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

Article preview from "The Gray Sheet"- December 3, 2013

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.

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

Article preview from "The Gray Sheet"- December 3, 2013

CMS will go forward with its recent proposal to centralize the review of investigational device exemption study coverage, but will delay implementation of the new approach until Jan. 1, 2015.

The agency explained the new process in its 2014 physician fee schedule final rule, released Nov. 27. The rule also creates a new set of criteria that IDE studies must be met to gain Medicare coverage.

The agency’s July proposal to replace the current Medicare Administrative Contractor-based coverage process generated significant debate within the device industry, with views ranging from qualified support to staunch opposition. The proposed study criteria also prompted concerns. CMS said 48 stakeholders submitted comments on the proposed rule.

Many device companies asked for more specifics on how the centralized review process would work, and CMS obliged by fleshing out several important details in the final rule.Sponsors will voluntarily seek Medicare coverage for their IDE trials by submitting a request letter to CMS’ Coverage and Analysis Group, including a description of the scope and nature of the study, a discussion of how the study meets CMS’ IDE study criteria, FDA’s approval letter for the IDE, the study protocol, one institutional review board approval letter, the national clinical trial number and any appropriate supporting materials.

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