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DESCRIPTIONCranial electrotherapy stimulation (CES), also known as cranial electrical stimulation, transcranial electrical stimulation, or electrical stimulation therapy, delivers weak pulses of electrical current to the earlobes, mastoid processes, or scalp with devices such as the Alpha-Stim®. Auricular electrostimulation involves the stimulation of acupuncture points on the ear.
Interest in cranial electrotherapy stimulation (CES) began in the early 1900s with the theory that weak pulses of electrical current would lead to a calming effect on the central nervous system. The technique was further developed in the U.S.S.R. and Eastern Europe in the 1950s as a treatment for anxiety and depression, and use of CES later spread to Western Europe and the U.S. as a treatment for a variety of psychological and physiological conditions. Presently, 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. One device used in the U.S. 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 auricular acupuncture points. The P-Stim™ device connects to 3 inserted acupuncture needles with caps and wires. The device is pre-programmed to be on for 180 minutes, then off for 180 minutes. The maximum battery life of this single-use device is 96 hours.
A number of devices for CES have received marketing clearance through the U.S. Food and Drug Administration’s (FDA) 510(k) process. The Alpha-Stim® CES device (Electromedical Products International) received marketing clearance in 1992 for the treatment of anxiety, insomnia, and depression.
The P-Stim™ (NeuroScience Therapy Corp) received marketing clearance through the U.S. Food and Drug Administration’s (FDA) 510(k) process in 2006. The P-Stim™ is intended for use as an electro-acupuncture device to stimulate appropriate auricular acupuncture points. The E-pulse received 510(k) marketing clearance in 2009, listing the P-Stim™ as a predicate device. The E-pulse is a microprocessor-controlled battery-powered unit designed to administer auricular point nerve stimulation treatment for pain therapy over a 96-hour period.
POLICYCranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational.
Electrical stimulation of auricular acupuncture points is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/17/2011: Approved by Medical Policy Advisory Committee.
01/09/2013: Policy description and policy statement revised to include cranial electrotherapy stimulation. Added the following investigational policy statement: Cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational. Policy title changed from "Auricular Electrostimulation" to "Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation" to reflect the scope of the policy.
04/29/2013: Added S8930 to the Code Reference section.
11/15/2013: Policy reviewed; no changes.
09/29/2014: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.58
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.