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Medicare CED Update Targets Study ‘Efficiency,’ But May Not Ease Data Collection Burden

 
• By Cathy Kelly

It's not clear that the proposed revisions and additions to the Centers for Medicare and Medicaid Services’ existing coverage with evidence development study design requirements would address what some experts view as a program failure – the fact that sponsors of the vast majority of technologies subject to CED have not generated the data CMS is looking for. 

Latest Update To 17-Year Old CED Policy Underway • Source: Shutterstock

The Centers for Medicare and Medicaid Services is considering a substantive update of the study design requirements for sponsors of treatments that are subject to a Medicare national coverage determination that conditions coverage on further evidence development.

A revised set of requirements was developed for CMS by the Agency for Healthcare Research and Quality and will be discussed by the Medicare Evidence Development and Coverage Advisory...

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