Daa Retreatment Vosevi denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for daa retreatment vosevi 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 Cigna Denied Vosevi as "Not FDA-Approved"

Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is an FDA-approved medication for chronic hepatitis C, including for retreatment after prior DAA-based therapy. A "not FDA-approved" denial from Cigna for Vosevi is a factual error — it is not a legitimate coverage determination — and is among the most straightforward denials to reverse. These denials typically result from administrative errors: incorrect NDC coding, application of an outdated coverage policy, or misrouting through a claims pathway that does not recognize the drug.

## Why This Denial Is Appealable

FDA approval is a matter of public record. You do not need clinical argument to rebut this denial — you need documents. The FDA approval letter and current prescribing information for Vosevi are publicly available through Drugs@FDA and directly contradict the denial's factual premise. Appeals grounded in documentary rebuttal of a factual error are resolved quickly in the patient's favor.

## Federal Appeal Framework

• Internal appeal (ACA §2719 / ERISA §503): Submit within the deadline printed on the denial letter. Include the FDA documentation with the initial appeal filing.
• Expedited appeal: If your prescriber certifies that the standard timeline would seriously jeopardize your health, request expedited internal review.
• External review: Available after a final internal denial under ACA §2719. File within approximately four months of the final internal determination. Expedited external review (often 72 hours) is available when medically urgent.
• State complaint: Filing a concurrent complaint with your state insurance department or HHS marketplace creates a parallel record and can accelerate Cigna's response.

## Concrete Appeal Steps

1. Download the Vosevi FDA approval letter and current prescribing information from Drugs@FDA. 2. Obtain a copy of the prescription showing the exact drug name and NDC. 3. Have your prescriber write a brief letter confirming the drug is FDA-approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and that the prescribed use is within the FDA-approved indication. 4. Submit the internal appeal with the FDA documents and prescriber letter attached, explicitly stating that the denial's factual premise is incorrect. 5. If denied internally, file external review immediately — the documentary record is unambiguous.

## Documentation to Gather

• FDA Drugs@FDA printout: Vosevi approval letter and current full prescribing information
• Prescription copy showing drug name and NDC
• Prescriber letter confirming FDA approval status and approved indication
• Denial letter with denial code
• Prior treatment records establishing the retreatment context

## Criteria-Mapping Structure

For a not-FDA-approved denial, the mapping is a single-row rebuttal: Cigna's stated reason ("not FDA-approved") in column one; the FDA approval letter date, the approval number, and the prescribing information section confirming approval in column two. Attach the FDA documents as exhibits. This structure leaves no ambiguity for the reviewer.