Ird Luxturna denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for ird luxturna 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 Luxturna as "Not FDA-Approved" — and Why That Is Appealable

Luxturna (voretigene neparvovec) is a gene therapy indicated for a specific inherited retinal dystrophy caused by confirmed mutations in a particular gene. Cigna occasionally issues "not FDA-approved" denials in error — either because the claim was coded against the wrong diagnosis code, the supporting genetic documentation was missing, or the system incorrectly flagged the therapy as investigational. In every case, a well-documented appeal can overturn this denial because the FDA did grant approval for this indication.

## Federal Appeal Rights

Your plan is subject to federal appeal protections. Under ACA §2719 and its implementing regulations, you have the right to an internal appeal followed by an independent external review conducted by an accredited Independent Review Organization (IRO). Under ERISA §503, if your plan is employer-sponsored, you are additionally entitled to a full-and-fair review with access to the clinical criteria used. The external review request window is generally 4 months from the final internal denial — do not let that deadline pass. An expedited external review (often resolved within 72 hours) is available when your vision condition poses an urgent or irreversible risk.

## Concrete Appeal Steps

1. Request the denial letter in writing and obtain Cigna's complete Coverage Policy for this gene therapy from their website or by calling the member services number on your insurance card. 2. Obtain the FDA-approved Prescribing Information (Package Insert) for Luxturna directly from the FDA label repository or the manufacturer. This document confirms approved indications. 3. File an internal appeal within Cigna's stated deadline (check your denial letter — typically 180 days for non-urgent matters). 4. If the internal appeal is denied, immediately file for independent external review.

## Documentation to Gather

• Genetic confirmation: A laboratory report from a certified molecular diagnostic lab confirming the specific gene mutation. This is the single most important document — without it, no appeal succeeds.
• Diagnosis and ophthalmologic records: Chart notes documenting the inherited retinal dystrophy diagnosis, visual field results, and functional vision assessments.
• Prescriber medical-necessity letter: A detailed letter from the treating ophthalmologist or retinal specialist explaining why this patient meets the FDA-approved indication, referencing the applicable guideline from the relevant specialty society (e.g., the American Academy of Ophthalmology).
• Prior treatment history: Documentation of any prior vision interventions tried, with dates and outcomes.

## Criteria-Mapping Structure

Pull every requirement listed in both the FDA label and Cigna's coverage policy. For each criterion, write the exact chart fact that satisfies it. This line-by-line match is the core of a winning appeal and leaves no ambiguity for the reviewer.

Cigna's medical reviewers are required to apply only evidence-based clinical criteria. Presenting the genetic confirmation alongside the FDA label and the criteria-mapping table directly addresses the stated basis of denial.