National Coverage Determination Analysis on Treatment for Alzheimer's Disease

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services Room 352-G 200 Independence Avenue, SW Washington, DC 20201 CMS NEWS FOR IMMEDIATE RELEASE July 12, 2021 Contact: CMS Media Relations CMS Media Inquiries  CMS Opens National Coverage Determination Analysis on Treatment for Alzheimer’s Disease Thorough Process Will Enable Careful Consideration of Coverage and Incorporate Public Input Today, the Centers for Medicare & Medicaid Services (CMS) is opening a National Coverage Determination (NCD) analysis, a process that will allow the agency to carefully review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease. NCDs are program instructions developed by CMS to describe the nationwide conditions for Medicare coverage for a specific item or service. This NCD analysis will be applicable to national coverage considerations for aducanumab, which was recently approved by the Food and Drug Administration (FDA), as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease. As part of the NCD process, a 30-day public comment period will begin today. CMS will also host two public listening sessions in July to provide an opportunity for public input. “Alzheimer’s is a devastating illness that has touched the lives of millions of American families and as CMS opens our National Coverage Determination analysis, we invite interested stakeholders to participate,” said CMS Administrator Chiquita Brooks-LaSure. “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available. That’s why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.” Currently, coverage determinations for aducanumab are being made at the local level by Medicare Administrative Contractors who represent 12 jurisdictions across the country. CMS’s coverage decisions are based on careful analysis of the evidence and benefits a given therapy provides to Medicare beneficiaries. To determine whether a national policy is appropriate, CMS will follow a standard process that includes multiple opportunities for the public to participate and present comments through both listening sessions and the CMS Coverage website. The analysis will determine whether the evidence meets the Medicare law’s requirements that items or services be “reasonable and necessary for the diagnosis or treatment of illness or injury…”. To make this determination, CMS uses a formal process established by statute. The process includes an assessment of the clinical evidence such as published clinical studies, professional society guidelines, and public comments to determine coverage.   Following this analysis, CMS will post a proposed national coverage determination, which will be open to a second 30-day public comment period. After reviewing all comments received on a proposed determination, CMS will announce its final decision for a national policy which could range from Medicare coverage of this product type, coverage with evidence development, non- coverage, or deference to the Medicare Administrative Contractors. A proposed decision is expected to be posted within 6 months and a final within 9 months.   NCDs are posted on the CMS Medicare Coverage Center website and provide stakeholders with the Medicare coverage criteria, a summary of the evidence considered, and CMS’s rationale for the decision.   For additional information about the NCD process, please visit: https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center#skipNavTarget To submit or view public comments, please visit: https://www.cms.gov/medicare-coverage- database/details/nca-tracking-sheet.aspx?NCAId=305 To register for the listening sessions: July 22 from 9:00 to 11:00 AM (EDT) or July 27 from 2:00 to 4:00 PM (EDT)    ### Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSgov.