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CMS denies coverage for VNS Therapy depression indication

This article was originally published in The Gray Sheet

Executive Summary

Medicare agency issues national noncoverage determination for Cyberonics' VNS Therapy vagus nerve stimulation implant for treatment resistant depression (TRD) on May 4. The action follows a Feb. 5 noncoverage proposal (1"The Gray Sheet" Feb. 12, 2007, p. 10). The agency "has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment resistant depression," CMS says. Last July, Cyberonics had requested coverage for TRD patients who either have been previously treated with or have refused treatment with electroconvulsive therapy, or have been previously hospitalized for depression. As a result of the depression reimbursement setback, Cyberonics has elected to refocus on its core business - which is centered on VNS Therapy's epilepsy indication...

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