Local Coverage Determination (LCD) for Nervous System Studies - Autonomic Function, Nerve Conduction and Electromyography (L28282)

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1 Search Home Medicare Medicaid CHIP About CMS Regulations & Guidance Research, Statistics, Data & Systems Outreach & Education People with Medicare & Medicaid Questions Careers Newsroom Contact CMS Acronyms Help Print Back to Local Coverage Determinations (LCDs) for Palmetto GBA (01192, MAC - Part B) Local Coverage Determination (LCD) for Nervous System Studies - Autonomic Function, Nerve Conduction and Electromyography (L28282) Select the Print Record, Add to Basket or Record buttons to print the record, to add it to your basket or to the record. Section Navigation Select Section Go Contractor Information Contractor Name Palmetto GBA Contractor Number Contractor Type MAC - Part B Back to Top LCD Information Document Information LCD ID Number L28282 LCD Title Nervous System Studies - Autonomic Function, Nerve Conduction and Electromyography Contractor's Determination Number J1B L AMA CPT/ADA CDT Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not Primary Geographic Jurisdiction California - Southern Oversight Region Region X Original Determination Effective Date For services performed on or after 09/02/2008 Original Determination Ending Date Revision Effective Date For services performed on or after 05/31/2012

2 recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Revision Ending Date CMS National Coverage Policy Title XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1862(a)(7) and 42 Code of Federal Regulations, , exclude routine physical examinations. Title XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim. Code of Federal Regulations 42 CFR states that all diagnostic tests must be ordered by a physician who is treating the beneficiary, and test results must be used in the management of the beneficiary s specific medical problem. Code of Federal Regulations 42 CFR states that all procedures performed in an independent diagnostic testing facility (IDTF) must be ordering by a treating physician who had a relationship with the beneficiary prior to the performance of the testing and who uses the results in the management of the beneficiary s specific medical problem. CMS Manual System, Pub , Medicare Benefits Policy Manual, Chapter 15, 80 explains that diagnostic tests falling under 1861(s)(3), are not under the incident to services created by 1861(s)(2). Supervision requirements for diagnostic tests originally appeared in Change Release 850 (CR 850) and are periodically updated in the Physician Fee Schedule Database. By regulation, Nurse Practitioners, Clinical Nurse Specialists, and Physician Assistants may perform diagnostic tests (pursuant to state law), and are treated as a physician for the ordering of tests, but are not a physician for the purpose of technician supervision. CMS Manual System, Pub , Medicare Program Integrity Manual, Chapter 3, Requesting Additional Documentation During Prepayment and Postpayment Review. CMS Manual System, Pub , Medicare Program Integrity Manual, Chapter 13, address when necessary contractors shall describe the circumstances under which a proposed LCD for the service is considered reasonable and necessary. HCFA (Health Care Financing Administration) Ruling 95-1 explains application of the Limitation of Liability provision ( 1879) and use of community standards in determinations regarding medical necessity (see especially 5 and 6). See also criteria in 42 CFR for determining that a provider, practitioner, or other supplier knew that items or services were excluded from coverage as custodial care or as not reasonable and necessary. Medicare Modernization Act, 306, Recovery Audit Contractors (RACs). The RAC shall

3 comply with all National Coverage Determinations (NCDs), Coverage Provisions in Interpretive Manuals, national coverage and coding articles, local coverage determinations (LCDs) and local coverage/coding articles in their jurisdiction. CMS Manual System, Pub , Medicare Program Integrity Manual, Chapter 3, ; Diagnosis Code Requirements. Indications and Limitations of Coverage and/or Medical Necessity REGULATORY GUIDELINES FOR MEDICARE DIAGNOSTIC TESTS Tests of the nervous system that are covered in this policy are: Nerve Conduction Studies (NCS), Electromyography (EMG), Autonomic Function Tests (AFT), and Somatosensory Evoked Potentials (SSEP). Coverage rules in this LCD are those followed by the contractor and by CMS authorized Recovery Audit Contractor(s) in this jurisdiction, during both primary review and appeals. Diagnostic tests are a distinct benefit of Medicare and not an incident-to service. Because of this, Medicare has special supervision guidelines for diagnostic tests which may be different than incident-to services. Clinical diagnostic tests can only be ordered by the treating physician or by a consulting physician; ordering physician includes non-physician practitioners such as nurse practitioners and physician assistants. Diagnostic tests are only payable by Medicare when they are necessary and used in the diagnosis or treatment of a specific disease by the treating physician. The ordering physician, with appropriate expertise and training must first clinically assess the patient in person, including completion of a thorough history and physical examination consistent with the nature and complexity of the patient s presenting complaint. When the ordering physician is a consultant (e.g. the patient has been referred by a family practitioner to a neurologist), the consulting physician should perform a history and physical examination typical of a consulting medical specialist. The ordering physician then decides which of the available diagnostic tests might provide useful diagnostic information. As part of a payment review, documentation of this full patient assessment made prior to testing may be requested of the ordering physician by the contractor. OVERVIEW OF ELECTRODIAGNOSTIC TESTS Electrophysiologic tests assess the physiology and/or functional status of the cranial and peripheral nerves, anterior horn cells and spinal nerve roots, the neuromuscular junction, muscles and the autonomic nervous system. Electrodiagnostic studies (EDX) use equipment which electrically stimulates nerves and which also amplifies and displays electrical signals generated by nerves and muscles. These studies include motor and sensory nerve conduction studies, needle electromyography (for muscle cell activity), repetitive nerve stimulation tests, and blink reflex studies, among others. Autonomic nerve studies are designed to locate causes which result in abnormal cardiovascular status, such as drops in blood pressure, increases or decreases in heart rate, as well as hyperhidrosis (excessive perspiration) and changes in skin color/temperature. Electromyography studies For appropriate patients, when testing is medically necessary after a thorough evaluation, electrodiagnostic studies will aid in the specific diagnosis of disease and in selection of treatment:

4 Identify normal and abnormal functioning of sensory and motor nerves, muscles, and neuromuscular junctions (NMJ). Localize regions of abnormal functioning. Define the type of abnormal functioning, such as axonal versus demylinating differential diagnosis. Determine the distribution of abnormalities. Determine the severity of abnormalities. Localize correct areas for intramuscular administration of agents such as botulinum toxin. EMG studies may require multiple fine needle insertions in multiple muscles and are often associated with patient discomfort and pain. Individuals performing the test continually refer to a screen where electrical waveforms generated by muscle fibers are displayed, and are simultaneously hearing auditory results of these waves amplified through a speaker. Interpretation of the test will occur simultaneously with its performance and may influence elements of the remainder of the test. Individuals performing the test decide during the test the optimal number of nerves and muscles to be tested to insure an adequate study. Dynamic tests Once undertaken, electrodiagnostic examinations are dynamic tests. The decision on which nerves or muscles are to be tested is dependent on the clinical diagnoses being considered and the findings obtained as the examination is being conducted. As testing is performed, information generated may determine if additional testing of the same or other anatomic regions would also be reasonable and necessary for diagnosis or therapy. Therefore, considerable expertise is required of the technician and physician % of patients required electromyographic studies in their evaluation for carpal tunnel surgery (Storm, 2005). Higher accuracy of carpal tunnel diagnostics is found when forearm/wrist conduction is available among the tests used (Jablecki, 2002). EMG such as must be personally performed by a physician or by a physical therapist certified by the American Board of Physical Therapy Specialties (ABPTS) as a Clinical Electrophysiologic Certified Specialist, per CMS regulations (see below). PROFESSIONAL PERSONNEL Physicians No absolute restrictions are placed on the specialty of physicians performing or supervising electrodiagnostic tests (except for an IDTF). Physicians must however have a depth of knowledge competent to perform the tests in a reasonable manner (preferably, but not required, with relevant training in neurology, rehabilitation medicine, orthopedic surgery, etc) and to assess and train personnel working with them. In contrast to neurologic populations, unselected practice patient populations have a low incidence of complex conditions requiring advanced neurodiagnostic tests. Non-physician Practitioners Under Medicare, when performing diagnostic testing themselves, within their scope and/or supervision regulations, non-physician practitioners (NPP; physician assistant, nurse practitioners, etc) are considered a physician. But, for the purpose of supervising a technician for a diagnostic test, NPPs are not considered a supervising physician. CMS Supervision Requirements Diagnostic tests are a distinct benefit under 1862(s)(3) of the SSA, as explained in the Benefit Policy Manual, Chapter 15, Section 80. Supervision levels are assigned by CMS (in the annual Physician Fee Schedule database) to each CPT code for clinical diagnostic tests, while the definitions for the numeric supervision levels (such as 7A ) are in the

5 Benefit Policy Manual, Section 80. Level 2 & 3 CPT code may be performed under direct (office suite) physician supervision, CPT code 95922, may be performed under personal (in-room) physician supervision. Level 6A/66 tests CPT codes , 95872, per CMS, may be performed personally by a physician or by a physical therapist (PT) with special certification by the ABPTS as a Clinical Electrophysiologic Certified Specialist. For all except (level 66), such a PT may supervise a licensed PT without such certification. Level 21 CPT codes 95925, 95926, may be performed by a physician, by a technician under personal supervision of the physician, or by a certified technician under direct supervision. Level 7A tests CPT code 95900, 95903, 95904, CMS defines Level 7A tests as performed by a physician, or a physical therapist (PT) with special certification by the ABPTS as a Clinical Electrophysiologic Certified Specialist, or by a physical therapist under direct (office suite) supervision of a physician, or by a nationally certified technician under general (or higher) supervision of a physician. Read closely, the CMS rules for Level 7A fail to describe any additional category of non-credentialed technician under the direct or personal supervision of the physician. However, this seems to be the practice of Medicare contractors and is therefore allowed by this A/B MAC. For the service to be reasonable and necessary, a non -credentialed technician must be trained and competent to perform complex testing and understand the test results during the dynamic management of the test. CMS states that covered services must be furnished by qualified personnel and furnished in accordance with accepted standards of medical practice. Physical Therapist Global Billing Physical therapists in private practice may bill for the technical and professional components for testing allowed by the supervision rules above. Technician does not "order" Test A technician may not perform any services that are not ordered by an ordering physician that is, a treating or consulting physician. IDTFs For IDTF services, both the supervising physician and technician must be credentialed. For an IDTF technician, only the registered supervising physician of the IDTF can supervise the IDTF technician. The supervising physician of an IDTF is almost never the ordering physician (e.g., he would have had a previous and ongoing physician management role for the patient). INDICATIONS FOR NERVE CONDUCTION STUDIES 2006 Policy Revisions Revisions to this policy reflect 2005/2006 data, that testing for many conditions, including diabetic neuropathy and carpal tunnel syndrome reached 20X national averages in parts of California despite similar national coverage in terms of CPT and ICD-9-CM codes alone. This drives several responses, which may include Program Safeguard Contractor investigations, contractor Medical Review investigations, contribution to CERT error rates, Recovery Audit Contractor recoupments, provider education articles, and revised LCDs. Additional clarification of Medicare s medical necessity conditions is provided. In addition, we stress that the interpretation of EDX studies is complex, the range of normal (and

