Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation

POLICY NUMBER

A.8.01.58

DESCRIPTION

Cranial electrotherapy stimulation, 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. Devices, including the P-Stim and E-pulse, provide ambulatory auricular electrical stimulation over a period of several days. Cranial electrotherapy stimulation is being evaluated for a variety of conditions, including pain, insomnia, depression, anxiety, and functional constipation. Auricular electrical stimulation is being evaluated for pain, weight loss, and opioid withdrawal.

Interest in cranial electrotherapy stimulation (CES) began in the early 1900s on the theory that weak pulses of electrical current have 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 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 been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In 1992, the Alpha-Stim CES device (Electromedical Products International) received marketing clearance for the treatment of anxiety, insomnia, and depression. Devices cleared since 2000 are summarized in the table below.

Cranial Electrotherapy Stimulation Devices Cleared by the U.S. Food and Drug Administration

Several devices for electroacupuncture designed to stimulate auricular acupuncture points have been cleared for marketing by the FDA through the 510(k) process. Devices cleared since 2000 are summarized in the table below.

Auricular Electrostimulation Devices Cleared by the U.S. Food and Drug Administration

ª "FDA cleared the NSS-2 Bridge Device for Substance Use Disorders through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence"N/A: Not applicable

Related medical policies are –

• Transcutaneous Electrical Nerve Stimulation (TENS)

• Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)

POLICY

Cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational in all situations.

Electrical stimulation of auricular acupuncture points is considered investigational in all situations.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative 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.

POLICY HISTORY

11/17/2011: 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 A.8.01.58 added.

02/28/2017: Policy reviewed; no changes.

05/24/2018: Medical policy links updated in policy description.

07/20/2018: Policy description updated regarding devices. Policy statements updated to state that cranial electrotherapy stimulation and electrical stimulation of auricular acupuncture points are considered investigational in all situations.

03/26/2019: Policy description updated regarding devices. Policy statements unchanged.

03/13/2020: Policy description updated regarding devices. Policy statements unchanged.

05/21/2021: Policy description updated regarding devices. Policy statements unchanged.

04/22/2022: Policy description updated regarding devices. Policy statements unchanged.

09/30/2022: Code Reference section updated to add HCPCS codes A4596 and K1002.

12/20/2022: Code Reference section updated to add new CPT code 0783T, effective 01/01/2023.

03/23/2023: Policy description updated regarding devices. Policy statements unchanged.

12/21/2023: Code Reference section updated to add new 2024 HCPCS code E0732, effective 01/01/2024.

03/21/2024: Policy description updated regarding devices. Policy statements unchanged.

10/01/2024: Code Reference section updated to add new HCPCS codes A4543 and E0721.

04/15/2025: Policy description updated regarding devices. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code K1002.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.58 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

Investigational Codes

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