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AetnaCommercial · Coverage · Medical Policy · OphthalmologyMedium impact

Revakinagene Taroretcel-lwey (Encelto) (CPB 1079, reviewed 2026-07-17)

Effective date
Jul 16, 2025
Identified
Aug 16, 2026

Summary

Aetna considers one intravitreal implant of revakinagene taroretcel-lwey (Encelto) medically necessary per affected eye for adults with idiopathic macular telangiectasia type 2 (MacTel) when all the listed criteria are met, and considers all other indications experimental, investigational or unproven. Eligibility requires fluorescein leakage in at least one eye with one of the listed features, a photoreceptor inner segment/outer segment break in the ellipsoid zone of 0.16 mm2 to 2.00 mm2 on spectral domain OCT, and best corrected visual acuity of 54 letters or better (20/80 or better) on the ETDRS chart. Exclusions include neovascular MacTel, prior intravitreal anti-VEGF therapy in the affected eye or in the non-affected eye within the past 3 months, glaucoma, uveitis, and inability to temporarily discontinue antithrombotic therapy. The implant must be prescribed by or in consultation with an ophthalmologist, and it requires precertification.

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What to do

Action · 4 steps
01Billing team: Before the implant, confirm precertification by calling (866) 752-7021 or faxing (888) 267-3277.
02Bill the implant as HCPCS J3403 per implant, and bill it with ICD-10 H35.071 through H35.079 only when the member meets the selection criteria: at least one eye positive for MacTel type 2 with fluorescein leakage and one listed feature, an ellipsoid zone break of 0.16 mm2 to 2.00 mm2, and best corrected visual acuity of 20/80 or better.
03Providers: Make sure the implant is administered at an Aetna Institutes GCIT Designated Network, unless the member's health plan has elected not to require it.
04Aetna considers removal of the implant medically necessary if a vitrectomy with a complete gas fill or silicone oil fill is required or infectious endophthalmitis occurs.

Codes mentioned

J3403H35.071H35.079B00.50B00.59E10.3211E10.3499E11.3211E11.3499H17.10H17.13H20.00H20.9H25.011H25.099H26.40H26.499H35.051H35.059H35.711H35.719H40.001H42H43.391H43.399H44.111H44.19H44.131H44.139H44.20H44.2E9Z79.01Z79.1Z79.826573065750657556585566170661726682167027670286703667043

Original notice

Revakinagene Taroretcel-lwey (Encelto) (CPB 1079, reviewed 2026-07-17)
aetna.com · Always check the source before changing claims.
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