mp-021
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Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation

Policy Number: MP-021

Latest Review Date: February 2021

Category:  DME/Medical  

Policy Grade:  B

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, transcraial 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:

The most recent literature review was updated through December 14, 2020.

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. Three trials studied headache and CES and 5 trials studied chronic pain and CES. 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

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: FDA-Cleared Devices for Cranial Electrotherapy Stimulation

Device Name

Manufacturer

Date Cleared

Indications

Cervella

Innovative Neurological Devices

2019

Insomnia, depression, anxiety

Cranial Electrical Nerve Stimulator

Johari Digital Healthcare

2009

Insomnia, depression, anxiety

Elexoma Medic™

Redplane AG

2008

Insomnia, depression, anxiety

CES Ultra™

Neuro-Fitness

2007

Insomnia, depression, anxiety

Net-2000 Microcurrent Stimulator

Auri-Stim Medical

2006

Insomnia, depression, anxiety

Transcranial Electrotherapy Stimulator-A, Model TESA-1

Kalaco Scientific

2003

Insomnia, depression, anxiety

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: FDA-Cleared Electroacupuncture Devices for Auricular Acupuncture Points

Device Name

Manufacturer

Year Cleared

Indications

Drug Relief

DyAnsys Inc

2018

Reduce symptoms of opioid withdrawl

Ansistem-Pp

DyAnsys Inc

2017

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

NSS-2 Bridge

Innovative Health Solutions

2017

Substance use disorders

Stivax System

Biegler

2016

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

ANSiStim®

DyAnsys, Inc

2015

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Pantheon Electrostimulator

Pantheon Research

2014

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Electro Auricular Device

Navigant Consulting, Inc

2014

Practice of acupuncture by qualified practitioners

as determined by the states

P-Stim

Biegler GMBH

2014

Practice of acupuncture by qualified practitioners

as determined by the states

Jiajian Cmn Stimulator

Wuxi Jiajian Medical Instrument

Co., Ltd.

2013

Practice of acupuncture by qualified practitioners

as determined by the states

JiaJian Electro-Acupuncture

Stimulators

Wuxi Jiajian Medical Instrument

Co., Ltd.

2013

Practice of acupuncture by qualified practitioners

as determined by the states

Multi-Purpose Health Device

UPC Medical Supplies, Inc. DBA

United Pacific Co.

2010

Unknown - Summary not provided

Electro-Acupuncture:

Aculife/Model ADOC-01

Inno-Health Technology, Inc

2010

Practice of acupuncture by qualified practitioners

as determined by the states

e-Pulse®

AMM Marketing

2009

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Model ES-130

Ito Co., LTD

2008

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

P-Stim™

NeuroScience Therapy Corp.

2006

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

Aculife

Inno-Health, Technology

2006

Practice of acupuncture by qualified practitioners of acupuncture as determined by the states

AcuStim

S.H.P. International

2002

As an electroacupuncture device

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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

The manufacturers are encouraging the suppliers to use procedure code E0730 TENS four lead, larger area/multiple nerve stimulation. 

Please note that E0730 is not the correct code to report cranial electrical devices.

CPT

97813 Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient
97814 ; with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with reinsertion of needle(s) (List separately in addition to code for primary procedure)  
64999  Unlisted procedure, nervous system

HCPCS:

E1399 Durable Medical Equipment Miscellaneous
S8930 Electrical stimulation of auricular acupuncture points; each 15 Minute of personal one-on-one contact with the patient
K1002 Cranial electrotherapy stimulation (ces) system, includes all supplies and accessories, any type (effective 01/01/20)

REFERENCES:

  1. Ahn H, Galle K, Mathis KB, et al. Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in olderadults 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. Cameron M, et al.  Transcutaneous electrical nerve stimulation (TENS) for dementia, Cochrane Database Syst Rev, January 2003(3): CD004032.
  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. Kavirajan HC, Lueck K, Chuang K. Alternating current cranial electrotherapy stimulation (CES) for depression. Cochrane Database Syst Rev. Jul 8 2014; 7:CD010521.
  10. 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.
  11. Kirsch, Daniel L. and Smith, Ray B. The use of cranial electrotherapy stimulation in the management of chronic pain: A review, NeuroRehabilitation, 14(2):85-95, 2000.
  12. Klawansky S, Yeung A, Berkey C et al. Meta-analysis of randomized controlled trials of cranial electrostimulation.  Efficacy in treating selected psychological and physiological conditions.  J Nerv Ment Dis 1995; 183(7):788-84.
  13. Kroening RJ, Oleson TD. Rapid narcotic detoxification in chronic pain patients treated with auricular electroacupuncture and naloxone. Int J Addict. Sep 1985; 20(9):1347-1360.
  14. Lichtbroun, Alan S., et al. The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology, 2001: 7(2):72-78.
  15. 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.
  16. 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.
  17. 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.
  18. O’Connell NE, Wand BM, Marston L et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev 2010; (9):CD008208.
  19. O'Connell NE, Wand BM, Marston L, et al. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014; 4:CD008208.
  20. Passini FG, Watson CG, Herder J.  The effects of cerebral electric therapy (electrosleep) on anxiety, depression, and hostility in psychiatric patients.  J Nerv Ment Dis 1976; 163(4):263-6.
  21. Pickworth WB, Fant RV, Butschky MF et al.  Evaluation of cranial electrostimulation therapy on short-term smoking cessation.  Pio Bsychiatry 1997; 42(2):116-21. 
  22. 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.
  23. Sator-Katzenschlager SM, Michalek-Kauberer A.  P-Stim auricular electroacupuncture stimulation device for pain relief.  Expert Rev Med Devices 2007; 4(1):23-32. 
  24. Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA et al.  The short-and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture.  Anesth Analg 2004; 98(5):1359-64, table of contents. 
  25. Sator-Katzenschlager SM, Szeles JC, Scharbert G et al.  Electrical stimulation of auricular acupuncture points is more effective than conventional manual auricular acupuncture in chronic cervical pain:  a pilot study.  Anesth Analg 2003; 97(5):1469-73.
  26. 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.
  27. 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).
  28. 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. 
  29. Southworth, S.  A study of the effects of cranial electrical stimulation on attention and concentration. Integr Physiol Behav Sci, Jan-Mar 1999; 34(1):43-53.
  30. 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. 
  31. 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.
  32. 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. Accessed January 3, 2020.
  33. www.alpha-stim.com
  34. 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.
  35. 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.

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).

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.