Updated Nov 4, 2026FDA and CMS public dataIndependent · free · not health advice
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At the pharmacy counter · How-to guide

How to appeal a drug coverage denial

The steps and deadlines for challenging a denied prescription in Medicare Part D and in private plans, from the first coverage request to independent review, with 2026 and 2027 dollar thresholds.

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Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation.

Insurers selling plans on HealthCare.gov denied 19 percent of in-network claims in 2024, and enrollees appealed fewer than 1 percent of the denials, KFF reported in March 20261 after analyzing CMS transparency data. When people did appeal, insurers upheld their original decision 66 percent of the time. The figures combine medical and prescription drug claims and count only claims filed after care was given, so they leave out denied prior authorization requests.

A denied prescription follows a path set by the type of coverage. Medicare drug plans run a five-level process with deadlines measured in hours at the early stages. Private plans follow Affordable Care Act and federal benefits-law rules, and many must also offer a separate fast-track exception process for drugs left off the formulary. The deadlines below are the ones written into the regulations, along with the dollar thresholds that apply in 2026 and 2027.

First, a formal coverage request

A claim rejected at the pharmacy counter is not, by itself, a formal decision that can be appealed. In Medicare Part D, the first formal step is a coverage determination, defined in 42 CFR 423.566. The enrollee, a representative or the prescriber asks the plan to cover the drug. The request can be made orally or in writing, except that requests for repayment of a drug already bought must be in writing, under 42 CFR 423.5683.

The plan must answer a standard request within 72 hours and an expedited one within 24 hours, under 423.568 and 423.5724. A request for repayment gets 14 calendar days. If the plan misses an expedited deadline, the regulation treats that as a denial and requires the plan to forward the case to an independent reviewer within 24 hours.

Some drug problems call for a different kind of request, an exception. Under 42 CFR 423.5785, an enrollee can ask a Part D plan to cover a drug that is not on its formulary, to waive a step therapy or quantity rule, or to charge a lower tier's cost sharing. Each requires a statement from the prescriber that the covered or preferred alternatives would be less effective for the patient, would cause adverse effects, or both. For exceptions, the 72-hour and 24-hour clocks start when the plan receives that statement. A plan may design its process so that a brand-name drug cannot get a tiering exception down to a tier that holds only generics. Once an exception is approved, the plan may not make the enrollee re-request it for refills during the plan year, as long as the prescriber keeps prescribing the drug and it remains safe. Our explainers on tiered formularies and prior authorization and step therapy cover the rules that usually trigger these requests.

The five levels of a Part D appeal

If the plan says no, the enrollee can appeal. The CMS prescription drug appeals page2 lists five levels, and the regulations set the timing for each.

LevelWho decidesTime to fileDecision deadline (standard / expedited)
1. RedeterminationThe Part D plan60 days from the coverage decision notice7 days / 72 hours (14 days for repayment)
2. ReconsiderationIndependent review entity under contract to CMS60 days from the plan's redeterminationSame as level 1
3. HearingAdministrative law judge or attorney adjudicator; $200 must remain in dispute in 202660 days from the reconsideration notice90 days / 10 days
4. Council reviewMedicare Appeals Council60 days from the hearing decision90 days / 10 days
5. Judicial reviewFederal district court; $1,960 must remain in dispute in 202660 days from the Council decisionSet by the court

Sources: 42 CFR 423.582, 423.5906, 423.6007, 423.2002, 423.2016, 423.2100, 423.2102 and 423.2130; CMS amount-in-controversy notice for 20268. The regulations presume a notice arrives five days after the date on it, and a plan may extend the deadline to request a redetermination for good cause.

A few details in those rules matter in practice. The prescriber can request a redetermination on the enrollee's behalf. A redetermination has to be requested in writing unless the plan accepts oral requests. At level 2, the independent review entity must ask for the prescriber's views, and for a non-formulary drug the prescriber must determine that every covered drug on any tier for the same condition would be less effective or cause adverse effects, under 423.600(c)7. At that level, a denial based on medical necessity must be reviewed by a physician with expertise in the relevant field of medicine.

The dollar thresholds for levels 3 and 5 rise with medical inflation. For requests filed in 2026, they are $200 and $1,960, according to a December 2025 CMS notice8; for 2025 they had been $190 and $1,900. An enrollee can count the value of refills prescribed for the rest of the plan year toward the total, and can combine certain appeals to reach it. The Part D payment rules and the 2025 to 2027 benefit changes affect how much an enrollee pays while a dispute is pending.

Private plans: exceptions, internal appeals and external review

Plans that must cover essential health benefits, generally non-grandfathered individual and small-group plans, need a drug exception process under 45 CFR 156.122(c)10. The plan must decide a standard request for a non-formulary drug within 72 hours and an expedited request within 24 hours. A request is expedited when a health condition may seriously jeopardize the enrollee's life, health or ability to regain maximum function, or when the enrollee is already in a course of treatment with the non-formulary drug. If the plan says no, the enrollee or prescriber can ask an independent review organization to look at the request, on the same 72-hour and 24-hour clocks. A granted standard exception covers the drug for the length of the prescription, including refills.

For private coverage, the general appeal rules come from the ACA regulation at 45 CFR 147.13611, which builds on the Labor Department's claims rule for employer plans, 29 CFR 2560.503-1. The key deadlines for a drug decision made before the drug is dispensed are in the list below.

  • Urgent requests must be decided within 72 hours, at the first decision and on appeal.
  • Non-urgent requests made before the drug is dispensed must be decided within 15 days, with one 15-day extension allowed.
  • An enrollee has 180 days from a denial to file an internal appeal.
  • A non-urgent appeal of a request made before dispensing must be decided within 30 days if the plan has one appeal level, or 15 days per level if it has two.
  • An enrollee has four months from a final internal denial to request external review, which an independent review organization must decide within 45 days, or within 72 hours if expedited.

External review is the step that takes the final word away from the insurer. "Your insurer is required by law to accept the external reviewer's decision," HealthCare.gov12 says. Depending on the state and plan, the review runs under a state process or a federal one.

What to gather, and who to ask

In both systems the prescriber's statement carries most of the weight. Part D exceptions cannot be granted without one, and the independent reviewer must seek the prescriber's views. Useful items to collect are the plan's written denial, which must give the specific reason and describe the next appeal step, the plan's formulary page for the drug, and a record of any alternatives already tried. Which alternative is clinically appropriate is a question for the prescriber, and how a plan counts deadlines is a question for the plan.

A patient who needs the drug before a decision arrives can ask the pharmacist (our pharmacist script has wording) about the cash price, which for some generics is lower than a copay, as our piece on cash prices and copays explains, and can ask the plan whether a payment request is possible if an appeal later succeeds. For requests filed on or after Jan. 1, 2027, the Part D thresholds become $200 for a hearing and $2,000 for federal court, CMS said in a September 2026 notice9.

Sources and notes

  1. KFF (2026). Claims Denials and Appeals in ACA Marketplace Plans in 2024
    www.kff.org/patient-consumer-protections/claims-denials-and-appeals-in-aca-marketplace-pla
  2. CMS (2026). Medicare Prescription Drug Appeals & Grievances
    www.cms.gov/medicare/appeals-grievances/prescription-drug
  3. eCFR. 42 CFR 423.568, Standard timeframe and notice requirements for coverage determinations
    www.ecfr.gov/current/title-42/section-423.568
  4. eCFR. 42 CFR 423.572, Timeframes and notice requirements for expedited coverage determinations
    www.ecfr.gov/current/title-42/section-423.572
  5. eCFR. 42 CFR 423.578, Exceptions process
    www.ecfr.gov/current/title-42/section-423.578
  6. eCFR. 42 CFR 423.590, Timeframes and responsibility for making redeterminations
    www.ecfr.gov/current/title-42/section-423.590
  7. eCFR. 42 CFR 423.600, Reconsideration by an independent review entity
    www.ecfr.gov/current/title-42/section-423.600
  8. Federal Register (2025). Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2026
    www.govinfo.gov/content/pkg/FR-2025-12-04/pdf/2025-21879.pdf
  9. Federal Register (2026). Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2027
    www.govinfo.gov/content/pkg/FR-2026-09-16/pdf/2026-19016.pdf
  10. eCFR. 45 CFR 156.122, Prescription drug benefits
    www.ecfr.gov/current/title-45/section-156.122
  11. eCFR. 45 CFR 147.136, Internal claims and appeals and external review processes
    www.ecfr.gov/current/title-45/section-147.136
  12. HealthCare.gov. External Review
    www.healthcare.gov/appeal-insurance-company-decision/external-review/

Superscript numbers in the text link to these sources. GxRadar data (NADAC histories, recall and shortage counts) come from CMS and FDA files described on the sources page. Researched and drafted with AI assistance and checked against the sources above. Information current as of Nov 3, 2026 and may change. Spot an error? It will be corrected once confirmed.

Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation. Laws, prices and program rules described here can change; confirm current details with the official source.