Medical Policy: 02.01.58
Original Effective Date: December 2017
Reviewed: December 2019
Revised: December 2019
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Cranial electrical stimulation (CES) is a noninvasive method of delivering electrical stimulation, frequently in the home setting, via a small, battery-operated device that delivers low level electrical stimulation (i.e., microcurrent) to the brain through electrodes that attach to the ear lobes via clips. Treatment time generally ranges from 20-60 minutes daily, or as directed by the patient’s physician. Its proposed indications include, but may not be limited to, anxiety, depression, insomnia, fibromyalgia, Alzheimer’s Disease, and pain-related disorders.
Cranial electrical stimulation (also known as electrosleep, electrotherapeutic sleep, cerebral electrotherapy, transcranial electrotherapy, transcerebral electrotherapy, craniofacial electrostimulation, and electric cerebral stimulation) is being studied for the treatment of insomnia, anxiety and depression. Low levels of electrical current are applied via electrodes clipped onto the ear lobes or attached behind the ears. CES is thought to have a direct effect on the brain's limbic system, hypothalamus, and/or reticular activation system. It has also been suggested that CES may activate the parasympathetic autonomic nervous system by stimulating the vagus nerve.
One device used in the Unites States is the Alpha-Stim® CES, which provides pulsed, low-intensity current via clip electrodes that attach to the earlobes. Other devices place the electrodes on the eyelids, frontal scalp, mastoid processes, or behind the ears. Treatments may be administered once or twice daily for a period of several days to several weeks.
Other devices have been developed that provide electrical stimulation to auricular acupuncture sites over several days. One device, the P-Stim™, is a single-use miniature electrical stimulator for auricular acupuncture points that is worn behind the ear with a self-adhesive electrode patch. A selection stylus that measures electrical resistance is used to identify 3 auricularacupuncture points. The P-Stim™ device connects to 3 inserted acupuncture needles with caps and wires. The device is preprogrammed to be on for 180 minutes, then off for 180 minutes. The maximum battery life of this single-use device is 96 hours.
The Fisher Wallace Stimulator® is a portable Cranial Electrotherapy Stimulation (CES) device that is cleared bythe FDA for the treatment of insomnia, anxiety, depression and chronic pain.
Sometimes called transcutaneous supraorbital nerve stimulation (t-SNS), neuromodulation or external trigeminal nerve stimulation (e-TNS), with the Cefaly® (DW Healthcare Partners, Toronto, Ontario) device stimulates the nervous system with electrical signals. This device is currently available over the counter. The Cefaly product line now includes 3 treatments: Cefaly Prevent, Cefaly Acute, and Cefaly Dual. All 3 devices are placed on the forehead through a magnetic connection to a self-adhesive electrode.
Navigated transcranial magnetic stimulation (nTMS) is a noninvasive imaging method for the evaluation of eloquent brain areas. Transcranial magnetic pulses are delivered to the patient as a navigation system calculates the strength, location, and direction of the stimulating magnetic field. The locations of these pulses are registered to a magnetic resonance imaging (MRI) image of the patient’s brain. Surface electromyography (EMG) electrodes are attached to various limb muscles of the patient. Moving the magnetic stimulation source to various parts of the brain causes the EMG electrodes to respond, indicating the part of the cortex involved in particular muscle movements. For evaluation of language areas, magnetic stimulation areas that disrupt specific speech tasks are thought to identify parts of the brain involved in speech function. nTMS can be considered a noninvasive alternative to direct cortical stimulation (DCS), in which electrodes are directly applied to the surface of the cortex during craniotomy.
A navigated TMS (nTMS) system received Naclearance from the FDA in 2009. The Nexstim eXimia Navigated Brain Stimulation System is marketed for use in pre-surgical planning of patients undergoing brain surgery. This system provides non-invasive functional mapping of the motor cortex using transcranial magnetic stimulation with standard MRI guidance. The studies to date on nTMS are limited by small sample size, limiting the validity of the study conclusions.
Auricular electrostimulation involves the stimulation of acupuncture points on the ear. Devices, have been developed to provide ambulatory electrical stimulation over a period of several days. Auricular electrostimulation is being evaluated for a variety of conditions, including pain, depression, opioid withdraw, and anxiety.
The FDA announced on November 15, 2017 the approval of a device called the Neuro-Stim System Bridge (NSS-2 Bridge) (Innovative Health Solutions, Inc.), which is meant to help reduce the symptoms of opioid withdrawal. The NSS-2 Bridge is a device system that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX, and X, as well as branches of the occipital nerves. The NSS-2 Bridge is a relatively simple device that attaches to the skin behind the ear, where it uses a chip to transmit controlled electrical pulses to stimulate four cranial nerves in the part of the brain that’s associated with processing pain information.
Another recently approved auricular stimulation device for opioid withdrawal is the Drug Relief Treatment® device. Drug Relief (DyAnsys) is cleared by the U.S. Food and Drug Administration for use during detoxification. The small, battery-operated wearable device is placed behind the ear and held in place with adhesives. Tiny needles are placed in the ear at nerve endings. During treatment, electrical pulses are sent through the needles into the nerve endings.
Several other auricular stimulating devices have received marketing clearance through the U.S. Food and Drug Administration’s (FDA) 510(k) process for use in treating acute or chronic pain by a qualified practitioner of acupuncture. The following are examples of FDA approved devices:
H-Wave devices are classified by the FDA as a powered muscle stimulator “intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.” H-Wave is used in both low frequency and high frequency settings. H-wave stimulation differs from other forms of stimulation in terms of its waveform. H-wave stimulation has been used for pain control, treatment of diabetic neuropathy, muscle sprains, temporomandibular joint dysfunctions or reflex sympathetic dystrophy. It has also been used to accelerate healing of wounds (e.g., diabetic ulcers).
A new portable, non-invasive Transcranial Magnetic Stimulation devices for treatment of migraine. SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. Prescribed by physicians but designed for patient use, it is a portable, TMS product that will allow migraine patients to administer treatment as needed—at home, in the office or on the go. The sTMS mini™ by eNeura® is indicated/FDA approved for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.
Cranial electrical stimulation (CES) (also known as cerebral electrotherapy, craniofacial electrostimulation, electric cerebral stimulation, electrosleep, electrotherapeutic sleep, transcerebral electrotherapy, transcranial electrotherapy, as well as the Fisher Wallace stimulator) is investigational for all uses, such as but not limited to:
At home neuro-stimulation therapy (i.e. Fisher Wallace Stimulator) also frequently referred to cranial electrical stimulation is considered investigational.
Review of available literature reveals a lack of controlled clinical trials that prove the value and effectiveness of the procedure. As such, CES devices used in the home and clinical setting are investigational.
Transcutaneous supraorbital nerve stimulation (t-SNS), neuromodulation or external trigeminal nerve stimulation (e-TNS), sometimes referred to external cranial stimulation with the Cefaly Prevent, Cefaly Acute, Cefaly Dual or any other device is considered investigational.
Navigated transcranial magnetic stimulation (nTMS) is considered investigational including but not limited to: preoperative treatment planning and diagnostic testing of motor function.
There is limited evidence at this time to permit conclusions regarding the impact of this diagnostic testing on net health outcomes. Additional well-designed clinical studies with larger patient populations are required.
Spring TMS/Single-Pulse TMS (s-TMS), including but not limited to the sTMS mini™ by eNeura® is considered investigational.
The use of auricular electrostimulation, including but not limited to the BRIDGE and the Drug Relief® Devices for opioid withdrawal, P-stim, E-Pulse, ANSiStim devices are considered investigational.
There is not enough research to show that auricular electrostimulation improves health outcomes for people with any indication, including but not limited to reducing the symptoms of opioid withdrawal, obesity, or acute and chronic pain. No clinical guidelines based on research recommend auricular electrostimulation. Therefore, auricular electrostimulation is considered investigational for all indications.
The use of H-Wave electrical stimulation devices, including but not limited to The H-Wave Muscle Stimulator is considered investigational.
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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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