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CMS Proposes Centralized Review, New Standards For Reimbursement Of IDE Studies

This article was originally published in The Gray Sheet

Executive Summary

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

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.

Final Medicare Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts

The CMS coverage and analysis group has had to divert its attention from finishing a CED guidance to finalizing proposed changes to the process for awarding Medicare coverage for investigational device trials, primarily due to staff cuts, says Louis Jacques, who heads the group.

Final Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts

The CMS coverage and analysis group has had to divert its attention from finishing a CED guidance to finalizing proposed changes to the process for awarding Medicare coverage for IDE trials, primarily due to staff cuts, says Louis Jacques, who heads the group.

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