Ird Luxturna denied for missing prior authorization 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 for Prior Authorization — and What to Do

Luxturna is a one-time administered gene therapy for an inherited retinal dystrophy. Because of its complexity and cost, Cigna requires prior authorization (PA) before the therapy is administered. A denial at this stage means Cigna has not yet confirmed the clinical criteria are met — it does not mean the therapy is never coverable. Most PA denials for Luxturna are overturned when complete genetic and clinical documentation is submitted.

## Federal Appeal Rights

A PA denial is a coverage decision and triggers your full federal appeal rights. Under ACA §2719, you may pursue an internal appeal and then an independent external review. Under ERISA §503 (for employer plans), you are entitled to a full-and-fair review with access to the specific criteria applied. The external review window is typically 4 months from the final internal denial letter. An expedited review path exists if delay would cause serious deterioration of your vision — progressive inherited retinal dystrophies are often eligible for expedited consideration.

## Concrete Appeal Steps

1. Obtain the denial letter and identify every criterion Cigna states was not satisfied. 2. Download Cigna's medical coverage policy for Luxturna (available on cigna.com under Medical Coverage Policies) and the FDA-approved Prescribing Information. 3. Resubmit with a complete documentation package (see below) through Cigna's formal appeal process within the deadline shown on the denial letter. 4. If the internal appeal is upheld, file immediately for independent external review.

## Documentation to Gather

• Confirmed genetic mutation report: Certified laboratory documentation of the biallelic mutation in the relevant gene. This is the threshold requirement — confirm the exact gene and mutation type required per both the FDA label and Cigna's policy.
• Ophthalmologic evaluation: Chart notes, visual function testing, and imaging demonstrating the current level of retinal function. Cigna's policy specifies minimum viability criteria; confirm those are documented in the chart.
• Prescriber medical-necessity letter: The treating specialist must attest in writing that the patient meets each stated coverage criterion, referencing applicable specialty-society guidelines.
• Treatment setting documentation: Evidence that the administering facility and clinical team meet any credentialing or program requirements specified in Cigna's policy.

## Criteria-Mapping Structure

Create a table with three columns: (1) Cigna's stated criterion, (2) the matching FDA label language, and (3) the exact chart fact or lab result that satisfies it. Submit this table as a cover document. This format directly mirrors the checklist Cigna's medical reviewer uses and dramatically reduces the chance of a secondary denial on a technicality.