Here's the short version. When your Part D plan won't cover a drug, you or your doctor can ask the plan for a formulary exception. An exception is when the plan agrees to cover a drug that's not on its drug list, or to waive a coverage rule like prior authorization, step therapy, or a quantity limit. Your prescriber must send a statement explaining the medical reason. The plan has 72 hours to decide a standard request and 24 hours for a fast one (see our appeals timelines reference). If the answer is still no, you have 65 days to appeal. The plan must decide that appeal within 7 days, or 72 hours if waiting could seriously harm your health. A second no goes to an independent reviewer. Don't take the first denial as the final word.
Step 1: Find out why the plan said no
Medicare drug plans can apply some or all of these rules to the drugs you take:
- Not on the formulary. The drug isn't on the plan's covered drug list.
- Prior authorization. The plan requires approval before it covers the drug. Your prescriber may need to show the drug is medically necessary for your condition.
- Step therapy. The plan wants you to try a cheaper drug on its list first, before it pays for a more expensive one.
- Quantity limits. The plan caps how much of a drug it covers in a period, such as 30 tablets a month.
The pharmacy counter is usually where you first learn about this. Ask the pharmacist which rule is blocking the fill, then call your plan to confirm. The reason decides which exception you ask for.
New to the plan? When your drug coverage begins, you may get a transition fill: a one-time, 30-day supply of a drug you've been taking that the plan doesn't cover or that needs prior authorization or step therapy. That buys time to request an exception.
Step 2: Ask for a coverage determination or exception
A coverage decision in a Medicare drug plan is called a coverage determination. You have the right to ask for one, by phone or in writing, to find out whether a drug is covered. For a drug you haven't gotten yet, you or your prescriber can ask for a coverage determination or an exception in one of these ways:
- Send the plan a completed "Model Coverage Determination Request" form.
- Write the plan a letter.
- Call the plan.
If you're asking to be paid back for a drug you already bought, you or your prescriber must make the request in writing.
You can also ask for a tiering exception to lower your share of the cost when a drug sits on a high tier and a similar drug on a lower tier won't work as well for you. Your prescriber's statement makes the case.
Step 3: Get your doctor's supporting statement
Every exception request needs a statement from your doctor or other prescriber explaining the medical reason the exception should be approved. For a formulary or prior authorization exception, the statement should explain the prescriber's belief that:
- Because of your medical condition, it's medically necessary for you to be on the drug, even if you don't meet the plan's requirements.
- You'll have negative health effects if you take a different drug.
- A different drug would be less effective.
For a step therapy exception, the statement should say why you need the more expensive drug without trying the cheaper one first. For a quantity limit exception, it should say why the limit isn't medically appropriate for you, such as needing a higher dose. A vague note gets denied. Specifics about what you've tried and what happened win cases.
Step 4: Know the decision clock
Once the plan has your request and the prescriber's statement, a standard coverage determination is decided within 72 hours, and an expedited one within 24 hours (see our appeals timelines reference).
You or your prescriber can ask for an expedited (fast) decision. The plan must grant it if the plan decides, or your prescriber tells the plan, that waiting for a standard decision may seriously jeopardize your life, health, or ability to regain maximum function. If you're out of medicine or close to it, say so and ask for the fast track.
Step 5: If the plan says no, appeal
A denial of your coverage determination is the start of the appeal process. The first level is called a redetermination. You, your representative, or your prescriber can ask for one. Follow the directions in the plan's denial notice.
- File within 65 days of the date on the denial notice. If you miss the deadline, you must give a reason for filing late.
- Include the essentials: your name, address, and Medicare Number; the drug you're appealing and why; your representative's name and proof of representation if you appointed one; and anything that helps, like a prescriber supporting statement.
- Ask for a fast appeal if waiting is dangerous. The standard decision takes up to 7 days for a benefit appeal and 14 days for a payment appeal. The plan must decide within 72 hours if it determines, or your doctor tells the plan, that waiting could seriously jeopardize your health.
- Level 2: independent review. If the plan upholds its denial, you have 60 days from the decision date to ask a Part D Independent Review Entity (IRE) for a reconsideration. The IRE decides in 7 days for a benefit appeal, 14 days for a payment appeal, or 72 hours for a fast appeal.
- Levels 3 to 5. If the IRE also says no, you have 60 days to ask for a hearing with the Office of Medicare Hearings and Appeals. Your case must meet a minimum dollar amount for that level. After that come the Medicare Appeals Council and federal court. Each decision letter tells you how to reach the next level. Our appeals levels and timelines reference maps the whole ladder.
Free help with the paperwork
Your State Health Insurance Assistance Program (SHIP) gives free, personal help with drug plan appeals. You can also appoint a trusted family member or friend as your representative. If you get Extra Help and think you're paying the wrong amount, contact your plan or call 1-800-MEDICARE; they can check your Extra Help level and fix your costs with the plan.
Common questions
Is this the same as prior authorization in Medicare Advantage?
No. Medical services in a Medicare Advantage plan follow different deadlines and rules. Drug coverage, whether from a standalone Part D plan or a Medicare Advantage plan with drug coverage, uses the exception and appeal process on this page. For medical care, see Medicare Advantage prior authorization.
Can I appeal if I already paid for the drug myself?
Yes. Ask the plan in writing to pay you back. That's a standard request you or your prescriber must make in writing. If the plan says no, the appeal follows the same steps, with a 14-day clock for payment appeals.
What if my plan drops my drug next year?
Plans change their formularies every year. Review your plan's Annual Notice of Change each fall, and compare plans during Medicare open enrollment if your drug is being dropped. See choosing a Part D plan. If you stay and the drug is gone in January, you may get a transition fill while you request an exception.
Is it worth appealing a drug denial?
Often, yes. Many denials come down to a missing or thin prescriber statement. Your doctor can strengthen it and the plan must look again. The appeal costs nothing, and a second denial goes to an independent reviewer outside the plan.
Related pages
- Medicare Part D — formularies, tiers, and plan rules.
- Appeals: Levels and Timelines — every appeal ladder, side by side.
- Medicare Advantage Prior Authorization — the medical-service side of denials.
- Your Rights — what plans must tell you and how to complain.
- Medicare Diabetes Coverage — insulin, CGMs, and supplies.
Official sources: Medicare.gov: Appeals in a Medicare drug plan and Medicare.gov: Drug plan rules.