On January 14, 2022, the U.S. Centers for Medicare & Medicaid Services (CMS) published this proposed national coverage determination for monoclonal antibodies directed against amyloid for the treatment of alzheimer’s disease. CMS proposes to cover FDA approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) under Coverage with Evidence Development (CED) in CMS approved randomized controlled trials that satisfy the coverage criteria specified in Section C below, and in trials supported by the National Institutes of Health (NIH). All trials must be conducted in a hospital-based outpatient setting . . .
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