Denial reason · Coverage
Drug not on the formulary
Do this first
Both are free and run in your browser.
The drug your doctor prescribed is not on the plan's list of covered drugs. You can ask for an exception. Your prescriber will need to state why this drug, and not the covered ones, is right for you.
On this page 7
- Who has to act first
- You and your provider together. Your prescriber writes the supporting statement explaining why this drug is medically necessary for you. You ask the pharmacy and plan for the denial in writing, then submit the request or appeal.
- Can it go to external review?
- Sometimes. It depends on what the decision turns on. A formulary exception denial can qualify for federal external review of a non-grandfathered plan when it turns on medical judgment; the reviewer decides that. Such a plan must allow at least four months after the denial or final internal denial to ask (check the date on your notice, which controls). In a Medicare drug plan, first ask the plan for a redetermination within 65 calendar days of the date on the denial notice. If the plan upholds its denial, ask the independent review entity in writing within 65 calendar days of the date on the redetermination notice.
Wording you may see on your letter
- Drug not on formulary
- Non-formulary medication
- This drug is not on your plan's covered drug list
- Not on the preferred drug list
What it means
A formulary is the plan’s list of covered drugs. Yours is not on it. A “formulary exception” asks the plan to cover a drug it does not normally list. It is a different request from a step therapy exception (try other drugs first) and from a tier exception (a lower price tier), so name the one you mean.
Often the first sign is a rejection at the pharmacy counter. That is not yet a written denial. Ask the plan for one, because the written notice carries your appeal rights.
Who has to act first
Your prescriber and you. The prescriber states the medical reasons. You get the denial in writing, follow the plan’s exception process, and make sure the request arrives on time.
In a Medicare drug plan (Part D), the first decision is a “coverage determination”. For a formulary exception the prescriber must give an oral or written supporting statement that the drug is medically necessary for a reason Medicare lists. The plan then has 72 hours to decide, or 24 hours if urgent, counted from when it receives the statement. If no statement arrives within 14 calendar days, the clock starts when that period ends. If the plan denies, ask for a redetermination within 65 calendar days of the date on the notice. It must decide in 7 calendar days, or 72 hours if expedited.
For an employer plan or a non-grandfathered individual plan, your plan document describes its exception process. Ask the plan in writing for its timeline. If it treats the request as a pre-service claim, the federal outer limits are 72 hours if urgent and 15 days otherwise (one 15-day extension is possible). You have at least 180 days after you receive a denial to appeal. Medicare, Medicaid and other public coverage differ. Check the date on your notice, which controls.
Arguments that work
- A supporting statement from your prescriber. It names the drug, dose and diagnosis, and explains why the drug is medically necessary for you.
- Address every covered alternative. For each one, the statement should say whether you tried it and how it went, or why it is not appropriate or could harm you.
- New to a Medicare drug plan. In your first 90 days in a new plan, the plan must give a one-time temporary supply of at least an approved month’s supply of a drug that is not on its formulary, with written notice within 3 business days.
- A change to the list. Before a negative formulary change, a Medicare drug plan must generally give affected members at least 30 days’ written notice.
- A lower price tier. If the drug is covered but at a high price, a tiering exception is a separate request. In a Medicare drug plan, the prescriber must say the preferred drug would not be as effective or would have adverse effects. A Medicare drug plan may exclude specialty-tier drugs from tiering exceptions.
Evidence to gather
- The pharmacy rejection message and the plan’s written denial (you, the pharmacy, the plan).
- The formulary page with the date you checked it (the plan’s website).
- The prescriber’s supporting statement (your prescriber).
- Records of covered drugs you tried, with dates, doses and results (your prescriber, your pharmacy).
- The plan’s exception form and instructions (the plan).
What to send
Send the exception request on the plan’s form, or as a letter, with the prescriber’s statement and records attached. Ask the pharmacy whether a hold or a partial fill is possible while the plan decides. If waiting could harm you, your prescriber says so and you ask for an expedited decision. Do not stop a medicine on your own. Ask your prescriber what to do while you wait.
When this is not worth an appeal
If your plan document excludes a whole category of drugs and offers no exception, an appeal can only ask the plan to apply its terms. Look instead at the not a covered benefit page, a request to your employer, and patient assistance programs that drug makers run.