PFCD Welcomes Medicare Alzheimer’s Blood Test Inclusion in National Registry

The Partnership to Fight Chronic Disease welcomes the recent decision by the Centers for Medicare & Medicaid Services (CMS) to update its National Coverage Determination  for amyloid‑targeting Alzheimer’s therapies (ATTs) to explicitly include blood‑based tests as a method of confirming amyloid pathology and providing another access pathway for approved therapies.

We’re pleased to see that CMS is recognizing the significance of Alzheimer’s blood tests as an important part of the diagnostic toolkit. Blood tests represent a significant advancement as a diagnostic tool for Alzheimer’s disease as they are less costly, more accessible to patients, and less complicated to administer than other diagnostic tools. By making this change, the agency is taking a positive step towards enabling more Medicare beneficiaries to access FDA-approved Alzheimer’s therapies. 

PFCD has long advocated for bringing Medicare coverage policies into closer alignment with the best available science to meet patient needs. Important questions remain about how to ensure timely and appropriate access to FDA-approved Alzheimer’s treatments. Outdated coverage policies within Medicare – such as the NCD’s overall Coverage with Evidence Development (CED) – continue to place unnecessary and burdensome registry participation as a condition of coverage. The CED policy impedes access, delays treatment, and limits patient choice. These impacts fall hardest on people in rural and other underserved communities. 

Additional research on FDA-approved therapies is welcome, and manufacturer-led post-market studies are ongoing. Medicare coverage should not be a condition of collecting it. We are committed to working with policymakers to address these barriers and ensure people living with serious chronic illnesses can access the treatments they need without unnecessary delays.