Medicare Part D drug-denial appeals
Part D covers pharmacy-benefit drugs. It uses a federal Medicare process even when the Part D benefit is bundled inside a Medicare Advantage plan.
- Redetermination deadline
- 65 calendar days from the notice date under current CMS instructions
- File with
- The Part D plan at the address or channel on the notice
- Standard decision
- 7 calendar days for redetermination
- Expedited decision
- 72 hours for an expedited redetermination
Exception request or appeal?
A formulary, tiering, quantity-limit, or step-therapy exception is a type of coverage determination. The prescriber explains why alternatives would not work as well or would cause adverse effects.
If the plan issues an unfavorable coverage determination, the first appeal is a redetermination. These are related steps, but their decision clocks are not interchangeable.
The five Part D appeal levels
- Plan redetermination.
- Independent Review Entity reconsideration.
- Administrative-law-judge hearing when requirements are met.
- Medicare Appeals Council review.
- Federal district court when requirements are met.
What to gather
- The coverage-determination or redetermination notice.
- The drug name, dose, diagnosis, and prescribing clinician.
- The prescriber's supporting statement.
- Prior drugs tried, outcomes, and adverse effects.
- The exact formulary, tier, step-therapy, or quantity-limit rule.
Medicare Part D appeal questions
How long do I have to appeal a Medicare Part D drug denial?
CMS currently instructs enrollees to file a Part D redetermination within 65 calendar days from the date of the coverage-determination notice. Use the deadline and instructions on the current notice.
What is a Part D formulary exception?
It is a coverage determination asking the plan to cover a non-formulary drug or waive a formulary restriction. A tiering exception asks for lower cost sharing. A prescriber's supporting statement is usually central.
How fast must a Part D plan decide?
For an exception coverage determination, the verified rules provide 72 hours standard and 24 hours expedited after the required supporting statement is received. For a first-level redetermination, CMS states 7 calendar days standard and 72 hours expedited.
Does state external review handle Part D denials?
No. Part D has a federal Medicare appeal track: plan redetermination, Independent Review Entity reconsideration, and three further federal levels when requirements are met.
Primary sources
- CMS — Redetermination by the Part D Plan Sponsor
- CMS — Medicare Part D Appeals Overview
- eCFR — 42 CFR § 423.578, Part D exceptions process