This CPB has been revised to add the following criteria for medical necessity of Luxturna: (i) confirmation of bi-allelic "pathogenic and/or likely pathogenic" RPE65 mutations, (ii) RPE65 gene mutations classifications based on the ACMG standards and guidelines for the interpretation of sequence variants (2015), and (iii) pathogenic and/or likely pathogenic classification of the RPE65 mutations have been affirmed within the last 12 months. This CPB has been updated to state that subretinal injection of Luxturna requires a pars plana vitrectomy.