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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
https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/Exceptions 1/3