Page 57

136 STAT. 1873 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(B) the percentage by which the applicable period CPI–U (as defined in subsection (g)(5)) for the period exceeds the benchmark period CPI–U (as defined in sub- section (g)(4)). ‘‘(4) DETERMINATION OF BENCHMARK PERIOD MANUFACTURER PRICE.—The benchmark period manufacturer price determined under this paragraph for a dosage form and strength, with respect to a part D rebatable drug and an applicable period, is the sum of the products of— ‘‘(A) the average manufacturer price (as defined in subsection (g)(6)) of such dosage form and strength, as calculated for a unit of such drug, with respect to each of the calendar quarters of the payment amount benchmark period (as defined in subsection (g)(3)); and ‘‘(B) the ratio of— ‘‘(i) the total number of units reported under sec- tion 1927 of such dosage form and strength with respect to each such calendar quarter of such payment amount benchmark period; to ‘‘(ii) the total number of units reported under sec- tion 1927 of such dosage form and strength with respect to such payment amount benchmark period. ‘‘(5) SPECIAL TREATMENT OF CERTAIN DRUGS AND EXEMP- TION.— ‘‘(A) SUBSEQUENTLY APPROVED DRUGS.—In the case of a part D rebatable drug first approved or licensed by the Food and Drug Administration after October 1, 2021, sub- paragraphs (A) and (B) of paragraph (4) shall be applied as if the term ‘payment amount benchmark period’ were defined under subsection (g)(3) as the first calendar year beginning after the day on which the drug was first mar- keted and subparagraph (B) of paragraph (3) shall be applied as if the term ‘benchmark period CPI–U’ were defined under subsection (g)(4) as if the reference to ‘January 2021’ under such subsection were a reference to ‘January of the first year beginning after the date on which the drug was first marketed’. ‘‘(B) TREATMENT OF NEW FORMULATIONS.— ‘‘(i) IN GENERAL.—In the case of a part D rebatable drug that is a line extension of a part D rebatable drug that is an oral solid dosage form, the Secretary shall establish a formula for determining the rebate amount under paragraph (1) and the inflation adjusted payment amount under paragraph (3) with respect to such part D rebatable drug and an applicable period, consistent with the formula applied under subsection (c)(2)(C) of section 1927 for determining a rebate obliga- tion for a rebate period under such section. ‘‘(ii) LINE EXTENSION DEFINED.—In this subpara- graph, the term ‘line extension’ means, with respect to a part D rebatable drug, a new formulation of the drug, such as an extended release formulation, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation. Effective dates. Applicability. Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00057 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw