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136 STAT. 1867 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(ii) the number of units for such billing and pay- ment code of such drug furnished during such calendar quarter— ‘‘(I) with respect to which the manufacturer provides a discount under the program under sec- tion 340B of the Public Health Service Act or a rebate under section 1927; or ‘‘(II) that are packaged into the payment amount for an item or service and are not sepa- rately payable. ‘‘(C) DETERMINATION OF INFLATION-ADJUSTED PAYMENT AMOUNT.—The inflation-adjusted payment amount deter- mined under this subparagraph for a part B rebatable drug for a calendar quarter is— ‘‘(i) the payment amount for the billing and pay- ment code for such drug in the payment amount bench- mark quarter (as defined in subparagraph (D)); increased by ‘‘(ii) the percentage by which the rebate period CPI–U (as defined in subparagraph (F)) for the cal- endar quarter exceeds the benchmark period CPI–U (as defined in subparagraph (E)). ‘‘(D) PAYMENT AMOUNT BENCHMARK QUARTER.—The term ‘payment amount benchmark quarter’ means the cal- endar quarter beginning July 1, 2021. ‘‘(E) BENCHMARK PERIOD CPI–U.—The term ‘benchmark period CPI–U’ means the consumer price index for all urban consumers (United States city average) for January 2021. ‘‘(F) REBATE PERIOD CPI–U.—The term ‘rebate period CPI–U’ means, with respect to a calendar quarter described in subparagraph (C), the greater of the benchmark period CPI–U and the consumer price index for all urban con- sumers (United States city average) for the first month of the calendar quarter that is two calendar quarters prior to such described calendar quarter. ‘‘(G) REDUCTION OR WAIVER FOR SHORTAGES AND SEVERE SUPPLY CHAIN DISRUPTIONS.—The Secretary shall reduce or waive the amount under subparagraph (A) with respect to a part B rebatable drug and a calendar quarter— ‘‘(i) in the case of a part B rebatable drug that is described as currently in shortage on the shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act at any point during the cal- endar quarter; or ‘‘(ii) in the case of a biosimilar biological product, when the Secretary determines there is a severe supply chain disruption during the calendar quarter, such as that caused by a natural disaster or other unique or unexpected event. ‘‘(4) SPECIAL TREATMENT OF CERTAIN DRUGS AND EXEMP- TION.— ‘‘(A) SUBSEQUENTLY APPROVED DRUGS.—In the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after December 1, 2020, clause (i) of paragraph (3)(C) shall be applied as if the term ‘payment amount benchmark quarter’ were defined Effective dates. Applicability. Time periods. Determination. Definition. Definition. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00051 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw