Coverage Policy Manual
Policy #: 1998141
Category: Medicine
Initiated: August 1998
Last Review: July 2022
  Quantitative Sensory Testing

Description:
Quantitative sensory testing (QST) systems are used for the noninvasive assessment and quantification of sensory nerve function in patients with symptoms of, or the potential for neurologic damage or disease. Types of sensory testing include current perception threshold testing, pressure-specified sensory testing, vibration perception testing (VPT), and thermal sensory testing. Information on sensory deficits identified using QST has been used in research settings to understand neuropathic pain better. It could be used to diagnose conditions linked to nerve damage and disease, and to improve patient outcomes by impacting management strategies.
 
Nerve damage and nerve diseases can reduce functional capacity and lead to neuropathic pain. There are also racial and ethnic disparities due to biological factors as well as social and environmental contributors in diseases that can lead to neuropathic pain (Spanakis, 2013). For example, incidence of neuropathy due to diabetic microvascular complications is higher in minority populations compared to non-Hispanic Whites (Taylor, 2018).
 
There is a need for tests that can objectively measure sensory thresholds. Moreover, quantitative sensory testing (QST) could aid in the early diagnosis of disease. Also, although the criterion standard for evaluation of myelinated, large fibers is electromyography nerve conduction study, there are no criterion standard reference tests to diagnose small fiber dysfunction.
 
Quantitative sensory test (QST) systems measure and quantify the amount of physical stimuli required for sensory perception to occur. As sensory deficits increase, the perception threshold of QST will increase, which may be informative in documenting the progression of neurologic damage or disease. Currently, QST has not been established for use as a sole tool for diagnosis and management but has been used with standard evaluative and management procedures (eg, physical and neurologic examination, monofilament testing, pinprick, grip and pinch strength, Tinel sign, and Phalen and Roos test) to enhance the diagnosis and treatment-planning process, and to confirm physical findings with quantifiable data. Stimuli used in QST include touch, pressure, pain, thermal (warm and cold), or vibratory stimuli.
 
The criterion standard for evaluation of myelinated, large fibers is the electromyography nerve conduction study. However, the function of smaller myelinated and unmyelinated sensory nerves, which may show pathologic changes before the involvement of the motor nerves, cannot be detected by nerve conduction studies. Small fiber neuropathy has traditionally been a diagnosis of exclusion in patients who have symptoms of distal neuropathy and a negative nerve conduction study.
 
Depending on the type of stimuli used, QST can assess both small and large fiber dysfunction. Touch and vibration measure the function of large myelinated A alpha and A beta sensory fibers. Thermal stimulation devices are used to evaluate pathology of small myelinated and unmyelinated nerve fibers; they can be used to assess heat and cold sensation, as well as thermal pain thresholds. Pressure-specified sensory devices assess large myelinated sensory nerve function by quantifying the thresholds of pressure detected with light, static, and moving touch. Finally, current perception threshold testing involves the quantification of the sensory threshold to transcutaneous electrical stimulation. In current perception threshold testing, typically 3 frequencies are tested: 5 Hz, designed to assess C fibers; 250 Hz, designed to assess A delta fibers; and 2000 Hz, designed to assess A beta fibers. Results are compared with those of a reference population.
 
Because QST combines the objective physical, sensory stimuli with the subject patient response, it is psychophysical and requires patients who are alert, able to follow directions, and cooperative. Also, to get reliable results, examinations need to include standardized instructions to the patients, and stimuli must be applied consistently by trained staff. Psychophysical tests have greater inherent variability, making their results more difficult to reproduce.
 
Primarily, QST has been applied in patients with conditions associated with nerve damage and neuropathic pain. A retrospective analysis of a prospective database maintained by the German Research Network on Neuropathic Pain by Forstenpointner et al compared QST profiles between patients with painful neuropathic conditions (n=332), patients with neuropathic conditions who did not report pain (n=111), and healthy controls (n=112). After extensive QST testing, including thermal, mechanical/vibration, and pain sensitivity, the researchers found similar QST profiles between patients who reported pain and patients who did not report pain, which raises concern about the role of QST in general in decision-making for neuropathic conditions (Forstenpointner, 2021). There have also been preliminary investigations to identify sensory deficits associated with conditions such as autism spectrum disorder, Tourette syndrome, restless legs syndrome, musculoskeletal pain, and response to opioid treatment.
 
Regulatory Status
A number of QST devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process:
 
FDA product code: LLN
    • Neurometer®, manufactured by Neurotron, was cleared in June of 1986 (K853608) for Current perception threshold testing
    • NK Pressure-Specified Sensory Device, Model PSSD, manufactured by NK Biotechnical Engineering, was cleared in August of 1994 (K934368) for Pressure-specified sensory testing
    • AP-4000, Air Pulse Sensory Stimulator, manufactured by Pentax Precision Instrument, was cleared in September of 1997 (K964815) for Pressure-specified sensory testing
    • Neural-Scan, manufactured by Neuro-Diagnostic Assoc., cleared in December of 1997 (K964622) for Current perception threshold testing
    • Vibration Perception Threshold (VPT) METER, manufactured by Xilas Medical, in December of 2003 (K030829) for Vibration perception testing
    • Pain Vision, Model PS-2100, manufactured by Osachi Co., LTD, cleared in January of 2009 (K072882) for Current perception threshold testing
FDA product code: NTU
    • Contact Heat-Evoked Potential Stimulator (Cheps), manufactured by Medoc, Advanced Medical Systems, cleared in February of 2005 (K041908) for Thermal sensory testing
    • Modified Contact-Heat Evoked Potential Stimulator (Cheps), manufactured by Medoc, Advanced Medical Systems, cleared in June 2005 (K051448) for Thermal sensory testing
    • Pathway - Ats/Cheps, manufactured by Medoc, Advanced Medical Systems, cleared in January of 2006 (K052357) for Thermal sensory testing
 
Coding
There is a HCPCS code, G0255, (Current perception threshold/sensory nerve conduction test, (SNCT) per limb, any nerve) Another distinction between a nerve conduction test and the current perception threshold test is that the former is performed in a laboratory setting, while the latter is performed in an office setting. Codes 95907-95913 might now be incorrectly reported for these services.

Policy/
Coverage:
Effective November 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Quantitative sensory testing, including but not limited to current perception threshold testing (e.g., Neurometer®, Neural-Scan™, Nervepace Digital Electroneurometer), pressure-specified sensory device testing (e.g., NK Pressure-Specified Sensory Device™, AP-4000, Air Pulse Sensory Stimulator), vibration perception threshold testing (e.g., Vibration Perception Threshold METER), and thermal threshold testing (Contact Heat-Evoked Potential Stimulator, Cheps), does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, quantitative sensory testing, including but not limited to current perception threshold testing (e.g., Neurometer®, Neural-Scan™, Nervepace Digital Electroneurometer), pressure-specified sensory device testing (e.g., NK Pressure-Specified Sensory Device™, AP-4000, Air Pulse Sensory Stimulator), vibration perception threshold testing (e.g., Vibration Perception Threshold METER), and thermal threshold testing (Contact Heat-Evoked Potential Stimulator, Cheps), is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to November 2021
 
The use of the Nervespace Digital Electroneurometer, the Neurometer CPT,  the Pressure-Specifying Sensory Device (PSSD), or any similar device, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, the use of the Nervespace Digital Electroneurometer, the Neurometer CPT, the Pressure-Specifying Sensory Device (PSSD), or any similar device  is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
Quantitative sensory testing (QST) can either be used as the initial diagnostic test or as a monitoring test in patients to assess ongoing sensory deficits. The type of data required to validate QST in these 2 different settings are different. For example, as an initial diagnostic test, one would like to see standard measures of diagnostic performance, such as sensitivity, specificity, positive and negative predictive values as compared to conventional tests, such as monofilament testing, pinprick, etc. In some cases, QST has been proposed as an alternative to nerve conduction studies, and, in this setting, one would like to compare the diagnostic performances of these 2 tests. When used as a monitoring technique, test/retest reliability is an important outcome, as well as defining a clinically significant change in sensory perception. As with any diagnostic test, it is important to evaluate how the results of the test will be used to enhance patient management, either in terms of instituting more prompt or more effective therapy, or in the avoidance of more invasive tests, such as nerve conduction studies.
 
In a 2003 report, the American Academy of Neurology (AAN) noted QST should not be used as a sole method for diagnosis of pathology.  The AAN indicated QST poses technical challenges in the methodology of testing, reproducibility, and psychophysical factors that limit the objectivity of testing results. Siao and Cros noted in a review that QST is influenced by many extraneous factors and may be subject to misinterpretation and misuse.  In addition, normal reference levels do not exist, and the reproducibility of QST has not been firmly established. Also, there are no generally recognized standards for QST techniques, performance, and interpretation.
 
Current Perception Threshold Testing
 
In 1999, the American Association of Electrodiagnostic Medicine (AAEM) published a technology review of the Neurometer® device.  This evaluation suggested the following criteria for the evaluation of the device:
    • A prospective study
    • Independent ascertainment of the clinical condition evaluated
    • A detailed description of the methodology
    • Attention to testing conditions that could potentially affect the results
    • A suitable reference population from the same laboratory
    • Criteria for abnormality obtained from the reference population and defined in statistical terms.
 
The AAEM assessment concluded that there is inadequate scientific literature meeting the above criteria to validate the clinical role of current perception threshold testing. Much of the literature compares the results of Neurometer® testing to nerve conduction studies in patients with known disease. In many instances the results of the Neurometer® testing demonstrated more numerous or pronounced abnormalities compared to nerve conduction studies, which was consistent with the hypothesis that abnormalities of small nerve fibers precede those of large nerve fibers tested in nerve conduction studies. However, this observation could also be related to the fact that use of the Neurometer® involves testing at multiple sites with 3 different frequencies and that any identified abnormality is considered significant. Testing the perception threshold at different frequencies is designed to evaluate the function of different subclasses of nerve fibers. However, this hypothesis has not been adequately evaluated, in part due to a lack of a diagnostic gold standard for comparison purposes. In this situation, validation of a diagnostic technology requires study of how the technique is used in the management of the patient and whether subsequent changes in the management of the patient are associated with improved health outcomes. Finally, results of the Neurometer® testing are compared to a normal reference population. The review by the AAEM found that the source of the normal values was not apparent from the published literature. The AAEM assessment concluded with the following recommendations regarding research to validate the clinical utility of the Neurometer®:
    • Reference values need to be established for well-characterized and representative populations.
    • Reproducibility and interoperator variability of the Neurometer® CPT normal values need to be established and expressed statistically in control subjects and patients with specific diseases.
    • The sensitivity and specificity need to be established and compared to an appropriate standard.
    • In promotional material, the Medi-Dx 7000™ device is presented as an alternative to the Neurometer® with the capability of identifying abnormalities in branches of individual nerves. A literature review failed to identify any articles in the published peer-reviewed literature specifically focusing on the Medi-Dx 7000™ device.
 
In an updated review of the literature, 2 studies reported on attempts to establish the diagnostic utility of current perception threshold testing. In Yamashita, 48 patients with lumbar radiculopathy were compared with 11 healthy controls to evaluate current perception thresholds using the Neurometer®.  The authors reported finding significantly higher current perception threshold values in the affected legs of patients with lumbar radiculopathy at 2000, 250, and 5 Hz frequencies than in the unaffected legs. Current perception threshold values in the affected legs were also significantly higher in control subjects at 2000 and 250 Hz frequencies but not significantly different at 5 Hz. The authors concluded that current perception threshold testing may be useful in quantifying sensory nerve dysfunction in patients with radiculopathy. However, there was no discussion of how this quantification could be used in the management of the patient.
 
Park and colleagues attempted to validate current perception threshold testing against the gold standard references for thermal sensory testing and von Frey tactile hair stimulation in a randomized, double-blind, placebo-controlled trial on 19 healthy volunteers. The authors reported finding that all current perception threshold measurements showed a higher degree of variability than thermal sensory testing and von Frey measurements, but concluded that there is some evidence that similar fiber tracts may be measured, especially C-fiber tract activity at 5 Hz, with current perception threshold, thermal sensory, and von Frey testing methods. However, none of these studies sufficiently address the AAEM recommendations for research to validate the clinical utility of current perception threshold testing.
 
Pressure-Specified Sensory Testing
A review of the literature on pressure-specified sensory device (PSSD) testing found insufficient evidence to demonstrate that PSSD testing will provide any further information than what can ordinarily be determined during standard evaluation and management of patients with potential nerve compression, disease, or damage. Standard evaluation and management consist of physical examination techniques and may include Semmes-Weinstein monofilament testing and, in some more complex cases, NCV testing. While PSSD may be a useful adjunct in neurosensory testing, no clinical trials were identified that demonstrated that use of the PSSD resulted in earlier and/or more accurate diagnoses of nerve damage and improved patient outcomes. Nor were any studies found that examined this technology for patient selection criteria for carpal or tarsal tunnel release, plexus neurolysis, etc. In addition, no clinical practice guidelines were found that addressed the use of PSSD. As noted here, in the evaluation of current perception threshold testing, further research is needed to validate the clinical utility of PSSD; to establish reference values for well-characterized and representative populations; to establish normal values in control subjects and patients with specific diseases to reduce interoperator variability and increase reproducibility; and to establish sensitivity and specificity comparisons to appropriate standards.
 
2006 Update
A literature review was conducted for the period of March 2005 through July 2006. No clinical studies were found that would alter the policy statement noted above. While studies using these technologies continue, the impact of this testing on improving clinical outcomes has not been shown. There also continues to be questions about the performance of the test; one recent study noted “significant” variability in thermal perception thresholds during a 1-hour time in 24 female volunteers.
 
2007-2008 Update
A search of the MEDLINE database was performed for the period of August 2006 through February 2008. A multicenter study funded by a pharmaceutical company compared vibration threshold testing (CASE IV, biothesiometer, C64 graduated tuning fork) with standard nerve conduction studies (NCS) in 195 (86% follow-up) subjects with diabetes mellitus. The tests were performed independently by trained technicians; all NCS evaluations were sent to a central reading center. Intra-class correlation coefficients for the tests ranged from 0.81 to 0.95, indicating excellent to highly reproducible results. Correlation coefficients for the various vibration QST instruments were moderate at -0.55 (CASE IV vs. tuning fork) to 0.61 (CASE IV vs. biothesiometer). In contrast, the correlation coefficient between CASE IV and a composite score for nerve conduction was low (r = 0.24). These results indicate that vibration threshold testing could not replace NCS testing, but might provide a complementary outcome measure. Overall, questions remain about the clinical utility of sensory nerve conduction threshold testing. Evidence is insufficient to demonstrate an improvement in health outcomes. Therefore, the policy statement remains unchanged.
 
Physician Specialty Society and Academic Medical Center Input
 
In response to the request for input from Physician Specialty Societies and Academic Medical Centers, input was received through the American Academy of Neurology and one academic medical center regarding use of quantitative sensory testing while the policy was under review. Input from both sources agreed with the policy statement that QST is considered investigational, as adopted in the policy in April 2008.
 
A 2003 report from the American Academy of Neurology concluded that QST is probably (level B recommendation) an effective tool in the documentation of sensory abnormalities and in documenting changes in sensory thresholds in longitudinal evaluation of patients with diabetic neuropathy. Evidence was weak or insufficient to support the use of QST in patients with other conditions (small fiber sensory neuropathy, pain syndromes, toxic neuropathies, uremic neuropathy, acquired and inherited demyelinating neuropathies, or malingering). General recommendations indicated that QST results should not be the sole criterion used to diagnose structural pathology, or either a peripheral or central nervous system (CNS) origin. Abnormalities on QST must be interpreted in the context of a thorough neurologic examination and other appropriate testing, such as electromyography (EMG), nerve biopsy, skin biopsy, or appropriate imaging studies.
 
The American Association of Electrodiagnostic Medicine published a technology literature review on quantitative sensory testing (light touch, vibration, thermal, and pain) in 2004. The review concluded that QST is a reliable psychophysical test of large- and small-fiber sensory modalities, but is highly dependent on the full cooperation of the patient. Abnormalities do not localize dysfunction to the central or peripheral nervous system, and no algorithm can reliably distinguish between psychogenic and organic abnormalities. The AAEM technology review also indicated that QST has been shown to be reasonably reproducible over a period of days or weeks in normal subjects, but for individual patients, more studies are needed to determine the maximum allowable difference between 2 QSTs that can be attributed to experimental error.
 
In 2004 the European Federation of Neurological Societies published guidelines on neuropathic pain assessment. The task force concluded that QST is helpful to quantify the effects of treatments on allodynia and hyperalgesia (grade A recommendation), but recommends the use of simple tools such as a brush and high-threshold von Frey filaments. Because QST abnormalities are also found in non-neuropathic pains, QST abnormalities cannot be taken as a conclusive demonstration of neuropathic pain. The recommendations also indicated that QST is expensive and time consuming, and thus difficult to use in clinical practice.
 
2012 Update
A search of the MEDLINE database conducted through July 2012 did not reveal any new information that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through July 2013 did not reveal any new literature that would prompt a change in the coverage statement. No comparative studies evaluating the impact of current perception testing on patient management decisions or health outcomes were identified.
 
Limited published evidence is available on the diagnostic performance of current perception threshold testing. Several studies have compared current perception threshold testing to other testing methods, but sensitivity and specificity have not been reported. For example, in 2012, Ziccardi and colleagues evaluated 40 patients presenting with trigeminal nerve injuries involving the lingual branch (Ziccardi, 2012).   Patients underwent current perception threshold testing, as well as standard clinical sensory testing. Statistically significant correlations were found between findings of electrical stimulation testing at 250 Hz and the reaction to pinprick testing (p=0.02), reaction to heat stimulation (p=0.01) and reaction to cold stimulation (p=0.004). In addition, significant correlations were found between electrical stimulation at 5 Hz and the reaction to heat stimulation (p=0.017), reaction to cold stimulation (p=0.004), but not the reaction to pinprick testing (p=0.096).
  
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2014 study by Ahmed et al addressed how QST might be used in practice, although it did not directly study clinical utility (Ahmad, 2014). The study was prospective and included 124 opioid-naïve patients scheduled for abdominal myomectomy or hysterectomy. Patients underwent preoperative thermal QST, conducted by the same investigator. Tests included warm and cold sensation in which patients activated a button as soon as they felt a temperature change and warm and cold pain modalities in which the button was pressed when pain thresholds were reached.
 
The primary outcome was morphine use in the 24 hours after surgery. Intravenous morphine was administered post-surgery such that an individual’s pain level rated less than 4 on a 0 to 10 scale; pain was assessed upon arrival and every 6 hours thereafter. In addition, a patient-controlled analgesia system was used to deliver morphine in the first 24 hours. Preoperative heat and cold pain thresholds were significantly correlated with 24-hour morphine consumption. Patients with initial heat pain thresholds above the median and cold pain thresholds above the median used more morphine (a median of 19 mg more, p=0.004). The authors stated that findings could be used to stratify patients pre-operatively based on their baseline thermal QST scores and manage patients’ more or less aggressively depending on their QST test findings. However, since the study did not prospectively manage patients and opioid administration was individualized to each patient; it is not clear how management would differ if QST scores had been incorporated in the management strategy.
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2015 study by Vuilleumier and colleagues evaluated reliability of QST in a low-back pain population; it included evaluation of thermal QST using an FDA-approved device by Medoc (Vuilleumier, 2015). A total of 89 patients participated in 2 QST sessions conducted at least 7 days apart. The median of 3 thermal perception trials on the first day was compared to the median on the second day (between-session reliability). Several measures of reliability were reported, ie the coefficient of variability (CV), the intraclass correlation coefficient (ICC) and the coefficient of reliability (CR). The reliability of heat pain detection and tolerance at the arm and leg were considered to be acceptable, with between-session CVs ranging from 1.8-6.1%. However, cold pain detection at the arm or leg did not have acceptable reliability, with between-session CVs ranging from 44- 87%.
 
2017 Update
A literature search conducted using the MEDLINE database through September 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Vibration Perception Testing
 
Clinically Valid
Goel et al published a cross-sectional study comparing the diagnostic performance of several testing methods to detect early symptoms of diabetic peripheral neuropathy (Goel, 2017). Five hundred twenty-three patients with type 2 diabetes between the ages of 18 and 65 (mean, 49.4 years) were first assessed with the modified Neuropathy Disability Score as the reference standard; then both feet were tested with electrochemical skin conductance, VPT, and Diabetic Neuropathy Symptom Score. For feet electrochemical skin conductance less than 60 μS, VPT, and Diabetic Neuropathy Symptom Score, the sensitivity was 85%, 72%, and 52%, respectively; specificity was 85%, 90%, and 60%, respectively. There was a significant inverse linear relation between VPT and feet electrochemical skin conductance (r
= -0.45, p<0.001); feet electrochemical skin conductance was determined to be superior to VPT for identifying early signs of diabetic peripheral neuropathy (DPN). The study lacked follow-up data.
 
Azzopardi et al published a prospective multicenter cross-sectional study comparing 3 types of vibration screening used to diagnose DPN (Azzopardi, 2018). The study collected data from 100 patients (age range, 40-80 years) who had type 2 diabetes for at least 10 years. Each participant was assessed with a VibraTip (not registered with FDA), neurothesiometer, and 128-Hz tuning fork in both feet. Vibrations were not perceived by 28.5% of patients when using VibraTip, 21% using a neurothesiometer, and 12% using a tuning fork; a small-to-moderately strong association (Cramer’s V, 0.167) was found between the instruments. The study lacked a criterion standard for assessing neuropathy. The authors concluded that multiple methods of assessment would be necessary to avoid a false-negative diagnosis.
 
Thermal Sensory Testing
 
Clinically Valid
Anand et al assessed 30 patients with nonfreezing cold injury, or trench foot, described as a peripheral vaso-neuropathy (Anand, 2017). The authors evaluated use of skin biopsies immunohistochemistry, clinical examination of the feet, including pinprick, as well as QST assessments, and NCSs as diagnostic tools. Abnormal pinprick sensation was reported in 67% of patients. Monofilament perception threshold was abnormal in 63% of patients, 40% for VPT thresholds, and between 67% and 83% for the various thermal thresholds; NCSs showed 23% of subjects had axonal neuropathy. It was noted that performing QST could be difficult for patients with cutaneous hypersensitivity and severe limb pain. No study limitations were reported.
 
2019 Update
A literature search was conducted through September 2019.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Papanas et al assessed the performance of VibraTip against two thresholds of the Neuropathy Disability Score (NDS) for diagnosing distal symmetrical polyneuropathy (DSPN) in 100 consecutive patients with type 2 diabetes (Papanas, 2019). The mean age was 62.3 years and the mean duration of illness was 12.6 years; 54 subjects were men. Two protocols were used to assess vibration perception: A) one foot site at the pulp of the hallux and B) three foot sites at the pulp of the hallux and first and third metatarsal head. NDS thresholds of 3 and 6 were used to establish the diagnosis of DSPN. Compared to the NDS 3 threshold, VibraTip demonstrated a sensitivity, NPV, specificity, and PPV of 91.3%, 92%, 85.2%, and 84% with protocol A; with protocol B, the sensitivity, NPV, and specificity were 95.6%, 96.1%, 90.7%, and 89.8%. Compared to the NDS 6 threshold, VibraTip demonstrated a sensitivity, NPV, and specificity of 100%, 100%, 95.2%, and 92.7% with protocol A; with protocol B, the sensitivity, NPV, and specificity were 100%, 100%, 96.8%, and 95%. The authors conclude that there appears to be no need to explore sites beyond the hallux, and that the device may be especially useful for the exclusion of DSPN. The study is limited by the lack of healthy controls and the use of an outdated version of the NDS.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A prospective nonrandomized cohort study by Ferdousi et al compared several strategies for evaluating DPN severity (Ferdousi, 2020). A total of 143 patients with diabetes and 30 controls underwent QST with VPT and thermal perception testing, nerve conduction studies, and a measure of corneal nerve loss (corneal confocal microscopy). Compared to controls, VPT was significantly higher in patients with no neuropathy (p=.02), mild neuropathy (p<.0001), and moderate-severe neuropathy (p<.0001), with a sensitivity of 55% and specificity of 90%. VPT findings worsened with worsening neuropathy severity. Thermal testing, nerve conduction testing, and corneal confocal microscopy were also significantly different between patients with DPN and controls (all p<.05). All other testing methods had lower specificity than VPT, but all had higher sensitivity than VPT with the exception of warm perception threshold. The study may have been limited by using Neuropathy Disability Scores to quantify DPN severity, which may explain the abnormal findings among patients categorized as having no neuropathy.
 
A retrospective study by Fabry et al in 245 patients with small fiber neuropathy symptoms compared several methods of evaluating small fibers: skin biopsy to determine intra-epidermal nerve fiber density, thermal sensory testing using QST (Thermotest device), quantitative sweat measurement, laser-evoked potentials, electrochemical skin conductance measurement, and autonomic cardiovascular tests (Fabry, 2020). Thermal sensory testing findings were not statistically different between patients who ultimately received a diagnosis of no SFN and those who received a diagnosis of definite SFN. The sensitivity, specificity, positive predictive value, and negative predictive value of thermal sensory testing were 72%, 39%, 57%, and 55%, respectively. All other testing methods had higher specificity (69% to 96%) but lower sensitivity (15% to 66%) compared to thermal sensory testing. The authors concluded that the best diagnostic strategy was a combination of skin biopsy, thermal sensory testing, laser-evoked potentials, and electrochemical skin conductance measurement (sensitivity, 92%; specificity, 88%; positive predictive value, 90%; negative predictive value, 91%).
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
0106TQuantitative sensory testing (QST), testing and interpretation per extremity; using touch pressure stimuli to assess large diameter sensation
0107TQuantitative sensory testing (QST), testing and interpretation per extremity; using vibration stimuli to assess large diameter fiber sensation
0108TQuantitative sensory testing (QST), testing and interpretation per extremity; using cooling stimuli to assess small nerve fiber sensation and hyperalgesia
0109TQuantitative sensory testing (QST), testing and interpretation per extremity; using heat pain stimuli to assess small nerve fiber sensation and hyperalgesia
0110TQuantitative sensory testing (QST), testing and interpretation per extremity; using other stimuli to assess sensation
95926Short latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in lower limbs
95927Short latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in the trunk or head
G0255Current perception threshold/sensory nerve conduction test, (snct) per limb, any nerve

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Ahmad S, De Oliveira GS, Jr., Bialek JM, et al.(2014) Thermal quantitative sensory testing to predict postoperative pain outcomes following gynecologic surgery. Pain Med. May 2014;15(5):857-864. PMID 24517836

Am Association of Electrodiagnostic Medicine Technology Review: Nervespace Digital Electroneurometer. Muscle Nerve 1999; Sup 8; S243-6.

Anand P, Privitera R, Yiangou Y, et al.(2017) Trench foot or non-freezing cold injury as a painful vaso-neuropathy: clinical and skin biopsy assessments. Front Neurol. Front Neurol. Sep 2017;8:514. PMID 28993756

Azzopardi K, Gatt A, Chockalingam N, et al.(2018) Hidden dangers revealed by misdiagnosed diabetic neuropathy: A comparison of simple clinical tests for the screening of vibration perception threshold at primary care level. Prim Care Diabetes. Apr 2018;12(2):111-115. PMID 29029862

Baquis GD, Brown, WF, Capell JT, et al.(1999) Technology Review: The Neurometer Current Perception Threshold (CPT). Am Assoc Electrodiagnostic Med 1999; Sup 8:S247-S259.

Chaudhry V.(1997) Nervespace Digital Electroneurometer. Muscle and Nerve 1997; Sept 1200-1203.

Fabry V, Gerdelat A, Acket B, et al.(2020) Which Method for Diagnosing Small Fiber Neuropathy?. Front Neurol. 2020; 11: 342. PMID 32431663

Ferdousi M, Kalteniece A, Azmi S, et al.(2020) Corneal confocal microscopy compared with quantitative sensory testing and nerve conduction for diagnosing and stratifying the severity of diabetic peripheral neuropathy. BMJ Open Diabetes Res Care. Dec 2020; 8(2). PMID 3335520

Forstenpointner J, Ruscheweyh R, Attal N, et al.(2021) No pain, still gain (of function): the relation between sensory profiles and the presence or absence of self-reported pain in a large multicenter cohort of patients with neuropathy. Pain. Mar 01 2021; 162(3): 718-727. PMID 32868752

Goel A, Shivaprasad C, Kolly A, et al.(2017) Comparison of electrochemical skin conductance and vibration perception threshold measurement in the detection of early diabetic neuropathy. PLoS One. Sep 2017;12(9):e0183973. PMID 28880907

Lefaucheur JP, Wahab A, Plante-Bordeneuve V, et al.(2015) Diagnosis of small fiber neuropathy: A comparative study of five neurophysiological tests. Neurophysiol Clin. Dec 2015;45(6):445-455. PMID 26596193

NK Pressure-Specified Sensory Device™ (Sensory Management Services LLC) for Tarsal Tunnel Syndrome Diagnosis. Hayes Brief: Oct 2006.

Papanas N, Pafili K, Demetriou M, et al.(2020) The Diagnostic Utility of VibraTip for Distal Symmetrical Polyneuropathy in Type 2 Diabetes Mellitus. Jan 2020; 11(1): 341-346. PMID 31782049

Peripheral nerve decompression for diabetic neuropathy. Hayes Brief: May 2006.

Spanakis EK, Golden SH.(2013) Race/ethnic difference in diabetes and diabetic complications. Curr Diab Rep. Dec 2013; 13(6): 814-23. PMID 24037313

Taylor YJ, Davis ME, Mahabaleshwarkar R et al.(2018) Racial/ethnic disparities in diabetes care and outcomes: A mixed methods study. Journal of Health Disparities Research and Practice. 2018; 11(2). Accessed April 27, 2022. https://digitalscholarship.unlv.edu/jhdrp/vol11/iss2/9

Vuilleumier PH, Biurrun Manresa JA, Ghamri Y, et al.(2015) Reliability of quantitative sensory tests in a low back pain population. Reg Anesth Pain Med. Jul 28 2015. PMID 26222349

Ziccardi VB, Dragoo J, Eliav E et al.(2012) Comparison of current perception threshold electrical testing to clinical sensory testing for lingual nerve injuries. J Oral Maxillofac Surg 2012; 70(2):289-94.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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