CMS Pub. 100-18, ch. 6, § 30.3.3.2

In order to promote best practices and protect the interests of Medicare beneficiaries, CMS will

generally give positive consideration to the following types of formulary changes:

• Removal or placement in a less preferred tier of a brand name drug upon the availability

and addition of an A-rated generic or multi-source brand name equivalent, at a tier with

lower cost to the beneficiary.

• Removal of a non-Part D drug inadvertently included on the formulary.

• Addition of utilization management tools based upon a new FDA boxed warning.

• Removal of a drug based upon a new FDA market withdrawal notice.

• Removal of a drug based on long term shortage and market availability (described in

chapter 5, section 50.13).

• Removal or placement in a less preferred tier based upon new clinical guidelines or

information recognized by CMS (e.g., CDC’s recommendation against using older

antivirals for treatment and prophylaxis of the flu).

• The addition of utilization management when necessary to effectuate other approved

formulary changes (e.g., prior authorization on a brand name drug when generic is now

available on formulary at a lower cost), to help determine B vs. D coverage (subject to

CMS guidance on least burdensome ways to make this determination), or to promote safe

utilization of a Part D drug based upon new clinical guidelines or information.

Part D sponsors will need to provide a justification when submitting formulary maintenance

change requests, but they may assume that change requests based upon these justifications are

approved if they do not hear from CMS within 30 days of submission.