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136 STAT. 1842 PUBLIC LAW 117–169—AUG. 16, 2022 shall be provided by the manufacturer to the pharmacy, mail order service, or other dispenser, with respect to such maximum fair price eligible individuals who are dispensed such drugs), as described in paragraph (1)(A) or (2)(A), as applicable; and ‘‘(B) hospitals, physicians, and other providers of serv- ices and suppliers with respect to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (B) of such section and are furnished or administered such drug, as described in para- graph (1)(B) or (2)(B), as applicable; ‘‘(4) the manufacturer submits to the Secretary, in a form and manner specified by the Secretary, for the negotiation period for the price applicability period (and, if applicable, before any period of renegotiation pursuant to section 1194(f)) with respect to such drug— ‘‘(A) information on the non-Federal average manufac- turer price (as defined in section 8126(h)(5) of title 38, United States Code) for the drug for the applicable year or period; and ‘‘(B) information that the Secretary requires to carry out the negotiation (or renegotiation process) under this part; and ‘‘(5) the manufacturer complies with requirements deter- mined by the Secretary to be necessary for purposes of admin- istering the program and monitoring compliance with the pro- gram. ‘‘(b) AGREEMENT IN EFFECT UNTIL DRUG IS NO LONGER A SELECTED DRUG.—An agreement entered into under this section shall be effective, with respect to a selected drug, until such drug is no longer considered a selected drug under section 1192(c). ‘‘(c) CONFIDENTIALITY OF INFORMATION.—Information submitted to the Secretary under this part by a manufacturer of a selected drug that is proprietary information of such manufacturer (as deter- mined by the Secretary) shall be used only by the Secretary or disclosed to and used by the Comptroller General of the United States for purposes of carrying out this part. ‘‘(d) NONDUPLICATION WITH 340B CEILING PRICE.—Under an agreement entered into under this section, the manufacturer of a selected drug— ‘‘(1) shall not be required to provide access to the maximum fair price under subsection (a)(3), with respect to such selected drug and maximum fair price eligible individuals who are eligible to be furnished, administered, or dispensed such selected drug at a covered entity described in section 340B(a)(4) of the Public Health Service Act, to such covered entity if such selected drug is subject to an agreement described in section 340B(a)(1) of such Act and the ceiling price (defined in section 340B(a)(1) of such Act) is lower than the maximum fair price for such selected drug; and ‘‘(2) shall be required to provide access to the maximum fair price to such covered entity with respect to maximum fair price eligible individuals who are eligible to be furnished, administered, or dispensed such selected drug at such entity at such ceiling price in a nonduplicated amount to the ceiling price if such maximum fair price is below the ceiling price for such selected drug. Requirement. Determination. Compliance. Requirements. Determination. Requirement. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00026 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw