What decision was made in regard to the final coverage for monoclonal antibodies and amyloid PET?
First, understand that FDA-approved monoclonal antibodies are antibodies that are used against amyloid for the purposes of Alzheimer’s disease treatment. The service occurs under Coverage with Evidence Development (CED) in FDA-approved, CMS-approved, or NIH-sponsored controlled trials with the national coverage determination (NCD) originally proposed in January. CMS finalized the decision to include no additional coverage for beta-amyloid PET scans. Even more, the PET scans will remain under the present policy, which contains massive restrictions including providing coverage only when meeting requirements for clinical trial protocol. Note that the restriction imposed is limited to only one per patient per lifetime. The decision by CMS is a blow to the many groups including radiology stakeholders like the Society of Nuclear Medicine and Molecular Imaging (SNMMI) who have put forth effort into Alzheimer’s disease advocacy, promoting some rebuke.