Electrical nerve stimulation is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.

Unilateral or bilateral deep brain stimulation (DBS) of the thalamic ventralis intermedius nucleus (VIM) may be considered medically necessary for the treatment of intractable tremors due to essential tremor or Parkinson's disease (PD), when ALL of the following criteria are met:

• Diagnosis of essential tremor or idiopathic Parkinson's disease (with the presence of at least two cardinal PD features - tremor, rigidity, bradykinesia) that is not responding satisfactorily to drug therapy; and
• Marked disabling tremor of at least three (3) or four (4) on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale (or equivalent scale), causing significant limitation in activities of daily living; and
• No diagnosed dementia, severe depression, cerebral atrophy, or Hoehn and Yahr stage V Parkinson's disease; and
• No focal lesion of the basal ganglia (e.g., a space occupying lesion or lacunae) at the target site that would negate the result of thalamic stimulation; and 
• Sufficient residual motor function in the upper extremity so that it is reasonable to expect an improvement following the surgery; and
• Willingness and ability of the individual to cooperate during a conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

Unilateral or bilateral deep brain stimulation of the subthalamic nucleus (STN) or globus pallidus interna (GPi) for the treatment of Parkinson's disease may be considered medically necessary when ALL of the following criteria are met:

• Diagnosis of advanced idiopathic Parkinson's disease as determined by the Hoehn and Yahr stage or a minimal score of 30 points on the Unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale when off medication for 12 hours; and
• Parkinson's disease (with the presence of at least two (2) cardinal PD features - tremor, rigidity, bradykinesia) that is not responding satisfactorily to drug therapy; and
• Presence of disabling Parkinson's disease symptoms or medication side effects (e.g., dyskinesia’s, motor fluctuations, or disabling "off" periods), despite optimal medical therapy; and
• No diagnosed dementia, severe depression, cerebral atrophy, or Hoehn and Yahr stage V Parkinson's disease; and
• Parkinson's disease is Levodopa responsive with clearly defined "on" periods; and
• Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

Deep brain stimulation may be considered medically necessary when it is used as a treatment for chronic intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven (7) years of age or above.

Intensive electronic analysis and programming of a deep brain stimulator may be necessary immediately following implantation to achieve optimal stimulus parameters. Recognizing these needs, six (6) such programming visits will be covered within 60 days of the surgical implantation of the deep brain stimulator, and once every 30 days thereafter, as necessary.

Deep brain stimulation is considered experimental/investigational and therefore non-covered when used in ANY ONE of the following situations:

• For other movement disorders, including but not limited to multiple sclerosis, post-traumatic dyskinesia, and tardive dyskinesia; or
• For treatment of tremor from other causes such as trauma, degenerative disorders, metabolic disorders, or infectious diseases; or
• For other indications, including cluster headaches, refractory depression, obsessive/compulsive disorder, and Tourette's syndrome.

Scientific evidence does not support the use of deep brain stimulation for any of the above indications.

Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS) may be considered medically necessary when used for the treatment of chronic intractable pain and as a means of assessing the need for continued treatment with an implanted electrical nerve stimulator.

• Chronic intractable pain is defined as chronic pain that has no significant chance of being altered by usual treatment modalities or natural healing.  Examples of chronic intractable are as follows:
  • An episode of low back pain that has persisted for three months or longer; and
  • Is not a manifestation of a clearly defined and generally recognizable primary disease entity. For example, there are cancers that, through metastatic spread to the spine or pelvis, may elicit pain in the lower back as a symptom; and certain systemic diseases such as 0rheumatoid arthritis and multiple sclerosis manifest many debilitating symptoms

The use of PENS and TENS for conditions other than chronic intractable pain is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indications.

Transcutaneous electrical nerve stimulation (TENS) may be considered medically necessary when the chronic intractable pain causes significant disruption of function when ALL of the following have been met:

• The individual is unresponsive to at least three (3) months of conservative medical therapy (e.g. non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); and
• The individual is responsive to a trial of TENS for at least two (2) weeks performed under medical supervision (e.g. physical therapy). For example, a demonstration of a reduction in pain that is clinically significant as defined by accepted documented outcome measures (e.g. pain scale); and
• The trial period is monitored and documented by a licensed professional that is qualified to provide treatment (e.g. physical therapist). 

Supplies for electrical stimulation device may be considered medically necessary when annual documentation is noted in the individual's medical record.

Normal utilization with a covered electrical stimulation device is:

• For two (2) lead device, four (4)  electrodes per month
• For four (4) lead device, eight (8) electrodes per month 

Phrenic nerve stimulator implantation may be considered medically necessary:

• For treatment of chronic ventilator or respiratory insufficiency requiring mechanical ventilation due to either:
  • lesions/injury of the spinal cord at or above the C-3 vertebral level; or
  • central alveolar hypoventilation, either primary or secondary to a brain stem disorder; or
• The phrenic nerve is viable and intact; and
• Diaphragmatic function is sufficient to accommodate chronic stimulation.

The use of phrenic nerve stimulation for ANY other indications is considered experimental/investigational and therefore  non-covered. Scientific evidence does not support the use of phrenic nerve stimulation other than the above indications as stated above.

The implantation of a vagus (vagal) nerve stimulator for seizure control may be considered medically necessary only when used as a last resort for individuals with epilepsy with partial onset seizures. Medical necessity is limited to those cases where the seizures cannot be controlled by any other method, i.e., surgery or medication.

The use of Vagus (vagal) nerve stimulation is considered experimental/investigational as a treatment of other conditions, including but not limited to heart failure, fibromyalgia, depression, essential tremor, obesity, headaches, tinnitus, and traumatic brain injury and therefore non-covered.  Scientific evidence has not demonstrated the long-term clinical efficacy of VNS and its impact on treatment-resistant depression. 

Nonimplantable vagus nerve stimulation devices (e.g.,gammaCore) may be considered medically necessary for the abortive treatment of episodic migraine or episodic cluster headache under ALL of the following circumstances;

·         The individual has a diagnosis of episodic migraine or episodic cluster headache; and

·         The individual has failed or has contraindication or has intolerance to at least two medications from each of the following categories: NSAIDS, Triptans, and Ergotamines; and    

·         The individual must be re-evaluated in 30 days. In order to obtain renewal of the device, there must be documentation of significant efficacy in the medical record. 

Nonimplantable stimulation devices are considered Experimenatl/Investigational for all other indications and circumstances except those outlined above and therefore non-covered. 

Implantable Hypoglossal Nerve Stimulators

Refer to Medical Policy Z-8 Diagnosis and Treatment of Obstructive Sleep Apnea for additional information.

The percutaneous or open (via incision) implantation of neuromuscular neurostimulator electrodes for chronic pain relief is considered experimental/investigational, and therefore non-covered. The clinical value of intramuscular stimulation for pain relief has not been validated by randomized controlled studies.

Occipital nerve stimulation (ONS) is considered experimental/investigational for ALL indications, and therefore, non-covered. Scientific evidence does not support its use for any indications.

Replacement batteries are not eligible for payment and therefore non-covered.

Use of electrical nerve stimulators and related services other than those specifically addressed within this policy, e.g., percutaneous neuromodulation therapy (PNT), or for conditions other than those addressed within this policy (e.g., multiple sclerosis, muscular dystrophy, or other motor function disorders), is considered experimental/investigational and therefore non-covered.  Scientific evidence does not support the use of electrical stimulators or related services for any other indications.