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Local Coverage Determination (LCD)
Tracking Sheet
L35124
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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
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
CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply. 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 notrecommending 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. Current Dental Terminology © 2023 American Dental Association. All rights reserved. Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission.No portion of the AHA copyrighted materials contained within this publication may becopied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes anddescriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative workwithout the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816. Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes,resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions;and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is onlyauthorized with an express license from the American Hospital Association.The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness oraccuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in thepreparation of this material, or the analysis of information provided in the material. The views and/or positionspresented in the material do not necessarily represent the views of the AHA. CMS and its products and services arenot endorsed by the AHA or any of its affiliates.
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: Indications: Limitations: The following indications are considered not medically reasonable and necessary and will not be covered: Equipment for Autonomic Nervous System Studies
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.
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:
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 N/A
Analysis of Evidence (Rationale for Determination) N/A
Proposed Process Information
Synopsis of Changes
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Associated Information
Sources of Information
Bibliography
Open Meetings
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Contractor Advisory Committee (CAC) Meetings
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
| Requestor Name | Requestor Letter |
|---|---|
| View Letter |
N/A
Contact for Comments on Proposed LCD
Coding Information
Bill Type Codes
| Code | Description |
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Revenue Codes
| Code | Description |
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N/A
CPT/HCPCS Codes
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Group 1
Group 1 Paragraph N/A
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N/A
ICD-10-CM Codes that Support Medical Necessity
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Group 1
Group 1 Paragraph: N/A
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N/A
ICD-10-CM Codes that DO NOT Support Medical Necessity
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Group 1
Group 1 Paragraph: N/A
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Additional ICD-10 Information
General Information
Associated Information Documentation Requirements Utilization Guidelines
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. |
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| 10/28/2021 | R8 | 10/28/2021 Moved sources of information to Bibliography. Review completed 9/23/2021. |
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| 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 |
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| 08/01/2018 | R6 | 08/01/2018 Annual review completed 06/27/2018 with no change in coverage. |
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| 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. |
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| 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. |
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| 09/01/2016 | R3 | 09/01/2016 Annual review, removed CPT codes from the body of the policy. No change to coverage. |
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| 02/01/2016 | R2 | 02/01/2016 removed CAC information and removed group 2 diagnosis section, corrected typographical errors no change in coverage. |
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| 10/01/2015 | R1 | 09/01/2015: Annual review, formatting changes, no changes in coverage. |
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Associated Documents
Attachments
N/A
Related Local Coverage Documents
Articles
A57551 - Billing and Coding: Autonomic Function Testing
Related National Coverage Documents
N/A
Public Versions
| Updated On | Effective Dates | Status | |
|---|---|---|---|
| 10/17/2023 | 10/26/2023 - N/A | Currently in Effect | You are here |
| 10/19/2021 | 10/28/2021 - 10/25/2023 | Superseded | View |
| Some older versions have been archived. Please visit theMCD Archive Site to retrieve them. | |||
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