![]() 42 CFR §405.930- Failure to Respond to Additional Documentation Requestĥ. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of BenefitsĤ. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary PayerĢ. Medical documentation will be reviewed to determine if the vagus nerve stimulator meets Medicare coverage criteria and/or is reasonable and necessary.ġ. VNS for treatment of resistant depression is non-covered when furnished outside of a CMS-approved CED study. VNS is reasonable and necessary for treatment-resistant depression through Coverage with Evidence Development (CED). VNS is not reasonable and necessary for all other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed. All maneuvers performed with the magnet can be done by the patient, family members, friends or caregivers.Vagus Nerve Stimulation (VNS) is reasonable and necessary for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. The patient does this by swiping over the pulse generator site to deliver extra stimulation regardless of the treatment schedule. For example, if the patient feels a seizure is about to occur, they can turn stimulation on or a loved can assist. The settings will be primarily set by neurologists, but the will also be provided a handheld magnet to control the stimulator at home. The device runs continuously and is programmed to turn on and shut off for specific periods of time - for example, 30 seconds on and five minutes off. The amount of stimulation varies by case, but is usually initiated at a low level and slowly increased to a suitable level for the individual. The strength and duration of the electrical impulses are programmed. The treating neurologist programs the stimulator in his or her office with a small hand-held computer, programming software and a programming wand. The stimulator is most commonly activated two to four weeks after implantation, although in some cases it may be activated in the operating room. When the battery is low, the chest device is replaced with a less invasive procedure which requires only opening the chest wall incision. The device in the chest looks like a heart pacemaker. While this device is meant to be permanent, it can be removed if needed. This is where the thin, flexible wires that connect the pulse generator to the vagus nerve are inserted (lead). A second incision is made horizontally on the left side of the lower neck, along a crease of skin. ![]() The first one is most commonly made on the upper left side of the chest where the battery is implanted (pulse generator). The procedure requires two small incisions. The device may malfunction, similar to any other electrical device. Other surgical risks of VNS include inflammation or pain at the incision site and damage to nearby nerves. As with all surgeries, there is a small risk of infection. It is usually performed on an outpatient basis. This procedure, performed by a neurosurgeon, usually takes about 1-1.5 hours, most commonly under general anesthesia. VNS decreases seizure frequency by at least half in 40-50% of patients, but rarely eliminates all seizures. Patients cannot generally feel these pulses. When the device is on, electrical pulses are sent through the vagus nerve to the brain. There is no physical involvement of the brain in this surgery, instead the device battery (pulse generator) is implanted in the chest and wires are placed in the neck and positioned around the left vagus nerve. The device is surgically implanted under the patient’s skin. Vagus nerve stimulation (VNS) is a device, similar to a pacemaker, which sends regular, mild pulses of electrical energy to the brain via the vagus nerve to alleviate seizures. It is also associated with both motor and sensory functions of the sinuses and esophagus. Specifically, it is involved in motor functions in the voice box, diaphragm, stomach, heart and sensory functions in the ears and tongue. It is responsible for regulating the functions of internal organs. The nerve begins at the brainstem and passes through the neck, traveling to the chest and abdomen. The vagus nerve is one of the cranial nerves that originates in the brain and is part of the autonomic nervous system, which controls involuntary body functions.
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