Medical Policy: 02.01.31 

Original Effective Date: January 2007 

Reviewed: April 2021 

Revised: April 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:

Nerve conduction velocity (NCV) studies are a type of electrodiagnostic study conducted to assess the integrity and function of the peripheral nervous system and to diagnose related diseases. NCV studies measure the velocity of nerve impulses, the amplitude and the wave shapes of the motor responses. Another relevant measurement is that of nerve conduction latency. Abnormal results include slowing of the nerve conduction signal, a completely blocked conduction, failure to elicit a motor response from a nerve signal or a diminished motor response. The results of these tests may assist the physician to arrive at a differential diagnosis based on the degree of demyelination or loss of axon function in various portions of the nerve.

 

Automated Point of Care Nerve Conduction Tests

Studies have shown the correlation of portable automated nerve conduction test results with standard testing; however, questions remain about the diagnostic performance and clinical utility (i.e., impact on outcomes) of point-of-care automated testing. Particularly needed are data on the sensitivity and specificity of automated nerve conduction tests performed by non-specialists at the point-of-care in comparison with the "gold standard" of laboratory NCS/EMG. One study from a tertiary care clinic found high sensitivity but low specificity for the diagnosis of lumbosacral radiculopathy. Another potential clinical use could be early identification of asymptomatic diabetic neuropathy to institute-appropriate clinical management before the onset of ulcerations, but no studies were identified that assessed the influence of point-of-care nerve conduction tests on clinical outcomes in this population. Overall, evidence addressing the utility of point-of-care automated nerve conduction tests in a clinical setting is limited. There is no peer-reviewed published medical literature on the use of voltage-actuated sensory nerve conduction tests and their impact on clinical outcomes. Overall, evidence remains insufficient to evaluate the effect of automated point-of-care nerve conduction tests on health outcomes. Therefore, automated point-of-care nerve conduction tests are considered investigational.

 

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, 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.

 

Practice Guidelines and Position Statements

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (2016) released guidelines on the management of carpal tunnel syndrome. The guidelines were endorsed by other specialty societies including the American College of Radiology and American College of Surgeons. The guidelines found "limited evidence" for a "hand-held nerve conduction study."

 

The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM)

Model Policy for Needle Electromyography and Nerve Conduction Studies: Limitations Nerve Conduction Studies EDX 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 NCSs, Approved by the American Association of Neuromuscular & Electrodiagnostic Medicine: February 2010. Updated December 2011. Updated and re-approved January 2016.

 

Regulatory Status

Multiple devices have been cleared for POC neural conduction testing. For example, in 1986, Neurometer® CPT/C (Neurotron®) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K853608). The device evaluates and documents sensory nerve impairments at cutaneous or mucosal sites. The evaluation detects and quantifies hyperesthesia in early stages of progressive neuropathy and hypoesthesia in more advanced conditions.

 

In 1998 NC-stat® (NeuroMetrix) was cleared by FDA through the 510(k) process (K982359). NC-stat® is intended "to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies." This version is no longer commercially available. It is the predicate device for the NC-stat DPNCheck® (K041320), cleared in 2004, and the NeuroMetrix Advance (K070109), cleared in 2008. The NC-stat DPNCheck device measures the sural nerve conduction velocity and sensory nerve action potential amplitude. It is a handheld device with an infrared thermometer, noninvasive electrical stimulation probes, and a single-use biosensor for each test. NC-stat DPNCheck is designed specifically for NCS of the sural nerve in the assessment of diabetic peripheral neuropathy. The NeuroMetrix ADVANCE is a POC test that can be used to perform needle EMG in addition to surface electrodes for the performance of NCSs. If the needle EMG module is used, then the device is also intended to measure signals useful in evaluating disorders of muscles.

 

On January 23, 2017, Cadwell Sierra Summit and Cadwell Sierra Ascent (Cadwell Industries) was cleared for marketing by FDA through the 510K process (K162383). There areportable laptop versions and a desktop application with a handheld device. The system is used for acquisition, display, storage, transmission, analysis, and reporting of electrophysiologic and environmental data including EMG, NCS, evoked potentials, and autonomic responses (RR interval variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

 

Prior Approval:

Not applicable

 

Policy:

Nerve conduction studies (NCV) are considered investigational when:

  • performed with automated or hand-held nerve conduction testing or screening devices (e.g., ADVANCE, NC-Stat by NeuroMetrix®, Neurometer® and Brevio® NCS-Monitor, XLTEK Neuropath by Excel-Tec, Virtual Medical Systems VT 3000 by Scientific Imaging) or
  • performed without the supervision of a physician.

 

Nerve conduction studies (NVC) are considered investigational for screening for all diagnosis, including but not limited to: polyneuropathy of diabetes or end-stage renal disease.

 

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, 2016). Currently, there is insufficient evidence in the published data to demonstrate that the use of automated nerve conduction testing devices are valid measures in the diagnosis of peripheral nerve disease. More studies are needed to prove the value of using automated, noninvasive nerve conduction testing.

 

Procedure Codes and Billing Guidelines:

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

  • 95905 Motor and/or sensory nerve conduction, using preconfigured electrode array(s), amplitude and latency/velcocity study, each limb, includes F-wave study when performed, wth intepretation and report.
  • 95999 Unlisted neurological or neuromuscular diagnostic procedure

 

Selected References:

  • American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Recommended policy for electrodiagnostic medicine. Endorsed by the American Academy of Neurology, The American Academy of Physical Medicine and Rehabilitation and The American Association of Neuromuscular and Electrodiagnostic Medicine. Updated 2014
  • American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Model Policy for Needle Electromyography and Nerve Conduction Studies. February 2010. Updated December 2011. Updated and re-approved January 2016.Washington State Department of Labor and Industries. NC-Stat® system, Neurometrix® Inc. Technology Assessment. May 2006.
  • Washington State Department of Labor and Industries. Coverage Decision: NC-Stat conduction Testing System. 06-01 February 2006; 2P.
  • ECRI Institute. Point-of-Care Nerve Conduction Tests. Plymouth Meeting (PA): ECRI Institute; 2009 May 18. 11p. [ECRI hotline response.]
  • 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.
  • England JD, Franklin GM. Automated hand-held nerve conduction devices: raw data, raw interpretations. Muscle Nerve 2011:43(1):6-8.
  • ECRI Institute. Point-of-Care Nerve Conduction Tests. Plymouth Meeting (PA): ECRI Institute; 2011 May.
  • 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. PMID 27238640
  • 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. PMID 27238858
  • American Academy of Orthopaedic Surgeons. Management of Carpal Tunnel Syndrome Evidence-Based Clinical Practice Guideline. 2016
  • 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. https://doi.org/10.1111/jdi.13007
                    

 

Policy History:

  • April 2021 - Annual Review, Policy Revised
  • April 2020 - Annual Review, Policy Renewed
  • April 2019 - Annual Review, Policy Renewed
  • April 2018 - Annual Review, Policy Renewed
  • April 2017 - Annual Review, Policy Renewed
  • April 2016 - Annual Review, Policy Revised
  • April 2015 - Annual Review, Policy Revised
  • April 2014 - Annual Review, Policy Renewed
  • June 2013 - Annual Review, Policy Revised
  • July 2012 - Annual Review, Policy Renewed
  • August 2011 - 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.