Date Printed: February 9, 2010: 06:17 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2010, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2010 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.

02-61000-22

Original Effective Date: 06/15/00

Reviewed: 05/28/09

Revised: 01/01/10

Subject: Vagus Nerve Stimulation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

DESCRIPTION:

Seizures have been defined as paroxysmal disorders of the central nervous system characterized by abnormal cerebral neuronal discharge, with or without a loss of consciousness. Seizures have been further subclassified into those with a generalized onset, beginning throughout the brain, and those with a partial onset, having a discrete focal onset. There are 3 principal subtypes of partial-onset seizures:

In about 70% of cases of epilepsy there is no known cause. For the remaining 30%, head trauma, infection, poisoning, brain tumor or stroke can be some identified factors.

In the past 10 years, significant advances have occurred in surgical treatment for epilepsy and in medical treatment of epilepsy with newly developed and approved medications. Despite these advances, 25%–50% of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs. Vagus nerve stimulation (VNS) has been investigated as a treatment alternative in patients with medically refractory partial-onset seizures for whom surgery is not recommended or for whom surgery has failed.

Surgery for implantation of a vagus nerve stimulator involves wrapping spiral electrodes around the left vagus nerve within the carotid sheath. The electrodes are connected to an electric pulse generator, which is subcutaneously imbedded under the clavicle. The programmable stimulator may be programmed in advance to stimulate at regular times or on demand by patients or family by placing a magnet against the subclavicular implant site. In 1997, the U.S. Food and Drug Administration (FDA) approved a vagus nerve stimulation device called the NeuroCybernetic Prosthesis (NCP®) system. The device was approved for use in conjunction with drugs or surgery “as an adjunctive treatment of adults and adolescents over 12 years of age with medically refractory partial onset seizures.”

Since 1997, it has been reported that recipients of vagus nerve stimulator have experience improvements in mood. There has been research interest in VNS as a treatment of refractory depression. On July 15, 2005, Cyberonics received PMA approval by the FDA for the VNS Therapy™ System “for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments”.

VNS therapy has also been investigated for use in other conditions such as headaches and essential tremors.

POSITION STATEMENT:

Vagus nerve stimulation meets the definition of medical necessity when ALL of the following criteria are met:

Vagus nerve stimulation is considered experimental or investigational as a treatment for all other indications and specifically for the following conditions:

Vagus nerve stimulation for the treatment of depression is considered experimental or investigational because the available scientific evidence does not support conclusions regarding the effectiveness of vagus nerve stimulation for this indication. Most of the studies have notable weaknesses to the study design. The studies have been case series or observational studies and inferring efficacy from case series data is difficult due to natural history, placebo effects, and patient and provider expectations. One published randomized-controlled trial maintained randomization for only a 10-week follow-up.

Vagus nerve stimulation as a treatment of essential tremor and headaches is considered experimental or investigational because there is insufficient evidence to support its effectiveness. The study sizes have been too small to draw conclusions and further study is needed.

BILLING/CODING INFORMATION:

The following codes are frequently used for reporting this procedure.

CPT Coding:

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT and PROGRAM EXCEPTIONS.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: CMS has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we are issuing the following national coverage determination: Vagus nerve stimulation is not covered for treatment resistant depression.

DEFINITIONS:

Epilepsy: recurrent, unprovoked paroxysmal transient disturbances of brain function that may be manifested as episodic impairment or loss of consciousness, abnormal motor phenomena, psychic or sensory disturbances, or perturbation of the autonomic nervous system.

Medically refractory seizures: seizures that occur in spite of therapeutic levels of antiepileptic drugs or seizures that cannot be treated with therapeutic levels of antiepileptic drugs because of intolerable adverse effects of these drugs.

Seizure: a transient disturbance of cerebral function due to an abnormal paroxysmal neuronal discharge in the brain.

Vagus nerve (nervus vagus): tenth cranial nerve; supplies sensory fibers to the ear, tongue, pharynx, and larynx, motor fibers to the pharynx, larynx, and esophagus, and parasympathetic and visceral afferent fibers to thoracic and abdominal viscera.

RELATED GUIDELINES:

Gastric Electrical Stimulation, 01-91000-04

OTHER:

None applicable.

REFERENCES:

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/28/09.

GUIDELINE UPDATE INFORMATION:

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2010, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2010 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.

Date Printed: February 9, 2010: 06:17 AM