The US Centers for Medicare and Medicaid Services is escalating its rhetorical support for using observational studies to fulfill Coverage with Evidence Development requirements to qualify for coverage, but more practical guidance on the design and data sources awaits a “forthcoming” guidance on “fit-for-purpose” CED trials.
Key Takeaways
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CMS continues to suggest observational studies can fulfill Coverage with Evidence Development requirements to gain coverage.
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More details are on the way in upcoming guidance on fit-for-purpose CED trials with more details on the features, sources and conduct
The strongest endorsement of observational studies for CED comes in materials accompanying the recently released revision of the agency’s guidance on CED. CMS details its thinking on various aspects of CED, including “ending CED,” in a separate document addressing comments from sponsors, researchers and patient advocacy groups on the proposed revisions