US · guidance
CMS Pub. 100-18, ch. 6, § 10.2
Covered Part D Drug
A covered Part D drug is a Part D drug that is included in a Part D sponsor’s formulary, or
treated as being included in a Part D plan’s formulary as a result of a coverage determination or
appeal under 42 CFR §§423.566, 423.580, and 423.600, and obtained at a network pharmacy or
an out-of-network pharmacy in accordance with 42 CFR §423.124. For the applicable drugs of
a manufacturer to be covered under Part D, the manufacturer must participate in the Medicare
Coverage Gap Discount Program. An applicable drug is a Part D drug that is approved under a
new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or a
biologics license application under section 351 of the Public Health Service Act (other than a
product licensed under subsection (k) of such Act). Thus the definition of applicable drugs
excludes biological products approved under the abbreviated licensure pathway (biosimilars).
History
(Rev. 18, Issued: 01-15-16, Effective: 01-15-16; Implementation: 01-15-16)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
d31eb5312ca087807cf3f6391daa9880f7bd6382af47c41804a1e1cbe277e406
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