42 U.S.C. § 1320f–5 | Administrative duties and compliance monitoring

(a)

Administrative duties

section 1320f(a)(4) of this titleFor purposes of , the administrative duties described in this section are the following:

(1)

The establishment of procedures to ensure that the maximum fair price for a selected drug is applied before—

(A)

any coverage or financial assistance 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 maximum fair price eligible individuals; and

(B)

any other discounts.

(2)

The establishment of procedures to compute and apply the maximum fair price across different strengths and dosage forms of a selected drug and not based on the specific formulation or package size or package type of such drug.

(3)

The establishment of procedures to carry out the provisions 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 subchapter XVIII or an MA–PD plan under part C of such subchapter; and

(B)

maximum fair price eligible individuals who are enrolled under part B of such subchapter, including who are enrolled in an MA plan under part C of such subchapter.

(4)

section 1320f–3 of this title The establishment of a negotiation process and renegotiation process in accordance with .

(5)

section 1320f–3(b)(2)(A) of this title The establishment of a process for manufacturers to submit information described in .

(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, producer, or importer or the determination of any date described in section 5000D(c)(1) of such Code. For purposes of the preceding sentence, such information shall include—

(A)

section 1395w–114a of this title the date on which the Secretary receives notification of any termination of an agreement under the Medicare coverage gap discount program under and the date on which any subsequent agreement under such program is entered into;

(B)

section 1395w–114c of this title the date on which the Secretary receives notification of any termination of an agreement under the manufacturer discount program under and the date on which any subsequent agreement under such program is entered into; and

(C)

section 1396r–8(b) of this title the date on which the Secretary receives notification of any termination of a rebate agreement described in and the date on which any subsequent rebate agreement described in such section is entered into.

(7)

section 1320f–1 of this title The establishment of procedures for purposes of applying subsections (d)(2)(B) and (f)(1)(C) of .

(b)

Compliance monitoring

section 1320f–2 of this titleThe Secretary shall monitor compliance by a manufacturer with the terms of an agreement under and establish a mechanism through which violations of such terms shall be reported.

Aug. 14, 1935, ch. 531 Pub. L. 117–169, title IAug. 16, 2022136 Stat. 1849(, title XI, § 1196, as added and amended , §§ 11001(a), 11002(a)(3), , , 1861.)

Editorial Notes

References in Text

section 5000D of Title 26Section 5000D of the Internal Revenue Code of 1986, referred to in subsec. (a)(6), is classified to , Internal Revenue Code.

Amendments

Pub. L. 117–169, § 11002(a)(3)section 1320f–1 of this title section 1320f–1(d)(2)(B) of this title2022—Subsec. (a)(7). , substituted “subsections (d)(2)(B) and (f)(1)(C) of ” for “”.