National Coverage Analysis (NCA) Tracking Sheet

Vagus Nerve Stimulation for Treatment of Resistant Depression (TRD)

CAG-00313R

Issue

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.

National Coverage Determinations

Benefit Category

Durable Medical Equipment
Incident to a physician's professional Service
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Richard L. Rudolph, MD (Cyberonics, Inc.) View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/07/2006
Expected NCA Completion Date
05/06/2007
Public Comment Period
08/07/2006 - 09/06/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/05/2007
Proposed Decision Memo Public Comment Period
02/05/2007 - 03/07/2007
Decision Memo Released
05/04/2007
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Beverly A. Lofton, MHA
Lead Medical Officers
Jyme Schafer, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

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

After considering the public comments and all clinical evidence on the proposed decision, CMS posts its final decision memo.