Definitions.

As used in this subpart— Affected party means any Part D sponsor or, for purposes of the Coverage Gap Discount Program, any manufacturer (as defined in § 423.100), or, for purposes of the Manufacturer Discount Program, any manufacturer that is an agreement holder (as defined in § 423.2704), impacted by an initial determination or, if applicable, by a subsequent determination or decision issued under this part, and “party” means the affected party or CMS, as appropriate. ALJ stands for Administrative Law Judge. Departmental Appeals Board or Board means a Board established in the Office of the Secretary to provide impartial review of disputed decisions made by the operating components of the Department. Part D sponsor has the meaning given the term in 423.4. [72 FR 68736, Dec. 5, 2007, as amended 77 FR 22171, Apr. 12, 2012; 91 FR 17592, Apr. 6, 2026]