Medical Policy: 02.01.58
Original Effective Date: December 2017
Reviewed: December 2017
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® (Cefaly Technology sprl, Herstal, Belgium) device stimulates the nervous system with electrical signals. This device is currently available over the counter.
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.
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 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.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
December 2017 - New Policy
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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