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136 STAT. 1886 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(bb) the total expenditures under part D for any one of the specified small manufac- turer drugs of the manufacturer that are cov- ered by the agreement or agreements under section 1860D–14A of such manufacturer for such year and covered under this part during such year are equal to or more than 80 percent of the total expenditures under this part for all specified small manufacturer drugs of the manufacturer that are covered by such agree- ment or agreements for such year and covered under this part during such year. ‘‘(II) SPECIFIED SMALL MANUFACTURER DRUGS.— ‘‘(aa) IN GENERAL.—For purposes of this clause, the term ‘specified small manufacturer drugs’ means, with respect to a specified small manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, com- pounded, converted, or processed by the manu- facturer. ‘‘(bb) AGGREGATION RULE.—All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 shall be treated as one manufac- turer for purposes of this subparagraph. For purposes of making a determination pursuant to the previous sentence, an agreement under this section shall require that a manufacturer provide and attest to such information as specified by the Secretary as necessary. ‘‘(III) LIMITATION.—The term ‘specified small manufacturer’ shall not include a manufacturer described in subclause (I) if such manufacturer is acquired after 2021 by another manufacturer that is not a specified small manufacturer, effective at the beginning of the plan year immediately following such acquisition or, in the case of an acquisition before 2025, effective January 1, 2025. ‘‘(iii) SPECIFIED SMALL MANUFACTURER PERCENT.— In this subparagraph, the term ‘specified small manu- facturer percent’ means, with respect to a year— ‘‘(I) for an applicable drug dispensed for an applicable beneficiary who has not 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 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 who has incurred costs, as VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00070 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw