June 24, 2022
On June 16, 2022, the Centers for Medicare and Medicaid Services (CMS) began a reconsideration process for its National Coverage Determination (NCD) for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease (CAG-00431R). Currently NCD 220.6.20 covers one PET amyloid-beta (Aß) scan per patient in CMS approved studies under coverage with evidence development (CED).
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 (AD) because clinical study protocols may involve more than one PET Aß scan per patient. The purpose of this NCD reconsideration is to determine if the current policy of one scan per patient per lifetime should be revised.
While SNMMI will be submitting comment, we also encourage all our members to submit their own individual comments. In our last round of comments to CMS regarding the monoclonal antibody therapy for AD (CAG-00460N), we stressed our opposition to the current policy of covering only one per patient per lifetime (under CED). In stark contrast, the decision explicitly covers other tests for detection of beta amyloid (e.g., cerebral spinal fluid) without limitation, despite the fact that beta-amyloid PET is the standard of care—and, in fact, the only test approved by the FDA—for detecting Aß. Members are encouraged to borrow from our last comment letter and other pertinent sources when formulating a response.
The public comment period associated with the reconsideration of this NCD ends July 15. The proposed decision by CMS on this NCD is expected by Dec. 16, with the final decision to be made by March 16, 2023.
***Update July 15, 2022***
Please find our comment letter regarding the reconsideration of NCD 220.6.20 here.