The national coverage determination (NCD) regarding the amount of PET scans that Alzheimer’s patients undergoing monoclonal antibody treatment can receive is being reconsidered by the U.S. Centers for Medicare and Medicaid Services.
The previous NCD allowed for only one PET amyloid-beta scan per patient. The patients must also be enrolled in a CMS approved clinical trial under coverage with evidence development (CED). The NCD, which was announced on April 14, was widely criticized among the imaging community, with some stating that the decision would “significantly restrict and delay access for patients and families.”
After chatter from many prominent voices in the imaging community, including the American College of Radiology, Society of Nuclear Medicine and Molecular Imaging, and Medical Imaging and Technology Alliance, the CMS initiated an official 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 NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease clinical study protocols may involve more than one PET Aß scan per patient,” the statement says.
Although the imaging community cited multiple concerns with several different aspects of the NCD, the pending review pertains specifically to revising the number of PET amyloid-beta scans that will be covered per patient per lifetime.
On June 16, CMS accepted the formal request to reconsider the NCD. That is also when the official review was initiated and when CMS opened the 30-day window for public comments on the matter. The proposed CMS decision is expected to be announced by December 16, 2022, with the goal of having made a final determination by March 16, 2023.
The full announcement can be viewed here.