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136 STAT. 1838 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(B) PART B 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 B of title XVIII, as determined by the Secretary in accordance with para- graph (3), during such most recent 12-month period, as described in subparagraph (A). ‘‘(2) EXCEPTION FOR SMALL BIOTECH DRUGS.— ‘‘(A) IN GENERAL.—Subject to subparagraph (C), the term ‘negotiation-eligible drug’ shall not include, with respect to the initial price applicability years 2026, 2027, and 2028, a qualifying single source drug that meets either of the following: ‘‘(i) PART D DRUGS.—The total expenditures for the qualifying single source drug under part D of title XVIII, as determined by the Secretary in accordance with paragraph (3)(B), during 2021— ‘‘(I) are equal to or less than 1 percent of the total expenditures under such part D, as so determined, for all covered part D drugs (as defined in section 1860D–2(e)) during such year; and ‘‘(II) are equal to at least 80 percent of the total expenditures under such part D, as so deter- mined, for all covered part D drugs for which the manufacturer of the drug has an agreement in effect under section 1860D–14A during such year. ‘‘(ii) PART B DRUGS.—The total expenditures for the qualifying single source drug under part B of title XVIII, as determined by the Secretary in accordance with paragraph (3)(B), during 2021— ‘‘(I) are equal to or less than 1 percent of the total expenditures under such part B, as so determined, for all qualifying single source drugs for which payment may be made under such part B during such year; and ‘‘(II) are equal to at least 80 percent of the total expenditures under such part B, as so deter- mined, for all qualifying single source drugs of the manufacturer for which payment may be made under such part B during such year. ‘‘(B) CLARIFICATIONS RELATING TO MANUFACTURERS.— ‘‘(i) 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 manufacturer for purposes of this para- graph. ‘‘(ii) LIMITATION.—A drug shall not be considered to be a qualifying single source drug described in clause (i) or (ii) of subparagraph (A) if the manufacturer of such drug is acquired after 2021 by another manufac- turer that does not meet the definition of a specified manufacturer under section 1860D–14C(g)(4)(B)(ii), effective at the beginning of the plan year immediately following such acquisition or, in the case of an acquisi- tion before 2025, effective January 1, 2025. Effective dates. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00022 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw