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136 STAT. 1834 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; ‘‘(4) carry out the publication and administrative duties and compliance monitoring in accordance with sections 1195 and 1196. ‘‘(b) DEFINITIONS RELATING TO TIMING.—For purposes of this part: ‘‘(1) INITIAL PRICE APPLICABILITY YEAR.—The term ‘initial price applicability year’ means a year (beginning with 2026). ‘‘(2) PRICE APPLICABILITY PERIOD.—The term ‘price applica- bility period’ means, with respect to a qualifying single source drug, the period beginning with the first initial price applica- bility year with respect to which such drug is a selected drug and ending with the last year during which the drug is a selected drug. ‘‘(3) SELECTED DRUG PUBLICATION DATE.—The term ‘selected drug publication date’ means, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year. ‘‘(4) NEGOTIATION PERIOD.—The term ‘negotiation period’ means, with respect to an initial price applicability year with respect to a selected drug, the period— ‘‘(A) beginning on the sooner of— ‘‘(i) the date on which the manufacturer of the drug and the Secretary enter into an agreement under section 1193 with respect to such drug; or ‘‘(ii) February 28 following the selected drug publication date with respect to such selected drug; and ‘‘(B) ending on November 1 of the year that begins 2 years prior to the initial price applicability year. ‘‘(c) OTHER DEFINITIONS.—For purposes of this part: ‘‘(1) MANUFACTURER.—The term ‘manufacturer’ has the meaning given that term in section 1847A(c)(6)(A). ‘‘(2) MAXIMUM FAIR PRICE ELIGIBLE INDIVIDUAL.—The term ‘maximum fair price eligible individual’ means, with respect to a selected drug— ‘‘(A) in the case such drug is dispensed to the individual at a pharmacy, by a mail order service, or by another dispenser, an individual who is enrolled in a prescription drug plan under part D of title XVIII or an MA–PD plan under part C of such title if coverage is provided under such plan for such selected drug; and ‘‘(B) in the case such drug is furnished or administered to the individual by a hospital, physician, or other provider of services or supplier, an individual who is enrolled under part B of title XVIII, including an individual who is enrolled in an MA plan under part C of such title, if payment may be made under part B for such selected drug. ‘‘(3) MAXIMUM FAIR PRICE.—The term ‘maximum fair price’ means, with respect to a year during a price applicability period and with respect to a selected drug (as defined in section 1192(c)) with respect to such period, the price negotiated pursu- ant to section 1194, and updated pursuant to section 1195(b), as applicable, for such drug and year. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00018 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw