Contractor Name
HealthNow UMD

Contract Number
00801

Contractor Type
Carrier

LCD Database ID Number
L3672

LCD Title
Autonomic Nervous System Function Testing

Contractor's Determination Number
NE002G01 End dated

AMA CPT Copyright Statement
CPT codes, descriptions, and other data only are copyright 2005 American Medical Association (or such other data of publication of CPT). All Rights Reserved. Applicable FARS/DFARS clauses apply. CDT-4 codes and descriptions are copyright 2002, 2004 American Dental Association. All rights reserved.

CMS National Coverage Policy

   -   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 1862 (a)(1)(A)

       This section allows coverage and payment for only those services
       considered medically reasonable and necessary.

   -   Title XVIII of the Social Security Act, Section 1833 (e)

       This section prohibits Medicare payment for any claim which lacks the
       necessary information to process the claim.

Oversight Region
Region II

CMS Consortium
Northeast

Original Determination Effective Date
For services performed on or after 10/16/2002

Original Determination Ending Date
04/25/2008

Revision Effective Date
For services performed on or after 07/29/2005

Revision Ending Date
04/25/2008

Indications and Limitations of Coverage and/or Medical Necessity
Autonomic Nervous System (ANS) Testing (CPT codes 95921-95922) measures alterations in the R-R interval of the ECG in response to parasympathetic and sympathetic system stimulation.

Autonomic disorders may be congenital or acquired - primary or secondary. Most 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 directed treatment for an autonomic disorder.

Indications
These tests are payable as reasonable and necessary to evaluate symptoms of vasomotor instability such as hypotension, orthostatic tachycardia and hyperhidrosis, generally after more common causes have been excluded by other testing. 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.

Autonomic function testing will be reimbursed as reasonable and necessary only when used for one or more of the following indications and when directed at establishing a more accurate or definitive diagnosis or contributing to clinically relevant medical decision-making:

   1.  Diagnose the presence of autonomic neuropathy in a patient with signs
       or symptoms suggesting a progressive autonomic neuropathy.

   2.  Evaluate the severity and distribution of a diagnosed progressive
       autonomic neuropathy.

   3.  Differentiate the diagnosis between certain complicated variants of
       syncopes from other causes of loss of consciousness.

   4.  Evaluate inadequate response to beta-blockade in vasodepressor
       syncope.

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

   6.  Differentiate the cause of postural tachycardia syndrome.

   7.  Evaluate change in type, distribution or severity of autonomic
       deficits in patients with autonomic failure.

   8.  Evaluate the response to treatment in patients with autonomic failure
       who demonstrate a change in clinical exam.

   9.  Diagnose axonal neuropathy or suspected autonomic neuropathy in the
       symptomatic patient.

   10. Evaluate and treat patients with recurrent unexplained syncope to
       demonstrate autonomic failure, generally after more common causes have
       been excluded by other standard testing.

   1.  Syndromes of autonomic dysfunction for which autonomic 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, orthostatic tachycardia)
       may formal autonomic testing be indicated to exclude or confirm rarer
       autonomic disorders.

   2.  The use of these tests to screen patients without signs or symptoms of
       autonomic dysfunction, including patients with diabetes, hepatic or
       renal disease, is not covered.

   3.  Testing for the sole purpose of monitoring disease intensity or
       treatment efficacy in diabetes, hepatic or renal disease is not
       considered reasonable and necessary.

   4.  Testing is not covered unless the results of testing are used in
       clinical decision-making and patient management.

   5.  Services described by 95921 and 95922 are not the same as R-R interval
       trending or heart rate variability (HRV). These measurements, used to
       asses the risk of sudden cardiac death are available as add on
       features to some cardiac monitoring devices, and are not reimbursable
       separately from the monitoring service.

   6.  Appropriate application and interpretation of these tests requires
       significant knowledge, training and expertise. For example, proper
       interpretation requires that test results be compared with findings in
       age matched control subjects, and that individual laboratories develop
       their own reference values based on the particular testing protocols
       employed and patient populations being tested.

CPT/HCPCS Codes

    95921           Testing of autonomic nervous system function;
                    cardiovagal innervation (parasympathetic function),
                    including two or more of the following: heart rate
                    response to deep breathing with recorded R-R
                    interval, Valsalva ratio, and 30:15 ratio

    95922           ; vasomotor adrenergic innervation (sympathetic
                    adrenergic function), including beat to  beat blood
                    pressure and R-R interval changes during Valsalva
                    maneuver and at least five minutes of passive tilt

Does the CPT 30% Coding Rule Apply?
No

ICD-9-CM Codes That Support Medical Necessity
TRUNCATED DIAGNOSIS CODES ARE NOT ACCEPTABLE.

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider's responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the service was performed.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical signs/symptoms must be present for the procedure to be paid. Further, these ICD-9-CM codes can be used only with the conditions listed in the "Indications" and "Limitations" section of this LCD.

    255.2           Dopamine beta hydroxylase deficiency

    333.0           Other degenerative diseases of the basal ganglia;
                    Olivopontocerebellar degeneration, Parkinsonism
                    syndrome associated with idiopathic orthostatic
                    hypotension or symptomatic orthostatic hypotension,
                    Shy-Drager syndrome, Multiple System Atrophy

    337.0           Idiopathic peripheral autonomic neuropathy

    337.1           Peripheral autonomic neuropathy in disorders
                    classified elsewhere

    337.20          Reflex sympathetic dystrophy, unspecified

    337.21          Reflex sympathetic dystrophy of the upper limb

    337.22          Reflex sympathetic dystrophy of the lower limb

    337.29          Reflex sympathetic dystrophy of other specified site

    337.3           Autonomic dysreflexia

    337.9           Unspecified disorder of autonomic nervous system

    358.1           Myasthenic syndromes (Eaton-Lambert)

    458.0           Orthostatic hypotension

    458.1           Chronic hypotension

    742.8           Other specified anomalies of nervous system

    780.2           Syncope and collapse

    785.0           Tachycardia unspecified

ICD-9-CM Codes That DO NOT Support Medical Necessity:
Use of any ICD-9-CM code not listed in the "ICD-9-CM Codes That Support Medical Necessity" section of this LCD will be denied.

Documentation Requirements

   1.  Each claim must be submitted with ICD-9-CM codes that reflect the
       condition of the patient, and indicate the reason(s) for which the
       service was performed.  Claims submitted without ICD-9-CM codes will
       be returned.

   2.  The diagnostic purpose or intent of the test must be clear in the
       medical record documentation.

   3.  The medical record must show the results of preceding evaluations such
       as: the history and physical, neurological evaluation, EKG, holter,
       echocardiogram, where necessary.

   4.  The medical record must show the protocol used, a recording of each
       test, interpretation by a physician and final report.

   5.  The medical record must show how the results of the test are used to
       guide further clinically relevant medical decision-making.

   6.  Documentation must be available to Medicare upon request.

   1.  Appropriate diagnostic testing may be performed once for patients to
       confirm or exclude specific autonomic disease.

   2.  Claims exceeding a frequency of two (2) per year will be denied as not
       reasonable and necessary.

   1.  Medicare Medical Policy, Palmetto Government Benefits Administrators,
       Policy #99-0019-L, effective 02/10/2000, with the following sources of
       information:

       -    Goldstein D, Holmes C, Cannon R, Eisenhofer G, Kopin I.
            Sympathetic Cardioneuropathy in Dysautonomias. The New England
            Journal of Medicine, March 1997: 336(10); 696-702.

       -    Ferguson J, Altrocchi P, Brin M, Goldstein M, Gorelick P, Hanley
            D, Lange D, Nuwer M, van den Noort S. Clinical autonomic testing
            report of the Therapeutics and Technology Assessment Subcommittee
            of the American Academy of Neurology. Neurology, March 1996: 46;
            873-879.

       -    Mathias CJ, Editorial: Autonomic Disorders and Their Recognition,
            The New England Journal of Medicine, March 1997: 336(10):
            721-724.

   2.  American College of Cardiology Position Statement: Heart Rate
       Variability for Risk Stratification of Life-Threatening Arrhythmias.
       Accessed from:  www.acc.org/clinical/position/72526.html.

   3.  Autonomic Disorders. Accessed 12/13/01 from:
       www.neuro.wustl.edu/neuromuscular/autonomic.html. Neuromuscular
       Disease Center,  Washington University School of Medicine.

   4.  McCarthy R, Aminoff M. Commentary on Electrophysiological Tests of
       Autonomic Function in Patients with Idiopathic Autonomic Failure
       Syndromes. Neurology Network Commentary, 1: 1-4, 1997.

   5.  Ravitz J. Autonomic Nervous System Testing. AAEM Minimonograph #48.
       Muscle & Nerve, August 1997: 919-937.

   6.  Ravitz J, Hallett M, Nilsson J, Polinsky R, Dambrosia J.
       Electrophysiological tests of autonomic function in patients with
       idiopathic autonomic failure syndromes. Muscle & Nerve, 1996: 19;
       758-763.

   7.  Sandroni, P. Testing the Autonomic Nervous System. Technical Corner
       from IASP (International Association for the Study of Pain)
       Newsletter, November/December 1998.

   1.  Consensus Statement: Report and Recommendations of the San Antonio
       Conference of Diabetic Neuropathy (July, 1998). Diabetes, 37,
       1000-1004.

   2.  Curtis, Brian M, MD, and O'Keffe Jr., James H, MD (2002). Autonomic
       Tone as a Cardiovascular Risk Factor: The Dangers of Chronic Fight or
       Flight. Mayo Clin Proc., 77, 45-54.

   3.  DeQuattro, V and Feng, M (2002). The sympathetic nervous system: the
       muse of primary hypertension. Journal of Human Hypertension, 16,
       64-69.

   4.  Freeman, Roy, MD, Komaroff, Anthony L, MD (1997, April). Does the
       Chronic Fatigue Syndrome Involve the Autonomic Nervous System? The
       American Journal of Medicine(R), 102, 357-364.

   5.  Gaede, Peter, MD, Vedel, Pernille, MD, Phd, Larsen, Nicolai, MD, PhD,
       Jensen, Gunnar V H, MD, PhD, Parving, Han-Henrik, MD, DMSc and
       Pedersen, Oluf, MD, DMSc. (2003, January 30). Multifactorial
       Intervention and Cardiovascular Disease in Patients with Type 2
       Diabetes. The New England Journal of Medicine, 348;5, 383-393.

   6.  Gerritsen, Jeanet, MSC, Dekker, Jacqueline M, PHD, Ten Voorde, Ben J,
       PHD, Heine, Robert J, MD, Bouter, Lex M, PHD, Heethaar, Rob M, PHD,
       and Stehouwer, Coen D A, MD (2001, October). Impaired Autonomic
       Function is Associated With Increased Mortality, Especially in
       Subjects With Diabetes, Hypertension, or a History of Cardiovascular
       Disease. Diabetes Care, Volume 24, Number 10, 1793-1798.

   7.  Grundy, Scott, MD, PhD, et al (1999, September 7). Diabetes and
       Cardiovascular Disease. Circulation, 1134-1146.

   8.  Jakobsen, J and Associates (1988, April). Autonomic and Somatosensory
       Nerve Function After 2 Years of Continuous Subcutaneous Insulin
       Infusion in Type I Diabetes. Diabetes, Volume 37, 452-455.

   9.  Kahn, Richard, MD (1992, August). Autonomic Nervous System Testing.
       Diabetes Care, 15, Supplement 3, 1095-1103.

   10. Langer, Anatoly, MD, Freeman, Michael R, MD, Josse, Robert G, MD,
       Steinger, George, MD, and Armstrong, Paul W, MD (1991, May 15).
       Detection of Silent Myocardial Ischemia in Diabetes Mellitus. The
       American Journal of Cardiology, Volume 67, 1073-1078.

   11. Levitt, Naomi S, MD and Associates (1996, July). The Natural
       Progression of Autonomic Neurophthy and Autonomic Function Tests in a
       Cohort of People with IDDM, Diabetes Care, Volume 19, Number 7,
       751-754.

   12. Low, Philip, MD (1996). Assessment: Clinical autonomic testing report
       of the Therapeutics and Technology Assessment Subcommittee of the
       American Academy of Neurology. Neurology, 46, 873-880.

   13. Low, Philip A, MD. (Ed.). Laboratory Evaluation of Autonomic Function,
       Autonomic Neuropathies, Other Extrapyramidal Disorders, Postural
       Tachycardia Syndrome, Clinical Autonomic Disorders, 2nd ed.,15,
       179-180, 36, 463-486, 43, 577-584, 689-692. Philadelphia:
       Lippincott-Raven.

   14. Mackay, J D, Page, M McB, Cambridge, J, and Watkins, P J (1980).
       Diabetic Autonomic Neuropathy: The Diagnostic Value of Heart Rate
       Monitoring. Diabetologia, 18, 471-478, Springer-Verlag.

   15. Maser, Raelene E, PhD, Lenhard, M James, MD, & DeCherney, G Stephen,
       MD, PhD (2000). Cardiovascular Autonomic Neuropathy: The Clinical
       Significance of Its Determination. The Endocrinologist, Volume 10, No.
       1, 27-33.

   16. Maser, Raelene E, PHD, Mitchell, Braxton D, PHD, Vinik, Aaron I, MD,
       PHD, and Freeman Roy, MD (2003, June). The association Between
       Cardiovascular Autonomic Neuropathy and Mortality in Individuals With
       Diabetes. Diabetes Care, Volume 26, Number 6.

   17. Neumann, C and Schmid, H (1995). Relationship between the degree of
       cardiovascular autonomic dysfunction and symptoms of neuropathy and
       other complications f diabetes mellitus. Brazilian Journal of Medical
       and Biological Research, 28, 751-757.

   18. O'Brien, I A, McFadden, J P and Corrall, R J M (1991, June). The
       Influence of Mortality in Insulin-dependent Diabetes. Quarterly
       Journal of Medicine, New Series 79, No. 290, 495-502.

   19. Ray, Nancy Fox, MS, Thamer, Mae, PhD, Gardner, Eric, MPP and Chan,
       Julien K, MS (1997). Economic Consequences of Diabetes Mellitus in the
       U.S in 1997.

   20. Reichard, P, Jensen-Urstad, K, Ericsson, M, Jensen-Urstad, M and
       Lindblad, L E (2000 Diabetes UK). Autonomic neuropathy- a complication
       less pronounced in patients with Type 1 diabetes mellitus who have
       lower blood glucose levels. Diabetic Medicine, 17, 860-866.

   21. Risk, Marcelo, PhD, Bril, Vera, MD, Broadbridge, Christopher, BS, and
       Cohen, Alan, BS (2001). Heart Rate Variability Measurement in Diabetic
       Neuropathy: Review of Methods. Diabetes Technology & Therapeutics,
       Volume 3, Number 1, 63-76.

   22. Rowe, Peter C, MD, and Calkins, Hugh, MD (1998, September 28).
       Neurally Mediated Hypotension and Chronic Fatigue Syndrome. The
       American Journal of Medicine(R), 105 (3A), 15-21.

   23. Shoemaker, William C, MD, Velmahos, George C, MD, PhD, and
       Demetriades, Demetrios, MD, PhD. Procedures and Monitoring for the
       Critically Ill. Critical Care Emergency Medicine, W. B. Saunders
       Company.

   24. Solomon, Caren G, MD (2003, January 30). Reducing Cardiovascular Risk
       in Type 2 Diabetes. The New England Journal of Medicine, 348;5,
       457-459.

   25. Stevens Et Al (1998, June). Scintigraphic Assessment of Regionalized
       Defects in Myocardial Sympathetic Innervation and Blood Flow
       Regulation in Diabetic Patients with Autonomic Neuropathy. JACC,
       Volume 31, No. 7, 1575-1584.

   26. Stevens Et Al (1998, September 8) Cardiac Sympathetic Dysinnervation
       in Diabetes Implications for Enhanced Cardiovascular Risk.
       Circulation, 98, 961-968.

   27. Task Force of the European Society of Cardiology and the North
       American Society of Pacing and Electrophysiology (1996, March 1).
       Heart Rate Variability Standards of Measurement, Physiological
       Interpretation, and Clinical Use. Circulation, Volume 93, No. 5,
       1043-1065.

   28. The DCCT Research Group (1997, August 5 and in revised form: 1997,
       November 12). The effect of intensive diabetes therapy on measures of
       autonomic nervous system function in the Diabetes Control and
       Complications Trial (DCCT). Diabetologia, Springer-Verlag 1998.

