Medical Policy: 02.01.15 

Original Effective Date: February 2000 

Reviewed: June 2021 

Revised: June 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Surface Electromyography (sEMG) for Neuromuscular Disorders and to Evaluate Abnormal Patterns of Electrical Activity in the Paraspinal Muscles

Surface electromyography (sEMG) technologies have been studied as a complement or potential alternative to needle electromyography (nEMG) and nerve condition studies (NCS) for the investigation of neuromuscular disorders and evaluate abnormal patterns of electrical activity in the paraspinal muscles in patients with back pain symptoms such as spasm, tenderness, limited range of motion, or postural disorders. The sEMG recording techniques vary significantly, but all involve analysis of myoelectrical signals using sensors positioned on the skin surface.

 

Surface Electromyography (sEMG)

Surface electromyography (sEMG) is also referred to as surface scanning EMG, is a non-invasive, computer-based technique that records the electrical impulses using electrodies placed on the surface of the skin overlying the nerve at rest (i.e., static) and during activity (i.e., dynamic). The procedure studies the topography of the motor unit action potential (MUAP) and is assessed by computer analysis of the frequency spectrum, amplitude or root mean square of the electrical action potential. The sEMG differs from needle electromyography (nEMG) with respect to technical requirements and electrical properties. sEMG electrodes measure from a wide area of muscle, have a relatively narrow frequency band (range 20 to 500 Hz), have a low-signal resolution, and are highly susceptible to movement artifact. The proposed use for this type of EMG is to aid in the diagnosis of neuromuscular disorders and low back pain, and to aid in assessing the prognosis of disorders involving muscle lesions. The technology has also been used to monitor bruxism (i.e., grinding and clenching of teeth). The electrical activity of muscle may be recorded with surface EMG, although spontaneous electrical activity and voluntary motor units cannot be. The clinical utility of surface EMG has not been proven in the peer-reviewed medical literature.

 

High Density Surface Electromyography (HD-sEMG)

High-density surface electromyography (HD-sEMG) is a non-invasive technique to measure electrical muscle activity with multiple (more than 2) closely spaced electrodes overlying a restricted area of the skin. Besides temporal activity, HD-sEMG also allows spatial EMG activity to be recorded, thus expanding the possibilities to detect new muscle characteristics. Muscle fiber conduction velocity (MFCV) measurements and the evaluation of single motor unit (MU) characteristics come into view. In principle, HD-sEMG allows pathological changes at the MU level to be detected, especially changes in neurogenic disorders and channelopathies. The clinical effectiveness of HD-sEMG has not been established; well- designed studies are needed to ascertain the clinical utility of HD-sEMG.

 

Paraspinal EMG

The difficulty in identifying the source of pathology for most low back pain disorders has led researchers to develop new technology to help in the diagnosis of low back pain. Assessment approaches based on paraspinal surface electromyography signal techniques have been proposed to overcome some of the problems identified in other technologies. The concept is to measure and identify the presence of abnormal muscle functioning in a manner that will suggest a form of treatment.

 

Paraspinal sEMG, also referred to as paraspinal EMG scanning, has been investigated as a method of assessing the paraspinal muscles of patients which provide support to the spinal column. Impairment of the paraspinal muscles may lead to abnormal motion and pain. The paraspinal sEMG is performed using a single electrode or an array of electrodes placed on the skin surface with recordings that are typically made at rest, in various positions or after physical activity.

 

Paraspinal surface EMG (sEMG) is an office- based procedure that may be most commonly used by physiatrists or chiropractors. The following clinical applications of the paraspinal sEMG have been proposed:

  • Clarification of a diagnosis (i.e., muscle, joint or disc disease)
  • Selection of a course of medical therapy
  • Selection of a type of physical therapy
  • Preoperative evaluation
  • Postoperative rehabilitation
  • Follow up of acute low back pain
  • Evaluation of exacerbation of chronic low back pain
  • Evaluation of pain management treatment techniques

 

The diagnostic utility of paraspinal sEMG is not known, and its role in patient management has not been established.

 

Summary of Evidence

There is insufficient evidence in the medical literature to support the use of any type of surface electromyography (sEMG) as the diagnostic utility is unknown and the role in patient management has not been established. Further well-designed clinical trials are needed to standardize sEMG approaches and diagnostic algorithms, increase diagnostic performance and to assess the role of sEMG in clinical practice. Therefore, this testing is considered investigational for all indications.

 

Surface Electromyography (sEMG) for Seizure Monitoring

There have been a limited number of studies in the peer-reviewed medical literature addressing the use of surface electromyography (sEMG) devices for seizure monitoring. Currently, there are no society guidelines that have published recommendations on the use of sEMG for this indication.

 

Surface electromyography (sEMG) devices have been proposed as an adjunct in recording and storing data for characterization of seizure events in the home during periods of rest. The sEMG device is placed on the belly of the biceps muscle of an individual. An alarm alerts the caregivers when the device detects signal patterns associated with unilateral, appendicular, tonic extension that is potentially related to a generalized tonic-clonic seizures (GTCS).

 

In 2017, Halford et. al. published a prospective, multicenter, phase III trial that investigated an surface electromyography (sEMG) monitoring system for the detection of generalized tonic-clonic seizures (GTCS). In 11 epilepsy centers, 199 individuals were monitored for GTCS by the sEMG seizure monitoring system between August 2013 and December 2015; however, 50 (25%) individuals did not have proper placement of the sEMG device or had technical issues, such as sEMG data not being archived for reprocessing, but were still included in the trial. There were 29 (15%) individuals who withdrew from the trial early; however, the sEMG data recorded prior to withdrawal was included in the final data analysis. Three video EEG (vEGG) reviewers, who were not study site investigators, evaluated system detections and GTCS identified by clinical care providers. Using a majority rules approach, the data was independently adjudicated by the vEEG reviewers, who were blinded to system detections and sEMG recordings. Results showed that 37 (19%) of the individuals had at least one GTCS with a total of 46 GTCS identified with vEEG. The sEMG device detected 35 of the 46 GTCS (76%; 95% CI, 0.65-1.0) with a mean false alarm rate (FAR) of 2.5 per 24 hours. For data recorded while the device was appropriately positioned over the midline of the biceps muscle, the test system detected 29 of 29 GTCS (100%; 95% CI, 0.88-1.00) with a mean false alarm rate (FAR) of 1.44 per 24 hours. However, FAR for those properly wearing the device varied between 0 and 10 per 24 hours. The results of this small validation study are promising but challenged by a high false alarm rate for many of the users.

 

In 2018, Beniczky et. al. reported on the results of a prospective, multicenter study that evaluated the accuracy of surface electromyography (sEMG) device in the detection of generalized tonic-clonic seizures (GTCS) in 71 individuals at 3 centers between October 2014 and January 2017. Individuals underwent video EEG (vEEG) monitoring as a comparison for the sEMG device and results were reviewed by three clinical neurophysiologists and epileptologists who were blinded to all sEMG device data until the analysis of the vEEG recordings was completed. The data showed that 20 (28%) individuals had at least 1 GTCS with a total of 32 GTCS. The sensitivity of the sEMG device, defined as the percentage of GTCS detected, was 93.8% (30 out of 32 GTCS) (95% CI, 86%-100%). The specificity of the sEMG device, defined as the false alarm rate (FAR), was 0.67 per day. There was a total of 161 seizures other than GTCS that were identified in the vEEG recordings. Large field studies, with long-term, ambulatory use of the device, are necessary to evaluate its potential in reducing the number of seizure-related injuries and ultimately the number of sudden unexpected death in epilepsy (SUDEP).

 

Summary of Evidence

Studies published to date are limited to studies performed in an inpatient setting. It is unclear if the test performance of surface electromyography (sEMG) monitoring of generalized tonic-clonic seizures (GTCS) in an ambulatory or home setting would be similar to the results obtained the inpatient settings. It is also unclear as to how using sEMG monitoring for GTCS would impact the management and treatment outcome (for example, seizure frequency, status epilepticus, aspiration, injury or death) of individuals with this disorder. Randomized, prospective comparative trials demonstrating the clinical utility of the device are needed. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Practice Guidelines and Position Statements

American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)

AANEM Evidenced Based Review: Use of Surface Electromyography in the Diagnosis and Study of Neuromuscular Disorders:

