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    v1.0.28
    OpenPayerPolicy UpdatesOphthalmology/OptometryEmblemHealth Encelto Coverage Update | OpenPayer
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    CurrentEmblemHealthPolicy MG.MM.PH.439

    Encelto (revakinagene taroretcel-lwey) — Coverage Criteria for Macular Telangiectasia Type 2

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    Clinical coverage policy governing use of the Encelto allogeneic encapsulated cell‑based gene therapy implant for adults with idiopathic macular telangiectasia type 2 (MacTel Type 2). Affects providers seeking authorization and reimbursement from EmblemHealth/ConnectiCare.

    Policy Summary
    PayerEmblemHealth
    PolicyEncelto (revakinagene taroretcel-lwey) — Coverage Criteria for Macular Telangiectasia Type 2
    Policy CodePolicy MG.MM.PH.439
    Change TypeNo material changes
    Effective DateAug 7, 2025
    Last ReviewAug 7, 2025
    Next Review DateAug 7, 2025
    Key ActionSubmit preauthorization with clinical documentation demonstrating the member meets all initial criteria, including age, infection status, hypersensitivity, monitoring plan, medication management, and recent intravitreal therapy status.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 dose/eyemaximum authorized doses

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    Age ≥18minimum patient age
    0.16–2.00 mm2EZ defect size required
    No anti‑VEGF/steroid in 3 monthsrecent intravitreal therapy exclusion
    J3590procedure/billing code
    82958-0501-xxproduct NDC

    Coverage Criteria for Encelto Implant

    Initial Criteria (General)

    Covered when ALL of the following are met:

    Initial general requirements: 1. Patient is at least 18 years of age; AND 2. Patient is free of ocular and/or peri-ocular infections; AND 3. Patient does not have a known hypersensitivity to Endothelial Serum Free Media (Endo SFM); AND 4. Patient will be monitored for signs and symptoms of vision loss (e.g., BCVA) and infectious endophthalmitis at baseline and periodically during treatment; AND 5. Patient will be monitored for signs and symptoms of retinal tears and/or retinal detachment (e.g., acute onset of flashing lights, floaters, and/or loss of visual acuity); AND 6. Patient does not have evidence of other ocular disease that would preclude treatment of MacTel; AND 7. Patient will temporarily discontinue antithrombotic medications (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) prior to the insertion surgery; AND 8. Patient has not received intravitreal steroid therapy or intravitreal anti-VEGF therapy for non-neovascular MacTel within the last 3 months.

    General eligibility and procedural safety requirements.

    Initial Criteria (Disease-specific for MacTel Type 2)

    AND the following disease-specific criteria must be met:

    MacTel Type 2 diagnostic and exclusion criteria: 1. Diagnosis of macular telangiectasia type 2 in at least one eye, evidenced by typical fluorescein leakage and at least one other defining feature: hyperpigmentation outside a 500-micron radius from the center of the fovea OR retinal opacification OR crystalline deposits OR right-angle vessels OR inner/outer lamellar cavities; AND 2. Patient does NOT have neovascular macular telangiectasia; AND 3. No evidence of advanced disease that would preclude treatment (e.g., significant retinal scarring and atrophy with retinal tissue that cannot be preserved); AND 4. Presence of an inner segment–outer segment (IS/OS) photoreceptor break and area of ellipsoid zone (EZ) loss measured by SD-OCT between 0.16 mm2 and 2.00 mm2; AND 5. No evidence of any of the following: (a) intraretinal or subretinal neovascularization (SRNV) (e.g., hemorrhage, hard exudate, subretinal or intraretinal fluid) in either eye; OR (b) central serous chorioretinopathy in either eye; OR (c) pathologic myopia in either eye; OR (d) significant media or corneal opacities in either eye; OR (e) history of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty; OR (f) specified lens opacities exceeding thresholds (cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or nuclear opacity > standard 3); OR (g) lens removal in previous 3 months or YAG laser within 4 weeks; OR (h) history of ocular herpes virus in either eye; OR (i) evidence of intraretinal hyperreflectivity by OCT.IS/OS break area 0.16–2.00 mm2

    Disease-specific inclusion and multiple explicit exclusions.

    The policy excludes eyes with evidence of intraretinal neovascularization or subretinal neovascularization (SRNV). Such neovascular disease may be identified by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye. Also excluded are eyes with central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, a history of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty, and specified clinically significant lens opacities. Recent lens removal within 3 months or a recent YAG laser procedure within 4 weeks are additional exclusions. A history of ocular herpes virus or the presence of intraretinal hyperreflectivity on OCT also precludes coverage.

    Use is not permitted for eyes with neovascular macular telangiectasia or for eyes with advanced disease with irreversible retinal tissue loss (for example, substantial retinal scarring and atrophy where retinal tissue cannot be preserved). The policy also disallows treatment when any of the listed comorbid ocular conditions are present, including intraretinal/subretinal neovascularization, central serous chorioretinopathy, pathologic myopia, significant media or corneal opacities, prior specified ocular surgeries, significant lens opacities beyond defined thresholds, recent lens removal or YAG laser, history of ocular herpes, or OCT evidence of intraretinal hyperreflectivity.

    Coding and Diagnostic Codes

    Applicable Procedure CodesHCPCS
    J3590Unclassified biologics
    Applicable NDCsNDC
    82958-0501-xxEncelto single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF (NTC-201-6A cell line)
    ICD-10 DiagnosesICD-10Covered
    H35.071Retinal telangiectasis, right eye
    H35.072Retinal telangiectasis, left eye
    H35.073Retinal telangiectasis, bilateral
    H35.079Retinal telangiectasis, unspecified eye
    IS/OS photoreceptor break / Ellipsoid zone (EZ) loss area — threshold (mm2)
    Measurement rangeIS/OS photoreceptor break and ellipsoid zone (EZ) loss area measured by SD-OCT between 0.16 mm2 and 2.00 mm2
    Imaging modalitySpectral domain optical coherence tomography (SD-OCT) measurement of IS/OS junction/EZ loss
    Location requirementApplies to the treated eye(s) with MacTel Type 2 diagnosis
    Relation to exclusionsEyes with intraretinal or subretinal neovascularization, advanced scarring/atrophy, or intraretinal hyperreflectivity on OCT are excluded regardless of EZ area

    Provider Actions, Authorization, and Documentation

    Prior Authorization

    Preauthorization required

    Preauthorization is required. Submit clinical documentation demonstrating the member meets all initial criteria (including age, infection status, hypersensitivity, monitoring plan, medication management, and recent intravitreal therapy status) when requesting authorization for the Encelto implant (HCPCS J3590).

    • Authorization requests must include evidence that the patient is ≥18 years old.
    • Include documentation that the patient is free of ocular/peri-ocular infection and has no known hypersensitivity to Endo SFM.
    • Provide plan for baseline and periodic monitoring for vision loss and infectious endophthalmitis, and for retinal tears/detachment.
    • Document temporary discontinuation of antithrombotic medications prior to insertion surgery and no intravitreal steroid/anti-VEGF for non‑neovascular MacTel within 3 months.
    Step Therapy

    No step therapy specified

    No step therapy pathway is specified in this policy; authorization depends on meeting the policy's eligibility and exclusion criteria for MacTel Type 2.

    Background

    Encelto is an allogeneic, encapsulated cell-based gene therapy implant that delivers recombinant human ciliary neurotrophic factor (rhCNTF) intended to promote photoreceptor survival in idiopathic macular telangiectasia type 2 (MacTel Type 2). Each single-dose implant contains approximately 200,000–440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF, and the device is indicated for treatment of MacTel Type 2 in adults.

    Definitions and Diagnostic Features

    Encelto — product description and mechanism
    Product class & indicationEncelto — an allogeneic encapsulated cell‑based gene therapy implant indicated for idiopathic macular telangiectasia type 2 (MacTel Type 2) in adults
    Cell counts per implantEach implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human CNTF
    Mechanism summaryDelivers recombinant human ciliary neurotrophic factor (CNTF); thought to act via Müller glia–mediated signaling to promote photoreceptor survival
    MacTel Type 2 diagnostic features — required findings
    Required fluorescein findingTypical fluorescein leakage consistent with MacTel Type 2 is required for diagnosis
    At least one supporting sign
    Policy Summary
    PayerEmblemHealth
    PolicyEncelto (revakinagene taroretcel-lwey) — Coverage Criteria for Macular Telangiectasia Type 2
    Policy CodePolicy MG.MM.PH.439
    Change TypeNo material changes
    Effective DateAug 7, 2025
    Last ReviewAug 7, 2025
    Next Review DateAug 7, 2025
    Key ActionSubmit preauthorization with clinical documentation demonstrating the member meets all initial criteria, including age, infection status, hypersensitivity, monitoring plan, medication management, and recent intravitreal therapy status.
    SourceLink
    On This Page
    Coverage Criteria for Encelto ImplantCoding and Diagnostic CodesProvider Actions, Authorization, and DocumentationBackgroundDefinitions and Diagnostic Features
    • Requests are evaluated against the disease‑specific inclusion/exclusion requirements (e.g., MacTel Type 2 diagnostic features, IS/OS break area 0.16–2.00 mm2, absence of neovascular MacTel and specified comorbidities).
    Documentation Required

    Required clinical documentation

    The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria for preauthorization or post-payment review.

    • Clinical records should demonstrate fulfillment of each applicable initial and disease‑specific criterion (age, infection status, diagnostic findings, OCT measurements, monitoring plan, medication instructions, and treatment history).
    Denial Risk

    Insufficient documentation will prevent review

    Failure to submit the required clinical evidence that the member meets the policy criteria will prevent EmblemHealth from properly reviewing the preauthorization request or a post-payment review, and may result in denial or lack of reimbursement.

    • Ensure all supporting documentation is provided with the authorization request to avoid administrative denial or payment issues.
    Hyperpigmentation outside a 500‑micron radius from the foveal center
    Additional supporting signsRetinal opacification OR crystalline deposits OR right‑angle vessels OR inner/outer lamellar cavities (one or more required)