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136 STAT. 1837 PUBLIC LAW 117–169—AUG. 16, 2022 respect to the initial price applicability year 2027, the Secretary shall apply paragraph (1) as if the reference to ‘negotiation- eligible drugs described in subsection (d)(1)’ were a reference to ‘negotiation-eligible drugs described in subsection (d)(1)(A)’ and as if the reference to ‘total expenditures for such drugs under parts B and D of title XVIII’ were a reference to ‘total expenditures for such drugs under part D of title XVIII’. ‘‘(c) SELECTED DRUG.— ‘‘(1) IN GENERAL.—For purposes of this part, in accordance with subsection (e)(2) and subject to paragraph (2), each nego- tiation-eligible drug included on the list published under sub- section (a) with respect to an initial price applicability year shall be referred to as a ‘selected drug’ with respect to such year and each subsequent year beginning before the first year that begins at least 9 months after the date on which the Secretary determines at least one drug or biological product— ‘‘(A) is approved or licensed (as applicable)— ‘‘(i) under section 505(j) of the Federal Food, Drug, and Cosmetic Act using such drug as the listed drug; or ‘‘(ii) under section 351(k) of the Public Health Service Act using such drug as the reference product; and ‘‘(B) is marketed pursuant to such approval or licen- sure. ‘‘(2) CLARIFICATION.—A negotiation-eligible drug— ‘‘(A) that is included on the list published under sub- section (a) with respect to an initial price applicability year; and ‘‘(B) for which the Secretary makes a determination described in paragraph (1) before or during the negotiation period with respect to such initial price applicability year; shall not be subject to the negotiation process under section 1194 with respect to such negotiation period and shall continue to be considered a selected drug under this part with respect to the number of negotiation-eligible drugs published on the list under subsection (a) with respect to such initial price applicability year. ‘‘(d) NEGOTIATION-ELIGIBLE DRUG.— ‘‘(1) IN GENERAL.—For purposes of this part, subject to paragraph (2), the term ‘negotiation-eligible drug’ means, with respect to the selected drug publication date with respect to an initial price applicability year, a qualifying single source drug, as defined in subsection (e), that is described in either of the following subparagraphs (or, with respect to the initial price applicability year 2026 or 2027, that is described in subparagraph (A)): ‘‘(A) PART D HIGH SPEND DRUGS.—The qualifying single source drug is, determined in accordance with subsection (e)(2), among the 50 qualifying single source drugs with the highest total expenditures under part D of title XVIII, as determined by the Secretary in accordance with para- graph (3), during the most recent 12-month period for which data are available prior to such selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date). Definition. Determinations. Time periods. Time period. Determination. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00021 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw