(a) Basis. This subpart implements section 1860D-14C of the Act and provisions included in section 1860D-43 of the Act.

(b) Scope. This subpart sets forth the requirements of the Medicare Part D Manufacturer Discount Program, which requires manufacturers to pay discounts for brand-name drugs and biological products when dispensed to Part D enrollees in the initial and catastrophic coverage phases of the Part D benefit, under the terms of an agreement with CMS, in order for such drugs to be coverable under Part D.