6 normal aging) is broad, and the tests are sensitive to factors such as temperature. The clinical conditions where, despite its limitations, EDX testing is medically required are limited, not widespread. NCS are performed to assess the integrity of, and to diagnose diseases of, the peripheral nervous system. Specifically, they assess the speed (conduction velocity and/or latency), size (amplitude), and shape of the response. Pathological findings include conduction slowing, conduction block, no response, and/or low amplitude response. NCS can be ordered to assess the degree of demyelination and axon loss in the segments of the nerve studied when these are required for differential diagnosis after detailed examination. NCS results should document the nerves evaluated, the distance between the stimulation and recording sites, the conduction velocity, latency values and amplitude. The temperature of the studied limb must be controlled. Performance of NCS involves the use of electrodes, both stimulating and recording. Motor, sensory and mixed nerve conductions are sometimes required to be done in the same session. For many diagnostic problems where the etiology and diagnosis are uncertain and EDX studies are therefore required, a nerve conduction study often is followed by or proceeded by a needle electrode examination (electromyography) Policy Revisions Nerve conduction testing limited to use as an adjunct to physical examination for the initial identification of the presence of peripheral neuropathy, accomplished with discriminatory devices that use fixed anatomic templates and computer-generated reports, is covered. The process for utilizing a point of care device is not identical to the process for conducting conventional nerve conduction studies (NCS). Documentation addressing the need to evaluate the patient for peripheral neuropathy must be maintained by the practitioner and made available to Medicare upon request. Documentation should also include the name of the device, such as NC-Stat. Medicare does not expect this testing to be used routinely on all patients. Sensory neuropathy Care of diabetic neuropathy in the feet and elsewhere is very important. Routine EDX studies are not required simply by the presence of diabetes. Unlike hemoglobin A1c testing or retinal testing, similar periodic EDX testing is not established in well-recognized national protocols for effective diabetic care. The value of incidental EDX testing or tracking in diabetics, including those with loss of sensation, has not been established to improve health outcomes over careful neurologic physical exam testing. EDX testing is appropriate for specific, complex clinical situations where diabetic neuropathy and entrapment or neurologic diagnoses must be further investigated. Examples include investigation of lumbar radiculopathies, carpal entrapment, and diagnostic differentials established by a detailed physical exam and history. While EDX studies have been used in Phase III clinical trials to test drug effectiveness, no current diabetic neuropathy drugs have FDA requirements for EDX monitoring during their use. Medicare s benefits for routine foot care in diabetics or other neuropathic patients do not require EDX testing before coverage, but are fulfilled by physical exam testing for loss of protective sensation. Entrapment Neuropathy Medical review data analysis shows the medically unbelievable use of EDX studies in general practice and IDTF-based EDX testing, such that virtually no patients whatever proceeded to carpal tunnel therapy or surgery except for a minute subset who had subsequent double-testing by a neurologic or orthopedic surgeon before therapeutic care. This is not a critique of any individual non-specialist, but a population study of actual claims. EDX testing for carpal tunnel syndrome has been the subject of numerous clinical guidelines and must follow a complete physical exam, history, and clinical treatment plan which can include minimal intervention or rest as a clinically reasonable therapeutic stage before costly EDX testing. (D Arcy, 2000; Jablecki, 2002; AANEM, 2002). According to the

7 NIH (2006), Initial treatment generally involves resting the affected hand and wrist for at least 2 weeks, avoiding activities that may worsen symptoms, and immobilizing the wrist in a splint to avoid further damage from twisting or bending. If there is inflammation, applying cool packs can help reduce swelling. There is no suggestion whatever that early treatment has been established to hinge on costly and elaborate EDX testing. Further, although 30 percent of frequent computer users complain of hand paresthesias, only 10 percent meet clinical criteria for carpal tunnel syndrome, and nerve conduction studies are abnormal in only 3.5 percent of these persons (emphasis added, Viera, 2003). According to the University of Maryland, Many people have abnormal electrodiagnostic test results but have no classic symptoms or even no symptoms at all. Furthermore, about 15% of the population has symptoms consistent with CTS, but most do not show test results indicating the disorder. (UMM, 2002) Katz (2006) also found a high incidence of non-clinical abnormalities in stat EDX testing of unselected populations. Therefore, a low threshold for initiation of EDX studies will simply result in tests which are not reasonable and necessary and not payable by Medicare. One outline of appropriate diagnostics includes the following (NIH, 2006; see also Jablecki, 2002: A physical examination of the hands, arms, shoulders, and neck can help determine if the patient's complaints are related to daily activities or to an underlying disorder, and can rule out other painful conditions that mimic carpal tunnel syndrome. The wrist is examined for tenderness, swelling, warmth, and discoloration. Each finger should be tested for sensation, and the muscles at the base of the hand should be examined for strength and signs of atrophy. Routine laboratory tests and X-rays can reveal diabetes, arthritis, and fractures. Physicians can use specific tests to try to produce the symptoms of carpal tunnel syndrome. In the Tinel test, the doctor taps on or presses on the median nerve in the patient's wrist. The test is positive when tingling in the fingers or a resultant shocklike sensation occurs. The Phalen, or wrist-flexion, test involves having the patient hold his or her forearms upright by pointing the fingers down and pressing the backs of the hands together. The presence of carpal tunnel syndrome is suggested if one or more symptoms, such as tingling or increasing numbness, is felt in the fingers within 1 minute. Doctors may also ask patients to try to make a movement that brings on symptoms. Vague Diagnosis Tests for vague conditions like skin sensation disturbance should also be undertaken only after a detailed history and physical and careful development of a credible and professional differential diagnosis, from which EDX testing follows as a medically necessary differential test. Evident Diagnosis In some cases, the etiology (e.g. known drug effect or herpetic neuralgia) and symptoms of a condition are so clearly a sensory neuropathy that additional testing is not clinically necessary. Repeat Testing Repeat testing is not usually required. Asymptomatic patients do not require testing and symptomatic patients with established diagnoses ordinarily will be followed clinically rather than repetitive (monthly, quarterly, etc) EDX testing. Equipment for Nerve Conduction Studies and EMG General professional standards apply for all equipment, which must be FDA approved.

