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Exceptions

Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary.

Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year.

For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins.

Plans are prohibited from assigning drugs approved under the exceptions process to a special tier, co-payment, or other cost-sharing requirement.

If a plan sponsor changes its formulary or the cost-sharing status of a drug during the plan year, it must: (1) give direct written notice to affected enrollees at least 60 days in advance of such change becoming effective, or (2) if the 60-day notice is not given, provide enrollees with a 60-day supply of the drug affected by the change and the notice when the enrollee request a refill. The written notice must contain the following information:

1.
The name of the affected covered Part D drug;

2. 
Whether the plan is removing the covered Part D drug from the formulary, or changing its preferred or tiered cost-sharing status;

3.
The reason why the plan is removing such covered Part D drug from the formulary, or changing its preferred or tiered cost-sharing status;

4.
Alternative drugs in the same therapeutic category, class, or cost-sharing tier, and expected cost-sharing for those drugs; and

5.
The means by which enrollees may obtain a coverage determination under 42 CFR 423.566 or exception under 42 CFR 423.578.

CMS has developed a model notice that a Part D plan sponsor can use to notify enrollees whenever it changes its formulary or the cost-sharing status of a drug during the plan year. If a plan sponsor makes any substantive change to a model notice, the proposed change must be approved through the appropriate CMS marketing procedures.

Note: Except as provided under 42 CFR 423.120 (b)(5)(iii), a Part D sponsor may not remove a covered Part D drug from its formulary, or make any change in the preferred or tiered cost-sharing status of a covered Part D drug on its formulary, between the beginning of the annual coordinated election period described in 42 CFR 423.3 8(b) and 60 days after the beginning of the contract year associated with that annual coordinated election period. See 42 CFR 423.120(b)(6).

Coverage Determination Request Form