CMS cites 'newly published evidence' in postponement of PET coverage decision
The Centers for Medicare and Medicaid Services announced that it will not yet be releasing an updated national coverage determination (NCD) on Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease as previously planned.
Prior to the December 15 announcement, CMS had released a different statement in June informing the public that they were reconsidering the amount of PET scans that Alzheimer’s patients undergoing monoclonal antibody treatment can receive. That official review began on June 16, with a proposed decision expected by December 16 after a period of invited public comments.
That timeline is now being delayed, as CMS reviews “newly published evidence that is relevant to the proposed NCD,” according to the statement.
As it stands, the NCD states that Alzheimer’s patients undergoing monoclonal antibody treatment can receive just one beta-amyloid PET scan per lifetime. That coverage is also contingent on patients being enrolled in a CMS approved clinical trial under coverage with evidence development (CED).
The current NCD was announced in April of 2022. It was widely criticized by numerous leading bodies in the imaging community, including the American College of Radiology, Society of Nuclear Medicine and Molecular Imaging, and the Medical Imaging and Technology Alliance.
The NCD reconsideration that was announced in June pertains specifically to the policy of one scan per patient per lifetime. In invited commentary on the decision, several big names in the industry provided evidence to support increasing the scan limit, citing the need for post-treatment scans as needed to assess for the removal of beta-amyloid from the brain.
Around a week prior to the latest announcement, a group of bipartisan U.S. lawmakers also called for CMS to expand access of PET imaging for the diagnosis and treatment of Alzheimer's disease.
CMS did not provide a specific date for when an update can be expected, just that a proposed decision is “forthcoming.”
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.