About this policy
Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD
Coverage indications
This Local Coverage Determination (LCD) addresses limited indications of the gene therapy, voretigene neparvovec-rzyl (Luxturna ® ). Voretigene neparvovec-rzyl will be considered reasonable and necessary for the following inherited retinal degenerations with confirmed biallelic RPE65 mutations: Retinitis pigmentosa Leber congenital amaurosis This limited coverage of voretigene neparvovec-rzyl (Luxturna ® ) allows for a single dose (1.5x 10 11 vector genomes) per eligible eye, per lifetime in beneficiaries who meet all of the coverage indications and documentation requirements as outlined in this LCD. Additionally, coverage is limited to manufacturer-designated Centers of Excellence with expertise in heritable retinal degenerations when performed by qualified vitreoretinal surgeons with evidence of completion of the manufacturer’s surgical and pharmacy training program for the appropriate storage, handling, and administration of voretigene neparvovec-rzyl (Luxturna ® ).
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.