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CMS Will Switch To Centralized Coverage Review Of IDE Trials, But Not Until 2015

This article was originally published in The Gray Sheet

Executive Summary

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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