Medicare Drug Plan Coverage Determination: How to Request One

What a Coverage Determination Is

A coverage determination is the plan's formal decision about whether it will cover a specific drug, how much your parent will pay, or whether a formulary restriction can be waived. It's the first step before any appeal — you can't appeal a decision that hasn't been made yet.

You request a coverage determination when:

• A drug isn't on the plan's formulary and you want the plan to cover it as an exception
• The plan requires prior authorization and you're submitting the clinical documentation
• You want the plan to waive a step therapy requirement
• You're asking for a tiering exception — covering a drug at a lower tier's cost-sharing rate
• Your parent was charged more than expected at the pharmacy and you believe it was an error

A coverage determination is distinct from a grievance. Grievances address service complaints (long hold times, rude staff, pharmacy access issues). Coverage determinations address whether the plan pays for a specific drug.

How to Submit the Request

Form CMS-10146

The standard model form for requesting a coverage determination is Form CMS-10146, available at cms.gov. The form asks for:

• Patient name and Medicare ID
• The specific drug being requested
• The reason for the request (formulary exception, tiering exception, prior authorization)
• The prescribing physician's name and contact information

You can also submit a written letter instead of the form — there's no legal requirement to use CMS-10146 specifically. But the form ensures you don't miss any required element.

The Physician's Supporting Statement

When the request involves a formulary exception, tiering exception, or prior authorization, the prescribing doctor must submit a clinical statement to the plan explaining:

1. Why this drug is medically necessary for the patient
2. Why formulary alternatives are inadequate — prior treatment failure, adverse reactions, or clinical contraindications
3. The expected clinical outcome if the drug is approved

Submit the physician's statement alongside the coverage determination request. Sending them separately can cause delays if the plan's coverage department can't match the documents.

Decision Timelines

For an exception request, the plan's clock starts when it receives the physician's supporting statement. Send the request and statement together to avoid matching delays.

Expedited review is available when the physician certifies that the standard 72-hour wait would seriously jeopardize the patient's life, health, or ability to regain maximum function. The plan must then decide within 24 hours.

What Happens After the Decision

If approved: The plan covers the drug under the terms of the exception. A formulary exception means the drug is covered. A tiering exception means it's covered at the lower tier's cost-sharing rate. Check the approval notice for the decision's terms and duration, and confirm whether renewal is needed in a later plan year.

If denied: The denial letter includes the reason and instructions for requesting a redetermination — the first level of the five-level appeals process. You have 65 calendar days from the initial denial notice to file. A denial is not final; you can request a redetermination through the appeals process.

Pharmacy-Level Denials

When your parent is denied at the pharmacy counter, the pharmacist should provide a standardized notice (Form CMS-10147) explaining why the drug wasn't covered and how to request a coverage determination. If the pharmacist doesn't offer this notice, ask for it — it's required.

The pharmacy notice is informational, not a formal denial. It tells you that a coverage determination is needed, not that one has been made. The formal process starts when you submit CMS-10146 (or a written request) to the plan's coverage department.

Our Medicare Part D guide includes a coverage determination request worksheet that pre-fills the required information and pairs with a physician statement template.

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