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.
The strongest endorsement of observational studies for CED comes in materials accompanying the recently released revision of the agency’s...
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