Encelto (Revakinagene Taroretcel-Lwey) implant — coverage criteria
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Defines clinical coverage and authorization requirements for Encelto implant therapy for adults with idiopathic macular telangiectasia type 2 under UnitedHealthcare Commercial and Individual Exchange benefit plans.
Policy includes an initial-therapy coverage criterion limiting authorization to no more than one treatment per eye per lifetime and for no longer than 60 days from approval.
Template updated and content transferred to a shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans.
Coverage Criteria
Initial Therapy — Encelto
Encelto is proven and medically necessary when ALL of the following are met for initial therapy:
Patients with neovascular (proliferative) macular telangiectasia (MacTel) were excluded from the pivotal randomized trials and therefore are not part of the enrollment criteria described in the clinical evidence. This exclusion means that individuals with neovascular/proliferative MacTel would not meet the trial-based eligibility assumptions underlying coverage determinations for Encelto; documentation confirming a non‑neovascular diagnosis should be provided when seeking authorization.
Plan and benefit language may impose additional limits beyond the clinical criteria in this policy. Some Certificates of Coverage permit or restrict coverage for experimental, investigational, or unproven treatments, and state mandates may further affect coverage for off‑label uses. Providers and authorizers should consult the member‑specific benefit plan document to determine whether Encelto is covered for a given member and under what conditions.
Coding and Diagnostic Codes
| J3403 | Revakinage taroretcel-lwey, per implant. |
| H35.071 | Retinal telangiectasis, right eye. |
| H35.072 | Retinal telangiectasis, left eye. |
| H35.073 | Retinal telangiectasis, bilateral. |
| H35.079 | Retinal telangiectasis, unspecified eye |
Provider Actions and Authorization
Prior authorization required
Prior authorization is required. Documentation submitted with the authorization request must confirm the patient is at least 18 years of age, include medical records confirming a diagnosis of non-proliferative macular telangiectasia type 2 in at least one eye, show that Encelto is prescribed by an ophthalmologist, describe a monitoring plan for retinal tears/detachment, and indicate dosing consistent with FDA-approved labeling. Authorization is limited to no more than one treatment per eye per lifetime and is valid for up to 60 days from approval.
- Patient age ≥18 years is required.
- Medical records confirming non-proliferative MacTel type 2 in ≥1 eye must be submitted.
- Prescriber must be an ophthalmologist.
- Monitoring plan for signs/symptoms of retinal tear or detachment must be documented.
- Dosing must follow FDA-approved labeling.
- Authorization limited to 1 treatment per eye per lifetime and ≤60 days from approval.
Step therapy / plan-level considerations
No step therapy requirements are specified in this policy. Coverage decisions may still be affected by the member-specific benefit plan language or applicable state mandates for experimental/investigational or off-label treatments.
- Check the member-specific benefit plan for any plan-level step therapy or coverage rules.
- Be aware that state mandates may supersede plan language for certain off-label or investigational uses.
Required documentation
Submit medical records (for example, chart notes) that document the diagnosis of non-proliferative macular telangiectasia type 2 in at least one eye and support the clinical indications for Encelto, including plans for monitoring for retinal tears or detachment.
- Chart notes or medical records confirming non-proliferative MacTel type 2 in ≥1 eye.
- Documentation of monitoring plan for retinal tear/detachment (e.g., symptoms to watch for and follow-up schedule).
Denial triggers
Requests that do not meet the policy criteria may be denied. Denial triggers include patients under 18 years of age, absence of medical records confirming non-proliferative MacTel type 2, lack of an ophthalmologist prescription, non‑adherence to FDA dosing, or requests exceeding the one-treatment-per-eye lifetime limit or the 60-day authorization window.
- Patient age <18 years.
- No submitted medical records confirming non-proliferative MacTel type 2.
- Prescriber is not an ophthalmologist.
- Dosing not consistent with FDA-approved labeling.
- Request exceeds 1 treatment per eye per lifetime or >60 days from approval.
Background
Idiopathic macular telangiectasia type 2 (MacTel type 2) is a neurodegenerative metabolic retinal disorder that principally affects the macula. It is characterized by dilated macular capillaries with leakage, progressive photoreceptor (ellipsoid zone/IS‑OS) loss, and potential for later neovascularization, scarring, and vision decline. Clinical course in the pivotal trials focused on progression of the EZ (ellipsoid zone) photoreceptor break area as an objective structural outcome, with functional measures such as best‑corrected visual acuity and microperimetry used as secondary endpoints. Encelto is an allogeneic encapsulated cell‑based implant designed to secrete recombinant human CNTF to slow photoreceptor degeneration in adults with idiopathic MacTel type 2; coverage criteria in this policy apply to that population and mirror the trial enrollment parameters.
Definitions
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