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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 stimulation of acupuncture points on the ear. Devices, including the P-Stim™ and E-pulse, have been developed to provide ambulatory auricular electrical stimulation over a period of several days. CES and auricular electrostimulation are being evaluated for a variety of conditions, including pain, insomnia, depression, anxiety, and weight loss.
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 various 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 several days to several weeks.
Other devices 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 three 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) 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 is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
07/13/2015: Code Reference section updated for ICD-10.
11/05/2015: Policy description updated regarding devices. Policy statements unchanged. Investigative definition updated in policy guidelines section.
04/18/2016: Policy reviewed; no changes.
05/26/2016: Policy number added.
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.