Latest Review Date: October 2024

Category: Medical

POLICY:

Automated nerve conduction tests (e.g. NC-Stat®, NeuroMetrix®, Neurometer® and Brevio® NCS-Monitor) are considered investigational for all indications, including but not limited to the diagnosis of carpel tunnel syndrome, peripheral neuropathy, and lumbar radiculopathy.

For coverage criteria addressing Neuromuscular and Electrodiagnostic Testing (EDX), see: Medical Policy #228 Nerve Conduction Studies (NCS) and Electromyography (EMG) Studies.

DESCRIPTION OF PROCEDURE OR SERVICE:

Portable devices have been developed to provide point-of-care nerve conduction studies including the delivery of stimulus, response analysis, and reporting. This testing is performed with pre-configured electrodes customized to a specific anatomic site. Automated nerve conduction could be used in various settings, including primary care, without the need for specialized training or equipment.

Nerve conduction studies (NCS) and needle electromyography (EMG), when properly performed by a trained practitioner, are considered the gold standard of electrodiagnostic testing, and may be used to diagnose neuropathies (e.g., carpel tunnel syndrome [CTS], peripheral neuropathies). However, the need for specialized equipment and personnel, along with additional time and cost, may limit the availability of electrodiagnostic testing for all patient populations.

Automated point-of-care nerve conduction studies, also known as automated nerve conduction studies, are performed using portable devices with computational algorithms that are able to drive stimulus delivery, measure and analyze the response, and provide a report of study results. They have been proposed for use by nontechnical clinic personnel as an alternative diagnostic test for CTS and other neuropathies.

KEY POINTS:

This evidence has been updated with a literature review using the PubMed database.  The most recent literature review was performed through October 3, 2024.

Summary of Evidence

For individuals who have entrapment carpal tunnel syndrome who received automated POC NCSs, the evidence includes studies on the diagnostic accuracy, and clinical outcomes from industry-sponsored trials, nonrandomized trials, and registry data. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. Four RCTs have reported on the diagnostic accuracy of automated POC nerve conduction testing to diagnose carpal tunnel syndrome. Sensitivity testing has suggested there could be diagnostic value in detecting carpal tunnel syndrome; specificity testing was inconsistent across trials. No reference ranges were validated, and normative values were not defined in these studies. No validation testing by trained medical assistants vs trained specialist was reported in the studies. The evidence on clinical outcomes was limited to a single nonrandomized clinical trial and NeuroMetrix registry data. Neither reported health outcomes assessing patient symptoms or changes in functional status. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with lumbosacral radiculopathy who received automated POC NCSs, the evidence includes industry-sponsored trials and a nonrandomized study of diagnostic accuracy. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. The evidence on the diagnostic accuracy of POC NCS in this population has shown variable test results across reported trials. No normative values were defined. Weaknesses of the studies included lack of applicable or valid reference ranges for testing, and variable test results validating or confirming pathology. The results of the two studies on diagnostic performance were inconclusive, with high false-positive results in a single trial. No trials on health outcomes assessing patient symptoms or changes in functional status were identified. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with diabetic peripheral neuropathy who received automated POC NCSs, the evidence includes industry-sponsored observational trials and nonrandomized studies on the diagnostic accuracy. Relevant outcomes are test accuracy and validity, symptoms, and functional outcomes. Of three studies reporting evidence on diagnostic accuracy, two used NC-stat DPN-Check. Sensitivity testing has suggested there could be diagnostic value in detecting diabetic peripheral neuropathy in symptomatic patients; the evidence to detect patients who are suspected of disease but who have mild symptoms was inconsistent. No reference ranges were validated, and normative values were not defined in two of the three studies. No validation testing by trained medical assistants vs trained specialist was reported in the studies. No trials on health outcomes assessing patient symptoms or changes in functional status were identified. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM)

The AANEM position statement, updated and validated in 2014, on the performance and interpretation of electrodiagnostic studies does not specifically address automated nerve conduction studies. However, the statement notes that “performance of NCSs without needle EMG has the potential of compromising patient care.” Further, the AANEM position statement provides the general conclusions that “Needle EMG studies are a necessary part of the evaluation in the diagnosis of myopathy, radiculopathy, plexopathy, disorders of the motor neuron, peripheral neuropathies and most disorders of the individual peripheral motor nerves. When the NCS is used on its own without integrating needle EMG findings or when an individual relies solely on a review of NCS data, the results can often be misleading, and important diagnoses will likely be missed. Patients may thus be subjected to incorrect, unnecessary, and potentially harmful treatment interventions.”

American Academy of Orthopaedic Surgeons

Updated 2024 AAOS guideline on the management of carpal tunnel syndrome states “Strong evidence suggests that CTS-6 (risk score) can be used to diagnose carpal tunnel syndrome, in lieu of routine use of Ultrasonography, or NCV/EMG.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Nerve conduction tests, automated nerve conduction tests, NC-stat, NeuroMetrix, Brevio® nerve conduction monitoring system, NeuroMetrix ADVANCE™, ADVANCE™, Axon-II™, XL Tek Neuropath, Cadwell Sierra® Summit, Cadwell Sierra® Ascent

APPROVED BY GOVERNING BODIES:

Multiple devices have been cleared for POC neural conduction testing.

Table 1. Examples of FDA Cleared Devices for Neural Conduction Testing

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: 

CPT codes 95900, 95903, 95904 should not be used to bill for automated point-of-care- nerve conduction tests.

CPT Codes:   

HCPCS Codes:                  

*Automated nerve conduction testing using devices such as the Axon II, which does not have stimulus and recording electrodes on the same preconfigured electrode array, should be reported using HCPCS code G0255.

REFERENCES:

1. American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). AANEM Proper Performance and Interpretation of Electrodiagnostic Studies. June 2014.
2. American Academy of Orthopaedic Surgeons Management of Carpal Tunnel Syndrome Evidence-Based Clinical Practice Guideline.  www.aaos.org/cts2cpg. 
3. American Association of Neuromuscular and Electrodiagnostic Medicine.  Recommended Policy for Electrodiagnostic Medicine, www.aanem.org. June 2004.
4. American Association of Neuromuscular and Electrodiagnostic Medicine.  AANEM position statement:  Proper performance and interpretation of electrodiagnostic studies. Muscle and Nerve 2006; 33(3):436-439.
5. American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). Proper Performance and Interpretation of Electrodiagnostic Studies. 2014; www.aanem.org/getmedia/bd1642ce-ec01-4271-8097- 81e6e5752042/Position-Statement_Proper-Performance-of-EDX_-2014.pdf.aspx. 
6. American Academy of Neurology (AAN). Practice Guidelines: Endorsed or Affirmed Guidelines. n.d.; www.aan.com/Guidelines/Home/ByStatusOrType?status=affirmed.
7. Armstrong TN, Dale AM, Al-Lozi MT et al. Median and ulnar nerve conduction studies at the wrist: criterion validity of the NC-stat automated device. J Occup Environ Med 2008:50 (7):758-64.
8. Boulton Andrew JM, Vinik Arthur I, et al. Diabetic neuropathies: A statement by the American Diabetes Association. Diabetes Care, April 2005, Vol. 28, No. 4.956-962.
9. Bourke HE, Read J, Kampa R et al. Clinic-based nerve conduction studies reduce time to surgery and are cost effective: a comparison with formal electrophysiological testing. Ann R Coll Surg Engl 2011; 93(3):236-40.
10. Chatzikosma G, Pafili K, Demetriou M, et al. Evaluation of sural nerve automated nerve conduction study in the diagnosis of peripheral neuropathy in patients with type 2 diabetes mellitus. Arch Med Sci. Apr 01 2016; 12(2):390-393.
11. Chen S, Andary M, Buschbacher R, et al. Electrodiagnostic reference values for upper and lower limb nerve conduction studies in adult populations. Muscle Nerve. Sep 2016; 54(3):371-377.
12. Dillingham T, Chen S, Andary M, et al. Establishing high-quality reference values for nerve conduction studies: A report from the normative data task force of the American Association of Neuromuscular & Electrodiagnostic Medicine. Muscle Nerve. Sep 2016; 54(3):366-370.
13. Elkowitz SJ, Dubin NH, Richards BE, and Wilgis EF. Clinical utility of portable versus traditional electrodiagnostic testing for diagnosing, evaluating, and treating carpal tunnel syndrome. Am J Orthop, August 2005; 34(8): 362-364.
14. England JD, Franklin GM. Automated hand-held nerve conduction devices: raw data, raw interpretations. Muscle Nerv 2011; 43(1):6-8.
15. Fisher MA. Comparison of automated and manual F-wave latency measurements. Clinical Neurophysiology, February 2005; 116(2): 264-269.
16. Fisher MA, Bajwa R, Somashekar KN. Routine electrodiagnosis and a multiparameter technique in lumbosacral radiculopathies. Acta Neurol Scand 2008; 118(2):99-105.
17. Hardy T, Sachson R, Shen S, et al. Does treatment with duloxetine for neuropathic pain impact glycemic control? Diabetes Care, January 2007, Vol. 30, No. 1, pp. 21-26.
18. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
19. Jabre Joe F, Salzsieder Byron T, and Gnemi Kenneth E. Criterion validity of the NC-stat automated nerve conduction measurement instrument. Physiol Meas, January 2007; 28: 95-104.
20. Katz RT. NC-stat as a screening tool for carpal tunnel syndrome in industrial workers. J Occup Environ Med, April 2006; 48(4): 414-418.
21. Kong X, Gozani SN, Hayes MT and Weinberg DH. NC-stat sensory nerve conduction studies in the median and ulnar nerves of symptomatic patients. Clin Neurophysiol, February 2006; 117(2): 405-413.
22. Kong X, Lesser Eugene A, Megerian J Thomas and Gozani Shai N. Repeatability of nerve conduction measurements using automation. Journal of Clinical Monitoring and Computing 2006; 20: 405-410.
23. Kong X, Lesser EA and Gozani SN. Repeatability of nerve conduction measurements derived entirely by computer methods. BioMedical Engineering Online 2009; 8:33.
24. Kong X, Schoenfeld DA, Lesser EA and Gozani SN. Implementation and evaluation of a statistical framework for nerve conduction study reference range calculation. Comput Methods Programs Biomed, January 2010; 97(1): 1-10.
25. Megerian J Thomas, Kong Xuan, Lesser Eugene and Gozani Shai N. NC-stat as a screening tool for carpal tunnel syndrome. Journal of Occupational and Environmental Medicine, August 2006, Vol. 48, No. 8.
26. Megerian J Thomas, Kong Xuan and Gozani Shai N. Utility of nerve conduction studies for carpal tunnel syndrome by family medicine, primary care and internal medicine physicians. J Am Board Fam Med 2007; 20(1):60-4.
27. Perkins Bruce A, Grewal Jaspreet, et al. Validation of a novel point-of-care nerve conduction device for the detection of diabetic sensorimtor polyneuropathy. Diabetes Care 2006; 29: 2023-2027.
28. Schmidt K, Chinea NM, Sorenson EJ et al. Accuracy of diagnoses delivered by an automated hand-held nerve conduction device in comparison to standard electrophysiological testing in patients with unilateral leg symptoms. Muscle Nerve 2011; 43(1):9-13.
29. Sharma S, Vas PR, Rayman G. Assessment of diabetic neuropathy using a point-of-care nerve conduction device shows significant associations with the LDIFLARE method and clinical neuropathy scoring. J Diabetes Sci Technol. Jan 2015; 9(1):123-131.
30. Shibata, Y., Himeno, T., Kamiya, T., Tani, H., Nakayama, T., Kojima, C., Sugiura-Roth, Y., Naito, E., Kondo, M., Tsunekawa, S., Kato, Y., Nakamura, J., & Kamiya, H. (2019). Validity and reliability of a point-of-care nerve conduction device in diabetes patients. Journal of diabetes investigation, 10(5), 1291–1298. 
31. U.S. Food and Drug Administration (FDA) 510(k) Summary Brevio. www.accessdata.fda.gov/cdrh_docs/pdf/k012069.pdf. 
32. Vinik AI, et al. Diabetic nerve conduction abnormalities in the primary care setting. Diabetes Technology Therapeutics, December 2006; 8(6): 654-662.

POLICY HISTORY:

Medical Policy Group, February 2007 (1)

Medical Policy Administration Committee, March 2007

Available for comment April 6-May 21, 2007

Medical Policy Group, November 2007

Medical Policy Group, April 2008 (2)

Medical Policy Administration Committee, April 2008

Available for comment April 4-May 18, 2008

Medical Policy Group, April 2008 (2)

Medical Policy Administration Committee May 2008

Available for comment May 3-June 16, 2008

Medical Policy Group, June 2008 (2)

Medical Policy Administration Committee, July 2008

Available for comment June 17-July 31, 2008

Medical Policy Panel June 2009

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, July 2009

Medical Policy Group, June 2010 (1): Policy update, no changes in coverage statement

Medical Policy Group, March 2011 (3)

Medical Policy Panel, June 2012

Medical Policy Group, July 2012 (2): Updated Key Points, Key Words, Approved by Governing Bodies, and References.  No change in coverage statement. Description updated to include the Axon-II™ (PainDx)

Medical Policy Panel, June 2013

Medical Policy Group, September 2013 (2): Policy Statement unchanged.   New codes added. Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (5): Policy Statement unchanged.

Medical Policy Panel, June 2015

Medical Policy Group, June 2015 (6): Updates to Description, Key Points, Approved by Governing Bodies, Coding and References; no change to policy statement.  

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (6): Updates to Description, Key Points, Governing Bodies, removed old deleted coding and References. No change to policy statement.

Medical Policy Panel, June 1018

Medical Policy Group, July 2018 (6): Updates to Description, Key Points, Governing Bodies and References.

Medical Policy Panel, June 2019

Medical Policy Group, June 2019 (3): 2019 Updates to Key Points, References and Key Words: added: Cadwell Sierra® Summit, Cadwell Sierra® Ascent. No changes to policy statement or intent.

Medical Policy Panel, October 2020

Medical Policy Group, November 2020 (3): 2020 Updated to Key Points and References. No changes to policy statement or intent. Active Policy but no longer scheduled for regular literature reviews and updates effective November 16, 2020.

Medical Policy Group, October 2021 (3): Updates to Key Points, Approved by Governing Bodies, and References. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Policy statement updated to remove “not medically necessary,” no change in intent.

Medical Policy Group, October 2022 (3): 2022 Updates to Key Points. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, October 2023 (6): Updates to Policy title: Automated Nerve Conduction Testing, Description, Key Points, Governing Bodies, Practice Guidelines, Benefit Application and References.

Medical Policy Group, October 2024 (6): Updates to Key Points, Practice Guidelines, and References. No changes to policy statement or intent.

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.