Humana Vagus Nerve Stimulation - Medicare Advantage Form

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Vagus Nerve Stimulation

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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.

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

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.

Devices classified as nonimplantable vagus nerve stimulation or transcutaneous noninvasive vagus nerve stimulation (nVNS)

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.

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.

This stimulation for acute pain and preventive treatment for cluster migraine headaches purportedly releases inhibitory neurotransmitters and reduces the overexpression of an excitatory neurotransmitter (glutamate). This device (e.g., GammaCore, Gammacore Sapphire) has been approved by the FDA.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above CMS guidance for Vagus Nerve Stimulation.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

• Vagus Nerve Stimulation

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage