BlueCross and BlueShield of Montana Medical Policy/Codes
Vagus Nerve Stimulation (VNS)
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: May 01, 2006
Publish Date: October 25, 2013
Revised Dates: March 1, 2010; June 1, 2011; October 16, 2012; October 1, 2013
Description

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

  • Simple partial seizures: Involve alteration of consciousness but may have observable motor components or may solely be a subjective sensory or emotional phenomenon.
  • Complex partial seizures: Partial-onset seizures that involve an alteration of consciousness.
  • Complex partial seizures, secondarily generalized tonic-clonic convulsions: Partial-onset seizures that progress to involve both sides of the brain and result in a complete loss of consciousness.

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

While the mechanisms for the therapeutic effects of VNS are not fully understood, the basic premise of VNS in the treatment of epilepsy is that vagal visceral afferents have a diffuse central nervous system projection, and activation of these pathways has a widespread effect on neuronal excitability. Surgery for implantation of a vagal nerve stimulator involves wrapping two spiral electrodes around the left vagus nerve within the carotid sheath. The electrodes are connected to an infraclavicular generator pack. The programmable stimulator may be programmed in advance to stimulate at regular times or on demand by patients or family by placing a magnet against the subclavicular implant site. In 1997, the U.S. Food and Drug Administration (FDA) approved a VNS device called the NeuroCybernetic Prosthesis (NCP®) system. The device was approved for use in conjunction with drugs or surgery “as an adjunctive treatment of adults and adolescents over twelve years of age with medically refractory partial-onset seizures.”

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

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

VNS requires not only the surgical implantation of the device, but also subsequent neurostimulator programming, which occurs intraoperatively and typically during additional outpatient visits.

Vagal Blocking Therapy

Vagal blocking therapy is a proposed treatment for obesity. The vagus nerves play a role in processing food and signaling the feeling of being full. Clinical investigation is underway to evaluate the potential for producing weight loss by intermittently blocking vagus nerve signals. Currently undergoing clinical investigation are vagal blocking devices, one of which is the Maestro system, by EnteroMedics® Inc. VBLOC®, a vagal blocking therapy, is reported to intermittently block vagus nerve signaling using a pacemaker-like device. By intermittently blocking the vagus nerve signals, it is thought that appetite may be reduced and may lead to weight loss. (34)    

The Maestro® System is made up of a subcutaneously implanted rechargeable neuroregulator and electrodes. The electrodes are placed in contact with the vagus nerves in the area above the junction between the esophagus and the stomach. The neuroregulator is implanted under the skin and supplies the electrical pulses to the vagus nerve via the electrodes. (34) A phase three study is currently underway to evaluate efficacy and safety of the Maestro RC2 System in producing weight loss in obese subjects. The study’s sponsor is EnteroMedics. (36)

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

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

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

Vagus nerve blocking therapy is considered experimental, investigational and unproven as a treatment for obesity.

Policy Guidelines

64569 should be reported when the electrode array is replaced or revised, with connection to an existing pulse generator. 61885 should be reported for replacement of the generator only, not involving placement of the electrode array.

Rationale

This policy was created in 2006 and updated periodically with literature review. The most recent update covered the period through January 2013. This section of the current policy has been substantially revised. Following is a summary of the key literature to date.

Treatment of Seizures

The policy regarding treatment of seizures has expanded the indications over time but was originally based, in part, on a 1998 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment (1) that offered the following conclusions.

  • Published evidence from 2 large, well-designed multicenter 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 6 partial-onset seizures/month reduces seizure frequency by approximately 25% after 3 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 vagus nerve stimulation in patients with other types of seizure disorders.

Based on this TEC Assessment, earlier versions of this policy supported the use of vagus nerve stimulation (VNS) for partial-onset seizures for patients older than 12 years of age.

Since that time, there has been interest in expanding the use of VNS to younger patients. Several studies have now reported results that support the safety of the device in children with refractory seizures. (2) For example, 60 pediatric patients were treated as part of the double-blind clinical trials conducted to support the FDA application. (3) 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, (4) and none resulted in termination of stimulation. Hornig and colleagues reported on a case series of 19 pediatric patients, with observation periods ranging up to 30 months. (5) Overall, 50% of patients had a 50% reduction in seizure frequency. Patwardhan and colleagues reported that among 38 patients aged 11 months to 16 years, 29% had a greater than 90% reduction in seizure frequency, while 39% had 50% to 90% reduction. (6) The major limitations of VNS are the following issues: that stimulation generally does not completely eliminate seizures, and it is not possible to predict which patients will optimally respond. Therefore, some authors suggest that VNS may be most appropriately used in patients with refractory seizures who are not candidates for surgery (i.e., bilateral or unresectable foci or no identified structural abnormality).

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.” (7) The authors suggest that these results may be particularly important since resective epilepsy surgery is generally not feasible in these patients. More recent reports are consistent with their 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 3 years’ follow-up. (8) Generalized epilepsy was predictive of a better outcome than partial epilepsy seizures. The authors concluded that VNS was a useful palliative procedure in severe generalized epilepsies with atonic or tonic-clonic seizures resulting in frequent falls, and entails less risk than callosotomy. 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. (9) Tecoma and Iragui cite a multicenter retrospective analysis of 50 children with Lennox Gastaut syndrome (LGS) treated with VNS. (7) 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. (10) 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. Seizure reduction of 61% was also reported in a case series of 12 patients with drug-resistant idiopathic generalized epilepsy. (11) Based on these data, one can conclude that VNS is an effective treatment for refractory seizures other than partial epilepsy.

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. (12) However, studies examining VNS for the treatment of depression are limited, and all published and unpublished data concerning clinical outcomes of VNS therapy for the indication of treatment-resistant depression come from company-sponsored clinical studies.

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. (13, 14) 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. (15, 16) Analyses from these study groups were presented for U.S. Food and Drug Administration (FDA) review and consisted of a case series of 60 patients receiving VNS (Study D-01), a short-term (i.e., 3-month) randomized sham-controlled clinical trial of 221 patients (Study D-02), and an observational study comparing 205 patients on VNS therapy to 124 patients receiving ongoing treatment for depression (Study D-04). (17) Patients who responded to sham treatment in the short-term randomized, controlled trial (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 side 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. (18-20) 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 to a sham control (implanted but inactivated VNS) showed a non-statistically significant result for the principal outcome. (16, 17) 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. (15, 17) 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. (17) Given these concerns about the quality of the observational data, these results did not provide strong evidence for the effectiveness of VNS therapy.

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. (17)

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.

Data from the case series and clinical trials have been reanalyzed in subsequent publications to show what proportions of patients who respond at one time are still responders at a subsequent time point. Among those who achieved a response at 3 or 12 months, 60–75% of such patients were judged to remain a responder after 1 year. However, this information by itself does not provide evidence of the efficacy of VNS beyond that provided by the original comparative trials. Overall, the available scientific evidence does not demonstrate efficacy of VNS for treatment-resistant depression.

A systematic review of the literature for VNS of treatment-resistant depression identified the randomized trial described above among the 18 studies that met the study’s inclusion criteria. (21) VNS was found to be associated with a reduction in depressive symptoms in the open studies. For example, a preliminary report from an ongoing European multicenter open-label efficacy and safety study of VNS for treatment-resistant depression described 1 responder (of 11) at 3 months, 2 responders at 6 months, and 6 responders (55%) at 1 year; 3 patients (27%) were considered to be in remission. (22) However, results from the only double-blind trial were considered to be inconclusive. (16, 17) Daban et al. concluded that further clinical trials are needed to confirm efficacy of VNS in treatment-resistant depression. Ongoing studies of VNS in depression documented at online site ClinicalTrials.gov include a registry for patients with treatment-resistant depression.

A review by Fitzgerald and Daskalakis states that “given the invasive nature of vagal nerve stimulation and potential side effects, further research is urgently required.” (23) A guideline statement from the Canadian Network for Mood and Anxiety Treatments included a review of the literature on VNS for depression in 2009 and concluded that there is a lack of substantial evidence for short-term and long-term efficacy in acute severe depression and that the appropriate place of VNS remains to be determined. (24)

Other case review reports identified 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. (25) A small study of 9 patients with rapid-cycling bipolar disorder showed improvements in several depression rating scales over 40 weeks of observation. (26) Another case series by Cristancho et al. that followed patients for one year showed that 4/15 responded and 1/15 remitted according to the principal response criteria. (27)

Given the limitations of prior literature as described in the 2006 TEC Assessment, 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 and colleagues studied VNS in 9 patients with essential tremor. (28) 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. (29) 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. (30) 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. (31) 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

A case series Phase II trial of VNS therapy for chronic heart failure was found. (32) In this study, De Ferrari et al. showed improvements in New York Heart Association (NYHA) class quality of life, 6-minute walk test, and left ventricular ejection fraction. These case series findings require confirmation in controlled clinical trials. A randomized study of VNS for heart failure is currently recruiting patients, according to clinicaltrials.gov.

Treatment of Fibromyalgia

Lange et al. conducted a Phase I/II trial of VNS of 14 patients with fibromyalgia. (33) 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.

Vagus nerve blocking

A randomized, prospective, double-blind trial to induce weight loss in morbidly obese subjects, the EMPOWER Study, included 15 centers. Two hundred ninety-four subjects were implanted with the vagal blocking system. Therapy was reported to have consisted of a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Results included: Twelve month percent excess weight loss (EWL) was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and control groups with ≥12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. The authors conclusions reported VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group (35).

The double blind, randomized ReCharge Clinical Trial (NCT01327976) is currently underway. This is a Phase 3 study, to determine the safety and efficacy of the Maestro RC2 system in producing weight loss in obese subjects. The Maestro RC2 system, will be implanted intra abdominally. The treatment group will receive a functional device that will deliver a charge (VBLOC therapy) during the study phase. The control group will receive a functional, non-active device. This trial has an estimated study completion date of December 2016 (36). 

Summary

For patients with refractory seizures, RCT evidence supports a reduction in seizure frequency following vagus nerve stimulation. A BCBSA TEC Assessment concluded that the evidence is sufficient to permit conclusions on the efficacy of this technique for treatment of refractory seizures. Therefore, vagus nerve stimulation may be considered medically necessary for patients with refractory seizures.

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

For other conditions, including headaches, obesity, essential tremor, heart failure, and fibromyalgia, the evidence is limited and not sufficient to permit conclusions on efficacy. Vagus nerve stimulation is considered experimental, investigational and unproven for these indications.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

02.93, 86.94-86.98, 278.00-278.02, 333.1, 345.00-345.91, 346.00-346.93, 784.0

ICD-10 Codes

E66.09-E66.9, G25.0 - G25.2, G40.001- G40.919, G43.001- G43.919, R51, 00HE0MZ, 00HE3MZ, 00HE4MZ, 00PE0MZ, 00PE3MZ, 00PE4MZ, 0JH60M6, 0JH60M7, 0JH60M8, 0JH60M9, 0JH63M6, 0JH63M7, 0JH63M8, 0JH63M9, 0JH80M6, 0JH80M7, 0JH80M8, 0JH80M9, 0JH83M6, 0JH83M7, 0JH83M8, 0JH83M9, 0JPT0MZ, 0JPT3MZ

Procedural Codes: 61885, 64553, 64568, 64569, 64570, 95974, 95975, 0312T, 0313T, 0314T, 0315T, 0316T, 0317T, L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689
References
  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Chronic vagus nerve stimulation for treatment of seizures. TEC Assessments 1998; Volume 13 Tab 9.
  2. Amar AP, Levy ML, McComb JG et al. Vagus nerve stimulation for control of intractable seizures in childhood. Pediatr Neurosurg 2001; 34(4):218-23.
  3. Murphy JV. Left vagal nerve stimulation in children with medically refractory epilepsy. The Pediatric VNS Study Group. J Pediatr 1999; 134(5):563-6.
  4. Morris GL, 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology 1999; 53(8):1731-5.
  5. Hornig G, Murphy JV, Schallert G et al. Left vagus nerve stimulation in children with refractory epilepsy: an update. South Med J 1997; 90(5):484-8.
  6. Patwardhan RV, Stong B, Bebin EM et al. Efficacy of vagal nerve stimulation in children with medically refractory epilepsy. Neurosurgery 2000; 47(6):1353-8.
  7. Tecoma ES, Iragui VJ. Vagus nerve stimulation use and effect in epilepsy: what have we learned? Epilepsy Behav 2006; 8(1):127-36.
  8. Montavont A, Demarquay G, Ryvlin P et al. Long-term efficiency of vagus nerve stimulation (VNS) in non-surgical refractory epilepsies in adolescents and adults article in French. Rev Neurol (Paris) 2007; 163(12):1169-77.
  9. You SJ, Kang HC, Kim HD et al. Vagus nerve stimulation in intractable childhood epilepsy: a Korean multicenter experience. J Korean Med Sci 2007; 22(3):442-5.
  10. You SJ, Kang HC, Ko TS et al. Comparison of corpus callosotomy and vagus nerve stimulation in children with Lennox-Gastaut syndrome. Brain Dev 2008; 30(3):195-9.
  11. Kostov H, Larsson PG, Roste GK. Is vagus nerve stimulation a treatment option for patients with drug-resistant idiopathic generalized epilepsy? Acta Neurol Scand Suppl 2007; 187:55-8.
  12. Elger H, Hoppe C, Falkai P et al. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res 2000; 42(3-Feb):203-10.
  13. Blue Cross and Blue Shield Assocation Technology Evaluation Center (TEC). Vagus nerve stimulation for treatment-resistant depression. TEC Assessments 2006; Volume 21, Tab 7.
  14. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Vagus nerve stimulation for treatment-resistant depression. TEC Assessments 2005; Volume 21, Tab 7.
  15. 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):364-73.
  16. 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):347-54.
  17. 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 . Last accessed January, 2011.
  18. Marangell LB, Rush AJ, George MS et al. Vagus nerve stimulation (VNS) for major depressive episodes: one-year outcomes. Biol Psychiatry 2002; 51(4):280-7.
  19. Rush AJ, George MS, Sackheim HA et al. Vagus nerve stimulation (VNS) for treatment-resistant depression: a multicenter study. Biol Psychiatry 2000; 47(4):276-86.
  20. 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):713-28.
  21. 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 2008; 110(1-2):1-15.
  22. Corcoran CD, Thomas P, Phillips J et al. Vagus nerve stimulation in chronic treatment-resistant depression: preliminary findings of an open-label study. Br J Psychiatry 2006; 189:282-3.
  23. Fitzgerald PB, Daskalakis ZJ. The use of repetitive transcranial magnetic stimulation and vagal nerve stimulation in the treatment of depression. Curr Opin Psychiatry 2008; 21(1):25-9.
  24. Kennedy SH, Milev R, Giacobbe PCNfM et al. Neurostimulation therapies. J Affect Disord 2009; 117(suppl 1):S44-53.
  25. 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):273-81.
  26. 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):183-9.
  27. 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):1376-82.
  28. Handforth A, Ondo WG, Tatter S et al. Vagus nerve stimulation for essential tremor: a pilot efficacy and safety trial. Neurology 2003; 61(10):1401-5.
  29. Mauskop A. Vagus nerve stimulation relieves chronic refractory migraine and cluster headaches. Cephalalgia 2005; 25(2):82-6.
  30. 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):S101-4.
  31. Bodenlos JS, Kose S, Borckardt JJ et al. Vagus nerve stimulation acutely alters food craving in adults with depression. Appetite 2007; 48(2):145-53.
  32. De FGM, 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):847-55. Available online at http //eurheartj.oxfordjournals.org. Last accessed January 11.
  33. 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):1406-13.
  34. EnteroMedics-About VBLOC® Therapy and VBLOC Maestro® Rechargeable System. Available at www.enteromedics.com (accessed-2013  August 26).       
  35. Sarr, MG., Billigton,CJ., Brancatisano, R., et al. The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight loss in Morbid Obesity. Obes Surg. 2012 Nov; 22(11):1771-1782.
  36. ClinicalTrials.gov. ReCharge Clinical Trial (NCT01327976). Available at clinicaltrials.gov (accessed - 2013 August 26).
  37. Vagus Nerve Stimulation. Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2013 March) Surgery 7.01.20.
History
June 1, 2011 Updated Policy, Description from not medically necessary to investigational, and References  
October 2012 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.  Removed CPT 64573.
October 2013 Policy formatting and language revised.  Policy statement unchanged.  Added codes 0312T, 0313T, 0314T, 0315T, 0316T, and 0317T.  Removed codes 61886 and L8684.
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Vagus Nerve Stimulation (VNS)