FDA

CMS Delays Codifying Definition of “Reasonable and Necessary”

May 20, 2021 - CMS announced that it will delay the effective date of a final rule updating the definition of “reasonable and necessary” and the guidelines surrounding the Medicare Coverage of Innovative Technology (MCIT) pathway. This delay is intended to give CMS time to address stakeholder issues that surfaced during its public comment...

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Spotlight on the Biden Administration’s Healthcare Team

by Jacqueline LaPointe

Healthcare remains one of the top priorities for the Biden administration as it inherits an ongoing pandemic and the unstable future of the Affordable Care Act. But the President is already unveiling...

FDA Allows Coronavirus Diagnostic Testing in Certain Hospital Labs

by Jacqueline LaPointe

In order to achieve more rapid coronavirus diagnostic testing capacity, the FDA will allow certain clinical laboratories, including some hospital labs, to use diagnostic kits developed in-house to test...

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