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Public Citizen steps up Cyberonics campaign

This article was originally published in The Gray Sheet

Executive Summary

Cyberonics' bid for national coverage of its Vagus Nerve Stimulation therapy for treatment-resistant depression, filed in July, is "an eleventh-hour attempt to save a failing product," Public Citizen claims in a Sept. 6 letter urging CMS to deny reimbursement. The nonprofit consumer advocacy organization points to the 10 local Medicare contractors in 14 states that have elected not to cover the implantable stimulation system, owing to abiding questions about its efficacy. CMS should "follow in these well-trodden footsteps," Public Citizen says. More than a thousand comments have been submitted to the agency - the majority in favor of coverage for the technology - from physicians, patients and Cyberonics employees. An unremitting critic of VNS for depression since FDA approval in February 2005, Public Citizen also has requested that FDA reverse its "ill-advised" decision...

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