Medical Policy



Subject: Automated Nerve Conduction Testing
Document #: MED.00092 Current Effective Date:    03/29/2017
Status: Reviewed Last Review Date:    02/02/2017

Description/Scope

This document addresses the use of automated, noninvasive nerve conduction testing devices as an alternative to conventional methods of performing nerve conduction testing.

Note: Please see the following related document for additional information:

Position Statement

Investigational and Not Medically Necessary:

Electrodiagnostic testing with automated, noninvasive nerve conduction testing devices is considered investigational and not medically necessary for all indications, including as an alternative method of performing nerve conduction velocity studies.

Rationale

Nerve conduction studies (NCS) are used to assess the integrity and diagnose diseases of the peripheral nervous system. NCS are part of a constellation of electrodiagnostic studies, including needle electromyelogram (EMG), neuromuscular junction studies and other specialized studies, used for evaluation of the peripheral nervous system. Automated nerve conduction studies have also been proposed for use in evaluating the peripheral nervous system. Automated and portable nerve conduction devices may be used by office staff without the need for specialized equipment and trained personnel. Automated systems use anatomically configured biosensors to perform the nerve conduction studies. The responses are recorded by a hand-held device which then transmits the data to the device company computer software for analysis and interpretation.

In 1998, the NC-stat® System (NEUROMetrix® , Inc., Waltham, MA) received United States Food and Drug Administration (FDA) clearance through the 510(k) clearance process, for measurement of neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. This original approval was for use as an adjunct to, and not as a replacement for, conventional electrodiagnostic testing. Although the device has been modified since the original FDA approval to extend its nerve testing capability, the intended use of the device has not changed. The NC-stat System is a portable, hand-held, noninvasive, automated nerve conduction testing device that has been marketed for use in an office or clinic setting to assess nerves of the upper and lower extremities to assist in the diagnosis of peripheral nerve disorders, such as carpal tunnel syndrome and diabetic peripheral neuropathy.

Schmidt and colleagues (2011) reported on the use of an automated hand-held nerve conduction device compared to NCS or needle electrode examination (standard electrodiagnostic tests) in the evaluation of individuals with unilateral leg symptoms. A total of 50 participants with complaints of unilateral leg pain, numbness or weakness were included in the study and underwent history with physical exam and standard electrodiagnostic testing. The participants were then tested using an automated hand-held nerve conduction device. A total of 22 participants had findings consistent with radiculopathy on standard electrodiagnostic test and 28 participants had a normal electrodiagnostic exam or evidence of another distinct neuromuscular diagnosis. During initial data analysis, a significant discrepancy was revealed between the results of standard electrodiagnostic tests and the automated test. For this reason, another 25 participants were recruited to serve as the control group. The control group participants had upper limb symptoms such as cervical radiculopathy, carpal tunnel syndrome or ulnar neuropathy. Of the 50 participants initially recruited, 28 were found to have normal standard electrodiagnostic tests. The automated tests corroborated the findings in 4 cases only. In the control group, all standard electrodiagnostic tests were normal, but the automated testing showed 18 of 25 participants had findings consistent with radiculopathy or polyneuropathy. Automated and standard testing correlated in 14 of 75 participants studied (11 of whom had normal exams with both testing methods). While this study has a small number of participants, the authors stated that "it is unlikely that larger study numbers would have increased specificity to acceptable levels of a clinically useful test, given the 95% confidence levels for the current data."

In a position statement on the Proper Performance and Interpretation of Electrodiagnostic Studies and the Recommended Use of Electrodiagnostic Medicine from the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM, 2006 and 2014), although no specific reference to or recommendation for automated nerve conduction testing devices is made, it is noted that "Nerve conduction studies performed independent of needle EMG studies may only provide a portion of the information needed to diagnose muscle, nerve root, and most nerve disorders."

And:

Individuals without a medical education in neuromuscular disorders and without special training in EDX procedures typically are not qualified to interpret the waveforms generated by NCSs and needle EMGs or to correlate the findings with other clinical information to reach a diagnosis.

Although portable, automated, noninvasive testing of nerve conduction has been suggested as an easier method for providers to obtain rapid results, the AANEM recommends that electrodiagnostic studies of EMG and NCS be performed together, except in unique situations, in a study design determined and interpreted by a trained physician, so that healthcare decisions are based on complete diagnostic information (AANEM, 2014). Currently, there is insufficient evidence in the published data to demonstrate that automated nerve conduction testing devices are valid measures in the diagnosis of peripheral nerve disease.

Since the clearance of the NC-stat, several other devices have also received FDA clearance listing the NC-stat as the predicate device. To date there has been very limited published evidence to demonstrate the safety and efficacy of automated, noninvasive nerve conduction testing devices, as compared to conventional "gold standard" electrodiagnostic testing using EMG and NCS. Most of the published clinical studies have evaluated use of an automated device for assessment of the median and ulnar nerves only (Katz, 2006; Kong, 2006).

Background/Overview

NCS provide information about the peripheral nervous system by assessing the speed (conduction velocity or latency), size (amplitude), and shape of the response. This requires specialized equipment and personnel which may not always be available. Automated and portable nerve conduction devices may be used by office staff thereby obviating the need for specialized equipment and personnel. The systems use anatomically configured biosensors that perform the nerve conduction studies. The responses are recorded by a hand-held device. The data is then transmitted to a company where computer software analyzes it and provides an interpretation.

Several devices have received FDA 510(k) clearance. The ADVANCE System (NEUROMetrix, Waltham, MA) was cleared by the FDA in 2008 and is intended to perform nerve conduction studies and needle EMG procedures. The intention is to measure neuromuscular signals to aid in diagnosing and evaluating individuals suspected of having common neuropathies. The Brevio® NCS-Monitor (NeuMed® , West Trenton, NJ) received FDA clearance in 2001 as an automated, hand-held device designed to perform nerve conduction testing on peripheral nerves. The Axon-II™ (PainDx, Inc., Laguna Beach, CA) is a nerve conduction system that allows detection of sensory neurological impairments caused by pathological conditions or exposure to toxic substances. A representative from the manufacturer reports this is a class II device with FDA clearance in 1998.

Definitions

Electromyography (EMG): Refers to the recording and study of the electrical activity of specific muscles through the use of a needle electrode which is inserted directly into a skeletal muscle. EMG testing is used to exclude, diagnose, describe and follow-up on diseases of the peripheral nervous system and the associated muscles.

Nerve conduction studies (NCS): This involves the application of surface electrodes to diagnose diseases of the peripheral nervous system. NCS assess the speed (conduction velocity/latency), size (amplitude), and shape of the electrical responses elicited from the targeted nerve and the muscle stimulated by that nerve.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the procedure codes listed below, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT  
95905 Motor and/or sensory nerve conduction, using preconfigured electrode array(s), amplitude and latency/velocity study, each limb, includes F-wave study when performed, with interpretation and report
95999 Unlisted neurological or neuromuscular diagnostic procedure [when specified as other portable automated nerve conduction testing]
   
HCPCS  
G0255 Current perception threshold/sensory nerve conduction test (SNCT), per limb, any nerve [when specified as other portable automated nerve conduction testing]
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Elkowitz SJ, Dubin NH, Richards BE, Wilgis EF. Clinical utility of portable versus traditional electrodiagnostic testing for diagnosing, evaluating and treating carpal tunnel syndrome. Am J Orthop. 2005; 34(8):362-364.
  2. England JD, Franklin GM. Automated hand-held nerve conduction devices: raw data, raw interpretations. Muscle Nerve. 2011; 43(1):6-8.
  3. Hilburn JW. General principles and use of electrodiagnostic studies in carpal and cubital tunnel syndrome. With special attention to pitfalls and interpretation. Hand Clin. 1996; 12(2):205-221.
  4. Jabre JF, Salzsieder BT, Gnemi KE. Criterion validity of the NC-stat automated nerve conduction measurement instrument. Physiol Meas. 2007; 28(1):95-104.
  5. Katz JN, Simmons BP. Carpal tunnel syndrome. N Engl J Med. 2002; 346(23):1807-1812.
  6. Katz RT. NC-stat as a screening tool for carpal tunnel syndrome in industrial workers. J Occup Environ Med. 2006; 48(4):414-418.
  7. Kong X, Gozani SN, Hayes MT, Weinberg DH. NC-stat sensory nerve conduction studies in the median and ulnar nerves of symptomatic patients. Clin Neurophysiol. 2006; 117(2):405-413.
  8. Leffler CT, Gozani SN, Cros D. Median neuropathy at the wrist: diagnostic utility of clinical findings and an automated electrodiagnostic device. J Occup Environ Med. 2000; 42(4):398-409.
  9. Megerian JT, Kong X, Gozani SN. 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):60-64.
  10. Perkins BA, Grewal J, Ng E, et al. Validation of a novel point-of-care nerve conduction device for the detection of diabetic sensorimotor polyneuropathy. Diabetes Care. 2006; 29(9):2023-2027.
  11. 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.
  12. Vinik AL, Emley MS, Megerian JT, Gozani SN. Median and ulnar nerve conduction measurements in patients with symptoms of diabetic peripheral neuropathy using the NC-stat system. Diabetes Technol Ther. 2004; 6(6):816-824.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Proper performance and interpretation of electrodiagnostic studies. Muscle Nerve. 2006; 33(3):436-439. Updated June 2014. Available at: https://www.aanem.org/getmedia/bd1642ce-ec01-4271-8097-81e6e5752042/Position-Statement_Proper-Performance-of-EDX_-2014.pdf.aspx . Accessed on January 6, 2017.
  2. American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Recommended policy for Electrodiagnostic Medicine. American Association of Neuromuscular & Electrodiagnostic Medicine. September 1997 and updated 2014. Available at: https://www.aanem.org/getmedia/ed2143b6-917f-4218-b699-e682b18ad15d/2014_Recommended_Policy_EDX_Medicine-(1).pdf . Accessed on January 6, 2017.
  3. England JD, Gronseth GS, Franklin G, et al. Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2005; 64(2):199-207. Reaffirmed 2014.
  4. U.S. Food and Drug Administration 510(k) Premarket Notification Database. ADVANCE. No. K070109. Rockville, MD: FDA. April 25, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070109.pdf. Accessed on January 6, 2017.
  5. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Brevio. No. K012069. Rockville, MD: FDA. August 1, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/k012069.pdf. Accessed on January 6, 2017.
  6. U.S. Food and Drug Administration 510(k) Premarket Notification Database. NeuroMetrix NC-stat. No. K060584. Rockville, MD: FDA. July 31, 2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060584.pdf. Accessed on January 6, 2017.
Index

ADVANCE
Automated Nerve Conduction Testing
Brevio Nerve Conduction System
NC-stat System
Nerve Conduction Studies, Electromyography
Nerve Conduction Velocity Studies

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Reviewed 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References section.
Reviewed 02/04/2016 MPTAC review.  Updated References.  Removed ICD-9 codes from Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Rationale and References.
Reviewed 02/13/2014 MPTAC review. Updated Rationale.
Reviewed 02/14/2013 MPTAC review. Updated Rationale, Background/Overview, Coding, and Reference sections.
Revised 02/16/2012 MPTAC review. Updated Rationale, Background/Overview, and References. Removed device name from Position Statement.
Reviewed 02/17/2011 MPTAC review. Updated References, Index. Removed Web Sites for Additional Information. Updated Coding section with 04/01/2011 HCPCS changes; removed S3905 deleted 03/31/2011.
Reviewed 02/25/2010 MPTAC review. References were updated.
  01/01/2010 Updated Coding section with 01/01/2010 CPT changes.
Reviewed 02/26/2009 MPTAC review. References were updated.
Reviewed 02/21/2008 MPTAC review. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting. References were updated.
  07/01/2007 Updated Coding section with 07/01/2007 HCPCS changes.
New 03/08/2007 MPTAC review. Initial document development.