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 28, 2013

Revision Date(s) 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 and headaches.

Related Policies

2.01.526

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

7.01.63

Deep Brain 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 requires not only the surgical implantation of the device, but also subsequent neurostimulator programming, which occurs intraoperative and typically during additional outpatient visits. There are CPT codes that specifically describe the neurostimulator programming and analysis of cranial nerve stimulation (i.e., vagus nerve) as follows:

95974 Electronic analysis of implanted neurostimulator pulse generator system; 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; complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with our without nerve interface testing, each additional 30 minutes.

Description

Stimulation of the vagus nerve can be performed by means of an implantable stimulator within the carotid artery sheath. This technique has been proposed as a treatment for refractory seizures, depression, and other disorders.

Background

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, 25-50% 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.

While the mechanisms for the antiepileptic 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 vagus nerve stimulation device called the NeuroCybernetic Prosthesis (NCP®) system through the Premarket Approval (PMA) process. The device was approved for use in conjunction with drugs or surgery “as an adjunctive treatment of adults and adolescents over 12 years of age with medically refractory partial onset seizures.”

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 of refractory depression. On July 15, 2005, Cyberonics received PMA approval 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.

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.

Benefit Application

N/A

Rationale

This policy was created in 2000 and updated periodically with literature review. The most recent update covered the period from January 2012 through January 2013.

Treatment of 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 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 a 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 over the age of 12 years.

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 facts 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 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 of whom 11 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-Gestaut 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 the TEC Assessment included study groups assembled by the manufacturer of the device, (Cyberonics) and reported on in various publications. (15, 16) 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) randomized sham-controlled clinical trial of 221 patients (Study D-02), and an observational study comparing 205 patients on VNS therapy compared 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 (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 prior to 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), which 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 IDS-SR was considered a secondary outcome, and showed a difference in outcome that was statistically significant in favor of VNS (17.4% versus 7.5%, p=0.04).

The observational study comparing patients participating in the RCT and a separately recruited control group (D-04 vs. D-02) 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 one 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 one responder (out of 11) at 3 months, two responders at 6 months, and 6 responders (55%) at one 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 include an industry-sponsored dose-comparison study of VNS and 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 nine 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 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, 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, NCT00461019, 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.

Summary

For patients with refractory seizures, RCT evidence supports a reduction in seizure frequency following vagus nerve stimulation. A 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, and vagus nerve stimulation is considered investigational 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 investigational for these indications.

Medicare Policy

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 which 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.

Information on the national coverage analysis leading to this determination can be found by clicking here http://www.cms.hhs.gov/mcd/viewnca.asp?where= index&nca_id= 195.

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, Apuzzo MLJ. Vagus nerve stimulation for control of intractable seizures in childhood. Pediatr Neurosurg 2001;34(4):218-23.
  3. Murphy JV. Left vagus nerve stimulation in children with medically refractory epilepsy. J Pediatr 1999;134(5):563-67.
  4. Morris GL, 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):1731-35.
  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):484-88.
  6. Patwardhan RV, Stong B, Bebin EM, et al. Efficacy of vagus 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, Noppe C, Falkai P, et al. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res 2000;42 (2-3):203-10.
  13. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Vagus Nerve Stimulation for Treatment-Resistant Depression. TEC Assessments 2005; Volume 20, Tab 8.
  14. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Vagus Nerve Stimulation for Treatment-Resistant Depression. TEC Assessments 2006; Volume 21, Tab 7.
  15. George MS, Rush AJ, Marangell LB, et al. A 1-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression. Biol Psychiatry 2005;58:364-73.
  16. Rush AJ, Marangell LD, Sackeim HA, et al. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry 2005;58:347-54.
  17. U.S. Food and Drug Administration Center for Devices. Summary of Safety and Effectiveness Data for the Vagus Nerve Stimulation (VNS) Therapy System. Last accessed April 11, 2013.
  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).
  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 P et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults: IV. Neurostimulation therapies. J Affect Disord 2009; 117:S44-S53.
  25. Bajbouj M, Merkl A, Schlaepfer TE et al. Two-year pilot study of vaugs 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 Nov 25; 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. Bofdenlos 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. DeFerrari 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):847-55. Last accessed April 16, 2013.
  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. Blue Cross and Blue Shield Association. Vagus Nerve Stimulation. Medical Policy Reference Manual, Policy 7.01.20, 2013.

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

02.93

Implantation or replacement of intracranial neurostimulator lead(s)

 

86.94

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

 

86.95

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

 

86.96

Insertion or replacement of other neurostimulator pulse generator

 

86.97

Insertion or replacement of single array rechargeable neurostimulator pulse generator

 

86.98

Insertion or replacement of dual array rechargeable neurostimulator pulse generator

ICD-9 Diagnosis

333.1

Essential and other specified forms of tremor (benign)

 

345.00

Generalized nonconvulsive epilepsy without mention of intractable epilepsy

 

345.01

Generalized nonconvulsive epilepsy with intractable epilepsy

 

345.1

Generalized convulsive epilepsy

 

345.10

Generalized convulsive epilepsy without mention of intractable epilepsy

 

345.11

Generalized convulsive epilepsy with intractable epilepsy

 

345.2

Petit mal status

 

345.3

Grand mal status

 

345.4

Localization-related (focal) (partial) epilepsy and epileptic syndromes with complex partial seizures

 

345.5

Localization-related (focal)(partial) epilepsy and epileptic syndromes with simple partial seizures

 

345.6

Infantile spasms

 

345.7

Epiliepsia partialis continua

 

345.8

Other forms of epilepsy and recurrent seizures

 

345.90

Unspecified epilepsy without mention of intractable epilepsy

 

345.91

Unspecified epilepsy with intractable epilepsy

 

346.0

Classical migraine without mention of intractable migraine

 

346.01

Classical migraine with intractable migraine, so stated

 

346.1

Common migraine

 

346.10

Common migraine without mention of intractable migraine

 

346.11

Common migraine with intractable migraine, so stated

 

346.2

Variants of migraine

 

346.20

Variants of migraine without mention of intractable migraine

 

346.21

Variants of migraine with intractable migraine, so stated

 

346.8

Other forms of migraine

 

346.80

Other forms of migraine without mention of intractable migraine

 

346.81

Other forms of migraine with intractable migraine, so stated

 

346.9

Migraine, unspecified

 

346.90

Unspecified migraine without mention of intractable migraine

 

346.91

Unspecified migraine with intractable migraine, so stated

 

346.92

Migraine, unspecified, without mention of intractable migraine with status migrainosus

 

346.93

Migraine, unspecified, with intractable migraine, so stated, with status migrainosus

 

784.0

Headache

ICD-10-CM
(effective 10/1/14)

G40.001-
G40-919

Epilepsy and recurrent seizures; code range

ICD-10-PCS
(effective 10/1/14)

00HE0MZ, 00HE3MZ, 00HE4MZ

Surgical, central nervous system, insertion, cranial nerve, neurostimulator lead, code by approach (open, percutaneous, percutaneous endoscopic)

 

00PE0MZ, 00PE3MZ, 00PE4MZ

Surgical, central nervous system, removal, cranial nerve, neurostimulator lead, code by approach

 

0JH60M6, 0JH60M7,
0JH60M8, 0JH60M9,
0JH80M6, 0JH63M6,
0JH63M7, 0JH63M8,
0JH63M9, 0JH80M7,
0JH80M8, 0JH80M9,
0JH83M6, 0JH83M7,
0JH83M8, 0JH83M9

Surgical, subcutaneous tissue and fascia, insertion, stimulator generator, code by body part (chest or abdomen), approach, number of arrays and whether rechargeable or not

 

0JPT0MZ, 0JPT3MZ

Surgical, subcutaneous tissue and fascia, removal, subcutaneous tissue and fascia, trunk, stimulator generator, code by 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.


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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