US · guidance
CMS Pub. 100-18, ch. 6, § 30.1.7
P&T Committee Role in Transition
At a minimum, a sponsor’s transition process, the minimum requirements of which are detailed
in section 30.4, will address procedures for medical review of non formulary drug requests and,
when appropriate, a process for switching new Part D sponsor enrollees to therapeutically
appropriate formulary alternatives failing an affirmative medical necessity determination. CMS
will look to transition process submissions for assurances that a sponsor’s P&T committee will
review and provide recommendations regarding the procedures for medical review of non-formulary drug requests. P&T committee involvement will help ensure that transition decisions
appropriately address situations involving enrollees stabilized on drugs that are not on the
sponsor’s formulary (or that are on the formulary but require prior authorization or step therapy
under a sponsor's utilization management requirements) and which are known to have risks
associated with any changes in the prescribed regimen.
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
9fc273ec2b6aafe1b9bd05e8b14286d141413dc9976f9b7a35001905d27160a5
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