42 CFR 428.404 - Manufacturer access to Rebate Reports.

Regulations last checked for updates: Jan 30, 2025

Title 42 - Public Health last revised: Jan 23, 2025

View all text of Subpart E [§ 428.400 - § 428.405]

§ 428.404 - Manufacturer access to Rebate Reports.

(a) General. CMS will establish a method and process for a manufacturer of the Part D rebatable drug to:

(1) Access the Rebate Report as set forth in §§ 428.401 and 428.402, including any report of a reconciled rebate amount as set forth in §§ 428.401 and 428.402;

(2) Submit a Suggestion of Error as set forth in §§ 428.402(c) and 428.403; and

(3) Pay a rebate amount as set forth in § 428.405.

(b) [Reserved]

authority: 42 U.S.C. 1395w-114b,1302,and

source: 89 FR 98588, Dec. 9, 2024, unless otherwise noted.

cite as: 42 CFR 428.404