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42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
70 FR 4525, Jan. 28, 2005, unless otherwise noted.
91 FR 17594, Apr. 6, 2026, unless otherwise noted.
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(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.