This document addresses the indications for use of an implantable vagus nerve stimulation (VNS) device, the electronic analysis of the implanted neurostimulator pulse generator system, and non-implantable (transcutaneous) VNS devices for the treatment of medically and surgically refractory seizures associated with intractable epilepsy and as a treatment of other conditions. Implantable devices may deliver stimulation in an open-loop fashion with continuous but intermittent (‘ON’ and ‘OFF’ cycles) stimulation of the vagus nerve (a hand-held magnet allows on-demand stimulation to interrupt seizure activity), or may utilize detection of extra-cerebral indicators, for example, cardiac-based seizure detection (also known as “responsive devices”, “devices with an automatic stimulation mode”, or “closed loop devices” that specifically use tachycardia as a surrogate marker for seizure prediction).

Note: The use of vagal nerve blocking for the treatment of morbid obesity is addressed in the following document:

• CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity

Note: Please see the following related documents for other treatments of epilepsy:

• CG-MED-05 Ketogenic Diet for Treatment of Intractable Seizures
• CG-SURG-91 Minimally Invasive Ablative Procedures for Epilepsy
• MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications
• SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation

Position Statement

Medically Necessary:

1. Implantation of a vagus nerve stimulation device is considered medically necessary in an individual with medically and surgically refractory seizures as evidenced by:
   1. Failure of more than one trial of single or combination antiepileptic medications, as evidenced by persistent seizures or intolerable side effects of drug therapy; and
   2. Individual has failed or is not a candidate for resective epilepsy surgery.
2. Electronic analysis of an implanted neurostimulator pulse generator system for vagus nerve stimulation is considered medically necessary when the implantation occurred because the above criteria were met.
3. Replacement or revision of an implanted neurostimulator pulse generator system (with or without lead changes) for vagus nerve stimulation is considered medically necessary when:
   1. The implantation occurred because the above criteria were met; and
   2. The current implanted device is no longer functioning appropriately.

Investigational and Not Medically Necessary:

1. Implantation of a vagus nerve stimulation device is considered investigational and not medically necessary when criteria are not met and for all other conditions, including, but not limited to:
   1. Alzheimer’s disease; or
   2. Anxiety and mood disorders; or
   3. Asthma; or
   4. Autism; or
   5. Bipolar disorders; or
   6. Bulimia; or
   7. Cerebral palsy; or
   8. Crohn’s disease; or
   9. Depression; or
   10. Essential tremors; or
   11. Headaches (including cluster and migraine headaches); or
   12. Heart failure; or
   13. Obesity, including obesity-related food cravings; or
   14. Pain syndromes (including fibromyalgia); or
   15. Sleep disorders; or
   16. Stroke rehabilitation
2. Electronic analysis of an implanted neurostimulator pulse generator system for vagus nerve stimulation is considered investigational and not medically necessary when the medically necessary criteria for device implantation are not met.
3. Replacement or revision of an implanted neurostimulator pulse generator system for vagus nerve stimulation (with or without lead changes) is considered investigational and not medically necessary when the medically necessary criteria for device implantation are not met or the current implanted device is functioning appropriately.
4. Non-implantable vagus nerve stimulation devices are considered investigational and not medically necessary for all conditions.