Medicare Coverage for Vagus Nerve Stimulation (VNS)

Actual information

Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. VNS provides indirect modulation of brain activity through the stimulation of the vagus nerve. The vagus nerve, the tenth cranial nerve, has parasympathetic outflow that regulates the autonomic (involuntary) functions of heart rate and gastric acid secretion and also includes the primary functions of sensation from the pharynx, muscles of the vocal cords, and swallowing. It is a nerve that carries both sensory and motor information to/from the brain. Medicare coverage for many tests, items, and services depends on where you live. 

Nationally Covered Indications 

VNS treatment is reasonable and necessary for patients with medically refractory partial-onset seizures for whom surgery is not recommended or for whom surgery has failed. Effective for services performed on or after February 15, 2019, the Centers for Medicare & Medicaid Services (CMS) will cover FDA-approved vagus nerve stimulation (VNS) devices for treatment-resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS-approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings. 

Nationally Non-Covered Indications 

VNS is not reasonable and necessary for all other types of seizure disorders that are medically refractory and for whom surgery is not recommended or for whom surgery has failed. VNS is non-covered for treatment-resistant depression (TRD) when furnished outside of a CMS-approved Coverage with Evidence Development (CED) study. All other indications of VNS for the treatment of depression are nationally non-covered. 

Patient Criteria

The following criteria must be used to identify patients demonstrating treatment-resistant depression (TRD):

• The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. In order to confirm the patient has MDD, accepted diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental Disorder (DSM) and a structured clinical assessment are to be used. 
• The patient’s depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose. 
• The patient is experiencing a major depressive episode (MDE) as measured by a guideline-recommended depression scale assessment tool on two visits, within a 45-day span before implantation of the VNS device.
• Patients must maintain a stable medication regimen for at least four weeks before device implantation. 
• If patients with bipolar disorder are included, the condition must be carefully characterized.