A Victory for Coverage With Evidence-Development

Merrill Goozner

First posted 9/8/11 on GoozNews

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

The Gateway-Wingspan system, manufactured by Stryker, was approved by the Food and Drug Administration in 2005 based on “a small, less rigorous study,” according to this morning’s Washington Post. But use has been limited by a decision by the Centers for Medicare and Medicaid Services to deny reimbursement unless patients receiving the device were enrolled in a clinical trial. This “coverage with evidence development” policy began during former CMS director Mark McClellan’s tenure during the Bush administration.

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