Health Affairs October 24, 2024
Caroline Marra, Amy P. Abernethy, Sean R. Tunis

When Medicare coverage for a drug, device, or other medical technology is conditioned on additional evidence development, several important policy questions arise: What will be the utility of the evidence generated for informing coverage decisions and, ultimately, the care of Medicare beneficiaries? What will be the burden of conducting the study? And how will the evidence development affect access to the technology by patients? The answer to each of these questions is driven in large part by specific parameters of the study or studies that Medicare deems acceptable.

This is why the recent endorsement by the Centers for Medicare and Medicaid Services (CMS) of the concept of a “fit-for-purpose” (FFP) study is so significant. Updated CMS policies, including several policies...

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