UnitedHealthcare · Rezdiffra Nash · US health-plan appeal rights

Rezdiffra Nash denied as not FDA-approved for this use by UnitedHealthcare?

Q: How long do I have to appeal a UnitedHealthcare Rezdiffra Nash denial?

Internal appeal window: Typically 180 days from the denial date. External review window: Typically 60–120 days after the final internal denial. The clock starts from the date on the denial letter.

Off-label use is widespread in medicine. If the literature and a recognised specialty-society guideline support the use, plans frequently approve on appeal — especially for cancer, cardiology, and rare disease.

By Michael John Ryan, Founder & Privacy Officer, DenialHelp, LLC

Last reviewed 2026-05-10

Policy data current as of 2026-04-26

US health-plan appeal rights

Cite: Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules

Most US health plans are required by federal law to give you both an internal appeal (where the insurer reconsiders) and an external review (where an independent reviewer decides). The exact timelines and processes depend on what kind of plan you have — marketplace / employer group, self-funded, Medicare Advantage, or Medicaid MCO — but in every case there's a window after the denial during which you have the right to fight it.

Internal appeal window

Typically 180 days from the denial date

External review window

Typically 60–120 days after the final internal denial

What UnitedHealthcare typically requires

UnitedHealthcare's specific coverage criteria for rezdiffra nash are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

Source policy: OptumRx Prior Authorization — Rezdiffra (Resmetirom) for NASH/MASH

The UnitedHealthcare angle on Rezdiffra Nash

## Why UHC Issues a Not-FDA-Approved Denial for Rezdiffra — and Why This Is Likely an Error

Rezdiffra (resmetirom) received full FDA approval for metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis. A "not-FDA-approved" denial in this context almost always reflects one of three administrative errors: (1) UHC's system has not yet updated to reflect the approval, (2) the prior authorization request listed a slightly different diagnosis code that doesn't match the approved indication, or (3) UHC is conflating an off-label use with the specific approved indication.

This category of denial is among the most straightforward to overturn: the FDA approval record is public, unambiguous, and dispositive. The appeal strategy is to place the FDA approval letter and current prescribing label directly in front of the reviewer and map the patient's diagnosis to the approved indication.

## Federal Appeal Framework

Internal appeal: File within 180 days of the denial. For a pre-service denial, UHC must respond within 30 days; post-service within 60 days.
Expedited review: Request expedited processing (72-hour turnaround) if the patient's liver disease is advancing and delay would jeopardize health.
External review (ACA §2719): After a final adverse internal decision, approximately four months remain to request independent external review. The IRO's decision is binding on UHC.
ERISA §503: For self-funded employer plans, request the full administrative record and invoke full-and-fair review rights. Identify which specific document UHC relied on to conclude Rezdiffra is not FDA-approved.

## Documentation to Gather

FDA approval evidence: Download the current prescribing label from DailyMed (dailymed.nlm.nih.gov) and the FDA approval letter from the FDA's Drugs@FDA database. Attach both as exhibits. Highlight the approved indication and approval date.
Diagnosis code verification: Confirm that the ICD-10 code submitted on the prior authorization matches the condition description in Rezdiffra's approved indication. If there was a coding mismatch, correct it and resubmit.
Prescriber attestation: A brief letter from the hepatologist or gastroenterologist confirming that the drug is being prescribed for the FDA-approved indication and that the patient meets the patient population described in the label.
Fibrosis staging documentation: Objective evidence of the patient's fibrosis stage (biopsy or validated non-invasive assessment) confirming it falls within the approved indication.

## Criteria-Mapping Structure

Request from UHC the specific coverage policy or clinical criterion document cited in the denial. Identify the language used to characterize Rezdiffra as not FDA-approved. Respond directly to that specific language with: (1) the FDA approval date, (2) the approved indication verbatim from the label, (3) the patient's diagnosis and how it maps to that indication, and (4) the prescriber's attestation. This targeted, document-anchored response leaves the reviewer no clinical basis for upholding the denial.

Next steps

Find the date on the denial letter — your appeal window starts there.
Read your plan's Summary of Benefits and Coverage (SBC) for the specific deadlines.
Request the insurer's claim file in writing — they must provide it.
Submit your appeal in writing with new clinical evidence and a physician statement.

Get the letter drafted

DenialHelp drafts your appeal in 5 minutes — $40 list price, $30 for your first letter (use code SEO25). We cite the federal regs and the specific clinical evidence your plan responds to. Your physician signs and sends.

Start my appeal — $30 with code SEO25 →

Related appeal guides

Other UnitedHealthcare appeals

Other denial reasons for UnitedHealthcare Rezdiffra Nash

denied as not medically necessary denied for failing step therapy denied as non-formulary denied for missing prior authorization denied as experimental or investigational

This guide describes general US federal appeal rights based on Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules. Your specific plan documents (Summary of Benefits and Coverage, Evidence of Coverage) override anything here. DenialHelp is not your lawyer and not your physician — we draft appeal letters that your physician signs. Outcomes depend on your insurer's decision and factors outside our control. Reviewed by Michael John Ryan on 2026-05-10. Editorial standards: denialhelp.com/authors.