Health Affairs September 8, 2025
Patient engagement has matured from aspiration to necessity as precision medicine moves from laboratory concept to bedside. Cutting-edge therapies increasingly target narrowly defined genetic or biomarker subgroups. Yet, prevailing Food and Drug Administration (FDA) approval and Centers for Medicare and Medicaid Services (CMS) coverage frameworks still rely on population averages that obscure what patients themselves value most—symptom relief, functional independence, manageable side effect profiles, and protection from crushing out-of-pocket costs. The FDA and CMS have each expanded programs to collect patient experience data, but their requirements remain misaligned, creating costly gaps between regulatory approval and actual access.
We examine why that misalignment persists, how the FDA and CMS are separately elevating patient voices, and where divergence undermines timely, equitable uptake...
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