Description

Vagus nerve stimulation (VNS) was initially developed as a treatment option for medically refractory epilepsy or the inability to control seizure activity with antiepileptic drug therapy. However, VNS has also been proposed as adjunct therapy for bipolar disorder, treatment resistant major depression and upper extremity stroke rehabilitation. VNS is being researched for a broad range of indications including Alzheimer’s disease, anxiety disorders, bulimia, chronic headache/migraine, cluster headache, heart failure and obesity. (Refer to Coverage Limitations section)

A VNS therapy system consists of an implantable pulse generator, a lead and an external programming system used to change stimulation settings. The pacemaker- like pulse generator is implanted just below the collarbone under the skin of the left upper chest and is connected by a stimulating lead to the left vagus nerve in the neck where intermittent impulses are delivered.

The vagus nerve in turn sends signals to the brain which stimulate the area believed to be involved in mood regulation and seizure activity; however, the exact mechanism of action is unknown. The pulse generator can be programmed to deliver stimulation within parameters that suit the individual’s needs. The lead electrode stimulation is performed only on the left vagal nerve, as the right vagal nerve helps control the heartbeat. A handheld magnet may be used to activate or deactivate the device.

The Vivistim Paired Vagus Nerve Stimulation System

is a US Food & Drug Administration (FDA) approved implantable neurostimulator system intended for use in combination with rehabilitative exercise in ischemic stroke rehabilitation to improve upper extremity function. The Vivistim system consists of a pulse generator, lead set, programming software and a wireless transmitter. VNS is known to cause the release of acetylcholine and norepinephrine, neurotransmitters that facilitate reorganization of cortical networks. Reportedly, when VNS is paired with rehabilitative exercises, it can help an individual’s brain relearn how to perform specific tasks.7,10 (Refer to Coverage Limitations section)

Devices classified as nonimplantable vagus nerve stimulation

or transcutaneous noninvasive vagus nerve stimulation (nVNS) are designed to prevent and treat cluster/ migraine headaches and treat medically refractory epilepsy and depression. There are two methods by which the nVNS technology can function. The first method consists of a hand-held battery-powered stimulation unit and ear electrode combination that purportedly stimulates the auricular branch of the vagus nerve through the skin over the concha of the outer ear to deliver treatment. Stimulation treatment for medically refractory epilepsy and depression occurs several hours daily and is administered by the individual. Currently, these devices are not approved by the FDA. (Refer to Coverage Limitations section)

The second method consists of a battery-powered portable stimulator comparable in size to a mobile phone, signal generating electronics and a digital controller. Two stainless steel round discs with conductive gel combine to function as skin contact surfaces to facilitate transmission of a mild electrical signal to the cervical branch of the vagus nerve.

Vagus Nerve Stimulation Effective Date: 08/24/2023

Revision Date: 08/24/2023
Review Date: 08/24/2023
Policy Number: HUM-0420-023
Page: 3 of 11

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

This stimulation for acute pain and preventive treatment for clusterVagus Nerve Stimulation purportedly releases inhibitory neurotransmitters and reduces the overexpression of an excitatory neurotransmitter (glutamate). This device (eg, GammaCore, Gammacore Sapphire) has been approved by the FDA.⁶ (Refer to Coverage Limitations section)

For information regarding obesity and vagus nerve blocking/stimulation, please refer to Bariatric Surgery Medical Coverage Policy.

Coverage Determination

Humana members may be eligible under the Plan for VNS when ALL of the following criteria are met:

• Medically refractory partial onset seizures with the following:
  • Confirmation of epilepsy diagnosis with electroencephalogram (EEG); AND
  • Failure of or intolerable side effects of 2 or more trials of single or combination antiepileptic drug therapy; AND
• No history of a bilateral or left cervical vagotomy; AND
• Surgery such as a lesionectomy or medial temporal lobectomy is not recommended or has failed

Electronic analysis of an implanted neurostimulator pulse generator system for vagus nerve stimulation may be considered medically necessary when the implantation occurred because the above criteria were met.

Replacement Humana members may be eligible under the Plan for the replacement/revision of a vagus nerve therapy system/handheld magnet if the system/magnet is no longer under warranty and cannot be repaired.

Lead and electrode replacement are not generally required at the time of generator replacement due to end of battery life.

Coverage Limitations

Humana members may NOT be eligible under the Plan for VNS for the treatment of seizures for any indications other than those listed above including, but may not be limited to:

• Alzheimer’s disease; OR
• Anxiety disorders; OR
• Autism spectrum disorders; OR
• Bipolar disorder; OR
• Bulimia nervosa; OR
• Chronic or cluster headache/migraine; OR
• Diabetes mellitus; OR
• Epilepsy associated with brain tumors; OR
• Generalized epilepsy syndromes; OR
• Heart failure; OR
• Multiple sclerosis; OR
• Refractory depression; OR
• Stroke (Vivistim system); OR
• Ventricular arrhythmia prevention

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the plan for nonimplantable or transcutaneous noninvasive vagus nerve stimulation (GammaCore, Gammacore Sapphire).

This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about Alzheimer’s disease, anxiety disorders, bipolar disorder, bulimia nervosa, chronic or cluster headache, depression, epilepsy, heart failure, migraine headache, obesity and stroke may be found from the following websites:

• American College of Physicians
• American Heart Association
• National Institute on Aging-Alzheimer's Disease Education and Referral Center
• National Institute of Mental Health
• National Institute of Neurological Disorders and Stroke
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.