In a recent statement from Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, she expressed support for the Food and Drug Administration’s (FDA’s) decision to grant accelerated approval for a new product that aims to treat Alzheimer’s disease.

The statement highlights the significant impact of the disease on millions of Americans and their families. The Administrator also noted that CMS will continue to promptly review data on such products, and is committed to ensuring timely access to treatments that improve clinically meaningful outcomes.

The statement goes on to explain that if the drug lecanemab receives traditional FDA approval, CMS would provide broader coverage for it under a framework called “coverage with evidence development.” This framework allows for coverage of a treatment while further evidence of its efficacy is gathered.

The statement also noted that this would apply to any other monoclonal antibody that is directed against amyloid for the treatment of Alzheimer’s disease and receives traditional FDA approval. In other words, CMS would consider covering any drugs that receive FDA traditional approval if evidence of efficacy can be demonstrated from a direct measure of clinical benefit.

We do note that a congressional investigation has discovered significant issues in the process by which the FDA approved the last high-priced Alzheimer’s drug, aducanumab. The investigation found that the FDA’s collaboration to approve the drug was “atypical” and “rife with irregularities.”

This suggests that the investigation of that drug found that the process of approving the drug deviated from the usual standards or procedures, and that there were a significant number of issues or problems within that process.

Let’s hope that the FDA has learned from its mistakes.

Programming note: Listen to live news reports Tuesdays on Talk Ten Tuesdays, 10 Eastern.


Timothy Powell, CPA

Timothy Powell is a nationally recognized expert on regulatory matters, including the False Claims Act, Zone Program Integrity Contractor (ZPIC) audits, and U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) compliance. He is a member of the RACmonitor editorial board and a national correspondent for Monitor Mondays.

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