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

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

Electrical nerve stimulation for pain control may be considered medically necessary when the following criteria have been met:

• For acute pain including post-operative pain the first 30 days from the day of surgery; or
• For chronic pain, an individual is unresponsive to at least three (3) months of conservative therapy (i.e., non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); and
  • The individual is responsive to a trial of electrical stimulation for chronic pain control for at least two (2) weeks performed under medical supervision (i.e., physical therapy). For example, a demonstration of a reduction in pain that is clinically significant as defined by accepted documented outcome measures (i.e., pain scale); and
  • The trial period is monitored and documented by a licensed professional that is qualified to provide treatment (i.e., physical therapist).

The use of PENS and TENS not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature. 

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; or
• For four (4) lead device, eight (8) electrodes per month.

Phrenic Nerve Stimulator

The implantation of a United States Food and Drug Administration (U.S. FDA) approved phrenic nerve stimulator may be considered medically necessary:

• The phrenic nerve is viable and intact; and
• Diaphragmatic function is sufficient to accommodate chronic stimulation; and
• For treatment of chronic ventilator or respiratory insufficiency requiring mechanical ventilation due to ONE (1) of the following conditions:
  • 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
  • Central sleep apnea (i.e., the Remede System) and central sleep related hypoventilation/hypoxemic syndromes.

Vagus Nerve Stimulator

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 (aged four (4) years and older) with partial onset seizures who have not undergone a bilateral or left cervical vagotomy.

 A U.S. FDA approved vagus nerve stimulator for the management of epilepsy with partial onset seizures may be considered medically necessary for individuals when seizures cannot be controlled by any other method such as:

• Drug-resistant epilepsy (“failure to control seizures with two (2) or more appropriately chosen drugs in adequate doses”); or
• When surgery cannot be performed.

Vagus (vagal) nerve stimulation not meeting the criteria as indicated in this policy is considered not medically necessary.

In order to maintain coverage for gammaCore, the following efficacy must be documented:

• Reduction of pain from moderate or severe to mild or pain free within 60 minutes, without the use of rescue medicine,  for at least 50% of attacks.

U.S. FDA approved non-implantable vagus nerve stimulation devices (i.e., gammaCore) may be considered medically necessary for the preventive treatment of migraine headache or for the acute treatment of pain associated with migraine headache under ALL of the following circumstances:

• The individual is aged between twelve 12 to 17 years of age; and
• The individual has a diagnosis of migraine; and
• The individual has failed or has contraindication or has intolerance to at least two (2) 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. 

In order to maintain coverage for gammaCore, the following efficacy must be documented:

• Reduction of pain from moderate or severe to mild or pain free within 60 minutes, without the use of rescue medicine, for at least 50% of attacks.

Non-implantable stimulation devices not meeting the criteria as indicated in this policy are considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature. 

Percutaneous Nerve Field Stimulator

The use of a Percutaneous nerve field stimulator in opioid withdrawal treatment is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Percutaneous Neuromodulation Therapy

The use of percutaneous neuromodulation therapy is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Percutaneous or Open Implantation of Neuromuscular Neurostimulator

The percutaneous or open (via incision) implantation of neuromuscular neurostimulator electrodes for chronic pain relief is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. 

Occipital Nerve Stimulation (ONS)

ONS is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Percutaneous Electrical Nerve Field Stimulator

The use of a Percutaneous Electrical Nerve Field Stimulator (PENFS) device is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

External Trigeminal Nerve Stimulation System

An external trigeminal nerve stimulation (eTNS) system is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

External Upper Limb Tremor Stimulator

An external upper limb tremor stimulator is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Transcutaneous Electrical Modulation Pain Reprocessing Therapy

Transcutaneous electrical modulation pain reprocessing therapy (TEMPR) (i.e., scrambler therapy) is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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