Coverage type · Medicare
Medicare drug plan (Part D)
A prescription drug plan under Medicare. A drug denial starts with a coverage decision or an exception request. The independent review step is not automatic: you or your prescriber must ask for it in writing.
On this page 7
- Who has this
- People who get prescription drug coverage under Medicare, either from a stand-alone drug plan or through a plan that includes drug coverage.
- Who regulates it
- The Centers for Medicare & Medicaid Services sets the federal rules for Medicare drug plans. The independent review entity that reviews the second appeal is C2C Innovative Solutions, Inc.
- Can your state help?
- Partly. The appeal steps are federal, so your state insurance department does not run them. Your state's State Health Insurance Assistance Program gives free one-on-one Medicare counseling. Find it on your state page. Find your state.
How to tell this is your coverage
- The pharmacy says the drug is not covered, needs approval, or costs more than you expected. That is not yet a denial. Call the plan for the reason and ask for a coverage decision.
- Your plan sends a written denial of a coverage decision. That notice explains how to ask for a redetermination, the first appeal.
- Your plan has a list of covered drugs (a formulary), with price tiers.
The appeal steps, in order
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Ask for a coverage decision or an exception
Official name: Coverage determination, including formulary and tiering exceptions
- Who decides
- Your Medicare drug plan
- Your deadline
- The rules we use give no filing deadline for this first request. Ask as soon as the pharmacy or plan says no, and check your plan's notice for any time limit, which controls. For an exception, your prescriber must give an oral or written supporting statement: for a lower price tier, that the preferred drug would not work as well or would cause harmful effects; for a drug not on the formulary, that the drug is medically necessary for a listed reason.
- Their deadline
- 72 hours (standard) or 24 hours (expedited) for a request for a drug benefit; 14 calendar days for a request for payment (reimbursement). For an exception, the clock starts when the plan receives your prescriber's supporting statement. If no statement arrives within 14 calendar days, the plan must decide within 72 hours (24 hours if expedited) after that 14-day period ends. If the plan misses the deadline, that counts as a denial and the plan must forward the request to the independent review entity within 24 hours.
- What to send
- Your coverage request, or an exception request, with a supporting statement from your prescriber. Your prescriber's part is the statement, and your part is the request.
- If you lose, or hear nothing
- If the plan denies the request, ask for a redetermination from the plan (first appeal).
- The rule
- 42 CFR 423.568, plan timeframe for standard coverage determinations
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First appeal
Official name: Redetermination
- Who decides
- Your Medicare drug plan
- Your deadline
- 60 calendar days after you receive the written denial. Medicare treats you as receiving it 5 calendar days after the date on the notice. The Centers for Medicare & Medicaid Services describes this as 65 calendar days from the date of the notice. Check the date on your notice, which controls.
- Their deadline
- 7 calendar days (standard), 72 hours (expedited) or 14 calendar days (for payment).
- What to send
- A written request saying what was denied and why you disagree, with a supporting statement from your prescriber. You, your representative or your prescriber can ask.
- If you lose, or hear nothing
- If the plan upholds its denial, you must ask the independent review entity in writing. The case is sent automatically only if the plan misses its own deadline, or for a decision under a plan drug management program for people at risk.
- The rule
- 42 CFR 423.582, request for a standard redetermination
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Independent review
Official name: Reconsideration by the Independent Review Entity
- Who decides
- C2C Innovative Solutions, Inc., the independent review entity under contract with the federal government
- Your deadline
- 60 calendar days after you receive the redetermination. Medicare treats you as receiving it 5 calendar days after the date on the notice. The Centers for Medicare & Medicaid Services describes this as 65 calendar days. Check the date on your notice, which controls.
- Their deadline
- 7 calendar days (standard), 72 hours (expedited) or 14 calendar days (for payment), the same as the plan.
- What to send
- A written request, with a copy of the plan's redetermination notice and any supporting evidence from your prescriber. You, your representative or your prescriber can file.
- If you lose, or hear nothing
- If the independent review entity upholds the denial and enough money is in dispute, you can request a hearing before an Administrative Law Judge.
- The rule
- 42 CFR 423.600, right to a reconsideration
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Hearing
Official name: Administrative Law Judge hearing
- Who decides
- An Administrative Law Judge at the Office of Medicare Hearings and Appeals
- Your deadline
- 60 calendar days after you receive the independent review decision. The amount in dispute must be at least $200 for 2026 and 2027. Check the date on your decision, which controls.
- Their deadline
- 90 calendar days, or 10 calendar days if an expedited hearing is granted.
- What to send
- A written hearing request with a copy of the independent review decision and your evidence.
- If you lose, or hear nothing
- If the judge upholds the denial, you can ask the Medicare Appeals Council to review it.
- The rule
- 42 CFR 423.2002, right to a hearing
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Appeals Council review
Official name: Medicare Appeals Council review
- Who decides
- The Medicare Appeals Council
- Your deadline
- 60 calendar days after you receive the judge's decision. Check the date on your decision, which controls.
- Their deadline
- The rules we use do not state this level's decision deadline for drug plan appeals. Your decision notice will say.
- What to send
- A written request saying which parts of the judge's decision you disagree with and why.
- If you lose, or hear nothing
- If the Council upholds the denial and enough money is in dispute, you can bring a civil action in federal court.
- The rule
- 42 CFR 423.2102, request for Appeals Council review
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Federal court
Official name: Judicial review in federal district court
- Who decides
- A federal district court
- Your deadline
- The amount in dispute must be at least $1,960 for 2026. It rises to $2,000 for requests filed on or after 1 January 2027. The rules we use do not state the filing deadline for court in drug plan appeals, so read the deadline in your Appeals Council decision, which controls.
- Their deadline
- The court sets its own schedule.
- What to send
- A civil action filed in court, which follows the court's own rules. Talk to a lawyer or a free legal aid program before this level.
- If you lose, or hear nothing
- This is the last level.
- The rule
- 42 CFR 423.2006, judicial review thresholds and process
If waiting could harm your health
Ask for an expedited (fast) decision when waiting could harm you. The plan must answer an expedited coverage request within 24 hours and an expedited redetermination within 72 hours. Your prescriber's supporting statement starts the clock for an exception. If your plan is new to you, you may be able to get a temporary supply: in the first 90 days of coverage under a new plan, the plan must provide a one-time temporary supply of at least an approved month's supply of a drug that is not on its formulary, or that needs prior authorization or step therapy, and must send written notice within 3 business days. Before a negative formulary change, the plan must generally give affected members at least 30 days' written notice, or a refill with notice when you ask for one. Check the date on your notice, which controls.
Free help for this coverage
- State Health Insurance Assistance Program (SHIP)
Free one-on-one Medicare counseling that is not connected to any insurance company. Find your local program at shiphelp.org or by calling 877-839-2675. Your state page lists your state's program.
- 1-800-MEDICARE
Call 1-800-633-4227 (text telephone 1-877-486-2048). If a complaint or appeal is unresolved, ask the representative to submit it to the Medicare Beneficiary Ombudsman.
- Medicare Rights Center helpline
A national nonprofit. Free helpline 800-333-4114, Monday to Friday (as listed in November 2026); Spanish is available by pressing 8. Help is by phone only, and the organization asks you not to send personal Medicare information online.
- Legal aid
Free civil legal help for people with low incomes. A program can advise you on an appeal, especially at the hearing level and beyond, but it cannot take every case. Your state page lists legal aid programs for your state.
Who this covers
This page is for denials from a Medicare prescription drug plan, called Part D. If your drug was given in a doctor’s office or outpatient setting (a Part B drug), it is decided under Original Medicare or Medicare Advantage, not Part D. Use the drug exception planner to prepare a request, and read the Medicare drug plan appeals guide.
How to tell this is your coverage
The first decision on a drug is called a coverage determination. A pharmacy rejection is usually the start, not the end. Call your plan, ask for the reason, and ask for a coverage decision in writing. A member can ask the plan to cover a drug that is not on its formulary (a formulary exception) or to charge a lower price tier (a tiering exception).
What does not apply to you
The independent review is not automatic in Part D. In Medicare Advantage the plan forwards your case, but in Part D you, your representative or your prescriber must file the request in writing. The plan forwards the case automatically only if it misses its own deadline.
A plan may refuse a tiering exception for a drug on its specialty tier to a lower non-specialty tier, and need not move a brand-name drug down to a tier that has only generics.
Where people go wrong
- Treating the pharmacy’s no as a denial. A pharmacy rejection is not a written denial. Call the plan and ask for a coverage decision so the clock starts.
- Forgetting the prescriber’s statement. An exception needs a supporting statement from your prescriber. The 72-hour or 24-hour clock does not start until the plan has it.
- Waiting for the independent reviewer. You must ask for it in writing, within 60 days after you receive the redetermination (65 days from the notice date, as the Centers for Medicare & Medicaid Services describes it).
- Relying on an older web page. Older web pages, including some official ones, can lag the regulation on dollar amounts and deadlines. This page uses the regulation and the annual Federal Register notice; if a page or letter shows different figures, use the stricter date and ask the plan which applies.
- Counting on a single expedited time. In Part D the expedited coverage decision is 24 hours, the expedited redetermination is 72 hours, and an expedited hearing decision can be 10 calendar days if granted.
Free help is listed above. Name someone to act for you with the authorized representative letter.
Sources
- 42 CFR 423.568 and 423.572, coverage determination timeframes
- 42 CFR 423.578, exceptions
- 42 CFR 423.582 and 423.590, redeterminations
- 42 CFR 423.600, reconsideration by the independent review entity
- 42 CFR 423.2002, 423.2006, 423.2016 and 423.2102, later appeal levels
- 42 CFR 423.120, transition fills and formulary changes
- CMS, Part D redetermination by the plan sponsor
- CMS, Part D reconsideration by the independent review entity
- Federal Register notice CMS-4213-N, amount in controversy threshold amounts (2026-19016, 16 September 2026)
- Medicare.gov, appeals in a Medicare drug plan
- Administration for Community Living, State Health Insurance Assistance Program