Rezdiffra Nash denied due to quantity / dose limits by UnitedHealthcare?

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.

## Why UHC Applies Quantity Limits to Rezdiffra for NASH — and Why You Can Appeal

UnitedHealthcare may impose quantity limits on Rezdiffra (resmetirom) — for example, restricting the days' supply, number of tablets per fill, or duration of authorized therapy. These limits sometimes reflect UHC's standard specialty-drug quantity management policies rather than clinical judgment about this patient's needs. When the FDA-approved prescribing label and the prescriber's clinical plan call for a supply or duration that exceeds the plan's quantity limit, a quantity-limit exception appeal is appropriate.

The appeal argument centers on two points: (1) the requested quantity is consistent with the FDA-approved dosing and treatment duration as described in the prescribing label, and (2) the patient's clinical trajectory — specifically the fibrosis staging and response monitoring plan — justifies the requested supply.

## Federal Appeal Framework

• Internal appeal: File within 180 days of the denial. UHC must respond within 30 days for pre-service or 60 days for post-service determinations.
• Expedited review: If the patient's condition is progressing and delay poses clinical risk, request expedited processing; UHC must respond within 72 hours.
• External review (ACA §2719): After a final adverse internal determination, approximately four months remain to request independent external review. The IRO's decision is binding on UHC.
• ERISA §503: For self-funded employer plans, invoke full-and-fair review rights and request the clinical criteria document UHC used to set the quantity limit.

## Documentation to Gather

• FDA prescribing label: Download the current Rezdiffra prescribing label from DailyMed. Identify the approved dosing regimen and any label language about treatment duration or monitoring intervals that supports the requested quantity.
• Prescriber's treatment plan: A letter from the treating hepatologist or gastroenterologist specifying the prescribed regimen, the clinical rationale for the requested supply, and the monitoring schedule (liver function tests, fibrosis reassessment intervals).
• Fibrosis staging and baseline labs: Objective documentation of the patient's fibrosis stage and relevant metabolic and hepatic laboratory values, supporting the need for continuous uninterrupted therapy.
• Clinical consequence of interruption: A statement from the prescriber addressing what clinical harm — worsening fibrosis progression, loss of treatment response — could result from reduced or interrupted supply.
• Quantity limit policy request: Ask UHC to provide the clinical basis for the specific quantity limit applied, so the appeal can address the stated rationale directly.

## Criteria-Mapping Structure

Obtain UHC's quantity limit policy or clinical criteria for Rezdiffra. For each criterion underlying the limit, document: (1) the prescribing label language supporting the requested quantity, (2) the prescriber's clinical justification, and (3) the patient-specific chart evidence demonstrating that the limit is insufficient for this individual's treatment course. If the quantity limit conflicts with the approved labeling, make that discrepancy explicit and central to the appeal letter.