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Local Coverage Determination (LCD)

Autonomic Function Testing

L35124

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Proposed LCD
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35124
Original ICD-9 LCD ID
Not Applicable
LCD Title
Autonomic Function Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL35124
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/26/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
08/01/2014
Notice Period End Date
09/15/2014

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Issue

Issue Description

Biannual review completed with no changes made.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1833 (e). This section states that no payment shall be made to any provider for any claims that lack necessary information to process the claim.

Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services.

CMS Manual System, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Part 3.2.3 Requesting Addition Documentation During Prepayment and Post-payment review.

42 CFR Section 410.32(a) indicates diagnostic tests are payable only when the physician who is treating the beneficiary for a specific medical problem uses the results in such treatment.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

The autonomic nervous system (ANS) regulates physiologic processes, such as blood pressure, heart rate, body temperature, digestion, metabolism, fluid and electrolyte balance, sweating, urination, defecation, sexual response, and other processes. Regulation occurs without conscious control, i.e., autonomously. The ANS has two major divisions: the sympathetic and parasympathetic systems. ANS testing measures alterations in the R-R interval of the electrocardiogram (ECG) in response to parasympathetic and sympathetic system stimulation. 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. Many organs are controlled primarily by either the sympathetic or parasympathetic system, although they may receive input from both; occasionally, functions are reciprocal (e.g., sympathetic input increases heart rate; parasympathetic decreases it).

The sympathetic nervous system is catabolic and activates fight-or-flight responses. Thus, sympathetic output increases heart rate and contractility, bronchodilation, hepatic glycogenolysis and glucose release, BMR (basal metabolism rate), and muscular strength; it also causes sweaty palms. Less immediately-life-preserving functions (e.g., digestion, renal filtration) are decreased.

The parasympathetic nervous system is anabolic; it conserves and restores. Gastrointestinal secretions and motility (including evacuation) are stimulated, heart rate is slowed, and blood pressure decreases.

Disorders of the ANS can affect any system of the body; they can originate in the peripheral or central nervous system and may be primary or secondary to other disorders. Symptoms suggesting autonomic dysfunction include orthostatic hypotension, heat intolerance, nausea, constipation, urinary retention or incontinence, nocturia, impotence, and dry mucous membranes. If a patient has symptoms suggesting autonomic dysfunction, cardiovagal, adrenergic, and sudomotor tests are usually done to help determine severity and distribution of the dysfunction.

ANS testing can be grouped into three general categories:

  1. Cardiovagal innervation - a test that provides a standardized quantitative evaluation of vagal innervation to parasympathetic function of the heart. Responses are based on the interpretation of changes in continuous heart recordings in response to standardized maneuvers and include heart rate response to deep breathing, Valsalva ratio, and 30:15 ratio heart rate responses to standing. A tilt table may be used, but is not required. 
  2. Vasomotor adrenergic innervation - evaluates adrenergic innervation of the circulation and of the heart in autonomic failure. The following tests are included: beat-to-beat blood pressure and R-R interval response to Valsalva maneuver, sustained hand grip, and blood pressure and heart rate responses to tilt-up or active standing and must be performed with a tilt table.
  3. Sudomotor - function testing is used to evaluate and document neuropathic disturbances that may be associated with pain. The quantitative sudomotor axon reflex test (QSART), thermoregulatory sweat test (TST), sympathetic skin responses, and silastic sweat imprints are tests of sympathetic cholinergic sudomotor function.

Indications:
Tests are useful in defining the presence of autonomic failure, their natural history, and response to treatment. They can also define patterns of dysautonomia that are useful in helping the clinician diagnose certain autonomic conditions. Selective autonomic failure (which only one system is affected) can be diagnosed by autonomic testing. An example is chronic idiopathic anhidrosis, where only sudomotor function is affected. Among the synucleinopathies, autonomic function tests can distinguish Parkinson’s disease (PD) from multiple system atrophy (MSA). There is a gradation of autonomic failure. PD is characterized by mild autonomic failure and a length-dependent pattern of sudomotor involvement. MSA and pure autonomic failure have severe generalized autonomic failure while Dementia with Lewy Bodies (DLB) is intermediate.

Limitations:
Syndromes of autonomic dysfunction which require formal autonomic function testing are relatively rare. Generally, only after excluding more common causes of autonomic signs or symptoms (e.g., hypotension, hyperhidrosis, and orthostatic tachycardia) may formal autonomic testing be indicated to exclude or confirm rarer autonomic disorders. Autonomic function testing is covered as reasonable and necessary when used as a diagnostic tool to evaluate symptoms indicative of vasomotor instability and the ANS testing is directed at establishing a more accurate or definitive diagnosis or contributing to clinically useful and relevant medical decision making for one of the following indications:

  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 syncope from other causes of loss of consciousness. 
  4. To evaluate inadequate response to beta blockade in vasodepressor syncope. 
  5. To evaluate distressing symptoms in a 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 or demonstrate autonomic failure, after more common causes have been excluded by other standard testing.

