DESCRIPTION
Cranial electrotherapy stimulation (CES), also referred to as cranial electrical stimulation, transcranial electrical stimulation, or electrical stimulation therapy, is a noninvasive procedure being evaluated as a treatment for a variety of conditions, including pain, insomnia, depression, anxiety, mood disorders and weight loss. Low levels of direct electrical current are applied via electrodes clipped to the ear lobes, mastoid processes, or scalp (e.g., Elexoma™ Medic, CES Ultra™, Alpha-Stim®).
The mechanism of action is thought to be the modulation of activity in brain networks by direct action in the hypothalamus, limbic system, and/or the reticular activating system. This device can be used in the home setting. Treatments may last several hours and can be administered once or twice daily for a period of several days to several weeks.
POLICY
Cranial electrotherapy stimulation is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Randomized controlled trials have not consistently demonstrated an improvement in health outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.
SOURCES
Barclay, T. & Barclay, R. (2014). A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. Journal of Affective Disorders, 164, 171-177. Abstract retrieved October 20, 2017 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (3:2024). Cranial electrotherapy stimulation and auricular electrostimulation (8.01.58). Retrieved September 6, 2024 from www.bcbsaoca.com/eps. (26 articles and/or guidelines reviewed)
Brunyé, T. T., Patterson, J. E., Wooten, T., & Hussey, E. K. (2021). A critical review of cranial electrotherapy stimulation for neuromodulation in clinical and non-clinical samples. Frontiers in Human Neuroscience, 15, 625321. [Epub ahead of print] doi.org/10.3389/fnhum.2021. (Level 1 evidence)
Gong, B., Ma, H., Zang, X., Wang, S., Zhang, Y., Jiang, N., et al. (2016). Efficacy of cranial electrotherapy stimulation combined with biofeedback therapy in patients with functional constipation. Journal of Neurogastroenterology and Motility, 22 (3), 497-508. (Level 2 evidence)
Lee, M., Kim, L., Yoon, I-Y., & Hong, J,K. Effects of cranial electrotherapy stimulation on improving depressive symptoms in people with stress: A randomized, double-blind controlled study. Journal of Effective Disorders, 1 (340), 835-842. Abstract retrieved September 6, 2024 from PubMed database.
National Institute for Health and Clinical Excellence. (2015, August). Transcranial direct current stimulation (tDCS) for depression. Retrieved June 10, 2022 from www.nice.org.uk/guidance.
Price, L., Briley, J., Haltiwanger, S., & Hitching, R. (2021). A meta-analysis of cranial electrotherapy stimulation in the treatment of depression. Journal of Psychiatric Research, 135, 119-134. (Level 1 evidence)
Shekelle, P.G., Cook, I.A., Miake-Lye, I.M., Booth, M.S., Beroes, J.M., & Mak, S. (2019). Benefits and harms of cranial electrical stimulation for chronic painful conditions, depression, anxiety, and insomnia: A systematic review. Annals of Internal Medicine, 168 (6), 414-421. Abstract retrieved July 7, 2020 from PubMed database.
U.S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database, K062284. Retrieved October 20, 2017 from https://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2024, March). Transcranial direct current stimulation for major depressive disorder. Retrieved September 6, 2024 from www.hayesinc.com/subscribers.
ORIGINAL EFFECTIVE DATE: 8/13/2005
MOST RECENT REVIEW DATE: 10/10/2024
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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