revakinagene taroretcel-lwey (Encelto) coverage for idiopathic macular telangiectasia (MacTel) type 2
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This policy governs coverage eligibility for Encelto (revakinagene taroretcel-lwey) for treating adults with idiopathic macular telangiectasia (MacTel) type 2 under Blue Cross Blue Shield - Louisiana Medicare Advantage plans.
No material clinical or coverage changes in this revision.
Coverage Criteria for Encelto (revakinagene taroretcel-lwey)
Initial therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
fluorescein leakage plus ≥1 listed finding required
Either ETDRS or Snellen acceptable
Single implant per affected eye
Coverage is not available for investigational medical treatments, procedures, drugs, devices, or biological products. Use of Encelto (revakinagene taroretcel-lwey) when the patient selection criteria in this policy are not met is considered investigational, except for those uses explicitly labeled as not medically necessary elsewhere in the policy.
The Health Plan considers use of Encelto to be not medically necessary when any required patient selection criterion is not satisfied. Examples include absence of documented fluorescein leakage with at least one qualifying retinal finding (hyperpigmentation outside a 500‑micron radius from the foveal center; retinal opacification; crystalline deposits; or inner/outer lamellar cavities); BCVA worse than the policy thresholds (less than 54 letters ETDRS or worse than 20/80 Snellen); an ellipsoid zone (EZ) photoreceptor break measured by SD‑OCT that is outside 0.16–2.00 mm2; presence of neovascular (proliferative) MacTel type 2; or prior intravitreal gene therapy.
Coding and Clinical Thresholds
| J3403 | Listed in policy as an example HCPCS code associated with this policy |
| All Related Diagnoses | ICD-10 Diagnosis — all related diagnoses |
| No codes | No CPT codes specified |
Provider Requirements and Authorization
Prior authorization required
Prior authorization is required for all codes listed on the Medical Policy; coverage for Encelto will be considered only when the patient meets the policy's selection criteria.
- Codes listed on the Medical Policy require prior authorization prior to claim submission.
Submit complete authorization request
Ensure authorization requests clearly reference this policy and include all required clinical documentation (diagnosis, imaging, and visual acuity) to allow coverage determination.
- Request prior authorization before providing services associated with Encelto.
- Include policy identifier (MA-224) and the codes being requested.
Required clinical documentation
Medical records must document idiopathic MacTel type 2 evidenced by fluorescein leakage plus at least one qualifying retinal finding, BCVA (ETDRS or Snellen), SD-OCT EZ break area (0.16–2.00 mm2), absence of neovascular MacTel, and no prior intravitreal gene therapy.
- Documentation of fluorescein leakage and at least one: hyperpigmentation outside 500 µm from foveal center; retinal opacification; crystalline deposits; or inner/outer lamellar cavities.
- Best-corrected visual acuity: 54 letters or better (ETDRS) OR 20/80 or better (Snellen).
- SD-OCT measurement showing EZ break area between 0.16 and 2.00 mm2.
- Clinical notes confirming no evidence of neovascular (proliferative) MacTel.
- Record that the patient has not previously received intravitreal gene therapy.
Denial triggers when selection criteria unmet
Claims may be considered not medically necessary and denied when the policy's patient selection criteria are not met.
- Diagnosis not documented by fluorescein leakage with ≥1 listed ocular finding (hyperpigmentation, opacification, crystalline deposits, or lamellar cavities).
- BCVA worse than 54 letters (ETDRS) or worse than 20/80 (Snellen).
- EZ break area on SD-OCT outside 0.16–2.00 mm2.
- Evidence of neovascular (proliferative) MacTel.
- Prior intravitreal gene therapy documented.
Background
Macular telangiectasia type 2 (MacTel type 2) is a bilateral macular degenerative disorder characterized by progressive central vision loss associated with loss of Müller cells. The disease can advance to a proliferative (neovascular) stage. Encelto is an intravitreal, encapsulated cell‑based implant containing allogeneic retinal pigment epithelial cells engineered to express recombinant human CNTF intended to slow photoreceptor degeneration in affected eyes.
Definitions
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