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.