Vagus Nerve Stimulation (VNS)


» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 07.01.60 
Original Effective Date: November 2000 
Reviewed: October 2014 
Revised: October 2015 


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description:

Vagus nerve stimulation (VNS) is delivered via a pacemaker-like device called a pulse generator that is surgically implanted in the left upper chest underneath the skin. The pulse generator is connected to an implanted lead that is attached to the left vagus nerve in the neck and delivers electrical impulses to the nerve at preprogrammed durations, frequencies and currents. The impulses are further transmitted to centers in the brain to achieve the therapeutic effects. 

 
The stimulator is generally activated two to four weeks after implantation. The physician programs the stimulator in his or her office with a small hand-held computer, programming software, and a programming wand. The strength and duration of the electrical impulses are programmed. The amount of stimulation varies by case, but is usually initiated at a low level and slowly increased to a suitable level for the individual. The device runs continuously and is programmed to turn on and shut off for specific periods of time (for example, 30 seconds on, and 5 minutes off).

 
Patients are provided with a handheld magnet to control the stimulator at home (which must be activated by the physician to magnet mode). When the magnet is placed over the pulse generator site and then moved away, extra stimulation is delivered, regardless of the treatment schedule. Holding the magnet over the pulse generator will turn the stimulation off. Removing it will resume the stimulation cycle. This can be done by the patient, family members, friends or caregivers.


The goal of VNS is to reduce the number, length and severity of seizures.

 
For patients with refractory seizures, evidence from randomized controlled trials (RTCs) and multiple observational studies supports a reduction in seizure frequency following vagus nerve stimulation (VNS). Based on the peer reviewed medical literature, the evidence is sufficient to permit conclusions on the efficacy of this technique for treatment of refractory seizures. Therefore, implantable VNS may be considered medically necessary for patients with medically refractory seizures and for whom surgery is not recommended or for whom surgery has failed.

 
For patients with depression, there is some evidence supporting improvements in depressive symptoms after VNS. However, there are a number of limitations of these data, including uncertain clinical significance, lack of evidence of durability, and lack of comparison with alternative treatments. As a result, it is not clear if VNS is as effective as alternatives for specific populations for patients with depression, and VNS is considered investigational for this indication.


For other conditions, including but not limited to headaches, obesity, essential tremor, heart failure, fibromyalgia, tinnitus, and traumatic brain injury, the evidence is limited and not sufficient to permit conclusions on efficacy. VNS is considered investigational for these indications.

 
Nonimplantable Vagnus Nerve Stimulation (Transcutaneous Vagus Nerve Stimulation (t-VNS)) 

 
The transcutaneous VNS (t-VNS®) system uses a non-invasive approach that combines a stimulation unit and ear electrode to stimulate the auricular branch of the vagus nerve (which supplies the skin over the concha of the ear) for the treatment of pharmacoresistant epilepsy. Individuals self-administer electric stimulation for several hours per day. Currently, the device does not have FDA approval.

 

Transcutaneous VNS has been investigated for a number of conditions. Some evidence for the efficacy of t-VNS for epilepsy comes from 1 small RCT, which reported lower seizure rates for active t-VNS-treated patients compared with sham controls; however, the high dropout rates in this study limit conclusions that may be drawn. One small RCT which compared t-VNS with sham stimulation for the treatment of depression demonstrated some improvements in depression scores with t-VNS; however, the lack of comparisons between groups limits conclusions that may be drawn. Additional RCT evidence is needed to permit conclusions about whether t-VNS is associated with improved outcomes for epilepsy, depression, or other conditions.


The body of evidence for the use of transcutaneous VNS (t-VNS) consists of small RCTs with methodologic limitations and case series. The evidence is insufficient to allow conclusions on the efficacy of t-VNS, and there are no transcutaneous stimulation devices that have U.S. Food and Drug Administration approval; therefore, transcutaneous VNS is considered investigational.    

 
Practice Guidelines and Position Statements


American Academy of Neurology (AAN)

In 1999, the American Academy of Neurology (AAN) released a consensus statement on the use of VNS in adults that stated, “VNS is indicated for adults and adolescents over 12 years of age with medically intractable partial seizures who are not candidates for potentially curative surfical resections, such as lesionectomies or mesial temporal lobectomies. AAN related an update to these guidelines in 2013, that stated, “VNS may be considered for seizures in children, for LGS [Lennox-Gastaut-syndrome]-associated seizures.

 
American Psychiatric Association (APA):
The American Psychiatric Association guidelines on treatment of major depressive disorder in adults, updated in November 2010, includes the following statement on the use of VNS: “Vagus nerve stimulation (VNS) may be an additional option for individuals who have not responded to at least four adequate trials of antidepressant treatment, include ECT (electroconvulsive therapy), with a level of evidence III (May be recommended on the basis of individual circumstances).

 

European Headache Federation
In 2013, the European Headache Federation issued a consensus statement on neuromodulation treatments for chronic headaches, which makes the following statement about the use of VNS: “Due to the lack of evidence, VNS should only be employed in chronic headache suffers using a randomized placebo controlled trial design.”


Regulatory Status
The FDA approved vagus nerve stimulator (VNS) therapy as adjunctive treatment for adults and adolescents over 12 years of age whose partial onset seizures are refractory to antiepileptic drugs.

 

To date, the FDA has not granted 501(k) clearance or PMA to any non-implantable t-VNA device for any indication for use in the United States. Cerbomed GmbH (Erlangen, Germany) has developed a t-VNS® System with NEMOS® that received European clearance (CE mark) in 2011 for treatment of drug-resistant epilepsy.

 

Another noninvasive VNS device called the gammaCore® (ElectroCore, LLC, Basking Ridge, NJ) is currently being investigated for the treatment of cluster/migraine headaches, severe gastroparesis, and other conditions. The gammaCore is currently unavailable for commercial distribution in the United States and has not received FDA 510(k) clearance or PMA for any indication.


Prior Approval:

Not applicable


Policy:

Implantable vagus nerve stimulation (VNS) may be considered medically necessary when both of the following criteria is met:

  • Patient has medically refractive seizures; and
  • The patient has failed or is not a candidate for resective epilepsy surgery

Note: Medically refractory seizures are defined as 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.

 
Replacement or revisions of an implantable vagus nerve stimulator and/or leads is considered medically necessary in an individual that meets the above criteria.

  

Vagus Nerve Stimulation (VNS) is considered investigational as treatment of all other conditions, including but not limited to the following:

  • Depression/ Bipolar Disorders
  • Heart failure
  • Fibromyalgia
  • Essential tremor
  • Headaches
  • Obesity
  • Alzheimer’s
  • Autism
  • Eating disorders
  • Sleeping disorders
  • Tinnitus
  • OCD
  • Cerebral Palsy

Based on peer reviewed literature the use of vagus nerve stimulation has been examined for additional indications. However, there are limited studies and there is insufficient evidence to conclude that vagus nerve stimulation is safe and/or effective for treating these indications and therefore, is considered investigational.

 

Non-implantable vagus nerve stimulation (transcutaneous vagus nerve stimulation (t-VNS) devices are considered investigational for all indications. 

 

The body of evidence for the use of transcutaneous VNS (t-VNS) consists of small RCTs with methodologic limitations and case series. The evidence is insufficient to allow conclusions on the efficacy of t-VNS, and there are no transcutaneous stimulation devices that have U.S. Food and Drug Administration approval; therefore, transcutaneous VNS is considered investigational.





Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • 61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to single electrode array.
  • 61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling;with connection to 2 or more electrode arrays.
  • 64553 Percutaneous implantation of neurostimulator electrode array; cranial nerve
  • 64568 Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
  • 64569 Revision or replacement of cranial nerve (eg vagus nerve) neurostimulator electrode array, including connection to existing pulse generator. 
  • 0312T Vagus nerve blocking therapy (morbid obesity); laparoscopic implantation of neurostimulator electrode array, anterior and posterior vagal trunks adjacent to esophagogastric junction (EGJ), with implantation of pulse generator, includes programming. 
  • 0313T Vagus nerve blocking therapy (morbid obesity); laparoscopic revision or replacement of vagal trunk neurostimulator electrode array, including connection to existing pulse generator. 
  • 0314T Vagus nerve blocking therapy (morbid obesity); laparoscopic removal of vagal trunk neurostimulator electrode array and pulse generator.
  • 0315T Vagus nerve blocking therapy (morbid obesity); removal of pulse generator. 
  • 0316T Vagus nerve blocking therapy (morbid obesity); replacement of pulse generator.
  • 0317T Vagus nerve blocking therapy (morbid obesity); neurostimulator pulse generator electronic analysis, includes reprogramming when performed. 
  • C1767 Generator neurostimulator (implantable) non-rechargeable
  • C1778 Lead, neurostimulator (implantable)
  • C1787 Patient programmer, neurostimulator
  • C1816 Receiver and/or transmitter, neurostimulator (implantable)
  • C1820 Generator, neurostimulator (implantable), non high-frequency with rechargeable battery and charging system
  • C1822 Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system
  • C1897 Lead, neurostimulator test kit (implantable)
  • L8679 Implantable neurostimulator, pulse generator any type
  • L8680 Implantable neurostimulator electrode, each
  • L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
  • L8682 Implantable neurostimulator radiofrequency receiver
  • L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
  • L8685 Implantable neurostimulator pulse generator, single array, rechargeable includes extension
  • L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
  • L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
  • L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
  • L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only
  • E1399 Durable medical equipment, miscellaneous (when specified as non-implantable VNS)
  • 95970 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming
  • 95974 Complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour
  • 95975 Complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour

Selected References:

Wellmark's policy is based on:

  • ECRI Institute. Vagus Nerve Stimulation for Controlling Medically Refractory Seizures in Children. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2012 July. [Hotline Response].
  • ECRI Institute. Vagus Nerve Stimulation for Treating Congestive Heart Failure. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2012 June. [Health Technology Forecast].
  • ECRI Institute. Vagus nerve blocking for treating obesity. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2012 May. [Health Technology Forecast].
  • ECRI Health Technology Information Service. Vagus Nerve Stimulation for Neurologic and Psycholgic Indications. Health Technology Assessment. November 11, 2009.
  • UpToDate. Vagus Nerve Stimulation Therapy for the Treatment of Epilepsy. Steven Karceski M.D., Steven C. Schachter M.D.. Topic Last Updated December 3, 2012.
  • American Association of Neurological Surgeons (AANS). Patient Information: Epilepsy. May 2012.
  • American Association of Neurological Surgeons(AANS). Patient Information: Vagus Nerve Stimulation. May 2007.
  • American Psychiatric Association Clinical Practice Guidelines, Major Depressive Disorder.
  • ECRI Institute. Vagus Nerve Stimulation for Treating Chronic Heart Failure. ECRI Health Technology Forecast. January 2013.
  • Neurosurg Focus. 2012 Mar;32 (3): E12. doi: 10.3171/2011.12. Vagal Nerve Stimulation for the Treatment of Medically Refractory Epilepsy: A Review of the Current Literature.
  • American Academy of Neurology. Evidence Based Guideline Update: Vagus Nerve Stimulation for the Treatment of Epilepsy: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2013; 81;1453-1459 Published Online before Print August 28, 2013.
  • National Coverage Determination (NCD) for VAGUS Nerve Stimulation (VNS) (160.18). 
  • Aaronson ST, Carpenter LL, Conway CR et al. Vagus nerve stimulation therapy randomized to different amounts of electrical charge for treatment-resistant depression: acute and chronic effects. Brain Stimul 2013; 6(4):631-40.
  • American Association of Neurological Surgeons (AANS), Patient Information – Epilepsy, Updated March 2015.
  • Martelletti Paolo, Jensen Rigmor, et. al. Neuromodulation of Chronic Headaches: Position Statement from the European Headache Federation, The Journal of Headache and Pain, 2013.
  • ECRI. Custom Product Briefs-Guidance, VNS Therapy System (Cyberonics Inc)for Treating Refractory Epilepsy, Published June 10, 2015.
  • ECR. Vagus Nerve Stimulation for Treating Chronic Heart Failure, Published June 13, 2012, Updated January 29, 2013.
  • National Institute for Health and Clinical Excellence (NICE), Vagus Nerve Stimulation for Refractory Epilepsy in Children (IPG50), Published March 2004.
  • National Institute for Health and Clinical Excellence (NICE), Vagus Nerve Stimulation for Treatment Resistant Depression (IPG330), Published December 2009. National Institute for Health and Clinical Excellence (NICE), The Epilepsies: The Diagnosis and Management of the Epilepsies in Adults and Children in Primary and Secondary Care (CG137), Published January 2012.
  • UpToDate. Vagus Nerve Stimulation Therapy for the Treatment of Epilepsy, Steven Karceski, M.D., Steven C. Schachter, M.D., Topic last updated June 11, 2015.
  • UpToDate. Depression in Adults: Overview of Neuromodulation Procedures, Paul E. Holtzheimer, M.D., Topic last updated August 25, 2015.
  • UpToDate. Unipolar Depression in Adults: Treatment with Surgical Approaches, Paul E. Holtzheimer, M.D., Topic last updated August 13, 2015.
  • UpToDate. Seizures and Epilepsy in Children: Refractory Seizures and Prognosis, Angus Wilfong M.D., Topic last updated August 13, 2015.
  • UpToDate. Evaluation and Management of Drug Resistant Epilepsy, Joseph I Sierven, M.D., Topic last updated March 17, 2015.

Policy History:

October 2015 - Annual Review, Policy Revised
February 2015 - Policy Revised
October 2014 - Annual Review, Policy Revised
January 2014 - Annual Review, Revision & New Policy Created
January 2013 - Annual Review, Policy Renewed
January 2012 - Annual Review, Policy Renewed
February 2011 - Interim Review, Policy Revised
October 2010 - Annual Review, Policy Renewed


Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.