This CPB has been revised to (i) clarify that the RPE65 gene mutations classifications are based on the current American College of Medical Genetics (ACMG) standards and guidelines for the interpretation of sequence variants (the current policy references the 2015 version); and (ii) state that voretigene neparvovec-rzyl (Luxturna) is considered medically necessary only for persons who have not received a previous treatment course of voretigene neparvovec-rzyl. This CPB is revised to state that genetic testing for the RPE65 variant medically necessary to confirm a diagnosis of biallelic RPE65 variant-associated retinal dystrophy in members who meet the other above-listed criteria for Luxturna when it is being considered as a treatment option.