US · guidance
CMS Pub. 100-18, ch. 6, § 30.2
Provision of an Adequate Formulary
CMS encourages Part D sponsors to submit formularies similar to those in widespread use today.
CMS will check the formulary to ensure inclusion of a range of drugs in a broad distribution of
therapeutic categories and classes, in order to satisfy the Medicare Modernization Act (MMA)
requirement that a sponsor’s categorization system does not substantially discourage enrollment
by any group of beneficiaries. CMS will consider the specific drugs, tiering and utilization
management strategies employed in each formulary. CMS will identify outliers from common
benefit management practices for further evaluation. Sponsors may be asked to provide written
clinical justification for unusual benefit features that are identified as outliers.
History
(Rev. 2, Issued: 07-18-08; Effective/Implementation Date: 07-18-08)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
c8a6127924989ddc5ed06d2d3e64fa896d96e949201feb23485794e93cac4dc4
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