In general
section 1320f(a)(2) of this titleFor purposes of , the Secretary shall enter into agreements with manufacturers of selected drugs with respect to a price applicability period, by not later than February 28 following the selected drug publication date with respect to such selected drug, under which—
section 1320f–3 of this title during the negotiation period for the initial price applicability year for the selected drug, the Secretary and the manufacturer, in accordance with , negotiate to determine (and, by not later than the last date of such period, agree to) a maximum fair price for such selected drug of the manufacturer in order for the manufacturer to provide access to such price—
section 1320f(c)(2) of this title to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (A) of and are dispensed such drug (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs) during, subject to paragraph (2), the price applicability period; and
to hospitals, physicians, and other providers of services 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 during, subject to paragraph (2), the price applicability period;
section 1320f–3 of this title the Secretary and the manufacturer shall, in accordance with , renegotiate (and, by not later than the last date of the period of renegotiation, agree to) the maximum fair price for such drug, in order for the manufacturer to provide access to such maximum fair price (as so renegotiated)—
section 1320f(c)(2) of this title to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (A) of and are dispensed such drug (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs) during any year during the price applicability period (beginning after such renegotiation) with respect to such selected drug; and
to hospitals, physicians, and other providers of services 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 during any year described in subparagraph (A);
subject to subsection (d), access to the maximum fair price (including as renegotiated pursuant to paragraph (2)), with respect to such a selected drug, shall be provided by the manufacturer to—
section 1320f(c)(2) of this title maximum fair price eligible individuals, who with respect to such drug are described in subparagraph (A) of , at the pharmacy, mail order service, or other dispenser at the point-of-sale of such drug (and 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
hospitals, physicians, and other providers of services 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 paragraph (1)(B) or (2)(B), as applicable;
section 1320f–3(f) of this titlesection 1320f–1(f) of this title 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 ), and for , with respect to such drug—
section 8126(h)(5) of title 38 information on the non-Federal average manufacturer price (as defined in ) for the drug for the applicable year or period;
information that the Secretary requires to carry out the negotiation (or renegotiation process) under this part; and
section 1320f–1(f) of this title information that the Secretary requires to carry out , including rebates under paragraph (4) of such section; and
the manufacturer complies with requirements determined by the Secretary to be necessary for purposes of administering the program and monitoring compliance with the program.
Agreement in effect until drug is no longer a selected drug
section 1320f–1(c) of this titleAn 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 .
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 determined 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.
Nonduplication with 340B ceiling price
Under an agreement entered into under this section, the manufacturer of a selected drug—
42 U.S.C. 256b(a)(4)42 U.S.C. 256b(a)(1)42 U.S.C. 256b(a)(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
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.
Aug. 14, 1935, ch. 531Pub. L. 117–169, title I136 Stat. 1841(, title XI, § 1193, as added and amended , §§ 11001(a), 11002(a)(2), , , 1861.)
Editorial Notes
Amendments
Pub. L. 117–169, § 11002(a)(2)(A)section 1320f–1(f) of this titlesection 1320f–3(f) of this title2022—Subsec. (a)(4). , inserted “, and for ,” after “)” in introductory provisions.
Pub. L. 117–169, § 11002(a)(2)(B)Subsec. (a)(4)(C). , (C), added subpar. (C).