall develop and implement a prospective payment system for determining payments under this part for outpatient rural primary care hospital services using a methodology that includes all costs in providing all such services (including related professional medical services) and that determines the payment amount for such services on a prospective basis.
(h) Payment for prosthetic devices and orthotics and prosthetics
(1) General rule for payment
(A) In general
Payment under this subsection for prosthetic devices and orthotics and prosthetics shall be made in a lump-sum amount for the purchase of the item in an amount equal to 80 percent of the payment basis described in subparagraph (B).
(B) Payment basis
Except as provided in subparagraphs (C) and (E), the payment basis described in this subparagraph is the lesser of-
(i) the actual charge for the item; or
(ii) the amount recognized under paragraph (2) as the purchase price for the item.
(C) Exception for certain public home health agencies
Subparagraph (B)(i) shall not apply to an item furnished by a public home health agency (or by another home health agency which demonstrates to the satisfaction of the Secretary that a significant portion of its patients are low income) free of charge or at nominal charges to the public.
(D) Exclusive payment rule
This subsection shall constitute the exclusive provision of this subchapter for payment for prosthetic devices, orthotics, and prosthetics under this part or under part A of this subchapter to a home health agency.
(E) Exception for certain items
Payment for ostomy supplies, tracheostomy supplies, and urologicals shall be made in accordance with subparagraphs (B) and (C) of subsection (a)(2) of this section.
(2) Purchase price recognized
For purposes of paragraph (1), the amount that is recognized under this paragraph as the purchase price for prosthetic devices, orthotics, and prosthetics is the amount described in subparagraph (C) of this paragraph, determined as follows:
(A) Computation of local purchase price
Each carrier under section 1395u of this title shall compute a base local purchase price for the item as follows:
(i) The carrier shall compute a base local purchase price for each item equal to the average reasonable charge in the locality for the purchase of the item for the 12-month period ending with June 1987.
(ii) The carrier shall compute a local purchase price, with respect to the furnishing of each particular item-
(I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 6-month period ending with December 1987, or
(II) in 1991, 1992 or 1993, equal to the local purchase price computed under this clause for the previous year increased by the applicable percentage increase for the year.
(B) Computation of regional purchase price
With respect to the furnishing of a particular item in each region (as defined by the Secretary), the Secretary shall compute a regional purchase price-
(i) for 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local purchase prices for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and
(ii) for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the applicable percentage increase for the year.
(C) Purchase price recognized
For purposes of paragraph (1) and subject to subparagraph (D), the amount that is recognized under this paragraph as the purchase price for each item furnished-
(i) in 1989, 1990, or 1991, is 100 percent of the local purchase price computed under subparagraph (A)(ii);
(ii) in 1992, is the sum of (I) 75 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1992, and (II) 25 percent of the regional purchase price computed under subparagraph (B) for 1992;
(iii) in 1993, is the sum of (I) 50 percent of the local purchase price computed under subparagraph (A)(ii)(II) for 1993, and (II) 50 percent of the regional purchase price computed under subparagraph (B) for 1993; and
(iv) in 1994 or a subsequent year, is the regional purchase price computed under subparagraph (B) for that year.
(D) Range on amount recognized
The amount that is recognized under subparagraph (C) as the purchase price for an item furnished-
(i) in 1992, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year; and
(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year.
(3) Applicability of certain provisions relating to durable medical equipment
Paragraphs (12), (15), and (17) and subparagraphs (A) and (B) of paragraph (10) and paragraph (11) of subsection (a) of this section shall apply to prosthetic devices, orthotics, and prosthetics in the same manner as such provisions apply to covered items under such subsection.
(4) Definitions
In this subsection-
(A) the term "applicable percentage increase" means-
(i) for 1991, 0 percent,
(ii) for 1992 and 1993, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; 6
(iii) for 1994 and 1995, 0 percent, and
(iv) for a subsequent year, the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year;
(B) the term "prosthetic devices" has the meaning given such term in section 1395x(s)(8) of this title, except that such term does not include parenteral and enteral nutrition nutrients, supplies, and equipment; and
(C) the term "orthotics and prosthetics" has the meaning given such term in section 1395x(s)(9) of this title, but does not include intraocular lenses or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a home health agency under section 1395x(m)(5) of this title.
(i) Payment for surgical dressings
(1) In general
Payment under this subsection for surgical dressings (described in section 1395x(s)(5) of this title) shall be made in a lump sum amount for the purchase of the item in an amount equal to 80 percent of the lesser of-
(A) the actual charge for the item; or
(B) a payment amount determined in accordance with the methodology described in subparagraphs (B) and (C) of subsection (a)(2) of this section (except that in applying such methodology, the national limited payment amount referred to in such subparagraphs shall be initially computed based on local payment amounts using average reasonable charges for the 12-month period ending December 31, 1992, increased by the covered item updates described in such subsection for 1993 and 1994).
(2) Exceptions
Paragraph (1) shall not apply to surgical dressings that are-
(A) furnished as an incident to a physician's professional service; or
(B) furnished by a home health agency.
(j) Requirements for suppliers of medical equipment and supplies
(1) Issuance and renewal of supplier number
(A) Payment
Except as provided in subparagraph (C), no payment may be made under this part after October 31, 1994, for items furnished by a supplier of medical equipment and supplies unless such supplier obtains (and renews at such intervals as the Secretary may require) a supplier number.
(B) Standards for possessing a supplier number
A supplier may not obtain a supplier number unless-
(i) for medical equipment and supplies furnished on or after October 31, 1994, and before January 1, 1996, the supplier meets standards prescribed by the Secretary in regulations issued on June 18, 1992; and
(ii) for medical equipment and supplies furnished on or after January 1, 1996, the supplier meets revised standards prescribed by the Secretary (in consultation with representatives of suppliers of medical equipment and supplies, carriers, and consumers) that shall include requirements that the supplier-
(I) comply with all applicable State and Federal licensure and regulatory requirements;
(II) maintain a physical facility on an appropriate site;
(III) have proof of appropriate liability insurance; and
(IV) meet such other requirements as the Secretary may specify.
(C) Exception for items furnished as incident to a physician's service
Subparagraph (A) shall not apply with respect to medical equipment and supplies furnished incident to a physician's service.
(D) Prohibition against multiple supplier numbers
The Secretary may not issue more than one supplier number to any supplier of medical equipment and supplies unless the issuance of more than one number is appropriate to identify subsidiary or regional entities under the supplier's ownership or control.
(E) Prohibition against delegation of supplier determinations
The Secretary may not delegate (other than by contract under section 1395u of this title) the responsibility to determine whether suppliers meet the standards necessary to obtain a supplier number.
(2) Certificates of medical necessity
(A) Limitation on information provided by suppliers on certificates of medical necessity
(i) In general
Effective 60 days after October 31, 1994, a supplier of medical equipment and supplies may distribute to physicians, or to individuals entitled to benefits under this part, a certificate of medical necessity for commercial purposes which contains no more than the following information completed by the supplier:
(I) An identification of the supplier and the beneficiary to whom such medical equipment and supplies are furnished.
(II) A description of such medical equipment and supplies.
(III) Any product code identifying such medical equipment and supplies.
(IV) Any other administrative information (other than information relating to the beneficiary's medical condition) identified by the Secretary.
(ii) Information on payment amount and charges
If a supplier distributes a certificate of medical necessity containing any of the information permitted to be supplied under clause (i), the supplier shall also list on the certificate of medical necessity the fee schedule amount and the supplier's charge for the medical equipment or supplies being furnished prior to distribution of such certificate to the physician.
