Clinical Policy: Vagus Nerve Stimulation Form

**CENTENE Corporation**

**Clinical Policy: Vagus Nerve Stimulation**
Reference Number: CP.MP.12
Date of Last Revision: 09/24

**Coding Implications**
**Revision Log**

See Important Reminder at the end of this policy for important regulatory and legal
information.

**Description**
Vagus nerve stimulation (VNS) has been used in the treatment of epilepsy and has been studied
for the treatment of refractory depression and other indications. Electrical pulses are delivered to
the cervical portion of the vagus nerve by an implantable device called a neurocybernetic
prosthesis. Chronic intermittent electrical stimulation of the left vagus nerve is designed to treat
medically refractory epilepsy.¹ VNS has recently been introduced and approved by the Food and
Drug Administration (FDA) as an adjunctive therapy for treatment-resistant major depression.²

**Policy/Criteria**
I. It is the policy of health plans affiliated with Centene Corporation® that vagus nerve
stimulation (VNS) is medically necessary in members/enrollees with medically refractory
seizures who meet all of the following:
- A. Diagnosis of focal onset (formerly partial onset) seizures or generalized onset seizures;
- B. Intractable epilepsy (both):
  - 1. Failure of at least one year of adherent therapy of at least two anti-seizure drugs;
  - 2. Continued seizures which have a major impact on activities of daily living;
- C. Not a suitable candidate for, is opposed to, or has failed epilepsy surgery;
- D. Request is for an FDA approved device.

II. It is the policy of health plans affiliated with Centene Corporation that the safety and efficacy
of VNS therapy has not been proven for any other conditions, including but not limited to the
following:
- A. Refractory (treatment resistant) major depression or bipolar disorder;
- B. Headaches;
- C. Cognitive impairment associated with Alzheimer’s disease;
- D. Addiction;
- E. Anxiety Disorders;
- F. Autism;
- G. Eating Disorders;
- H. Cancer;
- I. Crohn’s Disease;
- J. Essential tremor;
- K. Fibromyalgia;
- L. Heart failure;
- M. Impaired glucose tolerance/pre-diabetes;
- N. Inflammation;
- O. Overweight and obesity;
- P. Obsessive-compulsive disorder;
- Q. Panic disorder;
- R. Post-traumatic stress disorder;

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CLINICAL POLICY
Vagus Nerve Stimulation

recommend treatment for member/enrollees. Member/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, member/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, member/enrollees and their representatives agree to be bound by such terms and conditions by providing services to member/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid member/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare member/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

©2016 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene® and Centene Corporation® are registered trademarks exclusively owned by Centene Corporation.

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