J3398 — Injection, voretigene neparvovec-rzyl, 1 billion vector genomes
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Claims must include a valid ICD-10-CM diagnosis code that best describes the patient's condition; claims lacking a valid diagnosis code will be returned as incomplete under Section 1833(e).
- For services requiring a referring/ordering physician, the referring/ordering physician's name and NPI must be reported on the claim.
- Report diagnostic test results when known; if results are not available, report the symptoms that prompted the test.
- On claims for Luxturna® the HCPCS code (C9032 for 07/01/2018–12/31/2018; J3398 for dates of service on/after 01/01/2019) must be reported with the appropriate eye modifier (-RT or -LT) and the number of HCPCS units administered must be submitted.
Key Coverage Criteria
- Voretigene neparvovec-rzyl (Luxturna®) is covered for treatment of vision loss due to heritable retinal dystrophies in patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
- Coverage applies when the patient has sufficient viable photoreceptors such that a single subretinal administration is expected to clinically improve functional vision.
- Indications include patients with autosomal recessive retinitis pigmentosa (RP) or Leber congenital amaurosis (LCA) when caused by biallelic RPE65 mutations.
- Retinitis pigmentosa with confirmed biallelic pathogenic RPE65 mutations.
- Leber congenital amaurosis with confirmed biallelic pathogenic RPE65 mutations.
- Treatment of inherited retinal dystrophies (IRD) caused by mutations in the RPE65 gene in patients who meet all listed criteria.
6 Active Policies
UHC-POL-luxturna-voretigene-neparvovec-rzyl — Luxturna (Voretigene Neparvovec-Rzyl)
ANTHEM-MED.00120 — MED.00120 Gene Therapy for Ocular Conditions
A56419 — Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna)
L37863 — Voretigene Neparvovec-rzyl (Luxturna)
UMR-POL-UMR-luxturna-voretigene-neparvovec-rzyl — Luxturna (Voretigene Neparvovec-Rzyl)
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.