§ 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]