Today, the Centers for Medicare and Medicaid Services (CMS) announced they will be opening a National Coverage Determination (NCD) analysis on the treatment for Alzheimer’s disease. This NCD process will allow CMS 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.

Currently, coverage determinations for aducanumab are being made at the local level by Medicare Administrative Contractors (MACs) 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 NCD, 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.

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.

To register for the listening sessions:
July 22, 2021 from 9:00 am–11:00 am (EDT) or
July 27, 2021 from 2:00 pm–4:00 pm (EDT)

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. Comments can be submitted and viewed here.