| MP 7.01.20 | Vagus Nerve Stimulation | |
| Medical Policy | ||
| Section Surgery |
Original Policy Date 12/1/95 |
Last Review Status/Date Reviewed with literature search/11:2008 |
| Issue 11:2008 |
Return to Medical Policy Index |
Disclaimer
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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 subclassified into those with a generalized onset, beginning throughout the brain, and those with a partial onset, having a discrete focal onset. There are 3 principal subtypes of partial-onset seizures:
- Simple partial seizures: These do not involve alteration of consciousness but may have observable motor components or may solely be a subjective sensory or emotional phenomenon.
- Complex partial seizures: These are partial-onset seizures that involve an alteration of consciousness.
- Complex partial seizures, secondarily generalized tonic-clonic convulsions: These are partial-onset seizures that progress to involve both sides of the brain and result in a complete loss of consciousness.
In the past 10 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, 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 vagal nerve stimulation 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 2 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 and essential tremors.
Policy
Vagus nerve stimulation may be considered medically necessary as a treatment of medically refractory partial-onset seizures.
Vagus nerve stimulation is considered investigational as a treatment of other conditions including depression, essential tremor, obesity and headaches.
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 intraoperatively and typically during additional outpatient visits. Previously, neurostimulator programming was coded using CPT codes 63690-63691. In 1999, these codes were deleted, and 2 new time-based CPT codes were introduced 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 or without nerve interface testing, each additional 30 minutes.
Benefit Application
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. However, this policy considers specific applications of an FDA-approved device as investigational. Alternatively, FDA-approved devices may be assessed on the basis of their medical necessity.
Rationale
Vagus Nerve Stimulation as a Treatment of Seizures
This policy is based in part on a 1998 TEC Assessment (1) that offered the following conclusions.
1. Published evidence from 2 large, well-designed multicenter trials involving over 300 patients demonstrates that the use of vagus nerve stimulation 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.
2. Adverse effects are mild and consist primarily of hoarseness or voice change during “on” periods of stimulation.
3. There is limited information about the use of vagus nerve stimulation in patients with other types of seizure disorders.
Vagus Nerve Stimulation in Children for Treatment of Seizures
The original FDA approval limited the use of vagus nerve stimulation (VNS) to those 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).
Additional published studies were identified that support the safety and effectiveness of the device for adults and children with partial-onset seizures refractory to medical therapy. (7,8)
Vagus Nerve Stimulation as a 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. (9) 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. A June 2005 TEC Assessment on Vagus Nerve Stimulation for Treatment-Resistant Depression concluded that evidence was insufficient to permit conclusions of the effect of VNS therapy on health outcomes. (10) The available evidence for the TEC Assessment included study groups assembled by the manufacturer of the device, Cyberonics, and reported on in various publications. 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). (11) 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 in the TEC Assessment 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).
The case series data show 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. (11-14) 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. (11) 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 randomized clinical trial 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. (11) 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. 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.
Vagus Nerve Stimulation as a Treatment of Essential Tremor
Handforth and colleagues studied VNS in 9 patients with essential tremor. (15) 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.
Vagus Nerve Stimulation as a 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. (16) 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. However, this study is too small to draw conclusions on the effects of VNS for the treatment of headache, and further study is needed.
2006 Update
In 2006, the TEC Assessment for use of VNS for treatment-resistant depression was updated and information from the Executive Summary is included in the paragraphs below. (17) That assessment reviewed the available evidence to determine if VNS therapy is effective for treatment-resistant depression. Articles reviewed were case series, randomized trials, or observational studies evaluating clinical outcomes of VNS therapy. In the prior TEC Assessment (10), results were available only from documents posted to the FDA Web site. Subsequently, the same studies have been published in peer-reviewed journals, almost unchanged from the FDA documents. New publications analyze the same data in various ways examining duration of benefit.
The relevant clinical evidence evaluating VNS consists of a case series of 60 patients receiving VNS, a short-term (i.e., 3-month) randomized, sham-controlled clinical trial (RCT) of 222 patients, and an observational study comparing 205 of the RCT patients on VNS therapy to 124 patients receiving usual treatment for depression. Patients who responded to sham treatment in the short-term randomized, controlled trial (approximately 10%) were excluded from the long-term observational study.
Patient selection was a concern for all studies. 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.
The case series data show 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. Natural history, placebo effects, and patient and provider expectations make it difficult to infer efficacy from case series data.
The randomized study that compared VNS therapy to a sham control (implanted but inactivated VNS) did not show a statistically significant result for the principal outcome at 3 months. (18) Fifteen percent of VNS subjects responded, versus 10% of control subjects (p=0.25). There was a statistically significant result for a secondary outcome.
An observational study comparing patients participating in the randomized clinical trial and a separately recruited control group evaluated VNS therapy out to 1 year. (19) This observational study showed a statistically significant difference in the rate of change of depression score. However, issues such as unmeasured differences between patients and 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. Given these concerns about the quality of the observational data, these results are insufficient to support the effectiveness of VNS therapy.
Additional reanalysis of these same data to evaluate persistence of response show that among those who achieve a response at 3 or 12 months, 60%–75% of such patients are judged to remain a responder after 1 year. In the context of relatively low overall response rates, these data do not provide evidence of efficacy.
Between the 2005 TEC Assessment, there have been no studies reporting clinical outcomes on any new or different patients. Data from the case series and clinical trials have been reanalyzed to show what proportions of patients who respond at one time are still responders at a subsequent time point. However, this information by itself does not provide evidence of the efficacy of VNS beyond that provided by the original observational comparison of VNS versus treatment as usual. Overall, the available scientific evidence does not demonstrate efficacy of VNS for treatment-resistant depression.
2007-2008 Updates
Searches of the MEDLINE database were conducted for the periods of August 2006 through October 2007 and November 2007 through October 2008. 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, and these report seizure reduction rates similar or greater than those reported in partial epilepsy and that “this body of evidence suggests that VNS has broad antiepileptic efficacy.” (20) 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. (21) Generalized epilepsy was predictive of a better outcome than partial epilepsy seizures. The authors conclude that VNS is 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 that15 children (53.6%) showed a >50% reduction in seizure frequency and 9 (32%) had a >75% reduction, and there were no significant differences when groups were compared by seizure type or etiology. (22) Tecoma cites a multicenter retrospective analysis of 50 children with Lennox-Gestaut syndrome (LGS) treated with VNS. (20) Median seizure reduction at 6 months was 88% for tonic seizures and 81% for atypical absences. You et al compared VNS and total corpus callosotomy for LGS. (23) 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. (24) Based on these data one can conclude that VNS is an effective treatment for refractory seizures other than partial epilepsy. Therefore the policy statement has been revised to state that VNS may be considered medically necessary for patients whose seizures are refractory to medical treatment, or who have failed or are not candidates for resective epilepsy surgery.
A case series found that 8 of 9 children who had vagal nerve stimulators exhibited sleep-related breathing disorder with polysomnographic assessment. (25) In one child, severe obstructive sleep apnea (apnea-hypopnea index of 37) was observed when the stimulator was turned on, but resolved completely when the stimulator was turned off. Further study of this potential complication is warranted.
A systematic review of the literature for VNS of treatment-resistant depression identified one randomized trial (reference 18, reviewed above) out of 18 studies that met the study’s inclusion criteria. (26) 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, 2 responders at 6 months, and 6 responders (55%) at one year; 3 patients (27%) were considered to be in remission. (27) However, results from the only double-blind trial were considered to be inconclusive. (18) Daban 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. (28)
In a recent review, Fitzgerald and Daskalakis state that “given the invasive nature of vagal nerve stimulation and potential side effects, further research is urgently required”. (29) Given the limitations of prior literature as described in the 2006 TEC Assessment, combined with the lack of substantial new literature, the scientific evidence is considered to be insufficient to permit conclusions concerning the effect of this technology on major depression. Therefore; the policy statement relevant to depression remains unchanged.
Unintended weight loss has been observed in participants in studies of vagus nerve stimulation 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. (30) 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 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.
No new published studies of other applications of VNS were identified. A phase II pilot study of VNS for treatment of fibromyalgia is ongoing.
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 at: http://www.cms.hhs.gov/mcd/viewnca.asp?where= index&nca_id= 195
References:
- 1998 TEC Assessment: Tab 9..
- 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.
- Murphy JV. Left vagal nerve stimulation in children with medically refractory epilepsy. The Pediatric VNS Study Group. J Pediatr 1999; 134(5):563-6.
- 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):1731-5.
- 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.
- 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.
- Kirse DJ, Werle AH, Murphy JV et al. Vagus nerve stimulator implantation in children. Arch Otolaryngol Head Neck Surg 2002; 128(11):1263-8.
- Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology 2002; 59(6 suppl 4):S26-30
- Elger H, Hoppe C, Falkai P et al.Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res 2000; 42(2-3):203-10.
- TEC Assessment ; Tab 8.
- 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/cdrh/PDF/p970003s050b.pdf.
- 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.
- 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.
- 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.
- 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.
- Mauskop A. Vagus nerve stimulation relieves chronic refractory migraine and cluster headaches. Cephalalgia 2005; 25(2):82-6.
- 2006 TEC Assessment; Tab 7.
- 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.
- 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.
- Tecoma ES, Iragui VJ. Vagus nerve stimulation use and effect in epilepsy: what have we learned? Epilepsy Behav 2006; 8(1);127-36.
- 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.
- 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.
- 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.
- 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.
- Hsieh T, Chen M, McAfee A et al. Sleep-related breathing disorder in children with vagal nerve stimulators. Pediatr Neurol 2008; 38(2):99-103.
- 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):
- 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.
- http://www.clinicaltrials.gov/. Last viewed July 2008.
- 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.
- 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.
|
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 | |
| 64553 | Percutaneous implantation of neurostimulator electrodes; cranial nerve | |
| 64573 | Incision for implantation of neurostimulator electrodes; cranial nerve | |
| 95974, 95975 | Cranial nerve neurostimulator analysis and programming code range | |
| ICD-9 Procedure | 02.93 | Implantation of intracranial neurostimulator lead(s) |
| 86.94-86.98 | Insertion or replacement of neurostimulator pulse generator code range | |
| ICD-9 Diagnosis | 333.1 | Essential tremor (benign) |
| 345.00 – 345.91 | Epilepsy, code range | |
| 346.00 – 346.91 | Migraine, code range (beginning October 2008, the range will extend to 346.93) | |
| 784.0 | Headache | |
| HCPCS | L8680 | Implantable neurostimulator electrode, each |
| L8681, L8682, L8683, L8684, L8685, L8686, L8687, L8688, L8689 | Implantable neurostimulator pulse generator code range | |
| Type of Service | Surgery | |
| Place of Service | Inpatient | |
Index
NCP®
NeuroCybernetic Prosthesis (NCP)
Vagus Nerve Stimulation
Policy History
|
Date |
Action |
Reason |
|
12/01/95 |
Add to Surgery section |
New policy |
|
04/01/98 |
Replace policy |
Delete previous 7.01.20 (redundant policy with 8.01.14). Replace with new policy on Chronic Vagus Nerve Stimulation |
|
11/15/98 |
Coding update |
99 CPT coding release |
|
11/20/01 |
Replace policy |
Revised new indication for children, investigational as a treatment for depression |
|
04/29/03 |
Replace policy |
Literature review update for the period of October 2001 through December 2002; policy statement unchanged |
|
11/09/04 |
Replace policy |
Literature review update for the period of December 2002 through September 2004. FDA information and references added. Statement on investigational status of VNS treatment for essential tremor added |
|
06/27/05 |
Replace policy |
Policy updated with FDA approval of VNS for depression, a June 2005 TEC Assessment and literature review update through June 2005; reference numbers 10, 11, and 16 added. Added headaches to the investigational policy statement; otherwise policy statement unchanged. |
|
10/10/06 |
Replace policy |
Policy updated with June 2006 TEC Assessment (treatment-resistant depression) and literature review for other indications; policy statement unchanged. Reference numbers 17-19 added. HCPCS code updated. |
| 12/13/07 |
Replace policy |
Policy updated with literature review, references 20 – 22 added; policy statements unchanged. |
| 08/14/08 | Replace policy | Policy updated with literature review, references 21, 22 and 25 added; policy statements unchanged. |
| 11/13/08 | Replace policy | Policy updated with literature review, reference numbers 20 to 23, 25, 26, and 28 to 30 added. Prior references 20 and 21 renumbered to 24 and 27. Policy statements revised to indicate the VNS may be considered medically necessary in refractory seizures (not just in partial onset seizures) and is investigational in treatment of obesity. |
Find a Provider
Medicare
Prescription Drugs
Medicare Formulary