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136 STAT. 1876 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(II) there is no other drug approved under section 505(j) of the Federal Food, Drug, and Cos- metic Act that is rated as therapeutically equiva- lent (under the Food and Drug Administration’s most recent publication of ‘Approved Drug Prod- ucts with Therapeutic Equivalence Evaluations’) and that is being marketed, as identified in the Food and Drug Administration’s National Drug Code Directory; ‘‘(III) the manufacturer is not a ‘first applicant’ during the ‘180-day exclusivity period’, as those terms are defined in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act; and ‘‘(IV) the manufacturer is not a ‘first approved applicant’ for a competitive generic therapy, as that term is defined in section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic Act; or ‘‘(iii) a biological licensed under section 351 of the Public Health Service Act. ‘‘(2) UNIT.—The term ‘unit’ means, with respect to a part D rebatable drug, the lowest dispensable amount (such as a capsule or tablet, milligram of molecules, or grams) of the part D rebatable drug, as reported under section 1927. ‘‘(3) PAYMENT AMOUNT BENCHMARK PERIOD.—The term ‘pay- ment amount benchmark period’ means the period beginning January 1, 2021, and ending in the month immediately prior to October 1, 2021. ‘‘(4) BENCHMARK PERIOD CPI–U.—The term ‘benchmark period CPI–U’ means the consumer price index for all urban consumers (United States city average) for January 2021. ‘‘(5) APPLICABLE PERIOD CPI–U.—The term ‘applicable period CPI–U’ means, with respect to an applicable period, the con- sumer price index for all urban consumers (United States city average) for the first month of such applicable period. ‘‘(6) AVERAGE MANUFACTURER PRICE.—The term ‘average manufacturer price’ has the meaning, with respect to a part D rebatable drug of a manufacturer, given such term in section 1927(k)(1), with respect to a covered outpatient drug of a manu- facturer for a rebate period under section 1927. ‘‘(7) APPLICABLE PERIOD.—The term ‘applicable period’ means a 12-month period beginning with October 1 of a year (beginning with October 1, 2022). ‘‘(h) IMPLEMENTATION FOR 2022, 2023, AND 2024.—The Sec- retary shall implement this section for 2022, 2023, and 2024 by program instruction or other forms of program guidance.’’. (b) CONFORMING AMENDMENTS.— (1) TO PART B ASP CALCULATION.—Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)), as amended by section 11101(c)(1), is amended by striking ‘‘subsection (i) or section 1927’’ and inserting ‘‘subsection (i), section 1927, or section 1860D–14B’’. (2) EXCLUDING PART D DRUG INFLATION REBATE FROM BEST PRICE.—Section 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(I)), as amended by section 11101(c)(2), is amended by striking ‘‘or section 1847A(i)’’ and inserting ‘‘, section 1847A(i), or section 1860D–14B’’. Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00060 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw