Formulary Exception Letter Template for Medicare Part D

Your parent's doctor prescribes a brand-name medication that isn't on the plan's formulary. The pharmacy charges full retail price — $340 for a 30-day supply — because the plan won't cover it. The plan's formulary alternative is a drug your parent tried two years ago that caused severe side effects.

This is exactly when you file a formulary exception request. The plan must review it within 72 hours (standard) or 24 hours (expedited), and approval means the drug gets covered at the formulary tier the plan assigns.

What a Formulary Exception Request Requires

A successful exception request has two components that must be submitted together:

1. Your written request. You or your parent submit a letter or Form CMS-10146 (the model coverage determination request form) to the plan sponsor's coverage determination department. The request must identify the specific drug, explain why the formulary alternatives are inadequate, and state what you're asking for — either coverage of a non-formulary drug or placement on a lower cost-sharing tier (a tiering exception).

2. The prescribing physician's supporting statement. This is the make-or-break document. The doctor must provide a written clinical statement that explains:

• The medical necessity of the specific drug for your parent's condition
• That all covered formulary alternatives have been tried and failed, caused adverse reactions, or are medically inappropriate for clinical reasons
• The expected clinical consequences of forcing a switch to the formulary alternative

Without the physician's statement, the plan will deny the request. The letter from you alone is not sufficient.

How to Structure Your Request Letter

Address the letter to the plan's Coverage Determination Department (the address is on the plan's Evidence of Coverage document or the denial notice your parent received). Include:

Paragraph 1: State your parent's name, Medicare ID, the plan name and contract number, and that you are requesting a formulary exception under 42 CFR §423.578.

Paragraph 2: Identify the drug by exact name, strength, and dosage form. State that it is not on the plan's current formulary (or is on a higher tier than medically appropriate). Name the formulary alternatives and explain, specifically, why they are inadequate — prior treatment failure dates, documented side effects, clinical contraindications.

Paragraph 3: State that the prescribing physician's supporting statement is enclosed (or being submitted separately by fax from the doctor's office). Request expedited review if applicable — the physician must certify that waiting 72 hours would jeopardize your parent's life, health, or ability to regain maximum function.

Paragraph 4: Provide your contact information and reference your CMS-1696 Appointment of Representative form if you're filing on your parent's behalf.

The Doctor's Supporting Statement

Coach the prescribing doctor's office on what to include. Many physicians write vague letters ("I believe this medication is necessary") that don't meet the regulatory standard. The statement needs to be specific:

• Name the drug, the diagnosis, and the clinical rationale
• Document prior trials of formulary alternatives with dates, durations, and outcomes (e.g., "Patient tried metformin 500mg BID from March 2024 through August 2024; discontinued due to persistent GI intolerance documented in office visit notes dated 8/15/2024")
• State that no covered formulary alternative is medically appropriate for this patient
• If requesting expedited review, include the clinical urgency certification

The doctor can submit this via fax to the plan's medical review department. Get the fax confirmation page — you may need it if the plan claims they never received the statement.

Timelines and What Happens After Filing

Standard review: The plan must issue a decision within 72 hours of receiving the physician's supporting statement.

Expedited review: If the physician certifies clinical urgency, the plan must decide within 24 hours.

If approved: The drug is covered, typically at the tier the plan assigns. Your parent can fill the prescription immediately.

If denied: You have 65 calendar days from the denial notice to file a redetermination (Level 2 appeal) with the plan. If that's also denied, the case goes to C2C Innovative Solutions, the independent review entity (IRE), for a Level 3 reconsideration. The full Part D appeals process has five levels.

Don't Wait for the Denial

You don't have to wait until the pharmacy rejects the prescription. If you know a medication your parent needs isn't on the formulary — check the plan's online formulary search tool — file the exception request proactively before the prescription is filled. This avoids the pharmacy-counter crisis and gives the doctor's office time to prepare a thorough supporting statement.

Our Part D planning guide includes customizable exception request letter templates, a physician statement checklist, and filing instructions for each level of the appeals process.

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