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136 STAT. 1845 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(I) the average non-Federal average manufac- turer 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 average) 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; or ‘‘(II) the average non-Federal average manu- facturer price for such drug for the year prior to the selected drug publication date with respect to such initial price applicability year. ‘‘(2) PLAN SPECIFIC ENROLLMENT WEIGHTED AMOUNT.—For purposes of paragraph (1)(B)(i), the plan specific enrollment weighted amount for a prescription drug plan or an MA–PD plan with respect to a covered Part D drug is an amount equal to the product of— ‘‘(A) the negotiated price of the drug under such plan under part D of title XVIII, net of all price concessions received by such plan or pharmacy benefit managers on behalf of such plan, for the most recent year for which data is available; and ‘‘(B) a fraction— ‘‘(i) the numerator of which is the total number of individuals enrolled in such plan in such year; and ‘‘(ii) the denominator of which is the total number of individuals enrolled in a prescription drug plan or an MA–PD plan in such year. ‘‘(3) APPLICABLE PERCENT DESCRIBED.—For purposes of this subsection, the applicable percent described in this paragraph is the following: ‘‘(A) SHORT-MONOPOLY DRUGS AND VACCINES.—With respect to a selected drug (other than an extended- monopoly drug and a long-monopoly drug), 75 percent. ‘‘(B) EXTENDED-MONOPOLY DRUGS.—With respect to an extended-monopoly drug, 65 percent. ‘‘(C) LONG-MONOPOLY DRUGS.—With respect to a long- monopoly drug, 40 percent. ‘‘(4) EXTENDED-MONOPOLY DRUG DEFINED.— ‘‘(A) IN GENERAL.—In this part, subject to subpara- graph (B), the term ‘extended-monopoly drug’ means, with respect to an initial price applicability year, a selected drug for which at least 12 years, but fewer than 16 years, have elapsed since the date of approval of such drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act or since the date of licensure of such drug under section 351(a) of the Public Health Service Act, as applicable. ‘‘(B) EXCLUSIONS.—The term ‘extended-monopoly drug’ shall not include any of the following: Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00029 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw