MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Vagus Nerve Stimulation

Number 7.01.20*

Effective Date May 27, 2015

Revision Date(s) 05/12/15; 05/12/14; 05/13/13; 06/12/12; 03/08/11; 01/12/10; 01/13/09; 10/14/08; 01/08/08; 09/12/06; 09/13/05; 10/12/04; 09/12/03; 01/08/02; 06/02/00; 01/07/99; 06/25/98

Replaces N/A

*Medicare has a policy.

Policy

Vagus nerve stimulation may be considered medically necessary as a treatment of medically refractory seizures.

Vagus nerve stimulation is considered investigational as a treatment of other conditions, including but not limited to heart failure, fibromyalgia, depression, essential tremor, obesity, headaches, tinnitus, and traumatic brain injury.

Non implantable vagus nerve stimulation devices are considered investigational for all indications.

Related Policies

2.01.526

Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders

7.01.63

Deep Brain Stimulation

7.01.143

Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy

7.01.522

Gastric Electrical Stimulation

7.01.546

Spinal Cord Stimulation

Policy Guidelines

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.

Vagal nerve stimulation (VNS) requires not only the surgical implantation of the device, but also subsequent neurostimulator programming, that occurs intraoperatively and during additional outpatient visits. The specific CPT codes that describe the neurostimulator programming and analysis of cranial nerve stimulation (i.e., vagus nerve) are in the following table:

Coding

CPT

95974

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance, and patient compliance measurements); 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, with or without nerve interface testing, each additional 30 minutes after first hour

Description

One placement option for the implantable pulse generator VNS device is in the carotid artery sheath. This technique for stimulation of the vagus nerve has been proposed as a treatment for refractory seizures, depression, and other disorders. Devices that are implanted at different areas of the vagus nerve for vagus nerve stimulation are also available. This policy addresses only devices implanted within the carotid sheath, and not to other types of devices.

Vagus Nerve Stimulation

VNS was initially investigated as a treatment alternative in patients with medically refractory partial-onset seizures who were not surgical candidate or who failed to get relief of symptoms after surgery. Over time, the use of VNS has expanded to generalized seizures, and it has been investigated for a range of other conditions.

While the mechanisms for the therapeutic effects of VNS are not fully understood, the basic premise of VNS in the treatment of various conditions is that vagal visceral afferents have a diffuse central nervous system projection, and activation of these pathways has a widespread effect on neuronal excitability. Electrical stimulus is applied to axons of the vagus nerve, which have their cell bodies in the nodose and junctional ganglia and synapse on the nucleus of the solitary tract in the brainstem. From the solitary tract nucleus, vagal afferent pathways project to multiple areas of the brain. There are also vagal efferent pathways that innervate the heart, vocal cords, and other laryngeal and pharyngeal muscles, and provide parasympathetic innervation to the gastrointestinal tract that may also be stimulated by VNS.

The type of VNS device addressed in this policy consists of an implantable, programmable electronic pulse generator that delivers stimulation to the left vagus nerve at the carotid sheath. The pulse generator is connected to the vagus nerve via a bipolar electrical lead. Surgery for implantation of a vagal nerve stimulator involves implantation of the pulse generator in the infraclavicular region and wrapping two spiral electrodes around the left vagus nerve within the carotid sheath. 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.

Other types of vagus nerve stimulators to treat various conditions are also available. The vBLOC® Maestro® System (EnteroMedics, St. Paul, MN) consists of a subcutaneously-implanted pulse generator and electrodes that are placed in contact with the trunks of the vagus nerve at the gastroesophageal junction. These types of stimulators differ in the location of the pulse generator and electrodes and the stimulation programming settings, and are not addressed in this policy.

Potential Indications for VNS

VNS was originally approved for the treatment of medically refractory epilepsy. Significant advances have occurred in surgical treatment for epilepsy and in medical treatment of epilepsy with newly developed and approved medications. Despite these advances, however, 25% to 50% of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs. VNS has been used as an alternative to or adjunct to epilepsy surgery or medications as a therapy for refractory seizures.

Based on observations that patients treated with VNS experienced improvements in mood, VNS has been evaluated for the treatment of refractory depression. VNS has been investigated for multiple other conditions which may be affected by either the afferent or efferent stimulation of the vagus nerve, including headaches, tremor, obesity, heart failure, fibromyalgia, tinnitus, and traumatic brain injury.

Regulatory Status

  • NeuroCybernetic Prosthesis (NCP®) system is a VNS device that FDA approved through the Premarket Approval (PMA) process in 1997. The device was approved for use in combination with drugs or surgery “as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.” Modifications have been made to the device and software that controls the stimulator since the device was approved.

Since 1997, it has been reported that recipients of a vagus nerve stimulator have experienced improvements in mood. Therefore, there has been research interest in VNS as a treatment for refractory depression.

  • VNS Therapy™ System (Cyberonics, Inc.) received PMA supplement approval by FDA on July 15, 2005. The device is approved “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, obesity, and essential tremors. FDA product code: LYJ.

  • t-VNS® system (Cerbomed) is a transcutaneous VNS device that uses a combined stimulation unit and ear electrode to stimulate the auricular branch of the vagus nerve that supplies the skin over the concha of the ear. Patients self-administer electric stimulation for several hours a day; no surgical procedure is required. The device received the CE mark in Europe in 2011, but has not been FDA approved for use in the United States.
  • gammaCore® (Electrocore) is a noninvasive VNS device that is currently being investigated for headache; the device does not have FDA approval.
  • vBloc® Therapy, delivered via the Maestro ® System (EnteroMedics) is FDA approved for vagal blocking therapy to aid in supervised weight loss program. The indicated use is for a select population of obese adults with a BMI of 40 to 45 kg/m2 or a BMI of 35 to 39.9 kg/m2 and a related health condition such as high blood pressure or high cholesterol levels.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

N/A

Rationale

This policy was created in 2000 and updated periodically with literature review. The most recent update covered the period through March, 2015.

The review of evidence in this section will pertain to implantable vagus nerve stimulators unless otherwise indicated. The evidence on nonimplantable vagus nerve stimulators will be discussed separately.

Treatment of Seizures

Vagus Nerve Stimulation for Adult Partial-Onset Seizures

The policy regarding treatment of seizures has expanded the indications over time but was originally based, in part, on a 1998 TEC Assessment (1) that offered the following conclusions:

  • Published evidence from two large, well-designed multicenter randomized trials involving over 300 patients demonstrates that the use of vagus nerve stimulation (VNS) as an adjunct to optimal use of antiepileptic drugs in the treatment of medically refractory patients with at least six partial-onset seizures/month reduces seizure frequency by approximately 25% after three months of treatment. In patients who achieve an initial reduction in seizure frequency, the beneficial treatment effect appears to be maintained and may increase with time.
  • Adverse effects are mild and consist primarily of hoarseness or voice change during “on” periods of stimulation.
  • There is limited information about the use of VNS in patients with other types of seizure disorders.

Based on this TEC Assessment, earlier versions of this policy supported the use of VNS for partial-onset seizures for patients older than 12 years of age. A randomized controlled trial (RCT) published in 2014 reported long-term quality of life outcomes for 112 patients with pharmacoresistant focal seizures, which supported the beneficial effects of VNS for this group. (2)

VNS for Adult Generalized Seizures

Tecoma and Iragui observed in a 2006 review that, since approval of VNS for partial seizures, a number of case series including patients with generalized seizures have been published. These series report seizure reduction rates similar to or greater than those reported in partial epilepsy and note that “this body of evidence suggests that VNS has broad antiepileptic efficacy.” (3) The authors suggest that these results may be particularly important because resective epilepsy surgery is generally not feasible in these patients.

Other reports published since the Tecoma and Iragui review are consistent with the authors’ observations. In a French study of 50 consecutive refractory adolescents and adults who were not eligible for surgery and 11 of whom had generalized epilepsy, 58% were classified as responders at three years’ follow-up. (4) Generalized epilepsy was predictive of a better outcome than partial epilepsy seizures. Seizure reduction of 61% was also reported in a case series of 12 patients with drug-resistant idiopathic generalized epilepsy. (5) Garcia-Navarrete et al evaluated outcomes after 18 months of follow up for a prospectively-followed cohort of 42 patients with medication-resistant epilepsy who underwent VNS implantation. (6) Subjects’ seizure types were heterogeneous, but 52% had generalized epilepsy. Pharmacotherapy was unchanged during the course of the study. Twenty-seven subjects (63%) were described as “responders,” defined as having a 50% or greater reduction in seizure frequency compared with the year before VNS implantation. The reduction in seizure frequency was not statistically significantly different between subjects with generalized and focal epilepsy.

VNS for Childhood Seizures

Since publication of the 1998 TEC assessment, there has been interest in expanding the use of VNS to younger patients. Several studies have now reported results that support the safety and efficacy of the device in children with refractory seizures. (7) For example, 60 pediatric patients were treated as part of the double-blind clinical trials conducted to support the U.S. Food and Drug Administration (FDA) application. (8) At 18 months, the median reduction in seizure frequency was 50%, similar to the results achieved in adults. Adverse events were also similar to those recently reported in adults, (9) and none resulted in termination of stimulation. Hornig et al. reported on a case series of 19 pediatric patients, with observation periods ranging up to 30 months. (10) Overall, 50% of patients had a 50% reduction in seizure frequency. Patwardhan et al. reported that among 38 patients aged 11 months to 16 years with medically refractory seizures, both generalized and partial-onset, 29% had a greater than 90% reduction in seizure frequency after VNS implantation, while 39% had 50% to 90% reduction. (11) Healy et al reported that among 16 patients younger than 12 years who underwent VNS implantation at a single center, 9 (56%) experienced a reduction in their seizure frequency of 50% or more. (12) Results from an add-on study to an RCT designed to compare high-output with low-output VNS stimulation among 41 children with medically refractory epilepsy suggest that VNS does not have adverse effects on cognitive or psychosocial outcomes. (13) Other studies of pediatric patients that included patients with generalized and partial-onset seizures have supported the use of VNS in reducing seizure frequency. These have included a series of 41 children treated with VNS, randomized to a high- or low-dose stimulation protocol, (14) a retrospective case-control study with 36 VNS patients compared with 72 age- and sex-matched controls with refractory epilepsy not treated with VNS, (15) a retrospective cohort study including 252 pediatric patients with a variety of seizure types treated with VNS, (16) and a retrospective cohort study of 347 children with a variety of seizure types followed for up to 2 years post implantation. (17)

Similar to adult studies, pediatric studies suggest that VNS improves seizure frequency in generalized epilepsy syndromes. In a multicenter study of 28 children with refractory seizures, You et al. reported that 15 children (53.6%) showed a greater than 50% reduction in seizure frequency and 9 (32%) had a greater than 75% reduction, and there were no significant differences when groups were compared by seizure type or etiology. (18) Tecoma and Iragui cite a multicenter retrospective analysis of 50 children with Lennox-Gastaut syndrome (LGS) treated with VNS. (3) Median seizure reduction at 6 months was 88% for tonic seizures and 81% for atypical absence. You et al. compared VNS and total corpus callosotomy for LGS. (19) Of the 14 patients who underwent a corpus callosotomy, 9 (64%) had a greater than 50% reduction in seizure frequency and 5 (36%) had a greater than 75% reduction. Of the 10 patients who underwent VNS implantation, 7 (70%) had a greater than 50% reduction in seizure frequency and 2 (20%) had a greater than 75% reduction. For 24 children with LGS or LGS-like syndrome who underwent VNS implantation, Cukiert et al reported that at least a 50% seizure frequency decrease was seen for 35 different seizure types.(20)

The major limitations of VNS are the following issues: stimulation generally does not completely eliminate seizures, and it is not possible to predict which patients will optimally respond. One meta-analysis that included 74 retrospective and prospective studies assessing VNS efficacy in seizures found that predictors of efficacy included generalized epilepsy or mixed seizure types (compared with partial-onset seizures) and age younger than 18 years. (21) In 2013, Arya et al. reported results of a single-center retrospective chart review that included 43 pediatric patients who underwent VNS implantation over a 5-year period; the authors found that absence of magnetic resonance imaging lesion predicted a good outcome. (22) These studies support the use of VNS in children, in patients with generalized epilepsy, and in those who are not candidates for surgery (i.e., no identified structural brain abnormality).

Section Summary

The evidence on the efficacy of VNS for treatment of refractory seizures consists of 2 RCTs and numerous uncontrolled studies. The RCTs both reported a significant reduction in seizure frequency for patients with partial-onset seizures. The uncontrolled studies have consistently reported large reductions for a broader range of seizure types in both adults and children. The large reduction in seizures includes substantial numbers of patients who achieve a greater than 50% reduction in seizure frequency.

Treatment of Refractory Depression

Interest in the application of VNS for treatment of refractory depression is related to reports of improvement in depressed mood among epileptic patients undergoing VNS.(23) TEC Assessments written in 2005 and updated in 2006 concluded that evidence was insufficient to permit conclusions of the effect of VNS therapy on health outcomes. (24,25) The available evidence for these TEC Assessments included study groups assembled by the manufacturer of the device (Cyberonics) and have since been reported on in various publications. (26,27) Analyses from these study groups were presented for FDA review and consisted of a case series of 60 patients receiving VNS (Study D-01), a short-term (i.e., 3-month) sham-controlled RCT of 221 patients (Study D-02), and an observational study comparing 205 patients on VNS therapy with 124 patients receiving ongoing treatment for depression (Study D-04). (28) Patients who responded to sham treatment in the short-term RCT (approximately 10%) were excluded from the long-term observational study.

The primary outcome evaluated was the relief of depression symptoms that can usually be assessed by any one of many different depression symptom rating scales. A 50% reduction from baseline score is considered to be a reasonable measure of treatment response. An improvement in depression symptoms may allow reduction of pharmacologic therapy for depression, with a reduction in adverse effects related to that form of treatment. In the studies evaluating VNS therapy, the 4 most common instruments used were the Hamilton Rating Scale for Depression, Clinical Global Impression, Montgomery and Asberg Depression Rating Scale, and the Inventory of Depressive Symptomatology (IDS).

Several case series studies published before the randomized trial showed rates of improvement, as measured by a 50% improvement in depression score of 31% at 10 weeks to greater than 40% at 1 to 2 years, but there are some losses to follow-up. (29-31) Natural history, placebo effects, and patient and provider expectations make it difficult to infer efficacy from case series data.

The randomized study (D-02) that compared VNS therapy with a sham control (implanted but inactivated VNS) showed a non-statistically significant result for the principal outcome. (27,28) Fifteen percent of VNS subjects responded versus 10% of control subjects (p=0.31). The Inventory for Depressive Symptomatology Systems Review (IDS-SR) score was considered a secondary outcome and showed a difference in outcome that was statistically significant in favor of VNS (17.4% vs 7.5%, respectively, p=0.04).

The observational study that compared patients participating in the RCT and a separately recruited control group (D-04 vs D-02, respectively) evaluated VNS therapy out to 1 year and showed a statistically significant difference in the rate of change of depression score. (26,28) However, issues such as unmeasured differences between patients, nonconcurrent controls, differences in sites of care between VNS therapy patients and controls, and differences on concomitant therapy changes raise concern about this observational study. Analyses performed on subsets of patients cared for in the same sites, and censoring observations after treatment changes, generally showed diminished differences in apparent treatment effectiveness of VNS and almost no statistically significant differences. (28) Patient selection for the randomized trial and the observational comparison trial may be of concern. VNS is intended for treatment-refractory depression, but the entry criteria of failure of 2 drugs and a 6-week trial of therapy may not be a strict enough definition of treatment resistance. Treatment-refractory depression should be defined by thorough psychiatric evaluation and comprehensive management. It is important to note that patients with clinically significant suicide risk were excluded from all VNS studies. Given these concerns about the quality of the observational data, these results did not provide strong evidence for the effectiveness of VNS therapy.

In addition to the results of the TEC Assessment, several systematic reviews and meta-analyses have addressed the role of VNS in treatment-resistant depression.

A systematic review of the literature for VNS of treatment-resistant depression identified the randomized trial previously described among the 18 studies that met the study’s inclusion criteria. (32) VNS was found to be associated with a reduction in depressive symptoms in the open studies. However, results from the only double-blind trial were considered to be inconclusive. (27,28) Daban et al. concluded that further clinical trials are needed to confirm efficacy of VNS in treatment-resistant depression.

In a meta-analysis that included 14 studies, Martin and Martin-Sanchez reported that among the uncontrolled studies in their analysis, 31.8% of subjects responded to VNS treatment. (33) However, results from a meta-regression to predict each study’s effect size suggested that 84% of the observed variation across studies was explained by baseline depression severity. Berry et al reported results from a meta-analysis of 6 industry-sponsored studies of safety and efficacy for VNS in treatment-resistant depression, which included the D-01, D-02, Bajbouj et al (D-03), D-04, and Aaronson et al (D-21) study results. (34) In addition, the meta-analysis used data from a registry of patients with treatment-resistant depression (335 patients receiving VNS and treatment as usual and 301 patients receiving treatment as usual) that were unpublished at the time of the meta-analysis publication (NCT00320372). The authors report that adjunctive VNS was associated with a greater likelihood of treatment response (odds ratio, 3.19; 95% confidence interval [CI], 2.12 to 4.66). However, the meta-analysis did not have systematic study selection criteria, limiting the conclusions that can be drawn from it.

In 2014, Liu et al. conducted a systematic review of brain stimulation treatments, including deep brain stimulation, electroconvulsive therapy, transcranial magnetic stimulation, and VNS, for mental illnesses other than nonpsychotic unipolar depression in adults 65 years or older. (35) The authors identified 2 small studies which evaluated the effect of VNS on cognition in patients with Alzheimer disease, 1 with 10 subjects and 1 with 17 subjects, which were mixed in demonstrating clinical improvements.

In 2013, Aaronson et al. reported results from an active-controlled trial in which 331 patients with a history of chronic or recurrent bipolar disorder or major depressive disorder, with a current diagnosis of a major depressive episode, were randomized to 1 of 3 VNS current doses (high, medium, low). (36) Patients had a history of failure to respond to at least 4 adequate dose/duration of antidepressant treatment trials from at least 2 different treatment categories. After 22 weeks, the current dose could be adjusted in any of the groups. At follow-up visits at weeks 10, 14, 18, and 22 after enrollment, there was no statistically significant difference between the dose groups for the study’s primary outcome, change in IDS score from baseline. However, the mean IDS score improved significantly for each of the groups from baseline to the 22-week follow-up. At 50 weeks of follow-up, there were no significant differences between the treatment dose groups for any of the depression scores used. Most patients completed the study; however, there was a high rate of reported adverse events, including voice alteration in 72.2%, dyspnea in 32.3%, and pain in 31.7%. Interpretation of the IDS improvement over time is limited by the lack of a no treatment control group. Approximately 20% of the patients included had a history of bipolar disorder; as such, the results may not be representative of most patients with treatment resistant unipolar depression.

Other case series do not substantially strengthen the evidence supporting VNS. A case series study by Bajbouj et al. that followed patients for 2 years showed that 53.1% (26/49) patients met criteria for a treatment response and 38.9% (19/49) met criteria for remission. (37) A small study of 9 patients with rapid-cycling bipolar disorder showed improvements in several depression rating scales over 40 weeks of observation. (38) Another case series by Cristancho et al. that followed patients for one year showed that 4 of 15 responded and 1 of 15 remitted according to the principal response criteria. (39) In a 2014 case series which included 27 patients with treatment resistant depression, 5 patients demonstrated complete remission after 1 year and 6 patients were considered responders. (40)

Adverse effects of VNS therapy included voice alteration, headache, neck pain, and cough, which are known from prior experience with VNS therapy for seizures. Regarding specific concerns for depressed patients such as mania, hypomania, suicide, and worsening depression, there does not appear to be a greater risk of these events during VNS therapy.(28)

Section Summary

There is 1 RCT evaluating the efficacy of VNS for resistant depression. This study reported only short-term results and found no significant improvement for the primary outcome with VNS. Other available studies, which include nonrandomized comparative studies and case series, are limited by relatively small sizes and the potential for bias in selection; the case series are further limited by the lack of a control group .Given the limitations of this literature, combined with the lack of substantial new clinical trials, the scientific evidence is considered to be insufficient to permit conclusions concerning the effect of this technology on major depression.

Other Conditions

Treatment of Essential Tremor

Handforth et al. studied VNS in nine patients with essential tremor. (41) Four weeks after implantation of the VNS device, tremor assessment using a masked videotape of patients was performed. Raters found no improvement in upper -extremity tremors. Therefore, the authors of the study concluded that VNS is not likely to have any clinically meaningful effect in essential tremor treatment.

Treatment of Headaches

Drawing on the analgesic effects noted with VNS in the treatment of depression, Mauskop evaluated VNS in 5 patients with severe, refractory chronic cluster and migraine headaches. (42) Mauskop reported excellent results in 1 patient who was able to return to work and significant improvement in 2 patients. Other than nausea developed by 1 patient, VNS was well -tolerated. Cecchini et al. evaluated VNS in 4 patients suffering from daily headache and chronic migraine. (43) However, these studies are too small to draw conclusions on the effects of VNS for the treatment of headache, and further study is needed.

Treatment of Obesity

Unintended weight loss has been observed in participants in studies of VNS, prompting interest in use of the technology to prevent or treat obesity. Bodenlos et al. investigated whether VNS might affect food cravings in patients with chronic, treatment -resistant depression. (44) They recruited 33 participants and divided them into 3 groups; 11 subjects receiving VNS for depression, 11 patients with depression but not receiving VNS, and 11 healthy controls. Most participants (42%) had a body mass index (BMI) in the normal range. Participants viewed food images on a computer in random order and then a second time in the same order and were asked after each viewing how much they would like to eat each food if it were available and how well they would be able to resist tasting each one. VNS devices were turned on for one viewing and off for the other. The depression VNS group had greater differences in food cravings between viewings in the sweet food category than the other 2 groups. No significant differences between groups were found for foods in proteins and vegetables/fruits categories. A significant proportion of the variability in VNS-related changes in cravings for sweet foods was attributed to clinical VNS device settings, depression scores, and BMI. A number of limitations in the study prevent drawing conclusions about the impact of VNS on eating behavior including small study size, selection and lack of randomization, heterogeneity of groups with respect to depression, BMI, and age. Comorbidities including anxiety and medical conditions and drugs that might influence food intake and cravings were not considered. Large, well-designed and executed controlled studies are needed to evaluate the impact of VNS on eating behavior and obesity.

Treatment of Chronic Heart Failure

In 2014, Zannand et al. reported results from the NECTAR-HF trial, a randomized, sham-controlled trial, with outcomes from VNS in patients with severe left ventricular (LV) dysfunction, despite optimal medical therapy. (45) Ninety-six patients were implanted with VNS and randomized in a 2:1 manner to VNS ON or VNS OFF for 6 months. Programming of the generator was performed by a physician unblinded to treatment assignment, while all other investigators and site study staff involved in end point data collection were blinded to randomization. Sixty-three patients were randomized to the intervention, of whom 59 had paired pre-post data available, while 32 were randomized to control, of whom 28 had paired data available. The analysis was a modified intention-to-treat. For the primary end point of change in left ventricular end systolic diameter (LVESD) from baseline to 6 months, there were no significant differences between groups (p=0.60 between-group difference in LVESD change). Other secondary efficacy end points related to LV remodeling parameters, LV function, and circulating biomarkers of heart failure, did not differ between groups, with the exception of 36-Item Short-Form Health Survey Physical Component score, which showed greater improvement in the VNS ON group than in the control group (from 36.3 to 41.2 in the VNS ON group vs. from 37.7 to 38.4 in the control group; p=0.02). Subject blinding was found to be imperfect, which may have biased the subjective outcome data reporting.

In the ANTHEM-HF study, 60 patients with heart failure with reduced ejection fraction were implanted with VNS, randomly assigned to right- or left-sided implantation (n=29 and 31, respectively), and followed for 6 months. (46) Overall, from baseline to 6-month follow-up, LV ejection fraction improved by 4.5% (95% CI: 2.4 to 6.6), left ventricular end systolic volume (LVESV) improved by -4.1 mL (95% CI: -9.0 to 0.8), LVESD improved by -1.7 mm (95% CI: -2.8 to -0.7), heart rate variability improved by 17 ms (95% CI: 6.5 to 28), and 6-minute walk distance improved by 56 m (95% CI: 37 to 75). A case series Phase II trial of VNS therapy for chronic heart failure was published previously, which reported improvements in New York Heart Association class quality of life, 6-minute walk test, and LV ejection fraction. (47)

Treatment of Fibromyalgia

Lange et al. conducted a Phase I/II trial of VNS of 14 patients with fibromyalgia. (48) At 3 months, 5 patients had attained efficacy criteria based on a composite measure of improvement of fibromyalgia symptoms. At 11 months, 8 patients met efficacy criteria. This single -arm trial does not provide sufficient evidence for efficacy of VNS for this indication.

Treatment of Tinnitus

A 10-patient case series by De Ridder et al. suggested that VNS may be associated with clinical improvements in patients with tinnitus.(49)

Treatment of Traumatic Brain Injury

Shi et al have FDA approval to conduct a small pilot study to evaluate VNS in the treatment of traumatic brain injury.(50)

Non implantable VNS Devices

Transcutaneous VNS for Epilepsy

Aihua et al reported results from a series of 60 patients with pharmacoresistant epilepsy treated with a transcutaneous VNS (t-VNS) device, who were randomly assigned to receive stimulation over the earlobe (control group) or the Ramsay-Hunt zone, which includes the external auditory canal and the conchal cavity and is considered to be the somatic sensory territory of the vagus nerve. (51) Thirty patients were randomized to each group; 4 subjects from the treatment group were excluded from analysis due to loss to follow-up (n=3) or adverse effects (n=1), while 9 subjects from the control group were excluded from analysis due to loss to follow-up (n=2) or increase or lack of decrease in seizures or other reasons (n=7). In the treatment group, compared with baseline, the median monthly seizure frequency was significantly reduced after 6 months (5.5 vs. 6.0; p<0.001) and 12 months (4.0 vs. 6.0; p<0.001) of t-VNS therapy. At 12-month follow-up, t-VNS group subjects had a significantly lower median monthly seizure frequency compared with the control group (4.0 vs. 8.0; p<0.001).

Two small case series were identified that used a transcutaneous stimulator (t-VNS device) for treatment of medication refractory seizures. In a small case series of 10 patients with treatment resistant epilepsy, Stefan et al reported that 3 patients withdrew from the study, while 5 of 7 patients reported a reduction in seizure frequency.(52) In another small case series, He et al reported that among 14 pediatric patients with intractable epilepsy who were treated with bilateral t-VNS stimulation, of the 13 patients who completed follow-up, mean reduction in self-reported seizure frequency was 31.8% after 8 weeks, 54.1% from week 9 to 16, and 54.2% from week 17 to 24.(53)

Transcutaneous VNS for Psychiatric Disorders

Hein et al. reported results of 2 pilot RCTs of a t-VNS device for the treatment of depression, one which included 22 subjects and one with 15 subjects. (54) In the first study, 11 subjects each were randomized to active or sham t-VNS. At 2 weeks follow-up, Beck Depression Inventory (BDI) self-rating scores in the active-stimulation group decreased from 27.0 to 14.0 (p< 0.000), while the sham-stimulated patients did not show significant reductions in the BDI (31.0–25.8 points). In the second study, 7 patients were randomized to active t-VNS and 8 patients were randomized to sham t-VNS. In this study, BDI self-rating scores in the active stimulation group decreased from 29.4 to 17.4 (p<0.05) after 2 weeks, while the sham-stimulated patients did not show significant change in BDI (28.6 to 25.4). The authors do not report direct comparisons in BDI change between the sham- and active-stimulation groups.

Shiozawa et al. conducted a systematic review of studies evaluating the evidence related to transcutaneous trigeminal or VNS for psychiatric disorders. (55) In the article text, the authors state that they reviewed studies, 4 of which addressed t-VNS for psychiatric disorders and included a total of 84 subjects. Of those 4, 3 of the studies evaluated physiologic parameters in healthy patients, and 1 evaluated pharmacoresistant epilepsy (Stefan et al., previously described (52)). The authors also include a fifth study in 1 data table, although not in their text or reference list (Hein et al, previously described (54)) Overall, the studies included were limited by small size and poor generalizability.

