Denial reason · Clinical judgment
Step therapy required
Do this first
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The plan wants you to try cheaper drugs first. You can ask for an exception. Holding a denial letter? File the appeal by your deadline, and ask your doctor to send the exception request at the same time.
On this page 6
- Who has to act first
- You and your provider together. Your prescriber supplies the drug history and the reasons the required drug is wrong for you. You ask the plan for its step therapy rule in writing and file the exception request or appeal.
- Can it go to external review?
- Sometimes. It depends on what the decision turns on. A step therapy denial can qualify for federal external review when it turns on whether the required drug is appropriate or effective for you, which is a medical judgment; the reviewer decides that. Grandfathered plans are exempt. In a Medicare drug plan, the next level is an independent review you must ask for in writing within 65 calendar days of the plan's appeal decision (check the date on your notice, which controls).
Wording you may see on your letter
- Step therapy required
- You must try preferred medications first
- Fail-first requirement not met
- Requested drug is not approved until alternatives have been tried
What it means
Step therapy, also called “fail first”, is a plan rule that you must try one or more cheaper drugs before it will cover the one your prescriber chose. You may not have to climb the steps. You can ask the plan to waive them, and the request works best when it is specific about what you have already tried.
The rule can show up as a pharmacy rejection or as a written denial. A rejection at the counter is not yet a written denial, so ask the plan for one, because the written notice carries your appeal rights.
Who has to act first
What order? If you hold a denial letter, file the appeal by your deadline whatever else happens, and ask your doctor to send the exception request at the same time. We could not confirm that an exception request pauses the appeal deadline, so do not count on it.
Your prescriber and you, together. The prescriber writes the clinical case. You ask the plan for the step therapy rule it applied, the list of drugs it requires, and its exception process, and you file on time.
For an employer plan or non-grandfathered individual plan, you have at least 180 days after you receive the denial to appeal (check the date on your notice, which controls). Ask the plan in writing for its exception 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). Medicare, Medicaid and other public coverage differ.
In a Medicare drug plan (Part D), the first decision is a “coverage determination”. The plan must decide within 72 hours, or 24 hours if urgent, counted from when it receives the prescriber’s supporting statement. 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.
Arguments that work
- You already tried it. Give names, doses, start and stop dates and what happened. Patient groups call this proof of prior failure. Records from an earlier plan are worth sending too.
- The required drug is wrong for you. Your prescriber can explain that it is expected to be ineffective or likely to cause harm, for example because of another condition or medicine you take.
- You are stable on this drug. Your prescriber can explain why a change is a risk for you.
- The plan’s own rule. The notice must set out the internal rule used, or say a copy is free on request. Ask for it and for the exception process in writing.
- 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 needs step therapy or prior authorization, and must send written notice within 3 business days.
- State law. Some states give people in insured plans specific step therapy exceptions with set response times. Those laws generally do not reach self-funded employer plans. See your state page and the self-funded or fully insured guide.
- Mental health drugs. If the plan applies a fail-first rule to mental health or substance use drugs more strictly than it does to other drugs, ask about the mental health parity rules.
Evidence to gather
- The denial or the pharmacy rejection message (you).
- The plan’s step therapy rule and exception form (the plan).
- Pharmacy fill history for the drugs tried (your pharmacy).
- Clinic notes with dates, doses and results, including side effects or reactions (your prescriber).
- A prescriber letter stating the diagnosis and why the required drug is not appropriate (your prescriber).
- A treatment guideline or study your prescriber relies on (your prescriber).
- Records from an earlier plan (you, or the earlier plan).
What to send
Send the exception request or appeal to the address in the notice. Include the prescriber’s letter, the drug history with dates and results, and the supporting records. If delay could harm you, your prescriber states that, and you ask for an expedited decision. Do not stop or change a medicine on your own because of a denial. Ask your prescriber what to do while you wait.
Sources
- 42 CFR 423.568, Medicare drug plan coverage determinations
- 42 CFR 423.578, Medicare drug plan exceptions
- 42 CFR 423.120, Medicare drug plan access to drugs (transition fills)
- 29 CFR 2560.503-1, claims procedure
- ERISA section 514 (29 U.S.C. 1144), preemption of state law
- 29 CFR 2590.715-2719, external review (what qualifies)