Cranial Electrotherapy Stimulation and Auricular Electrostimulation Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2023 POLICY LAST REVIEWED: 03|19|2025 OVERVIEW Cranial 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. Devices, including the P-Stim and e-pulse, provide ambulatory auricular electrical stimulation over a period of several days. CES 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. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION
Not applicable POLICY STATEMENT Medicare Advantage Plans Cranial electrotherapy stimulation (also known as cranial electrostimulation therapy) is not covered as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Electrical stimulation of auricular acupuncture points is not covered as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Commercial Products Cranial electrotherapy stimulation (also known as cranial electrostimulation therapy) is not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Electrical stimulation of auricular acupuncture points is not medically necessary as the evidence is insufficient to determine. that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage.
BACKGROUND Cranial 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. Devices, including the P-Stim and E-pulse, 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, weight loss and opioid withdrawal. Interest in 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 Medical Coverage Policy | Cranial Electrotherapy Stimulation and Auricular Electrostimulation

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

Europe and the United States 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 United States 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 preprogrammed to be on for 180 minutes, then off for 180 minutes. The maximum battery life of this single-use device is 96 hours. Regulatory Status 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. Several devices for electroacupuncture designed to stimulate auricular acupuncture points have been cleared for marketing through the 510(k) process.

Cranial Electrotherapy Stimulation
For individuals who have acute or chronic pain who receive CES, the evidence includes a number of small sham-controlled randomized trials and pooled analyses. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Systematic reviews of randomized trials evaluated CES for headache and chronic pain. Pooled analyses found marginal benefits for a headache with CES and no benefits for chronic pain with CES. A subsequent sham-controlled trial of remotely supervised CES via secure videoconferencing found a significant benefit with CES for pain reduction, but it had important relevance and conduct and design limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have psychiatric, behavioral, or neurologic conditions (eg, depression and anxiety, Parkinson disease, addiction) who receive CES, the evidence includes a number of small sham-controlled randomized trials and a systematic review. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Four randomized controlled trials (RCTs) evaluated CES for depression and anxiety. One RCT found a significant benefit with CES for anxiety or depression, but both had important relevance limitations. Comparisons between these trials cannot be made due to the heterogeneity in study populations and treatment protocols. Studies evaluating CES for Parkinson disease, smoking cessation and tic disorders do not support the use of CES for these conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have functional constipation who receive CES, the evidence includes RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The single RCT reported positive results for the treatment of constipation with CES. However, the trial was unblinded, and most outcomes were self-reported. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Auricular Electrostimulation
For individuals who have acute or chronic pain (eg, acute pain from surgical procedures, chronic back pain, chronic pain from osteoarthritis or rheumatoid arthritis) who receive auricular electrostimulation, the evidence includes a limited number of trials. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Studies evaluating the effect of electrostimulation technology on acute pain are inconsistent, and the small amount of evidence on chronic pain has methodologic limitations. For example, a comparison of auricular electrostimulation with manual acupuncture for chronic low back pain did not include a sham control group, and, in a study of rheumatoid arthritis, auricular electrostimulation

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

was compared with autogenic training and resulted in a small improvement in visual analog scale pain scores of unclear clinical significance. Overall, the few published studies have small sample sizes and methodologic limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have obesity who receive auricular electrostimulation, the evidence includes small RCTs. and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The RCTs reported inconsistent results and used different treatment protocols. The systematic reviews are limited by high heterogeneity with respect to the interventions used, participants included, treatment period, and outcome measures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have opioid withdrawal symptoms who receive auricular electrostimulation, the evidence includes 2 observational studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Both studies report positive outcomes for the use of CES to treat opioid withdrawal symptoms. The studies used different treatment protocols and no comparators, limiting conclusions drawn from the results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following CPT and HCPCS codes are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 0783T Transcutaneous auricular neurostimulation, set-up, calibration, and patient education on use of equipment A4543 Supplies for transcutaneous electrical nerve stimulator, for nerves in the auricular region, per month (New Code Effective 10/1/2024) A4596 Cranial electrotherapy stimulation (ces) system supplies and accessories, per month E0721 Transcutaneous electrical nerve stimulator for nerves in the auricular region (New Code Effective 10/1/2024) E0732 Cranial electrotherapy stimulation (ces) system, any type S8930 Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with patient

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PUBLISHED Provider Update, May 2025 Provider Update, May 2024 Provider Update, April 2023 Provider Update, June 2022 Provider Update, April 2021

REFERENCES

1. U.S. Food & Drug Administration. FDA News Release: FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal. https://www.fda.gov/news- events/press-announcements/fda-grants-marketing-authorization-first-device-use-helping-reduce- symptoms-opioid-withdrawal. November 15, 2017. Accessed January 9, 2025.
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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

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15. Mischoulon D, De Jong MF, Vitolo OV, et al. Efficacy and safety of a form of cranial electrical stimulation (CES) as an add-on intervention for treatment-resistant major depressive disorder: A three week double blind pilot study. J Psychiatr Res. Nov 2015; 70: 98-105. PMID 26424428
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21. Gong BY, Ma HM, Zang XY, et al. Efficacy of Cranial Electrotherapy Stimulation Combined with Biofeedback Therapy in Patients with Functional Constipation. J Neurogastroenterol Motil. Jul 30 2016; 22(3): 497-508. PMID 26932836
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500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

24. Ilfeld BM, Abramson WB, Alexander B, et al. Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study. Reg Anesth Pain Med. Sep 02 2024; 49(9): 628-634. PMID 38388014
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28. Bernateck M, Becker M, Schwake C, et al. Adjuvant auricular electroacupuncture and autogenic training in rheumatoid arthritis: a randomized controlled trial. Auricular acupuncture and autogenic training in rheumatoid arthritis. Forsch Komplementmed. Aug 2008; 15(4): 187-93. PMID 18787327
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34. Miranda A, Taca A. Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. Am J Drug Alcohol Abuse. 2018; 44(1):56-63. PMID 28301217

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS