(1) Part D drugs that are not on a [Medicare Part D plan] sponsor’s [drug list or] formulary [non-formulary drugs],
(2) [Medicare Part D] drugs previously approved for coverage under an exception once the formulary exception expires, and
(3) Part D drugs that are on a [Medicare Part D plan] sponsor’s formulary but require prior authorization [PA] or step therapy [ST], or that have an approved [quantity limits or] QL lower than the beneficiary’s current dose, under a plan’s utilization management [UM] requirements.
This is because a formulary drug whose access is restricted via [usage management or] UM requirements is essentially equivalent to a non-formulary Part D drug to the extent that the relevant UM requirements are not met for a particular enrollee. However, if the plan’s [quantity limit or ] QL is equal to an FDA maximum dose limit, plans do not have to allow doses greater than this limit as part of a transition supply." [emphasis added]