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The Vagus Nerve Stimulation (VNS) system is comprised of an implantable pulse generator and lead and an external programming system used to change stimulation settings.
CMS currently provides coverage for VNS for patients with medically refractory partial onset seizures, for whom surgery is not recommended or for whom surgery has failed. VNS is not covered for patients with other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed.
A partial onset seizure has a focal onset in one area of the brain and may or may not involve a loss of motor control or alteration of consciousness. Partial onset seizures may be simple, complex, or complex partial seizures, secondarily generalized.
On July 26, 2006, CMS received a formal request for reconsideration from Cyberonics, Inc. The company proposed that CMS revise its current NCD to include coverage of VNS for treatment of resistant depression (TRD) for patients who have been either (1) previously treated with or refused treatment with electroconvulsive therapy (ECT), or (2) have been previously hospitalized for depression. The specific indication requested for coverage is for the adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode and have not had an adequate response to four or more adequate depression treatments.
Cyberonics, Inc. also requests that following to be considered as contraindications:
August 7, 2006
CMS opens this national coverage determination (NCD) as a reconsideration for the coverage decision made on VNS. Currently, CMS covers VNS for treatment of seizures with certain indications and limitations. However, CMS has received a formal request to reconsider expanding the coverage of VNS for treatment of resistant depression (TRD). CMS is requesting public comments.
After considering the public comments, CMS will release a proposed decision memorandum. Instructions for submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage
February 5, 2007
CMS posts the Proposed Decision Memorandum and opens a 30-day period on the proposed decision.
CMS is requesting public comments on the proposed decision memorandum. CMS is particularly interested in the quality of data and evidence cited in public comments rather than the quantity of comments received. Instructions for submitting comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.
May 4, 2007