  • On the basis of two class III studies, sEMG may be useful to detect the presence of neuromuscular disease (Level C: possibly effective, ineffective or harmful for the given condition in the specified population)
  • The data are insufficient to determine the clinical utility of sEMG for distinguishing between neuropathic and myopathic conditions or for detecting the more specific neuromuscular conditions of post-poliomyelitis syndrome, pathologic fasciculations, acquired demyelinating peripheral neuropathy, amyotrophic lateral sclerosis, myotonic dystrophy, and hypokalemic periodic paralsysis (Level U: data inadequate or conflicting given current knowledge, treatment is unproven)
  • The data are insufficient to address the question of disease severity detectable by sEMG (Level U: data inadequate or conflicting given current knowledge, treatment is unproven)
  • The data are insufficient to compare diagnostic utility of sEMG with the conventional technologies of nEMG, NCS and muscle ultrasonography (Level U: data inadequate or conflicting given current knowledge, treatment is unproven)

 

Further research is necessary to determine the clinical utility of sEMG in the diagnosis of neuromuscular diseases and in the differentiation of primary myopathic and neuropathic conditions.

 

American College of Occupational and Environmental Medicine (ACOEM)

In 2019 the American College of Occupational and Environmental Medicine (ACOEM), updated their practice guideline for diagnostic tests for low back disorders which states the following: Surface electromyography (sEMG) has been used to diagnose LBP and involves the recording of summated muscle electrical activity by skin electrodes (such as those used in an electrocardiogram or EKG). There are four moderate-quality studies incorporated into this analysis and no quality evidence of diagnostic efficacy, and thus, is not recommended to diagnose LBP. (Not Recommended, Insufficient Evidence (I), High Confidence).

 

Regulatory Status

SEMG devices approved by the U.S. Food and Drug Administration (FDA) include those that use a single electrode or a fixed array of multiple surface electrodes. Examples include the CMAP Pro (Medical Technologies) and Model 9200 EMG System (Myotronics-Noromed).

 

Several FDA approved devices combine SEMG along the spine with other types of monitors. For example, in 2007, the Insight Discovery (Fasstech) was cleared for marketing through the 510(k) process. The device contains 6 sensor types, one of which is for SEMG. The indications include measuring bilateral differences in SEMG along the spine and measuring SEMG along the spine during functional tasks.

 

sEMG devices have been proposed as an adjunct in recording and storing data for characterization of seizure events in the home or healthcare facilities during periods of rest. The sEMG device is placed on the belly of the biceps muscle of an individual. An alarm alert caregivers when the device detects signal patterns associated with unilateral, appendicular, tonic extension that is potentially related to a GTCS. While continuing to record sEMG data for future review, the alarms can be turned off by a physician order (U.S. Food and Drug Administration, 2019).

 

The U.S. Food and Drug Administration (FDA) cleared the SPEAC System (Brain Sentinel, Inc., San Antonio, TX), formerly known as the Brain Sentinel Monitoring and Alerting System (Predicate), through the 510(k) premarket approval process on May 11, 2019 as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The SPEAC System Traditional 510(k) Summary lists several warnings and limitations, including (FDA, 2019):

  • The System should not be used as a standalone monitor for monitoring seizures and is not intended to be used during physical activity.
  • The System alarms are not for standalone use and should not be used to guide medical therapy decisions
  • The System has not been demonstrated to affect any clinical outcome such as status epilepticus, brain damage, or death following a GTC seizure
  • The System does not predict sEMG signals that may be associated with GTC seizures
  • The device provides an alert following the onset of sEMG activity that may be associated with a GTC seizure
  • The System does not predict seizure onset
  • The safety and effectiveness of the System has not been established in pediatric populations
  • The safety and effectiveness of the SPEAC System has not been established in monitoring sEMG signals that may be associated with seizures other than the GTC seizure.

 

New features in the SPEAC System compared to the Brain Sentinel Monitoring and Alerting System include an increase in the surface area of the electrode patch and a feature for the physician to turn off alarms while still recording data. Currently, there are no other FDA cleared sEMG devices for seizure monitoring.

 

Prior Approval:

Not applicable

 

Policy:

Surface electromyography (sEMG) including but not limited to the following, for the evaluation of neuromuscular disorders and to evaluate abnormal patterns of electrical activity in the paraspinal muscles for any indication is considered investigational.

  • Paraspinal surface electromyography (sEMG) also referred to as paraspinal EMG scanning
  • Surface electromyography (sEMG) also referred to as surface scanning EMG (dynamic sEMG/static sEMG)
  • High-density surface electromyography (HD-sEMG)

 

There is insufficient evidence in the medical literature to support the use of any type of surface electromyography (sEMG) as the diagnostic utility is unknown and the role in patient management has not been established. Further well-designed clinical trials are needed to standardize sEMG approaches and diagnostic algorithms, increase diagnostic performance and to assess the role of sEMG in clinical practice. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

The use of surface electromyography (sEMG) devices for seizure monitoring and for all other indications is considered investigational, because the evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Procedure Codes and Billing Guidelines:

To eport provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • S3900 Surface electromyography (EMG)
  • 96002 Dynamic surface electromyography, during walking or other functional activities 1-12 muscles

 

Selected References:

  • The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
  • Hemingway MA, Biedermann H-J, Inglis J. Electromyographic Recordings of Paraspinal muscles: Variations Related to Subcutaneous Tissue Thickness. Biofeedback and Self-Regulation, vol. 20, no.1, 1995:39-49.
  • Roy SH, Oddsson LI. Classification of Paraspinal Muscle Impairments by Surface Electromyography. Physical Therapy, vol.78, no. 8, Aug1998:838-851.
  • Pullman SL, Goodin DS, et al. Clinical Utility of surface EMG: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology. Neurology. 2000 Jul 25;55(2):171-7.
  • Merlo A, Farina D, Member, IEEE, Merletti R. A fast reliable technique for muscle activity detection from surface EMG signals. IEEE Transactions on Biomedical Engineering 2003;50(3):316-323.
  • Lehman GJ.Clinical considerations in the use of surface eletromyographpy: Three experimental studies. J Manipulative Physiol Ther 2002;25:293-299.
  • Lariviere C, Arsenault AB, Gravel D, Gagnon D, Loisel P, Vadeboncoeur R. Elecromyographic assessment of back muscle weakness and muscle composition: Reliability and validity issues. Arch Phys Med Rehabil 2002;83:1206-1214.
  • Stokes IAF, Henry SM, Single RM. Surface EMG electrodes do not accurately record from lumber multifidus muscles. Clinical Biomechanics 2003;18:9-1.
  • ECRI. Surface Electromyography for Evaluating Back Pain. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 March 18. 11p.
  • American Academy of Neurology Clinical Utility of Surface EMG Technology assessment report. Neurology2000 July 25;55(2):171-7. This information is current as of April 10, 2009.
  • Enomoto M, Ukegawa D, Sakaki K, et al. Increase in paravertebral muscle activity in lumbar kyphosis patients by surface electromyography compared with lumbar spinal canal stenosis patients and healthy volunteers. J Spinal Disord Tech. 2012 Aug;25(6):E167-73.
  • Meekins G, So Y, Quan D. American Association of Neuromuscular and Electrodiagnostic Medicine Evidenced Based Review: Use of Surface Electromyography in the Diagnosis and Study of Neuromuscular Disorders, April 2008
  • Neblett R, Brede E, Mayer TG et al. What is the best surface EMG measure of lumbar flexion-relaxation for distinguishing chronic low back pain patients from pain-free controls? Clin J Pain 2013; 29(4):334-40.
  • National Guideline Clearinghouse. American College of Occupational and Environmental Medicine (ACOEM), Low Back Disorders, 2011. p. 333-796
  • Drost G, Stegeman DF, van Engelen BG, Zwarts MJ. Clinical applications of high-density surface EMG: a systematic review. J Electromyogr Kinesiol 2006;Dec:16(6):586-602. PMID 17085302
  • Jones SL, Hitt JR, DeSarno MJ, et. al. Individuals with non-specific low back pain in an active episode demonstrate temporally altered torque responses and direction-specific enhanced muscle activity following unexpected balance pertubations. Exp Brain Res. 2015 Sept:221(4):413-26 PMID 22875027
  • Sheeran L, Sparkes V, Caterson B, et. al. Spinal position sense and trunk muscle activity during sitting and standing in nonspecific chronic low back pain: classification analysis. Spine 2012 Apr 15:37(8):E486-95. PMID 22024899
  • Hanada EY, Johnson M, Hubley-Kozey C. A comparison of trunk muscle activation amplitudes during gait in older adults with and without chronic back pain. PM R 2011 Oct 3(10):920-8. PMID 22024323
  • Neblett R, Brede E, Mayer TG, et. al. What is the best surface EMG measure of lumbar flexion-relaxation for distinguishing chronic low back pain patients from pain-free controls? Clin J Pain 2013 Apr:29(4):334-40. PMID 23328325
  • Mohseni Bandpei MA, Rahmani N, Majdoleslam B, et. al. Reliability of surface electromyography in the assessment of paraspinal muscle fatigue: an update systemic review. J Manipulative Physiol Ther 2014 Sep;37(7):510-21. PMID 25204717
  • Hu Y, Kwok JW, Tse JY, et. al. Time-varying surface electromyography topography as a prognostic tool for chronic low back pain rehabilitation. Spine J 2014 Jun 1:14(6):1049-56. PMID 24530438
  • Hung CC, Shen TW, Liang CC, et. al. Using surface electromyography (SEMG) to classify low back pain based on lifting capacity evaluation with principal component analysis neural network method. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:18-21. PMID 25569886
  • Van Damme B, Stevens V, Perneel C, et. al . A surface electromyography based objective method to identify patients with nonspecific low back pain, presenting a flexion related movement control impairment. J Electromyogr Kinesiol 2014 Dec;24(6):954-64. PMID 25304196
  • American Chiropractic Association Coding Policy, Coding for Surface Electromyography. 2015 American Chiropractic Association
  • Zhou P, Xiaoyan L, Jahanmiri-Nezhad F, et. al. Duration of observation required in detecting fasciculation potentials in amyotrophic lateral sclerosis using high-density surface EMG. Journal of Neuroengineering and Rehabilitation 2012, 9:78
  • Rojas-Martinez M, Mananas M, Alonso J. High-density surface EMG maps from upper arm and forearm muscles. Journal of Neuroengineering and Rehabilitation 2012, 9:85
  • van de Steeg C, Daffertshofer A, Stegeman D, et. al. High-density surface electromyography improves the identification of oscillatory synaptic inputs to motoneurons. J Appl Physiol 116: 1263-1271, 2014
  • Hu X, Suresh NL, Xue C, et. al. Extracting extensor digitorum communis activation patterns using high-density surface electromyography. Front Physiol 2015 Oct 6:6:279. PMID 26500558
  • Hegmann K, Travis R, Belcourt R, et. al. Diagnostic Tests for Low Back Disorders. ACOEM Practice Guideline. JOEM Volume 61 Number 4 April 2019 
  • Kreiner DS, Matz P, Bono CM, et al. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. Jul 2020; 20(7): 998-1024. PMID 32333996
  • Dos Reis IMM, Ohara DG, Januário LB, et al. Surface electromyography in inspiratory muscles in adults and elderly individuals: A systematic review. J Electromyogr Kinesiol. 2019 Feb;44:139-155
  • Halford JJ, Sperling MR, Nair DR, et al. Detection of generalized tonic-clonic seizures using surface electromyographic monitoring. Epilepsia. 2017 Nov;58(11):1861-1869
  • Beniczy S, Conradsen I, Henning O, et. al. Automated real-time detection of tonic-clonic seizures using a wereable EMG device. Neurology 2018;90:e428-e434

 

Policy History:

  • June 2021 - Annual Review, Policy Revised
  • June 2020 - Annual Review, Policy Renewed
  • June 2019 - Annual Review, Policy Renewed
  • June 2018 - Annual Review, Policy Renewed
  • June 2017 - Annual Review, Policy Renewed
  • November 2016 - Interim Review, Policy Revised
  • June 2016 - Annual Review, Policy Revised
  • July 2015 - Annual Review, Policy Revised
  • July 2014 - Annual Review, Policy Renewed
  • September 2013 - Annual Review, Policy Renewed
  • October 2012 - Annual Review, Policy Renewed
  • October 2011 - Annual Review, Policy Renewed
  • September 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.