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136 STAT. 1885 PUBLIC LAW 117–169—AUG. 16, 2022 described in subclause (I) if such manufacturer is acquired after 2021 by another manufacturer that is not a specified manufacturer, effective at the beginning of the plan year immediately fol- lowing such acquisition or, in the case of an acquisition before 2025, effective January 1, 2025. ‘‘(iii) SPECIFIED LIS PERCENT.—In this subpara- graph, the ‘specified LIS percent’ means, with respect to a year— ‘‘(I) for an applicable drug dispensed for an applicable beneficiary described in clause (i) who has not incurred costs, as determined in accord- ance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year— ‘‘(aa) for 2025, 99 percent; ‘‘(bb) for 2026, 98 percent; ‘‘(cc) for 2027, 95 percent; ‘‘(dd) for 2028, 92 percent; and ‘‘(ee) for 2029 and each subsequent year, 90 percent; and ‘‘(II) for an applicable drug dispensed for an applicable beneficiary described in clause (i) who has incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in sec- tion 1860D–2(b)(4)(B)(i) for the year— ‘‘(aa) for 2025, 99 percent; ‘‘(bb) for 2026, 98 percent; ‘‘(cc) for 2027, 95 percent; ‘‘(dd) for 2028, 92 percent; ‘‘(ee) for 2029, 90 percent; ‘‘(ff) for 2030, 85 percent; and ‘‘(gg) for 2031 and each subsequent year, 80 percent. ‘‘(C) PHASE-IN FOR SPECIFIED SMALL MANUFACTURERS.— ‘‘(i) IN GENERAL.—In the case of an applicable drug of a specified small manufacturer (as defined in clause (ii)) that is marketed as of the date of enactment of this subparagraph and dispensed for an applicable beneficiary, the term ‘discounted price’ means the specified small manufacturer percent (as defined in clause (iii)) of the negotiated price of the applicable drug of the manufacturer. ‘‘(ii) SPECIFIED SMALL MANUFACTURER.— ‘‘(I) IN GENERAL.—In this subparagraph, sub- ject to subclause (III), the term ‘specified small manufacturer’ means a manufacturer of an applicable drug for which, in 2021— ‘‘(aa) the manufacturer is a specified manufacturer (as defined in subparagraph (B)(ii)); and VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00069 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw