Vagus Nerve Stimulation for the Treatment of Medically Refractory Movement Disorders, Headaches and Obesity
DESCRIPTION
The vagus nerve stimulator (e.g., NeuroCybernetic Prosthesis®) is an implantable stimulator that is used as an adjunctive treatment for medically refractory seizures. The device is similar to a pacemaker. It is surgically implanted in a subcutaneous pocket inferior to the left clavicle. Lead wires are wrapped around the vagus nerve. These wires extend from the electrode and are tunneled under the skin and connected to a pulse generator. The generator periodically stimulates the vagus nerve with an electrical current.
Stimulation of the vagus nerve has been shown to decrease seizure frequency and severity. Although the full mechanism of the effect is not fully understood, the proposed mechanisms of action include: desynchronization of brain activity, inhibition of structures with high epileptogenicity, monoaminergic modulation of seizure threshold, and reduction of the metabolic activity of the solitary nucleus.
Vagus nerve stimulation has been investigated for use in other condition such as obesity, headaches and essential tremors (i.e., occurring without an identifiable cause when moving or trying to move).
POLICY
The implantable vagus nerve stimulator as a treatment for medically refractory seizures is considered medically necessary when the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Vagus nerve stimulation for the treatment of other conditions including but not limited to essential tremors, obesity, and headaches is considered investigational.
Any vagus nerve stimulator utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
See also: Vagus Nerve Stimulation for the Treatment of Depression
MEDICAL APPROPRIATENESS
The implantation of a vagus nerve stimulator is considered medically appropriate if ALL of the following criteria are met:
Uncontrolled medically refractory seizures are present as defined by ANY ONE of the following:
Seizures occurring in spite of appropriate therapeutic levels of antiepileptic medication
Seizures that cannot be treated with therapeutic levels of anticonvulsive drugs because of intolerable adverse effects of these drugs
Surgery is either not recommended or has failed
ABSENCE of ALL of the following:
Prior vagus nerve resection
Pregnancy
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Generalized epilepsy is a seizure that involves both sides of the brain, and causes tonic and clonic movements (primary or secondary generalized), or another type of primary generalized epilepsy (e.g., absence or atonic seizure).
SOURCES
Abubakr, A., & Wambacq, I. (2008). Long-term outcome of vagus Nerve stimulation therapy in patients with refractory epilepsy. Journal of Clinical Neuroscience, 15 (2), 127-129. (Level 4 Evidence - Independent study)
Baaj, A. A., Benbades, S. R., Tatum, W. O.,& Vale, F. L. (2008). Trends in the use of vagus nerve stimulation for epilepsy: Analysis of a nationwide database. Neurosurgical Focus, 25 (3), e10.
BlueCross BlueShield Association. Medical Policy Reference Manual (11:2009). Vagus nerve stimulation (7.01.20). Retrieved September 17, 2010 from BlueWeb. (29 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer Software]. (2010, April). Vagus nerve stimulation for treatment of seizures (NCD 160.18, p. 2-80). Ingenix.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, April). Implantable vagus nerve stimulator for epilepsy. Retrieved September 17, 2010 from ECRI Institute. (20 articles and/or guidelines reviewed)
Epilepsy Foundation. (2010). Vagus nerve stimulation therapy. Retrieved September 20, 2010 http://www.epilepsyfoundation.org/answerplace/medical/treatment/vns/.
Franzoni, E., Gentile, V., Colonnelli, M. C., Brunetto, D., Cecconi, I., Iero, L., et al. (2010). VNS in drug resistant epilepsy: Preliminary report on a small group of patients. Italian Journal of Pediatrics, 36, 30. (Level 4 Evidence - Independent study)
National Guideline Clearinghouse. (2007 January). Epilepsy in adults. Retrieved November 21, 2008 from http://www.guidelines.gov.
Saneto, R. P., Sotero de Menezes, M. A., Ojemann, J. G., Bournival, B. D., Murphy, P. J., Cook, W. B., et al. (2006). Vagus nerve stimulation for intractable seizures in children. Pediatric Neurology, 35 (5), 323-326.
Treiman, D. M. (2010). Management of refractory complex partial seizures: Current state of the art. Neuropsychiatric Disease and Treatment, 24 (6), 297-308.
U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. Pre-market approval for VNS therapy system - P970003 S111. Retrieved September 20, 2010 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=13958.
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, October). Vagus nerve stimulation for epilepsy. Retrieved September 17, 2010 from www.Hayesinc.com/subscribers (93 articles and/or guidelines reviewed)
You, S. J., Kang, H. C., Kim, H. D., Ko, T. S., Kim, D. S., Hwang, Y. S., et al. (2007). Vagus nerve stimulation in intractable childhood epilepsy: A Korean multicenter experience. Journal of Korean Medical Science, 22 (3), 442-445. (Level 3 Evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 9/1997
MOST RECENT REVIEW DATE: 10/14/2010
ID_BT
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