CMS Pub. 100-18, ch. 6, § 30.4.3

CMS is aware that it may be difficult for Part D sponsors to distinguish between new

prescriptions for non-formulary Part D drugs and refills for ongoing drug therapy involving non-formulary Part D drugs. CMS believes a minimum of a 108 day look-back (consistent with other

reviews) is typically needed to adequately document ongoing drug therapy. Although Part D

sponsors may be able to access prior drug claims history for an enrollee of an affiliated plan, or

may attempt to follow up with prescribing physicians and pharmacies to ascertain the status of a

prescription presented during the transition period, CMS clarifies that if a sponsor is unable to

make this distinction at the point of sale, the sponsor is required to provide the enrollee with a

transition fill. In other words, for transition purposes, a brand-new prescription for a non-formulary drug will not be treated any differently than an ongoing prescription for a non-formulary drug when a distinction cannot be made at the point of sale.

Generally, a sponsor may apply any CMS approved PA or ST after the transition fill has been

satisfied if the sponsor determines that the transition fill was the first fill. However, for protected

class drugs that are subject to PA or ST on new starts only, in accordance with section 30.2.5, if

a sponsor allows an initial fill because it cannot determine at the point of sale that an enrollee is

not currently taking the protected class drug (during transition or otherwise), the sponsor shall

treat such enrollees as currently taking the drug. Therefore, any protected class PA or ST

requirements for new starts are no longer applicable after the first fill has been provided.