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136 STAT. 1882 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(1) ADMINISTRATION OF PROGRAM.—Administering the pro- gram, including— ‘‘(A) the determination of the amount of the discounted price of an applicable drug of a manufacturer; ‘‘(B) the establishment of procedures to ensure that, not later than the applicable number of calendar days after the dispensing of an applicable drug by a pharmacy or mail order service, the pharmacy or mail order service is reimbursed for an amount equal to the difference between— ‘‘(i) the negotiated price of the applicable drug; and ‘‘(ii) the discounted price of the applicable drug; ‘‘(C) the establishment of procedures to ensure that the discounted price for an applicable drug under this section is applied before any coverage or financial assist- ance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of applicable beneficiaries as specified by the Secretary; and ‘‘(D) providing a reasonable dispute resolution mecha- nism to resolve disagreements between manufacturers, prescription drug plans and MA–PD plans, and the Sec- retary. ‘‘(2) MONITORING COMPLIANCE.—The Secretary shall mon- itor compliance by a manufacturer with the terms of an agree- ment under this section. ‘‘(3) COLLECTION OF DATA FROM PRESCRIPTION DRUG PLANS AND MA–PD PLANS.—The Secretary may collect appropriate data from prescription drug plans and MA–PD plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section. ‘‘(d) ADMINISTRATION.— ‘‘(1) IN GENERAL.—Subject to paragraph (2), the Secretary shall provide for the implementation of this section, including the performance of the duties described in subsection (c). ‘‘(2) LIMITATION.—In providing for the implementation of this section, the Secretary shall not receive or distribute any funds of a manufacturer under the program. ‘‘(e) CIVIL MONEY PENALTY.— ‘‘(1) IN GENERAL.—A manufacturer that fails to provide discounted prices for applicable drugs of the manufacturer dis- pensed to applicable beneficiaries in accordance with an agree- ment in effect under this section shall be subject to a civil money penalty for each such failure in an amount the Secretary determines is equal to the sum of— ‘‘(A) the amount that the manufacturer would have paid with respect to such discounts under the agreement, which will then be used to pay the discounts which the manufacturer had failed to provide; and ‘‘(B) 25 percent of such amount. ‘‘(2) APPLICATION.—The provisions of section 1128A (other than subsections (a) 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). Determination. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00066 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw