Medical Policy: 07.01.60
Original Effective Date: November 2000
Reviewed: October 2014
Revised: February 2015
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.
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.
Position Statement or Guidelines
American Association of Neurological Surgeons
VNS, approved by the Food and Drug Administration in 1997, is designed to prevent seizures by sending regular, mild pulses of electrical energy to the brain via the vagus nerve. The treatment appears to be effective for seizures that do not respond well to medications alone. The effectiveness of this treatment is about the same as drug therapy. VNS decreases seizure numbers by at least half in 40 to 50 percent of patients, but rarely eliminates all seizures. Almost all patients need to continue taking medications after the stimulator has been placed, although dosages usually can be decreased.
The goal of VNS is to reduce the number, length and severity of seizures. VNS may also reduce the time it takes to recover after a seizure. However, VNS is not successful in all patients. The success of this treatment differs - some patients report less frequent seizures, others report a slight reduction, while some patients do not respond at all. The following results have been noted in select patients with epilepsy:
- Less severe or shorter seizures
- Better recovery after seizures (postictal period)
- Improved sense of well-being
- Improved mood
- Improved alertness, memory, and cognitive skills
- Fewer emergency room visits
VNS is a treatment option limited to select individuals with epilepsy and treatment resistant depression (TRD). Individuals with any of the following criteria are not considered suitable candidates for VNS because there is not sufficient safety or efficacy data:
- One vagus nerve
- Receiving other concurrent forms of brain stimulation
- Prior therapeutic brain surgery or brain injury
- Progressive neurological diseases other than epilepsy or depression
- Heart arrhythmias or other heart abnormalities
- Dysautonomias (abnormal functioning of the autonomic nervous system)
- Lung diseases or disorders (shortness of breath, asthma, etc.)
- Ulcers (gastric, duodenal, etc.)
- Vasovagal syncope (fainting)
- Preexisting hoarseness
The American Psychiatric Association (APA):
Practice guideline for the treatment of patients with major depressive disorder discusses vagus nerve stimulation (VNS) under other somatic therapies. The authors state that electroconvulsive therapy (ECT) remains the treatment of best established efficacy against which other stimulation treatments (e.g., VNS, deep brain stimulation, transcranial magnetic stimulation, other electromagnetic stimulation therapies) should be compared. VNS may be an additional option for individuals who have not responded to at least four adequate trials of antidepressant treatment, including ECT [III]. For patients whose depressive episodes have not previously responded to acute or continuation treatment with medications or a depression focused psychotherapy but who have shown a response to ECT, maintenance ECT may be considered [III]. Maintenance treatment with VNS is also appropriate for individuals whose symptoms have responded to this treatment modality [III]. According to the APA, relative to other antidepressive treatments, the role of VNS remains a subject of debate. However, it could be considered as an option for patients with substantial symptoms that have not responded to repeated trials of antidepressant treatment.
The three APA rating categories represent varying levels of clinical confidence:
- I: Recommended with substantial clinical confidence
- II: Recommended with moderate clinical confidence
- III: May be recommended on the basis of individual circumstances (Gelenberg, et al., 2010).
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. 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.
In 2013, the American Academy of Neurology (AAN) released an updated guideline evaluating the evidence regarding the efficacy and safety of VNS for epilepsy. The guidelines states that VNS may be considered for seizures (both partial and generalized) in children, for LGS [Lennox-Gastaut-syndrome]-associated seizures.
Vagus Nerve Stimulation (VNS) may be considered medically necessary as a treatment of medically refractory seizures for the following indication:
- Patients who have tried two or more anti-epileptic drugs (AEDs) without adequate control of their partial onset seizures; and
- Individual has failed or is not a candidate for resective epilepsy surgery
Epilepsy surgery criteria:
- the patient (or his or her parents for young children and patients with intellectual impairment) needs to understand the objective of the presurgical evaluation and to agree on the possibility of a surgical treatment;
- the patient should suffer from disabling seizures despite appropriate medical therapy; and
- available imaging and electroclinical data should be consistent with the possibility of a surgically remediable epileptic syndrome.
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
- Essential tremor
- Eating disorders
- Sleeping disorders
- 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 stimulators are considered investigational for all indications.
The available evidence does not permit conclusions about the usefulness of vagus nerve stimulation in the treatment of depression. Long-term data regarding the tolerability as well as symptomatic and functional outcomes of depressed patients receiving VNS are needed to gauge the effectiveness of this procedure for treating refractory depression.
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
- 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), 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)
- L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
- 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
- 95971 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 spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
- 95972 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); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour
- 95973 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); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (List separately in addition to code for primary procedure)
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). Available online at: http://www.cms.gov
- 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.
Date Reason Action
October 2010 Annual review Policy renewed
February 2011 Interim review Policy revised
January 2012 Annual review Policy renewed
January 2013 Annual review Policy renewed
January 2014 Annual review Revison & New Policy Created
October 2014 Annual review Policy revised
February 2015 Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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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.