How to appeal a step therapy denial
The short answer
Step therapy, or "fail first," means the plan wants you to try one or more other drugs before it covers the one your doctor prescribed. You can ask for an exception, backed by records of drugs already tried and the reasons the required drug is unsafe or unlikely to work for you. Many states regulate these exceptions, and Medicare has its own rules.
What step therapy is
Step therapy is a practice that requires a patient to try a lower-cost drug proven effective for most people with the condition before the plan covers a similar, more expensive one. The denial may say "step therapy required" or list the drugs you must try first.
It is still a coverage decision you can challenge. In employer plans, a denial resulting from the application of any utilization review is an adverse benefit determination, with the same appeal rights as other denials.
Ask for a step therapy exception
Ask the plan for its step therapy exception form and instructions. In Medicare drug plans, you, your representative or your prescriber can file the request; in other plans, ask whether you or the prescriber's office should submit it.
Ask your doctor's office to document:
- Every drug already tried for this condition, with doses, start and stop dates, and who prescribed it.
- What happened on each: no improvement, partial response, side effects, an allergic reaction, or lab results that changed.
- Why the required step drug is contraindicated for you, such as an interaction with another medicine, another condition you have, pregnancy, or a past reaction to a similar drug.
- Whether you are stable on the prescribed drug now, and what the doctor expects if you switch.
- Pharmacy records or claims from an earlier plan, if you tried the step drugs under different coverage.
- Clinical guidelines that support starting with the prescribed drug for your situation.
Ask how long the plan has to decide and whether an urgent request is available. If you are already taking the drug and a new plan or a formulary change triggered the step rule, say so at the top of the request, and ask your doctor to describe what a switch would mean for you.
State step therapy laws
An American Bar Association overview published in September 2026 counted 38 states plus D.C. with some form of step therapy regulation as of early 2026. Among those states, roughly 33 require an exception for a previously failed drug, 32 for a contraindication, and 31 where the drug is expected to be ineffective. Illinois banned step therapy entirely beginning January 1, 2026, though that ban does not reach self-funded employer plans.
One limit matters for many people with job-based coverage: state step therapy laws generally apply to fully insured plans and do not apply to self-funded plans. Ask your HR office which kind of plan you have. If you have a fully insured or individual plan, ask your state insurance department what your state requires and how fast the plan must answer.
Medicare Advantage and Part B drugs
Medicare Advantage plans can use step therapy for drugs covered under Part B, within limits. A plan must apply step therapy only to new administrations of Part B drugs, using at least a 365-day lookback period. If you received the drug in the past year, point that out in your request.
Each step program must be reviewed and approved by the plan's pharmacy and therapeutics committee, and a plan may not require you to try a drug it does not cover.
Part B drug requests move quickly. The plan must decide a standard request no later than 72 hours after receiving it and an expedited request no later than 24 hours. See Medicare Advantage appeals for the next steps if the answer is no.
Medicare Part D exceptions
Medicare drug plans must have an exceptions process that covers a coverage policy that blocks a drug because of cost utilization tools, such as a requirement for step therapy. The prescriber must give a supporting statement that the drug is medically necessary, for example because the drug alternatives required by step therapy have not worked, are likely not to work, or have caused or are likely to cause harm.
See Medicare Part D appeals for decision times and the levels of appeal after an exception is denied.
If the exception is denied
Appeal through your plan's normal process, and add anything the first request lacked. If the denial turns on medical judgment, such as whether the first drug is safe or likely to work for you, ask whether it qualifies for external review, which federal rules provide for denials involving medical necessity and appropriateness.
If the drug is not on your plan's formulary at all, plans that provide essential health benefits must also offer a drug exception process with independent review of denials. For deadlines, see the pages for employer plans, Marketplace plans and Medicaid.
Questions people ask
What is a step therapy exception?
It is a request asking the plan to cover the prescribed drug without trying the required drugs first, usually because you already tried them or they are unsafe or unlikely to work for you.
Does step therapy apply if I was already taking the drug?
It depends on your plan and state. In Medicare Advantage, step therapy for Part B drugs applies only to new administrations, with a 365-day lookback. Elsewhere, send records showing you are stable on the drug.
Do state step therapy laws apply to my employer plan?
Generally only if the plan is fully insured. State laws generally do not apply to self-funded plans.
How fast must Medicare Advantage decide a Part B step therapy request?
Within 72 hours for a standard request and within 24 hours for an expedited one.
Sources
- American Bar Association, Health Law Section (Health eSource), Sept. 29, 2026: State Step Therapy Laws and ERISA: An Overview
refers to a practice by health plans that requires a patient to try a lower-cost prescription drug that has been proven effective for most people with that condition before covering a similar and more expensive drug
- eCFR: 29 CFR 2560.503-1 Claims procedure
a benefit resulting from the application of any utilization review
- eCFR: 42 CFR 423.578 Exceptions process
An enrollee, the enrollee's representative, or the prescribing physician or other prescriber (on behalf of the enrollee) may file a request for an exception.
- National Association of Insurance Commissioners: Insurance Departments
Find contact information for insurance departments and local insurance agents, or file a complaint.
- eCFR: 42 CFR 422.136 Medicare Advantage (MA) and step therapy for Part B drugs
Apply step therapy only to new administrations of Part B drugs, using at least a 365 day lookback period;
- eCFR: 42 CFR 422.568 Standard timeframes and notice requirements for organization determinations
but no later than 72 hours after receipt of the request
- eCFR: 42 CFR 422.572 Timeframes and notice requirements for expedited organization determinations
but no later than 24 hours after receiving the request
- eCFR: 45 CFR 147.136 Internal claims and appeals and external review processes
requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness of a covered benefit; its determination that a treatment is experimental or investigational
- eCFR: 45 CFR 156.122 Prescription drug benefits
request and gain access to clinically appropriate drugs not otherwise covered by the health plan (a request for exception)
This page is general information about appeal rules in the United States. It is not legal or medical advice. Rules can change, and your plan’s documents and your denial letter control the dates that apply to you.