CMS Pub. 100-18, ch. 7, § 60.4

Part D sponsors must provide current and prospective enrollees (or their physician or authorized

representative) with information regarding specific prior authorization criteria and other

utilization management requirements (i.e., step therapy and quantity limits). This information

must be made available on a timely basis so that beneficiaries can make informed enrollment

decisions and so that physicians can access information that will help avoid delays at the

pharmacy and potential interruptions in drug therapy.

Instructions at 42 CFR 423.128(c)(1)(v) and (c)(2) require Part D sponsors to provide Part D

eligible beneficiaries information about their formulary and utilization management procedures.

Similarly, 42 CFR 423.128(d) requires Part D sponsors to provide current and prospective

beneficiaries “specific information” such as specific prior authorization requirements, “on a

timely basis” through a toll-free customer service call center. Accordingly, Part D sponsors must

explain their utilization management requirements and criteria through their customer service

call centers. To ensure that such requests are addressed in a timely manner, if the customer

service representative is unable to adequately address or answer the enrollee’s (or his/her

authorized representative’s) or physician’s questions, sponsors must expedite the call to their

pharmacy technical help call center where further detail can be provided on the drug and

utilization management criteria in question.