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Coverage with evidence development (CED)

What is coverage with evidence development (CED)?

CED refers to the Medicare coverage of a treatment or technology on the condition that data gathered through a clinical trial or registry will determine its effectiveness. It is implemented as part of the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD), a process for determining if an item or service is covered in the context of a clinical study.  

The CED cycle is considered to be completed when CMS removes the requirement of study participation as a condition of coverage.

While coverage is provided as part of CED, the evidence to determine if the technology is reasonable and necessary is continually collected. The goal of CED is to help CMS verify the appropriateness of using an item or service, generate clinical information to improve the evidence base, and consider future changes in coverage for an item or service.

How does CED improve healthcare?

CED drives the innovation for medical devices by increasing access to new technologies through clinical trials. It allows Medicare beneficiaries to access these promising therapies and services while they are still undergoing clinical trials, which also means that manufacturers can bring their technology into practice sooner, conditioned on evidence generation.