DESCRIPTION
The autonomic nervous system (ANS) controls physiologic processes that are not under conscious control. ANS disorders, also called dysautonomia, are heterogeneous in etiology, clinical symptoms, and severity. These disorders can be limited and focal, such as individuals with isolated neurocardiogenic syncope or idiopathic palmar hyper hidrosis. At the other extreme, some ANS disorders can be widespread and severely disabling, such as multiple system atrophy, which leads to widespread and severe autonomic failure.
ANS testing consists of a battery of tests intended to evaluate the integrity and function of the ANS. Although there is not a standard battery of tests for ANS testing, testing generally consists of individual tests in three areas; cardiovagal function, vasomotor adrenergic function (the primary method for evaluating individuals with syncope, orthostatic hypotension, postural tachycardia syndrome, and postural dizziness) and sudomotor function or sweat testing. Autonomic testing by well-established methods performed under controlled conditions, can take 90-120 minutes. The results of the battery of tests requires interpretation by a physician familiar with autonomic nervous system physiology.
According to the American Academy of Neurology (AAN) standard techniques used in autonomic testing include:
Measuring heart rate and blood pressure variability during deep breathing, tilt table, five minutes of standing and the Valsalva maneuver (attempting to breathe out with nose and mouth blocked) to assess cardiovagal and vasomotor function
Thermoregulatory sweat test (TST)
Sympathetic skin response (SSR)
Quantitative Sudomotor Axon Reflex Test (QSART device)
Numerous automated ANS testing devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510k process (e.g.,TM Flow system, QHRV System, VitalScan®, ANSAR® ANX, ZYTO® Scan Hand Cradle, Neuropad®, Sudoscan®, EZScan®, Natus VikingQuest, Bodytronic® 200). These devices, along with newer methodologies (e.g., quantitative direct and indirect testing of sudomotor function [QDIRT]) propose to generate data after approximately 10-15 minutes of testing and without physician interpretation. According to the American Academy of Neurology, these methods and/or devices have insufficient published literature to establish clinical utility. These automated devices perform a simplified battery of autonomic tests, typically the heart rate response to deep breathing, the heart rate response to a Valsalva maneuver, and the blood pressure response to standing. Many devices are severely limited in the validity of the data they generate because they do not measure or control for expiratory pressure or include beat-to-beat blood pressure measurement, both of which are requirements, not only for scientifically accurate assessment, but also for billing of autonomic testing.
POLICY
Autonomic nervous system testing, consisting of a battery of tests in several domains, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Autonomic nervous system testing is considered investigational for all other conditions/diseases, including, but not limited, to the evaluation of the following conditions:
Chronic fatigue syndrome
Myofascial pain syndrome/fibromyalgia
Raynaud’s phenomenon
Flushing syndrome
Anxiety and other psychological disorders
Generalized hyperhidrosis
Palmoplantar hyperhidrosis
Irritable bowel syndrome
Somatization disorder
Sleep apnea
Allergic conditions
Hypertension
Screening of asymptomatic individuals
Monitoring progression of disease or response to treatment
Cardiac dysrhythmia
Autonomic nervous system testing using automated devices (e.g., QHRV System, VitalScan®, ANSAR® ANX, ZYTO® Hand Cradle, Neuropad®, Sudoscan®, EZScan®, Natus VikingQuest, Bodytronic® 200), in which software generates an interpretation, is considered investigational for all indications.
MEDICAL APPROPRIATENESS
Autonomic nervous system testing is considered medically appropriate if ALL the following criteria are met:
Signs and/or symptoms of autonomic dysfunction such as ONE or MORE of the following:
Recurrent unexplained syncope
Lepromatous leprosy
Diabetic neuropathy
Recurrent orthostatic dizziness
Central neurodegenerative disorders (e.g., Parkinson’s disease, Lewy body disease)
Anhidrosis
Peripheral neuropathy (e.g., amyloidosis, Fabry’s disease, Sjögren’s syndrome, autoimmune and idiopathic neuropathies)
Progressive autonomic neuropathy
Postural tachycardia syndrome
Multiple systems atrophy
Familial dysautonomia or Riley Day syndrome
Baroreflex failure
Harlequin syndrome
Hereditary sensory and autonomic neuropathies
Ross syndrome
Lambert Eaton myasthenic syndrome
Morvan syndrome
Guillain-Barré syndrome
A definitive diagnosis cannot be made from clinical examination and routine laboratory testing alone
Diagnosis of the suspected autonomic disorder may lead to a change in management or eliminate the need for further testing
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
ANS testing should be performed in the setting of a dedicated ANS testing laboratory, under closely controlled conditions and interpretation of results performed by an individual with expertise in ANS testing. Automated testing in which software generates an interpretation has not been validated by clinical studies and has a greater potential to lead to erroneous results.
SOURCES
American Academy of Neurology. (2014, September). Autonomic testing - model coverage policy. Retrieved February 18, 2015 from www.aan.com.
American Academy of Neuromuscular & Electrodiagnostic Medicine. (2009).Evaluation of distal symmetric polyneuropathy: Role of autonomic testing, nerve biopsy, and skin biopsy (an evidence-based review). Retrieved April 14, 2021 from https://www.aanem.org.
American Association of Neuromuscular & Electrodiagnostic Medicine. (2017, May). Proper performance of autonomic function testing. Retrieved December 28, 2017 from www.aanem.com.
American Diabetes Association. (2021, January). Microvascular complications and foot care: standards of medical care in diabetes. Retrieved March 18, 2022 from https://diabetesjournals.org/.
BlueCross BlueShield Association. Evidence Positioning System. (7:2022). Autonomic nervous system testing (2.01.96). Retrieved April 14, 2023 from https://www.evidencepositioningsytem.com/. (27 articles and/or guidelines reviewed)
National Institute for Health and Clinical Excellence. (2018, September; last updated September 2022). Neuropad for detecting preclinical diabetic peripheral neuropathy. Retrieved April 17, 2023 from www.nice.org.uk/guidance.
Yousif, D., Bellos, I., Penzlin, A., Hijazi, M.M., Illigens, B.M., Pinter, A., & Siepmann, T. (2019). Autonomic dysfunction in preeclampsia: a systematic review. Frontiers in Neurology, 10, 816. (Level 3 evidence)
Ziemssen, T & Siepmann, T. (2019). The investigation of the cardiovascular and sudomotor autonomic nervous system - a review. Frontiers in Neurology, 10, 53. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 7/11/2015
MOST RECENT REVIEW DATE: 6/8/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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