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Voretigene Neparvovec-rzyl (Luxturna) (CPB 0927, reviewed 2026-04-20)

Aetna·Ophthalmology·Medical Policy
Effective date
Apr 20, 2026
We identified it
Aug 19, 2026
Days to comply

Summary

Aetna has issued a fresh clinical policy bulletin (CPB 0927) for Luxturna (voretigene neparvovec-rzyl), a gene therapy for biallelic RPE65 mutation-associated retinal dystrophy. The policy establishes strict coverage criteria including mandatory precertification, treatment via Aetna Institutes GCIT Network facilities, ophthalmologist prescription requirement, and specific patient selection criteria (age 12 months to <65 years with viable retinal cells). Billing teams must implement precertification workflows and ensure claims route through designated gene therapy networks.

Action Required

Action needed
Effective immediately (policy dated 2026-04-20): (1) Billing team must update authorization software to require mandatory precertification for all Luxturna claims before submission by contacting Aetna GCIT at (866) 752-7021 or faxing (888) 267-3277. (2) Implement precertification form requirements using Specialty Pharmacy Precertification portal (link specified in policy). (3) Verify all Luxturna administrations are routed to Aetna Institutes GCIT Designated Network facilities—claims from non-designated sites will be denied. (4) Update claim validation rules to ensure patient age is 12 months to <65 years; claims outside this range will be rejected. (5) Add requirement to verify genetic testing documentation (biallelic RPE65 mutation confirmed within 12 months per ACMG standards) before claim processing. (6) Flag claims for repeat administration (same eye) as experimental/non-covered and deny. (7) Providers must ensure ophthalmologist involvement; claims lacking specialist credential will be denied. (8) Ensure CPT 0810T is billed with supporting OCT/ophthalmoscopy documentation confirming viable retinal cells per policy criteria. Failure to precertify will result in claim denials; improper routing to non-GCIT sites will result in claim rejections.

Affected Billing Codes

67028
67036
67039
67040
67041
67042
67043
81406
81434
92134
92201
92202
J3398
H35.50