CMS Pub. 100-18, ch. 6, § 30.2.2.3

Part D sponsors should consistently utilize PA for those drugs with the highest likelihood of non-Part D covered uses, based on the following definitions:

• High likelihood that coverage is available under Parts A or B (versus D) for the drug as

prescribed and dispensed or administered, as discussed in section 20.2 of this chapter,

• High likelihood that the drug is excluded from Part D coverage (e.g., a drug or drug

class or its medical use that is excluded from coverage or otherwise restricted under Part

D as defined in section 1927(d)(2) of the Act), or

• High likelihood of use for non-medically accepted indications as defined in section

1860D-2(E)(4) of the Act (see section 10.6).

CMS recognizes that sponsors utilize standard PA forms to facilitate the collection of

information necessary to fulfill the PA. However, CMS has identified several non-allowable

practices that cannot be included on prior authorization forms, examples of which are provided

below:

• Requirements more restrictive than CMS-approved prior authorization criteria.

• Limited Access or Step Therapy restrictions not consistent with the CMS-approved

formulary.

• Quantity Limits inconsistent with FDA maximum dosing or not consistent with the CMS-approved formulary.

• Prior Authorization criteria not submitted for HPMS approved formulary medications.

• Steering of physicians or beneficiaries to a sponsor’s and/or PBM’s own mail order

pharmacy.

Steering of physicians or beneficiaries to a sponsor’s and/or PBM’s own specialty pharmacy for

any drugs which are not restricted to select pharmacies based on manufacturer or FDA

distribution limitations.