42 U.S.C. § 1395m — Special payment rules for particular

Page 3098 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m report the lesser-of-cost-or-charges determinations sep- arately with respect to payments for services under parts A and B of this subchapter other than diagnostic tests under subsec. (h) of this section, see section 2308(a) of Pub. L. 98–369, set out as a note under section 1395f of this title. DETERMINATION OF NOMINAL CHARGES FOR APPLYING NOMINALITY TEST For provision directing the Secretary to provide, in addition to other rules deemed appropriate, that charges representing 60 percent or less of costs be con- sidered nominal for purposes of applying the nominality test under subsec. (a)(2)(B)(ii) of this sec- tion, see section 2308(b)(1) of Pub. L. 98–369, set out as a note under section 1395f of this title. STUDY OF MEDICARE PART B PAYMENTS; COMPILATION OF CENTRALIZED CHARGE DATA BASE; REPORT TO CONGRESS Pub. L. 98–369, div. B, title III, § 2309, July 18, 1984, 98 Stat. 1074, directed Director of Office of Technology As- sessment to conduct a study of physician reimburse- ment under the Medicare program and make a report not later than Dec. 31, 1985, covering findings and rec- ommendations on methods by which payment amounts and other program policies under the program might be modified, and directed that Secretary of Health and Human Services compile a centralized Medicare part B charge data base to aid in the study. MONITORING PROVISION OF HEPATITIS B VACCINE; REVIEW OF CHANGES IN MEDICAL TECHNOLOGY Pub. L. 98–369, div. B, title III, § 2323(e), July 18, 1984, 98 Stat. 1086, provided that: ‘‘The Secretary shall mon- itor the provision of hepatitis B vaccine under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.], and shall review any changes in medical tech- nology which may have an effect on the amounts which should be paid for such service.’’ REPORT ON PREADMISSION DIAGNOSTIC TESTING EXPENSES Pub. L. 96–499, title IX, § 932(b), Dec. 5, 1980, 94 Stat. 2635, required a report to Congress, no later than one year after Dec. 5, 1980, on the policy respecting ex- penses incurred for preadmission diagnostic testing fur- nished to an individual at a hospital within seven days of an individual’s admission to another hospital. STUDY OF FEASIBILITY AND DESIRABILITY OF IMPOSING COPAYMENT REQUIREMENT ON RURAL HEALTH CLINIC VISITS; REPORT NOT LATER THAN DECEMBER 13, 1978 Pub. L. 95–210, § 1(c), Dec. 13, 1977, 91 Stat. 1485, di- rected Secretary of Health, Education, and Welfare to conduct a study of the feasibility and desirability of imposing a copayment for each visit to a rural health clinic for rural health clinic services under this part and that Secretary report to appropriate committee of Congress, not later than one year after Dec. 13, 1977, on such study. PROHIBITION AGAINST PAYMENTS IN CASES OF NONENTI- TLEMENT TO MONTHLY BENEFITS UNDER SUBCHAPTER II OR SUSPENSION OF BENEFITS OF ALIENS OUTSIDE THE UNITED STATES Pub. L. 89–97, title I, § 104(b)(1), July 30, 1965, 79 Stat. 334, provided that: ‘‘No payments shall be made under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] with respect to expenses incurred by an individual during any month for which such indi- vidual may not be paid monthly benefits under title II of such Act [42 U.S.C. 401 et seq.] (or for which such monthly benefits would be suspended if he were other- wise entitled thereto) by reason of section 202(t) of such Act [42 U.S.C. 402(t)] (relating to suspension of benefits of aliens who are outside the United States).’’ § 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 de- termined 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 de- scribed in subparagraph (B). (B) Payment basis Subject to subparagraph (F)(i), the pay- ment 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 satisfac- tion of the Secretary that a significant por- tion of its patients are low income) free of charge or at nominal charges to the public. (C) Exclusive payment rule Subject to subparagraph (F)(ii), this sub- section shall constitute the exclusive provi- sion of this subchapter for payment for cov- ered items under this part or under part A to a home health agency. (D) Reduction in fee schedules for certain items With respect to a seat-lift chair or trans- cutaneous electrical nerve stimulator fur- nished 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 trans- cutaneous electrical nerve stimulator fur- nished on or after January 1, 1991, the Sec- retary shall further reduce such payment amount (as previously reduced) by 45 per- cent. (E) Clinical conditions for coverage (i) In general The Secretary shall establish standards for clinical conditions for payment for cov- ered items under this subsection. (ii) Requirements The standards established under clause (i) shall include the specification of types or classes of covered items that require, as a condition of payment under this sub- section, a face-to-face examination of the individual by a physician (as defined in section 1395x(r) of this title), a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1395x(aa)(5) of this title) and a prescription for the item. (iii) Priority of establishment of standards In establishing the standards under this subparagraph, the Secretary shall first es- Page 3099 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m tablish standards for those covered items for which the Secretary determines there has been a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation to provide for payment of such covered items under this part. (iv) Standards for power wheelchairs Effective on December 8, 2003, in the case of a covered item consisting of a motorized or power wheelchair for an individual, pay- ment may not be made for such covered item unless a physician (as defined in sec- tion 1395x(r)(1) of this title), a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1395x(aa)(5) of this title) has conducted a face-to-face examination of the individual and written a prescription for the item. (v) Limitation on payment for covered items Payment may not be made for a covered item under this subsection unless the item meets any standards established under this subparagraph for clinical condition of cov- erage. (F) Application of competitive acquisition; limitation of inherent reasonableness au- thority In the case of covered items furnished on or after January 1, 2011, subject to subpara- graphs (G) and (H), that are included in a competitive acquisition program in a com- petitive acquisition area under section 1395w–3(a) of this title— (i) the payment basis under this sub- section for such items and services fur- nished in such area shall be the payment basis determined under such competitive acquisition program; (ii) the Secretary may (and, in the case of covered items furnished on or after Jan- uary 1, 2016, subject to clause (iii), shall) use information on the payment deter- mined under such competitive acquisition programs to adjust the payment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under section 1395w–3 of this title and in the case of such adjust- ment, paragraph (10)(B) shall not be ap- plied; and (iii) in the case of covered items fur- nished on or after January 1, 2016, the Sec- retary shall continue to make such adjust- ments described in clause (ii) as, under such competitive acquisition programs, additional covered items are phased in or information is updated as contracts under section 1395w–3 of this title are recompeted in accordance with section 1395w–3(b)(3)(B) of this title. (G) Use of information on competitive bid rates The Secretary shall specify by regulation the methodology to be used in applying the provisions of subparagraph (F)(ii) and sub- section (h)(1)(H)(ii). In promulgating such regulation, the Secretary shall consider the costs of items and services in areas in which such provisions would be applied compared to the payment rates for such items and services in competitive acquisition areas. In the case of items and services furnished on or after January 1, 2019, in making any ad- justments under clause (ii) or (iii) of sub- paragraph (F), under subsection (h)(1)(H)(ii), or under section 1395u(s)(3)(B) of this title, the Secretary shall— (i) solicit and take into account stake- holder input; and (ii) take into account the highest amount bid by a winning supplier in a competitive acquisition area and a com- parison of each of the following with re- spect to non-competitive acquisition areas and competitive acquisition areas: (I) The average travel distance and cost associated with furnishing items and services in the area. (II) The average volume of items and services furnished by suppliers in the area. (III) The number of suppliers in the area. (H) Diabetic supplies (i) In general On or after the date described in clause (ii), the payment amount under this part for diabetic supplies, including testing strips, that are non-mail order items (as defined by the Secretary) shall be equal to the single payment amounts established under the national mail order competition for diabetic supplies under section 1395w–3 of this title. (ii) Date described The date described in this clause is the date of the implementation of the single payment amounts under the national mail order competition for diabetic supplies under section 1395w–3 of this title. (I) Treatment of vacuum erection systems Effective for items and services furnished on and after July 1, 2015, vacuum erection systems described as prosthetic devices de- scribed in section 1395x(s)(8) of this title shall be treated in the same manner as erec- tile dysfunction drugs are treated for pur- poses of section 1395w–102(e)(2)(A) of this title. (2) Payment for inexpensive and other rou- tinely purchased durable medical equip- ment (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, (iii) which is an accessory used in con- junction with a nebulizer, aspirator, or a Page 3100 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m ventilator excluded under paragraph (3)(A), or (iv) in the case of devices furnished on or after October 1, 2015, which serves as a speech generating device or which is an ac- cessory that is needed for the individual to effectively utilize such a device, shall be made on a rental basis or in a lump- sum amount for the purchase of the item. The payment amount recognized for pur- chase 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 speci- fied 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 rea- sonable 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 con- sumers (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 subpara- graph (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 subpara- graph (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 sub- paragraph (C)(ii) for that year (reduced by 10 percent, in the case of a blood glucose testing strip furnished after 1997 for an in- dividual with diabetes). (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 pre- ceding 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 de- termined 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 deter- mined under this clause for the pre- ceding 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 cov- ered 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 ventila- tors that are either continuous airway pres- sure devices or intermittent assist devices with continuous airway pressure devices) for which there must be frequent and substan- tial 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 rea- sonable 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 subpara- graph (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 subpara- graph (C)(ii) for 1992; and Page 3101 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (iv) in 1993 and each subsequent year is the national limited payment amount for the item or device computed under sub- paragraph (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 pre- ceding 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 de- termined 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 deter- mined under this clause for the pre- ceding 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 cov- ered 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 modi- fied 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 car- rier’s individual consideration for that item, and (B) for the reasonable and necessary main- tenance 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 equip- ment 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), (E), and (F). (B) Add-on for portable oxygen equipment When portable oxygen equipment is used, but subject to subparagraph (D), the pay- ment amount recognized under subparagraph (A) shall be increased by the monthly pay- ment 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 pay- ment amount recognized under subpara- graph (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 sub- paragraph (A) shall be decreased by 50 per- cent. (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), which- ever 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 ox- ygen therapy services who, at the time such services are initiated, has an initial arterial blood gas value at or above a partial pres- sure 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. (F) Rental cap (i) In general Payment for oxygen equipment (includ- ing portable oxygen equipment) under this paragraph may not extend over a period of continuous use (as determined by the Sec- retary) of longer than 36 months. (ii) Payments and rules after rental cap After the 36th continuous month during which payment is made for the equipment under this paragraph— Page 3102 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (I) the supplier furnishing such equip- ment under this subsection shall con- tinue to furnish the equipment during any period of medical need for the re- mainder of the reasonable useful lifetime of the equipment, as determined by the Secretary; (II) payments for oxygen shall con- tinue to be made in the amount recog- nized for oxygen under paragraph (9) for the period of medical need; and (III) maintenance and servicing pay- ments shall, if the Secretary determines such payments are reasonable and nec- essary, be made (for parts and labor not covered by the supplier’s or manufactur- er’s warranty, as determined by the Sec- retary to be appropriate for the equip- ment), and such payments shall be in an amount determined to be appropriate by the Secretary. (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 pur- chase price recognized under paragraph (8). (7) Payment for other items of durable medical equipment (A) Payment In the case of an item of durable medical equipment not described in paragraphs (2) through (6), the following rules shall apply: (i) Rental (I) In general Except as provided in clause (iii), pay- ment for the item shall be made on a monthly basis for the rental of the item during the period of medical need (but payments under this clause may not ex- tend over a period of continuous use (as determined by the Secretary) of longer than 13 months). (II) Payment amount Subject to subclause (III) and subpara- graph (B), the amount recognized for the item, 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. (III) Special rule for power-driven wheel- chairs For purposes of payment for power- driven wheelchairs, subclause (II) shall be applied by substituting ‘‘15 percent’’ and ‘‘6 percent’’ for ‘‘10 percent’’ and ‘‘7.5 percent’’, respectively. (ii) Ownership after rental On the first day that begins after the 13th continuous month during which pay- ment is made for the rental of an item under clause (i), the supplier of the item shall transfer title to the item to the indi- vidual. (iii) Purchase agreement option for com- plex, rehabilitative power-driven wheelchairs In the case of a complex, rehabilitative power-driven wheelchair, at the time the supplier furnishes the item, the supplier shall offer the individual the option to purchase the item, and payment for such item shall be made on a lump-sum basis if the individual exercises such option. (iv) Maintenance and servicing After the supplier transfers title to the item under clause (ii) or in the case of a power-driven wheelchair for which a pur- chase agreement has been entered into under clause (iii), maintenance and serv- icing payments shall, if the Secretary de- termines such payments are reasonable and necessary, be made (for parts and labor not covered by the supplier’s or man- ufacturer’s warranty, as determined by the Secretary to be appropriate for the par- ticular type of durable medical equip- ment), and such payments shall be in an amount determined to be appropriate by the Secretary. (B) Range for rental amounts (i) For 1989 For items furnished during 1989, the pay- ment amount recognized under subpara- graph (A)(i) shall not be more than 115 per- cent, and shall not be less than 85 percent, of the prevailing charge established for rental of the item in January 1987, in- creased by the percentage increase in the consumer price index for all urban con- sumers (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 ap- plies to items furnished during 1989. (C) Replacement of items (i) Establishment of reasonable useful life- time In accordance with clause (iii), the Sec- retary shall determine and establish a rea- sonable 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 Page 3103 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 1 So in original. The semicolon probably should be a comma. into under subparagraph (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, ex- cept 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 life- time of 5 years is not appropriate with re- spect to a particular item, the Secretary shall establish an alternative reasonable lifetime for such item. (8) Purchase price recognized for miscella- neous devices and items For purposes of paragraphs (6) and (7), the amount that is recognized under this para- graph 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 aver- age 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 aver- age 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 Decem- ber 1986. (ii) The carrier shall compute a local purchase price, with respect to the fur- nishing of each particular item— (I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage in- crease in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with De- cember 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 pur- chase price With respect to the furnishing of a par- ticular 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 pur- chase prices for the item computed under such subparagraph for the year; (ii) for 1992 and 1993, the amount deter- mined under this subparagraph for the pre- ceding 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 na- tional limited purchase price may not ex- ceed 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 me- dian 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 sub- paragraph for the preceding year increased by the covered item update for such subse- quent year. (C) Purchase price recognized For purposes of paragraphs (6) and (7), the amount that is recognized under this para- graph as the purchase price for each item furnished— (i) in 1989 or 1990, is 100 percent of the local purchase price computed under sub- paragraph (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’’). Page 3104 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (A) Computation of local monthly payment rate Each carrier under this section shall com- pute a base local payment rate for each item as follows: (i) The carrier shall compute a base local average monthly payment rate per bene- ficiary 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 pe- riod for which the carrier made payment for the item under this subchapter. (ii) The carrier shall compute a local av- erage monthly payment rate for the item applicable— (I) to 1989 and 1990, equal to 95 percent of the base local average monthly pay- ment rate computed under clause (i) for the item increased by the percentage in- crease in the consumer price index for all urban consumers (U.S. city average) for the 6-month period ending with De- cember 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 na- tional 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 pay- ment 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 pay- ment rates computed for the item under such subparagraph for the year; (ii) for 1992 and 1993, the amount deter- mined under this subparagraph for the pre- ceding 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 com- puted for the item under such subpara- graph 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; (iv) for 1995, 1996, and 1997, equal to the amount determined under this subpara- graph for the preceding year increased by the covered item update for such subse- quent year; (v) for 1998, 75 percent of the amount de- termined under this subparagraph for 1997; and (vi) for 1999 and each subsequent year, 70 percent of the amount determined under this subparagraph for 1997. (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. (D) Authority to create classes (i) In general Subject to clause (ii), the Secretary may establish separate classes for any item of oxygen and oxygen equipment and sepa- rate national limited monthly payment rates for each of such classes. (ii) Budget neutrality The Secretary may take actions under clause (i) only to the extent such actions do not result in expenditures for any year to be more or less than the expenditures which would have been made if such ac- tions had not been taken. The requirement of the preceding sentence shall not apply beginning with the second calendar quar- ter beginning on or after December 27, 2020. (10) Exceptions and adjustments (A) Areas outside continental United States Exceptions to the amounts recognized under the previous provisions of this sub- section 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 The Secretary is authorized to apply the provisions of paragraphs (8) and (9) of sec- tion 1395u(b) of this title to covered items and suppliers of such items and payments under this subsection in an area and with re- spect to covered items and services for which the Secretary does not make a pay- ment amount adjustment under paragraph (1)(F). Page 3105 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (C) Transcutaneous electrical nerve stimu- lator (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 pa- tient, the Secretary may determine an ap- propriate 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 re- spect to such purchase is the payment amount determined under paragraph (2). (11) Improper billing and requirement of phy- sician 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 sub- section and which is furnished on a rental basis shall continue to supply the item with- out charge (other than a charge provided under this subsection for the maintenance and servicing of the item) after rental pay- ments may no longer be made under this subsection. If a supplier knowingly and will- fully violates the previous sentence, the Sec- retary may apply sanctions against the sup- plier 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 (i) In general 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 en- rolled under section 1395cc(j) of this title or an eligible professional under section 1395w–4(k)(3)(B) of this title that is en- rolled under section 1395cc(j) of this title has communicated to the supplier, before delivery of the item, a written order for the item. (ii) Requirement for face to face encounter The Secretary shall require that such an order be written pursuant to a physician, a physician assistant, a nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1395x(aa)(5) of this title) documenting such physician, physician assistant, practitioner, or spe- cialist has had a face-to-face encounter (including through use of telehealth under subsection (m) and other than with respect to encounters that are incident to services involved) with the individual involved dur- ing the 6-month period preceding such written order, or other reasonable time- frame as determined by the Secretary. (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, but not including implantable items for which payment may be made under section 1395l(t) of this title. (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 in- crease in the consumer price index for all urban consumers (U.S. city average) for the 12-month period ending with June of the pre- vious year reduced by 1 percentage point; (B) for 1993, 1994, 1995, 1996, and 1997, the percentage increase in the consumer price index for all urban consumers (U.S. city av- erage) for the 12-month period ending with June of the previous year; (C) for each of the years 1998 through 2000, 0 percentage points; (D) for 2001, the percentage increase in the consumer price index for all urban con- sumers (U.S. city average) for the 12-month period ending with June 2000; (E) for 2002, 0 percentage points; (F) for 2003, the percentage increase in the consumer price index for all urban con- sumers (U.S. urban average) for the 12- month period ending with June of 2002; (G) for 2004 through 2006— (i) subject to clause (ii), in the case of class III medical devices described in sec- tion 360c(a)(1)(C) of title 21, the percentage increase described in subparagraph (B) for the year involved; and (ii) in the case of covered items not de- scribed in clause (i), 0 percentage points; (H) for 2007— (i) subject to clause (ii), in the case of class III medical devices described in sec- tion 360c(a)(1)(C) of title 21, the percentage change determined by the Secretary to be appropriate taking into account rec- ommendations contained in the report of the Comptroller General of the United States under section 302(c)(1)(B) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; and (ii) in the case of covered items not de- scribed in clause (i), 0 percentage points; (I) for 2008— (i) subject to clause (ii), in the case of class III medical devices described in sec- tion 360c(a)(1)(C) of title 21, the percentage increase described in subparagraph (B) (as applied to the payment amount for 2007 de- termined after the application of the per- centage change under subparagraph (H)(i)); and (ii) in the case of covered items not de- scribed in clause (i), 0 percentage points; (J) for 2009— (i) in the case of items and services fur- nished in any geographic area, if such items or services were selected for com- petitive acquisition in any area under the competitive acquisition program under section 1395w–3(a)(1)(B)(i)(I) of this title before July 1, 2008, including related acces- Page 3106 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m sories but only if furnished with such items and services selected for such com- petition and diabetic supplies but only if furnished through mail order, - 9.5 percent; or (ii) in the case of other items and serv- ices, the percentage increase in the con- sumer price index for all urban consumers (U.S. urban average) for the 12-month pe- riod ending with June 2008; (K) for 2010, the percentage increase in the consumer price index for all urban con- sumers (U.S. urban average) for the 12- month period ending with June of the pre- vious year; and (L) for 2011 and each subsequent year— (i) the percentage increase in the con- sumer price index for all urban consumers (United States city average) for the 12- month period ending with June of the pre- vious year, reduced by— (ii) the productivity adjustment de- scribed in section 1395ww(b)(3)(B)(xi)(II) of this title. The application of subparagraph (L)(ii) may result in the covered item update under this paragraph being less than 0.0 for a year, and may result in payment rates under this sub- section for a year being less than such pay- ment rates for the preceding year. (15) Advance determinations of coverage for certain items (A) Development of lists of items by Sec- retary The Secretary may develop and periodi- cally update a list of items for which pay- ment may be made under this subsection that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization through- out a carrier’s entire service area or a por- tion of such area. (B) Development of lists of suppliers by Sec- retary The Secretary may develop and periodi- cally update a list of suppliers of items for which payment may be made under this sub- section with respect to whom— (i) the Secretary has found that a sub- stantial 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 pat- tern of overutilization resulting from the business practice of the supplier. (C) Determinations of coverage in advance A carrier shall determine in advance of de- livery 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 devel- oped by the Secretary under subparagraph (A); (ii) the item is furnished by a supplier included on the list developed by the Sec- retary 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 re- quests that such advance determination be made. (16) Disclosure of information and surety bond The Secretary shall not provide for the issuance (or renewal) of a provider number for a supplier of durable medical equipment, for purposes of payment under this part for dura- ble medical equipment furnished by the sup- plier, unless the supplier provides the Sec- retary on a continuing basis— (A) with— (i) full and complete information as to the identity of each person with an owner- ship or control interest (as defined in sec- tion 1320a–3(a)(3) of this title) in the sup- plier or in any subcontractor (as defined by the Secretary in regulations) in which the supplier directly or indirectly has a 5 percent or more ownership interest; and (ii) to the extent determined to be fea- sible under regulations of the Secretary, the name of any disclosing entity (as de- fined in section 1320a–3(a)(2) of this title) with respect to which a person with such an ownership or control interest in the supplier is a person with such an owner- ship or control interest in the disclosing entity; and (B) with a surety bond in a form specified by the Secretary and in an amount that is not less than $50,000 that the Secretary de- termines is commensurate with the volume of the billing of the supplier. The Secretary may waive the requirement of a bond under subparagraph (B) in the case of a supplier that provides a comparable surety bond under State law. The Secretary, at the Secretary’s discretion, may impose the re- quirements of the first sentence with respect to some or all providers of items or services under part A or some or all suppliers or other persons (other than physicians or other practi- tioners, as defined in section 1395u(b)(18)(C) of this title) who furnish items or services under this part. (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 regard- ing the furnishing of a covered item to the individual unless 1 of the following applies: (i) The individual has given written per- mission 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 fur- nishing of a covered item other than a cov- ered item already furnished to the indi- Page 3107 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m vidual, 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 indi- vidual in violation of subparagraph (A), no payment may be made under this part for any item subsequently furnished to the indi- vidual by the supplier. (C) Exclusion from program for suppliers en- gaging in pattern of unsolicited contacts If a supplier knowingly contacts individ- uals in violation of subparagraph (A) to such an extent that the supplier’s conduct estab- lishes a pattern of contacts in violation of such subparagraph, the Secretary shall ex- clude 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 cov- ered 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 sup- plier did not know and could not reason- ably have been expected to know that pay- ment may not be made for the item by rea- son 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 subpara- graph (A), the Secretary may apply sanc- tions 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 in- volved. (D) Timely basis defined A refund under subparagraph (A) is consid- ered 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 reconsid- eration or appeal is taken, the refund is made within 15 days after the date the sup- plier receives notice of an adverse deter- mination on reconsideration or appeal. (19) Certain upgraded items (A) Individual’s right to choose upgraded item Notwithstanding any other provision of this subchapter, the Secretary may issue regulations under which an individual may purchase or rent from a supplier an item of upgraded durable medical equipment for which payment would be made under this subsection if the item were a standard item. (B) Payments to supplier In the case of the purchase or rental of an upgraded item under subparagraph (A)— (i) the supplier shall receive payment under this subsection with respect to such item as if such item were a standard item; and (ii) the individual purchasing or renting the item shall pay the supplier an amount equal to the difference between the sup- plier’s charge and the amount under clause (i). In no event may the supplier’s charge for an upgraded item exceed the applicable fee schedule amount (if any) for such item. (C) Consumer protection safeguards Any regulations under subparagraph (A) shall provide for consumer protection stand- ards with respect to the furnishing of up- graded equipment under subparagraph (A). Such regulations shall provide for— (i) determination of fair market prices with respect to an upgraded item; (ii) full disclosure of the availability and price of standard items and proof of re- ceipt of such disclosure information by the beneficiary before the furnishing of the up- graded item; (iii) conditions of participation for sup- pliers in the billing arrangement; (iv) sanctions of suppliers who are deter- mined to engage in coercive or abusive practices, including exclusion; and (v) such other safeguards as the Sec- retary determines are necessary. (20) Identification of quality standards (A) In general Subject to subparagraph (C), the Secretary shall establish and implement quality stand- ards for suppliers of items and services de- scribed in subparagraph (D) to be applied by recognized independent accreditation orga- nizations (as designated under subparagraph (B)) and with which such suppliers shall be required to comply in order to— (i) furnish any such item or service for which payment is made under this part; and (ii) receive or retain a provider or sup- plier number used to submit claims for re- imbursement for any such item or service for which payment may be made under this subchapter. Page 3108 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (B) Designation of independent accreditation organizations Not later than the date that is 1 year after the date on which the Secretary implements the quality standards under subparagraph (A), notwithstanding section 1395bb(a) of this title, the Secretary shall designate and ap- prove one or more independent accreditation organizations for purposes of such subpara- graph. (C) Quality standards The quality standards described in sub- paragraph (A) may not be less stringent than the quality standards that would otherwise apply if this paragraph did not apply and shall include consumer services standards. (D) Items and services described The items and services described in this subparagraph are the following items and services, as the Secretary determines appro- priate: (i) Covered items (as defined in para- graph (13)) for which payment may other- wise be made under this subsection. (ii) Prosthetic devices and orthotics and prosthetics described in subsection (h)(4). (iii) Items and services described in sec- tion 1395u(s)(2) of this title. (iv) Lymphedema compression treatment items (as defined in section 1395x(mmm) of this title). (E) Implementation The Secretary may establish by program instruction or otherwise the quality stand- ards under this paragraph, including sub- paragraph (F), after consultation with rep- resentatives of relevant parties. Such stand- ards shall be applied prospectively and shall be published on the Internet website of the Centers for Medicare & Medicaid Services. (F) Application of accreditation requirement In implementing quality standards under this paragraph— (i) subject to clause (ii) and subpara- graph (G), the Secretary shall require sup- pliers furnishing items and services de- scribed in subparagraph (D) on or after Oc- tober 1, 2009, directly or as a subcontractor for another entity, to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under subparagraph (B) as meeting appli- cable quality standards, except that the Secretary shall not require under this clause pharmacies to obtain such accredi- tation before January 1, 2010, except that the Secretary shall not require a phar- macy to have submitted to the Secretary such evidence of accreditation prior to January 1, 2011; and (ii) in applying such standards and the accreditation requirement of clause (i) with respect to eligible professionals (as defined in section 1395w–4(k)(3)(B) of this title), and including such other persons, such as orthotists and prosthetists, as specified by the Secretary, furnishing such items and services— (I) such standards and accreditation re- quirement shall not apply to such profes- sionals and persons unless the Secretary determines that the standards being ap- plied are designed specifically to be ap- plied to such professionals and persons; and (II) the Secretary may exempt such professionals and persons from such standards and requirement if the Sec- retary determines that licensing, accred- itation, or other mandatory quality re- quirements apply to such professionals and persons with respect to the fur- nishing of such items and services. (G) Application of accreditation requirement to certain pharmacies (i) In general With respect to items and services fur- nished on or after January 1, 2011, in im- plementing quality standards under this paragraph— (I) subject to subclause (II), in apply- ing such standards and the accreditation requirement of subparagraph (F)(i) with respect to pharmacies described in clause (ii) furnishing such items and services, such standards and accredita- tion requirement shall not apply to such pharmacies; and (II) the Secretary may apply to such pharmacies an alternative accreditation requirement established by the Sec- retary if the Secretary determines such alternative accreditation requirement is more appropriate for such pharmacies. (ii) Pharmacies described A pharmacy described in this clause is a pharmacy that meets each of the following criteria: (I) The total billings by the pharmacy for such items and services under this subchapter are less than 5 percent of total pharmacy sales, as determined based on the average total pharmacy sales for the previous 3 calendar years, 3 fiscal years, or other yearly period speci- fied by the Secretary. (II) The pharmacy has been enrolled under section 1395cc(j) of this title as a supplier of durable medical equipment, prosthetics, orthotics, and supplies, has been issued (which may include the re- newal of) a provider number for at least 5 years, and for which a final adverse ac- tion (as defined in section 424.57(a) of title 42, Code of Federal Regulations) has not been imposed in the past 5 years. (III) The pharmacy submits to the Sec- retary an attestation, in a form and manner, and at a time, specified by the Secretary, that the pharmacy meets the criteria described in subclauses (I) and (II). Such attestation shall be subject to section 1001 of title 18. (IV) The pharmacy agrees to submit materials as requested by the Secretary, or during the course of an audit con- ducted on a random sample of phar- Page 3109 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m macies selected annually, to verify that the pharmacy meets the criteria de- scribed in subclauses (I) and (II). Mate- rials submitted under the preceding sen- tence shall include a certification by an accountant on behalf of the pharmacy or the submission of tax returns filed by the pharmacy during the relevant peri- ods, as requested by the Secretary. (21) Special payment rule for specified items and supplies (A) In general Notwithstanding the preceding provisions of this subsection, for specified items and supplies (described in subparagraph (B)) fur- nished during 2005, the payment amount oth- erwise determined under this subsection for such specified items and supplies shall be re- duced by the percentage difference be- tween— (i) the amount of payment otherwise de- termined for the specified item or supply under this subsection for 2002, and (ii) the amount of payment for the speci- fied item or supply under chapter 89 of title 5, as identified in the column entitled ‘‘Median FEHP Price’’ in the table entitled ‘‘SUMMARY OF MEDICARE PRICES COMPARED TO VA, MEDICAID, RETAIL, AND FEHP PRICES FOR 16 ITEMS’’ in- cluded in the Testimony of the Inspector General before the Senate Committee on Appropriations, June 12, 2002, or any subse- quent report by the Inspector General. (B) Specified item or supply described For purposes of subparagraph (A), a speci- fied item or supply means oxygen and oxy- gen equipment, standard wheelchairs (in- cluding standard power wheelchairs), nebulizers, diabetic supplies consisting of lancets and testing strips, hospital beds, and air mattresses, but only if the HCPCS code for the item or supply is identified in a table referred to in subparagraph (A)(ii). (C) Application of update to special payment amount The covered item update under paragraph (14) for specified items and supplies for 2006 and each subsequent year shall be applied to the payment amount under subparagraph (A) unless payment is made for such items and supplies under section 1395w–3 of this title. (22) Special payment rule for diabetic supplies Notwithstanding the preceding provisions of this subsection, for purposes of determining the payment amount under this subsection for diabetic supplies furnished on or after the first day of the calendar quarter during 2013 that is at least 30 days after January 2, 2013, and be- fore the date described in paragraph (1)(H)(ii), the Secretary shall recalculate and apply the covered item update under paragraph (14) as if subparagraph (J)(i) of such paragraph was amended by striking ‘‘but only if furnished through mail order’’. (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 serv- ices under this part, and (B) using such scale and appropriate con- version factors and subject to subsection (c)(1)(A), fee schedules (on a regional, state- wide, locality, or carrier service area basis) for payment for radiologist services under this part, to be implemented for such serv- ices furnished during 1989. (2) Consultation In carrying out paragraph (1), the Secretary shall regularly consult closely with the Physi- cian Payment Review Commission, the Amer- ican College of Radiology, and other organiza- tions 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 para- graph (1), including data on variations in cur- rent 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 vari- ations 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 fur- nish such services as may be appropriate to assure that payment amounts are equitable and designed to promote effective and effi- cient 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 pay- ments (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 port- able X-ray services) furnished under this part during 1990, after March 31 of such year, the conversion factors used under this sub- section 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 port- able X-ray services) furnished under this part during 1991, the conversion factors used in a locality under this subsection shall, sub- Page 3110 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m ject to clause (vii), be reduced to the ad- justed conversion factor for the locality de- termined as follows: (i) National weighted average conversion factor The Secretary shall estimate the na- tional weighted average of the conversion factors used under this subsection for serv- ices furnished during 1990 beginning on April 1, using the best available data. (ii) Reduced national weighted average The national weighted average esti- mated under clause (i) shall be reduced by 13 percent. (iii) Computation of 1990 locality index rel- ative to national average The Secretary shall establish an index which reflects, for each locality, the ratio of the conversion factor used in the local- ity 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 1⁄2 of the locally-adjusted amount determined under clause (v) and 1⁄2 of the GPCI-adjusted amount determined under clause (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 com- puted 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-ad- justed amount determined under this clause is the sum of— (I) the product of (a) the portion of the reduced national weighted average con- version 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 sec- tion 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 physi- cian 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 re- duced under this subparagraph by more than 9.5 percent below the conversion fac- tor applied in the locality under subpara- graph (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 (com- puted 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 re- duced by 10 percent. (F) Subsequent updating For radiologist services furnished in subse- quent years, the fee schedules shall be the schedules for the previous year updated by the percentage increase in the MEI (as de- fined in section 1395u(i)(3) of this title) for the year. (G) Nonparticipating physicians and sup- pliers Each fee schedule so established shall pro- vide 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 partici- pating physicians and suppliers. (5) Limiting charges of nonparticipating physi- cians and suppliers (A) In general In the case of radiologist services fur- nished after January 1, 1989, for which pay- ment is made under a fee schedule under this subsection, if a nonparticipating physician or supplier furnishes the service to an indi- vidual 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 fur- nished— (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 accord- ance with section 1395u(j)(2) of this title in the same manner as such sanctions may apply to a physician. Page 3111 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (6) ‘‘Radiologist services’’ defined For the purposes of this subsection and sec- tion 1395l(a)(1)(J) of this title, the term ‘‘radi- ologist services’’ only includes radiology serv- ices performed by, or under the direction or supervision of, a physician— (A) who is certified, or eligible to be cer- tified, 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) Payment and standards for screening mam- mography (1) In general With respect to expenses incurred for screen- ing mammography (as defined in section 1395x(jj) of this title), payment may be made only— (A) for screening mammography conducted consistent with the frequency permitted under paragraph (2); and (B) if the screening mammography is con- ducted by a facility that has a certificate (or provisional certificate) issued under section 263b of this title. (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 per- formed on a woman under 35 years of age; (ii) payment may be made under this part for only one screening mammography performed on a woman over 34 years of age, but under 40 years of age; and (iii) in the case of a woman over 39 years of age, payment may not be made under this part for screening mammography per- formed within 11 months following the month in which a previous screening mam- mography 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 mam- mography, based on age and such other factors as the Secretary believes to be per- tinent. (ii) Revision of frequency The Secretary, taking into consideration the review made under clause (i), may re- vise from time to time the frequency with which screening mammography may be paid for under this subsection. (d) Frequency limits and payment for colorectal cancer screening tests (1) Screening fecal-occult blood tests (A) Payment amount The payment amount for colorectal cancer screening tests consisting of screening fecal- occult blood tests is equal to the payment amount established for diagnostic fecal-oc- cult blood tests under section 1395l(h) of this title. (B) Frequency limit No payment may be made under this part for a colorectal cancer screening test con- sisting of a screening fecal-occult blood test— (i) if the individual is under 50 years of age; or (ii) if the test is performed within the 11 months after a previous screening fecal-oc- cult blood test. (2) Screening flexible sigmoidoscopies (A) Fee schedule With respect to colorectal cancer screen- ing tests consisting of screening flexible sigmoidoscopies, payment under section 1395w–4 of this title shall be consistent with payment under such section for similar or related services. (B) Payment limit In the case of screening flexible sigmoidoscopy services, payment under this part shall not exceed such amount as the Secretary specifies, based upon the rates recognized for diagnostic flexible sigmoidoscopy services. (C) Facility payment limit (i) In general Notwithstanding subsections (i)(2)(A) and (t) of section 1395l of this title, in the case of screening flexible sigmoidoscopy services furnished on or after January 1, 1999, that— (I) in accordance with regulations, may be performed in an ambulatory sur- gical center and for which the Secretary permits ambulatory surgical center pay- ments under this part, and (II) are performed in an ambulatory surgical center or hospital outpatient department, payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a hospital out- patient department in an area or the amount under the fee schedule that would apply to such services if they were per- formed in an ambulatory surgical center in the same area. (ii) Limitation on coinsurance Subject to section 1395l(a)(1)(Y) of this title, but notwithstanding any other provi- sion of this subchapter, in the case of a beneficiary who receives the services de- scribed in clause (i)— (I) in computing the amount of any ap- plicable copayment, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and (II) the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I). (D) Special rule for detected lesions Subject to section 1395l(a)(1)(Y) of this title, if during the course of such screening Page 3112 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 2 So in original. Subpar. (B) of par. (2) does not contain clauses. flexible sigmoidoscopy, a lesion or growth is detected which results in a biopsy or re- moval of the lesion or growth, payment under this part shall not be made for the screening flexible sigmoidoscopy but shall be made for the procedure classified as a flexi- ble sigmoidoscopy with such biopsy or re- moval. (E) Frequency limit No payment may be made under this part for a colorectal cancer screening test con- sisting of a screening flexible sigmoidoscopy— (i) if the individual is under 50 years of age; or (ii) if the procedure is performed within the 47 months after a previous screening flexible sigmoidoscopy or, in the case of an individual who is not at high risk for colorectal cancer, if the procedure is per- formed within the 119 months after a pre- vious screening colonoscopy. (3) Screening colonoscopy (A) Fee schedule With respect to colorectal cancer screen- ing test consisting of a screening colonoscopy, payment under section 1395w–4 of this title shall be consistent with pay- ment amounts under such section for similar or related services. (B) Payment limit In the case of screening colonoscopy serv- ices, payment under this part shall not ex- ceed such amount as the Secretary specifies, based upon the rates recognized for diag- nostic colonoscopy services. (C) Facility payment limit (i) In general Notwithstanding subsections (i)(2)(A) and (t) of section 1395l of this title, in the case of screening colonoscopy services fur- nished on or after January 1, 1999, that are performed in an ambulatory surgical cen- ter or a hospital outpatient department, payment under this part shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a hospital out- patient department in an area or the amount under the fee schedule that would apply to such services if they were per- formed in an ambulatory surgical center in the same area. (ii) Limitation on coinsurance Subject to section 1395l(a)(1)(Y) of this title, but notwithstanding any other provi- sion of this subchapter, in the case of a beneficiary who receives the services de- scribed in clause (i)— (I) in computing the amount of any ap- plicable coinsurance, the computation of such coinsurance shall be based upon the fee schedule under which payment is made for the services, and (II) the amount of such coinsurance is equal to 25 percent of the payment amount under the fee schedule described in subclause (I). (D) Special rule for detected lesions Subject to section 1395l(a)(1)(Y) of this title, if during the course of such screening colonoscopy, a lesion or growth is detected which results in a biopsy or removal of the lesion or growth, payment under this part shall not be made for the screening colonoscopy but shall be made for the proce- dure classified as a colonoscopy with such biopsy or removal. (E) Frequency limit No payment may be made under this part for a colorectal cancer screening test con- sisting of a screening colonoscopy for indi- viduals at high risk for colorectal cancer if the procedure is performed within the 23 months after a previous screening colonoscopy or for other individuals if the procedure is performed within the 119 months after a previous screening colonoscopy or within 47 months after a pre- vious screening flexible sigmoidoscopy. (e) Accreditation requirement for advanced diag- nostic imaging services (1) In general (A) In general Beginning with January 1, 2012, with re- spect to the technical component of ad- vanced diagnostic imaging services for which payment is made under the fee sched- ule established under section 1395w–4(b) of this title and that are furnished by a sup- plier, payment may only be made if such supplier is accredited by an accreditation or- ganization designated by the Secretary under paragraph (2)(B)(i).2 (B) Advanced diagnostic imaging services de- fined In this subsection, the term ‘‘advanced di- agnostic imaging services’’ includes— (i) diagnostic magnetic resonance imag- ing, computed tomography, and nuclear medicine (including positron emission to- mography); and (ii) such other diagnostic imaging serv- ices, including services described in sec- tion 1395w–4(b)(4)(B) of this title (excluding X-ray, ultrasound, and fluoroscopy), as specified by the Secretary in consultation with physician specialty organizations and other stakeholders. (C) Supplier defined In this subsection, the term ‘‘supplier’’ has the meaning given such term in section 1395x(d) of this title. (2) Accreditation organizations (A) Factors for designation of accreditation organizations The Secretary shall consider the following factors in designating accreditation organi- zations under subparagraph (B)(i) 2 and in re- viewing and modifying the list of accredita- tion organizations designated pursuant to subparagraph (C): Page 3113 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 3 So in original. Probably should be ‘‘a’’. (i) The ability of the organization to conduct timely reviews of accreditation applications. (ii) Whether the organization has estab- lished a process for the timely integration of new advanced diagnostic imaging serv- ices into the organization’s accreditation program. (iii) Whether the organization uses ran- dom site visits, site audits, or other strate- gies for ensuring accredited suppliers maintain adherence to the criteria de- scribed in paragraph (3). (iv) The ability of the organization to take into account the capacities of sup- pliers located in a rural area (as defined in section 1395ww(d)(2)(D) of this title). (v) Whether the organization has estab- lished reasonable fees to be charged to sup- pliers applying for accreditation. (vi) Such other factors as the Secretary determines appropriate. (B) Designation Not later than January 1, 2010, the Sec- retary shall designate organizations to ac- credit suppliers furnishing the technical component of advanced diagnostic imaging services. The list of accreditation organiza- tions so designated may be modified pursu- ant to subparagraph (C). (C) Review and modification of list of accred- itation organizations (i) In general The Secretary shall review the list of ac- creditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations des- ignated under subparagraph (B). (ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations In the case where the Secretary removes an organization from the list of accredita- tion organizations designated under sub- paragraph (B), any supplier that is accred- ited by the organization during the period beginning on the date on which the organi- zation is designated as an accreditation or- ganization under subparagraph (B) and ending on the date on which the organiza- tion is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect. (3) Criteria for accreditation The Secretary shall establish procedures to ensure that the criteria used by an accredita- tion organization designated under paragraph (2)(B) to evaluate a supplier that furnishes the technical component of advanced diagnostic imaging services for the purpose of accredita- tion of such supplier is specific to each imag- ing modality. Such criteria shall include— (A) standards for qualifications of medical personnel who are not physicians and who furnish the technical component of advanced diagnostic imaging services; (B) standards for qualifications and re- sponsibilities of medical directors and super- vising physicians, including standards that recognize the considerations described in paragraph (4); (C) procedures to ensure that equipment used in furnishing the technical component of advanced diagnostic imaging services meets performance specifications; (D) standards that require the supplier have procedures in place to ensure the safety of persons who furnish the technical compo- nent of advanced diagnostic imaging serv- ices and individuals to whom such services are furnished; (E) standards that require the establish- ment and maintenance of a quality assur- ance and quality control program by the supplier that is adequate and appropriate to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such supplier; and (F) any other standards or procedures the Secretary determines appropriate. (4) Recognition in standards for the evaluation of medical directors and supervising physi- cians The standards described in paragraph (3)(B) shall recognize whether a medical director or supervising physician— (A) in a particular specialty receives train- ing in advanced diagnostic imaging services in a residency program; (B) has attained, through experience, the necessary expertise to be a medical director or a supervising physician; (C) has completed any continuing medical education courses relating to such services; or (D) has met such other standards as the Secretary determines appropriate. (5) Rule for accreditations made prior to des- ignation In the case of a supplier that is accredited before January 1, 2010, by an accreditation or- ganization designated by the Secretary under paragraph (2)(B) as of January 1, 2010, such supplier shall be considered to have been ac- credited by an organization designated by the Secretary under such paragraph as of January 1, 2012, for the remaining period such accredi- tation is in effect. (f) Reduction in payments for physician pathol- ogy 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 3 physician pa- Page 3114 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m thology service furnished by a physician through an independent laboratory shall not be reduced pursuant to paragraph (1) to the ex- tent that such reduction would reduce such prevailing charge below 115 percent of the pre- vailing charge for the professional component of such service when furnished by a hospital- based physician in the same locality. For pur- poses of the preceding sentence, an inde- pendent laboratory is a laboratory that is independent of a hospital and separate from the attending or consulting physicians’ office. (g) Payment for outpatient critical access hos- pital services (1) In general The amount of payment for outpatient crit- ical access hospital services of a critical ac- cess hospital is equal to 101 percent of the rea- sonable costs of the hospital in providing such services, unless the hospital makes the elec- tion under paragraph (2). (2) Election of cost-based hospital outpatient service payment plus fee schedule for pro- fessional services A critical access hospital may elect to be paid for outpatient critical access hospital services amounts equal to the sum of the fol- lowing, less the amount that such hospital may charge as described in section 1395cc(a)(2)(A) of this title: (A) Facility fee With respect to facility services, not in- cluding any services for which payment may be made under subparagraph (B), 101 percent of the reasonable costs of the critical access hospital in providing such services. (B) Fee schedule for professional services With respect to professional services oth- erwise included within outpatient critical access hospital services, 115 percent of such amounts as would otherwise be paid under this part if such services were not included in outpatient critical access hospital serv- ices. Subsections (x) and (y) of section 1395l of this title shall not be taken into account in determining the amounts that would oth- erwise be paid pursuant to the preceding sentence. The Secretary may not require, as a condition for applying subparagraph (B) with respect to a critical access hospital, that each physician or other practitioner providing professional services in the hospital must assign billing rights with respect to such services, except that such subparagraph shall not apply to those physicians and practitioners who have not assigned such billing rights. (3) Disregarding charges The payment amounts under this subsection shall be determined without regard to the amount of the customary or other charge. (4) Treatment of clinical diagnostic laboratory services No coinsurance, deductible, copayment, or other cost-sharing otherwise applicable under this part shall apply with respect to clinical diagnostic laboratory services furnished as an outpatient critical access hospital service. Nothing in this subchapter shall be construed as providing for payment for clinical diag- nostic laboratory services furnished as part of outpatient critical access hospital services, other than on the basis described in this sub- section. For purposes of the preceding sen- tence and section 1395x(mm)(3) of this title, clinical diagnostic laboratory services fur- nished by a critical access hospital shall be treated as being furnished as part of out- patient critical access services without regard to whether the individual with respect to whom such services are furnished is physically present in the critical access hospital, or in a skilled nursing facility or a clinic (including a rural health clinic) that is operated by a crit- ical access hospital, at the time the specimen is collected. (5) Coverage of costs for certain emergency room on-call providers In determining the reasonable costs of out- patient critical access hospital services under paragraphs (1) and (2)(A), the Secretary shall recognize as allowable costs, amounts (as de- fined by the Secretary) for reasonable com- pensation and related costs for physicians, physician assistants, nurse practitioners, and clinical nurse specialists who are on-call (as defined by the Secretary) to provide emer- gency services but who are not present on the premises of the critical access hospital in- volved, and are not otherwise furnishing serv- ices covered under this subchapter and are not on-call at any other provider or facility. (h) Payment for prosthetic devices and orthotics and prosthetics (1) General rule for payment (A) In general Payment under this subsection for pros- thetic 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), (E), and (H)(i), the payment basis described in this subparagraph is the lesser of— (i) the actual charge for the item; or (ii) the amount recognized under para- graph (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 Subject to subparagraph (H)(ii), this sub- section shall constitute the exclusive provi- sion of this subchapter for payment for pros- Page 3115 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m thetic devices, orthotics, and prosthetics under this part or under part A to a home health agency. (E) Exception for certain items Payment for ostomy supplies, trache- ostomy supplies, and urologicals shall be made in accordance with subparagraphs (B) and (C) of subsection (a)(2). (F) Special payment rules for certain pros- thetics and custom-fabricated orthotics (i) In general No payment shall be made under this subsection for an item of custom-fab- ricated orthotics described in clause (ii) or for an item of prosthetics unless such item is— (I) furnished by a qualified practi- tioner; and (II) fabricated by a qualified practi- tioner or a qualified supplier at a facility that meets such criteria as the Secretary determines appropriate. (ii) Description of custom-fabricated item (I) In general An item described in this clause is an item of custom-fabricated orthotics that requires education, training, and experi- ence to custom-fabricate and that is in- cluded in a list established by the Sec- retary in subclause (II). Such an item does not include shoes and shoe inserts. (II) List of items The Secretary, in consultation with appropriate experts in orthotics (includ- ing national organizations representing manufacturers of orthotics), shall estab- lish and update as appropriate a list of items to which this subparagraph ap- plies. No item may be included in such list unless the item is individually fab- ricated for the patient over a positive model of the patient. (iii) Qualified practitioner defined In this subparagraph, the term ‘‘quali- fied practitioner’’ means a physician or other individual who— (I) is a qualified physical therapist or a qualified occupational therapist; (II) in the case of a State that provides for the licensing of orthotics and pros- thetics, is licensed in orthotics or pros- thetics by the State in which the item is supplied; or (III) in the case of a State that does not provide for the licensing of orthotics and prosthetics, is specifically trained and educated to provide or manage the provision of prosthetics and custom-de- signed or -fabricated orthotics, and is certified by the American Board for Cer- tification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Pros- thetist Certification, or is credentialed and approved by a program that the Sec- retary determines, in consultation with appropriate experts in orthotics and prosthetics, has training and education standards that are necessary to provide such prosthetics and orthotics. (iv) Qualified supplier defined In this subparagraph, the term ‘‘quali- fied supplier’’ means any entity that is ac- credited by the American Board for Cer- tification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Pros- thetist Certification, or accredited and ap- proved by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Board. (G) Replacement of prosthetic devices and parts (i) In general Payment shall be made for the replace- ment of prosthetic devices which are arti- ficial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restric- tions if an ordering physician determines that the provision of a replacement device, or a replacement part of such a device, is necessary because of any of the following: (I) A change in the physiological condi- tion of the patient. (II) An irreparable change in the condi- tion of the device, or in a part of the de- vice. (III) The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replace- ment device, or, as the case may be, of the part being replaced. (ii) Confirmation may be required if device or part being replaced is less than 3 years old If a physician determines that a replace- ment device, or a replacement part, is nec- essary pursuant to clause (i)— (I) such determination shall be con- trolling; and (II) such replacement device or part shall be deemed to be reasonable and necessary for purposes of section 1395y(a)(1)(A) of this title; except that if the device, or part, being re- placed is less than 3 years old (calculated from the date on which the beneficiary began to use the device or part), the Sec- retary may also require confirmation of necessity of the replacement device or re- placement part, as the case may be. (H) Application of competitive acquisition to orthotics; limitation of inherent reason- ableness authority In the case of orthotics described in para- graph (2)(C) of section 1395w–3(a) of this title furnished on or after January 1, 2011, subject to subsection (a)(1)(G), that are included in a competitive acquisition program in a com- petitive acquisition area under such sec- tion— (i) the payment basis under this sub- section for such orthotics furnished in such area shall be the payment basis deter- Page 3116 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 4 So in original. mined under such competitive acquisition program; and (ii) subject to subsection (a)(1)(G), the Secretary may use information on the pay- ment determined under such competitive acquisition programs to adjust the pay- ment amount otherwise recognized under subparagraph (B)(ii) for an area that is not a competitive acquisition area under sec- tion 1395w–3 of this title, and in the case of such adjustment, paragraphs (8) and (9) of section 1395u(b) of this title shall not be applied. (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 de- scribed 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 fur- nishing of each particular item— (I) in 1989 and 1990, equal to the base local purchase price computed under clause (i) increased by the percentage in- crease 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 par- ticular item in each region (as defined by the Secretary), the Secretary shall compute a regional purchase price— (i) for 1992, equal to the average (weight- ed 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 percent- age increase for the year. (C) Purchase price recognized For purposes of paragraph (1) and subject to subparagraph (D), the amount that is rec- ognized under this paragraph as the pur- chase 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 sub- paragraph (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 recog- nized 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 subpara- graphs (A) and (B) of paragraph (10) and para- graph (11) of subsection (a) shall apply to pros- thetic 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 in- crease’’ means— (i) for 1991, 0 percent; (ii) for 1992 and 1993, the percentage in- crease in the consumer price index for all urban consumers (United States city aver- age) for the 12-month period ending with June of the previous year; (iii) for 1994 and 1995, 0 percent; (iv) for 1996 and 1997, the percentage in- crease in the consumer price index for all urban consumers (United States city aver- age) for the 12-month period ending with June of the previous year; (v) for each of the years 1998 through 2000, 1 percent; (vi) for 2001, the percentage increase in the consumer price index for all urban con- sumers (U.S. city average) for the 12- month period ending with June 2000; (vii) for 2002, 1 percent; (viii) for 2003, the percentage increase in the consumer price index for all urban con- sumers (United States city average) for the 12-month period ending with June of the previous year; (ix) for 2004, 2005, and 2006, 0 percent; (x) for for 4 each of 2007 through 2010, the percentage increase in the consumer price Page 3117 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m index for all urban consumers (United States city average) for the 12-month pe- riod ending with June of the previous year; and (xi) for 2011 and each subsequent year— (I) the percentage increase in the con- sumer price index for all urban con- sumers (United States city average) for the 12-month period ending with June of the previous year, reduced by— (II) the productivity adjustment de- scribed in section 1395ww(b)(3)(B)(xi)(II) of this title. The application of subparagraph (A)(xi)(II) may result in the applicable percentage in- crease under subparagraph (A) being less than 0.0 for a year, and may result in pay- ment rates under this subsection for a year being less than such payment rates for the preceding 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 does not include an implantable item for which payment may be made under section 1395l(t) of this title; and (C) the term ‘‘orthotics and prosthetics’’ has the meaning given such term in section 1395x(s)(9) of this title (and includes shoes described in section 1395x(s)(12) of this title), but does not include intraocular lenses or medical supplies (including catheters, cath- eter supplies, ostomy bags, and supplies re- lated to ostomy care) furnished by a home health agency under section 1395x(m)(5) of this title. (5) Documentation created by orthotists and prosthetists For purposes of determining the reasonable- ness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to sup- port documentation created by eligible profes- sionals described in section 1395w–4(k)(3)(B) 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 ac- cordance with the methodology described in subparagraphs (B) and (C) of subsection (a)(2) (except that in applying such method- ology, 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 physi- cian’s professional service; or (B) furnished by a home health agency. (j) Requirements for suppliers of medical equip- ment 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 num- ber A supplier may not obtain a supplier num- ber 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 pre- scribed by the Secretary (in consultation with representatives of suppliers of med- ical equipment and supplies, carriers, and consumers) that shall include require- ments that the supplier— (I) comply with all applicable State and Federal licensure and regulatory re- quirements; (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 re- spect to medical equipment and supplies fur- nished 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 med- ical equipment and supplies unless the issuance of more than one number is appro- priate to identify subsidiary or regional en- tities under the supplier’s ownership or con- trol. (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 wheth- er suppliers meet the standards necessary to obtain a supplier number. Page 3118 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 5 So in original. Two subpars. (G) have been enacted. (2) Certificates of medical necessity (A) Limitation on information provided by suppliers on certificates of medical ne- cessity (i) In general Effective 60 days after October 31, 1994, a supplier of medical equipment and supplies may distribute to physicians, or to indi- viduals entitled to benefits under this part, a certificate of medical necessity for commercial purposes which contains no more than the following information com- pleted by the supplier: (I) An identification of the supplier and the beneficiary to whom such med- ical equipment and supplies are fur- nished. (II) A description of such medical equipment and supplies. (III) Any product code identifying such medical equipment and supplies. (IV) Any other administrative infor- mation (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 sup- plies being furnished prior to distribution of such certificate to the physician. (iii) Penalty Any supplier of medical equipment and supplies who knowingly and willfully dis- tributes 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 distrib- uted. 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 man- ner as they apply to a penalty or pro- ceeding 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 informa- tion required by the carrier to be submitted to show that an item is reasonable and nec- essary for the diagnosis or treatment of ill- ness or injury or to improve the functioning of a malformed body member. (3) Coverage and review criteria The Secretary shall annually review the cov- erage 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 appro- priate, shall develop and apply such criteria to such items. (4) Limitation on patient liability If a supplier of medical equipment and sup- plies (as defined in paragraph (5))— (A) furnishes an item or service to a bene- ficiary for which no payment may be made by reason of paragraph (1); (B) furnishes an item or service to a bene- ficiary for which payment is denied in ad- vance under subsection (a)(15); or (C) furnishes an item or service to a bene- ficiary 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 responsi- bility of such supplier. The individual shall have no financial responsibility for such ex- penses and the supplier shall refund on a time- ly 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) shall apply to refunds required under the previous sen- tence 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 sec- tion 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 sec- tion 1395x(s)(5) of this title); (E) items and services related to the ad- ministration of intravenous immune glob- ulin furnished on or after January 1, 2024, as described in section 1395x(zz) of this title; (F) lymphedema compression treatment items (as defined in section 1395x(mmm) of this title); (G) 5 such other items as the Secretary may determine; and (G) 5 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 de- scribed 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). Page 3119 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (k) Payment for outpatient therapy services and comprehensive outpatient rehabilitation services (1) In general With respect to services described in section 1395l(a)(8) or 1395l(a)(9) of this title for which payment is determined under this subsection, the payment basis shall be— (A) for services furnished during 1998, the amount determined under paragraph (2); or (B) for services furnished during a subse- quent year, 80 percent of the lesser of— (i) the actual charge for the services, or (ii) the applicable fee schedule amount (as defined in paragraph (3)) for the serv- ices. (2) Payment in 1998 based upon adjusted rea- sonable costs The amount under this paragraph for serv- ices is the lesser of— (A) the charges imposed for the services, or (B) the adjusted reasonable costs (as de- fined in paragraph (4)) for the services, less 20 percent of the amount of the charges imposed for such services. (3) Applicable fee schedule amount In this subsection, the term ‘‘applicable fee schedule amount’’ means, with respect to serv- ices furnished in a year, the amount deter- mined under the fee schedule established under section 1395w–4 of this title for such services furnished during the year or, if there is no such fee schedule established for such services, the amount determined under the fee schedule established for such comparable serv- ices as the Secretary specifies. (4) Adjusted reasonable costs In paragraph (2), the term ‘‘adjusted reason- able costs’’ means, with respect to any serv- ices, reasonable costs determined for such services, reduced by 10 percent. The 10-percent reduction shall not apply to services described in section 1395l(a)(8)(B) of this title (relating to services provided by hospitals). (5) Uniform coding For claims for services submitted on or after April 1, 1998, for which the amount of payment is determined under this subsection, the claim shall include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished. (6) Restraint on billing The provisions of subparagraphs (A) and (B) of section 1395u(b)(18) of this title shall apply to therapy services for which payment is made under this subsection in the same manner as they apply to services provided by a practi- tioner described in section 1395u(b)(18)(C) of this title. (7) Adjustment in discount for certain multiple therapy services In the case of therapy services furnished on or after April 1, 2013, and for which payment is made under this subsection pursuant to the applicable fee schedule amount (as defined in paragraph (3)), instead of the 25 percent mul- tiple procedure payment reduction specified in the final rule published by the Secretary in the Federal Register on November 29, 2010, the reduction percentage shall be 50 percent. (l) Establishment of fee schedule for ambulance services (1) In general The Secretary shall establish a fee schedule for payment for ambulance services whether provided directly by a supplier or provider or under arrangement with a provider under this part through a negotiated rulemaking process described in title 5 and in accordance with the requirements of this subsection. (2) Considerations In establishing such fee schedule, the Sec- retary shall— (A) establish mechanisms to control in- creases in expenditures for ambulance serv- ices under this part; (B) establish definitions for ambulance services which link payments to the type of services provided; (C) consider appropriate regional and oper- ational differences; (D) consider adjustments to payment rates to account for inflation and other relevant factors; and (E) phase in the application of the pay- ment rates under the fee schedule in an effi- cient and fair manner consistent with para- graph (11), except that such phase-in shall provide for full payment of any national mileage rate for ambulance services pro- vided by suppliers that are paid by carriers in any of the 50 States where payment by a carrier for such services for all such sup- pliers in such State did not, prior to the im- plementation of the fee schedule, include a separate amount for all mileage within the county from which the beneficiary is trans- ported. (3) Savings In establishing such fee schedule, the Sec- retary shall— (A) ensure that the aggregate amount of payments made for ambulance services under this part during 2000 does not exceed the aggregate amount of payments which would have been made for such services under this part during such year if the amendments made by section 4531(a) of the Balanced Budget Act of 1997 continued in ef- fect, except that in making such determina- tion the Secretary shall assume an update in such payments for 2002 equal to 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 pre- vious year reduced in the case of 2002 by 1.0 percentage points; (B) set the payment amounts provided under the fee schedule for services furnished in 2001 and each subsequent year at amounts equal to the payment amounts under the fee schedule for services furnished during the previous year, increased, subject to subpara- graph (C) and the succeeding sentence of this Page 3120 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m paragraph, by the percentage increase in the consumer price index for all urban con- sumers (U.S. city average) for the 12-month period ending with June of the previous year reduced in the case of 2002 by 1.0 percentage points; and (C) for 2011 and each subsequent year, after determining the percentage increase under subparagraph (B) for the year, reduce such percentage increase by the productivity ad- justment described in section 1395ww(b)(3)(B)(xi)(II) of this title. The application of subparagraph (C) may re- sult in the percentage increase under subpara- graph (B) being less than 0.0 for a year, and may result in payment rates under the fee schedule under this subsection for a year being less than such payment rates for the preceding year. (4) Consultation In establishing the fee schedule for ambu- lance services under this subsection, the Sec- retary shall consult with various national or- ganizations representing individuals and enti- ties who furnish and regulate ambulance serv- ices and share with such organizations rel- evant data in establishing such schedule. (5) Limitation on review There shall be no administrative or judicial review under section 1395ff of this title or oth- erwise of the amounts established under the fee schedule for ambulance services under this subsection, including matters described in paragraph (2). (6) Restraint on billing The provisions of subparagraphs (A) and (B) of section 1395u(b)(18) of this title shall apply to ambulance services for which payment is made under this subsection in the same man- ner as they apply to services provided by a practitioner described in section 1395u(b)(18)(C) of this title. (7) Coding system The Secretary may require the claim for any services for which the amount of payment is determined under this subsection to include a code (or codes) under a uniform coding system specified by the Secretary that identifies the services furnished. (8) Services furnished by critical access hos- pitals Notwithstanding any other provision of this subsection, the Secretary shall pay 101 percent of the reasonable costs incurred in furnishing ambulance services if such services are fur- nished— (A) by a critical access hospital (as defined in section 1395x(mm)(1) of this title), or (B) by an entity that is owned and oper- ated by a critical access hospital, but only if the critical access hospital or enti- ty is the only provider or supplier of ambu- lance services that is located within a 35-mile drive of such critical access hospital. (9) Transitional assistance for rural providers In the case of ground ambulance services furnished on or after July 1, 2001, and before January 1, 2004, for which the transportation originates in a rural area (as defined in section 1395ww(d)(2)(D) of this title) or in a rural cen- sus tract of a metropolitan statistical area (as determined under the most recent modifica- tion of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)), the fee schedule es- tablished under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 17 miles, and up to 50 miles, the rate otherwise established shall be increased by not less than 1⁄2 of the additional payment per mile established for the first 17 miles of such a trip originating in a rural area. (10) Phase-in providing floor using blend of fee schedule and regional fee schedules In carrying out the phase-in under para- graph (2)(E) for each level of ground service furnished in a year, the portion of the pay- ment amount that is based on the fee schedule shall be the greater of the amount determined under such fee schedule (without regard to this paragraph) or the following blended rate of the fee schedule under paragraph (1) and of a regional fee schedule for the region involved: (A) For 2004 (for services furnished on or after July 1, 2004), the blended rate shall be based 20 percent on the fee schedule under paragraph (1) and 80 percent on the regional fee schedule. (B) For 2005, the blended rate shall be based 40 percent on the fee schedule under paragraph (1) and 60 percent on the regional fee schedule. (C) For 2006, the blended rate shall be based 60 percent on the fee schedule under paragraph (1) and 40 percent on the regional fee schedule. (D) For 2007, 2008, and 2009, the blended rate shall be based 80 percent on the fee schedule under paragraph (1) and 20 percent on the regional fee schedule. (E) For 2010 and each succeeding year, the blended rate shall be based 100 percent on the fee schedule under paragraph (1). For purposes of this paragraph, the Secretary shall establish a regional fee schedule for each of the nine census divisions (referred to in sec- tion 1395ww(d)(2) of this title) using the meth- odology (used in establishing the fee schedule under paragraph (1)) to calculate a regional conversion factor and a regional mileage pay- ment rate and using the same payment adjust- ments and the same relative value units as used in the fee schedule under such paragraph. (11) Adjustment in payment for certain long trips In the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2009, regardless of where the trans- portation originates, the fee schedule estab- lished under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 50 miles the per mile rate otherwise established shall be increased by 1⁄4 of the payment per mile otherwise appli- cable to miles in excess of 50 miles in such trip. Page 3121 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (12) Assistance for rural providers furnishing services in low population density areas (A) In general In the case of ground ambulance services furnished on or after July 1, 2004, and before April 1, 2025, for which the transportation originates in a qualified rural area (identi- fied under subparagraph (B)(iii)), the Sec- retary shall provide for a percent increase in the base rate of the fee schedule for a trip established under this subsection. In estab- lishing such percent increase, the Secretary shall estimate the average cost per trip for such services (not taking into account mile- age) in the lowest quartile as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of all rural county popu- lations. (B) Identification of qualified rural areas (i) Determination of population density in area Based upon data from the United States decennial census for the year 2000, the Sec- retary shall determine, for each rural area, the population density for that area. (ii) Ranking of areas The Secretary shall rank each such area based on such population density. (iii) Identification of qualified rural areas The Secretary shall identify those areas (in subparagraph (A) referred to as ‘‘quali- fied rural areas’’) with the lowest popu- lation densities that represent, if each such area were weighted by the population of such area (as used in computing such population densities), an aggregate total of 25 percent of the total of the population of all such areas. (iv) Rural area For purposes of this paragraph, the term ‘‘rural area’’ has the meaning given such term in section 1395ww(d)(2)(D) of this title. If feasible, the Secretary shall treat a rural census tract of a metropolitan sta- tistical area (as determined under the most recent modification of the Goldsmith Modification, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725) as a rural area for purposes of this paragraph. (v) Judicial review There shall be no administrative or judi- cial review under section 1395ff, 1395oo of this title, or otherwise, respecting the identification of an area under this sub- paragraph. (13) Temporary increase for ground ambulance services (A) In general After computing the rates with respect to ground ambulance services under the other applicable provisions of this subsection, in the case of such services furnished on or after July 1, 2004, and before January 1, 2007, and for such services furnished on or after July 1, 2008, and before April 1, 2025,,4 for which the transportation originates in— (i) a rural area described in paragraph (9) or in a rural census tract described in such paragraph, the fee schedule established under this section shall provide that the rate for the service otherwise established, after the application of any increase under paragraphs (11) and (12), shall be increased by 2 percent (or 3 percent if such service is furnished on or after July 1, 2008, and be- fore April 1, 2025); and (ii) an area not described in clause (i), the fee schedule established under this subsection shall provide that the rate for the service otherwise established, after the application of any increase under para- graph (11), shall be increased by 1 percent (or 2 percent if such service is furnished on or after July 1, 2008, and before April 1, 2025). (B) Application of increased payments after applicable period The increased payments under subpara- graph (A) shall not be taken into account in calculating payments for services furnished after the applicable period specified in such subparagraph. (14) Providing appropriate coverage of rural air ambulance services (A) In general The regulations described in section 1395x(s)(7) of this title shall provide, to the extent that any ambulance services (wheth- er ground or air) may be covered under such section, that a rural air ambulance service (as defined in subparagraph (C)) is reim- bursed under this subsection at the air am- bulance rate if the air ambulance service— (i) is reasonable and necessary based on the health condition of the individual being transported at or immediately prior to the time of the transport; and (ii) complies with equipment and crew requirements established by the Secretary. (B) Satisfaction of requirement of medically necessary The requirement of subparagraph (A)(i) is deemed to be met for a rural air ambulance service if— (i) subject to subparagraph (D), such service is requested by a physician or other qualified medical personnel (as spec- ified by the Secretary) who certifies or reasonably determines that the individ- ual’s condition is such that the time need- ed to transport the individual by land or the instability of transportation by land poses a threat to the individual’s survival or seriously endangers the individual’s health; or (ii) such service is furnished pursuant to a protocol that is established by a State or regional emergency medical service (EMS) agency and recognized or approved by the Secretary under which the use of an air ambulance is recommended, if such agency does not have an ownership interest in the entity furnishing such service. Page 3122 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (C) Rural air ambulance service defined For purposes of this paragraph, the term ‘‘rural air ambulance service’’ means fixed wing and rotary wing air ambulance service in which the point of pick up of the indi- vidual occurs in a rural area (as defined in section 1395ww(d)(2)(D) of this title) or in a rural census tract of a metropolitan statis- tical area (as determined under the most re- cent modification of the Goldsmith Modi- fication, originally published in the Federal Register on February 27, 1992 (57 Fed. Reg. 6725)). (D) Limitation (i) In general Subparagraph (B)(i) shall not apply if there is a financial or employment rela- tionship between the person requesting the rural air ambulance service and the entity furnishing the ambulance service, or an entity under common ownership with the entity furnishing the air ambulance serv- ice, or a financial relationship between an immediate family member of such re- quester and such an entity. (ii) Exception Where a hospital and the entity fur- nishing rural air ambulance services are under common ownership, clause (i) shall not apply to remuneration (through em- ployment or other relationship) by the hospital of the requester or immediate family member if the remuneration is for provider-based physician services fur- nished in a hospital (as described in sec- tion 1395xx of this title) which are reim- bursed under part A and the amount of the remuneration is unrelated directly or indi- rectly to the provision of rural air ambu- lance services. (15) Payment adjustment for non-emergency ambulance transports for ESRD bene- ficiaries The fee schedule amount otherwise applica- ble under the preceding provisions of this sub- section shall be reduced by 10 percent for am- bulance services furnished during the period beginning on October 1, 2013, and ending on September 30, 2018, and by 23 percent for such services furnished on or after October 1, 2018, consisting of non-emergency basic life support services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in section 1395rr(b)(14)(B) of this title) furnished other than on an emergency basis by a provider of services or a renal dialysis facility. (16) Prior authorization for repetitive sched- uled non-emergent ambulance transports (A) In general Beginning January 1, 2017, if the expansion to all States of the model of prior authoriza- tion described in paragraph (2) of section 515(a) of the Medicare Access and CHIP Re- authorization Act of 2015 meets the require- ments described in paragraphs (1) through (3) of section 1315a(c) of this title, then the Secretary shall expand such model to all States. (B) Funding The Secretary shall use funds made avail- able under section 1395ddd(h)(10) of this title to carry out this paragraph. (C) Clarification regarding budget neutrality Nothing in this paragraph may be con- strued to limit or modify the application of section 1315a(b)(3)(B) of this title to models described in such section, including with re- spect to the model described in subpara- graph (A) and expanded beginning on Janu- ary 1, 2017, under such subparagraph. (17) Submission of cost and other information (A) Development of data collection system The Secretary shall develop a data collec- tion system (which may include use of a cost survey) to collect cost, revenue, utilization, and other information determined appro- priate by the Secretary with respect to pro- viders of services (in this paragraph referred to as ‘‘providers’’) and suppliers of ground ambulance services. Such system shall be designed to collect information— (i) needed to evaluate the extent to which reported costs relate to payment rates under this subsection; (ii) on the utilization of capital equip- ment and ambulance capacity, including information consistent with the type of in- formation described in section 1320a(a) of this title; and (iii) on different types of ground ambu- lance services furnished in different geo- graphic locations, including rural areas and low population density areas described in paragraph (12). (B) Specification of data collection system (i) In general The Secretary shall— (I) not later than December 31, 2019, specify the data collection system under subparagraph (A); and (II) identify the providers and suppliers of ground ambulance services that would be required to submit information under such data collection system, including the representative sample described in clause (ii). (ii) Determination of representative sample (I) In general Not later than December 31, 2019, with respect to the data collection for the first year under such system, and for each subsequent year through 2024, the Secretary shall determine a representa- tive sample to submit information under the data collection system. (II) Requirements The sample under subclause (I) shall be representative of the different types of providers and suppliers of ground ambu- lance services (such as those providers and suppliers that are part of an emer- gency service or part of a government Page 3123 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m organization) and the geographic loca- tions in which ground ambulance serv- ices are furnished (such as urban, rural, and low population density areas). (III) Limitation The Secretary shall not include an in- dividual provider or supplier of ground ambulance services in the sample under subclause (I) in 2 consecutive years, to the extent practicable. (C) Reporting of cost information For each year, a provider or supplier of ground ambulance services identified by the Secretary under subparagraph (B)(i)(II) as being required to submit information under the data collection system with respect to a period for the year shall submit to the Sec- retary information specified under the sys- tem. Such information shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this sub- paragraph. (D) Payment reduction for failure to report (i) In general Beginning January 1, 2022, subject to clause (ii), a 10 percent reduction to pay- ments under this subsection shall be made for the applicable period (as defined in clause (ii)) to a provider or supplier of ground ambulance services that— (I) is required to submit information under the data collection system with respect to a period under subparagraph (C); and (II) does not sufficiently submit such information, as determined by the Sec- retary. (ii) Applicable period defined For purposes of clause (i), the term ‘‘ap- plicable period’’ means, with respect to a provider or supplier of ground ambulance services, a year specified by the Secretary not more than 2 years after the end of the period with respect to which the Secretary has made a determination under clause (i)(II) that the provider or supplier of ground ambulance services failed to suffi- ciently submit information under the data collection system. (iii) Hardship exemption The Secretary may exempt a provider or supplier from the payment reduction under clause (i) with respect to an applica- ble period in the event of significant hard- ship, such as a natural disaster, bank- ruptcy, or other similar situation that the Secretary determines interfered with the ability of the provider or supplier of ground ambulance services to submit such information in a timely manner for the specified period. (iv) Informal review The Secretary shall establish a process under which a provider or supplier of ground ambulance services may seek an informal review of a determination that the provider or supplier is subject to the payment reduction under clause (i). (E) Ongoing data collection (i) Revision of data collection system The Secretary may, as the Secretary de- termines appropriate and, if available, taking into consideration the report (or reports) under subparagraph (F), revise the data collection system under subparagraph (A). (ii) Subsequent data collection In order to continue to evaluate the ex- tent to which reported costs relate to pay- ment rates under this subsection and for other purposes the Secretary deems appro- priate, the Secretary shall require pro- viders and suppliers of ground ambulance services to submit information for years after 2024 as the Secretary determines ap- propriate, but in no case less often than once every 3 years. (F) Ground ambulance data collection system study (i) In general Not later than the second June 15th fol- lowing the date on which the Secretary transmits data for the first representative sample of providers and suppliers of ground ambulance services to the Medi- care Payment Advisory Commission, and as determined necessary by such Commis- sion thereafter,,4 such Commission shall assess, and submit to Congress a report on, information submitted by providers and suppliers of ground ambulance services through the data collection system under subparagraph (A), the adequacy of pay- ments for ground ambulance services under this subsection, and geographic vari- ations in the cost of furnishing such serv- ices. (ii) Contents A report under clause (i) shall contain the following: (I) An analysis of information sub- mitted through the data collection sys- tem. (II) An analysis of any burden on pro- viders and suppliers of ground ambu- lance services associated with the data collection system. (III) A recommendation as to whether information should continue to be sub- mitted through such data collection sys- tem or if such system should be revised under subparagraph (E)(i). (IV) Other information determined ap- propriate by the Commission. (G) Public availability The Secretary shall post information on the results of the data collection under this paragraph on the Internet website of the Centers for Medicare & Medicaid Services, as determined appropriate by the Secretary. (H) Implementation The Secretary shall implement this para- graph through notice and comment rule- making. Page 3124 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (I) Administration Chapter 35 of title 44 shall not apply to the collection of information required under this subsection. (J) Limitations on review There shall be no administrative or judi- cial review under section 1395ff of this title, section 1395oo of this title, or otherwise of the data collection system or identification of respondents under this paragraph. (K) Funding for implementation For purposes of carrying out subparagraph (A), the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, of $15,000,000 to the Cen- ters for Medicare & Medicaid Services Pro- gram Management Account for fiscal year 2018. Amounts transferred under this sub- paragraph shall remain available until ex- pended. (m) Payment for telehealth services (1) In general Subject to paragraphs (8) and (9), the Sec- retary shall pay for telehealth services that are furnished via a telecommunications sys- tem by a physician (as defined in section 1395x(r) of this title) or a practitioner (as de- fined in paragraph (4)(E)) to an eligible tele- health individual enrolled under this part not- withstanding that the individual physician or practitioner providing the telehealth service is not at the same location as the beneficiary. For purposes of the preceding sentence, in the case of any Federal telemedicine demonstra- tion program conducted in Alaska or Hawaii, the term ‘‘telecommunications system’’ in- cludes store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multi- media formats. (2) Payment amount (A) Distant site Subject to paragraph (8), the Secretary shall pay to a physician or practitioner lo- cated at a distant site that furnishes a tele- health service to an eligible telehealth indi- vidual an amount equal to the amount that such physician or practitioner would have been paid under this subchapter had such service been furnished without the use of a telecommunications system. (B) Facility fee for originating site (i) In general Subject to clauses (ii) and (iii) and para- graph (6)(C), with respect to a telehealth service, subject to section 1395l(a)(1)(U) of this title, there shall be paid to the origi- nating site a facility fee equal to— (I) for the period beginning on October 1, 2001, and ending on December 31, 2001, and for 2002, $20; and (II) for a subsequent year, the facility fee specified in subclause (I) or this sub- clause for the preceding year increased by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for such subsequent year. (ii) No facility fee if originating site is the home No facility fee shall be paid under this subparagraph to an originating site de- scribed in paragraph (4)(C)(ii)(X). (iii) No facility fee for new sites In the case that the emergency period described in section 1320b–5(g)(1)(B) of this title ends before December 31, 2024, with respect to telehealth services identified in paragraph (4)(F)(i) as of March 15, 2022, that are furnished during the period begin- ning on the first day after the end of such emergency period and ending March 31, 2025, a facility fee shall only be paid under this subparagraph to an originating site that is described in paragraph (4)(C)(ii) (other than subclause (X) of such para- graph). (C) Telepresenter not required Nothing in this subsection shall be con- strued as requiring an eligible telehealth in- dividual to be presented by a physician or practitioner at the originating site for the furnishing of a service via a telecommuni- cations system, unless it is medically nec- essary (as determined by the physician or practitioner at the distant site). (3) Limitation on beneficiary charges (A) Physician and practitioner The provisions of section 1395w–4(g) of this title and subparagraphs (A) and (B) of sec- tion 1395u(b)(18) of this title shall apply to a physician or practitioner receiving payment under this subsection in the same manner as they apply to physicians or practitioners under such sections. (B) Originating site The provisions of section 1395u(b)(18) of this title shall apply to originating sites re- ceiving a facility fee in the same manner as they apply to practitioners under such sec- tion. (4) Definitions For purposes of this subsection: (A) Distant site Subject to paragraph (8), the term ‘‘distant site’’ means the site at which the physician or practitioner is located at the time the service is provided via a telecommunications system. (B) Eligible telehealth individual The term ‘‘eligible telehealth individual’’ means an individual enrolled under this part who receives a telehealth service furnished at an originating site. (C) Originating site (i) In general Except as provided in clause (iii) and paragraphs (5), (6), and (7), the term ‘‘origi- nating site’’ means only those sites de- scribed in clause (ii) at which the eligible Page 3125 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m telehealth individual is located at the time the service is furnished via a telecommuni- cations system and only if such site is lo- cated— (I) in an area that is designated as a rural health professional shortage area under section 254e(a)(1)(A) of this title; (II) in a county that is not included in a Metropolitan Statistical Area; or (III) from an entity that participates in a Federal telemedicine demonstration project that has been approved by (or re- ceives funding from) the Secretary of Health and Human Services as of Decem- ber 31, 2000. (ii) Sites described The sites referred to in clause (i) are the following sites: (I) The office of a physician or practi- tioner. (II) A critical access hospital (as de- fined in section 1395x(mm)(1) of this title). (III) A rural health clinic (as defined in section 1395x(aa)(2) of this title). (IV) A Federally qualified health cen- ter (as defined in section 1395x(aa)(4) of this title). (V) A hospital (as defined in section 1395x(e) of this title). (VI) A hospital-based or critical access hospital-based renal dialysis center (in- cluding satellites). (VII) A skilled nursing facility (as de- fined in section 1395i–3(a) of this title). (VIII) A community mental health center (as defined in section 1395x(ff)(3)(B) of this title). (IX) A renal dialysis facility, but only for purposes of section 1395rr(b)(3)(B) of this title. (X) The home of an individual, but only for purposes of section 1395rr(b)(3)(B) of this title or telehealth services described in paragraph (7). (XI) A rural emergency hospital (as de- fined in section 1395x(kkk)(2) of this title). (iii) Expanding access to telehealth serv- ices In the case that the emergency period described in section 1320b–5(g)(1)(B) of this title ends before December 31, 2024, with respect to telehealth services identified in subparagraph (F)(i) as of March 15, 2022, that are furnished during the period begin- ning on the first day after the end of such emergency period and ending on March 31, 2025, the term ‘‘originating site’’ means any site in the United States at which the eligible telehealth individual is located at the time the service is furnished via a tele- communications system, including the home of an individual. (D) Physician The term ‘‘physician’’ has the meaning given that term in section 1395x(r) of this title. (E) Practitioner The term ‘‘practitioner’’ has the meaning given that term in section 1395u(b)(18)(C) of this title and, in the case that the emer- gency period described in section 1320b–5(g)(1)(B) of this title ends before De- cember 31, 2024, for the period beginning on the first day after the end of such emergency period and ending on March 31, 2025, shall in- clude a qualified occupational therapist (as such term is used in section 1395x(g) of this title), a qualified physical therapist (as such term is used in section 1395x(p) of this title), a qualified speech-language pathologist (as defined in section 1395x(ll)(4)(A) of this title), and a qualified audiologist (as defined in sec- tion 1395x(ll)(4)(B) of this title). (F) Telehealth service (i) In general Subject to paragraph (8), the term ‘‘tele- health service’’ means professional con- sultations, office visits, and office psychi- atry services (identified as of July 1, 2000, by HCPCS codes 99241–99275, 99201–99215, 90804–90809, and 90862 (and as subsequently modified by the Secretary)), and any addi- tional service specified by the Secretary. (ii) Yearly update The Secretary shall establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes), as appropriate, to those specified in clause (i) for authorized pay- ment under paragraph (1). (5) Treatment of home dialysis monthly ESRD- related visit The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of section 1395rr(b)(3)(B) of this title, at an originating site described in subclause (VI), (IX), or (X) of paragraph (4)(C)(ii). (6) Treatment of stroke telehealth services (A) Non-application of originating site re- quirements The requirements described in paragraph (4)(C) shall not apply with respect to tele- health services furnished on or after Janu- ary 1, 2019, for purposes of diagnosis, evalua- tion, or treatment of symptoms of an acute stroke, as determined by the Secretary. (B) Inclusion of certain sites With respect to telehealth services de- scribed in subparagraph (A), the term ‘‘origi- nating site’’ shall include any hospital (as defined in section 1395x(e) of this title) or critical access hospital (as defined in section 1395x(mm)(1) of this title), any mobile stroke unit (as defined by the Secretary), or any other site determined appropriate by the Secretary, at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications sys- tem. (C) No originating site facility fee for new sites No facility fee shall be paid under para- graph (2)(B) to an originating site with re- Page 3126 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m spect to a telehealth service described in subparagraph (A) if the originating site does not otherwise meet the requirements for an originating site under paragraph (4)(C). (7) Treatment of substance use disorder serv- ices and mental health services furnished through telehealth (A) In general The geographic requirements described in paragraph (4)(C)(i) shall not apply with re- spect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder di- agnosis for purposes of treatment of such disorder or co-occurring mental health dis- order, as determined by the Secretary, or, on or after the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title, subject to sub- paragraph (B), to an eligible telehealth indi- vidual for purposes of diagnosis, evaluation, or treatment of a mental health disorder, as determined by the Secretary, at an origi- nating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph) or, for the period for which clause (iii) of paragraph (4)(C) applies, at any site described in such clause. (B) Requirements for mental health services furnished through telehealth (i) In general Payment may not be made under this paragraph for telehealth services furnished on or after April 1, 2025 by a physician or practitioner to an eligible telehealth indi- vidual for purposes of diagnosis, evalua- tion, or treatment of a mental health dis- order unless such physician or practitioner furnishes an item or service in person, without the use of telehealth, for which payment is made under this subchapter (or would have been made under this sub- chapter if such individual were entitled to, or enrolled for, benefits under this sub- chapter at the time such item or service is furnished)— (I) within the 6-month period prior to the first time such physician or practi- tioner furnishes such a telehealth serv- ice to the eligible telehealth individual; and (II) during subsequent periods in which such physician or practitioner furnishes such telehealth services to the eligible telehealth individual, at such times as the Secretary determines appropriate. (ii) Clarification This subparagraph shall not apply if pay- ment would otherwise be allowed— (I) under this paragraph (with respect to telehealth services furnished to an eli- gible telehealth individual with a sub- stance use disorder diagnosis for pur- poses of treatment of such disorder or co-occurring mental health disorder); or (II) under this subsection without ap- plication of this paragraph. (8) Enhancing telehealth services for Federally qualified health centers and rural health clinics (A) In general During the emergency period described in section 1320b–5(g)(1)(B) of this title and, in the case that such emergency period ends before December 31, 2024, during the period beginning on the first day after the end of such emergency period and ending on March 31, 2025— (i) the Secretary shall pay for telehealth services that are furnished via a tele- communications system by a Federally qualified health center or a rural health clinic to an eligible telehealth individual enrolled under this part notwithstanding that the Federally qualified health center or rural clinic providing the telehealth service is not at the same location as the beneficiary; (ii) the amount of payment to a Feder- ally qualified health center or rural health clinic that serves as a distant site for such a telehealth service shall be determined under subparagraph (B); and (iii) for purposes of this subsection— (I) the term ‘‘distant site’’ includes a Federally qualified health center or rural health clinic that furnishes a tele- health service to an eligible telehealth individual; and (II) the term ‘‘telehealth services’’ in- cludes a rural health clinic service or Federally qualified health center service that is furnished using telehealth to the extent that payment codes cor- responding to services identified by the Secretary under clause (i) or (ii) of para- graph (4)(F) are listed on the cor- responding claim for such rural health clinic service or Federally qualified health center service. (B) Special payment rule (i) In general The Secretary shall develop and imple- ment payment methods that apply under this subsection to a Federally qualified health center or rural health clinic that serves as a distant site that furnishes a telehealth service to an eligible telehealth individual during the periods for which subparagraph (A) applies. Such payment methods shall be based on payment rates that are similar to the national average payment rates for comparable telehealth services under the physician fee schedule under section 1395w–4 of this title. Not- withstanding any other provision of law, the Secretary may implement such pay- ment methods through program instruc- tion or otherwise. (ii) Exclusion from FQHC PPS calculation and RHC air calculation Costs associated with telehealth services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective pay- ment system under subsection (o) or for Page 3127 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m rural health clinic services under the methodology for all-inclusive rates (estab- lished by the Secretary) under section 1395l(a)(3) of this title. (9) Treatment of telehealth services furnished using audio-only telecommunications tech- nology In the case that the emergency period de- scribed in section 1320b–5(g)(1)(B) of this title ends before December 31, 2024, the Secretary shall continue to provide coverage and pay- ment under this part for telehealth services identified in paragraph (4)(F)(i) as of March 15, 2022, that are furnished via an audio-only com- munications system during the period begin- ning on the first day after the end of such emergency period and ending on March 31, 2025. For purposes of the previous sentence, the term ‘‘telehealth service’’ means a tele- health service identified as of March 15, 2022, by a HCPCS code (and any succeeding codes) for which the Secretary has not applied the re- quirements of paragraph (1) and the first sen- tence of section 410.78(a)(3) of title 42, Code of Federal Regulations, during such emergency period. (n) Authority to modify or eliminate coverage of certain preventive services Notwithstanding any other provision of this subchapter, effective beginning on January 1, 2010, if the Secretary determines appropriate, the Secretary may— (1) modify— (A) the coverage of any preventive service described in subparagraph (A) of section 1395x(ddd)(3) of this title to the extent that such modification is consistent with the rec- ommendations of the United States Preven- tive Services Task Force; and (B) the services included in the initial pre- ventive physical examination described in subparagraph (B) of such section; and (2) provide that no payment shall be made under this subchapter for a preventive service described in subparagraph (A) of such section that has not received a grade of A, B, C, or I by such Task Force. (o) Development and implementation of prospec- tive payment system (1) Development (A) In general The Secretary shall develop a prospective payment system for payment for Federally qualified health center services furnished by Federally qualified health centers under this subchapter. Such system shall include a process for appropriately describing the services furnished by Federally qualified health centers and shall establish payment rates for specific payment codes based on such appropriate descriptions of services. Such system shall be established to take into account the type, intensity, and dura- tion of services furnished by Federally quali- fied health centers. Such system may in- clude adjustments, including geographic ad- justments, determined appropriate by the Secretary. (B) Collection of data and evaluation By not later than January 1, 2011, the Sec- retary shall require Federally qualified health centers to submit to the Secretary such information as the Secretary may re- quire in order to develop and implement the prospective payment system under this sub- section, including the reporting of services using HCPCS codes. (2) Implementation (A) In general Notwithstanding section 1395l(a)(3)(A) of this title, the Secretary shall provide, for cost reporting periods beginning on or after October 1, 2014, for payments of prospective payment rates for Federally qualified health center services furnished by Federally quali- fied health centers under this subchapter in accordance with the prospective payment system developed by the Secretary under paragraph (1). (B) Payments (i) Initial payments The Secretary shall implement such pro- spective payment system so that the esti- mated aggregate amount of prospective payment rates (determined prior to the ap- plication of section 1395l(a)(1)(Z) of this title) under this subchapter for Federally qualified health center services in the first year that such system is implemented is equal to 100 percent of the estimated amount of reasonable costs (determined without the application of a per visit pay- ment limit or productivity screen and prior to the application of section 1395cc(a)(2)(A)(ii) of this title) that would have occurred for such services under this subchapter in such year if the system had not been implemented. (ii) Payments in subsequent years Payment rates in years after the year of implementation of such system shall be the payment rates in the previous year in- creased— (I) in the first year after implementa- tion of such system, by the percentage increase in the MEI (as defined in sec- tion 1395u(i)(3) of this title) for the year involved; and (II) in subsequent years, by the per- centage increase in a market basket of Federally qualified health center goods and services as promulgated through reg- ulations, or if such an index is not avail- able, by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) for the year involved. (C) Preparation for PPS implementation Notwithstanding any other provision of law, the Secretary may establish and imple- ment by program instruction or otherwise the payment codes to be used under the pro- spective payment system under this section. Page 3128 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 6 So in original. The period probably should be preceded by an- other closing parenthesis. (3) Additional payments for certain FQHCS with physicians or other practitioners re- ceiving data 2000 waivers (A) In general In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally qualified health center services (as defined in section 1395x(aa)(3) of this title) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the re- quirements described in subparagraph (C), the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Feder- ally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practi- tioner. (B) Application In order to receive a payment described in subparagraph (A), a Federally qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such sub- paragraph at such center. (C) Requirements For purposes of subparagraph (A), the re- quirements described in this subparagraph, with respect to a physician or practitioner, are the following: (i) The physician or practitioner is em- ployed by or working under contract with a Federally qualified health center de- scribed in subparagraph (A) that submits an application under subparagraph (B). (ii) The physician or practitioner first begins prescribing narcotic drugs in sched- ule III, IV, or V of section 812 of title 21 for the purpose of maintenance or detoxifica- tion treatment on or after January 1, 2021. (D) Funding For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended. (4) Payment for certain services furnished by federally qualified health centers (A) Attending physician services for hospice patients In the case of services described in section 1395d(d)(2)(A)(ii) of this title furnished on or after January 1, 2022, by an attending physi- cian (as defined in section 1395x(dd)(3)(B) of this title, other than a physician or practi- tioner who is employed by a hospice pro- gram) who is employed by or working under contract with a Federally qualified health center, a Federally qualified health center shall be paid for such services under the pro- spective payment system under this sub- section. (B) Mental health visits furnished via tele- communications technology In the case of mental health visits fur- nished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-person men- tal health visit requirements established under section 405.2463(b)(3) of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to April 1, 2025. (5) Special payment rule for intensive out- patient services (A) In general In the case of intensive outpatient services furnished by a Federally qualified health center, the payment amount for such serv- ices shall be equal to the amount that would have been paid under this subchapter for such services had such services been covered OPD services furnished by a hospital. (B) Exclusion Costs associated with intensive outpatient services shall not be used to determine the amount of payment for Federally qualified health center services under the prospective payment system under this subsection. (p) Quality incentives to promote patient safety and public health in computed tomography (1) Quality incentives In the case of an applicable computed to- mography service (as defined in paragraph (2)) for which payment is made under an applica- ble payment system (as defined in paragraph (3)) and that is furnished on or after January 1, 2016, using equipment that is not consistent with the CT equipment standard (described in paragraph (4)), the payment amount for such service shall be reduced by the applicable per- centage (as defined in paragraph (5)). (2) Applicable computed tomography services defined In this subsection, the term ‘‘applicable computed tomography service’’ means a serv- ice billed using diagnostic radiological imag- ing codes for computed tomography (identified as of January 1, 2014, by HCPCS codes 70450–70498, 71250–71275, 72125–72133, 72191–72194, 73200–73206, 73700–73706, 74150–74178, 74261–74263, and 75571–75574 (and any succeeding codes).6 (3) Applicable payment system defined In this subsection, the term ‘‘applicable pay- ment system’’ means the following: (A) The technical component and the tech- nical component of the global fee under the Page 3129 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m fee schedule established under section 1395w–4(b) of this title. (B) The prospective payment system for hospital outpatient department services under section 1395l(t) of this title. (4) Consistency with CT equipment standard In this subsection, the term ‘‘not consistent with the CT equipment standard’’ means, with respect to an applicable computed tomography service, that the service was furnished using equipment that does not meet each of the at- tributes of the National Electrical Manufac- turers Association (NEMA) Standard XR–29–2013, entitled ‘‘Standard Attributes on CT Equipment Related to Dose Optimization and Management’’. Through rulemaking, the Secretary may apply successor standards. (5) Applicable percentage defined In this subsection, the term ‘‘applicable per- centage’’ means— (A) for 2016, 5 percent; and (B) for 2017 and subsequent years, 15 per- cent. (6) Implementation (A) Information The Secretary shall require that informa- tion be provided and attested to by a sup- plier and a hospital outpatient department that indicates whether an applicable com- puted tomography service was furnished that was not consistent with the CT equip- ment standard (described in paragraph (4)). Such information may be included on a claim and may be a modifier. Such informa- tion shall be verified, as appropriate, as part of the periodic accreditation of suppliers under subsection (e) and hospitals under sec- tion 1395bb(a) of this title. (B) Administration Chapter 35 of title 44 shall not apply to in- formation described in subparagraph (A). (q) Recognizing appropriate use criteria for cer- tain imaging services (1) Program established (A) In general The Secretary shall establish a program to promote the use of appropriate use criteria (as defined in subparagraph (B)) for applica- ble imaging services (as defined in subpara- graph (C)) furnished in an applicable setting (as defined in subparagraph (D)) by ordering professionals and furnishing professionals (as defined in subparagraphs (E) and (F), re- spectively). (B) Appropriate use criteria defined In this subsection, the term ‘‘appropriate use criteria’’ means criteria, only developed or endorsed by national professional medical specialty societies or other provider-led en- tities, to assist ordering professionals and furnishing professionals in making the most appropriate treatment decision for a specific clinical condition for an individual. To the extent feasible, such criteria shall be evi- dence-based. (C) Applicable imaging service defined In this subsection, the term ‘‘applicable imaging service’’ means an advanced diag- nostic imaging service (as defined in sub- section (e)(1)(B)) for which the Secretary de- termines— (i) one or more applicable appropriate use criteria specified under paragraph (2) apply; (ii) there are one or more qualified clin- ical decision support mechanisms listed under paragraph (3)(C); and (iii) one or more of such mechanisms is available free of charge. (D) Applicable setting defined In this subsection, the term ‘‘applicable setting’’ means a physician’s office, a hos- pital outpatient department (including an emergency department), an ambulatory sur- gical center, and any other provider-led out- patient setting determined appropriate by the Secretary. (E) Ordering professional defined In this subsection, the term ‘‘ordering pro- fessional’’ means a physician (as defined in section 1395x(r) of this title) or a practi- tioner described in section 1395u(b)(18)(C) of this title who orders an applicable imaging service. (F) Furnishing professional defined In this subsection, the term ‘‘furnishing professional’’ means a physician (as defined in section 1395x(r) of this title) or a practi- tioner described in section 1395u(b)(18)(C) of this title who furnishes an applicable imag- ing service. (2) Establishment of applicable appropriate use criteria (A) In general Not later than November 15, 2015, the Sec- retary shall through rulemaking, and in con- sultation with physicians, practitioners, and other stakeholders, specify applicable appro- priate use criteria for applicable imaging services only from among appropriate use criteria developed or endorsed by national professional medical specialty societies or other provider-led entities. (B) Considerations In specifying applicable appropriate use criteria under subparagraph (A), the Sec- retary shall take into account whether the criteria— (i) have stakeholder consensus; (ii) are scientifically valid and evidence based; and (iii) are based on studies that are pub- lished and reviewable by stakeholders. (C) Revisions The Secretary shall review, on an annual basis, the specified applicable appropriate use criteria to determine if there is a need to update or revise (as appropriate) such speci- fication of applicable appropriate use cri- teria and make such updates or revisions through rulemaking. (D) Treatment of multiple applicable appro- priate use criteria In the case where the Secretary deter- mines that more than one appropriate use Page 3130 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m criterion applies with respect to an applica- ble imaging service, the Secretary shall apply one or more applicable appropriate use criteria under this paragraph for the service. (3) Mechanisms for consultation with applica- ble appropriate use criteria (A) Identification of mechanisms to consult with applicable appropriate use criteria (i) In general The Secretary shall specify qualified clinical decision support mechanisms that could be used by ordering professionals to consult with applicable appropriate use criteria for applicable imaging services. (ii) Consultation The Secretary shall consult with physi- cians, practitioners, health care tech- nology experts, and other stakeholders in specifying mechanisms under this para- graph. (iii) Inclusion of certain mechanisms Mechanisms specified under this para- graph may include any or all of the fol- lowing that meet the requirements de- scribed in subparagraph (B)(ii): (I) Use of clinical decision support modules in certified EHR technology (as defined in section 1395w–4(o)(4) of this title). (II) Use of private sector clinical deci- sion support mechanisms that are inde- pendent from certified EHR technology, which may include use of clinical deci- sion support mechanisms available from medical specialty organizations. (III) Use of a clinical decision support mechanism established by the Secretary. (B) Qualified clinical decision support mech- anisms (i) In general For purposes of this subsection, a quali- fied clinical decision support mechanism is a mechanism that the Secretary deter- mines meets the requirements described in clause (ii). (ii) Requirements The requirements described in this clause are the following: (I) The mechanism makes available to the ordering professional applicable ap- propriate use criteria specified under paragraph (2) and the supporting docu- mentation for the applicable imaging service ordered. (II) In the case where there is more than one applicable appropriate use cri- terion specified under such paragraph for an applicable imaging service, the mech- anism indicates the criteria that it uses for the service. (III) The mechanism determines the extent to which an applicable imaging service ordered is consistent with the ap- plicable appropriate use criteria so speci- fied. (IV) The mechanism generates and pro- vides to the ordering professional a cer- tification or documentation that docu- ments that the qualified clinical decision support mechanism was consulted by the ordering professional. (V) The mechanism is updated on a timely basis to reflect revisions to the specification of applicable appropriate use criteria under such paragraph. (VI) The mechanism meets privacy and security standards under applicable pro- visions of law. (VII) The mechanism performs such other functions as specified by the Sec- retary, which may include a requirement to provide aggregate feedback to the or- dering professional. (C) List of mechanisms for consultation with applicable appropriate use criteria (i) Initial list Not later than April 1, 2016, the Sec- retary shall publish a list of mechanisms specified under this paragraph. (ii) Periodic updating of list The Secretary shall identify on an an- nual basis the list of qualified clinical de- cision support mechanisms specified under this paragraph. (4) Consultation with applicable appropriate use criteria (A) Consultation by ordering professional Beginning with January 1, 2017, subject to subparagraph (C), with respect to an applica- ble imaging service ordered by an ordering professional that would be furnished in an applicable setting and paid for under an ap- plicable payment system (as defined in sub- paragraph (D)), an ordering professional shall— (i) consult with a qualified decision sup- port mechanism listed under paragraph (3)(C); and (ii) provide to the furnishing professional the information described in clauses (i) through (iii) of subparagraph (B). (B) Reporting by furnishing professional Beginning with January 1, 2017, subject to subparagraph (C), with respect to an applica- ble imaging service furnished in an applica- ble setting and paid for under an applicable payment system (as defined in subparagraph (D)), payment for such service may only be made if the claim for the service includes the following: (i) Information about which qualified clinical decision support mechanism was consulted by the ordering professional for the service. (ii) Information regarding— (I) whether the service ordered would adhere to the applicable appropriate use criteria specified under paragraph (2); (II) whether the service ordered would not adhere to such criteria; or (III) whether such criteria was not ap- plicable to the service ordered. (iii) The national provider identifier of the ordering professional (if different from the furnishing professional). Page 3131 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (C) Exceptions The provisions of subparagraphs (A) and (B) and paragraph (6)(A) shall not apply to the following: (i) Emergency services An applicable imaging service ordered for an individual with an emergency med- ical condition (as defined in section 1395dd(e)(1) of this title). (ii) Inpatient services An applicable imaging service ordered for an inpatient and for which payment is made under part A. (iii) Significant hardship An applicable imaging service ordered by an ordering professional who the Secretary may, on a case-by-case basis, exempt from the application of such provisions if the Secretary determines, subject to annual renewal, that consultation with applicable appropriate use criteria would result in a significant hardship, such as in the case of a professional who practices in a rural area without sufficient Internet access. (D) Applicable payment system defined In this subsection, the term ‘‘applicable payment system’’ means the following: (i) The physician fee schedule estab- lished under section 1395w–4(b) of this title. (ii) The prospective payment system for hospital outpatient department services under section 1395l(t) of this title. (iii) The ambulatory surgical center pay- ment systems under section 1395l(i) of this title. (5) Identification of outlier ordering profes- sionals (A) In general With respect to applicable imaging serv- ices furnished beginning with 2017, the Sec- retary shall determine, on an annual basis, no more than five percent of the total num- ber of ordering professionals who are outlier ordering professionals. (B) Outlier ordering professionals The determination of an outlier ordering professional shall— (i) be based on low adherence to applica- ble appropriate use criteria specified under paragraph (2), which may be based on com- parison to other ordering professionals; and (ii) include data for ordering profes- sionals for whom prior authorization under paragraph (6)(A) applies. (C) Use of two years of data The Secretary shall use two years of data to identify outlier ordering professionals under this paragraph. (D) Process The Secretary shall establish a process for determining when an outlier ordering profes- sional is no longer an outlier ordering pro- fessional. (E) Consultation with stakeholders The Secretary shall consult with physi- cians, practitioners and other stakeholders in developing methods to identify outlier or- dering professionals under this paragraph. (6) Prior authorization for ordering profes- sionals who are outliers (A) In general Beginning January 1, 2020, subject to para- graph (4)(C), with respect to services fur- nished during a year, the Secretary shall, for a period determined appropriate by the Sec- retary, apply prior authorization for applica- ble imaging services that are ordered by an outlier ordering professional identified under paragraph (5). (B) Appropriate use criteria in prior author- ization In applying prior authorization under sub- paragraph (A), the Secretary shall utilize only the applicable appropriate use criteria specified under this subsection. (C) Funding For purposes of carrying out this para- graph, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for each of fiscal years 2019 through 2021. Amounts transferred under the preceding sentence shall remain available until expended. (7) Construction Nothing in this subsection shall be con- strued as granting the Secretary the authority to develop or initiate the development of clin- ical practice guidelines or appropriate use cri- teria. (r) Payment for renal dialysis services for indi- viduals with acute kidney injury (1) Payment rate In the case of renal dialysis services (as de- fined in subparagraph (B) of section 1395rr(b)(14) of this title) furnished under this part by a renal dialysis facility or provider of services paid under such section during a year (beginning with 2017) to an individual with acute kidney injury (as defined in paragraph (2)), the amount of payment under this part for such services shall be the base rate for renal dialysis services determined for such year under such section, as adjusted by any applicable geographic adjustment factor ap- plied under subparagraph (D)(iv)(II) of such section and may be adjusted by the Secretary (on a budget neutral basis for payments under this paragraph) by any other adjustment fac- tor under subparagraph (D) of such section. (2) Individual with acute kidney injury defined In this subsection, the term ‘‘individual with acute kidney injury’’ means an individual who has acute loss of renal function and does not receive renal dialysis services for which pay- ment is made under section 1395rr(b)(14) of this title. Page 3132 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (s) Payment for applicable disposable devices (1) Separate payment The Secretary shall make a payment (sepa- rate from the payments otherwise made under section 1395fff of this title) in the amount es- tablished under paragraph (3) to a home health agency for an applicable disposable device (as defined in paragraph (2)) when furnished on or after January 1, 2017, to an individual who re- ceives home health services for which pay- ment is made under section 1395fff(b) of this title. (2) Applicable disposable device In this subsection, the term applicable dis- posable device means a disposable device that, as determined by the Secretary, is— (A) a disposable negative pressure wound therapy device that is an integrated system comprised of a non-manual vacuum pump, a receptacle for collecting exudate, and dressings for the purposes of wound therapy; and (B) a substitute for, and used in lieu of, a negative pressure wound therapy durable medical equipment item that is an inte- grated system of a negative pressure vacuum pump, a separate exudate collection can- ister, and dressings that would otherwise be covered for individuals for such wound ther- apy. (3) Payment (A) In general The separate payment amount established under this paragraph for an applicable dis- posable device for a year shall be equal to— (i) for a year before 2024, the amount of the payment that would be made under section 1395l(t) of this title (relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such de- vice; (ii) for 2024, the supply price used to de- termine the relative value for the service under the fee schedule under section 1395w–4 of this title (as of January 1, 2022) for the applicable disposable device, up- dated by the specified adjustment de- scribed in subparagraph (B) for such year; and (iii) for 2025 and each subsequent year, the payment amount established under this paragraph for such device for the pre- vious year, updated by the specified ad- justment described in subparagraph (B) for such year. (B) Specified adjustment (i) In general For purposes of subparagraph (A), the specified adjustment described in this sub- paragraph for a year is equal to— (I) the percentage increase in the con- sumer price index for all urban con- sumers (United States city average) for the 12-month period ending in June of the previous year; minus (II) the productivity adjustment de- scribed in section 1395ww(b)(3)(B)(xi)(II) of this title for such year. (ii) Clarification on application of the pro- ductivity adjustment The application of clause (i)(II) may re- sult in a specified adjustment of less than 0.0 for a year, and may result in the sepa- rate payment amount under this sub- section for an applicable device for a year being less than such separate payment amount for such device for the preceding year. (C) Exclusion of nursing and therapy serv- ices from separate payment With respect to applicable devices fur- nished on or after January 1, 2024, the sepa- rate payment amount determined under this paragraph shall not include payment for nursing or therapy services described in sec- tion 1395x(m) of this title. Payment for such nursing or therapy services shall be made under the prospective payment system es- tablished under section 1395fff of this title and shall not be separately billable. (4) Implementation As part of submitting claims for the sepa- rate payment established under this sub- section, beginning with 2024, the Secretary shall accept and process claims submitted using the type of bill that is most commonly used by home health agencies to bill services under a home health plan of care. (t) Site-of-service price transparency (1) In general In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this subchapter, the Sec- retary shall, for 2018 and each year thereafter, make available to the public via a searchable Internet website, with respect to an appro- priate number of such items and services— (A) the estimated payment amount for the item or service under the outpatient depart- ment fee schedule under subsection (t) of section 1395l of this title and the ambulatory surgical center payment system under sub- section (i) of such section; and (B) the estimated amount of beneficiary li- ability applicable to the item or service. (2) Calculation of estimated beneficiary liabil- ity For purposes of paragraph (1)(B), the esti- mated amount of beneficiary liability, with re- spect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a Medicare supplemental policy certified under section 1395ss of this title or any other supplemental insurance coverage is responsible. (3) Implementation In carrying out this subsection, the Sec- retary— (A) shall include in the notice described in section 1395b–2(a) of this title a notification Page 3133 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 7 So in original. The second closing parenthesis probably should not appear. of the availability of the estimated amounts made available under paragraph (1); and (B) may utilize mechanisms in existence on December 13, 2016, such as the portion of the Internet website of the Centers for Medi- care & Medicaid Services on which informa- tion comparing physician performance is posted (commonly referred to as the Physi- cian Compare Internet website), to make available such estimated amounts under such paragraph. (4) Funding For purposes of implementing this sub- section, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2017, to re- main available until expended. (u) Payment and related requirements for home infusion therapy (1) Payment (A) Single payment (i) In general Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement a payment system under which a single payment is made under this subchapter to a qualified home infusion therapy supplier for items and services described in sub- paragraphs (A) and (B) of section 1395x(iii)(2)) 7 of this title furnished by a qualified home infusion therapy supplier (as defined in section 1395x(iii)(3)(D) of this title) in coordination with the furnishing of home infusion drugs (as defined in sec- tion 1395x(iii)(3)(C) of this title) under this part. (ii) Unit of single payment A unit of single payment under the pay- ment system implemented under this sub- paragraph is for each infusion drug admin- istration calendar day in the individual’s home. The Secretary shall, as appropriate, establish single payment amounts for types of infusion therapy, including to take into account variation in utilization of nursing services by therapy type. (iii) Limitation The single payment amount determined under this subparagraph after application of subparagraph (B) and paragraph (3) shall not exceed the amount determined under the fee schedule under section 1395w–4 of this title for infusion therapy services fur- nished in a calendar day if furnished in a physician office setting, except such single payment shall not reflect more than 5 hours of infusion for a particular therapy in a calendar day. (B) Required adjustments The Secretary shall adjust the single pay- ment amount determined under subpara- graph (A) for home infusion therapy services under section 1395x(iii)(1) of this title to re- flect other factors such as— (i) a geographic wage index and other costs that may vary by region; and (ii) patient acuity and complexity of drug administration. (C) Discretionary adjustments (i) In general Subject to clause (ii), the Secretary may adjust the single payment amount deter- mined under subparagraph (A) (after appli- cation of subparagraph (B)) to reflect outlier situations and other factors as the Secretary determines appropriate. (ii) Requirement of budget neutrality Any adjustment under this subparagraph shall be made in a budget neutral manner. (2) Considerations In developing the payment system under this subsection, the Secretary may consider the costs of furnishing infusion therapy in the home, consult with home infusion therapy suppliers, consider payment amounts for simi- lar items and services under this part and part A, and consider payment amounts established by Medicare Advantage plans under part C and in the private insurance market for home infu- sion therapy (including average per treatment day payment amounts by type of home infu- sion therapy). (3) Annual updates (A) In general Subject to subparagraph (B), the Secretary shall update the single payment amount under this subsection from year to year be- ginning in 2022 by increasing the single pay- ment amount from the prior year by the per- centage increase in the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year. (B) Adjustment For each year, the Secretary shall reduce the percentage increase described in sub- paragraph (A) by the productivity adjust- ment described in section 1395ww(b)(3)(B)(xi)(II) of this title. The ap- plication of the preceding sentence may re- sult in a percentage being less than 0.0 for a year, and may result in payment being less than such payment rates for the preceding year. (4) Authority to apply prior authorization The Secretary may, as determined appro- priate by the Secretary, apply prior authoriza- tion for home infusion therapy services under section 1395x(iii)(1) of this title. (5) Accreditation of qualified home infusion therapy suppliers (A) Factors for designation of accreditation organizations The Secretary shall consider the following factors in designating accreditation organi- zations under subparagraph (B) and in re- Page 3134 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m viewing and modifying the list of accredita- tion organizations designated pursuant to subparagraph (C): (i) The ability of the organization to conduct timely reviews of accreditation applications. (ii) The ability of the organization to take into account the capacities of sup- pliers located in a rural area (as defined in section 1395ww(d)(2)(D) of this title). (iii) Whether the organization has estab- lished reasonable fees to be charged to sup- pliers applying for accreditation. (iv) Such other factors as the Secretary determines appropriate. (B) Designation Not later than January 1, 2021, the Sec- retary shall designate organizations to ac- credit suppliers furnishing home infusion therapy. The list of accreditation organiza- tions so designated may be modified pursu- ant to subparagraph (C). (C) Review and modification of list of accred- itation organizations (i) In general The Secretary shall review the list of ac- creditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations des- ignated under subparagraph (B). (ii) Special rule for accreditations done prior to removal from list of designated accreditation organizations In the case where the Secretary removes an organization from the list of accredita- tion organizations designated under sub- paragraph (B), any supplier that is accred- ited by the organization during the period beginning on the date on which the organi- zation is designated as an accreditation or- ganization under subparagraph (B) and ending on the date on which the organiza- tion is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect. (D) Rule for accreditations made prior to designation In the case of a supplier that is accredited before January 1, 2021, by an accreditation organization designated by the Secretary under subparagraph (B) as of January 1, 2019, such supplier shall be considered to have been accredited by an organization des- ignated by the Secretary under such para- graph as of January 1, 2023, for the remain- ing period such accreditation is in effect. (6) Notification of infusion therapy options available prior to furnishing home infusion therapy Prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan described in section 1395x(iii)(1) of this title for the individual shall provide notification (in a form, manner, and frequency determined appropriate by the Sec- retary) of the options available (such as home, physician’s office, hospital outpatient depart- ment) for the furnishing of infusion therapy under this part. (7) Home infusion therapy services temporary transitional payment (A) Temporary transitional payment (i) In general The Secretary shall, in accordance with the payment methodology described in subparagraph (B) and subject to the provi- sions of this paragraph, provide a home in- fusion therapy services temporary transi- tional payment under this part to an eligi- ble home infusion supplier (as defined in subparagraph (F)) for items and services described in subparagraphs (A) and (B) of section 1395x(iii)(2)) 7 of this title furnished during the period specified in clause (ii) by such supplier in coordination with the fur- nishing of transitional home infusion drugs (as defined in clause (iii)). (ii) Period specified For purposes of clause (i), the period specified in this clause is the period begin- ning on January 1, 2019, and ending on the day before the date of the implementation of the payment system under paragraph (1)(A). (iii) Transitional home infusion drug de- fined For purposes of this paragraph, the term ‘‘transitional home infusion drug’’ has the meaning given to the term ‘‘home infusion drug’’ under section 1395x(iii)(3)(C)) 7 of this title, except that clause (ii) of such section shall not apply if a drug described in such clause is identified in clauses (i), (ii), (iii) or (iv) of subparagraph (C) as of February 9, 2018. (B) Payment methodology For purposes of this paragraph, the Sec- retary shall establish a payment method- ology, with respect to items and services de- scribed in subparagraph (A)(i). Under such payment methodology the Secretary shall— (i) create the three payment categories described in clauses (i), (ii), and (iii) of subparagraph (C); (ii) assign drugs to such categories, in accordance with such clauses; (iii) assign appropriate Healthcare Com- mon Procedure Coding System (HCPCS) codes to each payment category; and (iv) establish a single payment amount for each such payment category, in accord- ance with subparagraph (D), for each infu- sion drug administration calendar day in the individual’s home for drugs assigned to such category. (C) Payment categories (i) Payment category 1 The Secretary shall create a payment category 1 and assign to such category Page 3135 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m drugs which are covered under the Local Coverage Determination on External Infu- sion Pumps (LCD number L33794) and billed with the following HCPCS codes (as identified as of January 1, 2018, and as sub- sequently modified by the Secretary): J0133, J0285, J0287, J0288, J0289, J0895, J1170, J1250, J1265, J1325, J1455, J1457, J1570, J2175, J2260, J2270, J2274, J2278, J3010, or J3285. (ii) Payment category 2 The Secretary shall create a payment category 2 and assign to such category drugs which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J1555 JB, J1559 JB, J1561 JB, J1562 JB, J1569 JB, or J1575 JB. (iii) Payment category 3 The Secretary shall create a payment category 3 and assign to such category drugs which are covered under such local coverage determination and billed with the following HCPCS codes (as identified as of January 1, 2018, and as subsequently modified by the Secretary): J9000, J9039, J9040, J9065, J9100, J9190, J9200, J9360, or J9370. (iv) Infusion drugs not otherwise included With respect to drugs that are not in- cluded in payment category 1, 2, or 3 under clause (i), (ii), or (iii), respectively, the Secretary shall assign to the most appro- priate of such categories, as determined by the Secretary, drugs which are— (I) covered under such local coverage determination and billed under HCPCS codes J7799 or J7999 (as identified as of July 1, 2017, and as subsequently modi- fied by the Secretary); or (II) billed under any code that is imple- mented after February 9, 2018, and in- cluded in such local coverage determina- tion or included in subregulatory guid- ance as a home infusion drug described in subparagraph (A)(i). (D) Payment amounts (i) In general Under the payment methodology, the Secretary shall pay eligible home infusion suppliers, with respect to items and serv- ices described in subparagraph (A)(i) fur- nished during the period described in sub- paragraph (A)(ii) by such supplier to an in- dividual, at amounts equal to the amounts determined under the physician fee sched- ule established under section 1395w–4 of this title for services furnished during the year for codes and units of such codes de- scribed in clauses (ii), (iii), and (iv) with respect to drugs included in the payment category under subparagraph (C) specified in the respective clause, determined with- out application of the geographic adjust- ment under subsection (e) of such section. (ii) Payment amount for category 1 For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 1 described in subparagraph (C)(i), are one unit of HCPCS code 96365 plus three units of HCPCS code 96366 (as identified as of January 1, 2018, and as subsequently modi- fied by the Secretary). (iii) Payment amount for category 2 For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 2 described in subparagraph (C)(i), are one unit of HCPCS code 96369 plus three units of HCPCS code 96370 (as identified as of January 1, 2018, and as subsequently modi- fied by the Secretary). (iv) Payment amount for category 3 For purposes of clause (i), the codes and units described in this clause, with respect to drugs included in payment category 3 described in subparagraph (C)(i), are one unit of HCPCS code 96413 plus three units of HCPCS code 96415 (as identified as of January 1, 2018, and as subsequently modi- fied by the Secretary). (E) Clarifications (i) Infusion drug administration day For purposes of this subsection, with re- spect to the furnishing of transitional home infusion drugs or home infusion drugs to an individual by an eligible home infusion supplier or a qualified home infu- sion therapy supplier, a reference to pay- ment to such supplier for an infusion drug administration calendar day in the indi- vidual’s home shall refer to payment only for the date on which professional services (as described in section 1395x(iii)(2)(A) of this title) were furnished to administer such drugs to such individual. For pur- poses of the previous sentence, an infusion drug administration calendar day shall in- clude all such drugs administered to such individual on such day. (ii) Treatment of multiple drugs adminis- tered on same infusion drug adminis- tration day In the case that an eligible home infu- sion supplier, with respect to an infusion drug administration calendar day in an in- dividual’s home, furnishes to such indi- vidual transitional home infusion drugs which are not all assigned to the same payment category under subparagraph (C), payment to such supplier for such infusion drug administration calendar day in the individual’s home shall be a single pay- ment equal to the amount of payment under this paragraph for the drug, among all such drugs so furnished to such indi- vidual during such calendar day, for which the highest payment would be made under this paragraph. (F) Eligible home infusion suppliers In this paragraph, the term ‘‘eligible home infusion supplier’’ means a supplier that is Page 3136 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m 8 So in original. Probably should be ‘‘determines’’. enrolled under this part as a pharmacy that provides external infusion pumps and exter- nal infusion pump supplies and that main- tains all pharmacy licensure requirements in the State in which the applicable infusion drugs are administered. (G) Implementation Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or other- wise. (v) Payment for outpatient physical therapy services and outpatient occupational therapy services furnished by a therapy assistant (1) In general In the case of an outpatient physical therapy service or outpatient occupational therapy service furnished on or after January 1, 2022, for which payment is made under section 1395w–4 of this title or subsection (k), that is furnished in whole or in part by a therapy as- sistant (as defined by the Secretary), the amount of payment for such service shall be an amount equal to 85 percent of the amount of payment otherwise applicable for the serv- ice under this part. Nothing in the preceding sentence shall be construed to change applica- ble requirements with respect to such services. (2) Use of modifier (A) Establishment Not later than January 1, 2019, the Sec- retary shall establish a modifier to indicate (in a form and manner specified by the Sec- retary), in the case of an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined), that the service was furnished by a therapy as- sistant. (B) Required use Each request for payment, or bill sub- mitted, for an outpatient physical therapy service or outpatient occupational therapy service furnished in whole or in part by a therapy assistant (as so defined) on or after January 1, 2020, shall include the modifier established under subparagraph (A) for each such service. (3) Implementation The Secretary shall implement this sub- section through notice and comment rule- making. (w) Opioid use disorder treatment services (1) In general The Secretary shall pay to an opioid treat- ment program (as defined in paragraph (2) of section 1395x(jjj) of this title) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treat- ment services (as defined in paragraph (1) of such section) that are furnished by such pro- gram to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment pro- gram. (2) Considerations The Secretary may implement this sub- section through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of serv- ices, the scope of services furnished, charac- teristics of the individuals furnished such services, or other factors as the Secretary de- termine 8 appropriate. In developing such bun- dles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under subchapter XIX or under the TRICARE pro- gram under chapter 55 of title 10. (3) Annual updates The Secretary shall provide an update each year to the bundled payment amounts under this subsection. (x) Payment rules relating to rural emergency hospitals (1) Payment for rural emergency hospital serv- ices In the case of rural emergency hospital serv- ices (as defined in section 1395x(kkk)(1) of this title), furnished by a rural emergency hospital (as defined in section 1395x(kkk)(2) of this title) on or after January 1, 2023, the amount of payment for such services shall be equal to the amount of payment that would otherwise apply under section 1395l(t) of this title for covered OPD services (as defined in section 1395l(t)(1)(B) of this title (other than clause (ii) of such section)), increased by 5 percent to re- flect the higher costs incurred by such hos- pitals, and shall include the application of any copayment amount determined under section 1395l(t)(8) of this title as if such increase had not occurred. (2) Additional facility payment (A) In general The Secretary shall make monthly pay- ments to a rural emergency hospital in an amount that is equal to 1⁄12 of the annual ad- ditional facility payment specified in sub- paragraph (B). (B) Annual additional facility payment amount The annual additional facility payment amount specified in this subparagraph is— (i) for 2023, a Medicare subsidy amount determined under subparagraph (C); and (ii) for 2024 and each subsequent year, the amount determined under this sub- paragraph for the preceding year, in- creased by the hospital market basket per- centage increase. (C) Determination of medicare subsidy amount For purposes of subparagraph (B)(i), the Medicare subsidy amount determined under this subparagraph is an amount equal to— Page 3137 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (i) the excess (if any) of— (I) the total amount that the Secretary determines was paid under this sub- chapter to all critical access hospitals in 2019; over (II) the estimated total amount that the Secretary determines would have been paid under this subchapter to such hospitals in 2019 if payment were made for inpatient hospital, outpatient hos- pital, and skilled nursing facility serv- ices under the applicable prospective payment systems for such services dur- ing such year; divided by (ii) the total number of such hospitals in 2019. (D) Reporting on use of the additional facil- ity payment A rural emergency hospital receiving the additional facility payment under this para- graph shall maintain detailed information as specified by the Secretary as to how the fa- cility has used the additional facility pay- ments. Such information shall be made available to the Secretary upon request. (3) Payment for ambulance services For provisions relating to payment for am- bulance services furnished by an entity owned and operated by a rural emergency hospital, see subsection (l). (4) Payment for post-hospital extended care services For provisions relating to payment for post- hospital extended care services furnished by a rural emergency hospital that has a unit that is a distinct part licensed as a skilled nursing facility, see section 1395yy(e) of this title. (5) Source of payments (A) In general Except as provided in subparagraph (B), payments under this subsection shall be made from the Federal Supplementary Med- ical Insurance Trust Fund under section 1395t of this title. (B) Additional facility payment and post-hos- pital extended care services Payments under paragraph (2) shall be made from the Federal Hospital Insurance Trust Fund under section 1395i of this title. (y) Payment for certain services furnished by rural health clinics (1) Attending physician services for hospice patients In the case of services described in section 1395d(d)(2)(A)(ii) of this title furnished on or after January 1, 2022, by an attending physi- cian (as defined in section 1395x(dd)(3)(B) of this title, other than a physician or practi- tioner who is employed by a hospice program) who is employed by or working under contract with a rural health clinic, a rural health clinic shall be paid for such services under the meth- odology for all-inclusive rates (established by the Secretary) under section 1395l(a)(3) of this title, subject to the limits described in section 1395l(f) of this title. (2) Mental health visits furnished via tele- communications technology In the case of mental health visits furnished via interactive, real-time, audio and video telecommunications technology or audio-only interactions, the in-person mental health visit requirements established under section 405.2463(b)(3) of title 42 of the Code of Federal Regulations (or a successor regulation) shall not apply prior to April 1, 2025. (3) Special payment rule for intensive out- patient services (A) In general In the case of intensive outpatient services furnished by a rural health clinic, the pay- ment amount for such services shall be equal to the amount that would have been paid under this subchapter for such services had such services been covered OPD services fur- nished by a hospital. (B) Exclusion Costs associated with intensive outpatient services shall not be used to determine the amount of payment for rural health clinic services under the methodology for all-inclu- sive rates (established by the Secretary) under section 1395l(a)(3) of this title. (z) Payment for lymphedema compression treat- ment items (1) In general The Secretary shall determine an appro- priate payment basis for lymphedema com- pression treatment items (as defined in sec- tion 1395x(mmm) of this title). In making such a determination, the Secretary may take into account payment rates for such items under State plans (or waivers of such plans) under subchapter XIX, the Veterans Health Adminis- tration, and group health plans and health in- surance coverage (as such terms are defined in section 300gg–91 of this title), and such other information as the Secretary determines ap- propriate. (2) Frequency limitation No payment may be made under this part for lymphedema compression treatment items furnished other than at such frequency as the Secretary may establish. (3) Application of competitive acquisition In the case of lymphedema compression treatment items that are included in a com- petitive acquisition program in a competitive acquisition area under section 1395w–3(a) of this title— (A) the payment basis under this sub- section for such items furnished in such area shall be the payment basis determined under such competitive acquisition program; and (B) the Secretary may use information on the payment determined under such com- petitive acquisition programs to adjust the payment amount otherwise determined under this subsection for an area that is not a competitive acquisition area under section 1395w–3 of this title, and in the case of such adjustment, paragraphs (8) and (9) of section 1395u(b) of this title shall not be applied. Page 3138 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m (Aug. 14, 1935, ch. 531, title XVIII, § 1834, as added and amended Pub. L. 100–203, title IV, §§ 4049(a)(2), 4062(b), Dec. 22, 1987, 101 Stat. 1330–91, 1330–100; Pub. L. 100–360, title II, §§ 202(b)(4), 203(c)(1)(F), 204(b), title IV, § 411(a)(3)(A), (B)(ii), (C)(ii), (f)(8)(A), (B)(ii), (D), (g)(1)(A), (B), July 1, 1988, 102 Stat. 704, 722, 726, 768, 779, 781; Pub. L. 100–485, title VI, § 608(d)(21)(C), (22)(A), Oct. 13, 1988, 102 Stat. 2420; Pub. L. 101–234, title II, § 201(a), title III, § 301(b)(1), (c)(1), Dec. 13, 1989, 103 Stat. 1981, 1985; Pub. L. 101–239, title VI, §§ 6102(f)(1), 6105(a), 6112(a), (c), (d)(1), (e)(2), 6116(b)(2), 6140, Dec. 19, 1989, 103 Stat. 2188, 2210, 2214–2216, 2220, 2224; Pub. L. 101–508, title IV, §§ 4102(a), (d), (f), 4104(a), 4152(a)(1), (b), (c)(1)–(4)(B)(i), (e), (f)(1), (g)(1), 4153(a)(1), (2)(D), 4163(b), Nov. 5, 1990, 104 Stat. 1388–55, 1388–57, 1388–59, 1388–74, 1388–77 to 1388–81, 1388–83, 1388–97; Pub. L. 103–66, title XIII, §§ 13542(a), 13543(a), (b), 13544(a)(1), (2), (b)(1), 13545(a), 13546, Aug. 10, 1993, 107 Stat. 587, 589, 590; Pub. L. 103–432, title I, §§ 102(e), 126(b)(1), (2), (4), (5), (g)(1), (10)(B), 131(a), 132(a), (b), 133(a)(1), 134(a)(1), 135(a)(1), (b)(1), (3), (d)(1), (e)(2)–(5), 145(a), 156(a)(2)(C), Oct. 31, 1994, 108 Stat. 4403, 4414–4416, 4419, 4421–4424, 4427, 4440; Pub. L. 105–33, title IV, §§ 4101(a), (c), 4104(b)(1), 4105(b)(2), 4201(c)(5), 4312(a), (c), 4316(b), 4531(b)(2), 4541(a)(2), 4551(a), (c)(1), 4552(a), (b), Aug. 5, 1997, 111 Stat. 360, 363, 367, 374, 386, 387, 392, 451, 455, 457–459; Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 201(e)(2), title III, § 321(k)(3), title IV, § 403(d)(1)], Nov. 29, 1999, 113 Stat. 1536, 1501A–340, 1501A–366, 1501A–371; Pub. L. 106–554, § 1(a)(6) [title I, §§ 103(b), 104(b), title II, §§ 201(a), 202(a), 204(a), 205(a), 221(a), 223(b), title IV, §§ 423(a)(1), (b)(1), 425(a), 426(a), 427(a), 428(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A–468, 2763A–469, 2763A–481, 2763A–482, 2763A–486, 2763A–487, 2763A–518 to 2763A–520, 2763A–522; Pub. L. 108–173, title III, § 302(a), (c)(1)(A), (2), (3), (d)(1), (2), title IV, §§ 405(a)(1), (b)(1), (d)(1), 414(a)–(c)(1), (d), 415(a), title VI, § 627(b)(1), title VII, § 736(b)(4), (5), Dec. 8, 2003, 117 Stat. 2223, 2230–2232, 2266, 2267, 2278–2281, 2321, 2356; Pub. L. 109–171, title V, §§ 5101(a)(1), (b)(1), 5113(b), Feb. 8, 2006, 120 Stat. 37, 38, 44; Pub. L. 110–275, title I, §§ 125(b)(5), 135(a)(1), 144(b)(1), 146(a), (b)(2)(A), 148(a), 149(a), 154(a)(2)(A), (3), (4), (b)(1)(A), (d)(2), July 15, 2008, 122 Stat. 2519, 2532, 2547–2549, 2563, 2564, 2567; Pub. L. 111–72, § 1(a), Oct. 13, 2009, 123 Stat. 2059; Pub. L. 111–148, title III, §§ 3105(a), (c), 3109(a), 3128(a), 3136(a), (b), 3401(j), (m), (n), title IV, § 4105(a), title V, §§ 5501(a)(2), (b)(2), 5502(b), title VI, §§ 6402(g)(1), 6405(a), 6407(b), 6410(b), title X, §§ 10311(a), (c), 10501(i)(1), (3)(A), Mar. 23, 2010, 124 Stat. 417, 418, 426, 437, 438, 486, 487, 558, 653, 654, 759, 768, 770, 773, 942, 943, 997; Pub. L. 111–309, title I, § 106(a), (c), Dec. 15, 2010, 124 Stat. 3287; Pub. L. 112–78, title III, § 306(a), (c), Dec. 23, 2011, 125 Stat. 1285; Pub. L. 112–96, title III, § 3007(a), (c), Feb. 22, 2012, 126 Stat. 190; Pub. L. 112–240, title VI, §§ 604(a), (c), 633(b), 636, 637, Jan. 2, 2013, 126 Stat. 2347, 2348, 2355–2357; Pub. L. 113–67, div. B, title I, § 1104, Dec. 26, 2013, 127 Stat. 1196; Pub. L. 113–93, title I, § 104, title II, § 218(a)(1), (b)(1), Apr. 1, 2014, 128 Stat. 1042, 1063, 1065; Pub. L. 113–295, div. B, title II, § 203, Dec. 19, 2014, 128 Stat. 4065; Pub. L. 114–10, title II, § 203, title V, §§ 504(a), 515(b), Apr. 16, 2015, 129 Stat. 144, 165, 174; Pub. L. 114–27, title VIII, § 808(b), June 29, 2015, 129 Stat. 418; Pub. L. 114–40, § 3, July 30, 2015, 129 Stat. 441; Pub. L. 114–113, div. O, title V, § 504(a), Dec. 18, 2015, 129 Stat. 3021; Pub. L. 114–255, div. A, title IV, § 4011, title V, § 5012(b), div. C, title XVI, § 16008(a), (b)(1), Dec. 13, 2016, 130 Stat. 1186, 1199, 1329; Pub. L. 115–123, div. E, title II, § 50203, title III, §§ 50302(b), 50325, title IV, §§ 50401(a), 50402, 50411, title XII, §§ 53107, 53108, Feb. 9, 2018, 132 Stat. 178, 191, 205, 214, 217, 220, 303; Pub. L. 115–271, title II, §§ 2001(a), 2005(c)(2), title VI, § 6083(a), Oct. 24, 2018, 132 Stat. 3924, 3929, 3994; Pub. L. 116–136, div. A, title III, § 3704, Mar. 27, 2020, 134 Stat. 416; Pub. L. 116–260, div. CC, title I, §§ 121(a), (b)(1), 122(c), 123(a), 125(a)(2)(B), (c), 132, Dec. 27, 2020, 134 Stat. 2955, 2956, 2964, 2966, 2976; Pub. L. 117–103, div. P, title III, §§ 301–305, 311, Mar. 15, 2022, 136 Stat. 804–806, 808; Pub. L. 117–215, title I, § 103(b)(4)(B), Dec. 2, 2022, 136 Stat. 2263; Pub. L. 117–328, div. FF, title I, § 1262(b)(6), title IV, §§ 4103, 4113(a)–(e), 4124(c), 4133(a)(2)(B), (b), 4134(c), 4136(a), Dec. 29, 2022, 136 Stat. 5682, 5896, 5898, 5899, 5909, 5919–5921, 5924; Pub. L. 118–158, div. C, title II, §§ 3203, 3207(a)–(e), Dec. 21, 2024, 138 Stat. 1765, 1766.) Editorial Notes REFERENCES IN TEXT Section 302(c)(1)(B) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, re- ferred to in subsec. (a)(14)(H)(i), is section 302(c)(1)(B) of Pub. L. 108–173, which is set out as a note under this section. Section 4531(a) of the Balanced Budget Act of 1997, re- ferred to in subsec. (l)(3)(A), is section 4531(a) of Pub. L. 105–33, which amended sections 1395u and 1395x of this title. Section 515(a) of the Medicare Access and CHIP Reau- thorization Act of 2015, referred to in subsec. (l)(16)(A), is section 515(a) of Pub. L. 114–10, title V, Apr. 16, 2015, 129 Stat. 174, which relates to the initial expansion of prior authorization model for repetitive scheduled non- emergent ambulance transports and is not classified to the Code. CODIFICATION Amendment of subsec. (a)(4) by Pub. L. 101–508, § 4152(c)(4)(B)(i), did not become effective pursuant to Pub. L. 101–508, § 4152(c)(4)(B)(ii), because of action of Secretary in developing specific criteria for the treat- ment of wheelchairs as customized items for purposes of subsec. (a)(4). See Effective Date of 1990 Amendment note below. PRIOR PROVISIONS A prior section 1395m, act Aug. 14, 1935, ch. 531, title XVIII, § 1834, as added July 30, 1965, Pub. L. 89–97, title I, § 102(a), 79 Stat. 303, prescribed limitations on pay- ments for home health services, prior to repeal by Pub. L. 96–499, title IX, § 930(i), Dec. 5, 1980, 94 Stat. 2631, ef- fective with respect to services furnished on or after July 1, 1981. AMENDMENTS 2024—Subsec. (l)(12)(A). Pub. L. 118–158, § 3203(1), sub- stituted ‘‘April 1, 2025’’ for ‘‘January 1, 2025’’. Subsec. (l)(13)(A). Pub. L. 118–158, § 3203(2), substituted ‘‘April 1, 2025’’ for ‘‘January 1, 2025’’ wherever appear- ing. Subsec. (m)(2)(B)(iii). Pub. L. 118–158, § 3207(a)(1), sub- stituted ‘‘ending March 31, 2025’’ for ‘‘ending December 31, 2024’’. Subsec. (m)(4)(C)(iii). Pub. L. 118–158, § 3207(a)(2), sub- stituted ‘‘ending on March 31, 2025’’ for ‘‘ending on De- cember 31, 2024’’. Subsec. (m)(4)(E). Pub. L. 118–158, § 3207(b), sub- stituted ‘‘ending on March 31, 2025’’ for ‘‘ending on De- cember 31, 2024’’. Page 3139 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (m)(7)(B)(i). Pub. L. 118–158, § 3207(d)(1), sub- stituted ‘‘on or after April 1, 2025’’ for ‘‘on or after Jan- uary 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title)’’ in introductory provi- sions. Subsec. (m)(8)(A). Pub. L. 118–158, § 3207(c), sub- stituted ‘‘ending on March 31, 2025’’ for ‘‘ending on De- cember 31, 2024’’. Subsec. (m)(9). Pub. L. 118–158, § 3207(e), substituted ‘‘ending on March 31, 2025’’ for ‘‘ending on December 31, 2024’’. Subsec. (o)(4)(B). Pub. L. 118–158, § 3207(d)(3), sub- stituted ‘‘April 1, 2025.’’ for ‘‘January 1, 2025 (or, if later, the first day after the end of the emergency pe- riod described in section 1320b–5(g)(1)(B) of this title).’’ Subsec. (y)(2). Pub. L. 118–158, § 3207(d)(2), substituted ‘‘April 1, 2025.’’ for ‘‘January 1, 2025 (or, if later, the first day after the end of the emergency period de- scribed in section 1320b–5(g)(1)(B) of this title).’’ 2022—Subsec. (a)(20)(D)(iv). Pub. L. 117–328, § 4133(b)(1), added cl. (iv). Subsec. (j)(5)(E). Pub. L. 117–328, § 4134(c)(2), added subpar. (E), relating to items and services related to the administration of intravenous immune globulin furnished on or after January 1, 2024, after subpar. (D). Former subpar. (E), added by Pub. L. 117–328, § 4133(b)(2)(B), redesignated (F). See note below. Pub. L. 117–328, § 4133(b)(2)(B), added subpar. (E), re- lating to lymphedema compression treatment items, after subpar. (D). Former subpar. (E) redesignated (F). Subsec. (j)(5)(F). Pub. L. 117–328, § 4134(c)(1), redesig- nated subpar. (E), added by Pub. L. 117–328, § 4133(b)(2)(B), relating to lymphedema compression treatment items, as (F). Former subpar. (F), as pre- viously redesignated by Pub. L. 117–328, § 4133(b)(2)(A), redesignated (G). Pub. L. 117–328, § 4133(b)(2)(A), redesignated subpar. (E) as (F). Former subpar. (F) redesignated (G). Subpar. (j)(5)(G). Pub. L. 117–328, § 4134(c)(1), redesig- nated subpar. (F), as previously redesignated by Pub. L. 117–328, § 4133(b)(2)(A), as (G). Pub. L. 117–328, § 4133(b)(2)(A), redesignated subpar. (F) as (G). Subsec. (l)(12)(A). Pub. L. 117–328, § 4103(1), substituted ‘‘January 1, 2025’’ for ‘‘January 1, 2023’’. Subsec. (l)(13)(A). Pub. L. 117–328, § 4103(2), substituted ‘‘January 1, 2025’’ for ‘‘January 1, 2023’’ wherever ap- pearing. Subsec. (l)(17)(F)(i). Pub. L. 117–103, § 311, substituted ‘‘Not later than the second June 15th following the date on which the Secretary transmits data for the first rep- resentative sample of providers and suppliers of ground ambulance services to the Medicare Payment Advisory Commission, and as determined necessary by such Commission thereafter,’’ for ‘‘Not later than March 15, 2023, and as determined necessary by the Medicare Pay- ment Advisory Commission thereafter’’. Subsec. (m)(1). Pub. L. 117–103, §§ 302(1), 305(1), sub- stituted ‘‘paragraphs (8) and (9)’’ for ‘‘paragraph (8)’’ and ‘‘(as defined in paragraph (4)(E))’’ for ‘‘(described in section 1395u(b)(18)(C) of this title)’’. Subsec. (m)(2)(B)(i). Pub. L. 117–103, § 301(b)(1), sub- stituted ‘‘clauses (ii) and (iii)’’ for ‘‘clause (ii)’’ in in- troductory provisions. Subsec. (m)(2)(B)(iii). Pub. L. 117–328, § 4113(a)(1), sub- stituted ‘‘In the case that the emergency period de- scribed in section 1320b–5(g)(1)(B) of this title ends be- fore December 31, 2024, with’’ for ‘‘With’’ and ‘‘that are furnished during the period beginning on the first day after the end of such emergency period and ending De- cember 31, 2024’’ for ‘‘that are furnished during the 151- day period beginning on the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title’’. Pub. L. 117–103, § 301(b)(2), added cl. (iii). Subsec. (m)(4)(C)(i). Pub. L. 117–103, § 301(a)(1)(A), in- serted ‘‘clause (iii) and’’ after ‘‘Except as provided in’’ in introductory provisions. Subsec. (m)(4)(C)(iii). Pub. L. 117–328, § 4113(a)(2), sub- stituted ‘‘In the case that the emergency period de- scribed in section 1320b–5(g)(1)(B) of this title ends be- fore December 31, 2024, with’’ for ‘‘With’’ and ‘‘that are furnished during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024’’ for ‘‘that are furnished during the 151-day period beginning on the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title’’. Pub. L. 117–103, § 301(a)(1)(B), added cl. (iii). Subsec. (m)(4)(E). Pub. L. 117–328, § 4113(b), sub- stituted ‘‘and, in the case that the emergency period described in section 1320b–5(g)(1)(B) of this title ends before December 31, 2024, for the period beginning on the first day after the end of such emergency period and ending on December 31, 2024’’ for ‘‘and, for the 151- day period beginning on the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title’’. Pub. L. 117–103, § 302(2), inserted before period at end: ‘‘and, for the 151-day period beginning on the first day after the end of the emergency period described in sec- tion 1320b–5(g)(1)(B) of this title, shall include a quali- fied occupational therapist (as such term is used in sec- tion 1395x(g) of this title), a qualified physical therapist (as such term is used in section 1395x(p) of this title), a qualified speech-language pathologist (as defined in section 1395x(ll)(4)(A) of this title), and a qualified audi- ologist (as defined in section 1395x(ll)(4)(B) of this title)’’. Subsec. (m)(7)(A). Pub. L. 117–103, § 301(a)(2), inserted ‘‘or, for the period for which clause (iii) of paragraph (4)(C) applies, at any site described in such clause’’ be- fore period at end. Subsec. (m)(7)(B)(i). Pub. L. 117–328, § 4113(d)(1), which directed the substitution of ‘‘on or after January 1, 2025 (or, if later, the first day after the end of the emer- gency period described in section 1320b–5(g)(1)(B) of this title)’’ for ‘‘on or after the day that is the 152nd day after the end of the period at the end of the emergency sentence described in section 1320b–5(g)(1)(B) of this title)’’ in introductory provisions, was executed by making the substitution for ‘‘on or after the day that is the 152nd day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title)’’, to reflect the probable intent of Congress. Pub. L. 117–103, § 304(a), inserted ‘‘on or after the day that is the 152nd day after the end of the emergency pe- riod described in section 1320b–5(g)(1)(B) of this title)’’ after ‘‘telehealth services furnished’’ in introductory provisions. Subsec. (m)(8). Pub. L. 117–103, § 303(1), struck out ‘‘during emergency period’’ after ‘‘clinics’’ in heading. Subsec. (m)(8)(A). Pub. L. 117–328, § 4113(c), sub- stituted ‘‘in the case that such emergency period ends before December 31, 2024, during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024’’ for ‘‘during the 151- day period beginning on the first day after the end of such emergency period’’ in introductory provisions. Pub. L. 117–103, § 303(2), inserted ‘‘and, during the 151- day period beginning on the first day after the end of such emergency period’’ after ‘‘section 1320b–5(g)(1)(B) of this title’’ in introductory provisions. Subsec. (m)(8)(B)(i). Pub. L. 117–103, § 303(3), sub- stituted ‘‘the periods for which subparagraph (A) ap- plies’’ for ‘‘such emergency period’’. Subsec. (m)(9). Pub. L. 117–328, § 4113(e), substituted ‘‘In the case that the emergency period described in section 1320b–5(g)(1)(B) of this title ends before Decem- ber 31, 2024, the Secretary shall continue to provide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of March 15, 2022, that are furnished via an audio-only communica- tions system during the period beginning on the first day after the end of such emergency period and ending on December 31, 2024’’ for ‘‘The Secretary shall con- tinue to provide coverage and payment under this part for telehealth services identified in paragraph (4)(F)(i) as of March 15, 2022, that are furnished via an audio- only telecommunications system during the 151-day pe- Page 3140 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m riod beginning on the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title’’. Pub. L. 117–103, § 305(2), added par. (9). Subsec. (o)(3)(C)(ii). Pub. L. 117–328, § 1262(b)(6), which directed substitution of ‘‘first begins prescribing nar- cotic drugs in schedule III, IV, or V of section 812 of title 21 for the purpose of maintenance or detoxifica- tion treatment on or after January 1, 2021’’ for ‘‘first receives a waiver under section 823(g) of title 21 on or after January 1, 2019’’, was executed by making the sub- stitution for ‘‘first receives a waiver under section 823(h) of title 21 on or after January 1, 2019’’, to reflect the probable intent of Congress and the intervening amendment made by Pub. L. 117–215. See note below. Pub. L. 117–215 substituted ‘‘823(h)’’ for ‘‘823(g)’’. Subsec. (o)(4). Pub. L. 117–328, § 4113(d)(3)(A), struck out ‘‘to hospice patients’’ after ‘‘federally qualified health centers’’ in heading. Pub. L. 117–103, § 304(c), substituted ‘‘certain’’ for ‘‘at- tending physician’’ in par. heading, designated existing provisions as subpar. (A) and inserted heading, and added subpar. (B). Subsec. (o)(4)(B). Pub. L. 117–328, § 4113(d)(3)(B), sub- stituted ‘‘prior to January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title)’’ for ‘‘prior to the day that is the 152nd day after the end of the emer- gency period described in section 1320b–5(g)(1)(B) of this title)’’. Subsec. (o)(5). Pub. L. 117–328, § 4124(c)(1), added par. (5). Subsec. (s)(3). Pub. L. 117–328, § 4136(a)(1), amended par. (3) generally. Prior to amendment, text read as fol- lows: ‘‘The separate payment amount established under this paragraph for an applicable disposable device for a year shall be equal to the amount of the payment that would be made under section 1395l(t) of this title (relat- ing to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such de- vice.’’ Subsec. (s)(4). Pub. L. 117–328, § 4136(a)(2), added par. (4). Subsec. (y). Pub. L. 117–328, § 4124(c)(2)(A), which di- rected amendment of subsec. (y) by striking out ‘‘to hospice patients’’ in heading, could not be executed in view of the intervening amendment by Pub. L. 117–328, § 4113(d)(2)(A). See below. Pub. L. 117–328, § 4113(d)(2)(A), struck out ‘‘to hospice patients’’ after ‘‘rural health clinics’’ in heading. Pub. L. 117–103, § 304(b), substituted ‘‘certain’’ for ‘‘at- tending physician’’ in heading, designated existing pro- visions as par. (1) and inserted heading, and added par. (2). Subsec. (y)(2). Pub. L. 117–328, § 4113(d)(2)(B), sub- stituted ‘‘prior to January 1, 2025 (or, if later, the first day after the end of the emergency period described in section 1320b–5(g)(1)(B) of this title)’’ for ‘‘prior to the day that is the 152nd day after the end of the emer- gency period described in section 1320b–5(g)(1)(B) of this title)’’. Subsec. (y)(3). Pub. L. 117–328, § 4124(c)(2)(B), added par. (3). Subsec. (z). Pub. L. 117–328, § 4133(a)(2)(B), added sub- sec. (z). 2020—Subsec. (a)(9)(D). Pub. L. 116–260, § 121(b)(1), made technical correction to Pub. L. 105–33, § 4552(b). See 1997 Amendment note below. Subsec. (a)(9)(D)(ii). Pub. L. 116–260, § 121(a), inserted at end ‘‘The requirement of the preceding sentence shall not apply beginning with the second calendar quarter beginning on or after December 27, 2020.’’ Subsec. (d)(2)(C)(ii), (3)(C)(ii). Pub. L. 116–260, § 122(c)(1), substituted ‘‘Subject to section 1395l(a)(1)(Y) of this title, but notwithstanding’’ for ‘‘Notwith- standing’’ in introductory provisions. Subsec. (d)(2)(D), (3)(D). Pub. L. 116–260, § 122(c)(2), substituted ‘‘Subject to section 1395l(a)(1)(Y) of this title, if during’’ for ‘‘If during’’. Subsec. (m)(1). Pub. L. 116–136, § 3704(1), substituted ‘‘Subject to paragraph (8), the Secretary’’ for ‘‘The Sec- retary’’. Subsec. (m)(2)(A). Pub. L. 116–136, § 3704(2), sub- stituted ‘‘Subject to paragraph (8), the Secretary’’ for ‘‘The Secretary’’. Subsec. (m)(4)(A). Pub. L. 116–136, § 3704(3)(A), sub- stituted ‘‘Subject to paragraph (8), the term’’ for ‘‘The term’’. Subsec. (m)(4)(C)(ii)(XI). Pub. L. 116–260, § 125(c), added subcl. (XI). Subsec. (m)(4)(F)(i). Pub. L. 116–136, § 3704(3)(B), sub- stituted ‘‘Subject to paragraph (8), the term’’ for ‘‘The term’’. Subsec. (m)(7). Pub. L. 116–260, § 123(a), substituted ‘‘disorder services and mental health services furnished through telehealth’’ for ‘‘disorder services furnished through telehealth’’ in heading, designated existing provisions as subpar. (A) and inserted heading, inserted ‘‘or, on or after the first day after the end of the emer- gency period described in section 1320b–5(g)(1)(B) of this title, subject to subparagraph (B), to an eligible tele- health individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder, as deter- mined by the Secretary,’’ after ‘‘as determined by the Secretary,’’, and added subpar. (B). Subsec. (m)(8). Pub. L. 116–136, § 3704(4), added par. (8). Subsec. (o)(4). Pub. L. 116–260, § 132(1), added par. (4). Subsec. (x). Pub. L. 116–260, § 125(a)(2)(B), added sub- sec. (x). Subsec. (y). Pub. L. 116–260, § 132(2), added subsec. (y). 2018—Subsec. (a)(2)(A)(iv). Pub. L. 115–123, § 50411, struck out ‘‘and before October 1, 2018,’’ after ‘‘October 1, 2015,’’. Subsec. (h)(5). Pub. L. 115–123, § 50402, added par. (5). Subsec. (l)(12)(A). Pub. L. 115–123, § 50203(a)(2), sub- stituted ‘‘2023’’ for ‘‘2018’’. Subsec. (l)(13)(A). Pub. L. 115–123, § 50203(a)(1), sub- stituted ‘‘2023’’ for ‘‘2018’’ wherever appearing. Subsec. (l)(15). Pub. L. 115–123, § 53108, substituted ‘‘during the period beginning on October 1, 2013, and ending on September 30, 2018, and by 23 percent for such services furnished on or after October 1, 2018’’ for ‘‘on or after October 1, 2013’’. Subsec. (l)(17). Pub. L. 115–123, § 50203(b), added par. (17). Subsec. (m)(2)(B). Pub. L. 115–123, § 50302(b)(2), redesig- nated existing provisions as cl. (i), inserted heading, substituted ‘‘Subject to clause (ii), with respect to’’ for ‘‘With respect to’’, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), substituted ‘‘subclause (I) or this subclause’’ for ‘‘clause (i) or this clause’’ in subcl. (II), and added cl. (ii). Subsec. (m)(2)(B)(i). Pub. L. 115–271, § 2001(a)(1)(A), substituted ‘‘clause (ii) and paragraph (6)(C)’’ for ‘‘clause (ii)’’ in introductory provisions. Subsec. (m)(2)(B)(ii). Pub. L. 115–271, § 2001(a)(1)(B), struck out ‘‘for home dialysis therapy’’ after ‘‘site’’ in heading. Subsec. (m)(4)(C)(i). Pub. L. 115–271, § 2001(a)(2)(A), substituted ‘‘paragraphs (5), (6), and (7)’’ for ‘‘paragraph (6)’’ in introductory provisions. Pub. L. 115–123, § 50325(1), substituted ‘‘Except as pro- vided in paragraph (6), the term’’ for ‘‘The term’’ in in- troductory provisions. Subsec. (m)(4)(C)(ii)(IX). Pub. L. 115–123, § 50302(b)(1)(A), added subcl. (IX). Subsec. (m)(4)(C)(ii)(X). Pub. L. 115–271, § 2001(a)(2)(B), inserted ‘‘or telehealth services described in paragraph (7)’’ before period at end. Pub. L. 115–123, § 50302(b)(1)(A), added subcl. (X). Subsec. (m)(5). Pub. L. 115–123, § 50302(b)(1)(B), added par. (5). Subsec. (m)(6). Pub. L. 115–123, § 50325(2), added par. (6). Subsec. (m)(7). Pub. L. 115–271, § 2001(a)(3), added par. (7). Subsec. (o)(3). Pub. L. 115–271, § 6083(a), added par. (3). Subsec. (u)(7). Pub. L. 115–123, § 50401(a), added par. (7). Page 3141 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (v). Pub. L. 115–123, § 53107, added subsec. (v). Subsec. (w). Pub. L. 115–271, § 2005(c)(2), added subsec. (w). 2016—Subsec. (a)(1)(G). Pub. L. 114–255, § 16008(a), in- serted at end ‘‘In the case of items and services fur- nished on or after January 1, 2019, in making any ad- justments under clause (ii) or (iii) of subparagraph (F), under subsection (h)(1)(H)(ii), or under section 1395u(s)(3)(B) of this title, the Secretary shall—’’ and added cls. (i) and (ii). Subsec. (h)(1)(H)(ii). Pub. L. 114–255, § 16008(b)(1), sub- stituted ‘‘subject to subsection (a)(1)(G), the Sec- retary’’ for ‘‘the Secretary’’. Subsec. (t). Pub. L. 114–255, § 4011, added subsec. (t). Subsec. (u). Pub. L. 114–255, § 5012(b), added subsec. (u). 2015—Subsec. (a)(2)(A)(iv). Pub. L. 114–40 added cl. (iv). Subsec. (a)(11)(B)(ii). Pub. L. 114–10, § 504(a), struck out ‘‘the physician documenting that’’ after ‘‘written pursuant to’’ and substituted ‘‘documenting such phy- sician, physician assistant, practitioner, or specialist has had a face-to-face encounter’’ for ‘‘has had a face- to-face encounter’’. Subsec. (l)(12)(A). Pub. L. 114–10, § 203(b), substituted ‘‘January 1, 2018’’ for ‘‘April 1, 2015’’. Subsec. (l)(13)(A). Pub. L. 114–10, § 203(a), substituted ‘‘January 1, 2018’’ for ‘‘April 1, 2015’’ wherever appear- ing. Subsec. (l)(16). Pub. L. 114–10, § 515(b), added par. (16). Subsec. (r). Pub. L. 114–27 added subsec. (r). Subsec. (s). Pub. L. 114–113 added subsec. (s). 2014—Subsec. (a)(1)(I). Pub. L. 113–295 added subpar. (I). Subsec. (l)(12)(A). Pub. L. 113–93, § 104(b), substituted ‘‘April 1, 2015’’ for ‘‘April 1, 2014’’. Subsec. (l)(13)(A). Pub. L. 113–93, § 104(a), substituted ‘‘April 1, 2015’’ for ‘‘April 1, 2014’’ wherever appearing. Subsec. (p). Pub. L. 113–93, § 218(a)(1), added subsec. (p). Subsec. (q). Pub. L. 113–93, § 218(b)(1), added subsec. (q). 2013—Subsec. (a)(1)(F). Pub. L. 112–240, § 636(a)(1), sub- stituted ‘‘subparagraphs (G) and (H)’’ for ‘‘subpara- graph (G)’’ in introductory provisions. Subsec. (a)(1)(H). Pub. L. 112–240, § 636(a)(2), added subpar. (H). Subsec. (a)(22). Pub. L. 112–240, § 636(b), added par. (22). Subsec. (k)(7). Pub. L. 112–240, § 633(b), added par. (7). Subsec. (l)(12)(A). Pub. L. 113–67, § 1104(b), substituted ‘‘April 1, 2014’’ for ‘‘January 1, 2014’’. Pub. L. 112–240, § 604(c), substituted ‘‘January 1, 2014’’ for ‘‘January 1, 2013’’. Subsec. (l)(13)(A). Pub. L. 113–67, § 1104(a), substituted ‘‘April 1, 2014’’ for ‘‘January 1, 2014’’ wherever appear- ing. Pub. L. 112–240, § 604(a), substituted ‘‘January 1, 2014’’ for ‘‘January 1, 2013’’ wherever appearing. Subsec. (l)(15). Pub. L. 112–240, § 637, added par. (15). 2012—Subsec. (l)(12)(A). Pub. L. 112–96, § 3007(c), sub- stituted ‘‘January 1, 2013’’ for ‘‘March 1, 2012’’. Subsec. (l)(13)(A). Pub. L. 112–96, § 3007(a), substituted ‘‘January 1, 2013’’ for ‘‘March 1, 2012’’ wherever appear- ing. 2011—Subsec. (l)(12)(A). Pub. L. 112–78, § 306(c), sub- stituted ‘‘March 1, 2012’’ for ‘‘January 1, 2012’’. Subsec. (l)(13)(A). Pub. L. 112–78, § 306(a), substituted ‘‘March 1, 2012’’ for ‘‘January 1, 2012’’ wherever appear- ing. 2010—Subsec. (a)(1)(F)(ii). Pub. L. 111–148, § 6410(b)(2)(A), inserted ‘‘(and, in the case of covered items furnished on or after January 1, 2016, subject to clause (iii), shall)’’ after ‘‘may’’. Subsec. (a)(1)(F)(iii). Pub. L. 111–148, § 6410(b)(1), (2)(B), (3), added cl. (iii). Subsec. (a)(7)(A)(i)(II). Pub. L. 111–148, § 3136(a)(1)(A), inserted ‘‘subclause (III) and’’ after ‘‘Subject to’’. Subsec. (a)(7)(A)(i)(III). Pub. L. 111–148, § 3136(a)(1)(B), added subcl. (III). Subsec. (a)(7)(A)(iii). Pub. L. 111–148, § 3136(a)(2)(B), inserted ‘‘complex, rehabilitative’’ after ‘‘case of a’’. Pub. L. 111–148, § 3136(a)(2)(A), inserted ‘‘complex, re- habilitative’’ after ‘‘option for’’ in heading. Subsec. (a)(7)(C)(ii)(II). Pub. L. 111–148, § 3136(b), struck out ‘‘(A)(ii) or’’ after ‘‘subparagraph’’. Subsec. (a)(11)(B). Pub. L. 111–148, § 6407(b)(1), des- ignated existing provisions as cl. (i) and inserted head- ing. Pub. L. 111–148, § 6405(a), substituted ‘‘physician en- rolled under section 1395cc(j) of this title or an eligible professional under section 1395w–4(k)(3)(B) of this title that is enrolled under section 1395cc(j) of this title’’ for ‘‘physician’’. Subsec. (a)(11)(B)(ii). Pub. L. 111–148, § 6407(b)(2), added cl. (ii). Subsec. (a)(14). Pub. L. 111–148, § 3401(m)(3), inserted concluding provisions. Subsec. (a)(14)(K). Pub. L. 111–148, § 3401(m)(1), struck out ‘‘2011, 2012, and 2013,’’ after ‘‘2010,’’ and inserted ‘‘and’’ at the end. Subsec. (a)(14)(L), (M). Pub. L. 111–148, § 3401(m)(2), added subpar. (L) and struck out former subpars. (L) and (M) which read as follows: ‘‘(L) for 2014— ‘‘(i) in the case of items and services described in subparagraph (J)(i) for which a payment adjustment has not been made under subsection (a)(1)(F)(ii) in any previous year, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June 2013, plus 2.0 percentage points; or ‘‘(ii) in the case of other items and services, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12- month period ending with June 2013; and ‘‘(M) for a subsequent year, the percentage increase in the consumer price index for all urban consumers (U.S. urban average) for the 12-month period ending with June of the previous year.’’ Subsec. (a)(16)(B). Pub. L. 111–148, § 6402(g)(1), inserted ‘‘that the Secretary determines is commensurate with the volume of the billing of the supplier’’ after ‘‘$50,000’’. Subsec. (a)(20)(F)(i). Pub. L. 111–148, § 3109(a)(1)(B), which directed amendment by inserting ‘‘, except that the Secretary shall not require a pharmacy to have submitted to the Secretary such evidence of accredita- tion prior to January 1, 2011’’ before semicolon ‘‘at the end’’, was executed by making the insertion before ‘‘; and’’ to reflect the probable intent of Congress. Pub. L. 111–148, § 3109(a)(1)(A), inserted ‘‘and subpara- graph (G)’’ after ‘‘clause (ii)’’. Subsec. (a)(20)(G). Pub. L. 111–148, § 3109(a)(2), added subpar. (G). Subsec. (g)(2)(A). Pub. L. 111–148, § 3128(a), inserted ‘‘101 percent of’’ after ‘‘subparagraph (B),’’. Subsec. (g)(2)(B). Pub. L. 111–148, § 5501(b)(2), sub- stituted ‘‘Subsections (x) and (y) of section 1395l’’ for ‘‘Section 1395l(x)’’. Pub. L. 111–148, § 5501(a)(2), inserted at end ‘‘Section 1395l(x) of this title shall not be taken into account in determining the amounts that would otherwise be paid pursuant to the preceding sentence.’’ Subsec. (h)(4)(A). Pub. L. 111–148, § 3401(n)(1)(D), in- serted concluding provisions. Subsec. (h)(4)(A)(x). Pub. L. 111–148, § 3401(n)(1)(B)(i), substituted ‘‘for each of 2007 through 2010’’ for ‘‘a subse- quent year’’. Subsec. (h)(4)(A)(xi). Pub. L. 111–148, § 3401(n)(1)(A), (B)(ii), (C), added cl. (xi). Subsec. (l)(3). Pub. L. 111–148, § 3401(j)(4), inserted con- cluding provisions. Subsec. (l)(3)(B). Pub. L. 111–148, § 3401(j)(2)(A), in- serted ‘‘, subject to subparagraph (C) and the suc- ceeding sentence of this paragraph,’’ after ‘‘increased’’. Subsec. (l)(3)(C). Pub. L. 111–148, § 3401(j)(1), (2)(B), (3), added subpar. (C). Subsec. (l)(8). Pub. L. 111–148, § 3128(a), inserted ‘‘101 percent of’’ after ‘‘pay’’ in introductory provisions. Subsec. (l)(12)(A). Pub. L. 111–309, § 106(c), substituted ‘‘2012’’ for ‘‘2011’’. Page 3142 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Pub. L. 111–148, § 10311(c), substituted ‘‘2011’’ for ‘‘2010, and on or after April 1, 2010, and before January 1, 2011’’. Pub. L. 111–148, § 3105(c), substituted ‘‘2010, and on or after April 1, 2010, and before January 1, 2011’’ for ‘‘2010’’. Subsec. (l)(13)(A). Pub. L. 111–309, § 106(a)(1), sub- stituted ‘‘2012,’’ for ‘‘2011’’ in introductory provisions. Pub. L. 111–148, § 10311(a)(1), in introductory provi- sions, substituted ‘‘2007, and for’’ for ‘‘2007, for’’ and ‘‘2011’’ for ‘‘2010, and for such services furnished on or after April 1, 2010, and before January 1, 2011’’. Pub. L. 111–148, § 3105(a)(1), in introductory provisions, substituted ‘‘2007, for’’ for ‘‘2007, and for’’ and ‘‘2010, and for such services furnished on or after April 1, 2010, and before January 1, 2011,’’ for ‘‘2010’’. Subsec. (l)(13)(A)(i), (ii). Pub. L. 111–309, § 106(a)(2), substituted ‘‘January 1, 2012’’ for ‘‘January 1, 2011’’. Pub. L. 111–148, § 10311(a)(2)(B), substituted ‘‘January 1, 2011’’ for ‘‘January 1, 2010’’. Pub. L. 111–148, § 10311(a)(2)(A), struck out ‘‘, and on or after April 1, 2010, and before January 1, 2011’’ after ‘‘January 1, 2010’’. Pub. L. 111–148, § 3105(a)(2), inserted ‘‘, and on or after April 1, 2010, and before January 1, 2011’’ after ‘‘January 1, 2010’’. Subsec. (n). Pub. L. 111–148, § 5502(b), which directed the addition of subsec. (n) relating to development and implementation of prospective payment system, was repealed by Pub. L. 111–148, § 10501(i)(1). Pub. L. 111–148, § 4105(a), added subsec. (n) relating to authority to modify or eliminate coverage of certain preventive services. Subsec. (o). Pub. L. 111–148, § 10501(i)(3)(A), added sub- sec. (o). 2009—Subsec. (a)(20)(F)(i). Pub. L. 111–72 inserted ‘‘, except that the Secretary shall not require under this clause pharmacies to obtain such accreditation be- fore January 1, 2010’’ before semicolon. 2008—Subsec. (a)(1)(E)(ii). Pub. L. 110–275, § 154(d)(2), substituted ‘‘1395x(r)’’ for ‘‘1395x(r)(1)’’. Subsec. (a)(1)(F). Pub. L. 110–275, § 154(a)(3), (4)(A)(i), in introductory provisions, substituted ‘‘January 1, 2011’’ for ‘‘January 1, 2009’’ and inserted ‘‘subject to subparagraph (G),’’ before ‘‘that are included’’. Subsec. (a)(1)(G). Pub. L. 110–275, § 154(a)(4)(A)(ii), added subpar. (G). Subsec. (a)(5)(F). Pub. L. 110–275, § 144(b)(1), sub- stituted ‘‘Rental cap’’ for ‘‘Ownership of equipment’’ in heading, added cl. (ii), and struck out former cl. (ii) which related to transfer of title to equipment and pay- ments for oxygen and maintenance and servicing. Subsec. (a)(14)(J) to (M). Pub. L. 110–275, § 154(a)(2)(A), added subpars. (J) to (L) and redesignated former sub- par. (J) as (M). Subsec. (a)(20)(B). Pub. L. 110–275, § 125(b)(5), sub- stituted ‘‘section 1395bb(a)’’ for ‘‘section 1395bb(b)’’. Subsec. (a)(20)(E). Pub. L. 110–275, § 154(b)(1)(A)(i), in- serted ‘‘including subparagraph (F),’’ after ‘‘under this paragraph,’’. Subsec. (a)(20)(F). Pub. L. 110–275, § 154(b)(1)(A)(ii), added subpar. (F). Subsec. (e). Pub. L. 110–275, § 135(a)(1), added subsec. (e). Subsec. (g)(4). Pub. L. 110–275, § 148(a), substituted ‘‘Treatment of’’ for ‘‘No beneficiary cost-sharing for’’ in heading and inserted at end ‘‘For purposes of the preceding sentence and section 1395x(mm)(3) of this title, clinical diagnostic laboratory services furnished by a critical access hospital shall be treated as being furnished as part of outpatient critical access services without regard to whether the individual with respect to whom such services are furnished is physically present in the critical access hospital, or in a skilled nursing facility or a clinic (including a rural health clinic) that is operated by a critical access hospital, at the time the specimen is collected.’’ Subsec. (h)(1)(H). Pub. L. 110–275, § 154(a)(3), (4)(B), in introductory provisions, substituted ‘‘January 1, 2011’’ for ‘‘January 1, 2009’’ and inserted ‘‘subject to sub- section (a)(1)(G),’’ before ‘‘that are included’’. Subsec. (l)(13)(A). Pub. L. 110–275, § 146(a)(1), inserted ‘‘and for such services furnished on or after July 1, 2008, and before January 1, 2010’’ after ‘‘2007,’’ in introduc- tory provisions, ‘‘(or 3 percent if such service is fur- nished on or after July 1, 2008, and before January 1, 2010)’’ after ‘‘2 percent’’ in cl. (i), and ‘‘(or 2 percent if such service is furnished on or after July 1, 2008, and be- fore January 1, 2010)’’ after ‘‘1 percent’’ in cl. (ii). Subsec. (l)(13)(B). Pub. L. 110–275, § 146(a)(2), sub- stituted ‘‘applicable period’’ for ‘‘2006’’ in heading and inserted ‘‘applicable’’ before ‘‘period’’ in text. Subsec. (l)(14)(B)(i). Pub. L. 110–275, § 146(b)(2)(A), sub- stituted ‘‘certifies or reasonably determines’’ for ‘‘rea- sonably determines or certifies’’. Subsec. (m)(4)(C)(ii)(VI) to (VIII). Pub. L. 110–275, § 149(a), added subcls. (VI) to (VIII). 2006—Subsec. (a)(5)(A). Pub. L. 109–171, § 5101(b)(1)(A), substituted ‘‘(E), and (F)’’ for ‘‘and (E)’’. Subsec. (a)(5)(F). Pub. L. 109–171, § 5101(b)(1)(B), added subpar. (F). Subsec. (a)(7)(A). Pub. L. 109–171, § 5101(a)(1), amended heading and text of subpar. (A) generally, revising and restating as cls. (i) to (iv) provisions of former cls. (i) to (vi). Subsec. (d)(2)(C)(ii). Pub. L. 109–171, § 5113(b), struck out ‘‘deductible and’’ before ‘‘coinsurance’’ in heading and struck out ‘‘deductible or’’ before ‘‘copayment’’ and before ‘‘coinsurance’’ in subcl. (I). Subsec. (d)(3)(C)(ii). Pub. L. 109–171, § 5113(b), struck out ‘‘deductible and’’ before ‘‘coinsurance’’ in heading and struck out ‘‘deductible or’’ before ‘‘coinsurance’’ in two places in subcl. (I). 2003—Subsec. (a)(1)(B). Pub. L. 108–173, § 302(d)(1)(A), substituted ‘‘Subject to subparagraph (F)(i), the pay- ment basis’’ for ‘‘The payment basis’’ in introductory provisions. Subsec. (a)(1)(C). Pub. L. 108–173, § 302(d)(1)(B), sub- stituted ‘‘Subject to subparagraph (F)(ii), this sub- section’’ for ‘‘This subsection’’. Subsec. (a)(1)(E). Pub. L. 108–173, § 302(a)(2), added sub- par. (E). Subsec. (a)(1)(F). Pub. L. 108–173, § 302(d)(1)(C), added subpar. (F). Subsec. (a)(10)(B). Pub. L. 108–173, § 302(d)(1)(D), in- serted ‘‘in an area and with respect to covered items and services for which the Secretary does not make a payment amount adjustment under paragraph (1)(F)’’ after ‘‘under this subsection’’. Subsec. (a)(14)(F). Pub. L. 108–173, § 302(c)(1)(A)(ii), substituted ‘‘2003’’ for ‘‘a subsequent year’’ and ‘‘2002;’’ for ‘‘the previous year.’’ Subsec. (a)(14)(G) to (J). Pub. L. 108–173, § 302(c)(1)(A)(i), (iii), added subpars (G) to (J). Subsec. (a)(17), (19). Pub. L. 108–173, § 302(a)(1)(A), re- designated par. (17), relating to certain upgraded items, as (19) and transferred it to the end of subsec. (a). Subsec. (a)(20). Pub. L. 108–173, § 302(a)(1)(B), added par. (20). Subsec. (a)(21). Pub. L. 108–173, § 302(c)(2), added par. (21). Subsec. (b)(4)(D)(iv). Pub. L. 108–173, § 736(b)(4), sub- stituted ‘‘clause (vi)’’ for ‘‘clauses (vi)’’. Subsec. (g)(1). Pub. L. 108–173, § 405(a)(1), inserted ‘‘equal to 101 percent of’’ before ‘‘the reasonable costs’’. Subsec. (g)(2). Pub. L. 108–173, § 405(d)(1), inserted con- cluding provisions. Subsec. (g)(5). Pub. L. 108–173, § 405(b)(1), in heading, inserted ‘‘certain’’ before ‘‘emergency’’ and substituted ‘‘providers’’ for ‘‘physicians’’, and, in text, substituted ‘‘physicians, physician assistants, nurse practitioners, and clinical nurse specialists who are on-call (as de- fined by the Secretary) to provide emergency services’’ for ‘‘emergency room physicians who are on-call (as de- fined by the Secretary)’’ and ‘‘services covered under this subchapter’’ for ‘‘physicians’ services’’. Subsec. (h)(1)(B). Pub. L. 108–173, § 302(d)(2)(A), sub- stituted ‘‘, (E), and (H)(i)’’ for ‘‘and (E)’’ in introduc- tory provisions. Subsec. (h)(1)(D). Pub. L. 108–173, § 302(d)(2)(B), sub- stituted ‘‘Subject to subparagraph (H)(ii), this sub- section’’ for ‘‘This subsection’’. Page 3143 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (h)(1)(H). Pub. L. 108–173, § 302(d)(2)(C), added subpar. (H). Subsec. (h)(4)(A)(viii). Pub. L. 108–173, § 302(c)(3)(B), substituted ‘‘2003’’ for ‘‘a subsequent year’’. Subsec. (h)(4)(A)(ix), (x). Pub. L. 108–173, § 302(c)(3)(A), (C), added cls. (ix) and (x). Subsec. (h)(4)(C). Pub. L. 108–173, § 627(b)(1), inserted ‘‘(and includes shoes described in section 1395x(s)(12) of this title)’’ after ‘‘in section 1395x(s)(9) of this title’’. Subsec. (l)(2)(E). Pub. L. 108–173, § 414(a)(1), inserted ‘‘consistent with paragraph (11)’’ after ‘‘in an efficient and fair manner’’. Subsec. (l)(8), (9). Pub. L. 108–173, § 414(a)(2), redesig- nated par. (8), relating to transitional assistance for rural providers, as (9). Subsec. (l)(10). Pub. L. 108–173, § 414(a)(3), added par. (10). Subsec. (l)(11). Pub. L. 108–173, § 414(b), added par. (11). Subsec. (l)(12). Pub. L. 108–173, § 414(c)(1), added par. (12). Subsec. (l)(13). Pub. L. 108–173, § 414(d), added par. (13). Subsec. (l)(14). Pub. L. 108–173, § 415(a), added par. (14). Subsec. (m)(4)(C)(ii)(III). Pub. L. 108–173, § 736(b)(5), substituted ‘‘1395x(aa)(2)’’ for ‘‘1395x(aa)(s)’’. 2000—Subsec. (a)(14)(C). Pub. L. 106–554, § 1(a)(6) [title IV, § 425(a)(2)], substituted ‘‘through 2000’’ for ‘‘through 2002’’ and struck out ‘‘and’’ at end. Subsec. (a)(14)(D) to (F). Pub. L. 106–554, § 1(a)(6) [title IV, § 425(a)(1), (3)], added subpars. (D) and (E) and redes- ignated former subpar. (D) as (F). Subsec. (c). Pub. L. 106–554, § 1(a)(6) [title I, § 104(b)], amended heading and text generally, substituting present provisions for provisions which had set forth similar standards for screening mammography but had provided for payment limited to 80 percent of the least of the actual charge, a statutory fee schedule, if appli- cable, or the indexed dollar limit described, and which had set forth provisions relating to reduction of in- dexed dollar limit, application of limit in a hospital outpatient setting, and limitation of charges of non- participating physicians. Subsec. (d)(2)(E)(ii). Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(1)], inserted before period at end ‘‘or, in the case of an individual who is not at high risk for colorectal cancer, if the procedure is performed within the 119 months after a previous screening colonoscopy’’. Subsec. (d)(3). Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(2)(A)], struck out ‘‘for individuals at high risk for colorectal cancer’’ after ‘‘colonoscopy’’ in heading. Subsec. (d)(3)(A). Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(2)(B)], struck out ‘‘for individuals at high risk for colorectal cancer (as defined in section 1395x(pp)(2) of this title)’’ after ‘‘screening colonoscopy’’. Subsec. (d)(3)(E). Pub. L. 106–554, § 1(a)(6) [title I, § 103(b)(2)(C)], inserted before period at end ‘‘or for other individuals if the procedure is performed within the 119 months after a previous screening colonoscopy or within 47 months after a previous screening flexible sigmoidoscopy’’. Subsec. (g)(2)(B). Pub. L. 106–554, § 1(a)(6) [title II, § 202(a)], inserted ‘‘115 percent of’’ before ‘‘such amounts’’. Subsec. (g)(4). Pub. L. 106–554, § 1(a)(6) [title II, § 201(a)], added par. (4). Subsec. (g)(5). Pub. L. 106–554, § 1(a)(6) [title II, § 204(a)], added par. (5). Subsec. (h)(1)(F). Pub. L. 106–554, § 1(a)(6) [title IV, § 427(a)], added subpar. (F). Subsec. (h)(1)(G). Pub. L. 106–554, § 1(a)(6) [title IV, § 428(a)], added subpar. (G). Subsec. (h)(4)(A)(v). Pub. L. 106–554, § 1(a)(6) [title IV, § 426(a)(2)], substituted ‘‘through 2000’’ for ‘‘through 2002’’ and struck out ‘‘and’’ at end. Subsec. (h)(4)(A)(vi) to (viii). Pub. L. 106–554, § 1(a)(6) [title IV, § 426(a)(1), (3)], added cls. (vi) and (vii) and re- designated former cl. (vi) as (viii). Subsec. (l)(2)(E). Pub. L. 106–554, § 1(a)(6) [title IV, § 423(b)(1)], inserted before period at end ‘‘, except that such phase-in shall provide for full payment of any na- tional mileage rate for ambulance services provided by suppliers that are paid by carriers in any of the 50 States where payment by a carrier for such services for all such suppliers in such State did not, prior to the im- plementation of the fee schedule, include a separate amount for all mileage within the county from which the beneficiary is transported’’. Subsec. (l)(3)(A), (B). Pub. L. 106–554, § 1(a)(6) [title IV, § 423(a)(1)], substituted ‘‘reduced in the case of 2002’’ for ‘‘reduced in the case of 2001 and 2002’’. Subsec. (l)(8). Pub. L. 106–554, § 1(a)(6) [title II, § 221(a)], added par. (8) relating to transitional assist- ance for rural providers. Pub. L. 106–554, § 1(a)(6) [title II, § 205(a)], added par. (8) relating to services furnished by critical access hos- pitals. Subsec. (m). Pub. L. 106–554, § 1(a)(6) [title II, § 223(b)], added subsec. (m). 1999—Subsec. (a)(13). Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(2)(A)], substituted ‘‘1395x(m)(5) of this title, but not including implantable items for which payment may be made under section 1395l(t) of this title’’ for ‘‘1395x(m)(5) of this title)’’. Subsec. (g). Pub. L. 106–113, § 1000(a)(6) [title IV, § 403(d)(1)], amended heading and text of subsec. (g) gen- erally. Prior to amendment, text read as follows: ‘‘The amount of payment under this part for outpatient crit- ical access hospital services is the reasonable costs of the critical access hospital in providing such services.’’ Subsec. (h)(4)(A)(i). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(3)(A)], substituted semicolon for comma at end. Subsec. (h)(4)(A)(v). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(3)(B)], substituted ‘‘; and’’ for ‘‘, and’’ at end. Subsec. (h)(4)(B). Pub. L. 106–113, § 1000(a)(6) [title II, § 201(e)(2)(B)], inserted ‘‘and does not include an implantable item for which payment may be made under section 1395l(t) of this title’’ before the semi- colon. 1997—Subsec. (a)(2)(B)(iv). Pub. L. 105–33, § 4105(b)(2), inserted before period at end ‘‘(reduced by 10 percent, in the case of a blood glucose testing strip furnished after 1997 for an individual with diabetes)’’. Subsec. (a)(9)(B)(iv). Pub. L. 105–33, § 4552(a)(2)(A), substituted ‘‘1995, 1996, and 1997’’ for ‘‘each subsequent year’’. Subsec. (a)(9)(B)(v), (vi). Pub. L. 105–33, § 4552(a)(1), (2)(B), (3), added cls. (v) and (vi). Subsec. (a)(9)(D). Pub. L. 105–33, § 4552(b), as amended by Pub. L. 116–260, § 121(b)(1), added subpar. (D). Subsec. (a)(10)(B). Pub. L. 105–33, § 4316(b), substituted ‘‘The Secretary’’ for ‘‘For covered items furnished on or after January 1, 1991, the Secretary’’ and struck out ‘‘(other than subparagraph (D))’’ before ‘‘of section 1395u(b) of this title’’ and ‘‘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 deter- mines (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’’ before period at end. Subsec. (a)(14)(B). Pub. L. 105–33, § 4551(a)(1)(B)(i), sub- stituted ‘‘1993, 1994, 1995, 1996, and 1997’’ for ‘‘a subse- quent year’’. Subsec. (a)(14)(C), (D). Pub. L. 105–33, § 4551(a)(1)(A), (B)(ii), (C), added subpars. (C) and (D). Subsec. (a)(16). Pub. L. 105–33, § 4312(c), inserted at end ‘‘The Secretary, at the Secretary’s discretion, may im- pose the requirements of the first sentence with respect to some or all providers of items or services under part A or some or all suppliers or other persons (other than physicians or other practitioners, as defined in section 1395u(b)(18)(C) of this title) who furnish items or serv- ices under this part.’’ Pub. L. 105–33, § 4312(a), added par. (16). Page 3144 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (a)(17). Pub. L. 105–33, § 4551(c)(1), added par. (17) relating to certain upgraded items. Subsec. (c)(1)(C). Pub. L. 105–33, § 4101(c), in introduc- tory provisions, struck out ‘‘, subject to the deductible established under section 1395l(b) of this title,’’ before ‘‘be equal to 80’’. Subsec. (c)(2)(A)(iii). Pub. L. 105–33, § 4101(a)(1), amended cl. (iii) generally. Prior to amendment, cl. (iii) read as follows: ‘‘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 Sec- retary), 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 can- cer, 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.’’ Subsec. (c)(2)(A)(iv), (v). Pub. L. 105–33, § 4101(a)(2), struck out cls. (iv) and (v), which read as follows: ‘‘(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, pay- ment may not be made for screening mammography performed within 23 months following the month in which a previous screening mammography was per- formed.’’ Subsec. (d). Pub. L. 105–33, § 4104(b)(1), added subsec. (d). Subsec. (g). Pub. L. 105–33, § 4201(c)(5), amended head- ing and text of subsec. (g) generally. Prior to amend- ment, text related to payment for outpatient rural pri- mary care hospital services as determined, in par. (1), by either the cost-based facility fee plus professional charges method or the all-inclusive rate method and, in par. (2), by the prospective payment system. Subsec. (h)(4)(A)(iv). Pub. L. 105–33, § 4551(a)(2)(B), substituted ‘‘1996 and 1997’’ for ‘‘a subsequent year’’. Subsec. (h)(4)(A)(v), (vi). Pub. L. 105–33, § 4551(a)(2)(A), (C), added cls. (v) and (vi). Subsec. (k). Pub. L. 105–33, § 4541(a)(2), added subsec. (k). Subsec. (l). Pub. L. 105–33, § 4531(b)(2), added subsec. (l). 1994—Subsec. (a)(3)(D). Pub. L. 103–432, § 135(e)(5), struck out heading and text of subpar. (D). Text read as follows: ‘‘If the reasonable useful lifetime of such an item, as established under paragraph (7)(C), has been reached during a continuous period of medical need, or the Secretary determines on the basis of investigation by the carrier that the item is lost or irreparably dam- aged, payment for an item serving as a replacement for such item shall be made on a monthly basis for the rental of the replacement item in accordance with sub- paragraph (A).’’ Subsec. (a)(5)(E). Pub. L. 103–432, § 135(d)(1), sub- stituted ‘‘pressure of 56’’ for ‘‘pressure of 55’’. Subsec. (a)(7). Pub. L. 103–432, § 135(e)(2), made tech- nical amendment to directory language of Pub. L. 101–508, § 4152(c)(2). See 1990 Amendment note below. Subsec. (a)(7)(A)(iii)(II). Pub. L. 103–432, § 135(e)(3), substituted ‘‘clause (vi)’’ for ‘‘clause (v)’’. Subsec. (a)(7)(C)(i). Pub. L. 103–432, § 135(e)(4), sub- stituted ‘‘this paragraph’’ for ‘‘this paragraph or para- graph (3)’’. Subsec. (a)(10)(B). Pub. L. 103–432, § 134(a)(1), inserted at end ‘‘In applying such provisions to payments for an item under this subsection, the Secretary shall make adjustments to the payment basis for the item de- scribed 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 fur- nished) that such payment basis is not inherently rea- sonable.’’ Pub. L. 103–432, § 126(g)(10)(B), substituted ‘‘would oth- erwise apply to physicians’ services’’ for ‘‘apply to phy- sicians’ services’’ and inserted before period at end ‘‘but for the application of section 1395w–4(i)(3) of this title’’. Subsec. (a)(14)(A). Pub. L. 103–432, § 135(a)(1), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: ‘‘for 1991 and 1992, reduction of 1 per- centage point; and’’. Subsec. (a)(15). Pub. L. 103–432, § 135(b)(1), amended heading and text of par. (15) generally. Prior to amend- ment, text read as follows: ‘‘(A) DEVELOPMENT OF LIST OF ITEMS BY SECRETARY.— The Secretary shall 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 sub- ject to unnecessary utilization, and shall include in such list seat-lift mechanisms, transcutaneous elec- trical nerve stimulators, and motorized scooters. ‘‘(B) DETERMINATIONS OF COVERAGE IN ADVANCE.—A carrier shall determine in advance whether payment for an item included on the list developed by the Sec- retary under subparagraph (A) may not be made be- cause of the application of section 1395y(a)(1) of this title.’’ Subsec. (a)(16). Pub. L. 103–432, § 131(a)(2), struck out heading and text of par. (16). Text read as follows: ‘‘(A) IN GENERAL.—A supplier of a covered item under this subsection may not distribute to physicians or to individuals entitled to benefits under this part for com- mercial purposes any completed or partially completed forms or other documents required by the Secretary to be submitted to show that a covered item is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. ‘‘(B) PENALTY.—Any supplier of a covered item who knowingly and willfully distributes a form or other document in violation of subparagraph (A) is subject to a civil money penalty in an amount not to exceed $1,000 for each such form or document so distributed. The pro- visions of section 1320a–7a of this title (other than sub- sections (a) and (b)) shall apply to civil money pen- alties under this subparagraph in the same manner as they apply to a penalty or proceeding under section 1320a–7a(a) of this title.’’ Subsec. (a)(17), (18). Pub. L. 103–432, § 132(a)(1), (2), added pars. (17) and (18). Subsec. (b)(4)(D). Pub. L. 103–432, § 126(b)(2)(A), in in- troductory provisions substituted ‘‘shall, subject to clause (vii), be reduced to the adjusted conversion fac- tor for the locality determined as follows:’’ for ‘‘shall be determined as follows:’’. Subsec. (b)(4)(D)(iv). Pub. L. 103–432, § 126(b)(2)(B), substituted ‘‘Adjusted conversion factor’’ for ‘‘Local adjustment’’ in heading and ‘‘The adjusted conversion factor for’’ for ‘‘Subject to clause (vii), the conversion factor to be applied to’’ in text. Subsec. (b)(4)(D)(vii). Pub. L. 103–432, § 126(b)(2)(C), (D), struck out ‘‘under this subparagraph’’ after ‘‘ap- plied to a locality’’ and inserted ‘‘reduced under this subparagraph by’’ before ‘‘more than 9.5 percent’’. Subsec. (b)(4)(E). Pub. L. 103–432, § 126(b)(5), inserted heading ‘‘Rule for certain scanning services’’. Pub. L. 103–432, § 126(b)(4), made technical amendment to directory language of Pub. L. 101–508, § 4102(d). See 1990 Amendment note below. Pub. L. 103–432, § 126(b)(1), redesignated subpar. (E), relating to subsequent updating, as (F). Subsec. (b)(4)(F), (G). Pub. L. 103–432, § 126(b)(1), redes- ignated subpars. (E), relating to subsequent updating, and (F) as (F) and (G), respectively. Subsec. (c)(1)(B). Pub. L. 103–432, § 145(a)(1), sub- stituted ‘‘is conducted by a facility that has a certifi- cate (or provisional certificate) issued under section 263b of this title’’ for ‘‘meets the quality standards es- tablished under paragraph (3)’’. Subsec. (c)(1)(C)(iii). Pub. L. 103–432, § 145(a)(2), sub- stituted ‘‘paragraph (3)’’ for ‘‘paragraph (4)’’. Page 3145 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (c)(3) to (5). Pub. L. 103–432, § 145(a)(3), (4), re- designated pars. (4) and (5) as (3) and (4), respectively, and struck out former par. (3) which directed Secretary to establish standards to assure the safety and accu- racy of screening mammography performed under this part. Subsec. (f). Pub. L. 103–432, § 126(g)(1), substituted ‘‘during 1991’’ for ‘‘during fiscal year 1991’’ in heading. Subsec. (g)(1). Pub. L. 103–432, § 102(e)(1)(A), (2), sub- stituted in introductory provisions ‘‘during a year be- fore the prospective payment system described in para- graph (2) is in effect’’ for ‘‘during a year before 1993’’ and inserted at end ‘‘The amount of payment shall be determined under either method without regard to the amount of the customary or other charge.’’ Subsec. (g)(1)(B). Pub. L. 103–432, § 156(a)(2)(C), struck out ‘‘and for items and services furnished in connection with obtaining a second opinion required under section 1320c–13(c)(2) of this title, or a third opinion, if the sec- ond opinion was in disagreement with the first opin- ion’’ after ‘‘section 1395x(s)(10)(A) of this title’’. Subsec. (g)(2). Pub. L. 103–432, § 102(e)(1)(B), sub- stituted ‘‘January 1, 1996’’ for ‘‘January 1, 1993’’. Subsec. (h)(3). Pub. L. 103–432, § 135(b)(3), substituted ‘‘Paragraphs (12), (15), and (17)’’ for ‘‘Paragraphs (12) and (17)’’. Pub. L. 103–432, § 132(b), substituted ‘‘Paragraphs (12) and (17)’’ for ‘‘Paragraph (12)’’. Subsec. (j). Pub. L. 103–432, § 131(a)(1), added subsec. (j). Subsec. (j)(4), (5). Pub. L. 103–432, § 133(a)(1), added par. (4) and redesignated former par. (4) as (5). 1993—Subsec. (a)(1)(D). Pub. L. 103–66, § 13545(a), sub- stituted ‘‘45 percent’’ for ‘‘15 percent’’ after ‘‘(as pre- viously reduced) by’’. Subsec. (a)(2)(A)(iii). Pub. L. 103–66, § 13543(b), added cl. (iii). Subsec. (a)(2)(C). Pub. L. 103–66, § 13542(a)(1), in cl. (i)(II), substituted ‘‘for 1992, 1993, and 1994’’ for ‘‘for 1992’’ and ‘‘update for the year’’ for ‘‘update for 1992’’, and in cl. (ii), struck out ‘‘and’’ at end of subcl. (I), added subcls. (II) and (III), and redesignated former subcl. (II) as (IV). Subsec. (a)(3)(A). Pub. L. 103–66, § 13543(a), substituted ‘‘IPPB machines and ventilators, excluding ventilators that are either continuous airway pressure devices or intermittent assist devices with continuous airway pressure devices’’ for ‘‘ventilators, aspirators, IPPB machines, and nebulizers’’. Subsec. (a)(3)(C). Pub. L. 103–66, § 13542(a)(1), in cl. (i)(II), substituted ‘‘for 1992, 1993, and 1994’’ for ‘‘for 1992’’ and ‘‘update for the year’’ for ‘‘update for 1992’’, and in cl. (ii), struck out ‘‘and’’ at end of subcl. (I), added subcls. (II) and (III), and redesignated former subcl. (II) as (IV). Subsec. (a)(8)(A)(ii)(III). Pub. L. 103–66, § 13542(a)(2)(A), substituted ‘‘1992, 1993, and 1994’’ for ‘‘1992’’. Subsec. (a)(8)(B)(ii) to (iv). Pub. L. 103–66, § 13542(a)(2)(B), added cls. (ii) and (iii) and redesignated former cl. (ii) as (iv). Subsec. (a)(9)(A)(ii)(II). Pub. L. 103–66, § 13542(a)(3)(A), substituted ‘‘1991, 1992, 1993, and 1994’’ for ‘‘1991 and 1992’’. Subsec. (a)(9)(B)(ii) to (iv). Pub. L. 103–66, § 13542(a)(3)(B), added cls. (ii) and (iii) and redesignated former cl. (ii) as (iv). Subsec. (h)(1)(B). Pub. L. 103–66, § 13544(a)(2), sub- stituted ‘‘subparagraphs (C) and (E)’’ for ‘‘subparagraph (C)’’ in introductory provisions. Subsec. (h)(1)(E). Pub. L. 103–66, § 13544(a)(1), added subpar. (E). Subsec. (h)(4)(A). Pub. L. 103–66, § 13546, struck out ‘‘and’’ at end of cl. (i), substituted ‘‘1992 and 1993’’ for ‘‘a subsequent year’’ in cl. (ii), and added cls. (iii) and (iv). Subsec. (i). Pub. L. 103–66, § 13544(b)(1), added subsec. (i). 1990—Subsec. (a). Pub. L. 101–508, § 4153(a)(2)(D)(i), struck out ‘‘, prosthetic devices, orthotics, and pros- thetics’’ after ‘‘medical equipment’’ in heading. Subsec. (a)(1)(D). Pub. L. 101–508, § 4152(a)(1), inserted before period at end ‘‘, and, in the case of a trans- cutaneous electrical nerve stimulator furnished on or after January 1, 1991, the Secretary shall further reduce such payment amount (as previously reduced) by 15 percent’’. Subsec. (a)(2)(A). Pub. L. 101–508, § 4153(a)(2)(D)(ii), substituted ‘‘(13)’’ for ‘‘(13)(A)’’. Pub. L. 101–508, § 4152(c)(4)(A), inserted ‘‘or’’ after ‘‘$150,’’ in cl. (i), struck out ‘‘or’’ after ‘‘purchase,’’ in cl. (ii), and struck out cl. (iii) which read as follows: ‘‘which is a power-driven wheelchair (other than a cus- tomized wheelchair that is classified as a customized item under paragraph (4) pursuant to criteria specified by the Secretary),’’. Subsec. (a)(2)(B). Pub. L. 101–508, § 4152(b)(1)(A), (B), struck out ‘‘or’’ after ‘‘1987;’’ in cl. (i), added cls. (ii) to (iv), and struck out former cl. (ii) which read as fol- lows: ‘‘in a subsequent year, is the amount specified in this subparagraph for the preceding 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 that preceding year.’’ Subsec. (a)(2)(C). Pub. L. 101–508, § 4152(b)(1)(C), added subpar. (C). Subsec. (a)(3)(B). Pub. L. 101–508, § 4152(b)(1)(A), (B), struck out ‘‘or’’ after ‘‘1987;’’ in cl. (i), added cls. (ii) to (iv), and struck out former cl. (ii) which read as fol- lows: ‘‘in a subsequent year, is the amount specified in this subparagraph for the preceding 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 that preceding year.’’ Subsec. (a)(3)(C). Pub. L. 101–508, § 4152(b)(1)(C), added subpar. (C). Subsec. (a)(3)(D). Pub. L. 101–508, § 4152(c)(3), added subpar. (D). Subsec. (a)(4). Pub. L. 101–508, § 4152(c)(4)(B)(i), di- rected amendment of par. (4) by inserting at end ‘‘In the case of a wheelchair furnished on or after January 1, 1992, the wheelchair shall be treated as a customized item for purposes of this paragraph if the wheelchair has been measured, fitted, or adapted in consideration of the patient’s body size, disability, period of need, or intended use, and has been assembled by a supplier or ordered from a manufacturer who makes available cus- tomized features, modifications, or components for wheelchairs that are intended for an individual pa- tient’s use in accordance with instructions from the pa- tient’s physician.’’ The amendment did not become ef- fective pursuant to Pub. L. 101–508, § 4152(c)(4)(B)(ii). See Effective Date of 1990 Amendment note below. Subsec. (a)(5)(A). Pub. L. 101–508, § 4152(g)(1)(A), sub- stituted ‘‘(B), (C), and (E)’’ for ‘‘(B) and (C)’’. Subsec. (a)(5)(E). Pub. L. 101–508, § 4152(g)(1)(B), added subpar. (E). Subsec. (a)(7)(A)(i). Pub. L. 101–508, § 4152(c)(2)(A), as amended by Pub. L. 103–432, § 135(e)(2), substituted ‘‘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’’ for ‘‘15 months’’. Pub. L. 101–508, § 4152(c)(1), substituted ‘‘for each of the first 3 months of such period’’ for ‘‘for each such month’’ and ‘‘, and for each of the remaining months of such period is 7.5 percent of such purchase price;’’ for semicolon at end. Subsec. (a)(7)(A)(ii), (iii). Pub. L. 101–508, § 4152(c)(2)(D), as amended by Pub. L. 103–432, § 135(e)(2), added cls. (ii) and (iii). Former cls. (ii) and (iii) redesig- nated (iv) and (v), respectively. Subsec. (a)(7)(A)(iv). Pub. L. 101–508, § 4152(c)(2)(B), as amended by Pub. L. 103–432, § 135(e)(2), redesignated cl. (ii) as (iv), substituted ‘‘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 pe- riod of medical need that follows the period of medical need during which payment is made under clause (i),’’ Page 3146 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m for ‘‘during the succeeding 6-month period of medical need,’’ and struck out ‘‘and’’ at end. Subsec. (a)(7)(A)(v). Pub. L. 101–508, § 4152(c)(2)(C), as amended by Pub. L. 103–432, § 135(e)(2), redesignated cl. (iii) as (v), inserted at beginning ‘‘in the case of an item for which a purchase agreement has not been entered into under clause (ii) or clause (iii),’’, and substituted ‘‘; and’’ for period at end. Subsec. (a)(7)(A)(vi). Pub. L. 101–508, § 4152(c)(2)(E), as amended by Pub. L. 103–432, § 135(e)(2), added cl. (vi). Subsec. (a)(7)(C). Pub. L. 101–508, § 4152(c)(2)(F), as amended by Pub. L. 103–432, § 135(e)(2), added subpar. (C). Subsec. (a)(8)(A)(ii). Pub. L. 101–508, § 4152(b)(2)(A), added subcl. (II), redesignated former subcl. (II) as (III), struck out ‘‘1991 or’’ before ‘‘1992’’, and substituted ‘‘the covered item update for the year’’ for ‘‘the percentage increase in the consumer price index for all urban con- sumers (U.S. city average) for the 12-month period end- ing with June of the previous year’’. Subsec. (a)(8)(B). Pub. L. 101–508, § 4152(b)(2)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: ‘‘With respect to the fur- nishing of a particular item in each region (as defined by the Secretary), the Secretary shall compute a re- gional purchase price— ‘‘(i) for 1991 and for 1992, equal to the average (weighted by relative volume of all claims among car- riers) 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 in- crease in the consumer price index for all urban con- sumers (U.S. city average) for the 12-month period ending with June of the previous year.’’ Subsec. (a)(8)(C). Pub. L. 101–508, § 4152(b)(2)(C)(ii), struck out ‘‘and subject to subparagraph (D)’’ after ‘‘and (7)’’ in introductory provisions. Subsec. (a)(8)(C)(ii). Pub. L. 101–508, § 4152(b)(2)(C)(i), (iii), in subcl. (I) substituted ‘‘67 percent’’ for ‘‘75 per- cent’’ and in subcl. (II) substituted ‘‘33 percent’’ for ‘‘25 percent’’ and ‘‘national limited purchase price’’ for ‘‘re- gional purchase price’’. Subsec. (a)(8)(C)(iii). Pub. L. 101–508, § 4152(b)(2)(C)(i), (iv), in subcl. (I) substituted ‘‘33 percent’’ for ‘‘50 per- cent’’ and ‘‘subparagraph (A)(ii)(III)’’ for ‘‘subpara- graph (A)(ii)(II)’’ and in subcl. (II) substituted ‘‘67 per- cent’’ for ‘‘50 percent’’ and ‘‘national limited purchase price’’ for ‘‘regional purchase price’’. Subsec. (a)(8)(C)(iv). Pub. L. 101–508, § 4152(b)(2)(C)(i), substituted ‘‘national limited purchase price’’ for ‘‘re- gional purchase price’’. Subsec. (a)(8)(D). Pub. L. 101–508, § 4152(b)(2)(D), struck out subpar. (D) which read as follows: ‘‘The amount that is recognized under subparagraph (C) as the purchase price for an item furnished— ‘‘(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 per- cent, and may not be lower than 90 percent, of the av- erage 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). Pub. L. 101–508, § 4152(b)(3)(A), substituted ‘‘the covered item increase for the year’’ for ‘‘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)(B). Pub. L. 101–508, § 4152(b)(3)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: ‘‘With respect to the fur- nishing of an item in each region (as defined by the Secretary), the Secretary shall compute a regional monthly payment rate— ‘‘(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 subpara- graph for the previous year increased by the percent- age 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). Pub. L. 101–508, § 4152(b)(3)(C)(i), (ii), in subcl. (I) substituted ‘‘67 percent’’ for ‘‘75 per- cent’’ and in subcl. (II) substituted ‘‘33 percent’’ for ‘‘25 percent’’ and ‘‘national limited monthly payment rate’’ for ‘‘regional monthly payment rate’’. Subsec. (a)(9)(C)(iii). Pub. L. 101–508, § 4152(b)(3)(C)(i), (iii), in subcl. (I) substituted ‘‘33 percent’’ for ‘‘50 per- cent’’ and in subcl. (II) substituted ‘‘67 percent’’ for ‘‘50 percent’’, ‘‘national limited monthly payment rate’’ for ‘‘regional monthly payment rate’’, and ‘‘subparagraph (B)(ii)’’ for ‘‘subparagraph (B)(i)’’. Subsec. (a)(9)(C)(iv). Pub. L. 101–508, § 4152(b)(3)(C)(i), substituted ‘‘national limited monthly payment rate’’ for ‘‘regional monthly payment rate’’. Subsec. (a)(9)(D). Pub. L. 101–508, § 4152(b)(3)(D), struck out subpar. (D) which read as follows: ‘‘The amount that is recognized under subparagraph (C) as the base monthly payment amount for an item fur- nished— ‘‘(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 per- cent, and may not be lower than 90 percent, of the av- erage of the base monthly payment amounts recog- nized under such subparagraph for all the carrier service areas in the United States in that year.’’ Subsec. (a)(12). Pub. L. 101–508, § 4152(b)(5), struck out ‘‘defined for purposes of paragraphs (8)(B) and (9)(B)’’ after ‘‘one or more entire regions’’. Subsec. (a)(13). Pub. L. 101–508, § 4153(a)(2)(D)(iii), sub- stituted ‘‘means durable medical equipment (as defined in section 1395x(n) of this title), including such equip- ment described in section 1395x(m)(5) of this title).’’ for ‘‘means— ‘‘(A) durable medical equipment (as defined in sec- tion 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 equip- ment; and ‘‘(C) orthotics and prosthetics (described in section 1395x(s)(9) of this title); but does not include intraocular lenses or medical sup- plies (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). Pub. L. 101–508, § 4152(b)(4), added par. (14). Subsec. (a)(15). Pub. L. 101–508, § 4152(e), added par. (15). Subsec. (a)(16). Pub. L. 101–508, § 4152(f)(1), added par. (16). Subsec. (b)(1)(B). Pub. L. 101–508, § 4163(b)(1), inserted ‘‘and subject to subsection (c)(1)(A)’’ after ‘‘conversion factors’’. Pub. L. 101–508, § 4102(f), inserted ‘‘locality,’’ after ‘‘statewide,’’. Subsec. (b)(4)(D). Pub. L. 101–508, § 4102(a)(2), added subpar. (D). Former subpar. (D) redesignated (E) relat- ing to subsequent updating. Subsec. (b)(4)(E). Pub. L. 101–508, § 4102(d), as amended by Pub. L. 103–432, § 126(b)(4), added subpar. (E) relating to rule for certain scanning services. Pub. L. 101–508, § 4102(a)(1), redesignated subpar. (D), relating to subsequent updating, as (E). Former subpar. (E) redesignated (F). Page 3147 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (b)(4)(F). Pub. L. 101–508, § 4102(a)(1), redesig- nated subpar. (E) as (F). Subsec. (c). Pub. L. 101–508, § 4163(b)(2), added subsec. (c). Subsec. (f). Pub. L. 101–508, § 4104(a), amended subsec. (f) generally, substituting provisions relating to reduc- tion in payments for physician pathology services dur- ing 1991 for provisions directing Secretary to provide for application of a fee schedule with respect to such services. Subsec. (h). Pub. L. 101–508, § 4153(a)(1), added subsec. (h). 1989—Subsec. (a)(1)(D). Pub. L. 101–239, § 6112(c), added subpar. (D). Subsec. (a)(2)(A)(iii). Pub. L. 101–239, § 6112(d)(1), added cl. (iii). Subsec. (a)(2)(B)(i), (3)(B)(i). Pub. L. 101–239, § 6112(a)(1), inserted ‘‘and in 1990’’ after ‘‘1989’’. Subsec. (a)(7)(A)(i). Pub. L. 101–239, § 6112(a)(4)(A), sub- stituted ‘‘this clause’’ for ‘‘this subparagraph’’. Subsec. (a)(7)(B)(i). Pub. L. 101–239, § 6112(a)(4)(B), in- serted ‘‘in’’ after ‘‘rental of the item’’. Subsec. (a)(7)(B)(ii). Pub. L. 101–239, § 6112(a)(4)(C), substituted ‘‘clause (i) shall apply in the same manner as it applies to items furnished during 1989’’ for ‘‘the payment amount recognized under subparagraph (A)(i) shall not be more than the maximum amount estab- lished under clause (i), and shall not be less than the minimum amount established under such clause, for 1989, each such amount increased by the percentage in- crease in the consumer price index for all urban con- sumers (U.S. city average) for the 12-month period end- ing with June 1989’’. Subsec. (a)(8)(A)(ii)(I). Pub. L. 101–239, § 6112(a)(2)(A), inserted ‘‘and 1990’’ after ‘‘1989’’. Subsec. (a)(8)(A)(ii)(II). Pub. L. 101–239, § 6112(a)(2)(B), substituted ‘‘1991 or 1992’’ for ‘‘1990, 1991, or 1992’’. Subsec. (a)(8)(D)(i). Pub. L. 101–239, § 6140(1), sub- stituted ‘‘1991, may not exceed 125 percent, and may not be lower than 85 percent’’ for ‘‘1991, may not exceed 130 percent, and may not be lower than 80 percent’’. Subsec. (a)(8)(D)(ii). Pub. L. 101–239, § 6140(2), sub- stituted ‘‘120 percent, and may not be lower than 90 per- cent’’ for ‘‘125 percent, and may not be lower than 85 percent’’. Subsec. (a)(9)(A)(ii)(I). Pub. L. 101–239, § 6112(a)(3)(A), inserted ‘‘and 1990’’ after ‘‘1989’’. Subsec. (a)(9)(A)(ii)(II). Pub. L. 101–239, § 6112(a)(3)(B), substituted ‘‘1991 and 1992’’ for ‘‘1990, 1991, and 1992’’. Subsec. (a)(9)(D)(i). Pub. L. 101–239, § 6140(1), sub- stituted ‘‘1991, may not exceed 125 percent, and may not be lower than 85 percent’’ for ‘‘1991, may not exceed 130 percent, and may not be lower than 80 percent’’. Subsec. (a)(9)(D)(ii). Pub. L. 101–239, § 6140(2), sub- stituted ‘‘120 percent, and may not be lower than 90 per- cent’’ for ‘‘125 percent, and may not be lower than 85 percent’’. Subsec. (a)(13). Pub. L. 101–239, § 6112(e)(2), inserted before period at end ‘‘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. (b)(1)(B). Pub. L. 101–234, § 201(a), repealed Pub. L. 100–360, § 204(b)(1), and provided that the provi- sions of law amended or repealed by such section are restored or revived as if such section had not been en- acted, see 1988 Amendment note below. Subsec. (b)(4)(A). Pub. L. 101–234, § 301(b)(1), (c)(1), amended subpar. (A) identically, substituting ‘‘coinsur- ance and deductibles under sections 1395l(a)(1)(J)’’ for ‘‘insurance and deductibles under section 1395n(a)(1)(I)’’. Subsec. (b)(4)(C) to (E). Pub. L. 101–239, § 6105(a), added subpar. (C) and redesignated former subpars. (C) and (D) as (D) and (E), respectively. Subsecs. (c) to (e). Pub. L. 101–234, § 201(a), repealed Pub. L. 100–360, §§ 202(b)(4), 203(c)(1)(F), 204(b)(2), and provided that the provisions of law amended or re- pealed by such sections are restored or revived as if such sections had not been enacted, see 1988 Amend- ment notes below. Subsec. (f). Pub. L. 101–239, § 6102(f)(1), added subsec. (f). Subsec. (g). Pub. L. 101–239, § 6116(b)(2), added subsec. (g). 1988—Pub. L. 100–360, § 411(g)(1)(A), inserted ‘‘items and’’ in section catchline. Subsec. (a)(1)(C). Pub. L. 100–360, § 411(g)(1)(B)(i), in- serted ‘‘or under part A to a home health agency’’ be- fore period at end. Subsec. (a)(2)(A). Pub. L. 100–360, § 411(g)(1)(B)(iii), struck out ‘‘rental’’ before ‘‘payments’’ in concluding provisions. Subsec. (a)(2)(B)(i). Pub. L. 100–360, § 411(g)(1) (B)(iii), substituted ‘‘reasonable’’ for ‘‘allowed’’. Subsec. (a)(3)(A). Pub. L. 100–360, § 411(g)(1)(B)(iv), struck out the extra space appearing in text of original act after ‘‘ventilators’’. Subsec. (a)(3)(B)(i). Pub. L. 100–360, § 411(g)(1) (B)(iii), substituted ‘‘reasonable’’ for ‘‘allowable’’. Subsec. (a)(4). Pub. L. 100–360, § 411(g)(1) (B)(v)–(vii), inserted ‘‘, and for that reason cannot be grouped with similar items for purposes of payment under this sub- chapter,’’ after ‘‘individual patient’’, inserted cl. (A) and (B) designations, and in cl. (B), substituted ‘‘serv- icing’’ for ‘‘service’’ in two places. Subsec. (a)(7)(A)(ii). Pub. L. 100–360, § 411(g)(1) (B)(vii), inserted ‘‘maintenance and’’ before ‘‘servicing’’. Subsec. (a)(7)(A)(iii). Pub. L. 100–360, § 411(g)(1) (B)(vii), (viii), substituted ‘‘maintenance and servicing’’ for ‘‘service and maintenance’’, and in subcl. (I) sub- stituted ‘‘fee or fees established by the Secretary’’ for ‘‘fee established by the carrier’’. Subsec. (a)(7)(B)(i). Pub. L. 100–360, § 411(a)(3)(A), (C)(ii), provided that subsec. (a)(7)(B)(i) of this section, as inserted by section 4062(b) of Pub. L. 100–203, is deemed to have a reference to ‘‘1987’’ immediately after ‘‘December’’. Subsec. (a)(8)(A)(i)(I). Pub. L. 100–360, § 411(g)(1) (B)(iii), substituted ‘‘reasonable’’ for ‘‘allowable’’. Subsec. (a)(8)(B). Pub. L. 100–360, § 411(g)(1)(B)(xi), as amended Pub. L. 100–485, § 608(d)(22)(A)(i), substituted ‘‘(as defined by the Secretary)’’ for ‘‘(as defined in sec- tion 1395ww(d)(2)(D) of this title)’’, and in cl. (i) struck out the comma after ‘‘1991’’. Subsec. (a)(9)(A)(ii)(I). Pub. L. 100–360, § 411(g)(1) (B)(ix), substituted ‘‘6-month’’ for ‘‘12-month’’. Subsec. (a)(9)(A)(ii)(II). Pub. L. 100–360, § 411(g)(1) (B)(x), substituted ‘‘, 1991, and 1992’’ for ‘‘and to 1991’’. Subsec. (a)(9)(B). Pub. L. 100–360, § 411(g)(1)(B)(xi), as amended by Pub. L. 100–485, § 608(d)(22)(A)(i), sub- stituted ‘‘(as defined by the Secretary)’’ for ‘‘(as de- fined in section 1395ww(d)(2)(D) of this title)’’, and in cl. (i) struck out the comma after ‘‘1991’’. Subsec. (a)(9)(C)(i). Pub. L. 100–360, § 411(g)(1) (B)(xii), substituted ‘‘subparagraph (A)(ii)’’ for ‘‘subparagraph (A)(ii)(I)’’. Subsec. (a)(10)(B). Pub. L. 100–360, § 411(g)(1) (B)(xiii), inserted before period at end ‘‘and payments under this subsection as such provisions apply to physicians’ serv- ices and physicians and a reasonable charge under sec- tion 1395u(b) of this title’’. Subsec. (a)(11)(A). Pub. L. 100–360, § 411(g)(1) (B)(vii), (xiv), inserted ‘‘maintenance and’’ before ‘‘servicing’’ and substituted ‘‘section 1395u(j)(2) of this title’’ for ‘‘subsection (j)(2) of this section’’. Subsec. (a)(12). Pub. L. 100–360, § 411(g)(1)(B)(xv), as amended by Pub. L. 100–485, § 608(d)(22)(A)(ii), sub- stituted ‘‘one or more entire regions defined for pur- poses of paragraphs (8)(B) and (9)(B)’’ for ‘‘each region (as defined in section 1395ww(d)(2)(D) of this title)’’. Subsec. (a)(14). Pub. L. 100–360, § 411(g)(1)(B)(xvi), struck out par. (14) which read as follows: ‘‘In this sub- section, any reference to the term ‘carrier’ includes a reference, with respect to durable medical equipment furnished by a home health agency as part of home health services, to a fiscal intermediary.’’ Subsec. (b). Pub. L. 100–360, § 411(a)(3)(A), (B)(ii), (f)(8)(B)(ii), amended Pub. L. 100–203, § 4049(a)(2), see 1987 Amendment note below. Subsec. (b)(1)(B). Pub. L. 100–360, § 204(b)(1), inserted ‘‘and subject to subsection (e)(1)(A) of this section’’ after ‘‘conversion factors’’. Page 3148 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Subsec. (b)(4)(C). Pub. L. 100–360, § 411(f)(8)(D)(ii), as added by Pub. L. 100–485, § 608(d)(21)(C), substituted ‘‘For radiologist’’ for ‘‘Radiologist’’ and ‘‘1395u(i)(3) of this title’’ for ‘‘1395u(b)(4)(E)(ii) of this title’’. Subsec. (b)(4)(D), (5). Pub. L. 100–360, § 411(f)(8)(D)(i), inserted ‘‘and suppliers’’ after ‘‘physicians’’ in heading. Subsec. (b)(5)(C). Pub. L. 100–360, § 411(f)(8)(D)(iii), (iv), formerly (ii), (iii), as redesignated by Pub. L. 100–485, § 608(d)(21)(C), substituted ‘‘bills’’ for ‘‘imposes a charge’’ and inserted ‘‘in the same manner as such sanctions may apply to a physician’’ before period at end. Subsec. (b)(6). Pub. L. 100–360, § 411(f)(8)(D)(v), for- merly (iv), as redesignated by Pub. L. 100–485, § 608(d)(21)(C), substituted ‘‘and section 1395l(a)(1)(J) of this title’’ for ‘‘, section 1395l(a)(1)(I) of this title, and section 1395u(h)(1)(B) of this title’’. Pub. L. 100–360, § 411(f)(8)(A), substituted ‘‘radiology’’ for ‘‘radiologic’’. Subsec. (b)(6)(B). Pub. L. 100–360, § 411(f)(8)(D)(vi), for- merly (v), as redesignated by Pub. L. 100–485, § 608(d)(21)(C), substituted ‘‘the total amount of charges’’ for ‘‘billings’’. Pub. L. 100–360, § 411(f)(8)(A), substituted ‘‘radiology’’ for ‘‘radiologic’’. Subsec. (c). Pub. L. 100–360, § 202(b)(4), added subsec. (c) relating to payment for covered outpatient drugs. Subsec. (d). Pub. L. 100–360, § 203(c)(1)(F), added sub- sec. (d) relating to home intravenous drug therapy services. Subsec. (e). Pub. L. 100–360, § 204(b)(2), added subsec. (e) relating to payments and standards for screening mammography. 1987—Subsec. (b). Pub. L. 100–203, § 4049(a)(2), as amended by Pub. L. 100–360, § 411(a)(3)(A), (B)(ii), (f)(8)(B)(ii), added subsec. (b). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Amendment by section 4124(c) of Pub. L. 117–328 appli- cable with respect to items and services furnished on or after Jan. 1, 2024, see section 4124(d) of Pub. L. 117–328, set out as a note under section 1395k of this section. EFFECTIVE DATE OF 2020 AMENDMENT Pub. L. 116–260, div. CC, title I, § 121(b)(2), Dec. 27, 2020, 134 Stat. 2955, provided that: ‘‘The amendment made by paragraph (1) [amending Pub. L. 105–33 which amended this section] shall take effect as if included in the enactment of the Balanced Budget Act of 1997 (Pub- lic Law 105–33).’’ Amendment by section 125(a)(2)(B), (c) of Pub. L. 116–260 applicable to items and services furnished on or after Jan. 1, 2023, see section 125(g) of Pub. L. 116–260, set out as a note under section 1395l of this title. EFFECTIVE DATE OF 2016 AMENDMENT Amendment by section 5012(b) of Pub. L. 114–255 ap- plicable to items and services furnished on or after Jan. 1, 2021, see section 5012(d) of Pub. L. 114–255, set out as a note under section 1395l of this title. EFFECTIVE DATE OF 2015 AMENDMENT Amendment by Pub. L. 114–113 applicable to items furnished on or after Jan. 1, 2017, see section 504(d) of Pub. L. 114–113, set out as a note under section 1395l of this title. EFFECTIVE DATE OF 2010 AMENDMENT Pub. L. 111–148, title III, § 3128(b), Mar. 23, 2010, 124 Stat. 426, provided that: ‘‘The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of section 405(a) of the Medicare Prescription Drug, Improvement, and Mod- ernization Act of 2003 (Public Law 108–173; 117 Stat. 2266).’’ Pub. L. 111–148, title III, § 3136(c), Mar. 23, 2010, 124 Stat. 438, provided that: ‘‘(1) IN GENERAL.—Subject to paragraph (2), the amendments made by subsection (a) [amending this section] shall take effect on January 1, 2011, and shall apply to power-driven wheelchairs furnished on or after such date. ‘‘(2) APPLICATION TO COMPETITIVE BIDDING.—The amendments made by subsection (a) shall not apply to payment made for items and services furnished pursu- ant to contracts entered into under section 1847 of the Social Security Act (42 U.S.C. 1395w–3) prior to January 1, 2011, pursuant to the implementation of subsection (a)(1)(B)(i)(I) of such section 1847.’’ Amendment by section 6405(a) of Pub. L. 111–148 ap- plicable to written orders and certifications made on or after July 1, 2010, see section 6405(d) of Pub. L. 111–148, set out as a note under section 1395f of this title. EFFECTIVE DATE OF 2008 AMENDMENT Amendment by section 125(b)(5) of Pub. L. 110–275 ap- plicable with respect to accreditations of hospitals granted on or after the date that is 24 months after July 15, 2008, with transition rule, see section 125(d) of Pub. L. 110–275, set out as an Effective Date of 2008 Amendment; Transition Rule note under section 1395bb of this title. Pub. L. 110–275, title I, § 144(b)(2), July 15, 2008, 122 Stat. 2547, provided that: ‘‘The amendments made by paragraph (1) [amending this section] shall take effect on January 1, 2009.’’ Pub. L. 110–275, title I, § 146(b)(2)(B), July 15, 2008, 122 Stat. 2548, provided that: ‘‘The amendment made by subparagraph (A) [amending this section] shall apply to services furnished on or after the date of the enactment of this Act [July 15, 2008].’’ Pub. L. 110–275, title I, § 148(b), July 15, 2008, 122 Stat. 2549, provided that: ‘‘The amendments made by sub- section (a) [amending this section] shall apply to serv- ices furnished on or after July 1, 2009.’’ Pub. L. 110–275, title I, § 149(c), July 15, 2008, 122 Stat. 2549, provided that: ‘‘The amendments made by this section [amending this section and section 1395yy of this title] shall apply to services furnished on or after January 1, 2009.’’ Pub. L. 110–275, title I, § 154(e), July 15, 2008, 122 Stat. 2568, provided that: ‘‘The amendments made by this section [amending this section, sections 1395u and 1395w–3 of this title, and provisions set out as notes under section 1395w–3 of this title] shall take effect as of June 30, 2008.’’ EFFECTIVE DATE OF 2006 AMENDMENT Pub. L. 109–171, title V, § 5101(a)(2), Feb. 8, 2006, 120 Stat. 38, provided that: ‘‘The amendment made by para- graph (1) [amending this section] shall apply to items furnished for which the first rental month occurs on or after January 1, 2006.’’ Pub. L. 109–171, title V, § 5101(b)(2), Feb. 8, 2006, 120 Stat. 39, provided that: ‘‘(A) IN GENERAL.—The amendments made by para- graph (1) [amending this section] shall take effect on January 1, 2006. ‘‘(B) APPLICATION TO CERTAIN INDIVIDUALS.—In the case of an individual receiving oxygen equipment on December 31, 2005, for which payment is made under section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)), the 36-month period described in paragraph (5)(F)(i) of such section, as added by paragraph (1), shall begin on January 1, 2006.’’ Amendment by section 5113(b) of Pub. L. 109–171 ap- plicable to services furnished on or after Jan. 1, 2007, see section 5113(c) of Pub. L. 109–171, set out as a note under section 1395l of this title. EFFECTIVE DATE OF 2003 AMENDMENT Amendment by section 405(a)(1) of Pub. L. 108–173 ap- plicable to payments for services furnished during cost reporting periods beginning on or after Jan. 1, 2004, see section 405(a)(2) of Pub. L. 108–173, set out as a note under section 1395f of this title. Page 3149 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Pub. L. 108–173, title IV, § 405(b)(2), Dec. 8, 2003, 117 Stat. 2266, provided that: ‘‘The amendments made by paragraph (1) [amending this section] shall apply with respect to costs incurred for services furnished on or after January 1, 2005.’’ Pub. L. 108–173, title IV, § 405(d)(2), Dec. 8, 2003, 117 Stat. 2267, provided that: ‘‘(A) IN GENERAL.—Except as provided in subpara- graph (B), the amendment made by paragraph (1) [amending this section] shall apply to cost reporting periods beginning on or after July 1, 2004. ‘‘(B) RULE OF APPLICATION.—In the case of a critical access hospital that made an election under section 1834(g)(2) of the Social Security Act (42 U.S.C. 1395m(g)(2)) before November 1, 2003, the amendment made by paragraph (1) shall apply to cost reporting pe- riods beginning on or after July 1, 2001.’’ Pub. L. 108–173, title IV, § 415(c), Dec. 8, 2003, 117 Stat. 2282, provided that: ‘‘The amendments made by this subsection [probably should be ‘‘this section’’, amend- ing this section and section 1395x of this title] shall apply to services furnished on or after January 1, 2005.’’ Amendment by section 627(b)(1) of Pub. L. 108–173 ap- plicable to items furnished on or after Jan. 1, 2005, see section 627(c) of Pub. L. 108–173, set out as a note under section 1395l of this title. EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106–554, § 1(a)(6) [title I, § 103(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–469, provided that: ‘‘The amend- ments made by this section [amending this section and section 1395x of this title] shall apply to colorectal can- cer screening services provided on or after July 1, 2001.’’ Pub. L. 106–554, § 1(a)(6) [title I, § 104(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–470, provided that: ‘‘The amend- ments made by subsections (a) and (b) [amending this section and section 1395w–4 of this title] shall apply with respect to screening mammographies furnished on or after January 1, 2002.’’ Amendment by section 1(a)(6) [title II, § 201(a)] of Pub. L. 106–554 applicable to services furnished on or after Nov. 29, 1999, see section 1(a)(6) [title II, § 201(c)] of Pub. L. 106–554, set out as a note under section 1395l of this title. Pub. L. 106–554, § 1(a)(6) [title II, § 202(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–481, provided that: ‘‘The amend- ment made by subsection (a) [amending this section] shall apply with respect to items and services furnished on or after July 1, 2001.’’ Pub. L. 106–554, § 1(a)(6) [title II, § 204(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–482, provided that: ‘‘The amend- ment made by subsection (a) [amending this section] shall apply to cost reporting periods beginning on or after October 1, 2001.’’ Amendment by section 1(a)(6) [title II, § 205(a)] of Pub. L. 106–554 applicable to services furnished on or after Dec. 21, 2000, see section 1(a)(6) [title II, § 205(c)] of Pub. L. 106–554, set out as a note under section 1395l of this title. Pub. L. 106–554, § 1(a)(6) [title II, § 221(d)], Dec. 21, 2000, 114 Stat. 2763, 2763A–487, provided that: ‘‘The amend- ment made by subsection (a) [amending this section] shall apply to services furnished on or after July 1, 2001. In applying such amendment to services furnished on or after such date and before January 1, 2002, the amount of the rate increase provided under such amendment shall be equal to $1.25 per mile.’’ Amendment by section 1(a)(6) [title II, § 223(b)] of Pub. L. 106–554 effective for services furnished on or after Oct. 1, 2001, see section 1(a)(6) [title II, § 223(e)] of Pub. L. 106–554, set out as a note under section 1395l of this title. Pub. L. 106–554, § 1(a)(6) [title IV, § 423(b)(2)], Dec. 21, 2000, 114 Stat. 2763, 2763A–518, provided that: ‘‘The amendment made by paragraph (1) [amending this sec- tion] shall apply to services furnished on or after July 1, 2001.’’ Pub. L. 106–554, § 1(a)(6) [title IV, § 428(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–522, provided that: ‘‘The amendment made by subsection (a) [amending this sec- tion] shall apply to items replaced on or after April 1, 2001.’’ EFFECTIVE DATE OF 1999 AMENDMENT Amendment by section 1000(a)(6) [title II, § 201(e)(2)] of Pub. L. 106–113 effective as if included in enactment of the Balanced Budget Act of 1997, Pub. L. 105–33, ex- cept as otherwise provided, see § 1000(a)(6) [title II, § 201(m)] of Pub. L. 106–113, set out as a note under sec- tion 1395l of this title. Amendment by section 1000(a)(6) [title III, § 321(k)(3)] of Pub. L. 106–113 effective as if included in the enact- ment of the Balanced Budget Act of 1997, Pub. L. 105–33, except as otherwise provided, see section 1000(a)(6) [title III, § 321(m)] of Pub. L. 106–113, set out as a note under section 1395d of this title. Pub. L. 106–113, div. B, § 1000(a)(6) [title IV, § 403(d)(2)], Nov. 29, 1999, 113 Stat. 1536, 1501A–371, as amended by Pub. L. 106–554, § 1(a)(6) [title II, § 201(b)(2)], Dec. 21, 2000, 114 Stat. 2763, 2763A–481, provided that: ‘‘Para- graphs (1) through (3) of section 1834(g) of the Social Se- curity Act [42 U.S.C. 1395m(g)(1)–(3)] (as amended by paragraph (1)) apply for cost reporting periods begin- ning on or after October 1, 2000.’’ EFFECTIVE DATE OF 1997 AMENDMENT Amendment by section 4101(a), (c) of Pub. L. 105–33 applicable to items and services furnished on or after Jan. 1, 1998, see section 4101(d) of Pub. L. 105–33, set out as a note under section 1395l of this title. Amendment by section 4104(b)(1) of Pub. L. 105–33 ap- plicable to items and services furnished on or after Jan. 1, 1998, see section 4104(e) of Pub. L. 105–33, set out as a note under section 1395l of this title. Pub. L. 105–33, title IV, § 4105(d), Aug. 5, 1997, 111 Stat. 367, provided that: ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by this section [amending this section and sections 1395w–4 and 1395x of this title] shall apply to items and services furnished on or after July 1, 1998. ‘‘(2) TESTING STRIPS.—The amendment made by sub- section (b)(2) [amending this section] shall apply with respect to blood glucose testing strips furnished on or after January 1, 1998.’’ Amendment by section 4201(c)(5) of Pub. L. 105–33 ap- plicable to services furnished on or after Oct. 1, 1997, see section 4201(d) of Pub. L. 105–33, set out as a note under section 1395f of this title. Pub. L. 105–33, title IV, § 4312(f)(1), Aug. 5, 1997, 111 Stat. 387, provided that: ‘‘The amendment made by sub- section (a) [amending this section] shall apply to sup- pliers of durable medical equipment with respect to such equipment furnished on or after January 1, 1998.’’ Pub. L. 105–33, title IV, § 4312(f)(3), Aug. 5, 1997, 111 Stat. 388, provided that: ‘‘The amendments made by subsections (c) through (e) [amending this section and section 1395x of this title] shall take effect on the date of the enactment of this Act [Aug. 5, 1997] and may be applied with respect to items and services furnished on or after January 1, 1998.’’ Pub. L. 105–33, title IV, § 4316(c), Aug. 5, 1997, 111 Stat. 392, provided that: ‘‘The amendments made by this sec- tion [amending this section and section 1395u of this title] shall take effect on the date of the enactment of this Act [Aug. 5, 1997].’’ Amendment by section 4531(b)(2) of Pub. L. 105–33 ap- plicable to services furnished on or after Jan. 1, 2000, see section 4531(b)(3) of Pub. L. 105–33, set out as a note under section 1395l of this title. Amendment by section 4541(a)(2) of Pub. L. 105–33 ap- plicable to services furnished on or after Jan. 1, 1998, including portions of cost reporting periods occurring on or after such date, except that subsec. (k) of this section inapplicable to services described in section 1395l(a)(8)(B) of this title that are furnished during 1998, see section 4541(e) of Pub. L. 105–33, set out as a note under section 1395l of this title. Pub. L. 105–33, title IV, § 4551(c)(2), Aug. 5, 1997, 111 Stat. 459, provided that: ‘‘The amendment made by Page 3150 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m paragraph (1) [amending this section] shall apply to purchases or rentals after the effective date of any reg- ulations issued pursuant to such amendment.’’ Pub. L. 105–33, title IV, § 4552(e), Aug. 5, 1997, 111 Stat. 459, provided that: ‘‘(1) OXYGEN.—The amendments made by subsection (a) [amending this section] shall apply to items fur- nished on and after January 1, 1998. ‘‘(2) OTHER PROVISIONS.—The amendments made by this section other than subsection (a) [amending this section] shall take effect on the date of the enactment of this Act [Aug. 5, 1997].’’ EFFECTIVE DATE OF 1994 AMENDMENT Pub. L. 103–432, title I, § 126(i), Oct. 31, 1994, 108 Stat. 4416, provided that: ‘‘Except as provided in subsection (h) [amending section 1395u of this title, enacting pro- visions set out as notes under sections 1395u and 1395w–4 of this title, and amending provisions set out as a note under section 1395w–4 of this title], the amend- ments made by this section and the provisions of this section [amending this section and sections 1395u, 1395w–1, and 1395w–4 of this title, enacting provisions set out as notes under sections 1395u and 1395w–4 of this title, and amending provisions set out as notes under this section and sections 1395u and 1395w–4 of this title] shall take effect as if included in the enactment of OBRA–1990 [Pub. L. 101–508].’’ Pub. L. 103–432, title I, § 131(a)(2), Oct. 31, 1994, 108 Stat. 4419, provided that the amendment made by that section is effective 60 days after Oct. 31, 1994. Pub. L. 103–432, title I, § 132(c), Oct. 31, 1994, 108 Stat. 4421, provided that: ‘‘The amendments made by sub- sections (a) and (b) [amending this section] shall apply to items furnished after the expiration of the 60-day pe- riod that begins on the date of the enactment of this Act [Oct. 31, 1994].’’ Pub. L. 103–432, title I, § 133(c), Oct. 31, 1994, 108 Stat. 4422, provided that: ‘‘The amendments made by this section [amending this section and sections 1395m and 1395pp of this title] shall apply to items or services fur- nished on or after January 1, 1995.’’ Pub. L. 103–432, title I, § 134(a)(2), Oct. 31, 1994, 108 Stat. 4422, provided that: ‘‘The amendment made by paragraph (1) [amending this section] shall take effect on the date of the enactment of this Act [Oct. 31, 1994].’’ Pub. L. 103–432, title I, § 135(a)(2), Oct. 31, 1994, 108 Stat. 4422, provided that: ‘‘The amendment made by paragraph (1) [amending this section] shall be effective on the date of the enactment of this Act [Oct. 31, 1994].’’ Pub. L. 103–432, title I, § 135(b)(1), Oct. 31, 1994, 108 Stat. 4422, provided that the amendment made by that section is effective Oct. 31, 1994. Pub. L. 103–432, title I, § 135(b)(3), Oct. 31, 1994, 108 Stat. 4423, provided that the amendment made by that section is effective Oct. 31, 1994. Pub. L. 103–432, title I, § 135(d)(2), Oct. 31, 1994, 108 Stat. 4424, provided that: ‘‘The amendment made by paragraph (1) [amending this section] shall be effective on the date of the enactment of this Act [Oct. 31, 1994].’’ Pub. L. 103–432, title I, § 135(e)(8), Oct. 31, 1994, 108 Stat. 4424, provided that: ‘‘The amendments made by this subsection [amending this section and provisions set out as notes under this section and section 1395cc of this title] shall take effect as if included in the enact- ment of OBRA–1990 [Pub. L. 101–508].’’ Pub. L. 103–432, title I, § 145(d), Oct. 31, 1994, 108 Stat. 4428, provided that: ‘‘The amendments made by this section [amending this section and sections 1395x to 1395bb of this title] shall apply to mammography fur- nished by a facility on and after the first date that the certificate requirements of section 354(b) of the Public Health Service Act [section 263b(b) of this title] apply to such mammography conducted by such facility.’’ Amendment by section 156(a)(2)(C) of Pub. L. 103–432 applicable to services provided on or after Oct. 31, 1994, see section 156(a)(3) of Pub. L. 103–432, set out as a note under section 1320c–3 of this title. EFFECTIVE DATE OF 1993 AMENDMENT Pub. L. 103–66, title XIII, § 13542(b), Aug. 10, 1993, 107 Stat. 589, provided that: ‘‘The amendments made by this section [amending this section] shall apply to items furnished on or after January 1, 1994.’’ Pub. L. 103–66, title XIII, § 13543(c), Aug. 10, 1993, 107 Stat. 589, provided that: ‘‘The amendments made by this section [amending this section] shall apply to items furnished on or after January 1, 1994.’’ Pub. L. 103–66, title XIII, § 13544(a)(3), Aug. 10, 1993, 107 Stat. 589, provided that: ‘‘The amendments made by this subsection [amending this section] shall apply to items furnished on or after January 1, 1994.’’ Amendment by section 13544(b)(1) of Pub. L. 103–66 ap- plicable to items furnished on or after Jan. 1, 1994, see section 13544(b)(3) of Pub. L. 103–66, set out as a note under section 1395l of this title. Pub. L. 103–66, title XIII, § 13545(b), Aug. 10, 1993, 107 Stat. 590, provided that: ‘‘The amendment made by sub- section (a) [amending this section] shall apply to items furnished on or after January 1, 1994.’’ EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–508, title IV, § 4102(i), Nov. 5, 1990, 104 Stat. 1388–58, provided that: ‘‘(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 Jan- uary 1, 1991. ‘‘(2) The amendment made by subsection (f) [amend- ing this section] shall be effective as if included in the enactment of the Omnibus Budget Reconciliation Act of 1987 [Pub. L. 100–203].’’ Amendment by section 4104(a) of Pub. L. 101–508 ap- plicable to services furnished on or after Jan. 1, 1991, see section 4104(d) of Pub. L. 101–508, set out as a note under section 1395l of this title. Pub. L. 101–508, title IV, § 4152(a)(3), Nov. 5, 1990, 104 Stat. 1388–74, as amended by Pub. L. 103–432, title I, § 135(e)(1), Oct. 31, 1994, 108 Stat. 4424, provided that: ‘‘The amendments made by this subsection [amending this section and section 1395x of this title] shall apply to items furnished on or after January 1, 1991.’’ Pub. L. 101–508, title IV, § 4152(c)(4)(B)(ii), Nov. 5, 1990, 104 Stat. 1388–79, provided that: ‘‘The amendment made by clause (i) [amending this section] shall apply to items furnished on or after January 1, 1992, unless the Secretary develops specific criteria before that date for the treatment of wheelchairs as customized items for purposes of section 1834(a)(4) of the Social Security Act [subsec. (a)(4) of this section] (in which case the amend- ment made by such clause shall not become effective).’’ [Criteria established by Secretary Nov. 1, 1991, see 56 F.R. 65995, Dec. 20, 1991, 42 CFR § 414.224.] Pub. L. 101–508, title IV, § 4152(f)(2), Nov. 5, 1990, 104 Stat. 1388–80, provided that: ‘‘The amendment made by paragraph (1) [amending this section] shall apply to forms and documents distributed on or after January 1, 1991.’’ Pub. L. 101–508, title IV, § 4152(g)(2), Nov. 5, 1990, 104 Stat. 1388–80, provided that: ‘‘The amendments made by paragraph (1) [amending this section] shall apply to pa- tients who first receive home oxygen therapy services on or after January 1, 1991.’’ Pub. L. 101–508, title IV, § 4152(i), Nov. 5, 1990, 104 Stat. 1388–81, provided that: ‘‘Except as otherwise provided, the amendments made by this section [amending this section, section 1395x of this title, and provisions set out as a note under section 1395f of this title] shall apply to items furnished on or after January 1, 1991.’’ Amendment by section 4153(a)(1), (2)(D) of Pub. L. 101–508 applicable to items furnished on or after Jan. 1, 1991, see section 4153(a)(3) of Pub. L. 101–508, set out as a note under section 1395k of this title. Amendment by section 4163(b) of Pub. L. 101–508 ap- plicable to screening mammography performed on or after Jan. 1, 1991, see section 4163(e) of Pub. L. 101–508, set out as a note under section 1395l of this title. EFFECTIVE DATE OF 1989 AMENDMENT Amendment by section 6102(f)(1) of Pub. L. 101–239 ap- plicable to services furnished on or after Jan. 1, 1991, Page 3151 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m see section 6102(f)(3) of Pub. L. 101–239, set out as a note under section 1395l of this title. Pub. L. 101–239, title VI, § 6112(e)(4), Dec. 19, 1989, 103 Stat. 2216, provided that: ‘‘The amendments made by this subsection [amending this section and sections 1395x and 1395cc of this title] shall apply with respect to items furnished on or after January 1, 1990.’’ Amendment by section 201(a) of Pub. L. 101–234 effec- tive Jan. 1, 1990, see section 201(c) of Pub. L. 101–234, set out as a note under section 1320a–7a of this title. Pub. L. 101–234, title III, § 301(b)(1), (c)(1), Dec. 13, 1989, 103 Stat. 1985, provided that the amendments made by that section are effective as if included in the enact- ment of the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100–203. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–485 effective as if included in the enactment of the Medicare Catastrophic Cov- erage Act of 1988, Pub. L. 100–360, see section 608(g)(1) of Pub. L. 100–485, set out as a note under section 704 of this title. Amendment by section 202(b)(4) of Pub. L. 100–360 ap- plicable to items dispensed on or after Jan. 1, 1990, see section 202(m)(1) of Pub. L. 100–360, set out as a note under section 1395u of this title. Amendment by section 203(c)(1)(F) of Pub. L. 100–360 applicable to items and services furnished on or after Jan. 1, 1990, see section 203(g) of Pub. L. 100–360, set out as a note under section 1320c–3 of this title. Pub. L. 100–360, title II, § 204(e), July 1, 1988, 102 Stat. 729, which provided that the amendments made by sec- tion 204 of Pub. L. 100–360 [amending this section and sections 1395l, 1395x to 1395z, 1395aa, 1395bb, 1396a, and 1396n of this title] applied to screening mammography performed on or after January 1, 1990, and that subsec. (e)(5) of this section only applied until such time as the Secretary of Health and Human Services implemented the physician fee schedules based on relative value scale developed under section 1395w–1(e) of this title, was repealed by Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981. Except as specifically provided in section 411 of Pub. L. 100–360, amendment by section 411(a)(3)(A), (B)(ii), (C)(ii), (f)(8)(A), (B)(ii), (D), (g)(1)(A) and (B) of Pub. L. 100–360, as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100–203, ef- fective as if included in the enactment of that provi- sion in Pub. L. 100–203, see section 411(a) of Pub. L. 100–360, set out as a Reference to OBRA; Effective Date note under section 106 of Title 1, General Provisions. EFFECTIVE DATE OF 1987 AMENDMENT Pub. L. 100–203, title IV, § 4049(b)(2), Dec. 22, 1987, 101 Stat. 1330–92, as amended by Pub. L. 101–239, title VI, § 6102(e)(6)(B), Dec. 19, 1989, 103 Stat. 2188; Pub. L. 101–508, title IV, § 4118(h)(2), Nov. 5, 1990, 104 Stat. 1388–70, provided that: ‘‘The amendments made by this section [amending this section and section 1395l of this title] shall apply to services performed on or after April 1, 1989.’’ [Pub. L. 101–508, title IV, § 4118(h), Nov. 5, 1990, 104 Stat. 1388–70, provided that the amendment by that sec- tion to section 4049(b)(2) of Pub. L. 100–203, set out above, is effective as if included in enactment of Omni- bus Budget Reconciliation Act of 1987, Pub. L. 100–203.] EFFECTIVE DATE Subsection (a) of this section applicable to covered items (other than oxygen and oxygen equipment) fur- nished on or after Jan. 1, 1989, and to oxygen and oxy- gen equipment furnished on or after June 1, 1989, see section 4062(e) of Pub. L. 100–203, set out as an Effective Date of 1987 Amendment note under section 1395f of this title. REGULATIONS Pub. L. 106–554, § 1(a)(6) [title IV, § 427(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–521, provided that: ‘‘Not later than 1 year after the date of the enactment of this Act [Dec. 21, 2000], the Secretary of Health and Human Services shall promulgate revised regulations to carry out the amendment made by subsection (a) [amending this section] using a negotiated rulemaking process under subchapter III of chapter 5 of title 5, United States Code.’’ CONSTRUCTION OF 2010 AMENDMENT Pub. L. 111–148, title III, § 3109(c), Mar. 23, 2010, 124 Stat. 420, provided that: ‘‘Nothing in the provisions of or amendments made by this section [amending this section and enacting provisions set out as a note under this section] shall be construed as affecting the appli- cation of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area under section 1847 of the Social Security Act (42 U.S.C. 1395w–3).’’ Pub. L. 111–148, title IV, § 4105(b), Mar. 23, 2010, 124 Stat. 559, provided that: ‘‘Nothing in the amendment made by paragraph (1) [probably means subsec. (a), amending this section] shall be construed to affect the coverage of diagnostic or treatment services under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].’’ CONSTRUCTION OF 2009 AMENDMENT Pub. L. 111–72, § 1(b), Oct. 13, 2009, 123 Stat. 2059, pro- vided that: ‘‘Nothing in subsection (a) [amending this section] shall be construed as affecting the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area under section 1847 of the Social Security Act (42 U.S.C. 1395w–3).’’ CONSTRUCTION OF 2008 AMENDMENT Pub. L. 110–275, title I, § 154(b)(1)(B), July 15, 2008, 122 Stat. 2565, provided that: ‘‘Section 1834(a)(20)(F)(ii) of the Social Security Act [42 U.S.C. 1395m(a)(20)(F)(ii)], as added by subparagraph (A), shall not be construed as preventing the Secretary of Health and Human Serv- ices from implementing the first round of competition under section 1847 of such Act [42 U.S.C. 1395w–3] on a timely basis.’’ TRANSFER OF FUNCTIONS Physician Payment Review Commission (PPRC) was terminated and its assets and staff transferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of Pub. L. 105–33, set out as a note under section 1395b–6 of this title. Section 4022(c)(2), (3) further provided that MedPAC was to be responsible for preparation and submission of reports required by law to be submitted by PPRC, and that, for that purpose, any reference in law to PPRC was to be deemed, after the appointment of MedPAC, to refer to MedPAC. IMPLEMENTATION OF AMENDMENT BY PUB. L. 118–158 Pub. L. 118–158, div. C, title II, § 3207(g), Dec. 21, 2024, 138 Stat. 1766, provided that: ‘‘The Secretary of Health and Human Services may implement the amendments made by this section [amending this section and sec- tion 1395f of this title] through program instruction or otherwise.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 117–328 Pub. L. 117–328, div. FF, title IV, § 4113(h), Dec. 29, 2022, 136 Stat. 5901, provided that: ‘‘Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, in- cluding amendments made by, this section [amending this section and section 1395f of this title] through pro- gram instruction or otherwise.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 117–103 Pub. L. 117–103, div. P, title II, § 309, Mar. 15, 2022, 136 Stat. 808, provided that: ‘‘Notwithstanding any other provision of law, the Secretary of Health and Human Page 3152 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Services may implement the provisions of, including amendments made by, sections 301 through 306 [amend- ing this section and section 1395f of this title] through program instruction or otherwise.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 116–260 Pub. L. 116–260, div. CC, title I, § 121(c), Dec. 27, 2020, 134 Stat. 2955, provided that: ‘‘Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section [amending this section and amending Pub. L. 105–33 which amended this section] by program instruction or otherwise.’’ Pub. L. 116–260, div. CC, title I, § 123(b), Dec. 27, 2020, 134 Stat. 2957, provided that: ‘‘Notwithstanding any other provision of law, the Secretary may implement the provisions of, or amendments made by, this section [amending this section] by interim final rule, program instruction, or otherwise.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 115–271 Pub. L. 115–271, title II, § 2001(b), Oct. 24, 2018, 132 Stat. 3925, provided that: ‘‘The Secretary of Health and Human Services (in this section [amending this sec- tion] referred to as the ‘Secretary’) may implement the amendments made by this section by interim final rule.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 114–10 Pub. L. 114–10, title V, § 504(b), Apr. 16, 2015, 129 Stat. 166, provided that: ‘‘Notwithstanding any other provi- sion of law, the Secretary of Health and Human Serv- ices may implement the amendments made by sub- section (a) [amending this section] by program instruc- tion or otherwise.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 111–148 Pub. L. 111–148, title III, § 3109(b), Mar. 23, 2010, 124 Stat. 419, provided that: ‘‘Notwithstanding any other provision of law, the Secretary may implement the amendments made by subsection (a) [amending this section] by program instruction or otherwise.’’ IMPLEMENTATION OF AMENDMENT BY PUB. L. 108–173 Pub. L. 108–173, title IV, § 414(e), Dec. 8, 2003, 117 Stat. 2280, provided that: ‘‘The Secretary [of Health and Human Services] may implement the amendments made by this section [amending this section, section 1395x of this title, and provisions set out as a note under this section], and revise the conversion factor ap- plicable under section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) for purposes of implementing such amendments, on an interim final basis, or by program instruction.’’ PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PROGRAM Pub. L. 117–328, div. FF, title IV, § 4139, Dec. 29, 2022, 136 Stat. 5926, provided that: ‘‘(a) AREAS OTHER THAN RURAL AND NONCONTIGUOUS AREAS.—The Secretary shall implement section 414.210(g)(9)(v) of title 42, Code of Federal Regulations (or any successor regulation), to apply the transition rule described in the first sentence of such section to all applicable items and services furnished in areas other than rural or noncontiguous areas (as such terms are defined for purposes of such section) through the re- mainder of the duration of the emergency period de- scribed in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)) or December 31, 2023, whichever is later. ‘‘(b) ALL AREAS.—The Secretary shall not implement section 414.210(g)(9)(vi) of title 42, Code of Federal Reg- ulations (or any successor regulation) until the date immediately following the last day of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), or January 1, 2024, whichever is later. ‘‘(c) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary may implement the pro- visions of this section by program instruction or other- wise.’’ PUBLICATION OF DATA Pub. L. 117–103, div. P, title II, § 308(b), Mar. 15, 2022, 136 Stat. 808, provided that: ‘‘Beginning July 1, 2022, the Secretary of Health and Human Services shall post on the public website of the Centers for Medicare & Med- icaid Services on a quarterly basis data with respect to Medicare claims for telemedicine services, including data on utilization and beneficiary characteristics.’’ ENCOURAGING USE OF TELECOMMUNICATIONS SYSTEMS FOR HOME HEALTH SERVICES FURNISHED DURING EMERGENCY PERIOD Pub. L. 116–136, div. A, title III, § 3707, Mar. 27, 2020, 134 Stat. 418, provided that: ‘‘With respect to home health services (as defined in section 1861(m) of the So- cial Security Act (42 U.S.C. 1395x(m)) that are furnished during the emergency period described in section 1135(g)(1)(B) of such Act (42 U.S.C. 1320b–5(g)(1)(B)), the Secretary of Health and Human Services shall consider ways to encourage the use of telecommunications sys- tems, including for remote patient monitoring as de- scribed in section 409.46(e) of title 42, Code of Federal Regulations (or any successor regulations) and other communications or monitoring services, consistent with the plan of care for the individual, including by clarifying guidance and conducting outreach, as appro- priate.’’ REVISING PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT UNDER THE MEDICARE PROGRAM THROUGH DURATION OF EMERGENCY PERIOD Pub. L. 116–136, div. A, title III, § 3712, Mar. 27, 2020, 134 Stat. 423, provided that: ‘‘(a) RURAL AND NONCONTIGUOUS AREAS.—The Sec- retary of Health and Human Services shall implement section 414.210(g)(9)(iii) of title 42, Code of Federal Reg- ulations (or any successor regulation), to apply the transition rule described in such section to all applica- ble items and services furnished in rural areas and non- contiguous areas (as such terms are defined for pur- poses of such section) as planned through December 31, 2020, and through the duration of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), if longer. ‘‘(b) AREAS OTHER THAN RURAL AND NONCONTIGUOUS AREAS.—With respect to items and services furnished on or after the date that is 30 days after the date of the enactment of this Act [Mar. 27, 2020], the Secretary of Health and Human Services shall apply section 414.210(g)(9)(iv) of title 42, Code of Federal Regulations (or any successor regulation), as if the reference to ‘dates of service from June 1, 2018 through December 31, 2020, based on the fee schedule amount for the area is equal to 100 percent of the adjusted payment amount established under this section’ were instead a reference to ‘dates of service from March 6, 2020, through the re- mainder of the duration of the emergency period de- scribed in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), based on the fee sched- ule amount for the area is equal to 75 percent of the ad- justed payment amount established under this section and 25 percent of the unadjusted fee schedule amount’.’’ DEMONSTRATION PROJECT TO ASSESS THE APPROPRIATE USE OF IMAGING SERVICES Pub. L. 110–275, title I, § 135(b), July 15, 2008, 122 Stat. 2535, provided that: ‘‘(1) CONDUCT OF DEMONSTRATION PROJECT.— ‘‘(A) IN GENERAL.—The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall conduct a demonstration project using the models described in paragraph (2)(E) to col- lect data regarding physician compliance with appro- priateness criteria selected under paragraph (2)(D) in Page 3153 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m order to determine the appropriateness of advanced diagnostic imaging services furnished to Medicare beneficiaries. ‘‘(B) ADVANCED DIAGNOSTIC IMAGING SERVICES.—In this subsection, the term ‘advanced diagnostic imag- ing services’ has the meaning given such term in sec- tion 1834(e)(1)(B) of the Social Security Act [42 U.S.C. 1395m(e)(1)(B)], as added by subsection (a). ‘‘(C) AUTHORITY TO FOCUS DEMONSTRATION PROJECT.—The Secretary may focus the demonstra- tion project with respect to certain advanced diag- nostic imaging services, such as services that account for a large amount of expenditures under the Medi- care program, services that have recently experi- enced a high rate of growth, or services for which ap- propriateness criteria exists. ‘‘(2) IMPLEMENTATION AND DESIGN OF DEMONSTRATION PROJECT.— ‘‘(A) IMPLEMENTATION AND DURATION.— ‘‘(i) IMPLEMENTATION.—The Secretary shall imple- ment the demonstration project under this sub- section not later than January 1, 2010. ‘‘(ii) DURATION.—The Secretary shall conduct the demonstration project under this subsection for a 2- year period. ‘‘(B) APPLICATION AND SELECTION OF PARTICIPATING PHYSICIANS.— ‘‘(i) APPLICATION.—Each physician that desires to participate in the demonstration project under this subsection shall submit an application to the Sec- retary at such time, in such manner, and con- taining such information as the Secretary may re- quire. ‘‘(ii) SELECTION.—The Secretary shall select phy- sicians to participate in the demonstration project under this subsection from among physicians sub- mitting applications under clause (i). The Sec- retary shall ensure that the physicians selected— ‘‘(I) represent a wide range of geographic areas, demographic characteristics (such as urban, rural, and suburban), and practice settings (such as private and academic practices); and ‘‘(II) have the capability to submit data to the Secretary (or an entity under a subcontract with the Secretary) in an electronic format in accord- ance with standards established by the Secretary. ‘‘(C) ADMINISTRATIVE COSTS AND INCENTIVES.—The Secretary shall— ‘‘(i) reimburse physicians for reasonable adminis- trative costs incurred in participating in the dem- onstration project under this subsection; and ‘‘(ii) provide reasonable incentives to physicians to encourage participation in the demonstration project under this subsection. ‘‘(D) USE OF APPROPRIATENESS CRITERIA.— ‘‘(i) IN GENERAL.—The Secretary, in consultation with medical specialty societies and other stake- holders, shall select criteria with respect to the clinical appropriateness of advanced diagnostic im- aging services for use in the demonstration project under this subsection. ‘‘(ii) CRITERIA SELECTED.—Any criteria selected under clause (i) shall— ‘‘(I) be developed or endorsed by a medical spe- cialty society; and ‘‘(II) be developed in adherence to appropriate- ness principles developed by a consensus organi- zation, such as the AQA alliance. ‘‘(E) MODELS FOR COLLECTING DATA REGARDING PHY- SICIAN COMPLIANCE WITH SELECTED CRITERIA.—Subject to subparagraph (H), in carrying out the demonstra- tion project under this subsection, the Secretary shall use each of the following models for collecting data regarding physician compliance with appro- priateness criteria selected under subparagraph (D): ‘‘(i) A model described in subparagraph (F). ‘‘(ii) A model described in subparagraph (G). ‘‘(iii) Any other model that the Secretary deter- mines to be useful in evaluating the use of appro- priateness criteria for advanced diagnostic imaging services. ‘‘(F) POINT OF SERVICE MODEL DESCRIBED.—A model described in this subparagraph is a model that— ‘‘(i) uses an electronic or paper intake form that— ‘‘(I) contains a certification by the physician furnishing the imaging service that the data on the intake form was confirmed with the Medicare beneficiary before the service was furnished; ‘‘(II) contains standardized data elements for di- agnosis, service ordered, service furnished, and such other information determined by the Sec- retary, in consultation with medical specialty so- cieties and other stakeholders, to be germane to evaluating the effectiveness of the use of appro- priateness criteria selected under subparagraph (D); and ‘‘(III) is accessible to physicians participating in the demonstration project under this sub- section in a format that allows for the electronic submission of such form; and ‘‘(ii) provides for feedback reports in accordance with paragraph (3)(B). ‘‘(G) POINT OF ORDER MODEL DESCRIBED.—A model described in this subparagraph is a model that— ‘‘(i) uses a computerized order-entry system that requires the transmittal of relevant supporting in- formation at the time of referral for advanced diag- nostic imaging services and provides automated de- cision-support feedback to the referring physician regarding the appropriateness of furnishing such imaging services; and ‘‘(ii) provides for feedback reports in accordance with paragraph (3)(B). ‘‘(H) LIMITATION.—In no case may the Secretary use prior authorization— ‘‘(i) as a model for collecting data regarding phy- sician compliance with appropriateness criteria se- lected under subparagraph (D) under the dem- onstration project under this subsection; or ‘‘(ii) under any model used for collecting such data under the demonstration project. ‘‘(I) REQUIRED CONTRACTS AND PERFORMANCE STAND- ARDS FOR CERTAIN ENTITIES.— ‘‘(i) IN GENERAL.—The Secretary shall enter into contracts with entities to carry out the model de- scribed in subparagraph (G). ‘‘(ii) PERFORMANCE STANDARDS.—The Secretary shall establish and enforce performance standards for such entities under the contracts entered into under clause (i), including performance standards with respect to— ‘‘(I) the satisfaction of Medicare beneficiaries who are furnished advanced diagnostic imaging services by a physician participating in the dem- onstration project; ‘‘(II) the satisfaction of physicians participating in the demonstration project; ‘‘(III) if applicable, timelines for the provision of feedback reports under paragraph (3)(B); and ‘‘(IV) any other areas determined appropriate by the Secretary. ‘‘(3) COMPARISON OF UTILIZATION OF ADVANCED DIAG- NOSTIC IMAGING SERVICES AND FEEDBACK REPORTS.— ‘‘(A) COMPARISON OF UTILIZATION OF ADVANCED DIAG- NOSTIC IMAGING SERVICES.—The Secretary shall con- sult with medical specialty societies and other stake- holders to develop mechanisms for comparing the uti- lization of advanced diagnostic imaging services by physicians participating in the demonstration project under this subsection against— ‘‘(i) the appropriateness criteria selected under paragraph (2)(D); and ‘‘(ii) to the extent feasible, the utilization of such services by physicians not participating in the dem- onstration project. ‘‘(B) FEEDBACK REPORTS.—The Secretary shall, in consultation with medical specialty societies and other stakeholders, develop mechanisms to provide feedback reports to physicians participating in the demonstration project under this subsection. Such feedback reports shall include— Page 3154 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m ‘‘(i) a profile of the rate of compliance by the phy- sician with appropriateness criteria selected under paragraph (2)(D), including a comparison of— ‘‘(I) the rate of compliance by the physician with such criteria; and ‘‘(II) the rate of compliance by the physician’s peers (as defined by the Secretary) with such cri- teria; and ‘‘(ii) to the extent feasible, a comparison of— ‘‘(I) the rate of utilization of advanced diag- nostic imaging services by the physician; and ‘‘(II) the rate of utilization of such services by the physician’s peers (as defined by the Sec- retary) who are not participating in the dem- onstration project. ‘‘(4) CONDUCT OF DEMONSTRATION PROJECT AND WAIV- ER.— ‘‘(A) CONDUCT OF DEMONSTRATION PROJECT.—Chapter 35 of title 44, United States Code, shall not apply to the conduct of the demonstration project under this subsection. ‘‘(B) WAIVER.—The Secretary may waive such pro- visions of titles XI and XVIII of the Social Security Act (42 U.S.C. 1301 et seq.; 1395 et seq.) as may be nec- essary to carry out the demonstration project under this subsection. ‘‘(5) EVALUATION AND REPORT.— ‘‘(A) EVALUATION.—The Secretary shall evaluate the demonstration project under this subsection to— ‘‘(i) assess the timeliness and efficacy of the dem- onstration project; ‘‘(ii) assess the performance of entities under a contract entered into under paragraph (2)(I)(i); ‘‘(iii) analyze data— ‘‘(I) on the rates of appropriate, uncertain, and inappropriate advanced diagnostic imaging serv- ices furnished by physicians participating in the demonstration project; ‘‘(II) on patterns and trends in the appropriate- ness and inappropriateness of such services fur- nished by such physicians; ‘‘(III) on patterns and trends in national and re- gional variations of care with respect to the fur- nishing of such services; and ‘‘(IV) on the correlation between the appro- priateness of the services furnished and image re- sults; and ‘‘(iv) address— ‘‘(I) the thresholds used under the demonstra- tion project to identify acceptable and outlier levels of performance with respect to the appro- priateness of advanced diagnostic imaging serv- ices furnished; ‘‘(II) whether prospective use of appropriateness criteria could have an effect on the volume of such services furnished; ‘‘(III) whether expansion of the use of appro- priateness criteria with respect to such services to a broader population of Medicare beneficiaries would be advisable; ‘‘(IV) whether, under such an expansion, physi- cians who demonstrate consistent compliance with such appropriateness criteria should be ex- empted from certain requirements; ‘‘(V) the use of incident-specific versus practice- specific outlier information in formulating future recommendations with respect to the use of ap- propriateness criteria for such services under the Medicare program; and ‘‘(VI) the potential for using methods (including financial incentives), in addition to those used under the models under the demonstration project, to ensure compliance with such criteria. ‘‘(B) REPORT.—Not later than 1 year after the com- pletion of the demonstration project under this sub- section, the Secretary shall submit to Congress a re- port containing the results of the evaluation of the demonstration project conducted under subparagraph (A), together with recommendations for such legisla- tion and administrative action as the Secretary de- termines appropriate. ‘‘(6) FUNDING.—The Secretary shall provide for the transfer from the Federal Supplementary Medical In- surance Trust Fund established under section 1841 of the Social Security Act (42 U.S.C. 1395t) of $10,000,000, for carrying out the demonstration project under this subsection (including costs associated with admin- istering the demonstration project, reimbursing physi- cians for administrative costs and providing incentives to encourage participation under paragraph (2)(C), en- tering into contracts under paragraph (2)(I), and evalu- ating the demonstration project under paragraph (5)).’’ AIR AMBULANCE PAYMENT IMPROVEMENTS Pub. L. 110–275, title I, § 146(b)(1), July 15, 2008, 122 Stat. 2548, as amended by Pub. L. 111–148, title III, § 3105(b), title X, § 10311(b), Mar. 23, 2010, 124 Stat. 417, 943; Pub. L. 111–309, title I, § 106(b), Dec. 15, 2010, 124 Stat. 3287; Pub. L. 112–78, title III, § 306(b), Dec. 23, 2011, 125 Stat. 1285; Pub. L. 112–96, title III, § 3007(b), Feb. 22, 2012, 126 Stat. 190; Pub. L. 112–240, title VI, § 604(b), Jan. 2, 2013, 126 Stat. 2348, provided that: ‘‘Notwithstanding any other provision of law, for purposes of making pay- ments under section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) for air ambulance services furnished during the period beginning on July 1, 2008, and ending on June 30, 2013, any area that was designated as a rural area for purposes of making payments under such section for air ambulance services furnished on Decem- ber 31, 2006, shall be treated as a rural area for purposes of making payments under such section for air ambu- lance services furnished during such period.’’ EVALUATION OF CERTAIN CODE Pub. L. 110–275, title I, § 154(c)(3), July 15, 2008, 122 Stat. 2566, provided that: ‘‘The Secretary of Health and Human Services shall evaluate the existing Health Care Common Procedure Coding System (HCPCS) codes for negative pressure wound therapy to ensure accurate reporting and billing for items and services under such codes. In carrying out such evaluation, the Secretary shall use an existing process, administered by the Du- rable Medical Equipment Medicare Administrative Contractors, for the consideration of coding changes and consider all relevant studies and information fur- nished pursuant to such process.’’ GAO REPORT ON CLASS III MEDICAL DEVICES Pub. L. 108–173, title III, § 302(c)(1)(B), Dec. 8, 2003, 117 Stat. 2231, provided that: ‘‘Not later than March 1, 2006, the Comptroller General of the United States shall sub- mit to Congress, and transmit to the Secretary [of Health and Human Services], a report containing rec- ommendations on the appropriate update percentage under section 1834(a)(14) of the Social Security Act (42 U.S.C. 1395m(a)(14)) for class III medical devices de- scribed in section 513(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(a)(1)(C) [360c(a)(1)(C)]) furnished to medicare beneficiaries dur- ing 2007 and 2008.’’ USE OF DATA Pub. L. 108–173, title IV, § 414(c)(2), Dec. 8, 2003, 117 Stat. 2280, provided that: ‘‘In order to promptly imple- ment section 1834(l)(12) of the Social Security Act [42 U.S.C. 1395m(l)(12)], as added by paragraph (1), the Sec- retary [of Health and Human Services] may use data furnished by the Comptroller General of the United States.’’ GAO REPORT ON COSTS AND ACCESS Pub. L. 108–173, title IV, § 414(f), Dec. 8, 2003, 117 Stat. 2280, which required the Comptroller General of the United States to submit to Congress initial and final reports on how costs differ among the types of ambu- lance providers and on access, supply, and quality of ambulance services in those regions and States that have a reduction in payment under the medicare ambu- lance fee schedule under section 1395m(l) of this title, Page 3155 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m was repealed by Pub. L. 111–68, div. A, title I, § 1501(e)(1), Oct. 1, 2009, 123 Stat. 2041. REPORT ON DEMONSTRATION PROJECT PERMITTING SKILLED NURSING FACILITIES TO BE ORIGINATING TELEHEALTH SITES; AUTHORITY TO IMPLEMENT Pub. L. 108–173, title IV, § 418, Dec. 8, 2003, 117 Stat. 2283, provided that: ‘‘(a) EVALUATION.—The Secretary [of Health and Human Services], acting through the Administrator of the Health Resources and Services Administration in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall evaluate dem- onstration projects conducted by the Secretary under which skilled nursing facilities (as defined in section 1819(a) of the Social Security Act (42 U.S.C. 1395i–3(a))[)] are treated as originating sites for tele- health services. ‘‘(b) REPORT.—Not later than January 1, 2005, the Sec- retary shall submit to Congress a report on the evalua- tion conducted under subsection (a). Such report shall include recommendations on mechanisms to ensure that permitting a skilled nursing facility to serve as an originating site for the use of telehealth services or any other service delivered via a telecommunications sys- tem does not serve as a substitute for in-person visits furnished by a physician, or for in-person visits fur- nished by a physician assistant, nurse practitioner or clinical nurse specialist, as is otherwise required by the Secretary. ‘‘(c) AUTHORITY TO EXPAND ORIGINATING TELEHEALTH SITES TO INCLUDE SKILLED NURSING FACILITIES.—Inso- far as the Secretary concludes in the report required under subsection (b) that it is advisable to permit a skilled nursing facility to be an originating site for telehealth services under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), and that the Sec- retary can establish the mechanisms to ensure such permission does not serve as a substitute for in-person visits furnished by a physician, or for in-person visits furnished by a physician assistant, nurse practitioner or clinical nurse specialist, the Secretary may deem a skilled nursing facility to be an originating site under paragraph (4)(C)(ii) of such section beginning on Janu- ary 1, 2006.’’ PAYMENT FOR NEW TECHNOLOGIES Pub. L. 106–554, § 1(a)(6) [title I, § 104(d)], Dec. 21, 2000, 114 Stat. 2763, 2763A–470, as amended by Pub. L. 108–173, title IX, § 900(e)(6)(H), Dec. 8, 2003, 117 Stat. 2374, pro- vided that: ‘‘(1) TESTS FURNISHED IN 2001.— ‘‘(A) SCREENING.—For a screening mammography (as defined in section 1861(jj) of the Social Security Act (42 U.S.C. 1395x(jj))) furnished during the period beginning on April 1, 2001, and ending on December 31, 2001, that uses a new technology, payment for such screening mammography shall be made as follows: ‘‘(i) In the case of a technology which directly takes a digital image (without involving film), in an amount equal to 150 percent of the amount of payment under section 1848 of such Act (42 U.S.C. 1395w–4) for a bilateral diagnostic mammography (under HCPCS code 76091) for such year. ‘‘(ii) In the case of a technology which allows con- version of a standard film mammogram into a dig- ital image and subsequently analyzes such result- ing image with software to identify possible prob- lem areas, in an amount equal to the limit that would otherwise be applied under section 1834(c)(3) of such Act (42 U.S.C. 1395m(c)(3)) for 2001, increased by $15. ‘‘(B) BILATERAL DIAGNOSTIC MAMMOGRAPHY.—For a bilateral diagnostic mammography furnished during the period beginning on April 1, 2001, and ending on December 31, 2001, that uses a new technology de- scribed in subparagraph (A), payment for such mam- mography shall be the amount of payment provided for under such subparagraph. ‘‘(C) ALLOCATION OF AMOUNTS.—The Secretary shall provide for an appropriate allocation of the amounts under subparagraphs (A) and (B) between the profes- sional and technical components. ‘‘(D) IMPLEMENTATION OF PROVISION.—The Secretary of Health and Human Services may implement the provisions of this paragraph by program memo- randum or otherwise. ‘‘(2) CONSIDERATION OF NEW HCPCS CODE FOR NEW TECH- NOLOGIES AFTER 2001.—The Secretary shall determine, for such mammographies performed after 2001, whether the assignment of a new HCPCS code is appropriate for mammography that uses a new technology. If the Sec- retary determines that a new code is appropriate for such mammography, the Secretary shall provide for such new code for such tests furnished after 2001. ‘‘(3) NEW TECHNOLOGY DESCRIBED.—For purposes of this subsection, a new technology with respect to a mammography is an advance in technology with re- spect to the test or equipment that results in the fol- lowing: ‘‘(A) A significant increase or decrease in the re- sources used in the test or in the manufacture of the equipment. ‘‘(B) A significant improvement in the performance of the test or equipment. ‘‘(C) A significant advance in medical technology that is expected to significantly improve the treat- ment of medicare beneficiaries. ‘‘(4) HCPCS CODE DEFINED.—The term ‘HCPCS code’ means a code under the Health Care Common Proce- dure Coding System (HCPCS).’’ MEDPAC STUDY AND REPORT ON MEDICARE COVERAGE OF CARDIAC AND PULMONARY REHABILITATION THER- APY SERVICES Pub. L. 106–554, § 1(a)(6) [title I, § 127], Dec. 21, 2000, 114 Stat. 2763, 2763A–479, provided that: ‘‘(a) STUDY.— ‘‘(1) IN GENERAL.—The Medicare Payment Advisory Commission shall conduct a study on coverage of car- diac and pulmonary rehabilitation therapy services under the medicare program under title XVIII of the Social Security Act [this subchapter]. ‘‘(2) FOCUS.—In conducting the study under para- graph (1), the Commission shall focus on the appro- priate— ‘‘(A) qualifying diagnoses required for coverage of cardiac and pulmonary rehabilitation therapy serv- ices; ‘‘(B) level of physician direct involvement and su- pervision in furnishing such services; and ‘‘(C) level of reimbursement for such services. ‘‘(b) REPORT.—Not later than 18 months after the date of the enactment of this Act [Dec. 21, 2000], the Com- mission shall submit to Congress a report on the study conducted under subsection (a) together with such rec- ommendations for legislation and administrative ac- tion as the Commission determines appropriate.’’ GAO STUDIES ON COSTS OF AMBULANCE SERVICES FURNISHED IN RURAL AREAS Pub. L. 106–554, § 1(a)(6) [title II, § 221(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–486, provided that: ‘‘(1) STUDY.—The Comptroller General of the United States shall conduct a study on each of the matters de- scribed in paragraph (2). ‘‘(2) MATTERS DESCRIBED.—The matters referred to in paragraph (1) are the following: ‘‘(A) The cost of efficiently providing ambulance services for trips originating in rural areas, with spe- cial emphasis on collection of cost data from rural providers. ‘‘(B) The means by which rural areas with low pop- ulation densities can be identified for the purpose of designating areas in which the cost of providing am- bulance services would be expected to be higher than similar services provided in more heavily populated areas because of low usage. Such study shall also in- Page 3156 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m clude an analysis of the additional costs of providing ambulance services in areas designated under the pre- vious sentence. ‘‘(3) REPORT.—Not later than June 30, 2002, the Comp- troller General shall submit to Congress a report on the results of the studies conducted under paragraph (1) and shall include recommendations on steps that should be taken to assure access to ambulance services in rural areas.’’ ADJUSTMENT IN RURAL RATES Pub. L. 106–554, § 1(a)(6) [title II, § 221(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–487, as amended by Pub. L. 108–173, title IV, § 414(f)(1), formerly § 414(g)(1), Dec. 8, 2003, 117 Stat. 2281, as renumbered by Pub. L. 111–68, div. A, title I, § 1501(e)(2), Oct. 1, 2009, 123 Stat. 2041, provided that: ‘‘In providing for adjustments under subparagraph (D) of section 1834(l)(2) of the Social Security Act (42 U.S.C. 1395m(l)(2)) for years beginning with 2004, the Secretary of Health and Human Services shall take into consider- ation the recommendations contained in the report under subsection (b)(3) [set out above] and shall adjust the fee schedule payment rates under such section for ambulance services provided in low density rural areas based on the increased cost (if any) of providing such services in such areas.’’ STUDY AND REPORT ON ADDITIONAL COVERAGE FOR TELEHEALTH SERVICES Pub. L. 106–554, § 1(a)(6) [title II, § 223(d)], Dec. 21, 2000, 114 Stat. 2763, 2763A–489, provided that: ‘‘(1) STUDY.—The Secretary of Health and Human Services shall conduct a study to identify— ‘‘(A) settings and sites for the provision of tele- health services that are in addition to those per- mitted under section 1834(m) of the Social Security Act [42 U.S.C. 1395m(m)], as added by subsection (b); ‘‘(B) practitioners that may be reimbursed under such section for furnishing telehealth services that are in addition to the practitioners that may be reim- bursed for such services under such section; and ‘‘(C) geographic areas in which telehealth services may be reimbursed that are in addition to the geo- graphic areas where such services may be reimbursed under such section. ‘‘(2) REPORT.—Not later than 2 years after the date of the enactment of this Act [Dec. 21, 2000], the Secretary shall submit to Congress a report on the study con- ducted under paragraph (1) together with such rec- ommendations for legislation that the Secretary deter- mines are appropriate.’’ SPECIAL RULES FOR PAYMENTS FOR 2001 Pub. L. 106–554, § 1(a)(6) [title IV, § 423(a)(2)], Dec. 21, 2000, 114 Stat. 2763, 2763A–518, provided that: ‘‘Notwith- standing the amendment made by paragraph (1) [amending this section], for purposes of making pay- ments for ambulance services under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.], for services furnished during 2001, the ‘percentage increase in the consumer price index’ specified in sec- tion 1834(l)(3)(B) of such Act (42 U.S.C. 1395m(l)(3)(B))— ‘‘(A) for services furnished on or after January 1, 2001, and before July 1, 2001, shall be the percentage increase for 2001 as determined under the provisions of law in effect on the day before the date of the en- actment of this Act [Dec. 21, 2000]; and ‘‘(B) for services furnished on or after July 1, 2001, and before January 1, 2002, shall be equal to 4.7 per- cent.’’ Pub. L. 106–554, § 1(a)(6) [title IV, § 425(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–519, provided that: ‘‘Notwith- standing the amendments made by subsection (a) [amending this section], for purposes of making pay- ments for durable medical equipment under section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)), other than for oxygen and oxygen equipment specified in paragraph (9) of such section, the payment basis rec- ognized for 2001 under such section— ‘‘(1) for items furnished on or after January 1, 2001, and before July 1, 2001, shall be the payment basis for 2001 as determined under the provisions of law in ef- fect on the day before the date of the enactment of this Act [Dec. 21, 2000] (including the application of section 228(a)(1) of BBRA [Pub. L. 106–113, § 1000(a)(6) [title II, § 228(a)(1)], set out as a note below]); and ‘‘(2) for items furnished on or after July 1, 2001, and before January 1, 2002, shall be the payment basis that is determined under such section 1834(a) if such section 228(a)(1) did not apply and taking into ac- count the amendment made by subsection (a), in- creased by a transitional percentage allowance equal to 3.28 percent (to account for the timing of imple- mentation of the CPI update).’’ Pub. L. 106–554, § 1(a)(6) [title IV, § 426(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–520, provided that: ‘‘Notwith- standing the amendments made by subsection (a) [amending this section], for purposes of making pay- ments for prosthetic devices and orthotics and pros- thetics (as defined in subparagraphs (B) and (C) of para- graph (4) of section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) under such section, the payment basis recognized for 2001 under paragraph (2) of such section— ‘‘(1) for items furnished on or after January 1, 2001, and before July 1, 2001, shall be the payment basis for 2001 as determined under the provisions of law in ef- fect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and ‘‘(2) for items furnished on or after July 1, 2001, and before January 1, 2002, shall be the payment basis that is determined under such section taking into ac- count the amendments made by subsection (a), in- creased by a transitional percentage allowance equal to 2.6 percent (to account for the timing of implemen- tation of the CPI update).’’ PREEMPTION OF RULE Pub. L. 106–554, § 1(a)(6) [title IV, § 428(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–522, provided that: ‘‘The pro- visions of section 1834(h)(1)(G) [42 U.S.C. 1395m(h)(1)(G)] as added by subsection (a) shall supersede any rule that as of the date of the enactment of this Act [Dec. 21, 2000] may have applied a 5-year replacement rule with regard to prosthetic devices.’’ GAO STUDY AND REPORT ON COSTS OF EMERGENCY AND MEDICAL TRANSPORTATION SERVICES Pub. L. 106–554, § 1(a)(6) [title IV, § 436], Dec. 21, 2000, 114 Stat. 2763, 2763A–527, provided that: ‘‘(a) STUDY.—The Comptroller General of the United States shall conduct a study on the costs of providing emergency and medical transportation services across the range of acuity levels of conditions for which such transportation services are provided. ‘‘(b) REPORT.—Not later than 18 months after the date of the enactment of this Act [Dec. 21, 2000], the Comp- troller General shall submit to Congress a report on the study conducted under subsection (a), together with recommendations for any changes in methodology or payment level necessary to fairly compensate suppliers of emergency and medical transportation services and to ensure the access of beneficiaries under the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].’’ TREATMENT OF TEMPORARY PAYMENT INCREASES AFTER CALENDAR YEAR 2001 Pub. L. 106–554, § 1(a)(6) [title V, § 547(d)], Dec. 21, 2000, 114 Stat. 2763, 2763A–553, provided that: ‘‘The payment increase provided under the following sections shall not apply after calendar year 2001 and shall not be taken into account in calculating the payment amounts ap- plicable for items and services furnished after such year: ‘‘(1) Section 401(c)(2) [set out as a note under sec- tion 1395l of this title] (relating to covered OPD serv- ices). Page 3157 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m ‘‘(2) Section 422(e)(2) [set out as a note under sec- tion 1395rr of this title] (relating to renal dialysis services paid for on a composite rate basis). ‘‘(3) Section 423(a)(2)(B) [set out above] (relating to ambulance services). ‘‘(4) Section 425(b)(2) [set out above] (relating to du- rable medical equipment). ‘‘(5) Section 426(b)(2) [set out above] (relating to prosthetic devices and orthotics and prosthetics).’’ STUDY OF DELIVERY OF INTRAVENOUS IMMUNE GLOB- ULIN (IVIG) OUTSIDE HOSPITALS AND PHYSICIANS’ OF- FICES Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 201(n)], Nov. 29, 1999, 113 Stat. 1536, 1501A–341, required the Sec- retary of Health and Human Services to conduct a study of the extent to which intravenous immune glob- ulin could be delivered and reimbursed under the medi- care program outside of a hospital or physician’s office and to submit a report on such study to Congress with- in 18 months after Nov. 29, 1999. TEMPORARY INCREASE IN PAYMENT RATES FOR DURABLE MEDICAL EQUIPMENT AND OXYGEN Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 228], Nov. 29, 1999, 113 Stat. 1536, 1501A–356, provided that: ‘‘(a) IN GENERAL.—For purposes of payments under section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) for covered items (as defined in paragraph (13) of that section) furnished during 2001 and 2002, the Sec- retary of Health and Human Services shall increase the payment amount in effect (but for this section) for such items for— ‘‘(1) 2001 by 0.3 percent, and ‘‘(2) 2002 by 0.6 percent. ‘‘(b) LIMITING APPLICATION TO SPECIFIED YEARS.—The payment amount increase— ‘‘(1) under subsection (a)(1) shall not apply after 2001 and shall not be taken into account in calcu- lating the payment amounts applicable for covered items furnished after such year; and ‘‘(2) under subsection (a)(2) shall not apply after 2002 and shall not be taken into account in calcu- lating the payment amounts applicable for covered items furnished after such year.’’ DEMONSTRATION OF COVERAGE OF AMBULANCE SERVICES UNDER MEDICARE THROUGH CONTRACTS WITH UNITS OF LOCAL GOVERNMENT Pub. L. 105–33, title IV, § 4532, Aug. 5, 1997, 111 Stat. 453, as amended by Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 225], Nov. 29, 1999, 113 Stat. 1536, 1501A–353, provided that: ‘‘(a) DEMONSTRATION PROJECT CONTRACTS WITH LOCAL GOVERNMENTS.—The Secretary of Health and Human Services shall establish up to 3 demonstration projects under which, at the request of a unit of local govern- ment, the Secretary enters into a contract with the unit of local government under which— ‘‘(1) the unit of local government furnishes (or ar- ranges for the furnishing of) ambulance services for which payment may be made under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] for individuals residing in the unit of local gov- ernment who are enrolled under such part, except that the unit of local government may not enter into the contract unless the contract covers at least 80 percent of the individuals residing in the unit of local government who are enrolled under such part but not in a Medicare+Choice plan; ‘‘(2) any individual or entity furnishing ambulance services under the contract meets the requirements otherwise applicable to individuals and entities fur- nishing such services under such part; and ‘‘(3) for each month during which the contract is in effect, the Secretary makes a capitated payment to the unit of local government in accordance with sub- section (b). The projects may extend over a period of not to exceed 3 years each. Not later than July 1, 2000, the Secretary shall publish a request for proposals for such projects. ‘‘(b) AMOUNT OF PAYMENT.— ‘‘(1) IN GENERAL.—The amount of the monthly pay- ment made for months occurring during a calendar year to a unit of local government under a dem- onstration project contract under subsection (a) shall be equal to the product of— ‘‘(A) the Secretary’s estimate of the number of in- dividuals covered under the contract for the month; and ‘‘(B) 1⁄12 of the capitated payment rate for the year established under paragraph (2). ‘‘(2) CAPITATED PAYMENT RATE DEFINED.—In this subsection, the term ‘capitated payment rate’ means, with respect to a demonstration project— ‘‘(A) in its first year, a rate established for the project by the Secretary, using the most current available data, in a manner that ensures that ag- gregate payments under the project will not exceed the aggregate payment that would have been made for ambulance services under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] in the local area of government’s jurisdiction; and ‘‘(B) in a subsequent year, the capitated payment rate established for the previous year increased by an appropriate inflation adjustment factor. ‘‘(c) OTHER TERMS OF CONTRACT.—The Secretary and the unit of local government may include in a contract under this section such other terms as the parties con- sider appropriate, including— ‘‘(1) covering individuals residing in additional units of local government (under arrangements en- tered into between such units and the unit of local government involved); ‘‘(2) permitting the unit of local government to transport individuals to non-hospital providers if such providers are able to furnish quality services at a lower cost than hospital providers; or ‘‘(3) implementing such other innovations as the unit of local government may propose to improve the quality of ambulance services and control the costs of such services. ‘‘(d) CONTRACT PAYMENTS IN LIEU OF OTHER BENE- FITS.—Payments under a contract to a unit of local government under this section shall be instead of the amounts which (in the absence of the contract) would otherwise be payable under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] for the serv- ices covered under the contract which are furnished to individuals who reside in the unit of local government. ‘‘(e) REPORT ON EFFECTS OF CAPITATED CONTRACTS.— ‘‘(1) STUDY.—The Secretary shall evaluate the dem- onstration projects conducted under this section. Such evaluation shall include an analysis of the qual- ity and cost-effectiveness of ambulance services fur- nished under the projects. ‘‘(2) REPORT.—Not later than January 1, 2000, the Secretary shall submit a report to Congress on the study conducted under paragraph (1), and shall in- clude in the report such recommendations as the Sec- retary considers appropriate, including recommenda- tions regarding modifications to the methodology used to determine the amount of payments made under such contracts and extending or expanding such projects.’’ [References to Medicare+Choice deemed to refer to Medicare Advantage, see section 201(b) of Pub. L. 108–173, set out as a note under section 1395w–21 of this title.] [Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 225], Nov. 29, 1999, 113 Stat. 1536, 1501A–353, provided that the amendment made by that section to section 4532 of Pub. L. 105–33, set out above, is effective as if included in the enactment of the Balanced Budget Act of 1997, Pub. L. 105–33.] PAYMENT FREEZE FOR PARENTERAL AND ENTERAL NUTRIENTS, SUPPLIES, AND EQUIPMENT Pub. L. 105–33, title IV, § 4551(b), Aug. 5, 1997, 111 Stat. 458, provided that: ‘‘In determining the amount of pay- ment under part B of title XVIII of the Social Security Page 3158 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m Act [42 U.S.C. 1395j et seq.] with respect to parenteral and enteral nutrients, supplies, and equipment during each of the years 1998 through 2002, the charges deter- mined to be reasonable with respect to such nutrients, supplies, and equipment may not exceed the charges determined to be reasonable with respect to such nutri- ents, supplies, and equipment during 1995.’’ SERVICE STANDARDS FOR PROVIDERS OF OXYGEN AND OXYGEN EQUIPMENT Pub. L. 105–33, title IV, § 4552(c), Aug. 5, 1997, 111 Stat. 459, provided that: ‘‘The Secretary shall as soon as practicable establish service standards for persons seeking payment under part B of title XVIII of the So- cial Security Act [42 U.S.C. 1395j et seq.] for the pro- viding of oxygen and oxygen equipment to beneficiaries within their homes.’’ ACCESS TO HOME OXYGEN EQUIPMENT Pub. L. 105–33, title IV, § 4552(d), Aug. 5, 1997, 111 Stat. 459, provided that: ‘‘(1) STUDY.—The Comptroller General of the United States shall study issues relating to access to home ox- ygen equipment and shall, within 18 months after the date of the enactment of this Act [Aug. 5, 1997], report to the Committees on Commerce and Ways and Means of the House of Representatives and the Committee on Finance of the Senate the results of the study, includ- ing recommendations (if any) for legislation. ‘‘(2) PEER REVIEW EVALUATION.—The Secretary of Health and Human Services shall arrange for peer re- view [now ‘‘quality improvement’’] organizations es- tablished under section 1154 of the Social Security Act [42 U.S.C. 1320c–3] to evaluate access to, and quality of, home oxygen equipment.’’ USE OF COVERED ITEMS BY DISABLED BENEFICIARIES Pub. L. 103–432, title I, § 131(b), Oct. 31, 1994, 108 Stat. 4419, provided that: ‘‘(1) IN GENERAL.—The Secretary of Health and Human Services, in consultation with representatives of suppliers of durable medical equipment under part B of the medicare program [42 U.S.C. 1395j et seq.] and in- dividuals entitled to benefits under such program on the basis of disability, shall conduct a study of the ef- fects of the methodology for determining payments for items of such equipment under such part on the ability of such individuals to obtain items of such equipment, including customized items. ‘‘(2) REPORT.—Not later than one year after the date of the enactment of this Act [Oct. 31, 1994], the Sec- retary shall submit a report to Congress on the study conducted under paragraph (1), and shall include in the report such recommendations as the Secretary con- siders appropriate to assure that disabled medicare beneficiaries have access to items of durable medical equipment.’’ CRITERIA FOR TREATMENT OF ITEMS AS PROSTHETIC DEVICES OR ORTHOTICS AND PROSTHETICS Pub. L. 103–432, title I, § 131(c), Oct. 31, 1994, 108 Stat. 4419, provided that not later than one year after Oct. 31, 1994, Secretary of Health and Human Services was to submit to Congress a report describing prosthetic de- vices or orthotics and prosthetics covered under this part that do not require individualized or custom fit- ting and adjustment to be used by a patient, including recommendations for appropriate methodology for de- termining amount of payment for such items. ADJUSTMENT REQUIRED FOR CERTAIN ITEMS Pub. L. 103–432, title I, § 134(b), Oct. 31, 1994, 108 Stat. 4422, provided that: ‘‘(1) IN GENERAL.—In accordance with section 1834(a)(10)(B) of the Social Security Act [42 U.S.C. 1395m(a)(10)(B)] (as amended by subsection (a)), the Secretary of Health and Human Services shall deter- mine whether the payment amounts for the items de- scribed in paragraph (2) are not inherently reasonable, and shall adjust such amounts in accordance with such section if the amounts are not inherently reasonable. ‘‘(2) ITEMS DESCRIBED.—The items referred to in para- graph (1) are decubitus care equipment, transcutaneous electrical nerve stimulators, and any other items con- sidered appropriate by the Secretary.’’ LIMITATION ON PREVAILING CHARGE FOR PHYSICIANS’ RADIOLOGY SERVICES FURNISHED DURING 1991; EXCEP- TIONS Pub. L. 101–508, title IV, § 4102(c), Nov. 5, 1990, 104 Stat. 1388–57, as amended by Pub. L. 103–432, title I, § 126(b)(3), Oct. 31, 1994, 108 Stat. 4415, provided that: ‘‘(1) IN GENERAL.—In applying part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.], the pre- vailing charge for physicians’ services, furnished dur- ing 1991, which are radiology services may not exceed the fee schedule amount established under section 1834(b) of such Act [42 U.S.C. 1395m(b)] with respect to such services. ‘‘(2) EXCEPTION.—Paragraph (1) shall not apply to nu- clear medicine services.’’ LIMITATION ON CARRIER ADJUSTMENTS FOR RADIOLOGIST SERVICES FURNISHED DURING 1991 Pub. L. 101–508, title IV, § 4102(e), Nov. 5, 1990, 104 Stat. 1388–57, provided that: ‘‘For radiologist services furnished during 1991 for which payment is made under section 1834(b) of the Social Security Act [42 U.S.C. 1395m(b)]— ‘‘(1) a carrier may not make any adjustment, under section 1842(b)(3)(B) of such Act [42 U.S.C. 1395u(b)(3)(B)], 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 cir- cumstances, 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 Pub. L. 101–508, title IV, § 4153(c), Nov. 9, 1990, 104 Stat. 1388–84, as amended by Pub. L. 103–432, title I, § 135(e)(6), Oct. 31, 1994, 108 Stat. 4424, directed Comp- troller General to conduct a study of feasibility and de- sirability of establishing a separate fee schedule for use in determining the amount of payments for covered items under subsec. (h) of this section with respect to suppliers of prosthetic devices, orthotics, and pros- thetics who provide professional services that would take into account the costs to such providers of pro- viding such services and, not later than 1 year after Nov. 5, 1990, submit a report on the study to Commit- tees on Energy and Commerce and Ways and Means of House of Representatives and Committee on Finance of Senate, including any recommendations regarding pay- ments for prosthetic devices, orthotics, and prosthetics under the medicare program. SPECIAL RULE FOR NUCLEAR MEDICINE PHYSICIANS Pub. L. 101–239, title VI, § 6105(b), Dec. 19, 1989, 103 Stat. 2210, as amended by Pub. L. 101–508, title IV, § 4102(g)(1), Nov. 5, 1990, 104 Stat. 1388–57, provided that: ‘‘In applying section 1834(b) of the Social Security Act [42 U.S.C. 1395m(b)] with respect to nuclear medicine services furnished by a physician for whom nuclear medicine services account for at least 80 percent of the total amount of charges made under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] beginning April 1, 1990, and ending December 31, 1991, there shall be substituted for the fee schedule other- wise applicable a fee schedule based 1⁄3 on the fee sched- ule computed under such section (without regard to this subsection) and 2⁄3 on 101 percent of the 1988 pre- vailing charge for such services.’’ Page 3159 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m SPECIAL RULE FOR INTERVENTIONAL RADIOLOGISTS; ‘‘SPLIT BILLING’’ Pub. L. 101–239, title VI, § 6105(c), Dec. 19, 1989, 103 Stat. 2210, as amended by Pub. L. 101–508, title IV, § 4102(h), Nov. 5, 1990, 104 Stat. 1388–58, provided that: ‘‘In applying section 1834(b) of the Social Security Act [42 U.S.C. 1395m(b)] to radiologist services furnished in 1990 or 1991, the exception for ‘split billing’ set forth at section 5262J of the Medicare Carriers Manual shall apply to services furnished in 1990 or 1991 in the same manner and to the same extent as the exception applied to services furnished in 1989.’’ RENTAL PAYMENTS FOR ENTERAL AND PARENTERAL PUMPS Pub. L. 101–239, title VI, § 6112(b), Dec. 19, 1989, 103 Stat. 2215, provided that: ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), the amount of any monthly rental payment under part B of title XVIII of the Social Security Act [42 U.S.C. 1395j et seq.] for an enteral or parenteral pump fur- nished on or after April 1, 1990, shall be determined in accordance with the methodology under which monthly rental payments for such pumps were determined dur- ing 1989. ‘‘(2) CAP ON RENTAL PAYMENTS, SERVICING, AND RE- PAIRS.—In the case of an enteral or parenteral pump de- scribed in paragraph (1) that is furnished on a rental basis during a period of medical need— ‘‘(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 Sec- retary of Health and Human Services determines to be reasonable and necessary to ensure the proper op- eration of the pump.’’ TREATMENT OF POWER-DRIVEN WHEELCHAIRS AS CUSTOMIZED ITEMS Pub. L. 101–239, title VI, § 6112(d)(2), Dec. 19, 1989, 103 Stat. 2215, provided that: ‘‘The Secretary of Health and Human Services shall by regulation specify criteria to be used by carriers in making determinations on a case-by-case basis as whether to classify power-driven wheelchairs as a customized item (as described in sec- tion 1834(a)(4) of the Social Security Act [42 U.S.C. 1395m(a)(4)]) for purposes of reimbursement under title XVIII of such Act [42 U.S.C. 1395 et seq.].’’ STUDY OF PAYMENT FOR PORTABLE X-RAY SERVICES Pub. L. 101–239, title VI, § 6134, Dec. 19, 1989, 103 Stat. 2222, directed Secretary of Health and Human Services to conduct a study of costs of furnishing, and payments for, portable x-ray services under part B and, not later than 1 year after Dec. 19, 1989, report to Congress on re- sults of such study including a recommendation re- specting whether payment for such services should be made in the same manner as for radiologists’ services or on the basis of a separate fee schedule. GAO STUDY OF STANDARDS FOR USE OF AND PAYMENT FOR ITEMS OF DURABLE MEDICAL EQUIPMENT Pub. L. 101–239, title VI, § 6139, Dec. 19, 1989, 103 Stat. 2224, directed Comptroller General to conduct a study of appropriate uses of items of durable medical equip- ment and of appropriate criteria for making determina- tions of medical necessity under this subchapter for such items, with particular emphasis on items (includ- ing seat-lift chairs) that may be subject to abusive bill- ing practices, such study to include an analysis of ap- propriate use of forms in making medical necessity de- terminations for items of durable medical equipment under such title, and procedures for identifying items of durable medical equipment that should no longer be covered under this subchapter, and to be conducted with a panel convened by the Comptroller General con- sisting of specialists in the disciplines of orthopedic medicine, rehabilitation, arthritis, and geriatric medi- cine, representatives of consumer organizations, and representatives of carriers under the medicare pro- gram, with the Comptroller General to submit not later than Apr. 1, 1991, a report to Committees on Ways and Means and Energy and Commerce of House of Rep- resentatives and Committee on Finance of Senate on the study including recommendations. REPORTS ON MEDICARE BENEFICIARY DRUG EXPENSES Pub. L. 100–360, title II, § 202(i), July 1, 1988, 102 Stat. 718, directed Secretary of Health and Human Services, by not later than Apr. 1, 1989, to report to Congress on expenses incurred by medicare beneficiaries for out- patient prescription drugs, and to provide Director of Congressional Budget Office with such data from that Survey as Director might request to make required es- timates, prior to repeal by Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981. ADDITIONAL STUDIES BY SECRETARY OR COMPTROLLER GENERAL Pub. L. 100–360, title II, § 202(k), July 1, 1988, 102 Stat. 719, directed Secretary of Health and Human Services to conduct a study, and make a report to Congress by Jan. 1, 1990, on possibility of including drugs which have not yet been approved under section 355 or 357 of Title 21, Food and Drugs, and biological products which have not been licensed under section 262 of this title but which are commonly used in the treatment of can- cer or in immunosuppressive therapy and other experi- mental drugs and biological products as covered out- patient drugs under medicare program, to conduct a study, and report to Congress by Jan. 1, 1990, evalu- ating potential to use mail service pharmacies to re- duce costs to medicare program and to medicare bene- ficiaries, to conduct a study, and report to Congress by Jan. 1, 1993, on methods to improve utilization review of covered outpatient drugs, and to conduct a longitu- dinal study, and report to Congress by Jan. 1, 1993, on use of outpatient prescription drugs by medicare bene- ficiaries with respect to medical necessity, potential for adverse drug interactions, cost (including whether lower cost drugs could have been used), and patient stockpiling or wastage, and which further directed Comptroller General to conduct studies, and report to Congress by not later than May 1, 1991, on comparing average wholesale prices with actual pharmacy acquisi- tion costs by type of pharmacy, on determining the overhead costs of retail pharmacies, and on discounts given by pharmacies to other third-party insurers, prior to repeal by Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981. DEVELOPMENT OF STANDARD MEDICARE CLAIMS FORMS Pub. L. 100–360, title II, § 202(l), July 1, 1988, 102 Stat. 720, directed Secretary of Health and Human Services to develop, in consultation with representatives of pharmacies and other interested individuals, a standard claims form (and a standard electronic claims format) to be used in requests for payment for covered out- patient drugs under medicare program and other third- party payors, prior to repeal by Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981. STUDIES AND REPORTS ON SCREENING MAMMOGRAPHY Pub. L. 100–360, title II, § 204(f), July 1, 1988, 102 Stat. 729, directed Physician Payment Review Commission to study and report, by July 1, 1989, to Committees on Ways and Means and Energy and Commerce of the House of Representatives and Committee on Finance of the Senate concerning the cost of providing screening mammography in a variety of settings and at different volume levels, prior to repeal by Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981. Page 3160 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395m–1 DEADLINE FOR ESTABLISHMENT OF FEE SCHEDULES FOR RADIOLOGIST SERVICES; REPORT TO CONGRESS Pub. L. 100–203, title IV, § 4049(b)(1), Dec. 22, 1987, 101 Stat. 1330–92, as amended by Pub. L. 100–360, title IV, § 411(f)(8)(E), July 1, 1988, 102 Stat. 780; Pub. L. 101–508, title IV, § 4118(g)(3), Nov. 5, 1990, 104 Stat. 1388–70, di- rected Secretary of Health and Human Services to pro- pose the relative value scale and fee schedules for radi- ologist services (under subsec. (b) of this section) by not later than Aug. 1, 1988. STUDY AND EVALUATION Pub. L. 100–203, title IV, § 4062(c), Dec. 22, 1987, 101 Stat. 1330–107, as amended by Pub. L. 100–360, title IV, § 411(g)(1)(C), July 1, 1988, 102 Stat. 782, provided that: ‘‘(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 cov- ered items and shall evaluate the appropriateness of the volume adjustment for oxygen and oxygen equip- ment under section 1834(a)(5)(C) of the Social Security Act [42 U.S.C. 1395m(a)(5)(C)] (as amended by subsection (b) of this section). The Secretary shall report to Con- gress, 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 alter- native methods of payment for covered items under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]. ‘‘(3) In this subsection, the term ‘covered item’ has the meaning given such term in section 1834(a)(13) of the Social Security Act [42 U.S.C. 1395m(a)(13)] (as amended by subsection (b) of this section). ‘‘(4) The Secretary shall, upon written request and payment of a reasonable copying fee which the Sec- retary 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 [42 U.S.C. 1395m(a)], 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 re- gional or national rates) by not later than January 1, 1991. Entities furnishing such items which fail to pro- vide 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 [42 U.S.C. 1320a–7(a)].’’ § 1395m–1. Improving policies for clinical diag- nostic laboratory tests (a) Reporting of private sector payment rates for establishment of medicare payment rates (1) In general (A) General reporting requirements Subject to subparagraph (B), beginning January 1, 2016, and every 3 years thereafter (or, annually, in the case of reporting with respect to an advanced diagnostic laboratory test, as defined in subsection (d)(5)), an ap- plicable laboratory (as defined in paragraph (2)) shall report to the Secretary, at a time specified by the Secretary (referred to in this subsection as the ‘‘reporting period’’), applicable information (as defined in para- graph (3)) for a data collection period (as de- fined in paragraph (4)) for each clinical diag- nostic laboratory test that the laboratory furnishes during such period for which pay- ment is made under this part. (B) Revised reporting period In the case of reporting with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the Secretary shall revise the reporting pe- riod under subparagraph (A) such that— (i) no reporting is required during the pe- riod beginning January 1, 2020, and ending December 31, 2025; (ii) reporting is required during the pe- riod beginning January 1, 2026, and ending March 31, 2026; and (iii) reporting is required every three years after the period described in clause (ii). (2) Definition of applicable laboratory In this section, the term ‘‘applicable labora- tory’’ means a laboratory that, with respect to its revenues under this subchapter, a majority of such revenues are from this section, section 1395l(h) of this title, or section 1395w–4 of this title. The Secretary may establish a low vol- ume or low expenditure threshold for exclud- ing a laboratory from the definition of appli- cable laboratory under this paragraph, as the Secretary determines appropriate. (3) Applicable information defined (A) In general In this section, subject to subparagraph (B), the term ‘‘applicable information’’ means, with respect to a laboratory test for a data collection period, the following: (i) The payment rate (as determined in accordance with paragraph (5)) that was paid by each private payor for the test dur- ing the period. (ii) The volume of such tests for each such payor for the period. (B) Exception for certain contractual ar- rangements Such term shall not include information with respect to a laboratory test for which payment is made on a capitated basis or other similar payment basis during the data collection period. (4) Data collection period defined (A) In general Subject to subparagraph (B), in this sec- tion, the term ‘‘data collection period’’ means a period of time, such as a previous 12 month period, specified by the Secretary. (B) Exception In the case of the reporting period de- scribed in paragraph (1)(B)(ii) with respect to clinical diagnostic laboratory tests that are not advanced diagnostic laboratory tests, the term ‘‘data collection period’’ means the period beginning January 1, 2019, and ending June 30, 2019. (5) Treatment of discounts The payment rate reported by a laboratory under this subsection shall reflect all dis-