Eligible enrollees include new enrollees after the annual coordinated election period, newly Medicare-eligible beneficiaries, enrollees who switch plans mid-year, current enrollees affected by negative formulary changes across contract years, and enrollees residing in long-term care (LTC) facilities.
Applies to Part D drugs that are not on the Plan Sponsor's formulary and to Part D drugs on the formulary that require prior authorization or step therapy or that have an approved quantity limit lower than the enrollee's current dose under the Plan Sponsor's utilization management rules.
The Plan Sponsor provides a temporary transition supply to address immediate needs and allow time to request a formulary exception or to work with the prescriber to switch to a therapeutically equivalent formulary alternative; the P&T committee's non-formulary criteria and medical review/exception processes apply as described in policy.
Six Protected Classes: Antidepressants, Antipsychotics, Anticonvulsants, Antineoplastics, Antiretrovirals, and Immunosuppressants (for transplant prophylaxis) must be granted continued coverage for the duration of treatment or active enrollment; utilization management (PA/ST) are not applied to transitioning enrollees on these agents (except for new enrollees naïve to therapy).
PA, step therapy, and quantity limit edits are applied after the enrollee has exhausted the transition supply as appropriate; for drugs with PA or ST on new starts only, an initial allowed transition fill treats the enrollee as a current utilizer thereafter.
Edits at point-of-sale that would otherwise prevent payment are overridden during the transition period except where needed to determine Part A vs Part D coverage, prevent coverage of non-Part D drugs, or to promote safe utilization (e.g., opioid beneficiary-level edits, FDA maximum dosing quantity limits, early refill safeguards). An automated transition fill process permits payment without a pharmacist hard-override.
The Plan Sponsor may deny quantities or doses during transition when FDA maximum recommended dosing or P&T-established clinical limits are exceeded; prior to denial the Plan Sponsor will verify an initial transition supply has been provided and that the enrollee or prescriber was assisted in filing an exception or that an exception was processed.
Transition period may be extended on a case-by-case basis until exception requests or appeals are resolved and an appropriate therapeutic transition or approval is made.
When a prescription cannot be distinguished as new versus ongoing at point-of-sale, the transition process is applied; CMS-approved PA, ST, or QL requirements are applied only after the transition supply is exhausted.
For negative formulary changes across contract years, transition protections are provided at the new contract year start when enrollee paid-claim history meets lookback requirements (policy describes lookback and cross-year application).