Formulary and Step Therapy Exceptions: How to Request One
When your plan says a drug is not on its list, sits on a costly tier, or has to wait until you try something cheaper, you can ask for an exception. Here is which kind to ask for, what your prescriber has to show, how fast the plan must answer, and which maker programs still help if it says no.
By mendmeds · Published · 10 min read
The short version
- An exception asks your plan to cover a drug it normally would not, or to drop a rule such as step therapy or a quantity limit. Your prescriber has to back the request with a medical reason.
- Medicare drug plans must decide within 72 hours of getting your prescriber’s statement, or 24 hours if the request is expedited. Marketplace plans have the same limits, counted from your request.
- An exception does not help with a drug your plan excludes altogether, such as a weight-loss drug under regular Medicare Part D coverage.
- As of November 2026, the terms of the copay cards for 31 drugs mendmeds tracks say your plan must cover the drug, so a denial can cost you the card too. Still, 4 cards and 7 free-drug programs help when the plan says no.
Which exception to ask for
A formulary is your plan’s list of covered drugs. The reason your plan gives tells you which request fits, so start with the denial letter or the pharmacy’s rejection message.
| What the plan told you | What to ask for | What your prescriber has to show |
|---|---|---|
| The drug is not on the formulary | Formulary exception | The listed drugs have not worked, are unlikely to work, or have caused or are likely to cause harm |
| You must try another drug first | Step therapy exception | The required drug has not worked, is unlikely to work, or has caused or is likely to cause harm |
| The plan limits the dose or quantity | Dose or quantity limit exception | The limit has not worked for you or is unlikely to |
| The drug is covered, but on a costly tier | Tier exception | Drugs on the lower tier would not work as well, would cause harm, or both |
These are Medicare Part D’s tests. HealthCare.gov lists similar grounds for Marketplace plans, and other private plans set their own.
Prior authorization is different. The drug is on the plan’s list, and the plan checks that you meet its criteria before it pays. With an exception, you are asking the plan to go beyond its list or its rules. If you do not meet the prior authorization criteria, your prescriber can ask for an exception to them.
How to ask
- Find the exact reason. Read the letter or ask the pharmacist what the rejection said. "Non-formulary", "step therapy required" and "quantity limit" can all lead to an exception. "Excluded" or "not a covered benefit" usually cannot, as explained below.
- Ask your prescriber’s office to file it. On Medicare, you or your prescriber can ask by letter, on a model form or by phone, but your prescriber has to give the medical reason. Private plans set their own process, so call the number on your card and ask for the plan’s drug exception process.
- Send the evidence. Name each drug you tried, when, and what happened, and explain why the plan’s alternatives are unsafe or unlikely to work for you. If you are stable on the drug, say for how long.
- Ask for an expedited decision if you cannot wait. Medicare allows one if waiting may seriously jeopardize your life, health or ability to regain maximum function. Marketplace plans also allow one if you are already being treated with a non-formulary drug.
- Keep the paperwork. Write down when the request went in and keep the decision letter. Some maker programs ask for it.
How fast your plan must decide
| Coverage | Standard | Expedited | If the plan says no |
|---|---|---|---|
| Medicare Part D | 72 hours after the plan gets your prescriber’s statement | 24 hours after the plan gets the statement | Ask the plan to redecide within 65 days of the denial notice. It has 7 days, or 72 hours if expedited. |
| Marketplace and other individual plans, and most small-employer plans | 72 hours after the request | 24 hours after the request | Ask for review by an independent organization, which has the same 72 or 24 hours. |
| Large-employer and self-funded plans | No deadline specific to exceptions; ask your plan | No deadline specific to exceptions; ask your plan | Internal appeal within 180 days, then external review |
Medicare’s clock starts when the plan has the statement, so ask your prescriber’s office to send it quickly and confirm it arrived.
If a Medicare plan misses its deadline, the rules treat that as a denial, and the plan must send your case to an independent reviewer within 24 hours.
Medicaid works differently. State programs must answer a prior authorization request within 24 hours and, in an emergency, supply at least 72 hours of the drug. Ask your state program or Medicaid plan how to request a drug it does not list.
What happens if it is approved
- How long it lasts. On Medicare, refills should not need a new approval during the plan year, as long as your prescriber keeps prescribing the drug and it stays safe for you. The plan may continue the approval into the next year but does not have to, so check at open enrollment. On Marketplace plans, a standard approval lasts for the prescription, including refills, and an expedited one lasts as long as the urgent need.
- What you pay. On Medicare, an approved tier exception gets you the lower tier’s cost, and a plan cannot create a special tier just for drugs approved by exception. HealthCare.gov says Marketplace plans generally charge the copay for their most expensive covered drugs, such as a non-preferred brand.
- Whether it counts. What you pay for a drug approved this way counts toward your yearly out-of-pocket limit, on Medicare and on Marketplace plans.
What an exception cannot fix
- Drugs your plan excludes. Some plans keep excluded drugs apart from non-formulary ones. One administrator’s list says excluded products are "NOT eligible for formulary exception review." With job-based coverage, ask your benefits office whether the exclusion is part of your plan’s design and whether any review exists.
- Weight-loss drugs on regular Medicare Part D. The law that created Part D excluded drugs used for weight loss, and the exceptions process cannot be used to cover a drug that is not a Part D drug. The Medicare GLP-1 Bridge is a separate, temporary program that covers some of these drugs at $50 a month.
- Some tier requests. A Part D plan can refuse to move a brand-name drug to a tier that holds only generics, or a biologic to a tier with no biologics. It can also keep specialty-tier drugs out of lower, non-specialty tiers. The federal rule for Marketplace plans covers drugs a plan does not otherwise cover and does not mention tiers, so ask your plan whether it takes tier requests.
Step therapy and state law
Step therapy, also called "fail first", means trying a lower-cost drug before the plan covers the one your prescriber chose. An American Bar Association survey found that, as of early 2026, 38 states and D.C. had some form of step therapy law. Most set limits rather than ban it. Roughly 33 states require an exception if the drug already failed for you, 32 if it is unsafe for you, and 31 if it is expected not to work. Illinois banned step therapy outright from January 1, 2026.
These laws generally do not reach self-funded employer plans, which federal law keeps out of state insurance rules, and about 67% of workers with job-based coverage were in such plans in 2025. Ask your benefits office whether your plan is self-funded or fully insured. A federal bill, the Safe Step Act (S. 2903 and H.R. 5509), would require an exception process in those plans too, but as of that September 2026 survey it had not become law.
While you wait
- Medicare. In your first 90 days in a new plan, you can get a one-time temporary supply of at least a month of a non-formulary drug. Plans also have to offer a transition if a formulary change affects you.
- Marketplace plans. HealthCare.gov says some insurers offer a one-time refill after you first enroll, and your plan may let you use the drug until it decides.
- Private insurance. Some makers supply the drug while you pursue coverage. We track 10 bridge programs, none of which accepts Medicare or Medicaid.
If the plan still says no
Check your copay card first, because a denial can end it. The terms of the cards for 31 drugs we track say your plan must cover the drug, including Humira, Ozempic, Wegovy and Zepbound. The cards for Ajovy, Brilinta and Symbicort also say the plan cannot have a step therapy or prior authorization restriction in place. A few cards name a price for when the plan does not cover the drug:
| Medication | Card | What you pay |
|---|---|---|
| Olumiant | Olumiant Together Savings Card | as little as $5/month if commercial insurance covers Olumiant, $25/month if commercial insurance does not cover Olumiant |
| Opzelura | OPZELURA Copay Savings Card | As little as $0 per tube if commercial plan covers Opzelura; $35 per prescription at participating pharmacies if commercial plan does not cover Opzelura (the $35 offer is not valid in Massachusetts) |
| Taltz | Taltz Together Savings Card | as little as $5 a month if covered by insurance, or $25 a month if not covered |
| Vraylar | VRAYPAY / VRAYLAR Savings Program | as little as $0 per prescription fill if plan covers Vraylar; $40 for up to two 30-day fills per lifetime if plan does not cover it |
Terms as each maker states them. Each medication’s page links the source and the date we checked it.
Some free-drug programs also take you when your plan will not pay. These are the ones whose terms say so:
| Medication | Program | Terms on coverage | Household income limit |
|---|---|---|---|
| Ajovy | Teva Cares Foundation - Ajovy PAP | If insured: prior-authorization or formulary-exception outcome letter required | 300% of the poverty level |
| Austedo | Teva Cares Foundation - Austedo PAP | Uninsured or insurance doesn’t cover Austedo | 300% of the poverty level |
| Entyvio | ENTYVIO Patient Assistance Program (Takeda Help at Hand) | Uninsured or insurance does not cover Entyvio | 500% of the poverty level |
| Jakafi | IncyteCARES Patient Assistance Program - Jakafi | No prescription drug insurance or insurance does not cover Jakafi | 500% of the poverty level |
| Keytruda | Merck Patient Assistance Program - Keytruda | No insurance or insurance does not cover Keytruda | 500% of the poverty level |
| Verzenio | Lilly Cares Foundation - Verzenio PAP | Commercial-insured may qualify if plan does not cover Verzenio | 500% of the poverty level |
| Xiidra | Bausch + Lomb Patient Assistance Program - Xiidra | Denied by your commercial insurer, with all appeal options exhausted | 300% of the poverty level |
The poverty-level table turns each income limit into dollars for your household size. Other programs may help too, so check your medication’s page.
If none of these fits, ask your prescriber about a covered alternative, and compare cash prices: a discount card can help with lower-cost drugs. How patient assistance programs work explains who qualifies for free-drug help.
Common questions
What is a formulary exception?
It is a request that your plan cover a drug that is not on its list of covered drugs. Your prescriber has to give a medical reason, such as the listed drugs having failed or being likely to harm you.
How long does a formulary exception take?
Medicare drug plans must decide within 72 hours of getting your prescriber’s statement, or 24 hours if expedited. Marketplace plans have the same limits from the date of your request. Large-employer and self-funded plans are outside that rule, so ask yours.
What is the difference between a formulary exception and prior authorization?
Prior authorization applies to a drug on the plan’s list: the plan checks that you meet its criteria before paying. A formulary exception asks the plan to cover a drug that is not on the list.
Can I get a formulary exception for Zepbound or Wegovy?
It depends on why the plan said no. If the drug is non-formulary, you can ask. If your plan excludes weight-loss drugs altogether, an exception usually will not work. On Medicare, regular Part D coverage cannot pay for them for weight loss, but the Medicare GLP-1 Bridge is a separate option.
What is a tier exception?
It is a request to pay a lower tier’s cost for a drug on a higher tier. Medicare drug plans have to consider them, within limits: a plan can refuse to move a brand-name drug to a tier that holds only generics.
What is a step therapy exception?
It is a request to skip a lower-cost drug your plan wants you to try first. Your prescriber shows that the drug has failed, is unlikely to work or is likely to harm you. Most states regulate step therapy, but those laws generally do not reach self-funded employer plans.
Want the numbers for your own prescription? Pick your drug and see which programs it offers, what each one requires, and the source we checked.
Sources
- 42 CFR 423.578: Medicare Part D exceptions process
- 42 CFR 423.568: standard coverage determination deadlines
- 42 CFR 423.572: expedited coverage determination deadlines
- 42 CFR 423.120: Part D formulary access and transition supply
- 45 CFR 156.122: exception process for plans providing essential health benefits
- 42 U.S.C. 1396r-8: Medicaid prior authorization requirements
- Medicare.gov: appeals in a Medicare drug plan
- HealthCare.gov: prescription medications in Marketplace plans
- American Bar Association: State Step Therapy Laws and ERISA (September 29, 2026)
- Safe Step Act, S. 2903, as introduced
- Congressional Research Service: Medicare Coverage of GLP-1 Drugs (IF12758)
- Medicare.gov: weight loss drugs
- Planned Administrators Inc.: non-formulary and excluded drug list (effective April 1, 2023)
Keep reading
This article is general information, not medical, legal or financial advice. Program rules change, so check the program’s own page before you apply.