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136 STAT. 1869 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(7) CIVIL MONEY PENALTY.—If a manufacturer of a part B rebatable drug has failed to comply with the requirements under paragraph (1)(B) for such drug for a calendar quarter, the manufacturer shall be subject to, in accordance with a process established by the Secretary pursuant to regulations, a civil money penalty in an amount equal to at least 125 percent of the amount specified in paragraph (3) for such drug for such calendar quarter. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). ‘‘(8) LIMITATION ON ADMINISTRATIVE OR JUDICIAL REVIEW.— There shall be no administrative or judicial review of any of the following: ‘‘(A) The determination of units under this subsection. ‘‘(B) The determination of whether a drug is a part B rebatable drug under this subsection. ‘‘(C) The calculation of the rebate amount under this subsection. ‘‘(D) The computation of coinsurance under paragraph (5) of this subsection. ‘‘(E) The computation of amounts paid under section 1833(a)(1)(EE).’’. (b) AMOUNTS PAYABLE; COST-SHARING.—Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended— (1) in subsection (a)(1)— (A) in subparagraph (G), by inserting ‘‘, subject to subsection (i)(9),’’ after ‘‘the amounts paid’’; (B) in subparagraph (S), by striking ‘‘with respect to’’ and inserting ‘‘subject to subparagraph (EE), with respect to’’; (C) by striking ‘‘and (DD)’’ and inserting ‘‘(DD)’’; and (D) by inserting before the semicolon at the end the following: ‘‘, and (EE) with respect to a part B rebatable drug (as defined in paragraph (2) of section 1847A(i)) fur- nished on or after April 1, 2023, for which the payment amount for a calendar quarter under paragraph (3)(A)(ii)(I) of such section (or, in the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c) for which, the payment amount described in section 1847A(b)(1)(B)) for such drug for such quarter exceeds the inflation-adjusted payment under paragraph (3)(A)(ii)(II) of such section for such quarter, the amounts paid shall be equal to the percent of the payment amount under paragraph (3)(A)(ii)(I) of such section or section 1847A(b)(1)(B), as applicable, that equals the difference between (i) 100 percent, and (ii) the percent applied under section 1847A(i)(5)(B)’’; (2) in subsection (i), by adding at the end the following new paragraph: ‘‘(9) In the case of a part B rebatable drug (as defined in paragraph (2) of section 1847A(i)) for which payment under this subsection is not packaged into a payment for a service furnished on or after April 1, 2023, under the revised payment system under this subsection, in lieu of calculation of coinsurance and the amount Effective date. Determination. Applicability. Effective date. Time period. Applicability. Applicability. Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00053 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw