Neurophysiologic Testing and Monitoring (for Tennessee Only)
Policy governs coverage and medical necessity of neurophysiologic/electrodiagnostic tests for Tennessee Medicaid and CoverKids providers, specifying which tests are proven and which are unproven or not medically necessary.
Policy Summary
PayerUnitedHealthcare
PolicyNeurophysiologic Testing and Monitoring (for Tennessee Only)
Policy CodePolicy CS082TN.U
Change TypeRemoved codescontent refresh
Effective DateApr 1, 2026
Next Review DateN/A
Key ActionDocument proven indications and include clinical documentation when ordering wearable, QST, or EDX testing; ensure one physician supervises and performs indicated EDX components and document device type and wear duration when applicable.
Removed CPT/HCPCS codes 95999 and A9279 from Applicable Codes.
Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information.
Archived previous policy version CS082TN.T.
Proven listProven indications listed
Unproven listUnproven technologies
TennesseeApplicable to
2Codes removed
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Coverage Criteria and Medical Necessity
Proven and medically necessary tests
Covered when ANY of the following known or suspected disorders are present and testing is performed as described:
Proven indications for NCS with or without standard late responses and for neuromuscular junction testing when performed with needle EMG: Peripheral neuropathy/polyneuropathy (e.g., inherited, metabolic, traumatic, entrapment syndromes); plexopathy; neuromuscular junction disorders (e.g., myasthenia gravis); myopathy; motor neuron disease; radiculopathy (cervical, thoracic, or lumbosacral); treatment guidance such as muscle localization for botulinum toxin injections.
From policy list
When NCS may be performed without needle EMG: Individuals treated with anticoagulants; or individuals with lymphedema; or individuals being evaluated for carpal tunnel syndrome.
Standalone NCS allowed only for these clinical situations
Limited standalone NCS
Covered when ALL of the following apply for NCS performed without needle EMG:
Indications permitting NCS without needle EMG: Testing is being done because the individual is treated with anticoagulants OR has lymphedema OR is being evaluated for carpal tunnel syndrome.
Standalone NCS without needle EMG is limited to these listed clinical situations
Indications and appropriateness criteria
EDX testing (NCS plus needle EMG) is indicated when clinical scenarios meet one of the following groups:
Focal/localizing indications: Focal neuropathies, entrapment neuropathies or compressive lesions (e.g., carpal tunnel, ulnar neuropathies), traumatic nerve lesions for diagnosis and prognosis, and procedures requiring precise muscle localization for injections (e.g., botulinum toxin).
Neuromuscular junction and motor neuron: Neuromuscular junction disorders (e.g., myasthenia gravis, myasthenic syndrome, botulism) and motor neuron disease.
Symptom-based, radiculopathy, or plexopathy: Symptom-based presentations such as limb pain, weakness, paresthesia, or sensory disturbance when pre-test evaluation is inconclusive; radiculopathy (cervical, lumbosacral); plexopathy (idiopathic, trauma, inflammatory or infiltrative).
Evidence summaries and practice recommendations
Evidence-based recommendations and performance summaries
Wearable seizure detection: Use clinically validated wearable devices for automated detection of generalized tonic-clonic seizures (GTCS) and focal to bilateral tonic-clonic seizures (FBTCS) when significant safety concerns exist, especially for unsupervised individuals not sharing a bedroom and where alarms can prompt rapid intervention within about 5 minutes (ILAE-IFCN conditional recommendation).N/A
High sensitivity (~0.91) for tonic-clonic seizures but variable and sometimes high false alarm rates (mean FAR ~2.1/24 h); limited evidence for other seizure types and PNES.
Wearable devices for movement disorders: Wearable and smartphone-based movement devices (e.g., PKG, KinetiGraph, sensor patches) can provide objective motor data that may influence management; validation studies vary in size and quality and further well-designed trials are needed. PKG studies used at least 6 days of wear in cited investigations.PKG wear ≥ 6 days
Algorithm performance varies; some classifiers showed sensitivity ~89% and specificity ~86.6% for identifying candidates for device-assisted therapy.
Evidence summaries informing medical necessity
Summary of clinical evidence and limitations informing coverage considerations
QST utility and requirements: QST is a psychophysical assessment of large- and small-fiber sensory modalities that requires reproducible instruments/methodologies and full subject cooperation; abnormalities do not localize pathology and thermal thresholds are less reproducible than vibration thresholds.
AANEM recommends use only of instruments/methodologies shown to be reproducible and strict adherence to calibration and testing protocols.
sEMG clinical evidence: Evidence for surface EMG (sEMG) and sEMG-based seizure monitoring is weak and variable; specific trials show feasibility for GTCS detection with high sensitivity in optimal placement but poor positive predictive value and substantial false alarm rates, and device tolerability issues (skin irritation) were reported.
Larger, well-designed studies and standardization are required before broad clinical utility is established.
sMMG and IMU systems: Surface mechanomyography (sMMG) with IMU systems has few published studies and insufficient evidence to conclude benefit on health outcomes.
Claims for nerve conduction studies (NCS) performed for conditions other than the proven indications listed in this policy and claims for non‑invasive automated/portable point‑of‑care NCS devices that only test distal motor latencies and conduction velocities are considered unproven and may be denied due to insufficient evidence of clinical efficacy. The policy identifies these point‑of‑care systems as not a substitute for a full electrodiagnostic evaluation and therefore not medically necessary for indications outside the specified proven uses.
The American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) states that performing NCS separately from needle EMG should be the exception. Reporting NCS and EMG in separate reports and routinely performing NCS without concurrent needle EMG removes complementary information normally required to establish an accurate diagnosis and may be considered inconsistent with accepted practice.
The ILAE‑IFCN Working Group conditionally recommends use of clinically validated wearable devices for automated detection of generalized tonic‑clonic seizures (GTCS) and focal‑to‑bilateral tonic‑clonic seizures (FBTCS) when significant safety concerns exist and alarms can prompt rapid intervention. The ILAE‑IFCN does not recommend current wearable devices for routine clinical use in seizure types other than GTCS/FBTCS. Separately, the American Academy of Neurology notes that quantitative sensory testing (QST) results should not be used as the sole method for diagnosis because of methodological and reproducibility limitations.
Techniques or instruments that lack demonstrated reproducibility or sufficient peer‑reviewed evidence are considered unproven. Examples called out in the evidence base include some QST instruments whose methods and calibration vary across platforms, and sMMG with concurrent IMU systems; current published data are limited and do not establish consistent, patient‑relevant benefit.
Regulatory clearance or approval by the U.S. Food and Drug Administration alone is not a basis for coverage. FDA status is provided for informational context, but coverage determinations rely on clinical evidence of net health benefit and plan terms.
Use of the technologies and tests listed as unproven — including point‑of‑care NCS that test only distal motor parameters, macro‑EMG, wearable physiologic monitoring for seizure or movement disorders, sEMG, sMMG, QST (including monofilament and CPT testing), and VEP testing for glaucoma — outside of specified, evidence‑based indications is considered not medically necessary because evidence is insufficient to demonstrate consistent clinical benefit.
Specific technologies identified as having weak or limited evidence and requiring further study include macro‑EMG, point‑of‑care NCS devices, and many physiologic wearable monitoring approaches for seizure and movement disorders. The literature to date is small, heterogeneous, and does not consistently demonstrate improved patient‑relevant outcomes, so routine coverage is not supported.
Monofilament testing for diabetic peripheral neuropathy shows limited sensitivity in systematic reviews (pooled sensitivity ~0.53 with pooled specificity ~0.88). Because of the limited sensitivity, monofilament testing is discouraged as a standalone screening test for diabetic peripheral neuropathy.
Available data do not support routine use of surface EMG (sEMG) to reliably distinguish neuropathic from myopathic conditions or to make other specific neuromuscular diagnoses. The AANEM finds the evidence insufficient (level U) and notes that sEMG studies to date are inadequate to establish clinical utility for many diagnostic distinctions.
Procedure Codes, HCPCS, and Product Codes
Covered CPT Codes (Needle EMG group)CPTCovered
95860
Needle electromyography; 1 extremity with or without related paraspinal areas.
95861
Needle electromyography; 2 extremities with or without related paraspinal areas.
95863
Needle electromyography; 3 extremities with or without related paraspinal areas.
95864
Needle electromyography; 4 extremities with or without related paraspinal areas.
Needle electromyography; thoracic paraspinal muscles (excluding T1 or T12).
95870
Needle electromyography; limited study of muscles in 1 extremity or non-limb (axial) muscles (unilateral or bilateral), other than thoracic paraspinal, cranial nerve supplied muscles, or sphincters.
1–10 of 13
1/2
Covered CPT Codes (NCS and related)CPTCovered
95885
Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude, and latency/velocity study; limited (List separately in addition to code for primary procedure).
95886
Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude, and latency/velocity study; complete, five or more muscles studied, innervated by three or more nerves or four or more spinal levels (List separately in addition to code for primary procedure).
95887
Needle electromyography, non-extremity (cranial nerve supplied or axial) muscle(s) done with nerve conduction, amplitude, and latency/velocity study (List separately in addition to code for primary procedure).
95905
Motor and/or sensory nerve conduction, using preconfigured electrode array(s), amplitude and latency/velocity study, each limb, includes F-wave study when performed, with interpretation and report.
95907
Nerve conduction studies; 1-2 studies.
95908
Nerve conduction studies; 3-4 studies.
95909
Nerve conduction studies; 5-6 studies.
95910
Nerve conduction studies; 7-8 studies.
95911
Nerve conduction studies; 9-10 studies.
95912
Nerve conduction studies; 11-12 studies.
1–10 of 12
1/2
QST, SEMG, sMMG and motion analysis codesCPT
96002
Dynamic surface electromyography, during walking or other functional activities, 1-12 muscles.
96004
Review and interpretation by physician or other qualified health care professional of comprehensive computer-based motion analysis, dynamic plantar pressure measurements, dynamic surface electromyography during walking or other functional activities, and dynamic fine wire electromyography, with written report
0106T
Quantitative sensory testing (QST), testing and interpretation per extremity; using touch pressure stimuli to assess large diameter sensation.
0107T
QST per extremity; using vibration stimuli to assess large diameter fiber sensation.
0108T
QST per extremity; using cooling stimuli to assess small nerve fiber sensation and hyperalgesia.
0109T
QST per extremity; using heat-pain stimuli to assess small nerve fiber sensation and hyperalgesia.
0110T
QST per extremity; using other stimuli to assess sensation.
0464T
Visual evoked potential, testing for glaucoma, with interpretation and report.
0778T
Surface mechanomyography (sMMG) with concurrent application of inertial measurement unit (IMU) sensors...
HCPCS / Other codesHCPCS
A9280
Alert or alarm device, not otherwise classified.
G0255
Current perception threshold/sensory nerve conduction test (SNCT), per limb, any nerve.
S3900
Surface electromyography (EMG).
FDA product codemixed
IKN
FDA product code referenced for EMG devices
Removed codesmixedNot Covered
95999
CPT/HCPCS code removed from Applicable Codes
A9279
HCPCS code removed from Applicable Codes
inv-21: Recommended components of EDX
Recommended EDX componentsAt least one motor and one sensory nerve conduction study and at least one distal and one proximal muscle studied by needle EMG when relevant.
Late-response testingInclude standard late responses (F-wave and H-reflex) during the same evaluation when indicated.
Complementary studiesNCS and needle EMG are complementary and typically performed together for accurate diagnosis (AANEM guidance).
inv-22: Minimum PKG wear time
Minimum PKG wear time≥ 6 days (PKG data logger worn during routine daily living activities).
Provider Responsibilities, Documentation, and Utilization Management
Documentation Required
Actionable Provider Responsibilities and Documentation
The following are provider responsibilities and documentation points to support medical necessity, billing, and utilization management for electrodiagnostic and related testing. Consolidated guidance below highlights action items, documentation expectations, and plan-governing rules.
Codes are reference only — Procedure and diagnosis codes listed in Applicable Codes are for reference and do not guarantee coverage or payment; benefit coverage is determined by federal, state, or contractual requirements and applicable law.
Medical indication documentation — Ensure the medical record includes a clear history, focused physical examination, and differential diagnosis that supports the clinical indication for the requested electrodiagnostic or ancillary test (e.g., symptoms, relevant prior testing, anticoagulation status, lymphedema, focal vs generalized neuropathy).
Clinical justification recommended — Provide clinical justification that testing will affect diagnosis or management (e.g., localization for focal neuropathy, confirmation of radiculopathy, evaluation of neuromuscular junction disorder, guidance for muscle localization prior to botulinum toxin injection).
sEMG monitoring documentation suggestion — When using surface EMG (sEMG) devices or SEMG-based seizure monitoring systems, document device type, sensor placement, wear duration, detection algorithm used, event review methodology, and any clinical correlation to recorded events.
Prior authorization and utilization management — This Medical Policy is guidance only; UnitedHealthcare may require prior authorization or apply third-party clinical criteria (for example, InterQual) consistent with federal/state/contractual plan terms. Check eligibility and prior-authorization requirements before performing tests.
Background and Clinical Context
Neurophysiologic testing (NCS and EMG) evaluates peripheral nerve and muscle electrical function and complements history and physical examination when motor or sensory deficits require further evaluation. Needle EMG and NCS are complementary in most electrodiagnostic evaluations; when relevant, a proper EDX exam should include history, targeted NCS (including appropriate late responses when indicated), and needle EMG with real‑time interpretation.
Definitions and Device Classifications
inv-46: Needle EMG
Needle EMG definitionElectromyography requiring insertion of needles through the skin to evaluate whether weakness is due to nerve, neuromuscular junction, or muscle disorders.
PurposeHelps determine whether muscle weakness results from nerve injury, neuromuscular junction disorders, or primary muscle disease.
Relation to NCSNeedle EMG is typically performed together with NCS as part of a complete EDX evaluation (AANEM recommendation).
inv-47: Surface EMG (SEMG)
Surface EMG (SEMG)Noninvasive EMG where electrodes placed on the skin measure underlying muscle electrical activity; includes paraspinal EMG.
ApplicationsUsed for diagnostic monitoring and may be applied in seizure monitoring systems (e.g., biceps placement for GTCS detection).
Policy Summary
PayerUnitedHealthcare
PolicyNeurophysiologic Testing and Monitoring (for Tennessee Only)
Policy CodePolicy CS082TN.U
Change TypeRemoved codescontent refresh
Effective DateApr 1, 2026
Next Review DateN/A
Key ActionDocument proven indications and include clinical documentation when ordering wearable, QST, or EDX testing; ensure one physician supervises and performs indicated EDX components and document device type and wear duration when applicable.
Includes AANEM recommendations for paraspinal mapping and peripheral limb EMG in lumbar radiculopathy
When EDX should be considered for distal symmetric polyneuropathy (DPN): When history, physical and standard neuropathy blood tests do not indicate a likely etiology OR symptoms/findings are moderate-to-severe OR presentation is atypical (predominantly motor, proximal, or asymmetric) OR rapid progression OR signs suggesting another disorder (e.g., radiculopathy) OR unknown duration/severity OR family history suggesting hereditary neuropathy OR exposure to neurotoxic agents OR discrepancy between signs and symptoms.
EDX testing is likely low yield when symptoms are mild, symmetric distal sensory, a known cause exists (e.g., diabetes), and little suspicion of coexisting nerve disorder.
Quantitative Sensory Testing (QST): QST may document sensory abnormalities (vibration, thermal, pain thresholds) and has Level B recommendations for diabetic neuropathy documentation but overall evidence is weak for predictive utility across conditions; QST should not be used as the sole diagnostic method and requires standardized instruments and strict calibration/protocols.N/A
Systematic reviews show inconsistent predictive value and monofilament testing has limited sensitivity (pooled ~0.53) for diabetic peripheral neuropathy.
Cannot conclude beneficial effect due to limited data.
icVEP for glaucoma: Isolated-check visual evoked potential (icVEP) shows promising diagnostic performance in small studies with variable sensitivity and specificity depending on SNR cutoff and population; further larger studies are required.Examples: icVEP SNR cutoffs reported at ≤ 1, 0.93, and 0.85 in studies
Heterogeneity and limited high-quality trials limit generalizability.
Purpose of wear durationProvides continuous objective measurement over multiple days to inform clinical management decisions.
Documentation guidanceDocument device type, wear duration, clinician interpretation, and how device data affected management.
inv-23: icVEP SNR cutoffs used in studies
Common icVEP abnormal cutoffSNR ≤ 1 considered abnormal in some studies (e.g., Fan et al. 2018).
Study-specific cutoffsXu et al. reported study-specific cutoffs at SNR = 0.85 and SNR = 0.93 with differing sensitivity/specificity tradeoffs.
SNR dependenceSNR is contrast dependent and diagnostic performance varies by chosen SNR threshold and study population.
EMG device codeIKN is the FDA product code referenced for EMG devices (Class II).
QST device codesQST instruments are classified under LLN, GXB, LQW, and GWI (esthesiometers, vibration, temperature devices).
Denial for unproven uses — Claims for nerve conduction studies, QST, SEMG, SEMG-based seizure monitoring systems, or other listed procedures for indications considered unproven by this policy are at risk for denial unless sufficient clinical justification and supporting evidence are documented.
Separate NCS and EMG reporting discouraged — Performing nerve conduction studies (NCS) separately from needle EMG or reporting them in separate reports is generally inappropriate except in limited, documented circumstances (e.g., anticoagulation, lymphedema, or other specific contraindications to needle EMG). Document rationale when components are performed separately.
QST interpretation caution — Quantitative sensory testing (QST) results should not be used as the sole method to make a diagnosis; interpret QST within the clinical context and alongside other diagnostic information.
QST instrument/methodology reproducibility — Use only QST instruments and testing methodologies demonstrated to be reproducible; ensure device calibration and validated protocols are followed and documented.
Plan-specific requirements govern — Coverage determinations must reference federal, state, or contractual benefit requirements; when conflicts exist, those requirements govern. Always verify plan terms (coverage, prior auth, network) for the specific member.
Provider qualifications and supervision — Needle EMG should be performed by physicians specially trained in electrodiagnostic medicine (neurologist or physiatrist with appropriate training/certification). NCS may be performed by trained individuals under the direct supervision of a physician; one physician should supervise and perform all components when appropriate.
Required components and supervision — A typical EDX exam should include a documented differential diagnosis based on history/exam, completion of indicated NCS and needle EMG when appropriate, use of equipment that assesses all signal parameters (not screening-only devices), and performance under indicated supervision with the EMG interpreted in real time.
QST calibration and protocol documentation — Document machine calibration, the exact testing protocol used, normative/reference values, subject cooperation status, and any steps taken to assure reproducibility when performing QST.
Check plan terms — Before ordering or performing testing, verify member plan terms, prior authorization requirements, and any contractual limitations that may affect coverage or payment.
Step considerations / low-yield situations — Document why testing is appropriate when presenting features are atypical, moderate to severe, rapidly progressive, asymmetric, predominantly motor, or when standard evaluations are inconclusive; recognize EDX testing may be low-yield for mild, symmetric, distal, predominantly sensory findings with a known cause (e.g., uncomplicated diabetes).
None specified in this section. — If no additional site-specific prior authorization instructions are provided, follow the plan-specific prior authorization process and clinical documentation standards.
.
LimitationsEvidence for many sEMG uses is weak; performance varies by placement and system (AANEM commentary).
inv-48: Nerve Conduction Studies (NCS)
Nerve Conduction Studies (NCS)Tests assessing conduction velocity, latency, amplitude, and response shape to diagnose peripheral nervous system diseases.
Complementary testingOften performed with needle EMG and may include late-response testing (F-wave, H-reflex) during the same evaluation.
Equipment requirementShould be performed using equipment that assesses all parameters of recorded signals; screening-only equipment is not acceptable.
inv-49: Non-invasive automated point-of-care NCS
Point-of-care NCS devicesPortable devices using surface electrodes and built-in software that test distal motor latencies, response amplitudes, and conduction velocities without real-time waveforms.
Intended useMay be used for screening in primary care or remote settings but are not a substitute for full electrodiagnostic testing.
Regulatory statusSeveral point-of-care NCS devices have received FDA 510(k) clearance and are classified under product code JXE (Class II).
inv-50: Real-time onsite EDX
Real-time onsite EDXEDX testing where history, tailored studies, waveform analysis, and interpretation occur while the patient is present in the EDX laboratory with immediate integration of findings.
Supervision and same-day testingAANEM recommends one physician supervises and performs all components and that testing occur on the same day.
Technologist roleTechnologists may perform selected NCS under the physician's supervision, but the physician should review unusual results immediately.
inv-51: Direct supervision
Direct supervisionPhysician in close physical proximity to the EDX lab while testing is done and immediately available to provide assistance and direction.
DelegationData collection may be delegated to trained technologists or supervised trainees, but physician oversight is required.
Alerting for unexpected resultsTechnologist should alert the physician immediately if results are unusual so alternative testing strategies can be developed.
inv-52: GTCS/FBTCS
GTCS/FBTCS wearables recommendationILAE-IFCN recommends clinically validated wearables for automated detection of GTCS and FBTCS when safety concerns exist (conditional recommendation).
LimitationsCurrent wearables are not recommended for seizure types other than GTCS/FBTCS pending further research.
Performance noteWearables show high sensitivity for tonic-clonic detection but variable false alarm rates; alarms should enable rapid intervention (~5 minutes).
inv-53: QST
QST definitionQuantitative Sensory Testing — psychophysical tests measuring vibration, thermal, and pain thresholds to assess sensory function; results are technique-sensitive and not definitive alone for diagnosis.
Reproducibility requirementUse only instruments and methodologies shown to be reproducible; strict calibration and testing protocols required.
Clinical roleMay document sensory abnormalities (Level B for diabetic neuropathy) but should not be used as the sole diagnostic method.
inv-54: Quantitative Sensory Testing (QST)
QST scopePsychophysical testing of touch-pressure, vibration, thermal, and pain stimuli assessing integrity of the sensory axis from receptors to brain.
LimitationsAbnormalities do not localize pathology and results depend on full subject cooperation; thermal thresholds less reproducible than vibration.
Use in research/clinical careLimit use to validated instruments/methodologies with reproducibility data; longitudinal studies should include reproducibility controls.
inv-55: Surface Electromyography (sEMG)
sEMG (surface EMG)Noninvasive recording of muscle electrical activity used for monitoring/diagnostic purposes including seizure detection and assessment of respiratory or neuromuscular function.
Seizure detection evidenceSome studies show high sensitivity for GTCS detection in specific placements, but overall PPV and false alarm rates limit broad clinical utility.
Regulatory statusSEMG devices for seizure monitoring are FDA Class II (product code IKN).
inv-56: Surface Mechanomyography (sMMG)
sMMG definitionNoninvasive measurement of muscle mechanical activity often used with inertial measurement units (IMUs) for motion and muscle function assessment.
Evidence statusFew published studies exist; insufficient evidence to conclude benefit on health outcomes.
Typical useUsed in research and emerging clinical applications for gait, posture, and multi-joint motion assessment when paired with IMUs.
icVEP descriptionAn objective electrophysiological test assessing visual pathway function with signal-to-noise ratio (SNR) metrics potentially useful for glaucoma detection.
Performance variabilityReported sensitivity and specificity vary across studies; diagnostic accuracy depends on SNR cutoff used.
Example SNR thresholdsStudies used SNR cutoffs such as ≤1 (abnormal), 0.93, and 0.85 with differing sensitivity/specificity results.
inv-58: Electromyography (EMG)
EMG FDA classificationEMG devices are FDA-classified as Class II medical devices (product code IKN).
ReferenceRefer to FDA product code IKN for device listings and clearances.
ImplicationFDA Class II status is informational; FDA approval alone is not a basis for coverage decisions.
SEMG seizure monitoring FDA codeSurface EMG devices for seizure monitoring are FDA-classified as Class II devices (product code IKN).
Device exampleDevices such as SPEAC system use biceps placement to analyze SEMG signals associated with generalized tonic-clonic seizures.
Evidence cautionDespite FDA classification, evidence for clinical utility is limited and variable; document placement and detection algorithm performance when used.
inv-60: Quantitative Sensory Testing (QST)
QST device product codesDevices for current perception threshold and sensory nerve conduction threshold testing are classified under product codes LLN, GXB, LQW, and GWI.
Device classesThese QST instruments are generally regulated as FDA Class II devices under various product codes for esthesiometers, vibration, and temperature discrimination devices.
ReferenceFDA product code searches (LLN, GXB, LQW, GWI) provide specific marketing clearances and device information.
inv-61: Point-of-care Nerve Conduction Devices
Point-of-care NCS FDA codePoint-of-care nerve conduction devices have FDA 510(k) clearance and are regulated as Class II devices (product code JXE).
Device roleIntended for rapid peripheral nerve evaluation in non-specialist settings but not a substitute for full EDX testing.
Regulatory noteSeveral such devices have received 510(k) clearance; check specific device clearances under product code JXE.
inv-62: Physiologic Recording Devices
Physiologic recording device codesDevices for physiologic recording of movement and/or seizure disorder symptoms are FDA Class II devices (product codes POS, GYD).
ExamplesIncludes wearable movement-recording systems and seizure monitoring devices; refer to product-specific FDA listings for details.
Coverage noteFDA classification is informational; clinical evidence drives coverage determinations.
inv-63: Visual Evoked Potentials (VEPs)
VEP FDA product codesEvoked response photic stimulators and related recording devices are FDA Class II (product codes GWE, HLX, GWQ) and may be used for VEP testing.
Use caseThese devices may have recording/measuring capabilities for visual evoked potential testing (e.g., glaucoma applications).
ReferenceRefer to FDA product code listings for device-specific clearances and details.