LCD L33609

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Autonomic Function Tests. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Autonomic Function Tests and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,

• Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

• CMS IOM Publication 100-08, Medicare Program Integrity Manual,

• Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

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

Federal Register References:

• Code of Federal Regulations (CFR), Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions and Part 410.33 Independent diagnostic testing facility.

Indications and Limitations of Coverage

History/Background/and/or General Information

The autonomic nervous system (ANS) is a regulatory branch of both the central and peripheral nervous system, which controls and regulates the autonomic functions within the body through sympathetic and parasympathetic nerves. 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 consists of impaired or absent function of autonomic responses, which may be sympathetic or parasympathetic or both and can involve specific organ systems or can be generalized. There are other autonomic disorders that consist of excessive function of autonomic responses. The concept of an imbalance between opposing autonomic systems is applicable to some disorders, such as some cardiac arrhythmias, but not in all autonomic disorders. 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. To the specialist, the presentation of autonomic dysfunction can be specific and diagnosed with simple clinical tests. Autonomic testing, properly performed and interpreted, is helpful toward achieving diagnostic specificity. Autonomic failure is associated with increased morbidity and mortality. Orthostatic hypotension is associated with an increased risk of falls and impairment in activities of daily living.

ANS testing can be grouped into the following general categories:

• 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.

• 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.

• 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.

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 of an 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.

• Combined cardiovagal and vasomotor adrenergic innervation testing (CPT code 95924) of the autonomic nervous system is specifically of parasympathetic function and vasomotor adrenergic function using at least a 5-minute tilt with a passive tilt table.

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 when ordered and performed appropriately playing both a primary diagnostic and 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.

Covered Indications:

Autonomic function testing is covered 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:

• To diagnose the presence of autonomic neuropathy in a patient with signs or symptoms suggesting a progressive autonomic neuropathy.

• To evaluate the severity and distribution of a diagnosed progressive autonomic neuropathy.

• To differentiate the diagnosis between certain complicated variants of syncope from other causes of loss of consciousness.

• To evaluate inadequate response to beta blockade in vasodepressor syncope.

• To evaluate distressing symptoms in a patient with a clinical picture suspicious for distal small fiber neuropathy in order to diagnose the condition.

• To differentiate the cause of postural tachycardia syndrome.

• To evaluate change in type, distribution, or severity of autonomic deficits in patients with autonomic failure.

• To evaluate the response to treatment in patients with autonomic failure who demonstrate a change in clinical exam.

• To diagnose axonal neuropathy or suspected autonomic neuropathy in the symptomatic patient.

• To evaluate and treat patients with recurrent unexplained syncope to demonstrate autonomic failure, 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 testing of autonomic nervous system function cardiovagal innervation (parasympathetic function) and vasomotor adrenergic innervation and does not ensure full test requirements, such as blood pressure monitoring, 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.

Limitations:

Syndromes of autonomic dysfunction for which ANS 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, and orthostatic tachycardia) may formal autonomic testing be indicated to exclude or confirm autonomic disorders. The following indications are not considered medically reasonable and necessary 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. Testing must be done for an accepted clinical indication by a properly trained examiner and interpreted by qualified individuals within their scope of practice (weekend courses may not demonstrate expertise). 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, and designated for the American Medical Association (AMA) category I credit by an ACCME (Accreditation Council for Continuing Medical Education) or SMS (State Medical Society) accredited CME provider.

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.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Provider Qualifications:

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.

For guidelines regarding general supervision during performance of a procedure, please refer to 42 CFR Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

For guidelines regarding studies performed in an Independent Diagnostic Testing Facility (IDTF), please refer to 42 CFR Section 410.33 Independent diagnostic testing facility.

Summary of Evidence

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Analysis of Evidence

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Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Autonomic Function Tests (A57651) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Autonomic Function Tests (A57651) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Bibliography

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