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Medicare 'Coverage With Evidence' May Rise With FDA Postmarket Emphasis

As FDA touts plans to shift clinical data requirements when possible to the postmarket phase, a top CMS official highlights the importance of the Medicare coverage with evidence development policy.

As FDA puts more emphasis on the potential of postmarket data collection to supplant premarket studies when possible, it raises the likelihood of more Medicare coverage-with-evidence development policies, CMS officials suggest.

Reimbursement considerations for products with less premarket data will also likely take more time to review and require closer collaboration...

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