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US Medicare To Offer Guidance On Real World Evidence To Support Coverage

 
• By Cole Werble

The US Medicare agency is encouraging use of observational trials to fulfill Coverage With Evidence Development requirements, but details will await an upcoming guidance on “fit for purpose” studies.

Real world evidence
More practical details likely will be included in upcoming guidance, CMS said. • Source: Shutterstock

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

  • 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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