Transcutaneous VNS for Other Disorders

Migraine Headache

Goadsby et al. reported results from an open-label pilot study of t-VNS for the treatment of migraine with or without aura. (56) Eighty migraine attacks were self-treated by 27 patients, of an initial sample of 30 patients (2 patients treated no migraine attacks with the device, 1 patient treated only an aura). Of 54 moderate or severe attacks treated, 12 subjects (22%) were pain-free at 2 hours post-treatment. Thirteen subjects reported adverse events, which were all considered mild or moderate.

Tinnitus

Kreuzer et al. reported a single-armed pilot study of t-VNS with 2 different devices for the treatment of tinnitus. (57) Forty-eight subjects were included in the study’s primary intention-to-treat analysis. For the study’s primary outcome of change in mean Tinnitus Questionnaire (TQ) score from baseline to 6-month follow-up, for the 24 subjects in the first phase of the study, who had used an earlier generation t-VNS device (Cerbomed), the TQ total score decreased by 3.7 points (p=0.036). Nine subjects (37.5%) were considered responders. For the 24 subjects in the second phase of the study, who had used a later-generation t-VNS device (Cerbomed), the mean TQ score decreased by 2.8 points (p=0.014). Eleven subjects were considered responders (45.8%). In a per-protocol analysis, which included 28 subjects who received treatment, there was no significant improvement in TQ scores. The authors conclude that t-VNS treatment did not result in significant improvement in tinnitus.

Impaired Glucose Tolerance

Huang et al. reported results of a pilot RCT of a t-VNS device that provides stimulation to the auricle for the treatment of impaired glucose tolerance. (58) The study included 70 patients with impaired glucose tolerance who were randomized to active or sham t-VNS, along with 30 controls who received no t-VNS treatment. After 12 weeks of treatment, patients who received active t-VNS were reported to have significantly lower 2-hour glucose tolerance test results than those who received sham t-VNS (7.5 vs. 8 mmol/L; p=0.004).

Section Summary

Transcutaneous VNS has been investigated for a number of conditions. Some evidence for the efficacy of t-VNS for epilepsy comes 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.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov identified the following comparative studies of VNS that are currently enrolling patients (see Table 1).

Table 1: Ongoing Comparative Studies of VNS

Trial Name

Trials No.

Planned Enrollment

Estimated Study Completion Date

Noninvasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache

NCT01792817

150

Jun 2014

A Randomized Multicenter Study for the Acute Relief of Episodic and Chronic Headache

NCT01958125

108

Mar 2014

Pilot Study: Anti-inflammatory Effect of Perioperative Stimulation of the Vagus Nerve

NCT01572155

24

Sep 2014

Controlled Randomized Vagus Nerve Stimulation (VNS) Therapy Versus Resection (CoRaVNStiR)

NCT02089243

40

Jul 2016
(follow-up through Jul 2017)

INcrease Of VAgal TonE in CHF (INOVATE-HF)

NCT01303718

650

Jun 2015

Summary of Evidence

For patients with refractory seizures, evidence from randomized controlled trials (RCTs) and multiple observational studies supports a reduction in seizure frequency following vagus nerve stimulation (VNS). A TEC Assessment concluded that the evidence is sufficient to permit conclusions on the efficacy of this technique for treatment of refractory seizures. Therefore, VNS may be considered medically necessary for patients with refractory seizures.

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 on 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 of 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.

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 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 surgical resections, such as lesionectomies or mesial temporal lobectomies.” (59) AAN released an update to these guidelines in 2013 that stated, “VNS may be considered for seizures in children, for LGS [Lennox-Gastaut-syndrome]-associated seizures, and for improving mood in adults with epilepsy (Level C). VNS may be considered to have improved efficacy over time (Level C).” (60)

American Psychiatric Association (APA)

The APA guidelines on the 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, including ECT [Electroconvulsive therapy],” with a level of evidence III (May be recommended on the basis of individual circumstances). (61)

European Headache Federation (EHF)

In 2013, the EHF 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 sufferers using a randomized, placebo controlled trial design.” (62)

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

Medicare has a national coverage determination for VNS. Medicare coverage policy notes that “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 that are medically refractory and for whom surgery is not recommended or for whom surgery has failed.” Effective for services performed on or after May 4, 2007, VNS is not reasonable and necessary for resistant depression. (63)

References

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  26. George MS, Rush AJ, Marangell LB, et al. A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression. Biol Psychiatry. 2005;58(5):364-373.
  27. Rush AJ, Marangell LB, Sackeim HA, et al. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry. 2005;58(5):347-354.
  28. U.S. Food and Drug Administration Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data for the Vagus Nerve Stimulation (VNS) Therapy System. Available online at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/4047b1_02_Summary%20of%20Safety%20and%20Effectiveness.pdf. Last accessed April, 2015.
  29. Marangell LB, Rush AJ, George MS, et al. Vagus nerve stimulation (VNS) for major depressive episodes: one-year outcomes. Biol Psychiatry. 2002; 51(4):280-287.
  30. Rush AJ, George MS, Sackheim HA, et al. Vagus nerve stimulation (VNS) for treatment-resistant depression: a multicenter study. Biol Psychiatry. 2000; 47(4):276-286.
  31. Sackeim HA, Rush AJ, George MS, et al. Vagus nerve stimulation (VNS) for treatment-resistant depression; efficacy, side effects and predictors of outcome. Neuropsychopharmacology. 2001; 25(5):713-728.
  32. Daban C, Martinez-Aran A, Cruz N, et al. Safety and efficacy of vagus nerve stimulation in treatment-resistant depression. A systematic review. J Affect Disord. Sep 2008; 110(1-2):1-15. PMID 18374988
  33. Martin JL, Martin-Sanchez E. Systematic review and meta-analysis of vagus nerve stimulation in the treatment of depression: variable results based on study designs. Eur Psychiatry. Apr 2012; 27(3):147-155. PMID 22137776
  34. Berry SM, Broglio K, Bunker M, et al. A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression. Med Devices (Auckl). 2013; 6:17-35. PMID 23482508
  35. Liu AY, Rajji TK, Blumberger DM, et al. Brain stimulation in the treatment of late-life severe mental illness other than unipolar nonpsychotic depression. Am J Geriatr Psychiatry. Mar 2014;22(3):216-240. PMID 23891366
  36. 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. Jul 2013; 6(4):631-640. PMID 23122916
  37. Bajbouj M, Merkl A, Schlaepfer TE, et al. Two-year outcome of vagus nerve stimulation in treatment-resistant depression. J Clin Psychopharmacol. 2010; 30(3):273-281.
  38. Marangell LB, Suppes T, Zboyan HA, et al. A 1-year pilot study of vagus nerve stimulation in treatment-resistant rapid-cycling bipolar disorder. J Clin Psychiatry. 2008; 69(2):183-189.
  39. Cristancho P, Cristancho MA, Baltuch GH, et al. Effectiveness and safety of vagus nerve stimulation for severe treatment-resistant major depression in clinical practice after FDA approval: outcomes at 1 year. J Clin Psychiatry. 2011;72(10):1376-1382.
  40. Tisi G, Franzini A, Messina G, et al. Vagus nerve stimulation therapy in treatment-resistant depression: a series report. Psychiatry Clin Neurosci. Aug 2014;68(8):606-611. PMID 25215365
  41. Handforth A, Ondo WG, Tatter S, et al. Vagus nerve stimulation for essential tremor: a pilot efficacy and safety trial. Neurology. 2003; 61(10):1401-1405.
  42. Mauskop A. Vagus nerve stimulation relieves chronic refractory migraine and cluster headaches. Cephalalgia. 2005; 25(2):82-86.
  43. Cecchini AP, Mea E, Tullo V, et al. Vagus nerve stimulation in drug-resistant daily chronic migraine with depression: preliminary data. Neurol Sci. 2009; 30(suppl 1):S101-104.
  44. Bodenlos JS, Kose S, Borckardt JJ, et al. Vagus nerve stimulation acutely alters food craving in adults with depression. Appetite. 2007; 48(2):145-153.
  45. Zannad F, De Ferrari GM, Tuinenburg AE, et al. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the neural cardiac therapy for heart failure (NECTAR-HF) randomized controlled trial. Eur Heart J. Aug 31 2014. PMID 25176942
  46. Premchand RK, Sharma K, Mittal S, et al. autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. Nov 2014;20(11):808-816. PMID 25187002
  47. De Ferrari GM, Crijns HJ, Borggrefe M, et al. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J. 2011; 32(7):847-855. Available online at http://eurheartj.oxfordjournals.org/content/32/7/847.full?sid=7b3132c2-ee92-4453-8d93-6d0a7d72023d. Last accessed April 2015.
  48. Lange G, Janal MN, Maniker A, et al. Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. Pain Med. 2011; 12(9):1406-1413.
  49. De Ridder D, Vanneste S, Engineer ND, et al. Safety and Efficacy of Vagus Nerve Stimulation Paired With Tones for the Treatment of Tinnitus: A Case Series. Neuromodulation. Nov 20 2013. PMID 24255953
  50. Shi C, Flanagan SR, Samadani U. Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial. Neurol Res. Apr 2013; 35(3):263-276. PMID 23485054
  51. Aihua L, Lu S, Liping L, et al. A controlled trial of transcutaneous vagus nerve stimulation for the treatment of pharmacoresistant epilepsy. Epilepsy Behav. Oct 2014;39:105-110. PMID 25240121
  52. Stefan H, Kreiselmeyer G, Kerling F, et al. Transcutaneous vagus nerve stimulation (t-VNS) in pharmacoresistant epilepsies: a proof of concept trial. Epilepsia. Jul 2012; 53(7):e115-118. PMID 22554199
  53. He W, Jing X, Wang X, et al. Transcutaneous auricular vagus nerve stimulation as a complementary therapy for pediatric epilepsy: a pilot trial. Epilepsy Behav. Sep 2013; 28(3):343-346. PMID 23820114
  54. Hein E, Nowak M, Kiess O, et al. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm. May 2013;120(5):821-827. PMID 23117749
  55. Shiozawa P, Silva ME, Carvalho TC, et al. Transcutaneous vagus and trigeminal nerve stimulation for neuropsychiatric disorders: a systematic review. Arq Neuropsiquiatr. Jul 2014;72(7):542-547. PMID 25054988
  56. Goadsby PJ, Grosberg BM, Mauskop A, et al. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia. Oct 2014;34(12):986-993. PMID 24607501
  57. Kreuzer PM, Landgrebe M, Resch M, et al. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study. Brain Stimul. Sep-Oct 2014;7(5):740-747. PMID 24996510
  58. Huang F, Dong J, Kong J, et al. Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study. BMC Complement Altern Med. 2014;14:203. PMID 24968966
  59. Fisher RS, Handforth A. Reassessment: vagus nerve stimulation for epilepsy: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. Sep 11 1999; 53(4):666-669. PMID 10489023
  60. Morris GL, 3rd, Gloss D, Buchhalter J, et al. 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. Oct 15 2013; 81(16):1453-1459. PMID 23986299
  61. American Psychiatric Association. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 2010; Third:http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. Accessed April, 2015.
  62. Martelletti P, Jensen RH, Antal A, et al. Neuromodulation of chronic headaches: position statement from the European Headache Federation. J Headache Pain. Oct 21 2013;14(1):86. PMID 24144382
  63. Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for VAGUS Nerve Stimulation (VNS) (160.18). http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=230&ncdver=2&CoverageSelection=National&KeyWord=vagus&KeyWordLookUp=Title&KeyWordSearchType=And&where=%252520index&nca_id=%252520195&bc=gAAAABAAAAAAAA%3d%3d&. Accessed April, 2015.
  64. Blue Cross and Blue Shield Association. Vagus Nerve Stimulation. Medical Policy Reference Manual, Policy 7.01.20, 2015.

Coding

Codes

Number

Description

CPT

61885

Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array

 

61886

with connection to two or more electrode arrays

 

61888

Revision or removal of cranial neurostimulator pulse generator or receiver

 

64553

Percutaneous implantation of neurostimulator electrodes; cranial nerve

 

64568

Incision for implantation of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

 

64569

Revision or replacement of cranial nerve (e.g., vagus nerve) neurostimulator electrode array, including connection to existing pulse generator

 

64570

Removal of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator

 

95971

Electronic analysis of implantation of neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (i.e., peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

 

95972

Complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour

 

95973

Complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour

 

95974

Electronic analysis of implantation of neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour

 

95975

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour

ICD-9 Procedure

86.95

Insertion or replacement of dual array neurostimulator pulse generator, not specified as rechargeable

ICD-10-PCS
(effective 10/01/15)

0JH60DZ

Insertion of Multiple Array Stimulator Generator into Chest Subcutaneous Tissue and Fascia, Open Approach

 

0JH63DZ

Chest Subcutaneous Tissue and Fascia, Percutaneous Approach

 

0JH70DZ

Insertion of Multiple Array Stimulator Generator into Back Subcutaneous Tissue and Fascia, Open Approach

 

0JH73DZ

Insertion of Multiple Array Stimulator Generator into Back Subcutaneous Tissue and Fascia, Percutaneous Approach

 

0JH80DZ

Abdomen Subcutaneous Tissue and Fascia, Open Approach

 

0JH83DZ

Abdomen Subcutaneous Tissue and Fascia, Percutaneous Approach

HCPCS

L8680

Implantable neurostimulator electrode, each

 

L8681

Patient programmer (external) for use with implantable programmable neurostimulator pulse generator

 

L8682

Implantable neurostimulator radiofrequency receiver

 

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

 

L8684

Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement

 

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

 

L8686

Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

 

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

 

L8688

Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

 

L8689

External recharging system for battery (internal) for use with implantable neurostimulator

Type of Service

Surgery

 

Place of Service

Inpatient

 

Appendix

N/A

History

Date

Reason

06/25/98

Add to Surgery Section - New Policy

01/07/99

Coding Update - 1999 CPT coding release.

06/02/00

Replace Policy - Added cross-references to other stimulation policies.

01/08/02

Replace Policy - Title change; revised new indication for children, investigational as a treatment for depression. Held for notification, published 4/15/02.

09/12/03

Replace Policy - Information update; policy statement unchanged.

10/12/04

Replace Policy - Policy reviewed with literature search. FDA information and a reference added. Statement on investigational status of VNS treatment for essential tremor added.

09/13/05

Replace Policy - Policy updated with literature review and FDA approval of VNS for depression. Added headaches and essential tremor as investigational in the policy statement; remaining policy statements unchanged.

02/06/06

Codes updated - No other changes.

06/09/06

Disclaimer and Scope update - No other changes.

09/12/06

Replace Policy - Policy updated with June 2006 TEC Assessment (treatment-resistant depression) and literature review for other indications; policy statement unchanged; references added.

01/08/08

Replace Policy - Policy updated with literature search; no change in policy statement. References and codes added.

10/14/08

Replace Policy - Policy updated with literature search; no change in policy statement. References and codes added.

01/13/09

Replace Policy - Policy updated with literature search. Policy statement revised to indicate the VNS may be considered medically necessary in refractory seizures (both partial and generalized) and is investigational in treatment of obesity. References added.

01/12/10

Replace Policy - Policy updated with literature search; no change to the policy statements. Rationale extensively reorganized and condensed. References added.

03/08/11

Replace Policy - Policy updated with literature search; references 30-32 have been added. No change to policy statements. ICD-10 codes added.

01/03/12

Deleted codes 64568, 64569, 64570 and 64573 removed.

06/26/12

Replace policy. Policy updated with literature search, references 26-28, 33, 34 added. Policy statement updated to include the addition of heart failure and fibromyalgia to the list of investigational conditions.

08/27/12

Update Related Policy – Add 2.01.50. Update coding section – ICD-10 codes are now effective 10/01/2014.

01/10/13

Coding update. New CPT codes 0312T – 0318T, effective 1/1/13, added to policy.

01/22/13

Update Related Policies. 2.01.50 replaced with 2.01.526.

02/15/13

Update Related Policies. Change title to policy 2.01.526.

05/28/13

Replace policy. Policy reviewed. Rationale section reformatted for readability, references renumbered to match the changes. A literature search through January 2013 did not prompt additions to the reference list. Vagus nerve blocking therapy codes (0312T-03127T) removed as inappropriate for this policy. Policy statement unchanged.

06/13/14

Annual Review. Policy updated with literature review through February 5, 2014. References 7, 13-17, 29-31, and 41-44 added. Policy statement updated to include the addition of tinnitus and traumatic brain injury to the list of investigational conditions. Rationale section reorganized.

01/26/15

Update Related Policy. Add 7.01.143.

03/13/15

Update Related Policies. Add 7.01.522.

05/27/15

Annual Review. Policy updated with literature review through January 27, 2015. Added vBloc Maestro system to Regulatory Status section. References 2, 14-17, 35, 40, 45-46, 51, 54-58, 62 added; others renumbered. Policy statements unchanged. Coding update: ICD-9 and ICD-10 diagnosis codes removed; ICD-9 procedure codes 02.93, 86.96, 86.97, and 86.98 removed; ICD-10 codes added for purposes of remediation.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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