(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]