Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

The vast majority of patients who have epilepsy can be controlled by conventional drug therapy. However some patients in spite of adequate dosage of anti-epilepsy drugs continue to have seizures. Vagus nerve stimulation (VNS) has been shown to shorten the duration and reduce the severity of seizures in certain patients who remain refractory despite optimal drug therapy or surgical intervention or in those with debilitating side effects of anti-epileptic medications.

Vagus Nerve Stimulation is not covered for other uses.

Vagus Nerve Stimulation requires pre certification.

Vagus nerve electrical stimulators (the NeuroCybernetic Prosthesis System) are considered medically necessary in members with partial onset seizures who remain refractory (G40.011-G40.019, G40.111-G40.119, and G40.211-G40.219) to:

1. Optimal anti-epileptic medications or;
2. Surgical intervention, or
3. Who have debilitating side effects from anti-epileptic medications.

Hayes B for patients > 12

Codes Used In This BI:

61885     Insertion/replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; w/connection to a single electrode array

64553     Percutaneous implantation of neurostimulator electrode array; cranial nerve

64568     Incision for implantation of cranial nerve neurostimulator electrode array and pulse generator

Vagus nerve stimulators are considered experimental and investigational for the treatment of all other indications, including autism, obesity, refractory depression and cognitive impairment associated with Alzheimer`s disease, and obsessive-compulsive disorder because its effectiveness for these indications has not been established.

The NCP System, approved by the FDA on July 16,1997, is a pacer-like device implanted under the skin in the upper left chest area. It is connected by wire to a lead that is wrapped around the left vagus nerve in the neck. Through the vagus nerve, it delivers intermittent electrical pulses 24 hours a day to the brain. When a patient senses the impending onset of a seizure, he/she can activate the device through a hand-held magnet to deliver an additional dose of stimulation. Treatment with the vagus nerve stimulator is not free of side effects. Patients have experienced cough, hoarseness, alterations in their voice, and shortness of breath.

Current evidence on the safety and efficacy of vagus nerve stimulation for refractory epilepsy in children appears adequate to support the use of this procedure.

1. Vagus nerve stimulation for depression, Arkansas BlueCross BlueShield Coverage Policy Manual at: http://www.arkbluecross.com/members/ex_report.asp?ID=2004049
2. Vagus nerve stimulation for the treatment of seizures, Arkansas BlueCross BlueShield Coverage Policy Manual at: http://www.arkbluecross.com/members/ex_report.asp?ID=1998145
3. Vagus nerve stimulation for epilepsy, Medical Technology Directory; Hayes, Jan. 25, 2003
4. Food and Drug Administration at: http://www.fda.gov/bbs/topics/NEWS/NEW00576.html
5. Koutroumanidis M, Binnie CD, Hennessy MJ, et al. VNS in patients with previous unsuccessful resective epilepsy surgery: Antiepileptic and psychotropic effects. Acta Neurol Scand. 2003;107(2):117-121.
6. Cohen-Gadol AA, Britton JW, Wetjen NM, et al. Neurostimulation therapy for epilepsy: Current modalities and future directions. Mayo Clin Proc. 2003;78(2):238-248.
7. Corabian P, Leggett P. Vagus nerve stimulation for refractory epilepsy. Health Technology Report. HTA 24: Series A. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); March 2001. Available at: http://www.ahfmr.ab.ca/hta/hta-publications/reports/vagus_nerve.pdf
8. Topfer L A, Hailey D. Vagus nerve stimulation (VNS) for treatment-resistant depression. Issues in Emerging Health Technologies. Issue 25. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); October 2001. Available at: https://www.ccohta.ca/entry_e.html
9. Zamponi N, Rychlicki F, Cardinali C, et al. Intermittent vagal nerve stimulation in paediatric patients: 1-year follow-up. Childs Nerv Syst. 2002;18(1-2):61-66.
10. Murphy JV, Torkelson R, Dowler I, et al. Vagal nerve stimulation in refractory epilepsy: The first 100 patients receiving vagal nerve stimulation at a pediatric epilepsy center. Arch Pediatr Adolesc Med. 2003;157(6):560-564.
11. Smyth MD, Tubbs RS, Bebin EM, et al. Complications of chronic vagus nerve stimulation for epilepsy in children. J Neurosurg. 2003;99(3):500-503.
12. National Institute for Clinical Excellence (NICE). Vagus nerve stimulation for refractory epilepsy in children. Interventional Procedure Guidance 50. London, UK: NICE; March 2004. Available at: http://www.nice.org.uk/page.aspx?o=56885
13. Elger G, Hoppe C, Falkai P, et al. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000;42(2-3):203-210.
14. Institute for Clinical Systems Improvement (ICSI). Major depression in adults for mental health care. Bloomington, MN: ICSI; May 2004.
15. Institute for Clinical Systems Improvement (ICSI). Major depression in adults in primary care. Bloomington, MN: ICSI; May 2004.
16. Scottish Intercollegiate Guidelines Network (SIGN). Diagnosis and management of epilepsy in adults. A national clinical guideline. SIGN Publication No. 70. Edinburgh, Scotland: SIGN; April 2003.