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CareReview's Approach to Medicare Part D Appeals Process
How CareReview supports Part D sponsors and PBMs through CMS's five-level appeals process — and where independent review fits.
CareReview's Approach to Medicare Part D Appeals Process
How CareReview supports Part D sponsors and PBMs through CMS's five-level appeals process — and where independent review fits.
CareReview's Approach
CareReview supports Part D sponsors and PBMs with independent, specialty-matched pharmacist and physician review at the coverage determination and Level 1 redetermination stages — where an objective clinical opinion strengthens the record before a case can escalate further. Every review runs through the same URAC-accredited infrastructure behind CareReview's broader pharmacy review work, so plans have a defensible determination in hand well before a case reaches CMS's Part D Independent Review Entity.
The Five Appeal Levels
For reference, here's how the full five-level appeals process breaks down.
- Coverage Determination: The plan sponsor's initial decision on whether a drug is covered, and on what terms — often informed by independent clinical review before the determination is issued.
- Level 1 — Redetermination: Handled by the same plan sponsor that made the original decision. Requests must be filed within 65 calendar days of the coverage determination notice.
- Level 2 — IRE Reconsideration: If the redetermination is unfavorable or only partially favorable, the case moves to reconsideration by CMS's Part D Independent Review Entity (IRE). Requests must be filed within 65 calendar days of the redetermination notice.
- Level 3 — OMHA: If the IRE's decision is still unfavorable, the case can move to a hearing before an Administrative Law Judge (ALJ) at the Office of Medicare Hearings and Appeals. This level has a minimum dollar threshold, which CMS recalculates each year.
- Level 4 — Medicare Appeals Council: An unfavorable OMHA decision can be appealed to the Medicare Appeals Council, a component of HHS's Departmental Appeals Board. Requests must be filed within 60 days of the OMHA decision notice.
- Level 5 — Federal Court: The final level is judicial review in federal district court, available within 60 days of the Council's decision — but only if the amount remaining in controversy meets a minimum threshold that CMS recalculates each year.
Where Independent Review Fits
Level 2 is where independent review becomes central to the process: CMS requires a reviewer with no stake in the original decision — structurally separate from the plan sponsor — before a denial can be escalated further. That's the same principle behind every URAC-accredited Independent Review Organization: independence isn't a courtesy, it's what makes a determination defensible.
What Plans and PBMs Are Responsible For
At every level, the plan sponsor — and, for pharmacy benefit management functions, the PBM administering the plan — is responsible for meeting CMS's decision and notice timeframes, maintaining a complete case file, and forwarding that file to the next level of review if the appeal continues. A missed redetermination deadline counts as an adverse decision, and the case is auto-forwarded to the IRE.
Read our companion guide, CareReview As Your Independent Review Organization, for more on how independent review works generally, or see how CareReview supports Government Programs and PBMs.