Daa Pangenotypic Mavyret denied as not FDA-approved for this use by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for daa pangenotypic mavyret 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 UnitedHealthcare Denied Mavyret as "Not FDA-Approved"

Mavyret (glecaprevir/pibrentasvir) is a pangenotypic direct-acting antiviral (DAA) for chronic hepatitis C that holds full FDA approval. A "not FDA-approved" denial for Mavyret is almost always a coding or routing error — the drug was entered under an incorrect NDC or the claim was processed against the wrong formulary tier — rather than a genuine regulatory question. This denial type is highly appealable because the factual premise is verifiable from public FDA records.

## Why This Denial Is Appealable

Because FDA approval status is a matter of public record, you can rebut this denial with documentary evidence rather than clinical argument. The approval letter and current prescribing information are available directly from the FDA's Drugs@FDA database. Attach those documents to your appeal letter so the reviewer cannot sustain the denial on factual grounds.

## Federal Appeal Framework

• Internal appeal (Level 1): UnitedHealthcare must acknowledge your appeal within the timeframe required by your plan documents (typically governed by ERISA §503 for employer-sponsored plans or ACA §2719 for individual/small-group plans). Submit within the deadline stated on your denial letter.
• External review: If the internal appeal is denied, you have the right to an independent external review under ACA §2719. The standard window is approximately four months from the date of the final internal denial. Expedited external review (often 72 hours) is available when your health condition makes the standard timeline medically inappropriate — ask your prescriber to document that urgency in writing.
• State insurance department: Filing a concurrent complaint with your state's insurance commissioner can accelerate UHC's internal review timeline.

## Concrete Appeal Steps

1. Obtain the denial letter and note the exact denial code and stated reason. 2. Download the current Mavyret FDA approval letter and prescribing information from Drugs@FDA. 3. Have your prescriber write a one-page letter confirming the prescribed drug is Mavyret (glecaprevir/pibrentasvir) and citing the NDC on the prescription. 4. Submit the internal appeal with both documents attached, explicitly citing the FDA-approval evidence. 5. If denied again, file for external review immediately.

## Documentation to Gather

• Diagnosis confirmation: hepatitis C genotype report, viral load (HCV RNA), liver fibrosis staging from your chart
• Prescriber letter: confirms drug identity, FDA-approval status, and medical rationale
• FDA Drugs@FDA printout: approval letter and current labeling for glecaprevir/pibrentasvir
• Denial letter with denial code

## Criteria-Mapping Structure

Copy the exact reason text from UHC's denial letter into column one of a table. In column two, write the specific rebuttal document and the page/section where the answer appears. For a "not FDA-approved" denial, the rebuttal is straightforward: the FDA approval letter directly contradicts the stated denial reason. Present this mapping clearly so the reviewing clinician can dispose of the denial without ambiguity.