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Portable devices have been developed to provide point-of-care (POC) nerve conductions studies (NCSs). These devices have computational algorithms that are able to drive stimulus delivery, measure and analyze the response, and provide a report of study results. Automated nerve conduction could be used in various settings, including primary care, without the need for specialized training or equipment.
Nerve conductions studies (NCS) and needle electromyography (EMG), when properly performed by a trained practitioner, are considered the criterion standard of electrodiagnostic testing. However, the need for specialized equipment and personnel may limit the availability of electrodiagnostic testing for some patients. One proposed use of automated nerve conduction devices is to assist in the diagnosis of carpal tunnel syndrome (CTS). CTS is a pressure-induced entrapment neuropathy of the median nerve as it passes through the carpal tunnel, resulting in sensorimotor disturbances. This syndrome is defined by its characteristic clinical symptoms, which may include pain, subjective feelings of swelling, and nocturnal paresthesia. A variety of simple diagnostic tools are available, and a positive response to conservative management (steroid injection, splints, modification of activity) can confirm the clinical diagnosis. Electrodiagnostic studies may also be used to confirm the presence or absence of a median neuropathy at the wrist, assess the severity of the neuropathy, and assess alternate associated diagnoses. Nerve conduction is typically assessed before surgical release of the carpal tunnel, but the use of EMG in the diagnosis of CTS is controversial.
Point-of-care nerve conduction testing has also been proposed for the diagnosis of peripheral neuropathy and, in particular, for detecting neuropathy in patients with diabetes. Peripheral neuropathy is relatively common in patients with diabetes mellitus, and the diagnosis is often made clinically through the physical examination. Diabetic peripheral neuropathy can lead to important morbidity including pain, foot deformity, and foot ulceration. Clinical practice guidelines recommend using simple sensory tools such as the 10-g Semmes-Weinstein monofilament or the 128-Hz vibration tuning fork for diagnosis. These simple tests predict the presence of neuropathy defined by electrophysiologic criteria with a high level of accuracy. Electrophysiologic testing may be used in research studies and may be required in cases with an atypical presentation.
NC-stat® by NeuroMetrix is a portable nerve conduction test device designed to be used at the point-of-care. The system comprises a biosensor array, an electronic monitor, and a remote report generation system. The biosensor is a single use, preconfigured array consisting of a stimulation anode and cathode, skin surface digital thermometer, and response sensor. Biosensor arrays are available for assessment of sensory and motor nerves of the wrist (median and ulnar), and for the foot (peroneal, posterior tibial, and sural). A chip imbedded in the biosensor panel measures skin surface temperature, the analysis algorithm adjusts for differences in temperature from 30º C, or if skin surface temperature is less than 23º C, the monitor will indicate that limb warming is necessary. Data are sent to a remote computer via a modem in the docking station, and the remote computer generates a report based on the average of 6 responses that is sent back by fax or email. In addition to the automated stimulus delivery and reporting, NC-stat® analysis adjusts the calculation for body temperature, height, and weight, and uses the average of 6 responses. Sensitivity of the device for sensory nerve amplitude potentials is 2.1 µV; values lower than this are analyzed as zero, and responses with artifact are automatically eliminated from the analysis.
The NeuroMetrix ADVANCE™ is a point-of-care test that includes the ability to perform needle EMG in addition to surface electrodes for the performance of nerve conduction studies. The NC-stat® DPN-Check™ is a handheld device that is applied to the skin posterior to the lateral malleolus in the area that overlies the distribution of the sural nerve. The device includes a biosensor pad, metal stimulating probes, and a thermometer that corrects for skin temperature. NC-stat® DPN-Check™ is designed specifically for NCS of the sural nerve for the assessment of diabetic peripheral neuropathy.
The Axon-II™ (PainDx) is an automated system that is being marketed for the detection of various sensory neurologic impairments caused by various pathologic conditions or toxic substance exposures, including signs of sympathetic dysfunction and detection of down-regulated A-delta function to locate injured nerve(s). The Axon-II software works with the Neural-Scan™ system (Neuro Diagnostics) and lists 7 automated studies (Cervical, Thoracic, Lumbar, Upper Extremities, Lower Extremities, Neuroma, Trigeminal), as well as a custom study. The Neural-Scan™ is a voltage-actuated sensory nerve conduction test device, which measures the voltage amplitude necessary to cause a discernible nerve impulse. Results are adjusted and compared with population means; the most severe hypoesthesia is considered the primary lesion.
Several devices are now being marketed for point-of-care neural conduction testing. NeuroMetrix received specific clearance to market NC-stat® via the U.S. Food and Drug Administration's (FDA) 510(k) process in 1998, listing as predicate devices the TECA model-10 electromyograph and the Neurometer® by Neurotron, which measures vibration threshold. The FDA-listed intended use was "to measure neromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies." In addition, the approved application stated that "The NC-stat is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements." The 2004 510(k) added a sural biosensor for use in diagnosing neuropathies affecting the sural nerve (K041320). NeuroMetrix also received FDA clearance to market models with biosensors and engineering changes that enable the NC-stat to be used for motor and sensory nerves of the wrist (median, ulnar) and foot (peroneal, tibial, and sural). The intended use as listed on the 510(k) approval from 2006 (K060584) is "to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies." The original NC-stat is no longer being produced. The current NeuroMetrix device, NC-stat® DPN-Check™, assesses the sural nerve. The NeuroMetrix ADVANCE™ system received marketing clearance in 2008 (K070109). It is intended to perform nerve conduction studies using disposable surface electrodes (similar to NC-stat) with an additional module for invasive needle EMG. NeuroMetrix lists NC-stat as a predicate device for the ADVANCE™ system.
Brevio® from Neurotron Medical received marketing clearance from FDA in 2001. The Brevio® is intended “for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.” The XLTek Neuropath (Excel- Tech) received clearance for marketing through the FDA’s 510(k) process in 2006; the indications are the same as those for NC-stat®.
POLICYAutomated nerve conduction tests are considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESNerve conduction studies performed without needle electromyography studies, unless contraindicated (i.e., an individual receiving anticoagulant therapy) are considered investigational.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/2/2007: Policy added
3/22/2007: Reviewed and approved by Medical Policy Advisory Committee (MPAC)
6/14/2007: Code Reference section updated per quarterly HCPCS and Category III revisions
10/11/2007: Code Reference section reviewed. CPT 95900, 95903, and 95904 removed from policy as non-covered for an automated point of care nerve conduction test (Note: Standard nerve conduction tests may be covered with these Copts); a specific HCPCS code for an automated point of care nerve conduction test became effective 7-1-2007
7/6/2009: Policy reviewed, description updated, policy statement unchanged
11/03/2010: Policy description section revised to provide a list of devices and research findings regarding portable automated nerve conduction tests compared to standard testing. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Added the following statement to the Policy Guidelines: Nerve conduction studies performed without needle electromyography studies, unless contraindicated (i.e., an individual receiving anticoagulant therapy) are considered investigational. Code Reference section revised to add 95905, 95999, and G0255 to the Non-Covered Codes Table. A note was also added to state that CPT Codes 95900, 95903 and 95904 should not be used to bill for automated nerve conduction testing.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
09/03/2013: Policy reviewed; no changes.
08/01/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.
07/08/2015: Code Reference section updated for ICD-10.
10/28/2015: Policy description updated regarding devices. Policy statement unchanged. Investigative definition updated in the policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.77
CODE REFERENCEThis is may not be a comprehensive list of procedure codes applicable to this policy.