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

Article preview from "The Gray Sheet" - July 15, 2013

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.

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

Article preview from "The Gray Sheet" - July 15, 2013

CMS has proposed some significant changes to the process for gaining Medicare coverage of device trials.

Responding to device industry complaints about the unwieldy process of obtaining jurisdiction-by-jurisdiction Medicare coverage for clinical study costs, the agency is proposing to make these coverage decisions centrally.

Perhaps more controversially, the agency is also proposing a new set of standards to govern which studies can be covered. One provision likely to attract industry attention calls for “automatically” covering a trial only if, among other conditions, it is designed to demonstrate the superiority of the treatment being investigated. Trials that don’t meet this condition would be subject to a more in-depth review, according to CMS.

The proposals apply to coverage reviews of studies conducted under an FDA investigational device exemption (IDE). They appear in CMS’ calendar year 2014 proposed physician fee schedule, released July 8.

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