The National Coverage Determination (NCD) regarding the number of PET scans that Alzheimer’s disease patients on monoclonal antibody therapy can receive is under review by the US Centers for Medicare and Medicaid Services.
The previous NCD allowed only one PET-amyloid-beta scan per patient. Patients must also be enrolled in a CMS-approved undercover evidence development (CED) clinical trial. The NCD, which was announced on April 14, has been widely criticized within the imaging community, with some saying the decision would be “significantly restrict and delay access for patients and families.
After discussions from many prominent voices in the imaging community, including the American College of Radiology, the Society of Nuclear Medicine and Molecular Imaging, and the Medical Imaging and Technology Alliance, the CMS launched a formal review of the NCD.
“CMS internally generated the opening of this NCD analysis based on stakeholder feedback, including public comments received during the finalization of the NCDs for amyloid-directed monoclonal antibodies for the treatment of Alzheimer’s disease. ‘Alzheimer’s clinical study protocols may involve more than one PET Aß scan per patient,’ the statement read.