(iii) Penalty
Any supplier of medical equipment and supplies who knowingly and willfully distributes a certificate of medical necessity in violation of clause (i) or fails to provide the information required under clause (ii) is subject to a civil money penalty in an amount not to exceed $1,000 for each such certificate of medical necessity so distributed. The provisions of section 1320a–7a of this title (other than subsections (a) and (b)) shall apply to civil money penalties under this subparagraph in the same manner as they apply to a penalty or proceeding under section 1320a–7a(a) of this title.
(B) "Certificate of medical necessity" defined
For purposes of this paragraph, the term "certificate of medical necessity" means a form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
(3) Coverage and review criteria
The Secretary shall annually review the coverage and utilization of items of medical equipment and supplies to determine whether such items should be made subject to coverage and utilization review criteria, and if appropriate, shall develop and apply such criteria to such items.
(4) Limitation on patient liability
If a supplier of medical equipment and supplies (as defined in paragraph (5))-
(A) furnishes an item or service to a beneficiary for which no payment may be made by reason of paragraph (1);
(B) furnishes an item or service to a beneficiary for which payment is denied in advance under subsection (a)(15) of this section; or
(C) furnishes an item or service to a beneficiary for which payment is denied under section 1395y(a)(1) of this title;
any expenses incurred for items and services furnished to an individual by such a supplier not on an assigned basis shall be the responsibility of such supplier. The individual shall have no financial responsibility for such expenses and the supplier shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected from the individual for such items or services. The provisions of subsection (a)(18) of this section shall apply to refunds required under the previous sentence in the same manner as such provisions apply to refunds under such subsection.
(5) "Medical equipment and supplies" defined
The term "medical equipment and supplies" means-
(A) durable medical equipment (as defined in section 1395x(n) of this title);
(B) prosthetic devices (as described in section 1395x(s)(8) of this title);
(C) orthotics and prosthetics (as described in section 1395x(s)(9) of this title);
(D) surgical dressings (as described in section 1395x(s)(5) of this title);
(E) such other items as the Secretary may determine; and
(F) for purposes of paragraphs (1) and (3)-
(i) home dialysis supplies and equipment (as described in section 1395x(s)(2)(F) of this title),
(ii) immunosuppressive drugs (as described in section 1395x(s)(2)(J) of this title),
(iii) therapeutic shoes for diabetics (as described in section 1395x(s)(12) of this title),
(iv) oral drugs prescribed for use as an anticancer therapeutic agent (as described in section 1395x(s)(2)(Q) of this title), and
(v) self-administered erythropoetin (as described in section 1395x(s)(2)(P) of this title).
(Aug. 14, 1935, ch. 531, title XVIII, §1834, as added and amended Dec. 22, 1987,
References in Text
Part A of this subchapter, referred to in subsecs. (a)(1)(C) and (h)(1)(D), is classified to section 1395c et seq. of this title.
Codification
Amendment of subsec. (a)(4) by
Prior Provisions
A prior section 1395m, act Aug. 14, 1935, ch. 531, title XVIII, §1834, as added July 30, 1965,
Amendments
1994-Subsec. (a)(3)(D).
Subsec. (a)(5)(E).
Subsec. (a)(7).
Subsec. (a)(7)(A)(iii)(II).
Subsec. (a)(7)(C)(i).
Subsec. (a)(10)(B).
Subsec. (a)(14)(A).
Subsec. (a)(15).
"(A)
"(B)
Subsec. (a)(16).
"(A)
"(B)
Subsec. (a)(17), (18).
Subsec. (b)(4)(D).
Subsec. (b)(4)(D)(iv).
Subsec. (b)(4)(D)(vii).
Subsec. (b)(4)(E).
Subsec. (b)(4)(F), (G).
Subsec. (c)(1)(B).
Subsec. (c)(1)(C)(iii).
Subsec. (c)(3) to (5).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(1)(B).
Subsec. (g)(2).
Subsec. (h)(3).
Subsec. (j).
Subsec. (j)(4), (5).
1993-Subsec. (a)(1)(D).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(C).
Subsec. (a)(3)(A).
Subsec. (a)(3)(C).
Subsec. (a)(8)(A)(ii)(III).
Subsec. (a)(8)(B)(ii) to (iv).
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(B)(ii) to (iv).
Subsec. (h)(1)(B).
Subsec. (h)(1)(E).
Subsec. (h)(4)(A).
Subsec. (i).
1990-Subsec. (a).
Subsec. (a)(1)(D).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (a)(3)(B).
Subsec. (a)(3)(C).
Subsec. (a)(3)(D).
Subsec. (a)(4).
Subsec. (a)(5)(A).
Subsec. (a)(5)(E).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(A)(ii), (iii).
Subsec. (a)(7)(A)(iv).
Subsec. (a)(7)(A)(v).
Subsec. (a)(7)(A)(vi).
Subsec. (a)(7)(C).
Subsec. (a)(8)(A)(ii).
Subsec. (a)(8)(B).
"(i) for 1991 and for 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local purchase prices for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and
"(ii) for each subsequent year, equal to the regional purchase price computed under this subparagraph for the previous year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year."
Subsec. (a)(8)(C).
Subsec. (a)(8)(C)(ii).
Subsec. (a)(8)(C)(iii).
Subsec. (a)(8)(C)(iv).
Subsec. (a)(8)(D).
"(i) in 1991, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year; and
"(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the purchase prices recognized under such subparagraph for all the carrier service areas in the United States in that year."
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(B).
"(i) for 1991 and 1992, equal to the average (weighted by relative volume of all claims among carriers) of the local monthly payment rates for the carriers in the region computed under subparagraph (A)(ii)(II) for the year, and
"(ii) for each subsequent year, equal to the regional monthly payment rates computed under this subparagraph for the previous year increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the previous year."
Subsec. (a)(9)(C)(ii).
Subsec. (a)(9)(C)(iii).
Subsec. (a)(9)(C)(iv).
Subsec. (a)(9)(D).
"(i) in 1991, may not exceed 125 percent, and may not be lower than 85 percent, of the average of the base monthly payment amounts recognized under such subparagraph for all the carrier service areas in the United States in that year; and
"(ii) in a subsequent year, may not exceed 120 percent, and may not be lower than 90 percent, of the average of the base monthly payment amounts recognized under such subparagraph for all the carrier service areas in the United States in that year."
Subsec. (a)(12).
Subsec. (a)(13).
"(A) durable medical equipment (as defined in section 1395x(n) of this title), including such equipment described in section 1395x(m)(5) of this title;
"(B) prosthetic devices (described in section 1395x(s)(8) of this title), but not including parenteral and enteral nutrition nutrients, supplies, and equipment; and
"(C) orthotics and prosthetics (described in section 1395x(s)(9) of this title);
but does not include intraocular lenses or medical supplies (including catheters, catheter supplies, ostomy bags, and supplies related to ostomy care) furnished by a home health agency under section 1395x(m)(5) of this title."
Subsec. (a)(14).
Subsec. (a)(15).
Subsec. (a)(16).
Subsec. (b)(1)(B).
Subsec. (b)(4)(D).
Subsec. (b)(4)(E).
Subsec. (b)(4)(F).
Subsec. (c).
Subsec. (f).
Subsec. (h).
1989-Subsec. (a)(1)(D).
Subsec. (a)(2)(A)(iii).
Subsec. (a)(2)(B)(i), (3)(B)(i).
Subsec. (a)(7)(A)(i).
Subsec. (a)(7)(B)(i).
Subsec. (a)(7)(B)(ii).
Subsec. (a)(8)(A)(ii)(I).
Subsec. (a)(8)(A)(ii)(II).
Subsec. (a)(8)(D)(i).
Subsec. (a)(8)(D)(ii).
Subsec. (a)(9)(A)(ii)(I).
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(D)(i).
Subsec. (a)(9)(D)(ii).
Subsec. (a)(13).
Subsec. (b)(1)(B).
Subsec. (b)(4)(A).
Subsec. (b)(4)(C) to (E).
Subsecs. (c) to (e).
Subsec. (f).
Subsec. (g).
1988-
Subsec. (a)(1)(C).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B)(i).
Subsec. (a)(3)(A).
Subsec. (a)(3)(B)(i).
Subsec. (a)(4).
Subsec. (a)(7)(A)(ii).
Subsec. (a)(7)(A)(iii).
Subsec. (a)(7)(B)(i).
Subsec. (a)(8)(A)(i)(I).
Subsec. (a)(8)(B).
Subsec. (a)(9)(A)(ii)(I).
Subsec. (a)(9)(A)(ii)(II).
Subsec. (a)(9)(B).
Subsec. (a)(9)(C)(i).
Subsec. (a)(10)(B).
Subsec. (a)(11)(A).
Subsec. (a)(12).
Subsec. (a)(14).
Subsec. (b).
Subsec. (b)(1)(B).
Subsec. (b)(4)(C).
Subsec. (b)(4)(D), (5).
Subsec. (b)(5)(C).
Subsec. (b)(6).
Subsec. (b)(6)(B).
Subsec. (c).
Subsec. (d).
Subsec. (e).
1987-Subsec. (b).
Effective Date of 1994 Amendment
Section 126(i) of
Section 131(a)(2) of
Section 132(c) of
Section 133(c) of
Section 134(a)(2) of
Section 135(a)(2) of
Section 135(b)(1) of
Section 135(b)(3) of
Section 135(d)(2) of
Section 135(e)(8) of
Section 145(d) of
Amendment by section 156(a)(2)(C) of
Effective Date of 1993 Amendment
Section 13542(b) of
Section 13543(c) of
Section 13544(a)(3) of
Amendment by section 13544(b)(1) of
Section 13545(b) of
Effective Date of 1990 Amendment
Section 4102(i) of
"(1) Except as otherwise provided, the amendments made by this section [amending this section, section 1395w–4 of this title, and provisions set out as a note below] shall apply to services furnished on or after January 1, 1991.
"(2) The amendment made by subsection (f) [amending this section] shall be effective as if included in the enactment of the Omnibus Budget Reconciliation Act of 1987 [
Amendment by section 4104(a) of
Section 4152(a)(3) of
Section 4152(c)(4)(B)(ii) of
Section 4152(f)(2) of
Section 4152(g)(2) of
Section 4152(i) of
Amendment by section 4153(a)(1), (2)(D) of
Amendment by section 4163(b) of
Effective Date of 1989 Amendments
Amendment by section 6102(f)(1) of
Section 6112(e)(4) of
Amendment by section 201(a) of
Section 301(b)(1), (c)(1) of
Effective Date of 1988 Amendments
Amendment by
Amendment by section 202(b)(4) of
Amendment by section 203(c)(1)(F) of
Section 204(e) of
Except as specifically provided in section 411 of
Effective Date of 1987 Amendment
Section 4049(b)(2) of
[Section 4118(h) of
Effective Date
Subsection (a) of this section applicable to covered items (other than oxygen and oxygen equipment) furnished on or after Jan. 1, 1989, and to oxygen and oxygen equipment furnished on or after June 1, 1989, see section 4062(e) of
Use of Covered Items by Disabled Beneficiaries
Section 131(b) of
"(1)
"(2)
Criteria for Treatment of Items as Prosthetic Devices or Orthotics and Prosthetics
Section 131(c) of
Adjustment Required for Certain Items
Section 134(b) of
"(1)
"(2)
Limitation on Prevailing Charge for Physicians' Radiology Services Furnished During 1991; Exceptions
Section 4102(c) of
"(1)
"(2)
Limitation on Carrier Adjustments for Radiologist Services Furnished During 1991
Section 4102(e) of
"(1) a carrier may not make any adjustment, under section 1842(b)(3)(B) of such Act [section 1395u(b)(3)(B) of this title], in the payment amount for the service under section 1834(b) on the basis that the payment amount is higher than the charge applicable, for a comparable service and under comparable circumstances, to the policyholders and subscribers of the carrier,
"(2) no payment adjustment may be made under section 1842(b)(8) of such Act, and
"(3) section 1842(b)(9) of such Act shall not apply."
