Posted by Michael Wonder on 15 Nov 2024
Representativeness of studies required under Medicare’s coverage with evidence development program
13 November 2024 - Medicare beneficiaries are often inadequately represented in clinical studies supporting US Food and Drug Administration medical product approvals
In certain circumstances, the Centers for Medicare & Medicaid Services (CMS) covers items and services under the coverage with evidence development (CED) program, which requires patient enrolment in CMS approved clinical studies to generate additional evidence relevant to the broader Medicare beneficiary population.
