UnitedHealthcare · Rezdiffra Nash · US health-plan appeal rights

Rezdiffra Nash denied for failing step therapy 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.

Step-therapy denials usually flip when the appeal documents that prior alternatives were tried and failed, or were contraindicated, or aren't safe for the patient.

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 Requires Step-Therapy Before Approving Rezdiffra for NASH — and Why You Can Appeal

UnitedHealthcare's step-therapy (or "fail-first") policy for Rezdiffra (resmetirom) may require that a patient first try and demonstrate an inadequate response to one or more other agents — commonly a GLP-1 receptor agonist or another metabolic medication — before Rezdiffra is authorized. This requirement is clinically contestable because Rezdiffra is the only FDA-approved drug specifically indicated for MASH with moderate-to-advanced liver fibrosis; no other currently approved agent has the same thyroid hormone receptor beta (THR-β) mechanism and the same approved indication.

Many states have enacted step-therapy reform laws that require insurers to grant a step-therapy exception when (1) the required first-step drug is contraindicated or clinically inappropriate, (2) the patient already failed the required drug, or (3) the required drug treats a different condition than the one being addressed. Check whether the patient's state law applies to this plan and raise the applicable exception.

## Federal Appeal Framework

Internal appeal: File within 180 days of the denial. UHC must respond within 30 days (pre-service) or 60 days (post-service).
Expedited review: If advancing fibrosis makes the standard timeline a clinical risk, request expedited processing — UHC must respond within 72 hours.
External review (ACA §2719): After a final internal denial, approximately four months remain to request independent external review. An IRO reversal is binding.
ERISA §503: For self-funded employer plans, request the complete administrative file, including the clinical criteria for the step-therapy requirement, and invoke full-and-fair review rights.
State step-therapy exception laws: If the plan is a fully insured state-regulated plan, identify whether the applicable state has a step-therapy exception statute and invoke the specific exception category that applies.

## Documentation to Gather

No equivalent formulary alternative: A letter from the prescribing hepatologist or gastroenterologist explaining that the step-therapy drug does not have FDA approval for MASH with the patient's fibrosis stage, and that it therefore cannot be a clinically equivalent substitute for Rezdiffra.
Prior use of required step(s): If the patient has already tried the required step-therapy agent, provide dates, dosing context (without specific numbers), duration, and objective clinical outcomes (liver function trends, fibrosis reassessment results) demonstrating inadequate response.
Clinical harm of delay: A prescriber statement describing the risk of fibrosis progression during the time required to complete a mandatory step-therapy trial of a non-equivalent agent.
FDA label comparison: Side-by-side note from the prescriber comparing the approved indications of Rezdiffra and the required step-therapy drug, demonstrating they are not interchangeable for this specific condition.
Fibrosis staging documentation: Objective confirmation (biopsy or validated non-invasive staging) of the patient's current fibrosis stage and disease trajectory.

## Criteria-Mapping Structure

Obtain UHC's step-therapy criteria for Rezdiffra. For each required step, document: (1) whether the step drug has FDA approval for MASH with this patient's fibrosis stage, (2) whether the patient has already completed that step and failed it (with dates and outcomes), and (3) the prescriber's clinical rationale for why proceeding directly to Rezdiffra is medically necessary. If invoking a state exception, cite the specific statute and the applicable exception category.

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

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Related appeal guides

Other UnitedHealthcare appeals

Other denial reasons for UnitedHealthcare Rezdiffra Nash

denied as not medically necessary denied as non-formulary denied for missing prior authorization denied as experimental or investigational denied as not FDA-approved for this use

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.