Step therapy exceptions

If your plan will not cover a drug until you have tried and failed one or more cheaper drugs, it is using step therapy. You do not always 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.

What order?

• You hold a denial letter, so file the appeal by your deadline whatever else happens. For job-based and non-grandfathered individual plans that is at least 180 days from the day you receive the notice.
• Ask your doctor to send the exception request at the same time.
• Do not count on the exception request to pause your appeal deadline. We could not confirm that it does.
• If you have no denial letter yet, start with the exception request and ask the plan for its answer in writing.

What this means

A step therapy exception (sometimes called a “fail first” waiver) asks the plan to cover your prescribed drug now. We found no single federal checklist for employer and Marketplace plans. The grounds that state laws list, and that patient groups such as the Crohn’s & Colitis Foundation and the Arthritis Foundation build their requests around, are broadly these:

• You already tried the required drug (or one like it) and it did not work. The Arthritis Foundation calls this proof of prior failure.
• The required drug is expected to be ineffective, or is likely to harm you, for example because of a condition you have.
• You are stable on the drug now, and the plan wants to change it.

Which grounds count for your plan depends on its exception process and on any state law. Some state pages list step therapy rules for insured plans, such as Washington, Colorado, California and Massachusetts. Several of these states set short deadlines for the plan’s answer. State rules generally do not reach self-funded employer plans.

What to do

1. Get the denial or rejection in writing. Ask the plan for the step therapy rule it applied and the drugs it requires. The pharmacy rejection script helps if the news came at the counter. (You.)
2. List what you have tried. For each earlier drug write the name, dose, start and stop dates, and what happened: no effect, side effects, a reaction. Your doctor’s office and pharmacy can print the history. (You, with your doctor’s office.)
3. Ask your prescriber to write the exception request. The step therapy clinician letter is a starting point. It should state the diagnosis, the drugs tried, why the required drug is inappropriate for you, and what happens if you wait. Your prescriber adds the clinical facts. (Your prescriber.)
4. Attach the proof. Attach pharmacy records, clinic notes and test results that show the drugs tried. Add the treatment guideline or study your prescriber cites. (You and your prescriber.)
5. Mark it urgent if delay could harm you. Your prescriber can say so in the letter. For employer plans, a physician who knows your condition can make a claim urgent, and an urgent decision is due within 72 hours. (Your prescriber.)
6. Appeal if refused. The step therapy exception appeal letter builds on the same facts. Employer and non-grandfathered individual plans must give at least 180 days after you receive the denial to appeal. Check the date on your notice, which controls.
7. Ask for external review when the denial turns on medical judgment. You have at least four months after the final internal denial.

What the plan may say, and what to say back

“You have not tried the preferred drug.” Reply with the dates and results of the drugs you tried, and your prescriber’s statement of why the preferred one is not appropriate. If you took the drug under an earlier plan, send those records too.

“Our records show no failure of the preferred drug.” Ask the plan which records it reviewed. Send pharmacy fill history, clinic notes and any side effect record, and ask for the claim file.

If you have a Medicare drug plan

Ask for a coverage determination, which is the plan’s first decision. Send your prescriber’s supporting statement with it. The plan must answer a coverage determination within 72 hours (24 hours if urgent). For formulary and tiering exceptions, that clock is counted from when the plan receives your prescriber’s statement, and if no statement comes within 14 calendar days, the plan must decide within 72 hours after that period ends. Ask the plan which clock applies to your request. In your first 90 days in a new plan, the plan must give a one-time temporary supply (at least an approved month’s supply) of a drug that needs prior authorization or step therapy, and must send written notice within 3 business days.

See also Medicare drug plan appeals.

The rule

For a Part D exception request, the 72-hour (24-hour expedited) clock starts when the plan receives the prescriber’s supporting statement. 42 Code of Federal Regulations (CFR) 423.568

Watch for

• Plan type. A fully insured employer plan or individual plan may follow its state’s step therapy law. A self-funded employer plan generally cannot be made to follow it. See self-funded or fully insured to find out which you have.
• A new plan. A plan switch may restart prior authorization and step therapy, so ask the new plan, before your next refill, what it will cover while you ask for an exception.
• Treatment history from earlier plans. Keep records of drugs you took under an earlier plan, and ask the new plan whether it will accept them as proof.
• Do not stop a medicine on your own because of a denial. Ask your prescriber what to do while you wait.

What next

• Formulary exceptions: when the drug is not on the plan’s list.
• Quantity limits, tier exceptions and switches: when the drug is covered but restricted.
• Ask your doctor for a letter: how to make it easy for the office.
• Prescription drugs topic page: every drug guide and letter.