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136 STAT. 1854 PUBLIC LAW 117–169—AUG. 16, 2022 (ii) in subclause (IV), by striking the period at the end and inserting ‘‘; and’’; and (iii) by adding at the end the following new sub- clause: ‘‘(V) in the case of a rebate period and a cov- ered outpatient drug that is a selected drug (as referred to in section 1192(c)) during such rebate period, shall be inclusive of the maximum fair price (as defined in section 1191(c)(3)) for such drug with respect to such period.’’. (3) MAXIMUM FAIR PRICES EXCLUDED FROM AVERAGE MANU- FACTURER PRICE.—Section 1927(k)(1)(B)(i) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)(B)(i)) is amended— (A) in subclause (IV) by striking ‘‘; and’’ at the end; (B) in subclause (V) by striking the period at the end and inserting ‘‘; and’’; and (C) by adding at the end the following new subclause: ‘‘(VI) any reduction in price paid during the rebate period to the manufacturer for a drug by reason of application of part E of title XI.’’. (c) IMPLEMENTATION FOR 2026 THROUGH 2028.—The Secretary of Health and Human Services shall implement this section, including the amendments made by this section, for 2026, 2027, and 2028 by program instruction or other forms of program guid- ance. SEC. 11002. SPECIAL RULE TO DELAY SELECTION AND NEGOTIATION OF BIOLOGICS FOR BIOSIMILAR MARKET ENTRY. (a) IN GENERAL.—Part E of title XI of the Social Security Act, as added by section 11001, is amended— (1) in section 1192— (A) in subsection (a), in the flush matter following paragraph (4), by inserting ‘‘and subsection (b)(3)’’ after ‘‘the previous sentence’’; (B) in subsection (b)— (i) in paragraph (1), by adding at the end the following new subparagraph: ‘‘(C) In the case of a biological product for which the inclusion of the biological product as a selected drug on a list published under subsection (a) has been delayed under subsection (f)(2), remove such biological product from the rankings under subparagraph (A) before making the selections under subparagraph (B).’’; and (ii) by adding at the end the following new para- graph: ‘‘(3) INCLUSION OF DELAYED BIOLOGICAL PRODUCTS.—Pursu- ant to subparagraphs (B)(ii)(I) and (C)(i) of subsection (f)(2), the Secretary shall select and include on the list published under subsection (a) the biological products described in such subparagraphs. Such biological products shall count towards the required number of drugs to be selected under subsection (a)(1).’’; and (C) by adding at the end the following new subsection: ‘‘(f) SPECIAL RULE TO DELAY SELECTION AND NEGOTIATION OF BIOLOGICS FOR BIOSIMILAR MARKET ENTRY.— ‘‘(1) APPLICATION.— 42 USC 1320f–1. 42 USC 1320f note. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00038 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw