Sec. 104. Establishment of maximum add-on payment for drugs and biologicals
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Section 1847A of the Social Security Act ( 42 U.S.C. 1395w–3a ), as amended by section 103, is further amended— in subsection (b)— in paragraph (1), in the matter preceding subparagraph (A), by striking paragraph
(7)and inserting paragraphs
(7)and
(10); and by adding at the end the following new paragraph: In determining the payment amount under the provisions of subparagraph (A), (B), or
(C)of paragraph
(1)of this subsection, subsection (c)(4)(A)(ii), or subsection (d)(3)(C) for a drug or biological furnished on or after January 1, 2021, if the applicable add-on payment (as defined in subparagraph (B)) for each drug or biological on a claim for a date of service exceeds the maximum add-on payment amount specified under subparagraph
(C)for the drug or biological, then the payment amount otherwise determined for the drug or biological under those provisions, as applicable, shall be reduced by the amount of such excess. In this paragraph, the term applicable add-on payment means the following amounts, determined without regard to the application of subparagraph (A): In the case of a multiple source drug, an amount equal to the difference between— the amount that would otherwise be applied under paragraph (1)(A); and the amount that would be applied under such paragraph if 100 percent were substituted for the applicable percent (as defined in paragraph (9)) for such drug. In the case of a single source drug or biological, an amount equal to the difference between— the amount that would otherwise be applied under paragraph (1)(B); and the amount that would be applied under such paragraph if 100 percent were substituted for the applicable percent (as defined in paragraph (9)) for such drug or biological. In the case of a biosimilar biological product, the amount otherwise determined under paragraph (8)(B). In the case of a drug or biological during the initial period described in subsection (c)(4)(A), an amount equal to the difference between— the amount that would otherwise be applied under subsection (c)(4)(A)(ii); and the amount that would be applied under such subsection if 100 percent were substituted, as applicable, for— 103 percent in subclause
(I)of such subsection; or any percent in excess of 100 percent applied under subclause
(II)of such subsection. In the case of a drug or biological to which subsection (d)(3)(C) applies, an amount equal to the difference between— the amount that would otherwise be applied under such subsection; and the amount that would be applied under such subsection if 100 percent were substituted, as applicable, for— any percent in excess of 100 percent applied under clause
(i)of such subsection; or 103 percent in clause
(ii)of such subsection. For purposes of subparagraph (A), the maximum add-on payment amount specified in this subparagraph is— with respect to a drug or biological (other than autologous cellular immunotherapy)— for each of 2021 through 2028, $1,000; and for a subsequent year, the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year; or with respect to a drug or biological consisting of autologous cellular immunotherapy— for each of 2021 through 2028, $2,000; and for a subsequent year, the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year. Any amount determined under this subparagraph that is not a multiple of $10 shall be rounded to the nearest multiple of $10. ; and in subsection (c)(4)(A)(ii), by striking in the case and inserting subject to subsection (b)(10), in the case . Section 1833(t)(14) of the Social Security Act ( 42 U.S.C. 1395l(t)(14) ) is amended— in subparagraph (A)(iii)(II), by inserting , subject to subparagraph
(I)after are not available ; and by adding at the end the following new subparagraph: In establishing the amount of payment under subparagraph
(A)for a specified covered outpatient drug that is furnished as part of a covered OPD service (or group of services) on or after January 1, 2021, if such payment is determined based on the average price for the year established under section 1847A pursuant to clause (iii)(II) of such subparagraph, the provisions of subsection (b)(10) of section 1847A shall apply to the amount of payment so established in the same manner as such provisions apply to the amount of payment under section 1847A. . Section 1833(i)(2)(D) of the Social Security Act ( 42 U.S.C. 1395l(i)(2)(D) ) is amended— by moving clause
(v)6 ems to the left; by redesignating clause
(vi)as clause (vii); and by inserting after clause
(v)the following new clause: If there is a separate payment under the system described in clause
(i)for a drug or biological furnished on or after January 1, 2021, the provisions of subsection (t)(14)(I) shall apply to the establishment of the amount of payment for the drug or biological under such system in the same manner in which such provisions apply to the establishment of the amount of payment under subsection (t)(14)(A). .
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- 42 USC 1395w–3a
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Sec. 104
Establishment of maximum add-on payment for drugs and biologicals
Cite42 USC 1395w–3a
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