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136 STAT. 1850 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(3) The establishment of procedures to carry out the provi- sions of this part, as applicable, with respect to— ‘‘(A) maximum fair price eligible individuals who are enrolled in a prescription drug plan under part D of title XVIII or an MA–PD plan under part C of such title; and ‘‘(B) maximum fair price eligible individuals who are enrolled under part B of such title, including who are enrolled in an MA plan under part C of such title. ‘‘(4) The establishment of a negotiation process and renego- tiation process in accordance with section 1194. ‘‘(5) The establishment of a process for manufacturers to submit information described in section 1194(b)(2)(A). ‘‘(6) The sharing with the Secretary of the Treasury of such information as is necessary to determine the tax imposed by section 5000D of the Internal Revenue Code of 1986, including the application of such tax to a manufacturer, pro- ducer, or importer or the determination of any date described in section 5000D(c)(1) of such Code. For purposes of the pre- ceding sentence, such information shall include— ‘‘(A) the date on which the Secretary receives notifica- tion of any termination of an agreement under the Medicare coverage gap discount program under section 1860D-14A and the date on which any subsequent agreement under such program is entered into; ‘‘(B) the date on which the Secretary receives notifica- tion of any termination of an agreement under the manu- facturer discount program under section 1860D-14C and the date on which any subsequent agreement under such program is entered into; and ‘‘(C) the date on which the Secretary receives notifica- tion of any termination of a rebate agreement described in section 1927(b) and the date on which any subsequent rebate agreement described in such section is entered into. ‘‘(7) The establishment of procedures for purposes of applying section 1192(d)(2)(B). ‘‘(b) COMPLIANCE MONITORING.—The Secretary shall monitor compliance by a manufacturer with the terms of an agreement under section 1193 and establish a mechanism through which viola- tions of such terms shall be reported. ‘‘SEC. 1197. CIVIL MONETARY PENALTIES. ‘‘(a) VIOLATIONS RELATING TO OFFERING OF MAXIMUM FAIR PRICE.—Any manufacturer of a selected drug that has entered into an agreement under section 1193, with respect to a year during the price applicability period with respect to such drug, that does not provide access to a price that is equal to or less than the maximum fair price for such drug for such year— ‘‘(1) to a maximum fair price eligible individual who with respect to such drug is described in subparagraph (A) of section 1191(c)(2) and who is dispensed such drug during such year (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs); or ‘‘(2) to a hospital, physician, or other provider of services or supplier with respect to maximum fair price eligible individ- uals who with respect to such drug is described in subparagraph (B) of such section and is furnished or administered such drug 42 USC 1320f–6. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00034 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw