MEDICAL POLICY
POLICY
RELATED POLICIES
POLICY GUIDELINES
CODING
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
APPENDIX
HISTORY
Automated Point-of-Care Nerve Conduction Tests
Number
2.01.77
Effective Date
September 1, 2016
Revision Date(s) 08/09/16;12/16/15; 08/11/15; 08/11/14; 08/12/13; 08/20/12;
08/09/11; 08/10/10; 09/15/09; 05/13/08; 06/12/07
Replaces
N/A
Policy
[TOP]
Automated nerve conduction tests are considered investigational.
Related Policies
[TOP]
None
Policy Guidelines
[TOP]
Automated Point-of-Care (POC) Nerve Conduction Devices
Portable, non-invasive devices are available to provide point-of-care (POC) nerve conductions studies (NCSs).
Electrodiagnostic NCS with automated, noninvasive devices measure nerve conduction velocity and conduction
time based on a stimulus applied to the peripheral nerve(s) through electrodes applied to the skin. The device
includes the nerve stimulator and the electronic processor to measure and display the response time and may be
contained in one hand-held unit.
An example of a device used at the point-of-care is the NC-stat® by NeuroMetrix. This device is marketed as an
alternative to conventional nerve conduction testing. It is a diagnostic and screening tool designed to perform
nerve conduction studies (NCSs). (See Regulatory Status for more examples.)
Coding
95905
95999
G0255
CPT
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
Unlisted neurological or neuromuscular diagnostic procedure
HCPCS
Current perception threshold/sensory nerve conduction test (SNCT), per limb
Administrative Guidelines
Sensory nerve conduction threshold (SNCT) testing codes (95907-95913) would NOT be used for automated
nerve conduction studies (NCS) that use preconfigured electrode array(s). (See code and description above).
Automated nerve conduction testing using devices that do not have stimulus and recording electrodes on the
same preconfigured electrode array, such as The Axon II™ (PainDX) device might be reported using either the
CPT or HCPCS code noted above.
Note: This policy only addresses use of automated, noninvasive nerve conduction testing devices as an
alternative to conventional methods of performing nerve conduction testing.
Description
[TOP]
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 and pharmacies without the need for specialized training or equipment.
Background
NCSs 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. (1) 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.
POC 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. (2) 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 POC. 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, sural). A chip embedded 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 POC 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.
Regulatory Status
Several devices are marketed for POC neural conduction testing.
NeuroMetrix received specific clearance to market NC-stat ® via the 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 neuromuscular 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, 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 NCSs 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. 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 FDA’s 510(k)
process in 2006; indications are the same as those for NC-stat ®.
FDA product code: JXE.
Scope
[TOP]
Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject
to the limits and conditions of the member benefit plan. Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
Benefit Application
[TOP]
N/A
Rationale
[TOP]
This policy was created in February 2007 and updated periodically with literature review. The most recent
literature review was through June, 2016.
Assessment of a diagnostic technology typically focuses on 3 categories of evidence:
1. Technical performance;
2. Diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) in appropriate
populations of patients;
3. Demonstration that the diagnostic information can be used to improve patient outcomes.
This evaluation will focus on the technical performance of NC-stat ®®, the first automated nerve conduction test
device to be marketed, and its reported performance in diagnosing patients (validity) with suspected deficits of
neuronal transmission (e.g., diabetic neuropathy, carpal tunnel syndrome [CTS], lumbosacral radiculopathy).
Technical Performance
Technical performance of a device is typically assessed with 2 types of studies;
1. Those that compare test measurements with a criterion standard and
2. Those that compare results taken with the same device on different occasions (test-retest reliability).
The criterion standard for nerve conduction testing is the electrophysiologic nerve conduction study (NCS)
combined with needle electromyography (EMG). Several studies have assessed the reliability and validity of NCstat ® when used by personnel trained in electrophysiology. These studies, most of which are companysponsored, are described next.
Comparison to the Reference Standard
A 2006 study compared results for sensory nerve testing from NC-stat ®NC-stat® and the reference standard in
median and ulnar nerves in 60 patients referred to an EMG laboratory for neck and shoulder pain who also
volunteered to undergo testing with NC-stat ®. (3) Reported correlations (Pearson correlation) between NC-stat ®
and the reference standard were high (0.91 for median nerve distal sensory latency [DSL], 0.70 for ulnar DSL,
0.88 for the median -ulnar difference of the DSL). However, this final correlation was calculated only with the
responses obtained for 81 (68%) of 120 possible nerve pairs. The authors of this study reported systematic
differences between the two techniques and indicated that use of NC-stat ® would require applicable reference
ranges.
A study of motor nerve function compared NC-stat ® with standard nerve conduction tests of the wrist in a small
study of 17 subjects with diabetes mellitus who had clinical evidence of peripheral neuropathy in either the upper
or lower extremity. (4) Again, Pearson correlation coefficients were relatively high and ranged from 0.70 for ulnar
distal motor latency (DML) to 0.96 for median nerve DML.
Another NeuroMetrix-sponsored trial compared NC-stat ® and standard EMG results for peroneal and posterior
tibial nerve conduction in 60 patients referred to an EMG laboratory. (5) The report indicated that all patients
referred to the laboratory were offered the opportunity to participate but did not provide the total number of
referrals. F-wave latency (FLAT) was found to have the highest correlation (Spearman p=0.91, 0.90, for peroneal
and posterior tibial nerves, respectively), with moderate correlations for amplitude (0.86, 0.73) and DML (0.70,
0.45). The authors concluded that there was excellent criterion validity for the peroneal and posterior tibial FLAT
and the peroneal amplitude; acceptable criterion validity for the peroneal DML and posterior tibial amplitude; but
the validity of the posterior tibial DML could not be demonstrated. Although NC-stat ® results were significantly
correlated with standard EMG tests in the study population as a whole, in subgroup analysis of the most abnormal
half of responses, the correlation coefficient for amplitude of the peroneal response was 0.62, and the correlation
coefficient for DML was only 0.32 for the posterior tibial nerve and 0.10 for the peroneal nerve. Thus, in this
pathologic subgroup analysis, criterion validity was lost for the peroneal DML and decreased from “excellent” to
“acceptable” for the other parameters. The authors noted that “this study did not address interpretations
performed by physicians using NC-stat ® data, nor the validity of the reference ranges used or the way these
were collected.”
In 2004, Rotman et al. reported A Pearson correlation coefficient of 0.944 for DML in 46 patients with CTS who
had a NCS at a different time (average difference, 28 days). (6) Another study compared results from NC-stat ®
and standard NCS in a previously diagnosed patient population. (7) This study compared DML of the median
nerve in 72 patients (of 400 treated) with established CTS before and after surgical intervention, finding a
correlation coefficient of 0.88 for the median nerve DML. However, a scatterplot indicated poor correlation for
longer latencies.
Test-Retest
NeuroMetrix reported intra-operator reliability in 15 healthy subjects who underwent measurements seven days
apart. (8) The report stated that “each upper- and lower -extremity nerve was tested twice by the same technician”
and that nine subjects participated in both upper- and lower -extremity studies. It is unclear from the report
whether the upper and lower extremities were designed as separate studies, or if 12 (29%) of 42 measurements
did not provide usable data. Of the data reported, the coefficient of variation ranged from 0.013 for F-wave latency
to 0.298 for the compound muscle action potential amplitude of the peroneal nerve. A 2010 publication by
NeuroMetrix reported test-retest reproducibility with the ADVANCE™ system in 30 subjects with symptoms
suggestive of neuropathies; 29 subjects completed the study. (9) Coefficients of variation ranged from 4.2% to
9.8% for tests measured three to seven days apart. Between -session intraclass correlation coefficients (ICCs)
ranged from 0.98 for F-wave latency to 0.77 for sural sensory conduction velocity.
Diagnostic Accuracy
Diagnostic performance is evaluated by the ability of a test to accurately diagnose a clinical condition in
comparison with a criterion standard. The sensitivity of a test is the ability to detect a disease when the condition
is present (true positive), while specificity indicates the ability to detect patients who are suspected of disease but
who do not have the condition (true negative). Evaluation of diagnostic performance, therefore, requires
independent assessment by the 2 methods in a population of patients who are suspected of disease but who do
not all have the disease. An additional issue with NC-stat ® is that this device is designed to be used by minimally
trained personnel (≈1 day for device-specific training), while the comparison standard is performed by specialists
with extensive training in EMG and electrophysiology. Studies that do not meet these criteria (broad patient
population and comparison of point-of-care [POC] use with the standard laboratory EMG) may be considered
relevant to the technical performance of the device but are inadequate for evaluation of its diagnostic
performance.
Carpal Tunnel Syndrome
In an early report of NC-stat ® technology using DML to diagnose CTS, Leffler et al. (2000) reported that in 248
symptomatic hands (apparently a combination of an initial and validation group), compared with conventional
diagnosis, testing using this device had a sensitivity of 86% and specificity of 90%. (10) In the 2004 report by
Rotman et al, (6) the NC-stat ® DML was shown to have a sensitivity of 89% “at the predetermined specificity of
95%” for the diagnosis of CTS for “70 hands” that met the standardized CTS case definition. However, in a POC
study evaluating industrial workers for possible CTS using DML, many patients who were identified with
prolonged DML by NC-stat ® fell within the normal range (using a 95% cutoff point) as defined by this study
population. (11) This study also commented on the importance of sensory nerve findings in the diagnosis of CTS,
suggesting a need to better define “normal” values.
Diabetic Peripheral Neuropathy
Another study assessed the validity of NC-stat ® to diagnose diabetic peripheral neuropathy through sural nerve
testing in patients from diabetes and diabetic neuropathy outpatient practices. (12) Perkins et al. (2006) enrolled
72 consecutive patients (64 with type 2 diabetes) who completed a clinical evaluation, a conventional NCS, and a
POC NC-stat ® assessment. The POC assessment was independently conducted by non-technologist research
staff following a single one-hour lesson in the NC-stat ® protocol. The amplitude potential of the sural nerve was
tested as an early indicator of diabetic neuropathy. Using a threshold of 6 µV, the authors reported that the
sensitivity and specificity of NC-stat ® for diagnosis of diabetic sensorimotor polyneuropathy, as defined by
clinical and conventional electrophysiologic evaluation, was 92% and 82%, respectively. The Spearman
correlation coefficient (compared with the reference standard) was 0.95. Further study is needed in a broad
spectrum of patients, including those who present with atypical neuropathy in a clinical setting.
In 2015, Sharma et al. assessed the technical accuracy of NC-stat ® DPN-Check in 162 patients with diabetes
and 80 healthy controls. (13) Based on the 10-point Neuropathy Disability Score, diabetic peripheral neuropathy
was categorized as none, mild, moderate, or severe. Measurements with the POC device were conducted by
blinded assessors. Receiver operating characteristic curves showed high overall accuracy in participants with
either no neuropathy or severe neuropathy. However, for patients with mild neuropathy who would benefit most
from early diagnosis, accuracy was substantially lower.
Further investigation is needed into specific approaches that include the POC NCS as a component of the clinical
care of those with polyneuropathy.
Lumbosacral Radiculopathy
Fisher et al. (2008) explored the relationship between NC-stat ® and routine NCS/needle EMG in 34 consecutive
patients with a clinical history and/or examination consistent with lumbosacral radiculopathy. (14) Inclusion in the
study was based on chart review of symptoms from clinical history and/or examination (including low back pain or
buttock pain, numbness, and/or paresthesias of one or both lower extremities) and having undergone testing with
both NC-stat ® and routine electrodiagnostic studies. All testing was conducted by the principal investigator, and
the reason for and timing of NC-stat ® testing was not specified. Of 34 patients included in the study, 28 had
magnetic resonance imaging (MRI) of the lumbosacral spine within six months of electrodiagnosis, two had a
post-myelogram computed tomography (CT) scan, and three had lumbosacral spine radiographs. A
neuroradiologist who was blinded to the clinical evaluation and electrodiagnostic results determined from MRI or
CT that lumbosacral root injury was likely at the L4-5 and/or L5-S1 levels in 18 patients (60%). The study found
some correlation between the electrodiagnostic testing and NC-stat ®. However, six of 10 patients who had
unremarkable routine electrodiagnostic results had abnormal F-wave and compound muscle action potential
amplitude abnormalities with NC-stat ® testing. The clinical implications of this finding are uncertain.
A 2011 report by Schmidt et al. assessed the accuracy of NC-stat ® diagnosis of lumbosacral radiculopathy in 50
patients and 25 controls with no prior history of lumbosacral radiculopathy. (15) The patient cohort included
patients referred to a tertiary referral EMG laboratory for testing of predominantly unilateral leg symptoms (pain,
numbness, weakness). Control subjects were recruited from clinic employees and from patients referred to the
EMG laboratory for upper -limb symptoms. All patients underwent focused history and physical examination and
both standard and automated electrodiagnostic testing. Automated testing was performed by experienced
technicians who were unaware of the electrodiagnostic test results. Data were transmitted to the manufacturer
and compared with a large database of previously recorded data, which were adjusted for the age and height of
the patient, and subsequently determined to be normal or abnormal. In the patient cohort, sensitivity of NC-stat ®
was found to be 0% for L4 radiculopathy, 69% for L5 radiculopathy, and 64% for S1 radiculopathy compared with
standard electrodiagnostic testing. By standard electrodiagnostic evaluation, 22 (44%) of the 50 symptomatic
patients had findings consistent with L4, L5, or S1 radiculopathy, and 28 patients (56%) were found to be normal
or to have a diagnosis other than lumbosacral radiculopathy; NC-stat ® identified only 4 of these 28 cases
(specificity, 14%). Standard electrodiagnostic testing also identified other important diagnoses in 9 patients (18%)
that were not identified by the automated test, while NC-stat ® reported 6 other diagnoses in patients found to be
normal by standard electrodiagnostic testing. All standard electrodiagnostic tests in the control group were
normal, but the automated test found that 18 of these subjects were abnormal (specificity, 32%). The study found
that raw nerve conduction data were comparable for the 2 techniques; however, computer-generated
interpretations by the automated device showed low specificity (numerous false-positives) in both symptomatic
patients and normal control subjects. An accompanying editorial by England and Franklin stated that the use of
automated nerve conduction devices is controversial and that the use of NC-stat ® for lumbosacral radiculopathy
would likely lead to a high misdiagnosis rate and potentially inappropriate treatment, including surgery. (16)
England and Franklin also concluded that an overly sensitive but not very specific test for CTS, or other mono- or
polyneuropathies, cannot replace expert use and interpretation of conventional electrodiagnostic testing.
Mixed Population
A 2008 report assessed the diagnostic performance of NC-stat ® against the criterion standard NCS in patients
who had been referred for electrodiagnostic testing at one of several academic medical centers. (17) Of 47
patients who were invited to participate in the study, 12 declined to participate, and records from one patient were
missing, resulting in data analysis of 33 patients. The goal of the study was to compare diagnostic performance of
the 2 methods of nerve conduction testing as they would be used in standard practice; thus, patients were not
excluded on the basis of the particular diagnosis for which they were referred. The diagnosis being tested was
CTS in 25 patients (76%), with the remaining eight patients having eight other potential diagnoses, including ulnar
neuropathy, upper -extremity paresthesias, and C6 radiculopathy. NC-stat ® testing was independently performed
by assistants (medical students, physical therapy assistants, occupational therapy assistants) who were trained to
operate the device following the manufacturer’s recommendations. NC-stat ® results could not be obtained for
two patients for median nerve motor studies and three patients for median nerve sensory studies (15%). Based
on the manufacturer’s suggested cutoff for abnormal nerve conduction, sensitivity was 100% for both the motor
and sensory median-ulnar difference; specificity was 62% to 69 % for the motor median-ulnar difference and 41%
to 47% for the sensory median-ulnar difference. Pearson correlation coefficients ranged from 0.40 for the ulnar
nerve to 0.91 for the median dorsal motor nerve. The ICCs had generally lower values than the Pearson
coefficients, reflecting systematic bias due to methodologic differences in the two methods of NCS. The authors
concluded that the recommended cutoff values for NC-stat ® may need to be adjusted, although specific study
results were limited by the small sample size. In addition, the authors noted that the study did not evaluate how
well physicians can assign clinical relevance to the results and that while the device may be suited for research
studies or screening of symptomatic patients, “in many clinical situations referral to a specialist for a more
comprehensive evaluation would be prudent.”
Normative Values
In 2009, NeuroMetrix published a study of reference ranges for key nerve conduction parameters in healthy
subjects. (18) Data analyzed in the article were pooled from five studies, including from 92 to 848 healthy subjects
with data on the median, ulnar, peroneal, tibial, and sural nerves. Subject age and height were found to affect the
parameters. In addition to providing reference ranges for clinicians to use (providing that NCS techniques are
consistent with those described in the article), the authors stated that clinicians could use the same method to
develop their own reference ranges. At this time, the proposed reference ranges have not been validated in a
clinical patient population.
Clinical Outcomes
In 2011, Bourke et al. reported a non-randomized comparison of clinic-based NC-stat ® versus referral to
standard electrodiagnostic testing that evaluated efficiency of workup and costs. The study included 142 patients
being considered for decompression surgery for CTS at a hand clinic. (19) Seventy-one patients who accepted
nerve NCSs in a nurse-led clinic were compared with 71 historical controls who had been sent for NCSs at the
regional neurophysiologic unit. Patients with known or suspected complex neurologic conditions were excluded
from the study. Outcome measures were time from presentation to carpal tunnel decompression, the cost of each
pathway, and the practicalities of using the device in the clinic. In the NC-stat ® group, 43 patients (61%) had a
diagnosis of CTS confirmed by NC-stat ® and underwent decompression surgery, and 28 patients (39%) had
normal or inconclusive tests. Of these 28 patients, 12 were referred for electrodiagnostic testing, and 2 of these
were recommended for decompression surgery (3% false negative). In the referred group, 44 patients (62%) had
confirmation of CTS and underwent decompression surgery. Use of NC-stat ® in the clinic reduced the time from
presentation to surgery from 198 days to 102 days. Cost saving for NC-stat ® was reduced by the need to refer
nearly 20% of patients for standard electrophysiologic testing, but still favored the clinic-based approach. Health
outcomes for the 2 approaches were not assessed.
The NeuroMetrix data registry was analyzed for all NC-stat ® studies that were performed by a primary care
provider and coded for CTS over a period of 10 days. (20) The initial data set consisted of studies on 1,190
patients performed by 613 different physician practices; studies that met CTS testing guidelines (82% met strict
guidelines, 93% met less restrictive guidelines) were further analyzed. Thus, in nearly one of five patients
(18.4%), the studies did not meet strict CTS testing guidelines. From the limited patient set, 31% were identified
as normal, 53% exhibited CTS, 5% demonstrated an ulnar neuropathy, and 11% showed a nonspecific
neuropathy. No comparison was made with standard nerve conduction testing nor was an assessment made of
the impact of this testing on relevant clinical outcomes.
A 2007 study used NC-stat ® to assess the effect of a pharmaceutical agent on nerve conduction in patients with
diabetic peripheral neuropathic pain. (21)
Ongoing and Unpublished Clinical Trials
One unpublished trial that might influence this policy is listed in Table 1.
Table 1. Summary of Key Trials
NCT No.
Unpublished
a
NCT01565317
Trial Name
Planned
Enrollment
Completion
Date
Evaluation of the Effect of Intensive Diabetes Control Through
Non-Surgical Intensive Lifestyle Modifications and Weight
Reduction on Diabetic Peripheral Neuropathy
70
Dec 2014
NCT: national clinical trial.
a
Denotes industry-sponsored or cosponsored trial.
Summary of Evidence
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 (POC) automated testing. Particularly needed are data on the sensitivity and specificity of automated
nerve conduction tests performed by non-specialists at the POC in comparison with the “criterion standard” of
laboratory nerve conduction studies/electromyography (NCSs/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 POC nerve
conduction tests on clinical outcomes in this population. Overall, evidence addressing the utility of POC
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 POC nerve conduction tests on health
outcomes. Therefore, automated POC nerve conduction tests are considered investigational.
Practice Guidelines and Position Statements
American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM)
In 2006 the AANEM issued a position statement that illustrated how standardized NCSs performed independent
of needle EMG studies may miss data essential for an accurate diagnosis. (22) AANEM discussed how nerve
disorders are far more likely to be misdiagnosed or missed completely if a practitioner without the proper skill and
training is interpreting the data, making a diagnosis, and establishing a treatment plan. The organization states
that, “the standard of care in clinical practice dictates that using a predetermined or standardized battery of NCSs
for all patients is inappropriate,” and concludes that, “It is the position of the AANEM that, except in unique
situations, NCSs and needle EMG should be performed together in a study design determined by a trained
neuromuscular physician.” This position statement was reviewed and updated by the Professional Practice
Committee and approved by the AANEM Board in June 2014.23 No changes were made to the earlier statement
on NCSs.
American Association of Electrodiagnostic Medicine (AANEM), American Academy of
Neurology (AAN), and American Academy of Physical Medicine and Rehabilitation
(AAPMR)
Practice Parameters (2002) from the AANEM, AAN, and AAPMR recommended measuring sensory and motor
nerve function in patients with suspected carpal tunnel syndrome. (24)
U.S. Preventive Services Task Force Recommendations
Not applicable.
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the
discretion of local Medicare carriers.
References
[TOP]
1. MacDermid JC, Doherty T. Clinical and electrodiagnostic testing of carpal tunnel syndrome: a narrative
review. J Orthop Sports Phys Ther. Oct 2004; 34(10):565-588. PMID 15552704
2. Boulton AJ, Vinik AI, Arezzo JC, et al. Diabetic neuropathies: a statement by the American Diabetes
Association. Diabetes Care. Apr 2005; 28(4):956-962. PMID 15793206
3. Kong X, Gozani SN, Hayes MT, et al. NC-stat ® sensory nerve conduction studies in the median and
ulnar nerves of symptomatic patients. Clin Neurophysiol. Feb 2006; 117(2):405-413. PMID 16403673
4. Vinik AI, Emley MS, Megerian JT, et al. Median and ulnar nerve conduction measurements in patients
with symptoms of diabetic peripheral neuropathy using the NC-stat ® system. Diabetes Technol Ther.
Dec 2004; 6(6):816-824. PMID 15684634
5. Jabre JF, Salzsieder BT, Gnemi KE. Criterion validity of the NC-stat ® automated nerve conduction
measurement instrument. Physiol Meas. Jan 2007; 28(1):95-104. PMID 17151423
6. Rotman MB, Enkvetchakul BV, Megerian JT, et al. Time course and predictors of median nerve
conduction after carpal tunnel release. J Hand Surg Am. May 2004; 29(3):367-372. PMID 15140473
7. Elkowitz SJ, Dubin NH, Richards BE, et al. Clinical utility of portable versus traditional electrodiagnostic
testing for diagnosing, evaluating, and treating carpal tunnel syndrome. Am J Orthop (Belle Mead NJ).
Aug 2005; 34(8):362-364. PMID 16187725
8. Kong X, Lesser EA, Megerian JT, et al. Repeatability of nerve conduction measurements using
automation. J Clin Monit Comput. Dec 2006; 20(6):405-410. PMID 16972142
9. Kong X, Schoenfeld DA, Lesser EA, et al. Implementation and evaluation of a statistical framework for
nerve conduction study reference range calculation. Comput Methods Programs Biomed. Jan 2010;
97(1):1-10. PMID 19497634
10. 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. Apr 2000; 42(4):398-409. PMID 10774509
11. Katz RT. NC-stat ® as a screening tool for carpal tunnel syndrome in industrial workers. J Occup Environ
Med. Apr 2006; 48(4):414-418. PMID 16607197
12. 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. Sep 2006; 29(9):2023-2027. PMID
16936147
13. 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. PMID 25231114
14. Fisher MA, Bajwa R, Somashekar KN. Routine electrodiagnosis and a multiparameter technique in
lumbosacral radiculopathies. Acta Neurol Scand. Aug 2008; 118(2):99-105. PMID 18355396
15. 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. Jan 2011; 43(1):9-13. PMID 21108323
16. England JD, Franklin GM. Automated hand-held nerve conduction devices: raw data, raw interpretations.
Muscle Nerve. Jan 2011; 43(1):6-8. PMID 21171092
17. 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. Jul 2008; 50(7):758-764.
PMID 18617831
18. Kong X, Lesser EA, Gozani SN. Repeatability of nerve conduction measurements derived entirely by
computer methods. Biomed Eng Online. 2009; 8:33. PMID 19895683
19. 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. Apr 2011;
93(3):236-240. PMID 21477439
20. 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. Jan-Feb
2007;20(1):60-64. PMID 17204736
21. Hardy T, Sachson R, Shen S, et al. Does treatment with duloxetine for neuropathic pain impact glycemic
control? Diabetes Care. Jan 2007; 30(1):21-26. PMID 17192327
22. American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). Proper performance
and interpretation of electrodiagnostic studies. Muscle Nerve. Mar 2006; 33(3):436-439. PMID 16395691
23. American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). AANEM Proper
Performance and Interpretation of Electrodiagnostic Studies. 2014
https://www.aanem.org/getmedia/bd1642ce-ec01-4271-8097-81e6e5752042/PositionStatement_Proper-Performance-of-EDX_-2014.pdf.aspx. Accessed July 2016.
24. Jablecki CK, Andary MT, Floeter MK, et al. Practice parameter: Electrodiagnostic studies in carpal tunnel
syndrome. Report of the American Association of Electrodiagnostic Medicine, American Academy of
Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. Jun 11
2002; 58(11):1589-1592. PMID 12058083
25. Chatzikosma G, Pafili K, Demetriou M, Vadikolias K, Maltezos E, Papanas N. Evaluation of sural nerve
automated nerve conduction study in the diagnosis of peripheral neuropathy in patients with type 2
diabetes mellitus. Archives of Medical Science : AMS. 2016;12(2):390-393. PMID 27186185
26. Blue Cross and Blue Shield Association. Automated Point-of-Care Nerve Conduction Tests. Medical
Policy Reference Manual, Policy 2.01.77, 2015.
Appendix
[TOP]
N/A
History
[TOP]
Date
06/12/07
05/13/08
09/15/09
08/10/10
08/09/11
08/20/12
08/16/13
09/03/14
08/11/15
12/16/15
08/09/16
Reason
Add to Medicine Section - New Policy
Replace Policy - Policy updated with literature search; no change to the policy statement.
Reference and code added.
Replace Policy - Policy updated with literature search; no change to the policy statement.
References added.
Replace Policy - Policy updated with literature search through April 2010; references have been
added and reordered. The policy statement remains unchanged. Code 95905 has been added.
Replace Policy – Policy updated with literature review through April 2011; references 15 and 16
added and references reordered; policy statement unchanged. Codes updated.
Replace policy. Policy updated with literature review through March 2012; reference 18 added and
references reordered; policy statement unchanged.
Replace policy. Policy updated with literature review through April 29, 2013; policy statement
unchanged.
Annual Review. Policy updated with literature review through May 23, 2014; no new references
added. Policy statement unchanged.
Annual Review. Policy updated with literature review through May 12, 2015; references 13 and 23
added. Policy statement unchanged.
Update Related Polices. Remove 2.01.39 as it is archived.
Annual Review. Policy updated with literature review through June, 2016; 1 reference added. Policy
statement unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts
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ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ
ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ
ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ
ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ
800-722-1471 (TTY: 800-842-5357).
‫( فارسی‬Farsi):
‫اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم‬. ‫اين اعالميه حاوی اطالعات مھم ميباشد‬
‫ به تاريخ ھای مھم در‬.‫ باشد‬Premera Blue Cross ‫تقاضا و يا پوشش بيمه ای شما از طريق‬
‫شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه‬. ‫اين اعالميه توجه نماييد‬
‫شما حق‬. ‫ به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد‬،‫ھای درمانی تان‬
‫ برای کسب‬.‫اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد‬
‫( تماس‬800-842-5357 ‫ تماس باشماره‬TTY ‫ )کاربران‬800-722-1471 ‫اطالعات با شماره‬
.‫برقرار نماييد‬
Polskie (Polish):
To ogłoszenie może zawierać ważne informacje. To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub
pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471
(TTY: 800-842-5357).
Português (Portuguese):
Este aviso contém informações importantes. Este aviso poderá conter
informações importantes a respeito de sua aplicação ou cobertura por meio
do Premera Blue Cross. Poderão existir datas importantes neste aviso.
Talvez seja necessário que você tome providências dentro de
determinados prazos para manter sua cobertura de saúde ou ajuda de
custos. Você tem o direito de obter esta informação e ajuda em seu idioma
e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Fa’asamoa (Samoan):
Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau
ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala
atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua
atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei
fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le
aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai
i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua
atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i
ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471
(TTY: 800-842-5357).
Español (Spanish):
Este Aviso contiene información importante. Es posible que este aviso
contenga información importante acerca de su solicitud o cobertura a
través de Premera Blue Cross. Es posible que haya fechas clave en este
aviso. Es posible que deba tomar alguna medida antes de determinadas
fechas para mantener su cobertura médica o ayuda con los costos. Usted
tiene derecho a recibir esta información y ayuda en su idioma sin costo
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Tagalog (Tagalog):
Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon
tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue
Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring
mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang
panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na
walang gastos. May karapatan ka na makakuha ng ganitong impormasyon
at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471
(TTY: 800-842-5357).
ไทย (Thai):
ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน
สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง
ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่
มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร
800-722-1471 (TTY: 800-842-5357)
Український (Ukrainian):
Це повідомлення містить важливу інформацію. Це повідомлення
може містити важливу інформацію про Ваше звернення щодо
страхувального покриття через Premera Blue Cross. Зверніть увагу на
ключові дати, які можуть бути вказані у цьому повідомленні. Існує
імовірність того, що Вам треба буде здійснити певні кроки у конкретні
кінцеві строки для того, щоб зберегти Ваше медичне страхування або
отримати фінансову допомогу. У Вас є право на отримання цієї
інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за
номером телефону 800-722-1471 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese):
Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông
tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua
chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông
báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn
để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có
quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình
miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).