Latest Review Date: February 2024

Category: Durable Medical Equipment (DME) 

POLICY:

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

Electrical stimulation of auricular acupuncture points is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 process, 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, have been developed to 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.

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 the brain networks by direct action in the hypothalamus, limbic system and/or the reticular activation 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 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 three 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.

KEY POINTS:

This evidence review was created with searches of the PubMed database. The most recent literature update was performed through January 3, 2024.

SUMMARY OF EVIDENCE:

Cranial Electrotherapy Stimulation

For individuals who have acute or chronic pain, who receive cranial electrotherapy stimulation, the evidence includes a number of randomized, small sham-controlled trials, along with several systematic reviews 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 headache with CES and no benefits for chronic pain with CES. 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 (e.g., 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. Only 1 RCT found a significant benefit with CES for depression, but it had important relevance gaps. 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 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 an 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 (e.g., 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 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 1 systematic review. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The RCTs reported inconsistent results and used different treatment protocols. 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 case series. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Both case series 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.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

No guidelines or statements were identified.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS:

Not applicable.

KEY WORDS:

Cranial electrotherapy stimulation (CES), cranial electrical stimulation, transcranial electrical stimulation, electrical stimulation therapy, Alpha-Stim®, Auricular electrostimulation, Stim™, E-pulse™, NSS-2 Bridge, Bridge Neurostimulation system, P-Stim, AcuStim, Stivax system, Ansistem-Pp, Cervella,AXUS ES-5, Drug Relief V1, Sparrow Therapy, Modius Sleep

APPROVED BY GOVERNING BODIES:

A number of devices for cranial electrotherapy stimulation (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. Those devices cleared since 2000 are summarized in Table 1.

Table 1: 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 through the 510(k) process. Those cleared since 2000 are summarized in Table 2.

Table 2: Auricular Devices Cleared by the U.S. Food and Drug Administration

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

There are no specific codes.

CPT:

HCPCS:

PREVOUS CODING:

REFERENCES:

1. Ahn H, Galle K, Mathis KB, et al. Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study. J Clin Neurosci. Jul 2020; 77: 128-133.
2. Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. Aug 2014; 164:171-177.
3. 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 2008;15(4):187-93. 
4. Bronfort G, Nilsson N, Haas M et al.  Non-invasive physical treatments for chronic/recurrent headache.  Cochrane Database Syst Rev 2004; (3):CD001878. 
5. Bystritsky A, Kerwin L and Feusner J.  A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder.  J Clin Psychiatry, March 2008; 69(3):412-417. (Abstract)
6. Ching PY, Hsu TW, Chen GW, et al. Efficacy and Tolerability of Cranial Electrotherapy Stimulation in the Treatment of Anxiety: A Systemic Review and Meta-Analysis. Front Psychiatry. 2022; 13: 899040.
7. 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.
8. Holzer A, Leitgeb U, Spacek A et al. Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trial. Minerva Anestesiol 2011;77(3):289-304.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. Kavirajan HC, Lueck K, Chuang K. Alternating current cranial electrotherapy stimulation (CES) for depression. Cochrane Database Syst Rev. Jul 8 2014; 7:CD010521.
11. Kim SY, Shin IS, Park YJ. Effect of acupuncture and intervention types on weight loss: a systematic review and meta-analysis. Obes Rev. Nov 2018;19(11):1585-1596.
12. Kim J, Kim H, Kim DH, et al. Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial. J Affect Disord. Dec 01 2021; 295: 856-864.
13. Lyon D, Kelly D, Walter J, et al. Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus. 2015; 4:369.
14. 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.
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.
16. Morriss R, Patel S, Boutry C, et al. Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial. Lancet Psychiatry. Mar2023; 10(3): 172-183.
17. O’Connell NE, Wand BM, Marston L et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev 2010; (9):CD008208.
18. O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014; 4:CD008208.
19. Price L, Briley J, Haltiwanger S, et al. A meta-analysis of cranial electrotherapy stimulation in the treatment of depression. JPsychiatr Res. Mar 2021; 135: 119-134.
20. Roh HT, So WY. Cranial electrotherapy stimulation affects mood state but not levels of peripheral neurotrophic factors or hypothalamic- pituitary-adrenal axis regulation. Technol Health Care. Nov 18 2016.
21. Schukro RP, Heiserer C, Michalek-Sauberer A, et al. The effects of auricular electroacupuncture on obesity in female patients--a prospective randomized placebo-controlled pilot study. Complement Ther Med. Feb 2014; 22(1):21-25.
22. Shekelle PG, Cook IA, Miake-Lye IM et al. Benefits and Harms of Cranial Electrical Stimulation for Chronic Painful Conditions, Depression, Anxiety, and Insomnia: A Systematic Review.. Ann. Intern. Med., 2018 Feb 13;168(6).
23. Shill HA, Obradov S, Katsnelson Y et al. A randomized, double-blind trial of transcranial electrostimulation in early Parkinson’s disease. Mov Disord 2011; 26(8):1477-80.
24. Tan G, Rintala DH, Jensen MP et al. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury:  a multi-site randomized controlled trial with a secondary 6-month open-label phase. J Spinal Cord Med 2011; 26(8):1477-80.
25. Tan G, Rintala DH, Thornby JI, et al. Using cranial electrotherapy stimulation to treat pain associated with spinal cord injury. J Rehabil Res Dev, July-August 2006; 43(4): 461-474.
26. 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.
27. U.S. National Library of Medicine Clinicaltrials.gov. The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression (TES), NCT03277846. Study Details and Study Results. https://clinicaltrials.gov/ct2/show/study/NCT03277846?term=NCT03277846&draw=2&rank=1.
28. Yeh ML, Chu NF, Hsu MY, et al. Acupoint stimulation on weight reduction for obesity: a randomized sham-controlled study. West J Nurs Res. Dec 2015; 37(12):1517-1530.
29. Yeh TL, Chen HH, Pai TP, et. al. The Effect of Auricular Acupoint Stimulation in Overweight and Obese Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evidence-Based Complementary and Alternative Medicine. 2017; vol. 2017, Article ID 3080547, 16 pages, 2017.
30. Wu WJ, Wang Y, Cai M, et al. A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents. Asian J Psychiatr. Jun 2020; 51: 101992.

POLICY HISTORY:

Medical Policy Manual, April 1982

Re-Evaluated 1989

Medical Policy Group, September 7, 2001

Medical Policy Group, January 2003

Medical Policy Group, February 2004

Medical Policy Group, February 2006 (1)

Medical Policy Group, February 2007 (1)

Medical Policy Group, February 2008 (1)

Medical Policy Group, February 2009 (1)

Medical Policy Group, February 2010 (1):  Policy reviewed. No changes

Medical Policy Panel, September 2012

Medial Policy Group, October 2012 (2): Title change, non-coverage policy statement added for Auricular Electrostimulation.  Key Points and References updated with literature search through June 2012.  Description, Key Words, and Approved by Governing Bodies updated with auricular electrostimulation information and “also known as” terms for Cranial Electrotherapy Stimulation

Medical Policy Administration Committee, October 2012

Available for comment October 24 through December 10, 2012

Medical Policy Administration Committee, August 2014

Medical Policy Group, August 2014 (5): Policy updated with literature review through July 16, 2014; Updated Description, Key Points and References.  No change to policy statement.

Medical Policy Panel, August 2015

Medical Policy Group, August 2015 (6):  Updates to Key Points; no change to policy statement

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (6):  Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (6): Updates to Key Points, Approved by Governing Bodies & References; No change to policy statement.

Medical Policy Panel, June 2018

Medical Policy Group, July 2018 (6): Updates to Description, Key Points, Governing Bodies, Key Words (NSS-2 Bridge, Bridge Neurostimulation system, P-Stim, AcuStim, Stivax system) and References.

Medical Policy Group, July 2018 (6): Added coding 64999.

Medical Policy Panel, February 2019

Medical Policy Group, February 2019 (6): Updates to Key Points and References.

Medical Policy Group, June 2019 (6): Updates to Governing Bodies and Key Words to include “IB-Stim”. No change to policy intent.

Medical Policy Group, December 2019 (6): 2020 Annual Coding Update, added new code K1002.

Medical Policy Group, January 2020 (6): Updated Coding (added E1399).

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points, Governing Bodies, Key Words (Ansistem-Pp, Cervella),Coding (97813, 97814) and References.

Medical Policy Panel, February 2021

Medical Policy Group, February 2021 (6): Updates to Key Points and References.

Medical Policy Group, July 2021 (6): IB-Stim transferred to MP 406 Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT).

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (6): Updates to Description, Key Points, Governing Bodies, Key Words and References.

Medical Policy Group, September 2022 (6): 2022 Quarterly Coding Update, added new HCPCS code A4596 to the Current Coding section.

Medical Policy Group, November 2022: 2023 Annual Coding Update. Added CPT codes 0783T to Current Coding Section.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (6): Updates to Key Points, Governing Bodies, Benefit Application and References.

Medical Policy Group, December 2023: 2024 Annual HCPCS Coding Update. Added E0732. Deleted K1002.

Medical Policy Panel, February 2024

Medical Policy Group, February 2024 (6): Updates to Key Points, Governing Bodies, Current Coding, Key Words and References.

Medical Policy Group, September 2024 (6): 2024 Quarterly Coding Update, added new HCPCS code A4543, E0721 to the Current Coding section.

Medical Policy Group, November 2024: 2025 Annual Coding Update. Revised CPT code 97814.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the     patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and   

   4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent                  

        therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.