Revakinagene taroretcel-lwey (Encelto) intravitreal implant — coverage criteria
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Medical policy governing coverage and clinical criteria for Encelto intravitreal implant to treat adults with idiopathic macular telangiectasia (MacTel) type 2 for Blue Cross NC members.
Added revenue codes 0891 and 0892 associated with the HCPCS code(s) for the product.
Added HCPCS code J3403 (1 unit per implant) to dosing reference and removed C9399, J3490, J3590 (termed 9/30/2025).
Coverage and Medical Necessity Criteria
Medical Necessity Criteria
Covered when ALL of the following are met:
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required; distribution via specialty pharmacy may be required
The following conditions are exclusions to coverage for Encelto intravitreal implant and must be documented as absent in the medical record prior to approval: evidence of intraretinal or subretinal neovascularization (e.g., hemorrhage, hard exudate, subretinal or intraretinal fluid), central serous chorioretinopathy, pathologic myopia, or significant media or corneal opacities in either eye. Also excluded are patients with prior vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty; specified lens opacities beyond standard thresholds; recent lens removal (within 3 months) or YAG laser (within 4 weeks); history of ocular herpes virus in either eye; or evidence of intraretinal hyperreflectivity on OCT.
Use of Encelto is limited to one implant per affected eye (lifetime) and to dosing that falls within the FDA‑labeled range; requests must not exceed the maximum units allowed for the approved duration. The policy specifies a duration of approval of 270 days corresponding to one single implant per eye per lifetime. Use is considered not medically necessary for dosing outside FDA labeling, for more than one implant per affected eye, or for patients with advanced retinal scarring/atrophy that would preclude preservation of functional retina. Additionally, patients who received intravitreal steroid or anti‑VEGF therapy for nonneovascular MacTel within the prior 3 months are not eligible.
Coding, Measurement Criteria, and Key Clinical Values
| J3403 | revakinagene taroretcel-lwey (Encelto) intravitreal implant — 1 unit per implant |
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy (possible revenue code) |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy (possible revenue code) |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required; HCPCS J3403 applies
Prior authorization is required. The request must document that all medical necessity criteria are met and that the requested dose and quantity align with FDA labeling (one implant per affected eye; maximum units = 1). HCPCS code J3403 applies to revakinagene taroretcel-lwey (Encelto) intravitreal implant (1 unit per implant).
- PA must verify requested dose is within FDA labeled dosing (one implant per affected eye containing 200,000–440,000 cells).
- Use HCPCS J3403 for billing the implant; distribution from a specialty pharmacy may be required.
No intravitreal steroid/anti‑VEGF within 3 months
Do not request coverage if the patient received intravitreal steroid or intravitreal anti-VEGF therapy for nonneovascular MacTel within the prior 3 months; documentation of no such treatment in the past 3 months is required.
- Medical record must show no intravitreal steroid or anti-VEGF therapy for nonneovascular MacTel within the last 3 months prior to the request.
Required medical record documentation for diagnosis and objective findings
Include specific medical record documentation with the prior authorization: diagnosis of idiopathic MacTel type 2, evidence of fluorescein leakage, one or more listed characteristic findings, SD‑OCT measurement of IS/OS PR break size, BCVA (ETDRS), absence of neovascular MacTel and infections, and prescriber specialty.
- Diagnosis confirmation: evidence of fluorescein leakage and ≥1 characteristic (hyperpigmentation outside 500‑micron radius from fovea, retinal opacification, crystalline deposits, right‑angle vessels, or inner/outer lamellar cavities).
- SD‑OCT measurement: IS/OS PR break (EZ loss) between 0.16 and 2.00 mm².
- BCVA: 54 ETDRS letters or better (20/80 Snellen equivalent or better).
- Document absence of neovascular MacTel and no active/suspected ocular or periocular infection.
- Verify prescriber is a specialist or that specialist consultation occurred.
Denial risk if required clinical findings or dosing limits are not documented
Claims may be denied if required clinical findings are not documented, including patient age (≥18), confirmed MacTel type 2 diagnosis, SD‑OCT IS/OS PR break size within 0.16–2.00 mm², BCVA ≥54 ETDRS letters, and absence of neovascular disease and listed exclusions.
- Failure to document any required element (age, diagnosis confirmation, fluorescein leakage, characteristic findings, SD‑OCT measurement, BCVA, absence of neovascular MacTel, or exclusion criteria) may trigger denial.
- Also ensure documentation that the requested dose/quantity does not exceed the maximum (one implant per affected eye).
Background
Encelto (revakinagene taroretcel‑lwey) is an intravitreal implant composed of allogeneic retinal pigment epithelial cells engineered to express recombinant human ciliary neurotrophic factor (rhCNTF). It is administered as a single surgical intravitreal insertion by a qualified ophthalmologist and contains approximately 200,000 to 440,000 cells per implant. When medically covered, distribution may require coordination through a specialty pharmacy.
Definitions and Code Notes
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