US · guidance
CMS Pub. 100-18, ch. 6, § 30.3.4.3
Provision of Notice Regarding Formulary Changes Subsequent to Removal from the Market
Part D sponsors may immediately remove from their formularies covered Part D drugs deemed
unsafe by the FDA or removed from the market by their manufacturer without meeting the
advance notice requirements specified in this section. However, Part D sponsors must provide
retrospective notice of any such formulary changes to affected enrollees, CMS, State
Pharmaceutical Assistance Programs (as defined in 42 CFR §423.454), entities providing other
prescription drug coverage (as described in 42 CFR §423.464(f)(1), authorized prescribers,
network pharmacies, and pharmacists consistent with the requirements set forth in this section.
CMS expects that this retrospective notice will occur as soon as possible to inform enrolled
beneficiaries of potential safety concerns surrounding medications they are taking, especially
those beneficiaries who may have a 90 day supply and will not interact with the pharmacy for an
extended period.
In instances where there has been an announcement of a market withdrawal, but the withdrawal
has not yet taken place, Part D sponsors may opt to either remove the drug immediately with a
retrospective notice to “affected enrollees” or provide an advance notice. CMS expects Part D
sponsors to consider all pertinent information available from the FDA related to the withdrawal.
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
10a2763b9a003eb7b4ecc741609277a31174648ec6f532bd6b64f54a2105cd40
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