Study of Payments for Prosthetic Devices, Orthotics, and Prosthetics
Section 4153(c) of
Special Rule for Nuclear Medicine Physicians
Section 6105(b) of
Special Rule for Interventional Radiologists; "Split Billing"
Section 6105(c) of
Rental Payments for Enteral and Parenteral Pumps
Section 6112(b) of
"(1)
"(2)
"(A) monthly rental payments shall not be made under part B of title XVIII of the Social Security Act for more than 15 months during such period, and
"(B) after monthly rental payments have been made for 15 months during such period, payment under such part shall be made for maintenance and servicing of the pump in such amounts as the Secretary of Health and Human Services determines to be reasonable and necessary to ensure the proper operation of the pump."
Treatment of Power-Driven Wheelchairs as Customized Items
Section 6112(d)(2) of
Study of Payment for Portable X-Ray Services
Section 6134 of
GAO Study of Standards for Use of and Payment for Items of Durable Medical Equipment
Section 6139 of
Reports on Medicare Beneficiary Drug Expenses
Section 202(i) of
Additional Studies by Secretary or Comptroller General
Section 202(k) of
Development of Standard Medicare Claims Forms
Section 202(l) of
Studies and Reports on Screening Mammography
Section 204(f) of
Deadline for Establishment of Fee Schedules for Radiologist Services; Report to Congress
Section 4049(b)(1) of
Study and Evaluation
Section 4062(c) of
"(1) The Secretary of Health and Human Services shall monitor the impact of the amendments made by this section [enacting this section, amending sections 1395f, 1395k, 1395l, and 1395cc of this title, and repealing section 1395zz of this title] on the availability of covered items and shall evaluate the appropriateness of the volume adjustment for oxygen and oxygen equipment under section 1834(a)(5)(C) of the Social Security Act [subsec. (a)(5)(C) of this section] (as amended by subsection (b) of this section). The Secretary shall report to Congress, by not later than January 1, 1991, on such impact and on the evaluation and shall include in such report recommendations for changes in payment methodology for covered items under section 1834(a) of such Act.
"(2) Before January 1, 1991, the Secretary may not conduct any demonstration project respecting alternative methods of payment for covered items under title XVIII of the Social Security Act [this subchapter].
"(3) In this subsection, the term 'covered item' has the meaning given such term in section 1834(a)(13) of the Social Security Act [subsec. (a)(13) of this section] (as amended by subsection (b) of this section).
"(4) The Secretary shall, upon written request and payment of a reasonable copying fee which the Secretary may establish, provide the data and information used in determining the payment amounts for covered items under section 1834(a) of the Social Security Act [subsec. (a) of this section], but only in a form which does not permit identification of individual suppliers.
"(5) The Comptroller General shall conduct a study on the appropriateness of the level of payments allowed for covered items under the medicare program, and shall report to Congress on the results of such study (including recommendations on the transition to regional or national rates) by not later than January 1, 1991. Entities furnishing such items which fail to provide the Comptroller General with reasonable access to necessary records to carry out the study under this paragraph are subject to exclusion from the medicare program under section 1128(a) of the Social Security Act [section 1320a–7(a) of this title]."
Section Referred to in Other Sections
This section is referred to in sections 1320a–7a, 1395f, 1395k, 1395l, 1395u, 1395w–4, 1395y, 1395cc, 1395pp of this title.
1 So in original. The semicolon probably should be a comma.
2 So in original. The closing parenthesis probably should not appear.
3 So in original. Probably should be "clause".
4 So in original. Probably should be "knowingly".