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www.fdanews.com/articles/61591-cyberonics-asks-cms-to-reconsider-vns-coverage-for-treatment-resistant-depression

CYBERONICS ASKS CMS TO RECONSIDER VNS COVERAGE FOR TREATMENT-RESISTANT DEPRESSION

August 9, 2006

The Centers for Medicare & Medicaid Services (CMS) received a letter dated July 24 from Cyberonics asking the agency to revise its current national coverage determinaton to include vagus nerve stimulation (VNS) for treatment-resistant depression.

The firm is asking the CMS to expand its coverage for VNS therapy for patients who have previously been treated with, or refused treatment with, electroconvulsive therapy and for patients who have been previously hospitalized for depression.

VNS treatment uses an implantable pulse generator. The CMS currently provides coverage for VNS only for patients with medically refractory partial onset seizures for whom surgery is not recommended or has failed.

To view the Cyberonics letter, go to www.cms.hhs.gov/DeterminationProcess/downloads/id195.pdf (http://www.cms.hhs.gov/DeterminationProcess/downloads/id195.pdf).