The following indications are considered not medically reasonable and necessary and will not be covered:

  1. Screening patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic or renal disease. 
  2. Testing for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic or renal disease. 
  3. Testing results that are not used in clinical decision-making or patient management. 
  4. Testing performed by physicians who do not have evidence of training, and expertise to perform and interpret these tests. (Physicians must have knowledge, training, and expertise to perform and interpret these tests, and to assess and train personnel working with them. This training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered, sponsored or endorsed by an academic [institution] in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as category I credit.) 
  5. General professional standards with FDA clearance apply for all equipment used in ANS testing.
  6. Testing with ANSAR ANX 3.0 or a similar machine is considered investigational for screening and will not be covered.

Equipment for Autonomic Nervous System Studies
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 cardiovagal innervation (parasympathetic function) or vasomotor adrenergic innervation (sympathetic adrenergic function), 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.
Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

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Associated Information
Sources of Information
Bibliography
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Contractor Advisory Committee (CAC) Meetings
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Reason for Proposed LCD
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This request was MAC initiated.
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Coding Information

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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 Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

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 Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

  1. Medical record documentation maintained by the performing provider must clearly support the medical necessity for ANS testing as well as the test reports and interpretation. Supportive documentation showing medically reasonable and necessary indications as outlined in this LCD are expected to be documented in the medical record and be available upon request. This documentation includes, but is not limited to, relevant medical history, physical examination and results of pertinent diagnostic tests or procedures used to rule out more common causes of autonomic signs or symptoms.
  2. General professional standards with FDA clearance apply for all equipment used in ANS testing.

Utilization Guidelines

  1. Diagnostic testing may be allowed once to confirm or exclude specific autonomic disease. For patients with diagnosed autonomic disorders, repeat testing is governed by a change in clinical status or response to a therapeutic intervention. If a repeat test is needed, it is not expected to exceed once per year. 
  2. Providers who perform these tests on an unusually high proportion of their patients, or at frequencies exceeding once per year may be subject to medical review.
  3. Providers who do not have tilt tables and are conducting Autonomic Function Tests may be subject to medical review. 
Sources of Information
N/A
Bibliography

Gunal, D., Afsar, N., Tanridag, T., & Aktan, S. (2002). Autonomic dysfunction in multiple sclerosis: correlation with disease-related parameters. European Neurology, 48(1), 1-5.

Illigens, Ben M. W., & Gibbons, C. (2009). "Sweat testing to evaluate autonomic function." Clinical Autonomic Research: Official Journal of The Clinical Autonomic Research Society, 19(2), 79-87.

Iodice, V., Lipp, A., Low, P., & et al. (2012). Autopsy confirmed multiple system atrophy cases: Mayo experience and role of autonomic function tests. Journal of Neurology, Neurosurgery, and Psychiatry, 83(4), 453-459.

Low, P.A., Tomalia, V.A., & Park, K.J. (2013). Autonomic Function Tests: Some Clinical Applications. Journal of Clinical Neurology, 9(1), 1–8.

Keet, S., Bulte, C., Boer, C., & Bouwman, R. (2011). Reproducibility of non-standardised autonomic function testing in the pre-operative assessment screening clinic. Anaesthesia, 66(1), 10-14.

Riley, D., & Chelimsky, T. Autonomic nervous system testing may not distinguish multiple system atrophy from Parkinson's disease. Journal of Neurology, Neurosurgery, and Psychiatry, 74(1), 56-60.

Wang, A., Fealey, R., Gehrking, T., & Low, P. (2008). Patterns of neuropathy and autonomic failure in patients with amyloidosis. Mayo Clinic Proceedings, 83(11), 1226-1230.

Zygmunt, A., & Stanczyk, J. (2010). Methods of evaluation of autonomic nervous system function. Archives of Medical Science, 6(1), 11–18.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/26/2023 R9

Posted 10/26/2023 Review completed 09/22/23 with no changes made.
  • Other (Review)
10/28/2021 R8

10/28/2021 Moved sources of information to Bibliography. Review completed 9/23/2021.
  • Other (Review)
11/01/2019 R7

11/01/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Billing and Coding Guidelines have been removed from this LCD and placed in the Billing and Coding Article related to this LCD. Consistent with Change Request 10901, if any language from IOMs and/or regulations was present in the LCD, it has been removed and the applicable manual/regulation has been referenced. Review completed 10/22/2019
  • Other (Changes in response to CMS Change Request 10901. Review completed.)
08/01/2018 R6

08/01/2018 Annual review completed 06/27/2018 with no change in coverage.
  • Other ((Annual review))
10/01/2017 R5

10/01/2017 ICD-10 code updates, In Group 1: deleted E85.8 and added the following codes: E85.81, E85.82, E85.89, G12.23 G12.24, and G12.25.
  • Revisions Due To ICD-10-CM Code Changes
09/01/2017 R4

09/01/2017 Annual review completed 07/31/2017. No change in coverage. Typographical error corrected. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Other (Annual Review)
09/01/2016 R3 09/01/2016 Annual review, removed CPT codes from the body of the policy. No change to coverage.
  • Other (Maintenance annual review)
02/01/2016 R2 02/01/2016 removed CAC information and removed group 2 diagnosis section, corrected typographical errors no change in coverage.
  • Typographical Error
  • Other
10/01/2015 R1 09/01/2015: Annual review, formatting changes, no changes in coverage.
  • Other (annual review)
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Associated Documents

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Related Local Coverage Documents
Articles
A57551 - Billing and Coding: Autonomic Function Testing
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/17/2023 10/26/2023 - N/A Currently in Effect You are here
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