---
kind: "section"
citation: "42 U.S.C. § 1320f–5"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320f–5"
heading: "Administrative duties and compliance monitoring"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320f-5"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XI — General Provisions, Peer Review, and Administrative Simplification"
  - "Part E — Price Negotiation Program To Lower Prices for Certain High-Priced Single Source Drugs"
---

# §1320f–5. Administrative duties and compliance monitoring

- (a) **Administrative duties—** For purposes of [section 1320f(a)(4) of this title](/usc/42/1320f.md?p=a-4), 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](/usc/42/11851.md?p=4) 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](/usc/42/11851.md?p=4) 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](/usc/42/11851.md?p=4) and not based on the specific formulation or package size or package type of such [drug](/usc/42/11851.md?p=4).
  - (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](/usc/42/1395w–151.md?p=a-14) under part D of subchapter XVIII or an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) under part C of such subchapter; and
    - (B) maximum fair price eligible individuals who are enrolled under part B of such subchapter, [including](/usc/42/1301.md?p=b) who are enrolled in an [MA plan](/usc/42/1395w–151.md?p=a-8) under part C of such subchapter.
  - (4) The establishment of a negotiation process and renegotiation process in accordance with [section 1320f–3 of this title](/usc/42/1320f–3.md).
  - (5) The establishment of a process for manufacturers to submit information described in [section 1320f–3(b)(2)(A) of this title](/usc/42/1320f–3.md?p=b-2-A).
  - (6) The sharing with the [Secretary](/usc/42/1301.md?p=a-6) 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](/usc/42/1301.md?p=b) 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) the date on which the [Secretary](/usc/42/1301.md?p=a-6) receives notification of any termination of an agreement under the Medicare coverage gap discount program under [section 1395w–114a of this title](/usc/42/1395w–114a.md) and the date on which any subsequent agreement under such program is entered into;
    - (B) the date on which the [Secretary](/usc/42/1301.md?p=a-6) receives notification of any termination of an agreement under the manufacturer discount program under [section 1395w–114c of this title](/usc/42/1395w–114c.md) and the date on which any subsequent agreement under such program is entered into; and
    - (C) the date on which the [Secretary](/usc/42/1301.md?p=a-6) receives notification of any termination of a rebate agreement described in [section 1396r–8(b) of this title](/usc/42/1396r–8.md?p=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 subsections (d)(2)(B) and (f)(1)(C) of [section 1320f–1 of this title](/usc/42/1320f–1.md).
- (b) **Compliance monitoring—** The [Secretary](/usc/42/1301.md?p=a-6) shall monitor compliance by a manufacturer with the terms of an agreement under [section 1320f–2 of this title](/usc/42/1320f–2.md) and establish a mechanism through which [violations](/usc/42/2000e–16a.md?p=c) of such terms shall be reported.

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1196, as added and amended Pub. L. 117–169, title I, §§ 11001(a), 11002(a)(3), Aug. 16, 2022, 136 Stat. 1849, 1861.)

## Notes

### Editorial Notes

### References in Text

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

### Amendments

2022—Subsec. (a)(7). Pub. L. 117–169, § 11002(a)(3), substituted “subsections (d)(2)(B) and (f)(1)(C) of section 1320f–1 of this title” for “section 1320f–1(d)(2)(B) of this title”.