Exceptions

An exception request is a type of coverage determination.  An enrollee, an enrollee's prescriber, or an enrollee's representative may request a tiering exception or a formulary exception.

• A tiering exception should be requested to obtain a non-preferred drug at the lower cost-sharing terms applicable to drugs in a preferred tier.
• A formulary exception should be requested to obtain a Part D drug that is not included on a plan sponsor's formulary, or to request to have a utilization management requirement waived (e.g., step therapy, prior authorization, quantity limit) for a formulary drug.

Exceptions requests are granted when a plan sponsor determines that a requested drug is medically necessary for an enrollee.  Therefore, an enrollee's prescriber must submit a supporting statement to the plan sponsor supporting the request.

• For tiering exceptions, the prescriber's supporting statement must indicate that the preferred drug(s) would not be as effective as the requested drug for treating the enrollee's condition, the preferred drug(s) would have adverse effects for the enrollee, or both.
• For formulary exceptions, the prescriber's supporting statement must indicate that the non-formulary drug is necessary for treating an enrollee's condition because all covered Part D drugs on any tier would not be as effective or would have adverse effects, the number of doses under a dose restriction has been or is likely to be less effective, or the alternative(s) listed on the formulary or required to be used in accordance with step therapy has(have) been or is(are) likely to be less effective or have adverse effects.

How to Submit a Supporting Statement

A prescriber may submit his or her supporting statement to the plan sponsor verbally or in writing.  If submitted verbally, the plan sponsor may require the prescriber to follow-up in writing.

A prescriber may submit a written supporting statement on the Model Coverage Determination Request Form found in the "Downloads" section below, on an exceptions request form developed by a plan sponsor or other entity, or on any other written document (e.g., a letter) prepared by the prescriber.

How a Plan Sponsor Processes an Exception Request

For requests for benefits, once a plan sponsor receives a prescriber's supporting statement, it must provide written notice of its decision within 24 hours for expedited requests or 72 hours for standard requests. The initial notice may be provided verbally so long as a written follow-up notice is mailed to the enrollee within 3 calendar days of the verbal notification.  

For requests for payment that involve exceptions, a plan sponsor must provide notice of its decision (and make payment when appropriate) within 14 calendar days after receiving a request.

If the plan sponsor's coverage determination is unfavorable, the decision will contain the information needed to file a request for redetermination with the plan sponsor.

A list of specific contacts at Part D sponsors can be found at: /Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/PartDContacts 

For more information about exceptions, see section 40.5 in the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance in the "Downloads" section below.