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National Coverage Determination (NCD)

Vagus Nerve Stimulation for Treatment of Seizures

160.18

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Tracking Information

Publication Number
100-3
Manual Section Number
160.18
Manual Section Title
Vagus Nerve Stimulation for Treatment of Seizures
Version Number
1
Effective Date of this Version
07/01/1999
Ending Effective Date of this Version
05/04/2007
Implementation Date
07/01/1999
Implementation QR Modifier Date

Description Information

Benefit Category
Durable Medical Equipment


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

In the past 10 years, there have been significant advances in surgical treatment for epilepsy and in medical treatment of epilepsy with newly developed and approved medications. Despite these advances, 25-50 percent of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs.

The vagus nerve is a mixed nerve carrying both somatic and visceral afferent and efferent signals. The majority of vagal nerve fibers are visceral afferents with wide distribution. The basic premise of vagus nerve stimulation in the treatment of epilepsy is that vagal visceral afferents have a diffuse central nervous system projection and the activation of these pathways has a widespread effect upon neuronal excitability. Besides activation of well-defined reflexes, vagal stimulation produces evoked potentials recorded from the cerebral cortex, the hippocampus, the thalamus, and the cerebellum.

The vagus nerve stimulation system is comprised of an implantable pulse generator and lead and an external programming system used to change stimulation settings.
Indications and Limitations of Coverage

Clinical evidence has shown that vagus nerve stimulation is safe and effective treatment for patients with medically refractory partial onset seizures, for whom surgery is not recommended or for whom surgery has failed. Vagus nerve stimulation 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.
Cross Reference
Also see the NCD on Electrical Nerve Stimulators (§160.7)
Claims Processing Instructions

Transmittal Information

Transmittal Number
114
Revision History

04/1999 - Provided that procedure is safe and effective for patients with medically refractory partial onset seizures for whom surgery is not recommended or has failed. Effective date 07/01/1999. (TN 114) (CR 470) 
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Vagus Nerve Stimulation (VNS) 3 02/15/2019 - N/A View
Vagus Nerve Stimulation (VNS) 2 05/04/2007 - 02/15/2019 View
Vagus Nerve Stimulation for Treatment of Seizures 1 07/01/1999 - 05/04/2007 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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