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

(a) Administrative duties. For section 1320f(a)(4), the Secretary's administrative duties are: (1) establishing procedures to ensure that a selected drug's maximum fair price is applied before (A) any coverage or financial assistance under another health-benefit plan or program that helps maximum-fair-price-eligible people buy or receive prescription drug coverage, and (B) any other discounts; (2) establishing procedures to compute and apply the maximum fair price across different strengths and dosage forms, without basing it on the drug's specific formulation, package size, or package type; (3) establishing procedures to carry out this part, as applicable, for maximum-fair-price-eligible people enrolled (A) in a Part D prescription drug plan or a Part C MA–PD plan, and (B) under Part B, including people enrolled in a Part C MA plan; (4) establishing a negotiation and renegotiation process under section 1320f–3; (5) establishing a process for manufacturers to submit the information described in section 1320f–3(b)(2)(A); (6) sharing with the Treasury Secretary the information needed to determine the tax imposed by section 5000D of the Internal Revenue Code of 1986, including applying that tax to a manufacturer, producer, or importer and determining dates described in section 5000D(c)(1). This information must include: (A) the date the Secretary receives notice that an agreement under the Medicare coverage gap discount program ended and the date a later agreement under that program begins; (B) the corresponding dates for an agreement under the manufacturer discount program; and (C) the corresponding dates for a rebate agreement under section 1396r–8(b); and (7) establishing procedures for applying subsections (d)(2)(B) and (f)(1)(C) of section 1320f–1. (b) Compliance monitoring. The Secretary must monitor whether a manufacturer complies with the terms of its agreement under section 1320f–2 and establish a way to report violations of those terms.