“Science, evidence, and stakeholder input led our team of career civil servants and clinicians through this national coverage determination process. There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality. “In arriving at this final decision, we looked at the very unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm. If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry. Lastly, we structured this decision to provide flexibility and assurance that CMS can respond quickly to providing coverage for any new drugs in this class when a clinical benefit is determined.”

CMS followed a long-standing process established by Congress in making NCDs, including a determination whether a medical item or service is reasonable and necessary for the diagnosis of and/or treatment of an illness or injury. CMS develops NCDs following this process, which uses all relevant published evidence and feedback received from stakeholders with multiple opportunities for public input.


CMS reviewed over 10,000 comments after proposing an initial NCD approach earlier this year. In addition, during the 2021 national coverage analysis public comment period, CMS held two national listening sessions, and reviewed public comments and more than 250 relevant peer-reviewed documents to help inform the initial proposed coverage determination. In response to the feedback the Agency heard, this final NCD creates a pathway for drugs in this class to be covered and for people with Medicare to quickly access these drugs upon determination of a clinical benefit through FDA traditional approval.

CMS will be monitoring future developments in this class of treatments and is committed to continuing to explore ways to improve care for people with Alzheimer’s disease.

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