Regulations last checked for updates: Jan 18, 2025

Title 42 - Public Health last revised: Jan 16, 2025
§ 427.504 - Manufacturer access to Rebate Reports.

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

(1) Access the manufacturer's Rebate Report as set forth in §§ 427.501 and 427.502, including any report of reconciled rebate amount as set forth in §§ 427.501(d) and 427.502(c)(2)(ii);

(2) Submit a Suggestion of Error as set forth in §§ 427.502(c)(1)(ii) and (c)(2)(i) and 427.503; and

(3) Pay a rebate amount as set forth in § 427.505.

(b) [Reserved]

authority: 42 U.S.C. 1395w-3a(i), 1302, and 1395hh
source: 89 FR 98578, Dec. 9, 2024, unless otherwise noted.
cite as: 42 CFR 427.504