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 and weight loss. Low levels of direct electrical current are applied via electrodes clipped to the ear lobes, mastoid processes or scalp. 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.
Cranial electrotherapy stimulation is considered investigational.
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, the express terms of the health plan will govern.
Randomized controlled trials have not consistently demonstrated an improvement in health outcomes. The largest body of evidence is for depression and anxiety. For this indication, in two of three sham-controlled trials, no differences were reported in outcomes between groups. The evidence is insufficient to determine the effects of the technology on health outcomes.
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. Medical Policy Reference Manual. (2:2017). Cranial electrotherapy stimulation and auricular electrostimulation (8.01.58). Retrieved October 19, 2017 from BlueWeb. (18 articles and/or guidelines reviewed)
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)
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/cdrh_docs/pdf6/k062284.pdf.
ORIGINAL EFFECTIVE DATE: 8/13/2005
MOST RECENT REVIEW DATE: 11/9/2017
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.
This document has been classified as public information.