CMS Will Switch To Centralized Coverage Review Of IDE Trials, But Not Until 2015
This article was originally published in The Gray Sheet
The Medicare agency is delaying, by one year, its plan to replace local coverage review of investigational device exemption studies with a centralized process. New scientific and ethical criteria for covered IDE studies will also go into effect in 2015 – minus controversial provisions that would have favored pivotal studies with a statistical superiority design.
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Whether they support centralized review or not, device manufacturers want CMS to provide more detail on how the process would work – including timelines, the extent of manufacturer interactions with agency staff, and how appeals would be handled.
Centralized CMS review for Medicare coverage of device studies, as proposed in the 2014 draft physician fee schedule, could make for a more manageable process. But a provision that IDE trials must be designed to show superiority to be “automatically” covered could face industry pushback.
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