8 FDA clearance generally does not require testing of utility in any specific clinical scenarios in the Medicare population. (For example, an MRI scanner is approved to image the body, not for specific medically necessary clinical situations or at any specific repeat intervals; these are determined by Medicare). This LCD does not proscribe individual FDA-cleared EDX testing devices by brand name. However, this LCD follows the same general principles used by other Medicare contractors. Psychophysical measurements (current, vibration, and thermal perceptions) even though they may involve delivery of a stimulus, are not covered as separately payable from a general examination. Psychophysical sensory threshold testing is not covered by a NCD (160.23). Indications for Electromyography The EMG portion of electrodiagnostic testing is always performed by a physician or a physical therapist with special training and certification to perform these tests. Needle EMG refers to the recording and study of electrical activity of a muscle. The EMG examination usually follows the NCS examination, but may precede it, depending on the circumstances. It involves the use of a very thin needle electrode placed into the muscle to measure the muscle s electrical characteristics at rest and during activity. This procedure is often painful for the patient. The EMG interpretation includes analysis of oscilloscope tracings and the characteristic sounds produced by electrical potentials. The final interpretation of the study is a synthesis by the electrodiagnostic physician of the patient s history, physical exam, and all components of the electrodiagnostic studies. EMG and NCS examinations usually provide complementary findings. Medical necessary number of tests Please see the table contained in the Utilization Guidelines section of this policy that contains the maximum numbers of tests usually needed to reach a diagnosis. This table is excerpted from the Recommended Policy for Electrodiagnostic Medicine from the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). Although not quoted in full in this LCD, this policy of the AANEM represents a major recognized guideline for clinical practice. The Association s guidelines are a major source of information for reasonable and necessary decisions made by contractors regarding CMS s very explicit usage of association guidelines for the medical necessity decisions. The web site for AANEM is at An example from this policy would be the recommendation that to diagnose Carpel Tunnel Disease, unilateral, no more than 3 motor NCS tests should be necessary to reach a diagnosis. In some cases, fewer numbers of tests than shown in the table are adequate to reach a diagnosis. The AANEM guidelines reflect tests per patient per diagnosis; see Utilization Guidelines. See also clinical guidelines of the American Academy of Neurology (Jablecki et al., 2002). Indications for Autonomic Function Tests Autonomic Nervous System Testing (ANS) measures alterations in the R-R interval of the electrocardiogram (ECG) in response to parasympathetic and sympathetic system stimulation. Autonomic disorders may be congenital or acquired primary or secondary. Most are diagnosed clinically, with laboratory and formal diagnostic testing playing an adjunctive or confirmatory role. Testing may also be appropriate to monitor disease progression when there is a change in clinical status, or to evaluate a patient s response to specific treatment for an autonomic disorder.

9 The aim of such testing is to correlate signs and symptoms of possible autonomic dysfunction with objective measurement in a way that is clinically useful. Appropriate application and interpretation of these tests requires significant knowledge, training and expertise such as that generally found at dedicated neurodiagnostic laboratories and academic facilities. For example, proper interpretation requires that test results be compared with findings in age matched control subjects, and that individual laboratories develop their own reference values based on the particular testing protocols employed and patient populations being tested. Equipment to noninvasively measure cardiorespiratory and circulatory parameters and to measure sweat production is commercially available. Proper testing is time consuming, averaging 1 hour per patient. Adequate baseline acclimatization and proper positioning of subjects are crucial. Efforts should be made to keep the patients as comfortable as possible to limit pain-induced artifacts. Drugs can have substantial effects on the results of ANS testing and are a common cause of falsely abnormal results. Patients should refrain from caffeine, nicotine, and alcohol at least 3 hours prior to testing. All medications with adrenergic and anticholinergic properties need to be discontinued at least 48 hours prior to the study. These would include but are not necessarily limited to the following: chlorpromazine, thioridazine, the tricyclic and tetracyclic antidepressants, bupropion, mirtazapine, venlafaxine, clonidine, alpha-blockers, beta-blockers, calcium channel blockers, opiates, topical capsaicin and diphenhydramine (diphenhydramine is commonly found in over the counter products for sleep and for cold symptoms). CPT code includes heart rate response to deep breathing with recorded R-R interval, Valsalva ratio and 30:15 ratio. To determine the heart rate response to deep breathing the patient is supine with the head elevated to 30 degrees. The patient breathes deeply at six respirations per minute, allowing 5 seconds for each inspiration and expiration. The minimal and maximal heart rates within each respiratory cycle and the mean variation are determined. The E to I ratio or index is calculated as the sum of the six longest R-R intervals of each of the six respirations divided by the sum of the six shortest R-R intervals. Other standardized calculation methods are also available. To determine the Valsalva ratio the patient begins supine with head slightly elevated. The patient then strains against 40mmHg for 15 seconds by blowing into a mouthpiece attached to a sphygmomanometer. Following cessation of the Valsalva strain, the patient relaxes and breathes at a normal rate. The ECG is monitored during the strain and at seconds afterwards. Maximum and minimum heart rates are obtained respectively at about 1 second after cessation of strain, and then seconds later. This is repeated three times, and the largest simple heart rate ratio is considered the best reflection of autonomic function. The Valsalva ratio is the longest to the shortest R-R interval at seconds after and at 1 second after Valsalva respectively. To determine the 30:15 ratio the patient lies supine for 20 minutes, and then rises to the standing position. The 30:15 ratio is the ratio of the R-R interval at 30 seconds (longest interval) to that at 15 seconds (shortest interval) upon standing. This ratio is an index of the integrity of parasympathetic cholinergic (cardiovagal) function. CPT code includes measurement of beat-to-beat blood pressure and R-R interval changes during Valsalva maneuver and at least 5 minutes of passive tilt. This testing involves continuous heart rate recording and requires photoplethysmographic beat-to-beat blood pressure recording. Analysis of heart rate and blood pressure responses reflects the integrity of vasomotor adrenergic innervation. These tests are payable as reasonable and necessary to evaluate symptoms of vasomotor instability such as hypotension, orthostatic tachycardia and hyperhidrosis, generally after more common causes have been excluded by other testing. Autonomic function testing will be reimbursed as reasonable and necessary only when used for one or more of the following indications and when directed at establishing a more accurate or definitive diagnosis or contributing to clinically relevant medical decision-making:

