Luxturna (voretigene neparvovec-rzyl) Clinical Coverage Criteria
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Clinical coverage criteria and prior authorization requirements for Luxturna for Fallon Community Health Plan members, including product description, medical necessity criteria, coding, and payer-specific variations (Medicare, MassHealth). Applies to Fallon Health products listed in the policy.
Added new sections for Medicare Variation and MassHealth Variation.
Under Clinical Coverage Criteria, added: The member has not received any prior gene therapy for RPE65 mutation-associated retinal dystrophy.
Updated Overview section to include information on chorioretinal atrophy as a previously undescribed complication of subretinal injection of Luxturna.
Updated Coding section to inform providers that 340B stock may not be used for MassHealth ACO and NaviCare SCO members.
Coverage Criteria for Luxturna
Initial Therapy — Luxturna is considered medically necessary when ALL of the following are met
Luxturna is considered medically necessary when ALL of the following are met:
From policy clinical coverage criteria
From policy clinical coverage criteria
Initial coverage criteria
- One of: a) An area of retina within the posterior pole >100 µm thickness on OCT.
OCT threshold specified in policy
- One of: b) ≥3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole.
Ophthalmoscopy viability criterion
- One of: c) Remaining visual field within 30 degrees of fixation measured by a III4e isopter or equivalent.
Visual field viability criterion
Dose, timing between eyes, and corticosteroid regimen per FDA prescribing info and policy
Contraindications/exclusions recorded in policy (includes 6.c added 04/29/2025)
Applicable coverage conditions (partial) — policy applies when external Medicare or MassHealth coverage rules are met and when plan benefit terms allow coverage
Policy applies when external Medicare or MassHealth coverage rules are met and when plan benefit terms allow coverage.
Added to clinical coverage criteria effective 04/29/2025; supports eligibility screening.
Instructions for Use describe precedence of external policies and plan benefit terms; coverage also governed by member's benefit plan and applicable state/federal mandates.
Use of Luxturna (voretigene neparvovec-rzyl) in infants younger than 12 months of age is not recommended. This guidance reflects concern that active retinal cell proliferation in this age group may lead to dilution or loss of administered product, potentially reducing effectiveness.
The safety and efficacy of repeat administration of Luxturna have not been evaluated; repeat dosing therefore lacks established evidence of benefit or risk. Additionally, members who have previously received any gene therapy for RPE65 mutation-associated retinal dystrophy are excluded from eligibility for further Luxturna therapy.
Not all services described in this policy are covered for every Fallon product or employer group. Coverage for a specific member is governed by the terms of that member's benefit plan, which may include exclusions or limitations that apply regardless of medical necessity. Providers should consult the member's Evidence of Coverage to confirm applicable benefit limitations.
Members who have received prior gene therapy for RPE65 mutation-associated retinal dystrophy are not eligible for Luxturna under the clinical coverage criteria. This exclusion was explicitly added to the policy clinical criteria during the 04/29/2025 update.
Benefit plan provisions and product-specific rules may exclude services even when a service meets medical necessity criteria. When there is a discrepancy between this clinical policy and a member's benefit plan, the benefit plan provisions govern, subject to applicable state or federal mandates.
Coding and Billing
| H35.50 | Unspecified hereditary retinal dystrophy |
| H35.52 | Pigmentary retinal dystrophy |
| 340B | Note: 340B stock may not be used for MassHealth ACO and NaviCare SCO members (coding guidance referenced). |
| MassHealth Drug List Table 72 | Agents Not Otherwise Classified — referenced for context |
| MassHealth Managed Care Entity Bulletin 42 | Updated MassHealth Acute Hospital Carve-Out Drugs Requirements |
| MassHealth Managed Care Entity Bulletin 125 | Cell and Gene Therapy Adjudicated Payment Amount per Discharge and Adjudicated Payment per Episode of Care Carve-Out |
Provider Actions, Prior Authorization, and Documentation
Obtain prior authorization before administering Luxturna
Prior authorization must be obtained before administration of Luxturna. For most Fallon Health products, prior authorization is required by a Fallon Health Medical Director. For MassHealth ACO members (effective April 1, 2025), prior authorization requests for Luxturna must be submitted to the MassHealth Drug Utilization Review (DUR) Program for review and approval prior to administration; this prior authorization for the drug is separate from any prior authorization for the member's inpatient or outpatient encounter.
- Prior authorization for Luxturna is required before administration for Fallon Health products and is obtained from a Fallon Health Medical Director except as noted for MassHealth ACO.
- MassHealth ACO prior authorization requests for Luxturna (APAD/APEC carve-out drugs) must be submitted to the MassHealth DUR Program for review and approval for dates of service on or after 04/01/2025.
Follow applicable Medicare NCDs/LCDs or MassHealth guidelines
Prior authorization and coverage determinations will follow applicable Medicare national and local coverage determinations (NCDs/LCDs) or MassHealth Medical Necessity Guidelines depending on the member's product; Fallon Health may create internal criteria only when external criteria are not fully established.
- For Medicare Advantage and NaviCare members, Fallon follows CMS NCDs/LCDs and applicable Medicare statutes and regulations when making medical necessity determinations.
- For MassHealth members, Fallon generally follows MassHealth Medical Necessity Guidelines; in their absence Fallon may create clinical criteria per 130 CMR 450.204.
Limit to one treatment per eye (lifetime)
A single treatment of Luxturna per eye, per lifetime is considered medically reasonable and necessary when all coverage criteria are met.
- Treatment for each eye is administered on separate days (no fewer than 6 days apart) per FDA dosing instructions.
No step therapy specified
No step therapy requirements are specified in this policy for Luxturna.
- The document states that no step therapy rules are specified in this part of the policy.
Provide genetic test results and retinal viability documentation
Submit clinical documentation that includes genetic test results confirming biallelic RPE65 pathogenic variants and documentation demonstrating sufficient viable retinal cells as determined by non‑invasive methods (one of the specified OCT, ophthalmoscopy, or visual field findings).
- Provide a copy of the genetic test report confirming homozygous or compound heterozygous biallelic RPE65 pathogenic variants.
- Document one of the retinal viability findings: (a) posterior pole OCT area >100 µm thickness; (b) ≥3 disc areas without atrophy/pigmentary degeneration in the posterior pole; or (c) remaining visual field within 30° of fixation by a III4e isopter or equivalent.
Record which external coverage framework governs the request
Document which external coverage framework applies to the member—CMS NCDs/LCDs for Medicare Advantage/NaviCare members or MassHealth Medical Necessity Guidelines for MassHealth members—since coverage and prior authorization decisions depend on the member's product and applicable external rules.
- If Medicare NCDs/LCDs govern the member, cite the applicable NCD/LCD used for the determination.
- If MassHealth governs the member, reference the MassHealth Medical Necessity Guidelines or relevant MassHealth bulletins and note that Fallon follows MassHealth guidance for MassHealth members.
Secure appropriate prior authorization path by product
Prior authorization is required by a Fallon Health Medical Director for Fallon products; for MassHealth ACO members, submit the Luxturna prior authorization request to the MassHealth DUR Program for review and approval effective April 1, 2025.
- For Fallon Medicare Plus, NaviCare, PACE, and other Fallon products, obtain Fallon Medical Director prior authorization as directed in the policy.
- For MassHealth ACO enrollees, use the MassHealth DUR Program submission process for APAD/APEC carve-out drugs (including Luxturna) for dates of service on or after 04/01/2025.
Denial risk if external or plan criteria are not met
Failure to meet applicable external criteria (Medicare NCDs/LCDs or MassHealth guidelines) or the plan’s specific benefit terms may result in denial of coverage for Luxturna.
- Coverage determinations follow external frameworks; if the member does not meet those criteria, or if the member's benefit plan excludes the service, the request may be denied.
- Not all services are covered for all products—consult the member’s Evidence of Coverage and applicable state or federal mandates.
Background
Luxturna (voretigene neparvovec-rzyl) is an adeno-associated virus–based gene therapy approved to treat vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy (including Leber congenital amaurosis type 2 and retinitis pigmentosa type 20). It is administered by subretinal injectionperifoveal chorioretinal atrophy in a subset of patients following subretinal injection.
Definitions
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