Non-formulary generics: what to do when coverage is denied

Non-formulary generics: what to do when coverage is denied

November 16, 2025 Eamon Thornfield

When your doctor prescribes a generic medication and the pharmacy says it’s not covered, it’s not a mistake. It’s a non-formulary generic-a drug that’s FDA-approved, safe, and effective, but your insurance plan doesn’t list it on their approved drug list. This isn’t rare. In 2022, over 12% of all generic prescriptions faced some kind of formulary restriction. For people managing chronic conditions like diabetes, Crohn’s disease, or high blood pressure, this isn’t just inconvenient-it’s dangerous.

Why your insurance won’t cover a generic drug

You might think generics are always covered because they’re cheap. But insurance companies build formularies to control costs, not just to ensure access. Even though a generic version of a drug costs 80-90% less than the brand name, insurers still pick which ones they’ll pay for. They often choose the cheapest option in a class, even if it’s not the best fit for you. For example, if your plan covers one brand of metformin ER but not another-even though both are identical in active ingredient-they’ll deny the one your doctor prescribed.

The result? You’re stuck paying full price. SmithRx found patients pay 3.7 times more for non-formulary generics. One man in Ohio paid $417 for 90 days of generic metformin ER when the same drug normally costs $15. He didn’t know he could appeal. He skipped doses for weeks.

The exceptions process: your legal right to coverage

Federal law says your plan must let you request an exception. This isn’t a favor. It’s a requirement under Medicare Part D and most commercial plans. You’re not asking for special treatment-you’re asking for the medication your doctor says you need.

The process starts at the pharmacy. When they tell you the drug isn’t covered, ask for a Coverage Determination. They’re required to give you this in writing within 24 hours. This document is your first piece of evidence. Keep it.

Next, your doctor fills out a form. But here’s the catch: a generic “I need this drug” note won’t cut it. The CMS requires specific clinical reasoning. Your doctor must explain:

  • Why every formulary alternative would fail for you
  • Which drugs you’ve tried before and why they didn’t work
  • Specific lab results or symptoms showing medical necessity
  • How switching drugs could harm you
Dr. Jane Sarasohn-Kahn says the most successful requests include measurable data: “Hemoglobin A1c levels for diabetes, fecal calprotectin for IBD, or blood pressure trends. Numbers beat opinions.”

What happens after you submit the request

Once your doctor submits the form, the clock starts. For standard requests, the plan has 72 business hours to respond. If your condition is urgent-like a flare-up of Crohn’s disease or uncontrolled seizures-you can request an expedited review. They must respond within 24 hours.

Approval rates vary. For Medicare Part D plans, about 68% of exceptions are approved on the first try. But it’s not random. The Crohn’s & Colitis Foundation found that 74% of well-documented requests get approved immediately. That’s not luck. It’s preparation.

If you’re denied, don’t stop. You have 60 days to file an internal appeal. If that fails, you can ask for an external review by an independent third party. The Bleeding Disorders Advocacy Alliance reports that 58% of initial denials are overturned on appeal. That means more than half of people who give up after the first “no” are actually eligible for coverage.

Doctor writing medical exception form with lab data and clock ticking toward deadline.

What to do while you wait

Waiting 72 hours without medication isn’t safe. Federal rules say plans must provide a 72-hour emergency supply of the drug while your request is reviewed. But a 2023 compliance report found 37% of plans ignore this rule.

If your plan refuses, call them. Ask for the name of the person you’re speaking with. Say: “I’m requesting my emergency supply under CMS guidelines Section 423.560.” If they still say no, file a formal complaint with your state’s insurance department. Most states have consumer protection units that respond within 48 hours.

In the meantime, ask your doctor if they can prescribe a short-term alternative that is covered, even if it’s less ideal. Sometimes a temporary switch can keep you stable until the exception is approved.

Costs don’t stop when coverage is denied

Even if you win your exception, there’s a hidden trap. Once approved, you still can’t request a lower cost-sharing tier. That means your plan can approve the drug but make you pay the same high price as if it were brand-name. Dr. Mark Parisi calls this a “coverage loophole.” You get the drug, but you’re still financially punished.

Some patients end up paying hundreds more per month than they should. That’s why GoodRx found 38% of people skip doses or cut pills in half when faced with non-formulary denials. It’s not noncompliance-it’s survival.

Patient holding emergency meds as insurance machine crumbles under appeal light.

How to improve your chances of approval

The Crohn’s & Colitis Foundation offers a free template doctors can use. Here’s what works:

  1. Include dates of past failed medications
  2. Attach lab results showing your condition worsened on formulary drugs
  3. Explain side effects you experienced (rash, dizziness, GI distress)
  4. State clearly: “This drug is medically necessary. Alternatives are ineffective or harmful.”
Doctors spend an average of 22.7 minutes filling out a complete form. Incomplete ones take 14 minutes-but get denied 60% more often. Don’t let rushed paperwork cost you your health.

What’s changing in 2025

The system is slowly improving. In October 2023, CMS rolled out standardized clinical criteria for common drug classes. That means doctors now have clearer guidelines for what evidence to include. CMS says this will reduce denials by 15-20%.

Starting in 2024, Medicare Part D must automatically approve exceptions for insulin and naloxone-two drugs where delays can be deadly.

By 2025, CMS plans to integrate exception requests directly into electronic health records. That could cut processing time by 40%. But until then, you still have to fight.

What you can do right now

If you’ve been denied coverage for a generic drug:

  • Get your Coverage Determination letter from the pharmacy
  • Call your doctor’s office and ask them to submit an exception request with clinical documentation
  • Ask if you qualify for an expedited review
  • Request your 72-hour emergency supply
  • Keep a log of every call, date, and person you speak with
  • If denied, file an appeal within 60 days
Don’t wait. Don’t assume it’s hopeless. The system is broken-but it’s not unbeatable. People win these appeals every day. You just need to know how to ask.

What is a non-formulary generic?

A non-formulary generic is a generic medication that your insurance plan does not list on its approved drug list (formulary). Even though it’s the same active ingredient as a covered drug, the plan won’t pay for it unless you get an exception approved.

Can I appeal a denial for a non-formulary generic?

Yes. Federal law requires all Medicare Part D and most commercial plans to have an exceptions process. You can request coverage based on medical necessity, and if denied, you can appeal. About 58% of initial denials are overturned on appeal.

How long does the exceptions process take?

For standard requests, plans have 72 business hours to respond. For urgent cases-like a disease flare or risk of hospitalization-you can request an expedited review, and they must respond within 24 hours.

Do I have to pay full price while waiting for approval?

No. Federal rules require your plan to provide a 72-hour emergency supply of the medication while your request is reviewed. If they refuse, contact your state insurance department or file a complaint with CMS.

Why do some doctors refuse to help with exceptions?

Many doctors are overwhelmed. The AMA found physicians spend over 13 hours a week just managing prior authorizations and exceptions. But a well-documented request takes only 22 minutes. Ask your doctor to use a template from patient advocacy groups like the Crohn’s & Colitis Foundation to make it easier.

Can I switch to a different plan to avoid this?

You can only switch plans during Open Enrollment (October 15-December 7) or if you qualify for a Special Enrollment Period (like moving or losing other coverage). Don’t wait-review your plan’s formulary every year before enrollment.

Are there programs to help pay for non-formulary drugs?

Yes. Many drug manufacturers offer patient assistance programs for generics, even if they’re not on formulary. Check GoodRx, NeedyMeds, or RxAssist. Some nonprofit organizations also offer grants for chronic condition medications.