CMS Pub. 100-18, ch. 6, § 30.3.4.1

Prior to making any negative formulary change during the contract year, a Part D sponsor must

either:

• Provide direct written notice to affected enrollees at least 60 days prior to the date the

change becomes effective; or

• At the time an affected enrollee requests a refill of the Part D drug, provide such enrollee

with a 60 day supply of the Part D drug under the same terms as previously allowed and

written notice of the formulary change.

If a beneficiary is not “affected” by a formulary change (in other words, exempted from a

formulary change), notice is not required.

The written notice must contain the following information:

• The name of the affected covered Part D drug;

• Whether the Part D sponsor is removing the covered Part D drug or changing its

preferred or tiered cost-sharing status;

• The reason why the Part D sponsor is removing such covered Part D drug from the

formulary, or changing its preferred or tiered cost-sharing status;

• Alternative drugs in the same therapeutic category or class or cost-sharing tier and

expected cost-sharing for those drugs; and

• The means by which enrollees may obtain a coverage determination under 42 CFR

§423.566 or exception under 42 CFR §423.578.

As an alternative to providing written notice, Part D sponsors may provide such notice

electronically if, and only if, an enrollee affirmatively elects to receive such notice electronically.