Vagus Nerve Stimulation for Treatment of Resistant Depression (TRD)

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:

• The VNS Therapy System cannot be used in patients after a bilateral or left cervical vagotomy.
• Do not use short wave diathermy, microwave diathermy or therapeutic ultrasound diathermy on patients implanted with a VNS Therapy System.  Diagnostic ultrasound is not included in this contraindication.

August 7, 2006

February 5, 2007

May 4, 2007