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136 STAT. 1844 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(F) LIMITATIONS ON OFFER AMOUNT.—In negotiating the maximum fair price of a selected drug, with respect to the initial price applicability year for the selected drug, and, as applicable, in renegotiating the maximum fair price for such drug, with respect to a subsequent year during the price applicability period for such drug, the Secretary shall not offer (or agree to a counteroffer for) a maximum fair price for the selected drug that— ‘‘(i) exceeds the ceiling determined under sub- section (c) for the selected drug and year; or ‘‘(ii) as applicable, is less than the floor determined under subsection (d) for the selected drug and year. ‘‘(c) CEILING FOR MAXIMUM FAIR PRICE.— ‘‘(1) GENERAL CEILING.— ‘‘(A) IN GENERAL.—The maximum fair price negotiated under this section for a selected drug, with respect to the first initial price applicability year of the price applica- bility period with respect to such drug, shall not exceed the lower of the amount under subparagraph (B) or the amount under subparagraph (C). ‘‘(B) SUBPARAGRAPH (B) AMOUNT.—An amount equal to the following: ‘‘(i) COVERED PART D DRUG.—In the case of a cov- ered part D drug (as defined in section 1860D–2(e)), the sum of the plan specific enrollment weighted amounts for each prescription drug plan or MA–PD plan (as determined under paragraph (2)). ‘‘(ii) PART B DRUG OR BIOLOGICAL.—In the case of a drug or biological product for which payment may be made under part B of title XVIII, the payment amount under section 1847A(b)(4) for the drug or biological product for the year prior to the year of the selected drug publication date with respect to the initial price applicability year for the drug or biological product. ‘‘(C) SUBPARAGRAPH (C) AMOUNT.—An amount equal to the applicable percent described in paragraph (3), with respect to such drug, of the following: ‘‘(i) INITIAL PRICE APPLICABILITY YEAR 2026.—In the case of a selected drug with respect to which such initial price applicability year is 2026, the average non-Federal average manufacturer price for such drug for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such drug for 2021, for the first full year following the market entry for such drug), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city aver- age) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the year of the selected drug publication date with respect to such initial price applicability year. ‘‘(ii) INITIAL PRICE APPLICABILITY YEAR 2027 AND SUBSEQUENT YEARS.—In the case of a selected drug with respect to which such initial price applicability year is 2027 or a subsequent year, the lower of— VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00028 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw