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136 STAT. 1874 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(C) SELECTED DRUGS.—In the case of a part D rebatable drug that is a selected drug (as defined in section 1192(c)) with respect to a price applicability period (as defined in section 1191(b)(2)), in the case such drug is no longer considered to be a selected drug under section 1192(c), for each applicable period (as defined under sub- section (g)(7)) beginning after the price applicability period with respect to such drug, subparagraphs (A) and (B) of paragraph (4) shall be applied as if the term ‘payment amount benchmark period’ were defined under subsection (g)(3) as the last year beginning during such price applica- bility period with respect to such selected drug and subparagraph (B) of paragraph (3) shall be applied as if the term ‘benchmark period CPI–U’ were defined under subsection (g)(4) as if the reference to ‘January 2021’ under such subsection were a reference to ‘January of the last year beginning during such price applicability period with respect to such drug’. ‘‘(6) RECONCILIATION IN CASE OF REVISED INFORMATION.— The Secretary shall provide for a method and process under which, in the case where a PDP sponsor of a prescription drug plan or an MA organization offering an MA–PD plan submits revisions to the number of units of a rebatable covered part D drug dispensed, the Secretary determines, pursuant to such revisions, adjustments, if any, to the calculation of the amount specified in this subsection for a dosage form and strength with respect to such part D rebatable drug and an applicable period and reconciles any overpayments or underpay- ments in amounts paid as rebates under this subsection. Any identified underpayment shall be rectified by the manufacturer not later than 30 days after the date of receipt from the Sec- retary of information on such underpayment. ‘‘(c) REBATE DEPOSITS.—Amounts paid as rebates under sub- section (b) shall be deposited into the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund established under section 1841. ‘‘(d) INFORMATION.—For purposes of carrying out this section, the Secretary shall use information submitted by— ‘‘(1) manufacturers under section 1927(b)(3); ‘‘(2) States under section 1927(b)(2)(A); and ‘‘(3) PDP sponsors of prescription drug plans and MA organization offering MA–PD plans under this part. ‘‘(e) CIVIL MONEY PENALTY.—If a manufacturer of a part D rebatable drug has failed to comply with the requirement under subsection (a)(2) with respect to such drug for an applicable period, the manufacturer shall be subject to a civil money penalty in an amount equal to 125 percent of the amount specified in sub- section (b) for such drug for such period. 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 subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). ‘‘(f) LIMITATION ON ADMINISTRATIVE OR JUDICIAL REVIEW.— There shall be no administrative or judicial review of any of the following: ‘‘(1) The determination of units under this section. Applicability. Deadline. Effective date. Applicability. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00058 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw