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Healthcare Operations Utilization Management Protocol

Extraoperative Neurophysiologic Testing NEU023

For Sierra Health-Care Options products, please review plan documents prior to issuing a determination. Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the following tests used to diagnose nervous system disorders: needle electromyography, surface electromyography, quantitative sensory testing, nerve conduction testing, and evoked potential testing. Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Commercial, Medicare & Medicaid Coverage Rationale:

Non-Surgical Evoked Potential Testing: · Brainstem auditory evoked potential (BAEP) [also called brain stem auditory evoked response (BAER)] studies are medically necessary when used for the following: o During an assessment for multiple sclerosis to test the peripheral hearing apparatus and brainstem auditory tracts. o Evaluation of degenerative disorders that may involve the brainstem. o Evaluation of intrinsic brainstem tumors. o Evaluation of brainstem function in compromised neonates; o Evaluation of visual and auditory processing. o Evaluation of basilar migraine. o Evaluation of Chiari malformations. o Evaluation of suspected hearing loss when audiologic testing is limited or inaccurate. · Brainstem auditory evoked potential (BAEP) studies are not medically necessary when used for the following: o detection of acoustic neuromas o predicting prognosis of comatose patients and the evaluation of all other disorders not listed above as medical necessary due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Dermatomal somatosensory evoked potential (DSEP) testing not medically necessary due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. Motor evoked potential (MEP) testing (also called transcranial motor stimulation) is medically necessary when used for the following:

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* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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o diagnosis of cervical myelopathy o evaluation of spinal cord injury · Motor evoked potential (MEP) testing is not medically necessary for all conditions other than those listed above as proven due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature Somatosensory evoked potential (SEP) studies are medically necessary when used for the following conditions: (AANEM, Recommended Policy for Electrodiagnostic Medicine, 2004) o brain or spinal cord trauma o coma o diabetic peripheral neuropathy o multiple sclerosis o myoclonus o nontraumatic spinal cord lesions (e.g., cervical spondylosis or myelopathy) o spinocerebellar degeneration o subacute combined degeneration of spinal cord Somatosensory evoked potential (SEP) studies are not medically necessary when used for the evaluation of all other disorders not listed above as medical necessary due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Visual evoked potential (VEP) [also called Visual Evoked Response (VER)] studies are medically necessary for the following: o evaluation and management of multiple sclerosis after MRI studies have been completed o suspected optic neuritis or other optic neuropathy o familial ataxia syndromes (e.g., Friedreich ataxia) o optic atrophy o adrenoleukodystrophy o traumatic brain injury o toxic and nutritional neuropathies (e.g., B12 deficiency, alcohol-tobacco amblyopia) o compressive lesions of the visual pathway o sarcoidosis VEP studies are not medically necessary when used for the following: o Detection of glaucoma o Assessment of vision in a child who has potential visual disturbance and is unable to cooperate with standard visual testing and the evaluation of all other disorders not listed above as medical necessary due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Blink reflex studies are medically necessary when used to detect neuropathies in the cranial nerves or the brainstem.

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* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Blink reflex studies are not medically necessary for the evaluation of all other disorders not listed above as medical necessary due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Quantitative sudomotor axon reflex test (QSART) is not medically necessary due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. Quantitative Sensory Testing: Quantitative sensory testing, including monofilament testing, pressure-specified sensory testing, computer assisted sensory examinations, and current perception threshold (CPT) testing for the diagnosis and evaluation of nervous system disorders is not medically necessary due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. Electromyography (EMG): Needle electromyography (NEMG) including single fiber electromyography is medically necessary for the evaluation of following suspected or known disorders: o peripheral nerve entrapment syndromes o metabolic, nutritional, demyelinating, toxic, infectious, and idiopathic peripheral neuropathies o hereditary polyneuropahties such as Fabry disease o disorders of brachial and lumbosacral plexi o neuromuscular junction disorders o myopathies including polymyositis, dermatomyositis, and congenital myopathies o motor neuron disease o spine disorder with impingement of nerve root seen on spinal imaging o tremor o symptoms suggestive of peripheral nerve, muscle or neuromuscular junction involvement including muscle weakness, muscle atrophy, muscle fasciculation, myokymia, mytonia, loss of dexterity, spasticity, hyperreflexia, sensory deficits, diplopia, ptosis, swallowing dysfunction, dysarthria, impaired bowel motility, and gait dysfunction Needle electromyography (NEMG) including single fiber electromyography is not medically necessary for all conditions other than those listed above as medical necessary due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Surface electromyography (SEMG) is not medically necessary due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Macroelectromyography (macro-EMG) testing is not medically necessary due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature.

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* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Nerve Conduction Studies: Nerve conduction studies with or without late responses (e.g., F-wave and H-reflex tests) are medically necessary for the evaluation of the following suspected or known disorders only when performed in conjunction with needle electromyography except in limited circumstances* o peripheral nerve entrapment syndromes that include ulnar neuropathy at the elbow, peroneal neuropathy, and tarsal tunnel syndrome o metabolic, nutritional, demyelinating, toxic, infectious, and idiopathic peripheral neuropathies o hereditary polyneuropahties such as Fabry disease o disorders of brachial and lumbosacral plexi o neuromuscular junction disorders o myopathies including polymyositis, dermatomyositis, and congenital myopathies o motor neuron disease o spine disorder with impingement of nerve root seen on spinal imaging o tremor o symptoms suggestive of peripheral nerve, muscle or neuromuscular junction involvement including muscle weakness, muscle atrophy, muscle fasciculation, myokymia, mytonia, loss of dexterity, spasticity, hyperreflexia, sensory deficits, diplopia, ptosis, swallowing dysfunction, dysarthria, impaired bowel motility, and gait dysfunction · *Nerve conduction studies are medically necessary when performed without needle electromyography in patients on anticoagulants, patients who have lymphedema, or patients who are being evaluated for carpal tunnel syndrome. (AANEM, Needle EMG in certain uncommon clinical contexts, 2005; Jablecki et al., 2002) Nerve conduction studies are not medically necessary for all conditions other than those listed above as proven due to inadequate clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. F-wave and H-reflex tests are medically necessary for the diagnosis and evaluation of disorders affecting the peripheral nervous system only when conducted in conjunction with needle electromyography and motor and sensory nerve conduction studies including nerve conduction velocity studies except in limited circumstances.* *Nerve conduction studies are medically necessary when performed without needle electromyography in patients on anticoagulants, patients who have lymphedema, or patients who are being evaluated for carpal tunnel syndrome. (AANEM, Needle EMG in certain uncommon clinical contexts, 2005; Jablecki et al., 2002) F-wave and H-reflex tests are not medically necessary for the diagnosis and evaluation of disorders affecting the peripheral nervous system if they are conducted in the absence of needle electromyography and motor and sensory nerve conduction studies due to inadequate

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* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature. · Non-invasive automatic or portable nerve conduction monitoring systems that test only distal motor latencies and conduction velocities, such as NC-stat, Brevio, or NervePace are not medically necessary for the purpose of electrodiagnostic testing due to inadequate clinical evidence of safety and/or efficacy in published, peer-reviewed medical literature.

Benefit specific criteria: · Nerve conduction studies are only medically necessary when performed by an appropriate practitioner as stated below: o Appropriate Practitioners for Nerve Conduction studies and Electromyography Services are as follows: Persons performing electrodiagnosis must be appropriately trained and qualified. Recognition and experience in the management of disparate diseases that produce common electrodiagnostic findings is necessary. Without awareness of the behavior of different diseases and the fact that the results of nerve conduction studies and electromyography may be similar in different diseases, diagnosis solely by EMG-NCS findings may be both wrong and detrimental to the patient. Ongoing real-time clinical diagnostic evaluation is required, especially during EMG examination.

Guidelines published by AAEM (American Association of Electrodiagnostic Medicine) and other medical organizations, in response to inquiries about: (1) physicians interpreting NCS data without any direct patient contact and without providing direct oversight over the performance of NCS; and (2) NCS being utilized to diagnose patients without a complementary needle EMG study has recommended that: Electrodiagnostic studies should be performed by physicians properly trained in electrodiagnostic medicine, That interpretation of NCS data alone without face-to-face patient interaction and control over the process provides substandard care, and that the performance of NCSs without needle EMG has the potential of compromising patient care. It is in the best interest of patients, in the majority of situations, for the needle EMG and the NCS examination to be conducted and interpreted at the same time.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Nerve conduction studies (NCS) are traditionally carried out by a neurologist or other specialist in a specialized electromyographic laboratory, where other procedures such as electromyography (EMG; recording electrical activity directly within muscles through needle electrodes) are often necessary for diagnosis.

Levels of physician supervision Coding Guidelines: Code 95860-95872 92265 Description · Needle Electromyography · Needle Oculoelectromyography Level of Physician Supervision Procedure must be personally performed by a physician or a physical therapist that is qualified by the American Board of Physical Therapy Specialties (ABPTS) as a qualified electrophysiologic clinical specialist and is permitted to provide the service under State law. Nerve Conduction, Amplitude and · A Physical Therapist (PT) with Latency/Velocity Study ABPTS certification (TC & PC), or Orbicularis Oculi (Blink) Reflex · A technician [not a physical therapist] with certification and general H-Reflex Amplitude and Latency supervision of physician (TC only PC Study by physician) procedure. Neuromuscular Junction Testing

95900-95904 95933-95937

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Frequency of testing is determined by clinical justification. Clear, responsible and evidence-based documentation for any repeat study is required. This applies to all studies including those for patients: Under medical, surgical or rehabilitative treatment, For neuropathy, and For patients with chronic renal failure and/or dialysis. The following table lists the American Association of Electrodiagnostic Medicine's recommendations concerning a reasonable maximum number of NCV studies per diagnostic category needed for a physician to render a diagnosis. Generally, the following diagnoses may be established without exceeding the unit limits given below. CPT 95900­95903 Motor NCV studies with and/or without F-wave 3 4 CPT 95904 Sensory NCV studies 4 6

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Indications Carpal tunnel (unilateral) Carpal tunnel (bilateral)

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Radiculopathy Mononeuropathy/Polyneuropathy Myopathy Motor neuron disease (eg, ALS) Plexopathy Neuromuscular junction

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2 4 2 2 6 2

Utilization of nerve conduction studies described by CPT Codes 95900 - 95904 at a frequency of 2 sessions per year is considered appropriate for most conditions (e.g., unilateral or bilateral carpal tunnel syndrome, radiculopathy, mononeuropathy, polyneuropathy, myopathy, and neuromuscular junction disorders). Nerve conduction velocity studies performed more frequently than twice a year may be reviewed for medical necessity.

Medicare & Medicaid Coverage Rationale:

National Coverage Determinations for Neurophysiological testing does not have a national medical policy for surface electromyelography/electrodiagnostic studies. Local Carrier Determinations (LCD) does not exist for Nevada. LCD for other states does exist. Compliance with these policies is required where applicable. Please review if Local Coverage Determinations apply to other states outside of Nevada. http://www.cms.hhs.gov/mcd/search Medical Products Electromyography (EMG): A number of EMG devices are available that are too numerous to mention here. Surface EMG devices include but are not limited to the following: Spinoscope (Spinex Corp.) Quantitative Sensory Testing and Nerve Conduction Studies: Testing devices include but are not limited to the following: Medi-Dx 7000TM Single-Electrode Sensory Nerve Conduction Threshold Device (NDA Inc, Laguna Beach, CA), Neurometer® CPT Electrodiagnostic Neurostimulator (Neurotron Inc, Baltimore, MD), NC-stat System (NeuroMetrix, Inc.), Brevio (NeuMed,Inc.), NervePace (Neurotron, Inc.); Neural-Scan, formally known as Medi-Dx 7000® (Neuro-Diagnostic Associates); Nk PressureSpecified Sensory Device (Nk Biotechnical Engineering); Vibration Perception Threshold (VPT) Meter® (Xilas Medical Inc.); Medi-Dx 7000 (Neuro-Diagnostic Assoc. (NDA) Inc.); CASETM IV System: Computer Aided Sensory Evaluator (WR Medical Electronics Co.); Neurometer® (Neurotron Inc.); VibrameterTM (Somedic AB, Sweden); Thermal sensitivity tester (Sensortek, Inc., Clifton, NJ) Non-Surgical Evoked Potential Testing: Testing systems include but are not limited to Neuropack (various models, manufactured by Nihon Kohden). Other manufacturers of evoked potential recording systems include Nicolet/Viasys, Cadwell, and XLTek.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Background Neurophysiologic studies are used to evaluate patients with suspected or known central and peripheral nervous system disorders. This policy focuses on non-surgical applications of neurophysiologic testing and includes information on the following tests: - Electromyography (EMG): EMG measures muscle response to electrical or nerve stimulation. The test is used to evaluate the function of individual nerves and muscles and has various applications in sports, ergonomics, rehabilitation, orthopedics, psychology, and neurology. Two main types of EMG exist: needle EMG (NEMG) and surface EMG (SEMG). Needle electromyography requires insertion of needles through the patient's skin and is helpful in determining whether muscle weakness results from an injury or a disorder in the nerves that control the muscles. NEMG, in combination with nerve conduction studies (NCSs), is the gold standard methodology for assessing the neurophysiologic characteristics of neuromuscular diseases. The term EMG is often used to encompass nerve conduction studies which measure the action potentials that result from peripheral nerve stimulation. Nerve conduction studies, also referred to as nerve conduction velocity (NCV) studies, aid in evaluating a differential diagnosis and complements the EMG studies. Performed in combination, EMG and NCS testing is usually conducted several weeks after an initial injury; however, in some cases NCS and EMG may prove useful immediately after nerve injury. There is no established standard regarding timing of testing. (American Association of Neuromuscular and Electrodiagnostic Medicine [AANEM], Recommended policy for electrodiagnostic medicine, 2004) Single fiber electromyography (SFEMG) is a specialized electrodiagnostic test that evaluates muscle fibers within a motor unit. Similar to conventional NEMG, it is performed by percutaneous insertion of a small needle electrode into the muscle under study. Macroelectromyography (macro-EMG) is an electrodiagnostic technique that is used to assess the size of the entire motor unit. It is performed by inserting a special type of needle into the muscle being studied. SEMG is represented as a noninvasive alternative modality to NEMG. SEMG uses electrodes that are placed on the skin surface to measure the electrical activity of the underlying muscle. SEMG was developed to assess neuromuscular function when NEMG cannot be used or when results from NEMG are inconclusive. SEMG is also often employed in patients with no obvious underlying pathology, which is often the case in the evaluation of back pain. Paraspinal SEMG or paraspinal EMG scanning has been researched as a technique to establish the etiology of back pain. Spinoscopy consists of SEMG with associated video-recordings. Many variations in instrumentation and protocol exist for SEMG. Therefore, the results of research studies have been inconsistent and difficult to compare, thereby raising questions about the validity of SEMG as a diagnostic tool. In response to the need for standardized assessment of SEMG, the European Union initiated the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles project (SENIAM) to coordinate SEMG research and formulate technical recommendations. (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles [SENIAM]) - Non-Surgical Evoked Potential Testing: Evoked potential (EP) testing, or evoked response testing,

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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evaluates the function of peripheral nerves and various regions of the brain and spinal cord. These tests measure peak amplitudes (voltage) and latencies (time to response) following stimulation of nerves as recorded by electrodes. Magnetic resonance imaging (MRI) is now used in place of some EP testing for certain diagnostic applications. Brain stem auditory evoked potentials (BAEP), somatosensory evoked potentials (SEP), and visual evoked potentials (VEP) are types of EP. Brain stem auditory evoked potentials (BAEP) are also called brain stem auditory evoked responses (BAER).BAEP measure conduction across the auditory nerve and along the auditory pathways in the brain stem. Visual evoked potentials (VEP) are also called visual evoked responses (VER). SEP testing measures response of peripheral nerves and of parts of the central somatosensory pathways, including the spinal cord, the brainstem, and the somatosensory cortex to percutaneous stimulation of nerves in the upper and lower limbs. The dermatomal somatosensory evoked potential (DSEP) test involves mild stimulation of the dermatomal region and records the reaction time to the cortex. DSEPs are performed in a manner analogous to standard somatosensory evoked potential recordings, except that stimulating electrodes are placed over a dermatome rather than a specific nerve. Standard VEP testing typically measures response to a reversing checkerboard pattern visual stimulus (pattern onset VEP, or pattern reversal VEP) presented to the entire visual field at once. There are variations based on segmenting the visual field (multifocal VEP (mfVEP)) and using color contrast versus luminance (black/white) contrast. VEP testing has been considered in recent years as an objective alternative to static automated perimetry, a reference standard also referred to as a Humphrey test. However, static automated perimetry and other tests of visual field loss are limited by their reliance on subjective outcome measures. VEP may be performed to detect multiple sclerosis (MS) when MRI is normal as well as to detect clinical variants of MS and to monitor its clinical progression. VEP is also being investigated as a tool to detect subclinical glaucoma pathology. Motor Evoked Potentials (MEP), also called transcranial motor stimulation are elicited by either electrical or magnetic stimulation of the motor cortex or the spinal cord. Recordings are obtained from the descending motor pathways within the spinal cord or as myogenic potentials from the innervated muscle. MEPs may also be used to stimulate the motor cortex for extraoperative diagnosis of pathology affecting the central nervous system motor tracts. The electrically elicited blink reflex is an electrophysiologic analog of the corneal reflex that is recorded on the orbicularis oculi muscle after electrical stimulation of the supar-orbital branch of the trigeminal nerve. It can be used to localize pathology in the brainstem or cranial nerves. The quantitative sudomotor axon reflex test (QSART) has been used to evaluate the postganglionic segment of a patient's thermal pathway. The QSART test involves the stimulation of sympathetic nerve fibers to the sweat glands at standard sites by the iontophoresis of acetylcholine and measuring the evoked sweat response by sudorometers.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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- Quantitative Sensory Testing (QST): In an attempt to make objective assessments of peripheral neuropathy, QST techniques have been developed. QST usually evaluates the response to one particular stimulus, such as vibration, touch-pressure, heat or cold, and these tests are used to provide information about the function of specific types of nerve fibers. Two types of QST are current perception threshold (CPT) tests (also called sensory nerve conduction threshold [sNCT] testing) and voltage actuated sensory nerve conduction threshold (V-sNCT) tests. These tests rely on the perception of electrical stimuli rather than touch or temperature stimuli. Pressure-specified sensory testing is another type of QST and is used to assess nerve function by quantifying the thresholds of pressure detected with light, static, and moving touch. The NK Pressure-Specified Sensory Device is a pressure-specified sensory testing device that measures pressure sensation using a probe with two blunt prongs that are pressed against the skin but do not break through the skin. Other types of AST testing include monofilament testing and computer assisted sensory examinations. These tests have been used to detect and quantitate sensory deficits in diabetic ulcers and diabetic neuropathy. The term sensory nerve conduction threshold (sNCT) tests should not be confused with the term motor and sensory nerve conduction studies (NCS), a broader term that includes the measurement of conduction velocity, onset latency and amplitude. CPT and sNCT are also different from short-latency somatosensory evoked potentials. - Nerve conduction studies (NCSs): NCSs also referred to as nerve conduction velocity studies (NCV), are performed to assess the integrity and diagnose diseases of the peripheral nervous system. The nerve is stimulated with electrodes placed on the skin over the nerve in various locations. A mild electrical stimulus is applied to the nerve at one or more points. Recording of the electrical response to stimulation of the nerve at these points is conducted and compared to normal values. NCS are routinely performed in conjunction with NEMG. (AANEM, Proper Performance and Interpretation of Electrodiagnostic Studies, 2006) Another type of NCS is late response testing (H-reflex and F-wave testing). Late response studies are complementary to NCV and are performed during the same patient evaluation. In some cases, the late response may be the only abnormality. (AANEM, 2004).The Fwave is a late response evoked by maximal stimulation during a motor nerve conduction study. The H-reflex is the electrophysiological component of the ankle reflex. The H-reflex is obtained from the calf muscle after stimulation of the posterior tibial nerve. In S-1 radiculopathy, the H-reflex is often absent or prolonged in latency. The H-reflex may also be recorded from other sites such as flexor carpi radialis. The NC-stat is a non-invasive, automatic, portable nerve conduction monitoring system used for electrodiagnostic testing at the point of care setting. Other devices used for non-invasive nerve conduction measurement include the Brevio and NervePace (the NervePace is no longer in production). A distinguishing feature of these devices is that they test distal motor latencies response amplitudes and conduction velocities but do not produce real time wave forms. Clinical Information

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Clinical Recommendations Note: This section provides detailed information about the clinical intended use for the treatment that is the topic of this Technology Assessment. The detailed information provided in this section is NOT used to decide whether or not a service is paid for. Rather, it provides background information and rationale about the scientifically appropriate use of the treatment, for discussion purposes with providers. See "Coverage" section to determine what procedure(s) are covered/non-covered (i.e., paid for where such benefits are available). Non-Surgical Evoked Potential Testing: Clinical evidence supports the use of brainstem auditory evoked potential (BAEP) [also called brain stem auditory evoked response (BAER)] studies for the following: · during an assessment for multiple sclerosis to test the peripheral hearing apparatus and brainstem auditory tracts · evaluation of degenerative disorders that may involve the brainstem · evaluation of intrinsic brainstem tumors · evaluation of brainstem function in compromised neonates · evaluation of visual and auditory processing · evaluation of basilar migraine · evaluation of Chiari malformations · evaluation of suspected hearing loss when audiologic testing is limited or inaccurate 0 Clinical evidence does not support the use of brainstem auditory evoked potential (BAEP) studies when used for the following: · · detection of acoustic neuromas predicting prognosis of comatose patients and the evaluation of all other disorders not listed above as proven.

Brain stem auditory evoked potential (BAEP) testing shows promise for detection of acoustic neuroma but has not demonstrated sufficient sensitivity to serve as a diagnostic modality where there is high suspicion of acoustic neuroma. While BAEP testing has been used for a variety of disorders not listed above as proven, insufficient evidence exists to support the use of BAEP for improving management for patients with these disorders. Clinical evidence does not support the use of dermatomal somatosensory evoked potential (DSEP) testing. There are conflicting data regarding the clinical utility of DSEP testing and insufficient evidence to conclude that DSEP testing has a positive impact on the management or clinical outcomes of patients with suspected nerve root compression and/or radiculopathy. Clinical evidence supports the use of motor evoked potential (MEP) testing (also called transcranial motor stimulation) when used for the following: · diagnosis of cervical myelopathy · evaluation of spinal cord injury

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Clinical evidence does not support the use of motor evoked potential (MEP) testing for all conditions other than those listed above as proven. There is insufficient evidence to conclude that MEP has a positive impact on patient management or clinical outcomes in patients with other disorders. Clinical evidence supports the use of somatosensory evoked potential (SEP) studies when used for the following conditions: (AANEM, Recommended Policy for Electrodiagnostic Medicine, 2004) · brain or spinal cord trauma · coma · diabetic peripheral neuropathy · multiple sclerosis · myoclonus · nontraumatic spinal cord lesions (e.g., cervical spondylosis or myelopathy) · spinocerebellar degeneration · subacute combined degeneration of spinal cord Clinical evidence does not support the use of somatosensory evoked potential (SEP) studies when used for the evaluation of all other disorders not listed above as proven. The evidence for SEP testing for all other disorders is limited and insufficient to support the use of SEP for these disorders. Clinical evidence supports the use of visual evoked potential (VEP) [also called Visual Evoked Response (VER)] studies for the following: · evaluation and management of multiple sclerosis after MRI studies have been completed · suspected optic neuritis or other optic neuropathy · familial ataxia syndromes (e.g., Friedreich ataxia) · optic atrophy · adrenoleukodystrophy · traumatic brain injury · toxic and nutritional neuropathies (e.g., B12 deficiency, alcohol-tobacco amblyopia) · compressive lesions of the visual pathway · sarcoidosis VEP studies are used in this setting to monitor the physiologic function of the optic pathways in order to assess for progression or improvement in the demyelinating disease process. Clinical evidence does not support the use of VEP studies when used for the following: · detection of glaucoma · assessment of vision in a child who has potential visual disturbance and is unable to cooperate with standard visual testing and the evaluation of all other disorders not listed above as proven. Visual evoked potential (VEP) studies show some promise as a tool for diagnosing or monitoring

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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glaucoma, but definitive conclusions cannot be drawn due to evidence that is inconsistent and indirect. While VEP testing has been used for a variety of disorders not listed above as proven, insufficient evidence exists to support the use of VEP for these disorders. Clinical evidence supports the use of blink reflex studies only when used to detect neuropathies in the cranial nerves or the brainstem. Clinical evidence does not support the use of blink reflex studies for the evaluation of all other disorders not listed above as proven. While blink reflex testing has been used for a variety of disorders, there is insufficient evidence that blink reflex studies have a positive impact on patient management for disorders other than those listed as proven. Clinical evidence does not support the use of quantitative sudomotor axon reflex test (QSART). There is insufficient evidence to conclude that QSART has a positive impact on patient management or clinical outcomes in patients with neuropathy. Quantitative Sensory Testing: Clinical evidence does not support the use of quantitative sensory testing, including monofilament testing, pressure-specified sensory testing, computer assisted sensory examinations, and current perception threshold (CPT) testing for the diagnosis and evaluation of nervous system disorders. Current perception threshold (CPT) testing shows some promise as a tool for psychophysical assessment of nerve functions, but clinical evidence is inconsistent. Furthermore, in the absence of other testing, CPT tests do not include sensory nerve conduction amplitudes or other critical data and standards medically necessary to reach conclusions on diagnoses. There is not sufficient evidence to demonstrate that pressure-specified sensory testing provides more information than what can be determined during standard evaluation and management of patients with potential nerve compression, disease, or damage. Further research is needed to validate the clinical utility of pressure-specified sensory testing. Electromyography (EMG): Clinical evidence supports the use of needle electromyography (NEMG) including single fiber electromyography for the evaluation of following suspected or known disorders: · peripheral nerve entrapment syndromes · metabolic, nutritional, demyelinating, toxic, infectious, and idiopathic peripheral neuropathies · hereditary polyneuropahties such as Fabry disease · disorders of brachial and lumbosacral plexi · neuromuscular junction disorders · myopathies including polymyositis, dermatomyositis, and congenital myopathies · motor neuron disease · spine disorder with impingement of nerve root seen on spinal imaging · tremor · symptoms suggestive of peripheral nerve, muscle or neuromuscular junction involvement including muscle weakness, muscle atrophy, muscle fasciculation, myokymia, mytonia, loss of

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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dexterity, spasticity, hyperreflexia, sensory deficits, diplopia, ptosis, swallowing dysfunction, dysarthria, impaired bowel motility, and gait dysfunction NEMG is the gold standard methodology for assessing the neurophysiologic characteristics of neuromuscular diseases. Needle EMG is usually performed in conjunction with nerve conduction studies. (American Association of Neuromuscular and Electrodiagnostic Medicine [AANEM], Recommended policy for electrodiagnostic medicine, 2004) Clinical evidence does not support the use of needle electromyography (NEMG) including single fiber electromyography for all conditions other than those listed above as proven. There is insufficient evidence to conclude that NEMG testing has a positive impact on the management or clinical outcomes of patients with conditions other than those listed above as proven. Clinical evidence does not support the use of surface electromyography (SEMG). While the current evidence suggests that surface electromyography (SEMG) may have a potential for use as a diagnostic tool, studies varied considerably in SEMG instrumentation, SEMG protocol, and diagnostic algorithm. Depending on the study's SEMG approach, diagnostic performance ranged from poor to fair. The most promising results were achieved for large-array/high-spatial-resolution SEMG in the investigation of chronic low back pain and neuromuscular disease. However, further research is needed to confirm these results, standardize SEMG approaches and diagnostic algorithms, increase diagnostic performance, and to assess the role of SEMG in clinical practice. Clinical evidence does not support the use of macroelectromyography (macro-EMG) testing. There is insufficient evidence to conclude that macro-EMG has a positive impact on patient management or clinical outcomes in patients with neuromuscular disorders. Only physicians such as neurologists or physiatrists, specially trained in electrodiagnostic medicine should perform needle EMG examinations since these test are simultaneously performed and interpreted. (American Association of Neuromuscular and Electrodiagnostic Medicine [AANEM], Recommended policy for electrodiagnostic medicine, 2004 ) Nerve Conduction Studies: Clinical evidence support the use of nerve conduction studies with or without late responses (e.g., Fwave and H-reflex tests) for the evaluation of the following suspected or known disorders only when performed in conjunction with needle electromyography except in limited circumstances*: · peripheral nerve entrapment syndromes that include ulnar neuropathy at the elbow, peroneal neuropathy, and tarsal tunnel syndrome · metabolic, nutritional, demyelinating, toxic, infectious, and idiopathic peripheral neuropathies · hereditary polyneuropahties such as Fabry disease · disorders of brachial and lumbosacral plexi · neuromuscular junction disorders · myopathies including polymyositis, dermatomyositis, and congenital myopathies · motor neuron disease

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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· · ·

spine disorder with impingement of nerve root seen on spinal imaging tremor symptoms suggestive of peripheral nerve, muscle or neuromuscular junction involvement including muscle weakness, muscle atrophy, muscle fasciculation, myokymia, mytonia, loss of dexterity, spasticity, hyperreflexia, sensory deficits, diplopia, ptosis, swallowing dysfunction, dysarthria, impaired bowel motility, and gait dysfunction

*Clinical evidence supports the use of nerve conduction studies performed without needle electromyography in patients on anticoagulants, patients who have lymphedema, or patients who are being evaluated for carpal tunnel syndrome. (AANEM, Needle EMG in certain uncommon clinical contexts, 2005; Jablecki et al., 2002) The American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) states that it is in the best interest of patients, in the majority of situations, for the needle EMG and the NCS examination to be conducted and interpreted at the same time. (AANEM, Proper Performance and Interpretation of Electrodiagnostic Studies, 2006) Clinical evidence does not support the use of nerve conduction studies for all conditions other than those listed above as proven. There is insufficient evidence to conclude that nerve conduction studies have a positive impact on the management or clinical outcomes of patients with conditions other than those listed above as proven. Clinical evidence supports the use of F-wave and H-reflex tests for the diagnosis and evaluation of disorders affecting the peripheral nervous system only when conducted in conjunction with needle electromyography and motor and sensory nerve conduction studies including nerve conduction velocity studies except in limited circumstances.* *Clinical evidence supports the use of nerve conduction studies performed without needle electromyography in patients on anticoagulants, patients who have lymphedema, or patients who are being evaluated for carpal tunnel syndrome. (AANEM, Needle EMG in certain uncommon clinical contexts, 2005; Jablecki et al., 2002) Clinical evidence does not support the use of F-wave and H-reflex tests for the diagnosis and evaluation of disorders affecting the peripheral nervous system if they are conducted in the absence of needle electromyography and motor and sensory nerve conduction studies. In the absence of other testing, F-wave and H-reflex studies, in and of themselves, do not include critical information and standards medically necessary to reach conclusions on neuromuscular diagnoses. Clinical evidence does not support the use of non-invasive automatic or portable nerve conduction monitoring systems that test only distal motor latencies and conduction velocities, such as NC-stat, Brevio, or NervePace for the purpose of electrodiagnostic testing. Studies of these devices are primarily small case series comparing portable with conventional nerve conduction studies in the same patient. Studies that did use controls did not always report the patients' conditions. Large, robust

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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randomized, controlled studies are needed to prove the safety and efficacy of this technology. Furthermore, the U.S. Food and Drug Administration (FDA) approved the NC-stat System as an adjunct to, and not a replacement for, conventional electrodiagnostic measurements. Nerve conduction studies should be performed by a trained physician or a trained individual under direct supervision of a physician. Direct supervision indicates that the physician is in close physical proximity to the electrodiagnostic laboratory while testing is being done and is immediately available to provide assistance and direction. (American Association of Neuromuscular and Electrodiagnostic Medicine [AANEM], Recommended policy for electrodiagnostic medicine, 2004) Collection of the clinical and electrophysiologic data should be entirely under the supervision of the qualified physician electrodiagnostic (EDX) consultant. The consultant may collect all of the data directly from the patient or may delegate collection of some data to a specifically trained nonphysician or physician in a residency training program or fellowship. In the case of nerve conduction studies (NCSs) and somatosensory evoked potential (SEP) testing, the physician need not be present in the room when the procedure is performed but should be immediately available. Once the physician has determined the preliminary differential diagnosis on the basis of the patient's history and examination, a technologist may perform the NCS and SEP tests selected by the physician. The physician should be alerted immediately during the testing if any results appear to be unusual or unexpected, so that there is opportunity to reassess the differential diagnosis and develop alternative testing strategies. The patient should remain in the room until the supervising EDX consultant has reviewed the NCS and SEP results. (AANEM, Technologists Conducting Nerve Conduction Studies and Somatosensory Evoked Potential Studies Independently to be Reviewed by a Physician at a Later Time, 1999) Clinical Precautions Electromyography (EMG): Needle EMG has potential for complications such as bleeding, infection, nerve injury, pneumothorax and other local trauma. EMG may be contraindicated in persons receiving anticoagulant therapy because the needle electrodes may cause bleeding within the muscle. See the following Web site (Guidelines in Electrodiagnostic Medicine 1999, American Association of Electrodiagnostic Medicine) for more information; http://www.aanem.org/documents/risksinEDXMed.pdf. Accessed April 2008. Surface EMG is a noninvasive modality without any inherent risks to or safety concerns for the patient. Transient involuntary muscle twitching may occur during SEMG. (Wenzel et al., 1998) The main concern is that an incorrect diagnosis may delay treatment, thereby prolonging the patient's discomfort and/or progression of the disease. No clinical precautions or potential complications were described in the literature for evoked potential testing other than the possibility (but no reported incidence) of burn marks caused by somatosensory evoked potential (SEP) stimulation. This risk was identified in one study (Pelosi et al., 2002). Regulatory Requirements

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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U.S. Food and Drug Administration (FDA): Electromyography (EMG): Electromyography devices are approved by the FDA as Class II medical devices. See the following Web site for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=890.1375. Accessed February 2008. Non-Surgical Evoked Potential Testing: Numerous evoked potential (EP) stimuli generators have been approved (Class II; product codes GWE, GWF, GWJ, and HLX). See the following Web site for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed April 2008. Quantitative Sensory Testing and Nerve Conduction Studies: The Neurometer®was approved for marketing in June 1986. A similar device, the Medi-Dx 7000TM Single-Electrode Sensory Nerve Conduction Threshold Device (NDA Inc, Laguna Beach, CA) received marketing approval from the FDA in December 1997. See the following Web site for more information: http://www.fda.gov/cdrh/pdf/K964622.pdf. Accessed May 2008. Neurosensory testing systems such as the NK Pressure-Specified Sensory Device (PSSD) are regulated by the FDA as Class II devices. The PSSD was approved via the FDA 510(k) process (K934368) on August 11, 1994. See the following Web site for more information regarding other sensory testing systems: (use product code LLN [Vibration threshold measurement device]) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed February 2008. The NC-stat System received initial FDA 510(k) approval on October 2, 1998 for measurement of neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. It was approved as an adjunct to, and not a replacement for, conventional electrodiagnostic measurements. Four subsequent 510(k) approvals have been issued for this device, the most recent one being issued in July 2006. See the following Web site for more information: http://www.fda.gov/cdrh/pdf6/K060584.pdf. Accessed May 2008. The intended use for this device remained essentially unchanged in all approvals issued. Research Evidence Electromyography (EMG): Needle EMG (NEMG): NEMG is accepted as an established method for diagnosing, excluding, and evaluating neuromuscular disorders. (American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), Recommended policy for electrodiagnostic medicine, 2004) NEMG is indicated for the following conditions: peripheral nerve entrapment syndromes; metabolic, nutritional, demyelinating, toxic, infectious, and idiopathic peripheral neuropathies; hereditary polyneuropahties such as Fabry disease; disorders of brachial and lumbosacral plexi; neuromuscular junction disorders; myopathies including polymyositis, dermatomyositis, and congenital myopathies motor neuron disease; spine disorder with impingement of nerve root seen on spinal imaging; and tremor. (Buxton, 2006; Burns, 2006, Chemali, 2005; Gerschlager, 2004; McAuley, 2004, Gutmann, 2005; Meriggioli, 2005; Siddiqi, 2006; Falah, 2005; Haig, 2005; Carette, 2005)

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Surface EMG (SEMG): Studies were selected for detailed review of surface electromyography (SEMG) if they (1) investigated the use of SEMG for neurodiagnostic purposes; (2) enrolled at least 30 study participants, and (3) included a control or reference group of healthy persons. Studies that used SEMG solely as an outcome measure or investigated SEMG for gait analysis or as part of a biofeedback protocol were excluded. SEMG used for Chronic Back Pain: Hayes provided the following summary of studies published from 1995 to 2005 that evaluated the efficacy and safety of SEMG for the investigation of low back pain. The studies evaluated SEMG in 57 to 350 study participants (total, n=1463). The evidence included one retrospective and twelve prospective evaluation studies and one meta-analysis of SEMG in patients with low back pain and healthy controls. While SEMG could differentiate between patients with low back pain and healthy persons, effect sizes were small to moderate and sensitivity and specificity were poor to fair for all types of SEMG and varied considerably among studies. In a meta-analysis, Geisser et al. (2005) evaluated diagnostic performance of SEMG for low back pain among 44 studies that were published during the years 1988 to 2002. The mean sensitivity and specificity was 39.6% and 90.8% for static SEMG, 88.8% and 81.3% for dynamic SEMG, and 84.4% and 89.8% for static SEMG during isometric exertion, respectively. The most promising results were achieved with large-array SEMG. (Finneran et al.,2003) The study enrolled 163 healthy persons, 13 persons with acute back pain, and 25 persons with chronic back pain. All participants underwent a standardized SEMG protocol while the patient was standing or during isometric exertion. The data obtained from the healthy participants were stratified by sex and body mass index and served as a reference for the back pain patients. This approach reached a sensitivity of 90% and specificity of 93% for the detection of back pain. SEMG could not distinguish between patients with acute and chronic back pain. The current evidence suggests that while SEMG measurements differ among patients and healthy persons, the diagnostic performance is not sufficient to recommend SEMG as a diagnostic tool in the evaluation of back pain. There is no information as to how its use would affect patient outcomes. More research is required to standardize SEMG approaches and to assess their diagnostic value in clinical practice. (Hayes, Surface Electromyography for Evaluation of Low Back Pain, 2005) SEMG used for Neuromuscular Disorders Huppertz et al. (1997) evaluated the diagnostic performance of high-spatial resolution SEMG in 6 patients with Becker muscular dystrophy, 35 patients with Duchenne muscular dystrophy, 10 patients with hereditary motor and sensory neuropathy, and 21 spinal muscular atrophy patients. Based on reference data obtained from 61 healthy participants; sensitivity, specificity, and positive predictive value were 82%, 97%, and 97%, respectively, for neuromuscular disorders; 85%, 97%, and 92% for myopathic disorders; and 68%, 97%, and 92% for neuropathic disorders.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Wenzel et al. (1998) compared SEMG with myosonography for the detection of fasciculation in patients with polyneuropathy (n=44), lower motor neuron disease (n=15), hereditary motor and sensory neuropathy (n=11), inflammatory myopathy (n=3), and adrenomyeloneuropathy (n=3). SEMG and myosonography had similar diagnostic performance for the detection of fasciculation. Sensitivity, specificity, and accuracy were 56%, 91%, and 74%, respectively, for SEMG compared with 63%, 93%, and 79% for myosonography, respectively. The current evidence suggests that SEMG has the potential for use as a diagnostic tool in the evaluation of neuromuscular, myopathic, and neuropathic disorders but may be less useful for the detection of fasciculation in patients with neuromuscular disease. SEMG used for Essential Tremor: One study (Gironell et al., 2004) evaluated SEMG for the initial diagnosis of essential tremor in 300 patients who present for the first time with postural tremor of the hands as the predominant symptom. SEMG detected essential tremor in this patient group with 98% sensitivity and 82% specificity, and achieved a positive predictive value of 95% and negative predictive value of 91%. This result suggests SEMG may be an appropriate diagnostic tool for the initial evaluation of essential tremor in symptomatic patients; however, the impact on patient management and outcomes must be evaluated before SEMG can be recommended for the routine evaluation of essential tremor. Macroelectromyography (Macro-EMG) Testing. A small number of studies have evaluated the use of macro-EMG. Lange et al. (1989) used quantitative motor unit potential analysis, single-fiber electromyography, and macroelectromyography (macro-EMG) to determine if these techniques could identify weakening muscles. They classified 18 previously affected muscles according to strength from 12 patients who had had poliomyelitis 18 to 50 years earlier. And conclude that low-amplitude macro-EMG signals may be useful in the identification of muscles weakened by postpolio muscular atrophy. There is insufficient evidence to conclude that macro-EMG has a positive impact on patient management or clinical outcomes in patients with neuromuscular disorders. Professional Societies and Organizations: American Academy of Neurology (AAN): The AAN considers the use of SEMG as unacceptable for the diagnosis of neuromuscular disease and low back pain. However, SEMG is an acceptable modality for kinesiologic analysis of movement disorders; for differentiating types of tremors, myoclonus, and dystonia; for evaluating gait and posture disturbances; and for evaluating psychophysical measures of reaction and movement time (based on Class III data - evidence provided by expert opinion, nonrandomized historical controls, or observation(s) from case series). (Pullman et al., 2000) Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM): SENIAM has issued recommendations regarding appropriate SEMG electrode shape, size, material, inner electrode distance, sensor construction, and proper placement. These guidelines are reissued on an annual basis. (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles [SENIAM]) SENIAM makes no recommendations for the use of SEMG.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) (formally the American Association of Electrodiagnostic Medicine)/American Academy of Physical Medicine and Rehabilitation: According to a Technology Review titled, The Use of Surface EMG in the Diagnosis and Treatment of Nerve and Muscle Disorders, there are no clinical indications for the use of SEMG in the diagnosis and treatment of disorders of nerve or muscle. With further development, SEMG with specialized computer signal processing may prove clinically useful in the noninvasive monitoring of the progression of a nerve or muscle disorder. It may also become a complementary test in the primary diagnosis of such disorders, but is unlikely to be useful without needle examination in this regard without substantial scientific breakthroughs and validating clinical research. (Haig et al., 1999) American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM): The AANEM recommends that a typical EMG examination includes all of the following: development of a differential diagnosis based upon appropriate history and physical, completion of indicated nerve conduction studies (recording and studying of electrical responses from peripheral nerves or muscles), and the completion of indicated needle EMG studies for selected muscles. The needle EMG studies are interpreted in real time as they are being performed. In addition, the AANEM recommends only one attending physician perform and supervise all components of the electrodiagnostic testing and that the testing occur on the same day. Reporting NCS and EMG results into separate reports is inappropriate and would be an exception to clinical practice. (American Association of Neuromuscular and Electrodiagnostic Medicine [AANEM], Recommended policy for electrodiagnostic medicine, 2004 ) Based on the literature, the AANEM's position is that there are no contraindications to EMG in patients with lymphedema. However, the AANEM believes that reasonable caution should be taken in performing needle examinations in lymphedematous regions to avoid complications. Clinical judgment should be used in deciding whether the risk of complication is greater than the value of the information to be obtained from the EMG. (AANEM, Needle EMG in certain uncommon clinical contexts, 2005) Non-Surgical Evoked Potential Testing: Brain Stem Auditory Evoked Potentials (BAEP) or Brain Stem Auditory Evoked Response (BAER) Detection of Acoustic Neuromas Five generally low quality studies provide conflicting evidence regarding the usefulness of standard BAEP for detection of acoustic neuroma, and they provide some evidence that a novel method called stacked BAEP dramatically improves sensitivity. Two retrospective studies (El-Kashlan et al., 2000, Marangos et al., 2001) and two prospective studies (Cueva, 2004, Rupa et al., 2003) applied BAEP to groups of patients being evaluated for suspected acoustic neuroma. A prospective study which explored stacked BAEP included a group of patients who had already been screened and found to have small acoustic neuromas, and a control group of healthy volunteers (Don et al., 2005). Methodological weaknesses in these studies include retrospective design for two of them, no report of blinded evaluation except in Cueva, and selection biases in Don et al. Prognosis in Comatose Patients

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Three studies that differed in the clinical histories of the study groups and in the specific BAEP measures used were also inconsistent in their findings regarding the ability of BAEP to predict coma outcomes (Balogh et al., 2001, Fischer et al., 2004, Tiainen et al., 2005). In a prospective study of 116 comatose patients (mixed etiologies), Balogh et al. provided evidence of moderate quality regarding the ability of BAEP wave VI to avoid an inappropriately poor prognosis (BAEP testing usually focuses on waves I to V of the EEG tracing). Statistically, the unilateral absence of wave VI at 1 month was strongly associated with a poor outcome (patient either did not awaken or awoke with severe disability, i.e., Glasgow Outcome Scale score 1 to 3), and both specificity and PPV were high (93% and 100%, respectively). A similarly designed study (n=346; mixed etiology) did not demonstrate a role for BAEP (Fischer et al, 2004). There was no significant difference between patients with normal BAEP and those with abnormal BAEP in the proportion who had a good outcome at 1 year using regression models. Other electrophysiological measures were found to be significant predictors of outcome, but BAEP was not. A retrospective but blinded assessment of early BAEP and its relationship to coma outcome at 6 months in 70 patients who had suffered cardiac arrest found no discernible pattern between BAEP latencies and poor outcome. (Tiainen et al. 2005) Suspected Hearing Loss BAEP is indicated for the evaluation of suspected hearing loss when audiologic testing is limited or inaccurate. (Wellman, 2003; Lew, 2004) Dermatomal Somatosensory Evoked Potential (DSEP) The diagnostic value of electrophysiological tests was evaluated in 25 patients with monoradicular sciatica. The electrophysiological exam consisted of DSEPs, electromyography (EMG), F-wave latencies, H-reflexes and motor and sensory nerve conduction determinations. EMG sensitivity was high but specificity was low in all patients. DSEP results showed low sensitivity but high specificity. None of the electrophysiological tests provided statistically significant outcomes. The use of these studies as a stand-alone examination in patients with sciatica would not be sufficient for determining the cause of these symptoms. (Albeck et al., 2000) A prospective study of radiologic versus neurophysiologic findings from 20 patients with radicular syndrome, were compared pre- and postsurgery. Prior to surgery, each patient underwent three neurophysiologic tests which included: EMG, F-responses, and DSEP. Neurophysiologic testing during this study was not useful in confirming the presence of a nerve root lesion, and abnormal findings may lead to additional patient testing in the absence of a pathological deficit. (Tullberg et al., 1993) There are conflicting data regarding the clinical utility of DSEP testing, and insufficient evidence to conclude that DSEP testing has a positive impact on the management or clinical outcomes of patients with suspected nerve root compression and/or radiculopathy. (Hayes, Dermatomal Somatosensory Evoked Potentials. May 2008)

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Motor Evoked Potentials (MEP) Several studies have demonstrated that MEP is beneficial for the diagnosis of cervical myelopathy (Lo et al., 2006) and the evaluation of spinal cord injury. (Clarke et al., 1994) Somatosensory Evoked Potentials (SEP) Prognosis in Patients Comatose Following Cardiac Arrest According to Hayes, evidence from a number of prospective studies and 2 systematic reviews of earlier studies indicates that SEP testing is highly accurate in identifying patients who will have a poor neurological outcome following cardiac arrest. Although short follow-up times may have been responsible to some extent for the very low false positive (FP) rate (0%) reported in these studies, the findings of 100% specificity for poor outcome were consistent among the individual studies and agreed with the pooled estimates of FP rate provided in the systematic reviews. In addition, these studies suggest that a tentative prognosis of poor outcome may be made on the basis of SEP findings sooner than clinical findings would allow and that the sensitivity of SEP testing may be improved by combining it with an assessment of creatinine kinase BB (CKBB) isoenzyme levels. (Hayes, Somatosensory Evoked Potentials for Prognosis of Coma Following Cardiac Arrest, 2006) In a study of 131 comatose patients with a mix of causative etiologies, the prognostic value of shortlatency SEP was found to vary according to etiology. (Logi et al. 2003) Bilateral amplitude reduction in the anoxic-ischemic subgroup (cardiac or respiratory failure; n=49) had the following values for sensitivity, specificity, PPV, and NPV: 47%, 100%, 100%, and 38%. Bilateral absence of response had only 10% sensitivity but 100% specificity. Testing with middle latency auditory evoked potentials provided additional prognostic information in traumatic brain-injured and stroke groups but not in the anoxic-ischemic group. Robinson et al. conducted a systematic review of the literature spanning the years 1993 to 2000. For 1136 adult patients in anoxic-ischemic coma they calculated pooled PPVs for PVS/death of 100% for absent SEP and 74% for abnormal SEP. Normal SEP had a 68% PPV for awakening (Robinson et al. 2003). Visual Evoked Potentials (VEP) Glaucoma Hayes analyzed 9 studies involving multifocal VEP (mfVEP) testing or color-contrast VEP testing. There were no studies focusing on standard pattern VEPs (PVEPs) with luminance contrast. Study groups included 30 to 308 patients with confirmed or suspected glaucoma. Studies that evaluated color-contrast VEP testing were generally larger than those that evaluated mfVEP testing. Patients were similar across studies with respect to most characteristics. Sensitivity of at least 75%, and in some studies 90% or better, was consistently reported for both mfVEP and blue-on-yellow (B/Y) color-contrast VEP testing in study groups not restricted to patients with mild glaucoma. There was limited evidence that moderate to high specificity can also be achieved without sacrificing sensitivity. The evidence supporting B/Y VEP testing is stronger than that supporting mfVEP testing in terms of the number of patients tested (601 and 251 patients, respectively) and uniformity of protocols. One study of mfVEP testing and two studies of B/Y VEP testing demonstrated low sensitivity (less than

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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50%) for mild glaucoma. Most of the studies did not provide evidence of specificity based on an a priori cutoff point and none tested VEPs in patients with disease mimicking glaucoma. Hayes concluded that VEP testing shows some promise as a tool for diagnosing glaucoma; however data are limited and evidence of specificity and the comparative value of VEP and SAP is lacking. Data regarding the use of VEP testing for monitoring progression in patients at risk for glaucoma is too limited to allow evaluation of sensitivity or positive predictive value. (Hayes, Visual Evoked Potentials for Diagnosing and Monitoring Glaucoma, 2006) Thienprasiddhi et al., 2006, utilized VEP for early detection of functional damage in 25 patients with suspected glaucoma, 25 patients with ocular hypertension, and 50 controls. The mfVEP results were abnormal in 4% of the eyes from normal subjects. Abnormal mfVEPs were detected in 20% of the eyes of glaucoma suspect (GS) patients and 16% of the eyes of patients with ocular hypertension (OHT). Significantly more mfVEP abnormalities were detected in GS patients than in normal controls. There was no significant difference in mfVEP results between OHT patients and normal controls. The investigators concluded that the mfVEP technique can detect visual field deficits in a minority of eyes with glaucomatous optic disks and normal standard automated perimetry (SAP) results. Klistorner et al. (2007) evaluated the sensitivity and specificity of blue-on-yellow mfVEPs in early glaucoma. The study included 50 patients with a confirmed diagnosis of early glaucoma and 60 normal participants. Patients underwent blue-on-yellow mfVEPs and achromatic SAP. Based on the definition of visual field defect, in the group of glaucomatous eyes with SAP defects, amplitude of blue-on-yellow mfVEP was abnormal in all 64 cases (100% sensitivity), whereas black-and-white mfVEP missed 5 cases (92.2% sensitivity). The investigators concluded that the blue-on-yellow mfVEP is a sensitive and specific tool for detecting early glaucoma. Other Conditions VEP is indicated for the following conditions: evaluation and management of multiple sclerosis after MRI studies have been completed, suspected optic neuritis or other optic neuropathy, familial ataxia syndromes (e.g., Friedreich ataxia), optic atrophy, adrenoleukodystrophy, traumatic brain injury, toxic and nutritional neuropathies (e.g., B12 deficiency, alcohol-tobacco amblyopia), compressive lesions of the visual pathway, and sarcoidosis. (Walsh, 2005, Robbins, 2003, Crewther, 2004) Blink Reflex The electrically elicited blink reflex is a reflex recorded on the orbicularis oculi muscle. The latency of the responses can help localize pathology in the cranial nerves or in the brainstem. When elicited by electrical stimulation, the blink reflex is a controlled and reliable model in clinical neurophysiology (Esteban 1999; AANEM, Recommended policy for electrodiagnostic medicine, 2004). Quantitative Sudomotor Axon Reflex Test (QSART): Several studies regarding autonomic neuropathy have been conducted; however, there are only a few that focus specifically on the use of

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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the quantitative sudomotor axon reflex test (QSART). Itoh et al. (2003) evaluated the relation between orthostatic hypotension and results obtained from a QSART in 38 individuals with type 2 diabetes and 13 non-diabetic individuals (control group). The investigators found that orthostatic hypotension may be measured by obtaining QSART outcomes at the dorsum of the foot in type 2 diabetics. Several studies have reached conflicting conclusions concerning the appropriate use of the QSART versus other tests that may be utilized during the examination of a patient who exhibits symptoms that could be the result of sympathetic or parasympathetic neuropathy. (Low et al., 2006; Shimada et al., 2001). There is insufficient evidence to conclude that the quantitative sudomotor axon reflex test (QSART) has a positive impact on patient management or clinical outcomes in patients with autonomic neuropathy. (Hayes, Quantitative sudomotor axon reflex test (QSART) May 2008) Professional Societies and Organizations American Academy of Neurology (AAN): The AAN states that visual evoked potentials and somatosensory evoked potentials are probably useful to identify patients at increase risk for developing clinically definite multiple sclerosis (MS). The AAN states that the evidence is insufficient to recommend brain stem auditory evoked potentials (BAEP) as a useful test to identify patients with increased risk of MS. (AAN Practice parameter: The usefulness of evoked potentials in identifying clinically silent lesions in patients with suspected multiple sclerosis, 2000) According to the AAN, there is insufficient evidence that DSEP findings provide any reliable information beyond the routine clinical examination and there is insufficient evidence to suggest DSEP is superior to already established neurophysiologic techniques. (AAN Assessment: Dermatomal Somatosensory Evoked Potentials. 1997) American Clinical Neurophysiology Society (ACNS): The ACNS has developed technical standards for the performance and interpretation of EP. These include criteria for clinically significant abnormalities. (ACNS Guidelines) American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) In a Position Statement for Technologists Conducting Nerve Conduction Studies and Somatosensory Evoked Potential Studies Independently to be Reviewed by a Physician at a Later Time, the AANEM stated that the collection of the clinical and electrophysiologic data should be entirely under the supervision of the qualified physician electrodiagnostic (EDX) consultant. The consultant may collect all of the data directly from the patient or may delegate collection of some data to a specifically trained nonphysician or physician in a residency training program or fellowship. In the case of nerve conduction studies (NCSs) and somatosensory evoked potential (SEP) testing, the physician need not be present in the room when the procedure is performed but should be immediately available. Once the physician has determined the preliminary differential diagnosis on the basis of the patient's history and examination, a technologist may perform the NCS and SEP tests selected by the physician. The physician should be alerted immediately during the testing if any results appear to be unusual or unexpected, so that there is opportunity to reassess the differential diagnosis and develop alternative testing strategies. The patient should remain in the room until the supervising EDX consultant has reviewed the NCS and SEP results.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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To conform with Medicare regulations, a physician must provide direct supervision throughout the performance of the NCS or SEP testing. Medicare regulations concerning diagnostic tests rendered by nonphysicians state that direct supervision by the physician is established if the following conditions are met: 1. The physician must be present in the office suite, however, the actual presence of the physician is not required in the room when the procedure is performed (unless otherwise required by state law). 2. The physician must be immediately available to furnish the nonphysician employee with assistance and direction, if needed, throughout the performance of the entire procedure. The qualifications for who may legally practice electrodiagnostic medicine in a specific geographic area are dependent upon legislation enacted by the particular state or on interpretive rulings by appropriate authorities, such as the medical practice board or state attorney general. To determine what official legal, governmental, or private criteria govern in a specific state, please look to the appropriate authorities in that state. (AANEM, Technologists Conducting Nerve Conduction Studies and Somatosensory Evoked Potential Studies Independently to be Reviewed by a Physician at a Later Time, 1999) In a policy for electrodiagnostic medicine, the AANEM states that common diagnoses where SEPs have demonstrated usefulness include but are not limited to the following: spinal cord trauma, subacute combined degeneration, nontraumatic spinal cord lesions (e.g., cervical spondylosis), multiple sclerosis, spinocerebellar degeneration, myoclonus, coma, and intraoperative monitoring of spinal cord, brainstem, and brain sensory tracts. (AANEM, Recommended policy for electrodiagnostic medicine, 2004) International Panel on the Diagnosis of MS: Revised diagnostic guidelines issued by the International Panel on the Diagnosis of MS in 2001 recommend the use of VEP testing to supplement MRI diagnosis, particularly in situations where MRI abnormalities are few, or to help establish a diagnosis when MRI is unavailable. The Panel concluded that other forms of EP testing are not useful in diagnosing MS. (McDonald et al., 2001) Multi-Society Task Force on Permanent Vegetative State (PVS): A 1994 consensus statement issued by The Multi-Society Task Force on PVS concluded that SEP responses may be useful in determining the likelihood of PVS as the outcome of coma but cautioned that both false positives and false negatives are possible and that EP testing often has a primarily statistical rather than clinical value. The Task Force stated that BAEP responses were of limited value. (Multi-Society Task Force on Persistent Vegetative State, 1994) Nerve Conduction Studies (NCS): The use of nerve conduction studies including F-wave and H-reflex tests for the diagnosis of early stage polyneuropathies and proximal nerve lesions is confirmed in reviews and studies. (KosteraPruszczyk et al.,2004; Trujillo-Hernandez et al., 2005; Bal et al., 2006; Kocer et al., 2005; Mesrati

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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and Vecchierini, 2004) The results of preliminary studies for automatic or portable nerve conduction monitoring systems are promising; however the studies are primarily small case series comparing portable with conventional nerve conduction studies in the same patient. (Kong et al., 2006; Fisher, 2005; Guyette and Wilgis, 2004) A Hayes report found that there is insufficient evidence to determine whether the use of the NC-stat System is equivalent to traditional NCS for the evaluation of upper extremity neuropathy. (Hayes Brief, NC-stat System for Noninvasive Nerve Conduction Testing of Upper Extremity Neuropathy, 2007) A retrospective study involving 1,190 patients who underwent point-of-service NCS (using NC-stat) for the evaluation of carpal tunnel syndrome concluded that point-of-service NCS generated relevant diagnostic outcomes. (Megerian et al., 2007) Nerve conduction studies are indicated for the following conditions: peripheral nerve entrapment syndromes that include ulnar neuropathy at the elbow, peroneal neuropathy, and tarsal tunnel syndrome; metabolic, nutritional, demyelinating, toxic, infectious, and idiopathic peripheral neuropathies; hereditary polyneuropahties such as Fabry disease; disorders of brachial and lumbosacral plexi; neuromuscular junction disorders; myopathies including polymyositis, dermatomyositis, and congenital myopathies; motor neuron disease; spine disorder with impingement of nerve root seen on spinal imaging; and tremor. (Buxton, 2006; Burns, 2006, Chemali, 2005; Gerschlager, 2004; McAuley, 2004, Gutmann, 2005; Meriggioli, 2005; Siddiqi, 2006; Falah, 2005; Haig, 2005; Carette, 2005) Professional Societies/Organizations American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM): The AANEM recommends that a typical examination performed for nerve conduction studies include: development of a differential diagnosis based upon appropriate history and physical, the NCV study (recording and studying of electrical responses from peripheral nerves or muscles) and the completion of indicated needle EMG studies to evaluate the differential diagnosis and to complement the nerve conduction study. The minimum standards for NCV testing are as follows: - The testing is medically indicated. - It is performed using equipment that provides assessment of all parameters of the recorded signals (equipment designed for screening purposes is not acceptable).signals (equipment designed for screening purposes is not acceptable). - The test is performed by a physician, or by a trained technician under the direct supervision of a physician. - The EMG must be performed by a trained physician. - One physician supervises and performs all components of the exam. (American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), Recommended policy for electrodiagnostic medicine, 2004) The position statement of the AANEM regarding the performance and interpretation of electrodiagnostic studies states that the performance of or interpretation of NCS separately from the needle EMG component of the testing should clearly be the exception. Nerve conduction studies

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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performed independent of needle EMG may only provide a portion of the information needed to diagnose muscle, nerve root, and most nerve disorders. When the NCS is used on its own without integrating needle EMG findings or when an individual relies solely on a review of NCS data, the results can be misleading and important diagnoses may be missed. (AANEM, Proper performance and interpretation of electrodiagnostic studies, 2006) A 2002 practice parameter for electrodiagnostic studies in carpal tunnel syndrome developed by the AANEM, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation , lists NCS as a standard diagnostic test for carpal tunnel syndrome and NEMG as an optional test for diagnosing carpal tunnel syndrome. (Jablecki et al., 2002) A 2005 AANEM practice guideline for usefulness of electrodiagnostic techniques in the evaluation of suspected tarsal tunnel syndrome recommends NCS for confirming the presence of tarsal tunnel syndrome. The guideline states that the utility of needle EMG in the assessment of tarsal tunnel syndrome is unclear. (Patel et al., 2005) A 2005 AANEM practice parameter for utility of electrodiagnostic techniques in evaluating patients with suspected peroneal neuropathy states that NCSs are possibly useful to make or confirm the diagnosis of suspected peroneal neuropathy. The guideline indicates that the data are insufficient to determine the role of needle EMG in making the diagnosis of peroneal neuropathy. (Marciniak et al., 2005) A 1999 practice parameter for electrodiagnostic studies in ulnar neuropathy at the elbow by the AANEM, American Academy of Neurology, and American Academy of Physical Medicine and Rehabilitation, states that ulnar sensory and motor NCSs should be performed with surface stimulation and recordings for patients with suspected ulnar neuropathy at the elbow. The guideline also states that depending on the results of NCSs, needle EMG may be indicated. (AANEM practice parameter for electrodiagnostic studies in ulnar neuropathy at the elbow: summary statement, 1999) Quantitative Sensory Testing: Published case series have described the use of sensory threshold testing to help diagnose or describe a wide range of conditions in which peripheral damage may occur. In the absence of a "gold standard" diagnostic test with which to compare sensory threshold testing in each of these disorders, the sensitivity and specificity of this diagnostic tool cannot be determined. ECRI identified 11 nonrandomized controlled trials, all of which pertained to the current perception threshold (CPT) test. (Aird et al., 2006; Matsutomo et al., 2005; Nishimura et al., 2004; Toda et al., 2004; Kudoh et al., 2003; Nishimura et al., 2003; Tseng, 2003; Watanabe et al., 2002; Yamashita et al. 2002; Kurozawa and Nasu, 2001; Raj et al., 2001) Generally, patient groups have higher CPT values than healthy controls. There were no clinical studies on the voltage actuated sensory nerve conduction threshold (V-sNCT) test identified in literature. (ECRI, Sensory Nerve Conduction Threshold Tests Including Current Perception Threshold and Voltage Nerve Conduction Threshold Tests, 2006) Nishirmura et al. (2003) found that current threshold perception testing had a specificity

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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of 74% and a sensitivity of 73% for the diagnosis of carpal tunnel syndrome. Hayes identified three small studies (n=14 to 47) that evaluated pressure-specified sensory testing for detection of tarsal tunnel syndrome. (Hayes Brief, NK Pressure-Specified Sensory Device, Sensory Management Services LLC, for Tarsal Tunnel Syndrome Diagnosis. October 2006) In addition to small size, only two of these studies compared pressure-specified sensory testing diagnosis of tarsal tunnel syndrome with other methods of sensory testing and all three studies were conducted by the coinventor of the device. (Tassler and Dellon, 1995; Barber et al., 2001; Tassler and Dellon, 1996) Professional Societies And Organizations: American Academy of Neurology (AAN): In a 2003 report, the AAN noted quantitative sensory testing (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 which limit the objectivity of testing results. (Shy et al., 2003) American Association of Electrodiagnostic Medicine (AAEM): In 2004, AAEM reviewed the technical aspects and reproducibility of different methods to determine threshold for light touchpressure, vibration, thermal, and pain stimuli. Clinical uses and limitations of QST were also reviewed. The report found that the results of QST are highly dependent on methodology and the full cooperation of the subject. QST has been shown to be reasonably reproducible over a period of days or weeks in normal subjects. The use of QST in research and patient care should be limited to instruments and their corresponding methodologies that have been shown to be reproducible. Literature data do not allow conclusions regarding the relative merits of individual QST instruments. (Chong and Cros, 2004) Local Carrier Determinations (LCD) exist. Compliance with these policies is required where applicable. Available at: http://www.cms.hhs.gov/MCD/index_local_alpha.asp? from=alphalmrp&letter=N.Refer testing for urinary incontinence. References and Resources Resources Aird J, Cady R, Nagi H, Kullar S, MacDermid JC. The impact of wrist extension provocation on current perception thresholds in patients with carpal tunnel syndrome: a pilot study. J Hand Ther. 2006;19(3):299-305. Albeck MJ. Taher G. Lauritzen M. et al. Diagnostic value of electrophysiological tests in patients with sciatica. Acta Neurologica Scandinavica. 2000;101(4):249-254. American Academy of Neurology (AAN). Practice parameter: The usefulness of evoked potentials in identifying clinically silent lesions in patients with suspected multiple sclerosis (an evidence-based review). 2000. Available at: http://www.neurology.org/cgi/reprint/54/9/1720.pdf. Accessed April 2008.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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American Academy of Neurology (AAN).Assessment: Dermatomal Somatosensory Evoked Potentials. 1997. Available at: http://aan.com/professionals/practice/pdfs/pdf_1995_thru_1998/1997.49.1127.pdf. Accessed May 2008. American Association of Electrodiagnostic Medicine, American Academy of Neurology, American Academy of Physical Medicine and Rehabilitation Practice parameter for electrodiagnostic studies in ulnar neuropathy at the elbow: summary statement. Muscle Nerve. 1999 Mar;22(3):408-11. American Association of Neuromuscular & Electrodiagnostic Medicine. Needle EMG in certain uncommon clinical contexts. Muscle Nerve. 2005 Mar;31(3):398-9. American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Proper performance and interpretation of electrodiagnostic studies. Position statement. 2006. Available at: http://www.aanem.org/documents/ProperPerformance.pdf. Accessed May 2008. American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Recommended policy for electrodiagnostic medicine. Endorsed by the American Academy of Neurology, The American Academy of Physical Medicine and Rehabilitation, and The American Association of Electrodiagnostic Medicine. Updated 2004. Available at: http://www.aanem.org/PracticeIssues/RecPolicy/recommended_policy_1.cfm. Accessed February 2008. American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Technologists Conducting Nerve Conduction Studies and Somatosensory Evoked Potential Studies Independently to be Reviewed by a Physician at a Later Time, 1999. Available at: http://www.aanem.org/practiceissues/positionstatements/TechsNCSSEP.cfm. Accessed April 2008. American Clinical Neurophysiology Society (ACNS) Guidelines. Web site. Available at: http://www.acns.org. Accessed April 2008. Bal S, Celiker R, Palaoglu S, et al. F wave studies of neurogenic intermittent claudication in lumbar spinal stenosis. Am J Phys Med Rehabil. 2006 Feb;85(2):135-40. Balogh A, Wedekind C, Klug N. Does wave VI of BAEP pertain to the prognosis of coma? Neurophysiol Clin. 2001;31(6):406-411. Barber MA, Conolley J, Spaulding CM, Dellon AL. Evaluation of pressure threshold prior to foot ulceration: one-versus two-point static touch. J Am Podiatr Med Assoc. 2001;91(10):508-514. Barboi AC, Barkhaus PE. Electrodiagnostic testing in neuromuscular disorders. Neurol Clin 22 2004;619-641. Burns JM, Mauermann ML, Burns TM. An easy approach to evaluating peripheral neuropathy. Journal

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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of Family Practice 2006;55(10):853-61. Buxton WG, Dominick JE. Electromyography and nerve conduction studies of the lower extremity: uses and limitations. Clinics in Podiatric Medicine and Surgery 2006;23(3):531-43. DOI: 10.1016/j.cpm.2006.04.003. Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. New England Journal of Medicine 2005;353(4):392-9. Chemali KR, Tsao B. Electrodiagnostic testing of nerves and muscles: when, why, and how to order. Cleveland Clinic Journal of Medicine 2005;72(1):37-48. Chong PST, Cros DP. American Association of Electrodiagnostic Medicine (AAEM) Practice Topic in Electrodiagnostic Medicine: Technology literature review: quantitative sensory testing. Muscle Nerve. 2004;29:734-47. Clarke CE, Modarres-Sadeghi H, Twomey JA, Burt AA. Prognostic value of cortical magnetic stimulation in spinal cord injury. Paraplegia. 1994 Aug;32(8):554-60. Crewther DP, Luu CD, Kiely PM, Kowal L, Crewther SG. Clinical application of the multifocal visual evoked potential. Clinical and Experimental Optometry 2004;87(3):163-70. Cueva RA. Auditory brainstem response versus magnetic resonance imaging for the evaluation of asymmetric sensorineural hearing loss. Laryngoscope. 2004;114(10):1686-1692. D'Olhaberriague L, Espadaler Gamissans JM, Marrugat J, Valls A, Oliveras Ley C, Seoane JL. Transcranial magnetic stimulation as a prognostic tool in stroke. J Neurol Sci. 1997 Mar 20;147(1):7380. Don M, Kwong B, Tanaka C, et al. The stacked ABR: a sensitive and specific screening tool for detecting small acoustic tumors. Audiol Neurootol. 2005;10(5):274-290. ECRI Institute. Point of Care Nerve Conduction Tests. May 2007. ECRI Institute. Sensory Nerve Conduction Threshold Tests (Including Current Perception Threshold and Voltage Nerve Conduction Threshold Tests). December 2006. El-Kashlan HK, Eisenmann D, Kileny PR. Auditory brain stem response in small acoustic neuromas. Ear Hear. 2000;21(3):257-262. Esteban A. A neurophysiological approach to brainstem reflexes. Blink reflex. Neurophysiol Clin. 1999 Feb;29(1):7-38. Falah M, Schiff D, Burns TM. Neuromuscular complications of cancer diagnosis and treatment.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Journal of Supportive Oncology 2005;3(4):271-82. Finneran MT, Mazanec D, Marsolais ME, et al. Large-array surface electromyography in low back pain: a pilot study. Spine. 2003;28(13):1447-1454. Fischer C, Luaute J, Adeleine P, Morlet D. Predictive value of sensory and cognitive evoked potentials for awakening from coma. Neurology. 2004;63(4):669-673. Fisher MA. Comparison of automated and manual F-wave latency measurements. Clin Neurophysiol. 2005 Feb;116(2):264-9. Fuhr P, Borggrefe-Chappuis A, Schindler C, Kappos L. Visual and motor evoked potentials in the course of multiple sclerosis.Brain. 2001 Nov;124(Pt 11):2162-8. Geisser ME, Ranavaya M, Haig AJ, et al. A meta-analytic review of surface electromyography among persons with low back pain and normal, healthy controls. J Pain. 2005;6(11):711-726. Gerschlager W, et al. Natural history and syndromic associations of orthostatic tremor: a review of 41 patients. Movement Disorders 2004;19(7):788-95. Gironell A, Kulisevsky J, Pascual-Sedano B, Barbanoj M. Routine neurophysiologic tremor analysis as a diagnostic tool for essential tremor: a prospective study. J Clin Neurophysiol. 2004;21(6):446-450. Gutmann L, Pawar GV. An approach to electrodiagnosis of peripheral neuropathies. Seminars in Neurology 2005;25(2):160-7. DOI: 10.1055/s-2005-871324. Guyette TM and Wilgis EF. Timing of improvement after carpal tunnel release. J Surg Orthop Adv. 2004;13(4):206-9. Haig AJ, et al. The sensitivity and specificity of electrodiagnostic testing for the clinical syndrome of lumbar spinal stenosis. Spine 2005;30(23):2667-76. Haig AJ, Gelblum JB, Rechtien JJ, Gitter AJ. Technology review: The use of surface EMG in the diagnosis and treatment of nerve and muscle disorders. American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). 1999. Available at: http://www.aanem.org/practiceissues/technologyreviews/use_surface_emg.cfm. Accessed February 2008. Hayes Inc. Custom Report. Dermatomal Somatosensory Evoked Potentials (DSEPs). May 2008. Hayes Inc. Custom Reports. Quantitative sudomotor axon reflex test (QSART). May 2008. Hayes Inc. Hayes Brief. Nc-stat System (NeuroMetrix Inc.) for Noninvasive Nerve Conduction Testing of Upper Extremity Neuropathy. February 2007.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Hayes Inc. Hayes Brief. NK Pressure-Specified Sensory Device (Sensory Management Services LLC) for Tarsal Tunnel Syndrome Diagnosis. October 2006. Update search October 2007. Hayes Inc., Research Highlights. Electromyography (EMG) or Nerve Conduction Studies for Intraoperative Monitoring. March 2008. Hayes Inc. Hayes Search & Summary. Neural-Scan NCSs System (Neuro-Diagnostic Associates Inc.) as a Screening Procedure for the Detection of Peripheral Neuropathy. December 2007. Hayes, Inc. Search & Summary. Brainstem Auditory Evoked Response (BAER) for Diagnosis of Chiari Malformations. March 5, 2007. Hayes, Inc. Search and Summary. Electromyography for the Diagnosis of Neuromuscular Disorders. October 2007. Hayes, Inc. Directory. Somatosensory Evoked Potentials for Prognosis of Coma Following Cardiac Arrest. March 4, 2006. Updated April 2008. Hayes, Inc. Directory. Surface Electromyography for Evaluation of Low Back Pain. December 2005. Update search January 2008. Hayes, Inc. Directory. Visual Evoked Potentials for Diagnosing and Monitoring Glaucoma. February 16, 2006. Updated March 2008. Hayes, Inc. Directory. Visual Evoked Potentials in the Diagnosis/Prognosis of Multiple Sclerosis. March 1, 2006. Updated March 2008. Huppertz HJ, Disselhorst-Klug C, Silny J, et al. Diagnostic yield of noninvasive high spatial resolution electromyography in neuromuscular diseases. Muscle Nerve. 1997;20(11):1360-1370. Itoh H, Uebori S, Asai M, et al. Early detection of orthostatic hypotension by quantitative sudomotor axon reflex test (QSART) in type 2 diabetic patients. Intern Med. 2003;42(7):560-564. Jablecki CK, Andary MT, Floeter et al.; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. 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. 2002 Jun 11;58(11):1589-92. Available at: http://www.neurology.org/cgi/content/full/58/11/1589#TBL1. Accessed February 2008. Klistorner A, Graham SL, Martins A, et al. Multifocal blue-on-yellow visual evoked potentials in early glaucoma. Ophthalmology. 2007 Sep;114(9):1613-21.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Kocer A, Gozke E, Dortcan N, et al. A comparison of F waves in peripheral nerve disorders. Electromyogr Clin Neurophysiol. 2005 Dec;45(7-8):417-23. 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. 2006 Feb;117(2):405-13. Kostera-Pruszczyk A, Rowinska-Marcinska K, Owsiak S, et al. F-wave amplitude in peripheral nervous system lesions. Neurol Neruochir Pol. 2004 Nov-Dec;38(6):465-70. Kudoh A, Katagai H, Takazawa T. Current perception thresholds of patients with long-term administration of maprotiline. Pharmacopsychiatry. 2003;36(2):57-60. Kurozawa Y, Nasu Y. Current perception thresholds in vibration-induced neuropathy. Arch Environ Health. 2001;56(3):254-6. Lange DJ, Smith T, Lovelace RE. Postpolio muscular atrophy. Diagnostic utility of macroelectromyography. Arch Neurol. 1989 May;46(5):502-6. Lew HL, Lee EH, Miyoshi Y, Chang DG, Date ES, Jerger JF. Brainstem auditory-evoked potentials as an objective tool for evaluating hearing dysfunction in traumatic brain injury. American Journal of Physical Medicine and Rehabilitation 2004;83(3):210-5. Lo YL, Chan LL, Lim W, Tan SB, Tan CT, Chen JL, Fook-Chong S, Ratnagopal P. Transcranial magnetic stimulation screening for cord compression in cervical spondylosis. J Neurol Sci. 2006 May 15;244(1-2):17-21. Logi F, Fischer C, Murri L, Mauguiere F. The prognostic value of evoked responses from primary somatosensory and auditory cortex in comatose patients. Clin Neurophysiol. 2003;114:1615-1627. Low VA, Sandroni P, Fealey RD, Low PA. Detection of small-fiber neuropathy by sudomotor testing. Muscle Nerve. 2006;34(1):57-61. Marangos N, Maier W, Merz R, Laszig R. Brainstem response in cerebellopontine angle tumors. Otol Neurotol. 2001;22(1):95-99. Marciniak C, Armon C, Wilson J, Miller R. Practice parameter: utility of electrodiagnostic techniques in evaluating patients with suspected peroneal neuropathy: an evidence-based review. Muscle Nerve. 2005 Apr;31(4):520-7. Matsutomo R, Takebayashi K, Aso Y. Assessment of peripheral neuropathy using measurement of the current perception threshold with the neurometer in patients with type 2 diabetes mellitus. J Int Med Res. 2005;33(4):442-53. McAuley J, Rothwell J. Identification of psychogenic, dystonic, and other organic tremors by a

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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coherence entrainment test. Movement Disorders 2004;19(3):253-67. McDonald WI, Compston A, Edan G, et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001;50(1):121-127. 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. 2007 JanFeb;20(1):60-4. Meriggioli MN, Sanders DB. Advances in the diagnosis of neuromuscular junction disorders. American Journal of Physical Medicine and Rehabilitation 2005;84(8):627-38. Mesrati F, Vecchierini MF. F-waves: neurophysiology and clinical value. Neurophysiol Clin. 2004 Dec;34(5):217-43. Milliman Care Guidelines. Ambulatory Care. 12th edition. Multi-Society Task Force on Persistent Vegetative State. Medical aspects of the persistent vegetative state (1). The Multi-Society Task Force on PVS. N Engl J Med. 1994;330(21):1499-1508. Nishimura A, Ogura T, Hase H, et al., A correlative electrophysiologic study of nerve fiber involvement in carpal tunnel syndrome using current perception thresholds. Clin Neurophysiol. 2004;115(8):1921-4. Nishimura A, Ogura T, Hase H, et al. Objective evaluation of sensory function in patients with carpal tunnel syndrome using the current perception threshold. J Orthop Sci. 2003;8(5):625-8. Patel AT, Gaines K, Malamut R, Park TA, Toro DR, Holland N; American Association of Neuromuscular and Electrodiagnostic Medicine. Usefulness of electrodiagnostic techniques in the evaluation of suspected tarsal tunnel syndrome: an evidence-based review. Muscle Nerve. 2005 Aug;32(2):236-40. Pelosi L, Lamb J, Grevitt M, et al. Combined monitoring of motor and somatosensory evoked potentials in orthopaedic spinal surgery. Clin Neurophysiol. 2002;113(7):1082-1091. Pullman SL, Goodin DS, Marquinez AI, et al. Clinical utility of surface EMG: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2000;55(2):171-177. Raj PP, Chado HN, Angst M,et al,. Painless electrodiagnostic current perception threshold and pain tolerance threshold values in CRPS subjects and healthy controls: a multicenter study. Pain Pract. 2001;1(1):53-60.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Robbins SL, Christian WK, Hertle RW, Granet DB. Vision testing in the pediatric population. Ophthalmology Clinics of North America 2003;16(2):253-67. Robinson LR, Micklesen PJ, Tirschwell DL, Lew HL. Predictive value of somatosensory evoked potentials for awakening from coma. Crit Care Med. 2003;31(3):960-967. Rupa V, Job A, George M, Rajshekhar V. Cost-effective initial screening for vestibular schwannoma: auditory brainstem response or magnetic resonance imaging? Otolaryngol Head Neck Surg. 2003;128(6):823-828. Shimada H, Kihara M, Kosaka S, et al. Comparison of SSR and QSART in early diabetic neuropathy-the value of length-dependent pattern in QSART. Auton Neurosci. 2001;92(1-2):72-75. Shy ME, Frohman EM, So YT, et al. Quantitative sensory testing: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2003;60(6):898-904. Available at: http://www.neurology.org/cgi/content/abstract/60/6/898. Accessed February 2008. Siddiqi ZA, Sanders DB, Massey JM. Peripheral neuropathy in Krabbe disease: electrodiagnostic findings. Neurology 2006;67(2):263-7. Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) [website]. SENIAM. Available at: http://www.seniam.org. Accessed February 2008. Tassler PL, Dellon AL. Correlation of measurements of pressure perception using the pressurespecified sensory device with electrodiagnostic testing. J Occup Environ Med. 1995;37(7):862-866. Tassler PL, Dellon AL. Pressure perception in the normal lower extremity and in the tarsal tunnel syndrome. Muscle Nerve. 1996;19(3):285-289. Thienprasiddhi P, Greenstein VC, Chu DH, et al. Detecting early functional damage in glaucoma suspect and ocular hypertensive patients with the multifocal VEP technique. J Glaucoma. 2006 Aug;15(4):321-7. Tiainen M, Kovala TT, Takkunen OS, Roine RO. Somatosensory and brainstem auditory evoked potentials in cardiac arrest patients treated with hypothermia. Crit Care Med. 2005;33(8):1736-1740. Toda K, Hiroshi M, Asou T, Kimura H. Comparison of current perception threshold between each side in unilateral complex regional pain syndrome patients does not measure the patient's pain. Hiroshima J Med Sci. 2004;53(1):1-5. Trujillo-Hernandez B, Huerta M, Trujillo X, et al. F-wave and H-reflex alterations in recently

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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diagnosed diabetic patients. J Clin Neurosci. 2005 Sep;12(7):763-6. Tseng CH. Abnormal current perception thresholds measured by neurometer among residents in blackfoot disease-hyperendemic villages in Taiwan. Toxicol Lett. 2003;146(1):27-36. Tullberg T. Svanborg E. Isacsson J. et al. A preoperative and postoperative study of the accuracy and value of electrodiagnosis in patients with lumbosacral disc herniation. Spine. 1993;18(7):837-842. Walsh P, Kane N, Butler S. The clinical role of evoked potentials. Journal of Neurology, Neurosurgery, and Psychiatry 2005;76 Suppl 2:16-22. DOI: 10.1136/jnnp.2005.068130. Watanabe S, Otsubo Y, Araki T. The current perception thresholds in normal pregnancy. J Nippon Med Sch. 2002;69(4):342-6. Wellman MB, Sommer DD, McKenna J. Sensorineural hearing loss in postmeningitic children. Otology and Neurotology 2003;24(6):907-12. Wenzel S, Herrendorf G, Scheel A, et al. Surface EMG and myosonography in the detection of fasciculations: a comparative study. J Neuroimaging. 1998;8(3):148-154. Yamashita T, Kanaya K, Sekine M, et al. A quantitative analysis of sensory function in lumbar radiculopathy using current perception threshold testing. Spine. 2002;27(14):1567-70.

Approval History 09/18/2008 05/15/2008 06/26/2009 Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document. CPT Codes (proven) 92585 Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; comprehensive 92586 Auditory evoked potentials for evoked response audiometry and/or testing of the central

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

Medical Technology Assessment Committee Corporate Medical Affairs Committee Corporate Medical Affairs Committee (Revised)

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nervous system; limited 92620 Evaluation of central auditory function, with report; initial 60 minutes 92621 Evaluation of central auditory function, with report; each additional 15 minutes 95860 Needle electromyography; one 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 95865 Needle electromyography; larynx 95866 Needle electromyography; hemidiaphragm 95867 Needle electromyography; cranial nerve supplied muscle(s), unilateral 95868 Needle electromyography; cranial nerve supplied muscles, bilateral 95869 Needle electromyography; thoracic paraspinal muscles (excluding T1 or T12) 95870 Needle electromyography; limited study of muscles in one extremity or non-limb (axial) muscles (unilateral or bilateral), other than thoracic paraspinal, cranial nerve supplied muscles, or sphincters 95872 Needle electromyography using single fiber electrode, with quantitative measurement of jitter, blocking and/or fiber density, any/all sites of each muscle studied 95874 Needle electromyography for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure) 95900 Nerve conduction, amplitude and latency/velocity study, each nerve; motor, without F-wave study 95903 Nerve conduction, amplitude and latency/velocity study, each nerve; motor, with F-wave study 95904 Nerve conduction, amplitude and latency/velocity study, each nerve; sensory 95925 Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper limbs 95926 Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in lower limbs 95927 Short-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 95928 Central motor evoked potential study (transcranial motor stimulation); upper limbs 95929 Central motor evoked potential study (transcranial motor stimulation); lower limbs

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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95930 Visual evoked potential (VEP) testing central nervous system, checkerboard or flash 95933 Orbicularis oculi (blink) reflex, by electrodiagnostic testing 95934 H-reflex, amplitude and latency study; record gastrocnemius/soleus muscle 95936 H-reflex, amplitude and latency study; record muscle other than gastrocnemius/soleus muscle HCPCS Code Section (not medically necessary) S3900 Surface electromyography (emg) CPT Codes (not medically necessary) 0106T Quantitative sensory testing (QST), testing and interpretation per extremity; using touch pressure stimuli to assess large diameter sensation 0107T Quantitative sensory testing (QST), testing and interpretation per extremity; using vibration stimuli to assess large diameter fiber sensation 0108T Quantitative sensory testing (QST), testing and interpretation per extremity; using cooling stimuli to assess small nerve fiber sensation and hyperalgesia 0109T Quantitative sensory testing (QST), testing and interpretation per extremity; using heat-pain stimuli to assess small nerve fiber sensation and hyperalgesia 0110T Quantitative sensory testing (QST), testing and interpretation per extremity; using other stimuli to assess sensation 95923 Testing of autonomic nervous system function; sudomotor, including one or more of the following: quantitative sudomotor axon reflex test (QSART), silastic sweat imprint, thermoregulatory sweat test, and changes in sympathetic skin potential 96002 Dynamic surface electromyography, during walking or other functional activities, 1-12 muscles 96003 Dynamic fine wire electromyography, during walking or other functional activities, 1 muscle 96004 Physician review and interpretation 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 This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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Confidential and Proprietary, © UnitedHealthcare, Inc. 2009

* These protocols are to be used as guidelines in the decision-making process and do not represent standards of care of any individual patient. They are proprietary documents and may not be copied or distributed without express permission.

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