Page 59

136 STAT. 1875 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(2) The determination of whether a drug is a part D rebatable drug under this section. ‘‘(3) The calculation of the rebate amount under this section. ‘‘(g) DEFINITIONS.—In this section: ‘‘(1) PART D REBATABLE DRUG.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), the term ‘part D rebatable drug’ means, with respect to an applicable period, a drug or biological described in subparagraph (C) that is a covered part D drug (as such term is defined under section 1860D–2(e)). ‘‘(B) EXCLUSION.— ‘‘(i) IN GENERAL.—Such term shall, with respect to an applicable period, not include a drug or biological if the average annual total cost under this part for such period per individual who uses such a drug or biological, as determined by the Secretary, is less than, subject to clause (ii), $100, as determined by the Sec- retary using the most recent data available or, if data is not available, as estimated by the Secretary. ‘‘(ii) INCREASE.—The dollar amount applied under clause (i)— ‘‘(I) for the applicable period beginning October 1, 2023, shall be the dollar amount specified under such clause for the applicable period beginning October 1, 2022, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12- month period beginning with October of 2023; and ‘‘(II) for a subsequent applicable period, shall be the dollar amount specified in this clause for the previous applicable period, increased by the percentage increase in the consumer price index for all urban consumers (United States city aver- age) for the 12-month period beginning with October of the previous period. Any dollar amount specified under this clause that is not a multiple of $10 shall be rounded to the nearest multiple of $10. ‘‘(C) DRUG OR BIOLOGICAL DESCRIBED.—A drug or biological described in this subparagraph is a drug or biological that, as of the first day of the applicable period involved, is— ‘‘(i) a drug approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act; ‘‘(ii) a drug approved under an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act, in the case where— ‘‘(I) the reference listed drug approved under section 505(c) of the Federal Food, Drug, and Cos- metic Act, including any ‘authorized generic drug’ (as that term is defined in section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act), is not being marketed, as identified in the Food and Drug Administration’s National Drug Code Directory; Time periods. Effective dates. Determinations. Estimate. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00059 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw