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136 STAT. 1861 PUBLIC LAW 117–169—AUG. 16, 2022 be substituted for the maximum fair price described in clause (i)(I) or (ii)(I) of such subparagraph (B), as applicable. ‘‘(ii) AMOUNT DESCRIBED.—The amount described in this clause is an amount equal to 65 percent of the average non-Federal average manufacturer price for the biological product for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such biological product for 2021, for the first full year following the market entry for such biological product), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the selected drug publication date with respect to the ini- tial price applicability year that would have applied but for this subsection. ‘‘(D) REBATE DEPOSITS.—Amounts paid as rebates under this paragraph shall be deposited into— ‘‘(i) in the case payment is made for such biological product under part B of title XVIII, the Federal Supple- mentary Medical Insurance Trust Fund established under section 1841; and ‘‘(ii) in the case such biological product is a covered part D drug (as defined in section 1860D–2(e)), the Medicare Prescription Drug Account under section 1860D–16 in such Trust Fund. ‘‘(5) DEFINITIONS OF BIOSIMILAR BIOLOGICAL PRODUCT.—In this subsection, the term ‘biosimilar biological product’ has the meaning given such term in section 1847A(c)(6).’’; (2) in section 1193(a)(4)— (A) in the matter preceding subparagraph (A), by inserting ‘‘, and for section 1192(f),’’ after ‘‘section 1194(f))’’; (B) in subparagraph (A), by striking ‘‘and’’ at the end; (C) by adding at the end the following new subpara- graph: ‘‘(C) information that the Secretary requires to carry out section 1192(f), including rebates under paragraph (4) of such section; and’’; (3) in section 1196(a)(7), by striking ‘‘section 1192(d)(2)(B)’’ and inserting ‘‘subsections (d)(2)(B) and (f)(1)(C) of section 1192’’; (4) in section 1197— (A) by redesignating subsections (b), (c), and (d) as subsections (c), (d), and (e), respectively; and (B) by inserting after subsection (a) the following new subsection: ‘‘(b) VIOLATIONS RELATING TO PROVIDING REBATES.—Any manu- facturer that fails to comply with the rebate requirements under section 1192(f)(4) shall be subject to a civil monetary penalty equal to 10 times the amount of the rebate the manufacturer failed to pay under such section.’’; and (5) in section 1198(b)(2), by inserting ‘‘the application of section 1192(f),’’ after ‘‘section 1192(e)’’. 42 USC 1320f–7. Penalties. 42 USC 1320f–6. 42 USC 1320f–5. 42 USC 1320f–2. Time periods. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00045 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw