CMS Pub. 100-18, ch. 6, § 30.4.1

A Part D sponsor’s transition process is necessary with respect to the transition of: (1) new

enrollees into prescription drug plans following the annual coordinated election period; (2) newly

eligible Medicare beneficiaries from other coverage; (3) enrollees who switch from one plan to

another after the start of the contract year; (4) current enrollees affected by negative formulary

changes (as defined in section 30.3.3.1) across contract years; and (5) enrollees residing in LTC

facilities (see section 30.4.6). See Appendix E for a listing of multiple scenarios when

beneficiaries may be eligible for a transition fill under this guidance.

A Part D sponsor’s transition process must address situations in which an individual first

presents at a network pharmacy with a prescription for a drug that is non-formulary, and should

be presumed to be unaware of what is covered by the plan or of the sponsor’s exceptions process

for providing access to Part D drugs that are not covered.

A beneficiary’s transition period begins with the date of each enrollment. CMS receives frequent

questions about who constitutes a “new” enrollee, and who constitutes a current enrollee

affected by negative formulary changes, who are entitled to a transition fill. CMS believes these

questions should first be considered in the context of the purpose of the transition policy. The

purpose of the transition policy is to address situations when an enrollee’s ongoing drug therapy

(whether the Part D sponsor is able to actually ascertain ongoing therapy or not) could be

potentially interrupted by a drug being non-formulary. Thus, an enrollee who stays with the

same contract number but changes PBPs is potentially entitled to a transition fill because the

enrollee could experience a negative formulary change. However, just because a member’s drug

therapy could potentially be interrupted does not mean that the member will necessarily receive

a transition fill. In this example, for instance, the formulary may not have changed (which

means there have also been no addition of utilization management edits). Also, in some cases,

the sponsor may have the claims history for the member from the just prior PBP, and thus, the

sponsor may be able to determine that the member is not taking a non-formulary medication. In

other words, the sponsor may be able to determine at the POS that there will be no interruption

in medication therapy for the member, and therefore the member is not eligible for a transition

fill.