L31461-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Autonomic Function Tests (L31461)

Contractor Information Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L31461

LCD Title Autonomic Function Tests

Contractor's Determination Number 95921

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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 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.

Original Determination Effective Date

For services performed on or after 01/23/2011 Original Determination Ending Date

Revision Effective Date

For services performed on or after 06/14/2011 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 80.

Indications and Limitations of Coverage and/or Medical Necessity

The autonomic nervous system (ANS) is a regulatory branch of the central nervous system which controls and regulates the autonomic functions within the body. These functions include regulation of blood pressure, heart rate, airway size and airflow to the lungs, digestive tract functions, sweat production, bladder control and sexual function. The ANS acts through a balance of its own two components, the sympathetic and parasympathetic nervous systems. Autonomic failure results from an imbalance between the two components and can affect any system of the body. Autonomic disorders may be congenital or acquired – primary or secondary. If it becomes unbalanced, a person may experience a variety of symptoms that are sometimes vague and can affect many bodily functions.

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. 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 limited to the following drugs: chlorpromazine, thioridazine, the tricyclic and tetracyclic antidepressants, bupropion, mirtazapine, venlafaxine, clonidine, alpha-blockers, beta-blockers, calcium channel blockers, opiates, topical capsaicin, and diphenhydramine.

ANS testing can be grouped into three general categories:

• Cardiovagal innervation (CPT code 95921) – 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.

• Vasomotor adrenergic innervation (CPT code 95922) – 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.

• Sudomotor (CPT code 95923) – 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.

The QSART measures axon reflex-mediated sudomotor responses quantitatively and evaluates post-ganglionic sudomotor function. Recording is usually carried out from the forearm and three lower extremity skin sites to assess the distribution of post-ganglionic deficits.

The TST evaluates the distribution of sweating by a change in color ofan indicator powder. This test has a high sensitivity, and its specificity for delineating the site of lesion is greatly enhanced when used in conjunction with QSART.

Sweat imprints are formed by the secretion of active sweat glands into a plastic (silastic) imprint. The test can determine sweat gland density, a histogram of sweat droplet size and sweat volume per area.

Indications:

Appropriate application and interpretation of ANS testing requires a detailed knowledge of the testing criterion and a match between the tests of suspected clinical/functional impairment with the autonomic activity being tested. Most autonomic disorders 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.

Autonomic function testing is covered by First Coast Service Options (FCSO) Medicare as reasonable and necessary when used as a diagnostic tool to evaluate symptoms indicative of vasomotor instability, such as hypotension, orthostatic tachycardia, and hyperhidrosis after more common causes have been excluded by other testing, 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 patientwith 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 to demonstrate autonomic failure, after more common causes have been excluded by other standard testing.

Limitations:

Syndromes of autonomic dysfunction for which ANS might add valuable clinical information 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. The following indications are not considered medically reasonable and necessary by FCSO Medicare and will not be covered:

• To screen patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic or renal disease;

• Testing for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic or renal disease;

• Testing where the results are not used in clinical decision-making and patient management;

• 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 or 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.)

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 coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

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.

CPT/HCPCS Codes

TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; CARDIOVAGAL INNERVATION

95921 (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

95922 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

95923 FOLLOWING: QUANTITATIVE SUDOMOTOR AXON REFLEX TEST (QSART), SILASTIC SWEAT IMPRINT, THERMOREGULATORY SWEAT TEST, AND CHANGES IN SYMPATHETIC SKIN POTENTIAL

ICD-9 Codes that Support Medical Necessity

250.60 - 250.63 DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED

277.30 - 277.39 AMYLOIDOSIS, UNSPECIFIED - OTHER AMYLOIDOSIS

333.0 OTHER DEGENERATIVE DISEASES OF THE BASAL GANGLIA

337.00 IDIOPATHIC PERIPHERAL AUTONOMIC NEUROPATHY, UNSPECIFIED

337.09 OTHER IDIOPATHIC PERIPHERAL AUTONOMIC NEUROPATHY

337.20 - 337.29 REFLEX SYMPATHETIC DYSTROPHY UNSPECIFIED - REFLEX SYMPATHETIC DYSTROPHY OF OTHER SPECIFIED SITE

356.4 IDIOPATHIC PROGRESSIVE POLYNEUROPATHY

356.8 OTHER SPECIFIED IDIOPATHIC PERIPHERAL NEUROPATHY

356.9 UNSPECIFIED IDIOPATHIC PERIPHERAL NEUROPATHY

458.0 ORTHOSTATIC HYPOTENSION

780.2 SYNCOPE AND COLLAPSE

780.8 GENERALIZED HYPERHIDROSIS

785.0 TACHYCARDIA UNSPECIFIED

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements

General professional standards with FDA clearance apply for all equipment used in ANS testing. Providers may be asked to supply information on the equipment used to perform ANS studies to ensure all studies performed meet the requirements of the procedure.

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 to FCSO Medicare upon request. This documentation includes, but is not limited to,

relevant medical history, physical examination, results of pertinent diagnostic tests or procedures, and after more common causes of autonomic signs or symptoms have been excluded (see limitations section of LCD).

The CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf outlines that “reasonable and necessary" services are "ordered and/or furnished by qualified personnel."

A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare.

B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

If the provider of the ANS studies is other than the ordering/referring physician/nonphysician practitioner, the provider of the service must maintain a copy of the test results and interpretation, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the studies.

Appendices

Utilization Guidelines

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.

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.

Sources of Information and Basis for Decision

Aetna Clinical Policy Bulletin # 0485: Autonomic Testing/Sudomotor Tests, 2009.

Aker, K. (2008). Complex regional pain syndrome: A review of diagnostic tools. Reflex Sympathetic Dystrophy Syndrome Association. Retrieved August 4, 2010, from http://www.rsds.org/4/resources/CRPS_Diagnosis.htm.

American Academy of Neurology. (2010). Complex regional pain syndrome. Retrieved August 19, 2010, from http://patients.aan.com/disorders/index.cfm?event=view&disorder_id=894

American Heart Association. Autonomic Nervous System. 2010. Retrieved July 21, 2010, from http://www.amhrt.org/presenter.jhtml?identifier=4463

Current Procedural Terminology (CPT) Assistant 2002 – 2006.

England, J., Gronseth, G., Franklin, F., Carter, G., Kinsella, L., Cohen, J. et al. (2009). Practice Parameter: Evaluation of distal symmetric polyneuropathy: Role of autonomic testing, nerve biopsy, and skin biopsy (an evidence-based review). Neurology 72:177-184.

Mayo Foundation for Medical Education and Research. (2001-2010). Amyloidosis. Retrieved August 19, 2010 at http://www.mayoclinic.org/amyloidosis/

Neuroscience/Neurology Services – Greenwich hospital. Autonomic Function Laboratory, 2000-2010. Retrieved July 21, 2010, from http://www.greenhosp.org/medicalservices_neuroscience_autonomic.asp

Palmetto GBA LCD L28282 - Nervous System Studies – Autonomic Function, Nerve Conduction and Electromyography, revised 2010.

The Merck Manual for Healthcare Professionals. Autonomic Nervous System. The Merck Manuals online library, 2009. Retrieved July 21, 2010, from http://www.merck.com/mmpe/print/sec16/ch208/ch208a.html

UPMC Health Plan, Policy and Procedure Manual. Autonomic Nervous System Testing, 2009.

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.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Florida Contractor Advisory Committee meeting held October 16, 2010.

Puerto Rico and U.S. Virgin Islands Contractor Advisory Committee meeting held October 21, 2010.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/09/2010

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2011 Revised Effective Date:06/14/2011

LCR B2011-082

June 2011 Connection

Explanation of Revision: Based on an outside request to clarify our current training statement outlined in this LCD, language under the “Documentation Requirements” section of the LCD has been deleted and replaced with a revised statement regarding the qualification and training. Revisions will be effective based on process date.

Revision Number:Original

Start Date of Comment Period:09/30/2010 Start Date of Notice Period:12/09/2010 Original Effective Date:01/23/2011

LCR B2010-078

December 2010 Update

Reason for Change