Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Autonomic Nervous System Testing
Policy #:MA07.027c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Autonomic nervous system (ANS) testing is considered medically necessary and, therefore, covered when either of the following indications is met:
  • ANS testing is being used as a diagnostic tool to evaluate symptoms indicative of vasomotor instability (e.g., hypotension, postural tachycardia, hyperhidrosis) after more common causes have been excluded by other testing.
OR
  • ANS testing is contributing to clinical decision-making for one of the following indications:
    • 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 vasovagal syncope
    • To evaluate distressing symptoms suggestive of distal small fiber neuropathy
    • To differentiate the cause of postural tachycardia syndrome
    • To evaluate change in type, distribution, or severity of autonomic deficits in individuals with autonomic failure
    • To evaluate the response to treatment in individuals with autonomic failure who demonstrate a change in clinical exam
    • To diagnose axonal neuropathy or suspected autonomic neuropathy
    • To evaluate and treat individuals with recurrent unexplained syncope to demonstrate autonomic failure after more common causes have been excluded by other standard testing
    • To evaluate level of autonomic system dysfunction in distal symmetric polyneuropathy of diabetes when other standard testing yields inconclusive or atypical test results, including:
      • Greater motor than sensory nerve involvement
      • Asymmetry
      • Rapid progression of polyneuropathy
    • To diagnose cardiovascular autonomic neuropathy of diabetes and determine its severity and distribution

NOT MEDICALLY NECESSARY

Autonomic nervous system (ANS) testing is considered not medically necessary and, therefore, not covered for any of the following indications:
  • Screening of individuals who are without signs or symptoms of autonomic dysfunction, including individuals with diabetes, hepatic disease, or renal disease
  • Testing for the sole purpose of monitoring disease intensity or treatment efficacy in individuals with diabetes, hepatic disease, or renal disease
  • Testing when the results will not be used for clinical decision-making and management of an individual
  • Testing for the diagnosis of Acute Motor Axonal Neuropathy (AMAN)

NOT COVERED

Testing performed by professional providers who are not trained and are without the expertise to perform and interpret these tests is not covered.

Autonomic nervous system (ANS) testing using devices such as SUDOSCAN or “ESC” (electrochemical skin conductance), ANSAR ANX 3.0, and similar devices do not meet the definition of CPT code 95923 in that the subject preparation, environmental requirements, and specially trained medical personnel requirements are not met. Therefore, they are not eligible for reimbursement consideration.

BILLING REQUIREMENTS

ANS testing using SUDOSCAN and similar devices do not meet the definition of CPT code 95923 in that the subject preparation, environmental requirements, and specially trained medical personnel requirements are not met.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

Most autonomic nervous system (ANS) testing is performed in a laboratory with formal diagnostic testing for clinical diagnosis of an autonomic nervous system (ANS) disorder.

Testing may be appropriate to monitor disease progression when there is a change in the individual's clinical status, or to evaluate the individual's response to a specific treatment for an autonomic disorder.

Frequency of testing depends on changes in clinical status or response to intervention.

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, autonomic nervous system (ANS) testing is covered under the medical benefits of Company’s Medicare Advantage products when medical necessity criteria in the medical policy are met.

However, services that are identified in this policy as not medically necessary and not covered are not eligible for coverage or reimbursement by the Company.

Description

The autonomic nervous system (ANS) is a complex neural regulatory network that controls involuntary visceral actions. The 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 is subdivided into two systems, the parasympathetic and sympathetic systems, that work together to maintain equilibrium of physiologic processes within the body.


The parasympathetic nervous system controls the physiological processes that control and store energy, often called the "rest and digest" system. Theparasympathetic system, which is primarily involved with catabolic processes,conserves energy as it slows the heart rate, increases intestinal and gland activity, increases splanchnic circulation, and relaxes sphincter muscles in the gastrointestinal tract. As a counterbalance, the sympathetic nervous system is responsible for arousal, and is known as the "fight-or-flight" response. Stimulation of the sympathetic nervous system results in an increase in pulse and blood pressure, increased sweating, decreased gastrointestinal motility, increased synthesis of important metabolic products for energy expenditure, and increase in glandular exocrine secretions. It also causes sweaty palms, and less immediate life-preserving functions (e.g., digestion, renal filtration) are decreased.

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 an individual has symptoms suggesting autonomic dysfunction, cardiovagal, adrenergic, and sudomotor tests are usually done to help determine severity and distribution of the dysfunction.

Drugs can have substantial effects on the results of ANS testing and are a common cause of falsely abnormal results. Individuals should refrain from caffeine, nicotine, and alcohol at least three 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 consists of a battery of tests intended to evaluate the integrity and function of the ANS. As most of the ANS is inaccessible to testing, the available tests are measures of end-organ response rather than direct measures of ANS function. 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. There are numerous individual tests of ANS function, and a combination of them is typically used in ANS testing. ANS testing can be grouped into three general categories:

Cardiovagal innervation: 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 (HR) response to deep breathing, Valsalva ratio, and 30:15 ratio heart rate responses to standing. Reduced, or absent, heart rate variability is a sign of autonomic dysfunction.

  • Heart rate response to deep breathing: The most widely used test, and considered by some as the optimal test, of cardiovagal function. This test measures the maximal HR variability during deep breathing (six breaths/min) in the laboratory setting, where the confounding variables of age, rate, and depth of respiration are controlled.
  • Valsalva ratio: This test measures the ratio derived from the maximal HR generated by the Valsalva maneuver divided by the lowest HR following the maneuver.
  • Heart rate response to standing: This index of cardiovagal function measures the normal tachycardia and bradycardia associated with proper baroreflex function while moving from sitting to standing. The test provides information to calculate the 30:15 ratio (R-R interval at beat 30)/(R-R interval at beat 15).

Vasomotor adrenergic innervation: Evaluates adrenergic sympathetic innervation of the circulation and of the heart in autonomic failure. The following tests are included: beat-to-beat blood pressure (BP) and R-R interval response to Valsalva maneuver, BP and HR response to active standing, tilt table testing, and sustained hand grip.
  • Beat-to-beat BP recordings of the Valsalva maneuver: This test records blood pressure changes in response to the different stages of the Valsalva maneuver, for comparison to age- and sex-standardized values.
  • BP and HR response to standing: This test is a recording of BP change when the patient shifts from supine to standing position, for comparison to age- and sex-standardized values.
  • Tilt-table testing: This test evaluates for orthostatic intolerance. The patient lies on the table and is strapped in with a foot rest. The table is then inclined to the upright position, with monitoring of the pulse and BP. Symptoms of lightheadedness or syncope in conjunction with changes in pulse or BP constitute a positive test. A provocative medication, such as isoproterenol, can be given to increase the sensitivity of the test.
  • Sustained hand grip: This test measures blood pressure response to sustained handgrip, in which continual muscle contraction causes a rise in systolic and diastolic BP and HR. Efferent fibers travel to the muscle and heart, resulting in increased cardiac output, BP, and HR. Abnormal values indicate sympathetic damage.

Sudomotor function testing: Evaluates and documents 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.
  • QSART: This test 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.
  • TST: This test 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.
  • Sympathetic skin response tests: These tests use an electric current to stimulate sympathetic nerves in order to measure the change in electrical resistance, which is altered in the presence of sweat.
  • Silastic sweat imprints: This test is used to determine sweat gland density, sweat droplet size, and sweat volume per area. Silicone-based plastic material is placed on the skin, and the droplets from active sweat glands form indentations on the surface, allowing quantitation of the degree of sweating present.

ANS TESTING DEVICES

Several ANS testing devices have been cleared for marketing since 1976. The ANSAR ANX 3.0 is a noninvasive, real-time digital autonomic nervous system monitor. The ANSAR ANX 3.0 received FDA approval in 2004, and is being promoted as a device that measures both branches of the ANS (the sympathetic and the parasympathetic) independently and simultaneously in real-time. The ANSAR ANX 3.0 performs respiratory-based digital testing of the ANS and heart rate variability measurements.

Another device, SUDOSCAN or electrochemical skin conductance (ESC) test, consists of two sets of large-area stainless steel electrodes for the hands and feet that are connected to a computer for recording and for data-management purposes. SUDOSCAN, cleared for marketing in 2010, is a noninvasive device being marketed for the early detection of small nerve fibers and to help define and monitor a treatment to improve and control complications such as peripheral neuropathy, which is caused by type 2 diabetes.

Devices such as ANSAR ANX 3.0, SUDOSCAN, and similar devices are being used for screening purposes and do not require special preparation of the individual or specially trained medical personnel to operate. Using automated devices, with interpretation of the results by computer software, has not been validated and has the potential for invalid results.
References

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American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). Position statement: proper performance of autonomic function testing. May 2017. Available at: https://www.aanem.org/getmedia/6cc31195-8af3-4d6a-98ec-f524eb9ac778/Proper-Performance-of-Autonomic-Function-Testing_FINAL.pdf. Accessed April 27, 2020.

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Benditt DG, Maloney JD, Ferguson DW, et al. ACC expert consensus document: tilt table testing for assessing syncope. Journal of the American College of Cardiology. 1996;28(1):263-275.

Brignole M, Alboni P, Benditt D, et al. Guidelines on management (diagnosis and treatment) of syncope. European Heart Journal.2001;22:1256-1306.

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Callaghan BC, Cheng H, Stables CL, et al. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurology. 2012;11(6):521-534.

Casellini CM, Parson HK, Richardson MS, et al. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013;15(11):948-953.

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Ewing DJ, Martyn CN, Young RJ, et al. The value of cardiocascular autonomic function tests: 10 years experience in diabetes. Diabetes Care. 1985;8(5):491-498.

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Hoeldtke Rh, Bryner KD, Horvath GG, et al. Redistribution of sudomotor responses is an early sign of sympathetic dysfunction in type 1 diabetes. Diabetes. 2001;50:436-443.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

95921, 95922, 95923, 95924, 95943

NOT COVERED

THE FOLLOWING CODE IS USED TO REPRESENT AUTONOMIC NERVOUS SYSTEM TESTING WITH DEVICES (eg: SUDOSCAN, ESC, and ANSAR ANX 3.0)

95999


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified

E08.41 Diabetes mellitus due to underlying condition with diabetic mononeuropathy

E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy

E08.43 Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy

E08.44 Diabetes mellitus due to underlying condition with diabetic amyotrophy

E08.49 Diabetes mellitus due to underlying condition with other diabetic neurological complication

E08.610 Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy

E09.40 Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy, unspecified

E09.41 Drug or chemical induced diabetes mellitus with neurological complications with diabetic mononeuropathy

E09.42 Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy

E09.43 Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic (poly)neuropathy

E09.44 Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophy

E09.49 Drug or chemical induced diabetes mellitus with neurological complications with other diabetic neurological complication

E09.610 Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathy

E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified

E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy

E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy

E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy

E10.44 Type 1 diabetes mellitus with diabetic amyotrophy

E10.49 Type 1 diabetes mellitus with other diabetic neurological complication

E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy

E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified

E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy

E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy

E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy

E11.44 Type 2 diabetes mellitus with diabetic amyotrophy

E11.49 Type 2 diabetes mellitus with other diabetic neurological complication

E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy

E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified

E13.41 Other specified diabetes mellitus with diabetic mononeuropathy

E13.42 Other specified diabetes mellitus with diabetic polyneuropathy

E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy

E13.44 Other specified diabetes mellitus with diabetic amyotrophy

E13.49 Other specified diabetes mellitus with other diabetic neurological complication

E13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathy

E85.0 Non-neuropathic heredofamilial amyloidosis

E85.1 Neuropathic heredofamilial amyloidosis

E85.3 Secondary systemic amyloidosis

E85.4 Organ-limited amyloidosis

E85.81 Light chain (AL) amyloidosis

E85.82 Wild-type transthyretin-related (ATTR) amyloidosis

E85.89 Other amyloidosis

G23.0 Hallervorden-Spatz disease

G23.1 Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]

G23.2 Striatonigral degeneration

G23.8 Other specified degenerative diseases of basal ganglia

G56.83 Other specified mononeuropathies of bilateral upper limbs

G57.83 Other specified mononeuropathies of bilateral lower limbs

G60.3 Idiopathic progressive neuropathy

G60.8 Other hereditary and idiopathic neuropathies

G60.9 Hereditary and idiopathic neuropathy, unspecified

G61.82 Multifocal motor neuropathy

G62.9 Polyneuropathy, unspecified

G90.09 Other idiopathic peripheral autonomic neuropathy

G90.3 Multi-system degeneration of the autonomic nervous system

G90.4 Autonomic dysreflexia

G90.50 Complex regional pain syndrome I, unspecified

G90.511 Complex regional pain syndrome I of right upper limb

G90.512 Complex regional pain syndrome I of left upper limb

G90.513 Complex regional pain syndrome I of upper limb, bilateral

G90.519 Complex regional pain syndrome I of unspecified upper limb

G90.521 Complex regional pain syndrome I of right lower limb

G90.522 Complex regional pain syndrome I of left lower limb

G90.523 Complex regional pain syndrome I of lower limb, bilateral

G90.529 Complex regional pain syndrome I of unspecified lower limb

G90.59 Complex regional pain syndrome I of other specified site

G90.8 Other disorders of autonomic nervous system

G90.9 Disorder of the autonomic nervous system, unspecified

I95.0 Idiopathic hypotension

I95.1 Orthostatic hypotension

I95.89 Other hypotension

I95.9 Hypotension, unspecified

L74.510 Primary focal hyperhidrosis, axilla

L74.511 Primary focal hyperhidrosis, face

L74.512 Primary focal hyperhidrosis, palms

L74.513 Primary focal hyperhidrosis, soles

L74.519 Primary focal hyperhidrosis, unspecified

L74.52 Secondary focal hyperhidrosis

R00.0 Tachycardia, unspecified

R55 Syncope and collapse

R61 Generalized hyperhidrosis



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

REVISIONS FROM MA07.027c:
06/22/2020This version of the policy will become effective 06/22/2020.

The following unlisted code is used to represent Autonomic Nervous System Testing with Devices (e.g., SUDOSCAN, ESC, and ANSAR ANX 3.0), and has been added to this policy as not covered: 95999

The following ICD-10 Diagnosis Codes were added to this policy: E08.40, E08.41, E08.42, E08.43, E08.44, E08.49, E08.610, E09.40, E09.41, E09.42, E09.43, E09.44, E09.49, E09.610, E13.40

REVISIONS FROM MA07.027b:
04/24/2019This policy has been reissued in accordance with the Company's annual review process.
01/14/2019This version of the policy will become effective 01/14/2019. The Company’s coverage position has changed from Not Medically Necessary to Medically Necessary on the use of autonomic nervous system testing for diabetic neuropathy (including distal symmetric polyneuropathy and autonomic neuropathy).

    The following ICD-10 codes have been added to this policy:
    G90.8 Other disorders of autonomic nervous system
    G90.9 Disorder of the autonomic nervous system, unspecified
    I95.0 Idiopathic hypotension
    I95.89 Other hypotension
    I95.9 Hypotension, unspecified
    L74.510 Primary focal hyperhidrosis, axilla
    L74.511 Primary focal hyperhidrosis, face
    L74.512 Primary focal hyperhidrosis, palms
    L74.513 Primary focal hyperhidrosis, soles
    L74.519 Primary focal hyperhidrosis, unspecified
    L74.52 Secondary focal hyperhidrosis

REVISIONS FROM MA07.027a:
10/01/2017This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 CM code has been termed from this policy.

E85.8: Other amyloidosis

The following ICD-10 CM codes have been added to this policy:

E85.81: Light chain (AL) amyloidosis
E85.82: Wild-type transthyretin-related (ATTR) amyloidosis
E85.89: Other amyloidosis


REVISIONS FROM MA07.027:
08/01/2017This is a new policy that has been developed to communicate the Company's coverage criteria for autonomic nervous system function tests.




Version Effective Date: 06/22/2020
Version Issued Date: 06/22/2020
Version Reissued Date: N/A