10 1. To diagnose the presence of autonomic neuropathy in a patient with signs or symptoms suggesting a progressive autonomic neuropathy. 2. To evaluate the severity and distribution of a diagnosed progressive autonomic neuropathy. 3. To differentiate the diagnosis between certain complicated variants of syncopes from other causes of loss of consciousness. 4. To evaluate inadequate response to beta-blockade in vasodepressor syncope. 5. To evaluate distressing symptoms in the patient with a clinical picture suspicious for distal small fiber neuropathy in order to diagnose the condition. 6. To differentiate the cause of postural tachycardia syndrome. 7. To evaluate change in type, distribution or severity of autonomic deficits in patients with autonomic failure. 8. To evaluate the response to treatment in patients with autonomic failure who demonstrate a change in clinical exam. 9. To diagnose axonal neuropathy or suspected autonomic neuropathy in the symptomatic patient. 10. To evaluate and treat patients with recurrent unexplained syncope to demonstrate autonomic failure, generally after more common causes have been excluded by other standard testing. Equipment for Autonomic Nervous System Studies General professional standards apply for all equipment. Unknown algorithms untested on the Medicare population in systematic trials do not constitute the professional component of diagnostic testing. Equipment with FDA clearance for heart rate variability measurements in response to paced respirations and exercises that tests only heart rate variability does not meet the full range of testing parameters required for the performance of and 95922, and does not ensure full test requirements, such as blood pressure monitoring and blood oxygen levels; nor do they incorporate proper testing conditions, such as the use of a tilt table. Providers may be asked to supply information on the equipment used to perform autonomic nervous system studies, to ensure that all studies performed meet the requirements of the procedure. Somatosensory Evoked Potentials (SSEP) Somatosensory evoked potentials have been defined by Levatt (2006) as follows: Evoked potentials are the electrical signals generated by the nervous system in response to sensory stimuli. Auditory, visual, and somatosensory stimuli are used commonly for clinical evoked potential studies. Somatosensory evoked potentials (SSEPs) consist of a series of waves that reflect sequential activation of neural structures along the somatosensory pathways. While SSEPs can be elicited by mechanical stimulation, clinical studies utilize electrical stimulation of peripheral nerves, which gives larger and more robust responses. The stimulation sites typically used for clinical diagnostic SSEP studies are the median nerve at the wrist, the common peroneal nerve at the knee, and/or the posterior tibial nerve at the ankle. Recording electrodes are placed over the scalp, the spine, and peripheral nerves proximal to the stimulation site. As clearly described by Burneo (2006) and others, in many circumstances standard NCS or EMG studies are preferable to SSEP for peripheral nervous system disorders. SSEP are indicated only under special circumstances. SSEPs may be useful in some spinal cord trauma conditions including surgical monitoring. SSEP may assist in cortical mapping

11 during neurologic surgery. MRI has largely supplanted SSEP testing in conditions such as multiple sclerosis. SSEPs are not generally useful in most neurodegenerative disorders although on occasional special clinical circumstances and differential diagnoses may occur. In all cases, a clear clinical use or differential diagnosis must be present and findings must be interpreted carefully. Limitations For clarity of text, most limitations are also included in the appropriate part of the Indications section. Nervous system studies must be ordered by a treating physician and must be both reasonable and necessary for the management of the patient. Test results must be required for and used in the management of the patient. Nervous system studies should not be performed when a neurological diagnosis can be made clinically and when localization, distribution, and progression of the disease will not aid in the selection or duration of treatment options (such as diabetic distal symmetric sensory polyneuropathy). This does not exclude clinical situations where electrodiagnostic study is a key to rule in/rule out a secondary condition (e.g. entrapment neuropathy) or is a necessary factor in allowing the treating physician to counsel the patient. The number of nerves to be tested should be the minimum number necessary to address the clinical issue without unnecessary testing. In almost all studies, this will appropriately include evaluation of 1 or more nerves that have normal test results. In nerve conduction studies, each nerve tested is billed as an individual unit. It is inappropriate to inch up or down a nerve and bill for more than one unit. For ANS tests, syndromes of autonomic dysfunction for which autonomic testing might add valuable clinical information are relatively rare. Generally, only after excluding more common causes of autonomic signs or symptoms (e.g., hypotension, hyperhidrosis, orthostatic tachycardia), including incorrect/inappropriate medication dosing, may formal autonomic testing be indicated to exclude or confirm rarer autonomic disorders. The use of these tests to screen patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic or renal disease, is not covered. Testing for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic or renal disease is not considered reasonable and necessary. For all diagnoses listed in the ICD-9-CM section of this LCD, the usage of an ICD-9- CM diagnosis alone does not guarantee that the services rendered are clinically necessary. The ICD-9-CM diagnoses section list conditions that may be payable assuming all other conditions of this LCD are met and assuming that the evaluation, testing, and follow-up management are consistent with good community practice. Back to Top Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that

12 coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 999x Not Applicable Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes Not Applicable CPT/HCPCS Codes Nerve Conduction Studies (NCS) * The process for utilizing point of care devices like NC-Stat is not identical to the process conducting conventional nerve conduction studies (NCS),therefore, CPT code should for these type services NERVE CONDUCTION, AMPLITUDE AND LATENCY/VELOCITY STUDY, EACH NERVE; MOTOR, WITHOUT F-WAVE STUDY NERVE CONDUCTION, AMPLITUDE AND LATENCY/VELOCITY STUDY, EACH NERVE; MOTOR, WITH F-WAVE STUDY NERVE CONDUCTION, AMPLITUDE AND LATENCY/VELOCITY STUDY, EACH NERVE; SENSORY H-REFLEX, AMPLITUDE AND LATENCY STUDY; RECORD GASTROCNEMIUS/SOLEUS MUSCLE H-REFLEX, AMPLITUDE AND LATENCY STUDY; RECORD MUSCLE OTHER THAN GASTROCNEMIUS/SOLEUS MUSCLE NEUROMUSCULAR JUNCTION TESTING (REPETITIVE STIMULATION, PAIRED STIMULI), EACH NERVE, ANY 1 METHOD UNLISTED NEUROLOGICAL OR NEUROMUSCULAR DIAGNOSTIC PROCEDURE Electromyography (EMG) NEEDLE ELECTROMYOGRAPHY; 1 EXTREMITY WITH OR WITHOUT RELATED PARASPINAL AREAS NEEDLE ELECTROMYOGRAPHY; 2 EXTREMITIES WITH OR WITHOUT RELATED PARASPINAL AREAS NEEDLE ELECTROMYOGRAPHY; 3 EXTREMITIES WITH OR WITHOUT RELATED PARASPINAL AREAS

13 NEEDLE ELECTROMYOGRAPHY; 4 EXTREMITIES WITH OR WITHOUT RELATED PARASPINAL AREAS NEEDLE ELECTROMYOGRAPHY; CRANIAL NERVE SUPPLIED MUSCLE(S), UNILATERAL NEEDLE ELECTROMYOGRAPHY; CRANIAL NERVE SUPPLIED MUSCLES, BILATERAL NEEDLE ELECTROMYOGRAPHY; THORACIC PARASPINAL MUSCLES (EXCLUDING T1 OR T12) NEEDLE ELECTROMYOGRAPHY; LIMITED STUDY OF MUSCLES IN 1 EXTREMITY OR NON-LIMB (AXIAL) MUSCLES (UNILATERAL OR BILATERAL), OTHER THAN THORACIC PARASPINAL, CRANIAL NERVE SUPPLIED MUSCLES, OR SPHINCTERS NEEDLE ELECTROMYOGRAPHY USING SINGLE FIBER ELECTRODE, WITH QUANTITATIVE MEASUREMENT OF JITTER, BLOCKING AND/OR FIBER DENSITY, ANY/ALL SITES OF EACH MUSCLE STUDIED NEEDLE ELECTROMYOGRAPHY, EACH EXTREMITY, WITH RELATED PARASPINAL AREAS, WHEN PERFORMED, DONE WITH NERVE CONDUCTION, AMPLITUDE AND LATENCY/VELOCITY STUDY; LIMITED (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) NEEDLE ELECTROMYOGRAPHY, EACH EXTREMITY, WITH RELATED PARASPINAL AREAS, WHEN PERFORMED, DONE WITH NERVE CONDUCTION, AMPLITUDE AND LATENCY/VELOCITY STUDY; COMPLETE, FIVE OR MORE MUSCLES STUDIED, INNERVATED BY THREE OR MORE NERVES OR FOUR OR MORE SPINAL LEVELS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) NEEDLE ELECTROMYOGRAPHY, NON-EXTREMITY (CRANIAL NERVE SUPPLIED OR AXIAL) MUSCLE(S) DONE WITH NERVE CONDUCTION, AMPLITUDE AND LATENCY/VELOCITY STUDY (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) Autonomic Function Tests (AFT) TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; CARDIOVAGAL INNERVATION (PARASYMPATHETIC FUNCTION), INCLUDING 2 OR MORE OF THE FOLLOWING: HEART RATE RESPONSE TO DEEP BREATHING WITH RECORDED R-R INTERVAL, VALSALVA RATIO, AND 30:15 RATIO TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; VASOMOTOR ADRENERGIC INNERVATION (SYMPATHETIC ADRENERGIC FUNCTION), INCLUDING BEAT-TO-BEAT BLOOD PRESSURE AND R-R INTERVAL CHANGES DURING VALSALVA MANEUVER AND AT LEAST 5 MINUTES OF PASSIVE TILT TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; SUDOMOTOR, INCLUDING 1 OR MORE OF THE FOLLOWING: QUANTITATIVE SUDOMOTOR AXON REFLEX TEST (QSART), SILASTIC SWEAT IMPRINT, THERMOREGULATORY SWEAT TEST, AND CHANGES IN SYMPATHETIC SKIN POTENTIAL Somatosensory Evoked Potential (SSEP) Testing

14 SHORT-LATENCY SOMATOSENSORY EVOKED POTENTIAL STUDY, STIMULATION OF ANY/ALL PERIPHERAL NERVES OR SKIN SITES, RECORDING FROM THE CENTRAL NERVOUS SYSTEM; IN UPPER LIMBS SHORT-LATENCY SOMATOSENSORY EVOKED POTENTIAL STUDY, STIMULATION OF ANY/ALL PERIPHERAL NERVES OR SKIN SITES, RECORDING FROM THE CENTRAL NERVOUS SYSTEM; IN LOWER LIMBS 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 SHORT-LATENCY SOMATOSENSORY EVOKED POTENTIAL STUDY, STIMULATION OF ANY/ALL PERIPHERAL NERVES OR SKIN SITES, RECORDING FROM THE CENTRAL NERVOUS SYSTEM; IN UPPER AND LOWER LIMBS CENTRAL MOTOR EVOKED POTENTIAL STUDY (TRANSCRANIAL MOTOR STIMULATION); IN UPPER AND LOWER LIMBS ICD-9 Codes that Support Medical Necessity Usage of an ICD-9-CM diagnosis alone does not guarantee that the services rendered are clinically necessary. The ICD-9-CM diagnoses section list conditions that may be payable assuming all other conditions of this LCD are met and assuming that the evaluation, testing, and follow-up management are consistent with good community practice. CPT Codes applicable for these ICD-9 codes 95900, 95903, 95904, 95934, 95936, 95937, 95999, , 95863, 95864,95867, 95868, 95869, 95870, 95872, 95885, 95886, 95887, 95921, 95922, BOTULISM FOOD POISONING 037 TETANUS POSTHERPETIC POLYNEUROPATHY 138 LATE EFFECTS OF ACUTE POLIOMYELITIS MALIGNANT NEOPLASM OF CRANIAL NERVES MALIGNANT NEOPLASM OF SPINAL CORD MALIGNANT NEOPLASM OF SPINAL MENINGES MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS SYSTEM

15 225.1 BENIGN NEOPLASM OF CRANIAL NERVES BENIGN NEOPLASM OF SPINAL CORD BENIGN NEOPLASM OF SPINAL MENINGES BENIGN NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM NEUROFIBROMATOSIS UNSPECIFIED NEUROFIBROMATOSIS TYPE 1 VON RECKLINGHAUSEN'S DISEASE NEUROFIBROMATOSIS TYPE 2 ACOUSTIC NEUROFIBROMATOSIS SCHWANNOMATOSIS OTHER NEUROFIBROMATOSIS SECONDARY DIABETES MELLITUS WITH NEUROLOGICAL MANIFESTATIONS, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED SECONDARY DIABETES MELLITUS WITH NEUROLOGICAL MANIFESTATIONS, UNCONTROLLED DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED ADRENOGENITAL DISORDERS OTHER AND UNSPECIFIED MANIFESTATIONS OF THIAMINE DEFICIENCY DEFICIENCY OF OTHER VITAMINS LIPOPROTEIN DEFICIENCIES CORTICOBASAL DEGENERATION OTHER DEGENERATIVE DISEASES OF THE BASAL GANGLIA MYOCLONUS GENETIC TORSION DYSTONIA ATHETOID CEREBRAL PALSY BLEPHAROSPASM OROFACIAL DYSKINESIA - ORGANIC WRITERS' CRAMP

16 OTHER FRAGMENTS OF TORSION DYSTONIA FRIEDREICH'S ATAXIA - CEREBELLAR ATAXIA IN DISEASES CLASSIFIED ELSEWHERE OTHER SPINOCEREBELLAR DISEASES SPINOCEREBELLAR DISEASE UNSPECIFIED WERDNIG-HOFFMANN DISEASE SPINAL MUSCULAR ATROPHY UNSPECIFIED KUGELBERG-WELANDER DISEASE OTHER SPINAL MUSCULAR ATROPHY - PRIMARY LATERAL SCLEROSIS OTHER MOTOR NEURON DISEASES OTHER ANTERIOR HORN CELL DISEASES ANTERIOR HORN CELL DISEASE UNSPECIFIED SYRINGOMYELIA AND SYRINGOBULBIA - MYELOPATHY IN OTHER DISEASES CLASSIFIED ELSEWHERE OTHER MYELOPATHY UNSPECIFIED DISEASE OF SPINAL CORD IDIOPATHIC PERIPHERAL AUTONOMIC NEUROPATHY, UNSPECIFIED OTHER IDIOPATHIC PERIPHERAL AUTONOMIC NEUROPATHY PERIPHERAL AUTONOMIC NEUROPATHY IN DISORDERS CLASSIFIED ELSEWHERE REFLEX SYMPATHETIC DYSTROPHY UNSPECIFIED - REFLEX SYMPATHETIC DYSTROPHY OF THE LOWER LIMB REFLEX SYMPATHETIC DYSTROPHY OF OTHER SPECIFIED SITE AUTONOMIC DYSREFLEXIA UNSPECIFIED DISORDER OF AUTONOMIC NERVOUS SYSTEM 340 MULTIPLE SCLEROSIS NEUROMYELITIS OPTICA SCHILDER'S DISEASE

17 ACUTE (TRANSVERSE) MYELITIS NOS - IDIOPATHIC TRANSVERSE MYELITIS OTHER DEMYELINATING DISEASES OF CENTRAL NERVOUS SYSTEM DEMYELINATING DISEASE OF CENTRAL NERVOUS SYSTEM UNSPECIFIED FLACCID HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE - FLACCID HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE - SPASTIC HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE OTHER SPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE - OTHER SPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE UNSPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE - UNSPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE CONGENITAL DIPLEGIA - INFANTILE HEMIPLEGIA OTHER SPECIFIED INFANTILE CEREBRAL PALSY INFANTILE CEREBRAL PALSY UNSPECIFIED QUADRIPLEGIA UNSPECIFIED - QUADRIPLEGIA C5-C7 INCOMPLETE OTHER QUADRIPLEGIA PARAPLEGIA DIPLEGIA OF UPPER LIMBS MONOPLEGIA OF LOWER LIMB AFFECTING UNSPECIFIED SIDE - MONOPLEGIA OF LOWER LIMB AFFECTING NONDOMINANT SIDE MONOPLEGIA OF UPPER LIMB AFFECTING UNSPECIFIED SIDE - MONOPLEGIA OF UPPER LIMB AFFECTING NONDOMINANT SDE UNSPECIFIED MONOPLEGIA CAUDA EQUINA SYNDROME WITHOUT NEUROGENIC BLADDER CAUDA EQUINA SYNDROME WITH NEUROGENIC BLADDER LOCKED-IN STATE OTHER SPECIFIED PARALYTIC SYNDROME

18 344.9 PARALYSIS UNSPECIFIED TRIGEMINAL NEURALGIA ATYPICAL FACE PAIN OTHER SPECIFIED TRIGEMINAL NERVE DISORDERS TRIGEMINAL NERVE DISORDER UNSPECIFIED BELL'S PALSY GENICULATE GANGLIONITIS OTHER FACIAL NERVE DISORDERS FACIAL NERVE DISORDER UNSPECIFIED DISORDERS OF PNEUMOGASTRIC (10TH) NERVE - MULTIPLE CRANIAL NERVE PALSIES UNSPECIFIED DISORDER OF CRANIAL NERVES BRACHIAL PLEXUS LESIONS - NEURALGIC AMYOTROPHY OTHER NERVE ROOT AND PLEXUS DISORDERS UNSPECIFIED NERVE ROOT AND PLEXUS DISORDER CARPAL TUNNEL SYNDROME - MONONEURITIS MULTIPLEX OTHER MONONEURITIS OF UPPER LIMB MONONEURITIS OF UPPER LIMB UNSPECIFIED LESION OF SCIATIC NERVE - LESION OF PLANTAR NERVE CAUSALGIA OF LOWER LIMB OTHER MONONEURITIS OF LOWER LIMB MONONEURITIS OF LOWER LIMB UNSPECIFIED MONONEURITIS OF UNSPECIFIED SITE HEREDITARY PERIPHERAL NEUROPATHY - IDIOPATHIC PROGRESSIVE POLYNEUROPATHY OTHER SPECIFIED IDIOPATHIC PERIPHERAL NEUROPATHY UNSPECIFIED IDIOPATHIC PERIPHERAL NEUROPATHY

19 ACUTE INFECTIVE POLYNEURITIS - POLYNEUROPATHY DUE TO OTHER TOXIC AGENTS CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS CRITICAL ILLNESS POLYNEUROPATHY OTHER INFLAMMATORY AND TOXIC NEUROPATHY UNSPECIFIED INFLAMMATORY AND TOXIC NEUROPATHIES MYASTHENIA GRAVIS WITHOUT (ACUTE) EXACERBATION MYASTHENIA GRAVIS WITH (ACUTE) EXACERBATION MYASTHENIC SYNDROMES IN DISEASES CLASSIFIED ELSEWHERE TOXIC MYONEURAL DISORDERS LAMBERT-EATON SYNDROME, UNSPECIFIED LAMBERT-EATON SYNDROME IN NEOPLASTIC DISEASE LAMBERT-EATON SYNDROME IN OTHER DISEASES CLASSIFIED ELSEWHERE OTHER SPECIFIED MYONEURAL DISORDERS MYONEURAL DISORDERS UNSPECIFIED CONGENITAL HEREDITARY MUSCULAR DYSTROPHY HEREDITARY PROGRESSIVE MUSCULAR DYSTROPHY MYOTONIC MUSCULAR DYSTROPHY - DRUG INDUCED MYOTONIA OTHER SPECIFIED MYOTONIC DISORDER PERIODIC PARALYSIS - SYMPTOMATIC INFLAMMATORY MYOPATHY IN DISEASES CLASSIFIED ELSEWHERE INCLUSION BODY MYOSITIS OTHER INFLAMMATORY AND IMMUNE MYOPATHIES, NEC CRITICAL ILLNESS MYOPATHY OTHER MYOPATHIES MYOPATHY UNSPECIFIED ESOTROPIA UNSPECIFIED - ALTERNATING ESOTROPIA WITH OTHER NONCOMITANCIES

20 EXOTROPIA UNSPECIFIED - ALTERNATING EXOTROPIA WITH OTHER NONCOMITANCIES INTERMITTENT HETEROTROPIA UNSPECIFIED - INTERMITTENT EXOTROPIA ALTERNATING HETEROTROPIA UNSPECIFIED - ACCOMMODATIVE COMPONENT IN ESOTROPIA HETEROPHORIA UNSPECIFIED - ALTERNATING HYPERPHORIA PARALYTIC STRABISMUS UNSPECIFIED - TOTAL OPHTHALMOPLEGIA MECHANICAL STRABISMUS UNSPECIFIED - LIMITED DUCTION ASSOCIATED WITH OTHER CONDITIONS DUANE'S SYNDROME - STRABISMUS IN OTHER NEUROMUSCULAR DISORDERS PALSY OF CONJUGATE GAZE - OTHER DISSOCIATED DEVIATION OF EYE MOVEMENTS UNSPECIFIED DISORDER OF EYE MOVEMENTS ORTHOSTATIC HYPOTENSION CHRONIC HYPOTENSION UNSPECIFIED PARALYSIS OF VOCAL CORDS - COMPLETE BILATERAL PARALYSIS OF VOCAL CORDS LARYNGEAL SPASM ACHALASIA AND CARDIOSPASM CHRONIC KIDNEY DISEASE, STAGE V END STAGE RENAL DISEASE STRESS INCONTINENCE FEMALE PERIPHERAL NEURITIS IN PREGNANCY UNSPECIFIED AS TO EPISODE OF CARE - POSTPARTUM PERIPHERAL NEURITIS DERMATOMYOSITIS - EOSINOPHILIA MYALGIA SYNDROME CERVICAL SPONDYLOSIS WITHOUT MYELOPATHY - LUMBOSACRAL SPONDYLOSIS WITHOUT MYELOPATHY SPONDYLOSIS WITH MYELOPATHY THORACIC REGION SPONDYLOSIS WITH MYELOPATHY LUMBAR REGION