In the wake of the Food and Drug Administration’s (FDA’s) controversial decision to approve aducanumab for Alzheimer’s disease, how will, and how should, Medicare respond? We propose a coverage with evidence development (CED) option for the Centers for Medicare and Medicaid Services (CMS), and we examine how the agency’s past decisions on high-price technology may offer a guide. While others have written generally about Medicare’s options for aducanumab, including possible action from CMS’s Center for Medicare and Medicaid Innovation, we elaborate on the design of CED studies, drawing on lessons from historical CMS decisions