   29. Valensi, Paul, MD, Sachs, Regis-Nessim, MD, Harfouche, Boubakeur, MD,
       Lormeau, Boris, MD, Paries, Jacques, MD, Cosson, Emmanuel, MD, Paycha,
       Frederic, MD, PHD, Leutenegger, Marc, MD, and Attali, Jean-Raymond, MD
       (2001, February). Predictive Value of Cardiac Autonomic Neuropathy in
       Diabetic Patients With or Without Silent Myocardial Ischemia. Diabetes
       Care, Volume 24, Number 2, 339-343.

   30. Vinik, Aaron I, MD, PhD and Erbas, Tomris, MD (2001, November).
       Recognizing and treating diabetic autonomic neuropathy. Cleveland
       Clinic Journal of Medicine, 68, No. 11, 928-944.

   31. Vinik, Aaron I, MD, Phd (1999, August 30). Diabetic Neuropathy:
       Pathogenesis and Therapy. The American Journal of Medicine(R), 107
       (2B), 17-26.

   32. Vinik, Aaron I, MD, PHD, Maser, Ralene E, PHD, Mitchell, Braxton D,
       PHD, and Freeman Roy, MD (2003, May). Diabetic Autonomic Neuropathy.
       Diabetic Care, Volume 26, Number 5.

   33. Writing Group, (1999, September 7). Diabetes Mellitus: A Major Risk
       Factor for Cardiovascular Disease. Circulation, 1132-1133.

   34. Young et al, (2003) Diagnosis of CAD in Patients with Diabetes: Who to
       Evaluate. Current Diabetes Reports, 3, 19-27.

   35. Other Carriers policy; Virginia, TrailBlazer Health Enterprises, LLC,
       Policy Number F-41B.1.

The following additional sources were received during the comment period (10/13/2004-12/11/2004):

   1.  Bell, David S.H., "Heart Failure ­ The Frequent, Forgotten, and Often
       Fatal Complication of Diabetes," Diabetes Care 26 (2003), 2433-2441
       (Abstract only).

   2.  Cole, Christopher R, Lauer, Michael S., and Bigger, Thomas J,
       "Clinical Assessment of the Autonomic Nervous System," in Textbook of
       Cardiovascular Medicine, 2nd ed., 1615-1629.

   3.  Joint Editorial Statement by the American Diabetes Association; the
       National Heart, Lung and Blood Institute; the Juvenile Diabetes
       Foundation International; the National Institute of Diabetes and
       Digestive and Kidney Disease; and the American Heart Association,
       "Diabetes Mellitus: A Major Risk Factor for Cardiovascular Disease,"
       Circulation 100 (1999), 1132-1133 (Editorial).

   4.  Low, Phillip A. and Engstrom, John W., "Disorders of the Autonomic
       Nervous System," in Harrison's Principles of Internal Medicine, 16th
       Ed., pp. 2428-2434.

   5.  Poirier, Paul and Eckel, Robert H., "Management of Diabetes and Heart
       Disease,: Cardiology Special Edition 7:1 (2001), 17-21.

   6.  Prendergast, J. Joseph, "Diabetic Autonomic Neuropathy, Part 1 ­ Early
       Detection," Practical Diabetology, March 2001, 7-14.

   7.  Prendergrast, J. Joseph, "Diabetic Autonomic Neuropathy, Part 2 ­
       Treatment," Practical Diabetology, June 2001, 33-36.

   8.  Saper, Clifford B., "Autonomic Disorders and Their Management," in
       Cecil textbook of Medicine, 22nd Ed., 2364-2370.

   9.  Talman, William T. and Benarroch, Eduardo E., "Neural Control of
       Cardiac Function," in Peripheral Neuropathy, 3rd Ed., 177-186.

   10. Thomas, P.K. and Tomlinson, D.R., "Diabetic and Hypoglycemic
       Neuropathy," in Peripheral Neuropathy, 3rd Ed., 1219-1250.

   11. Vinik, Aaron, "Autonomic Nerve Function in Diabetes," ADA 64th
       Scientific Sessions, Orlando, June 2004.

   -   This LCD was presented at the October 13, 2004, Carrier Advisory
       Committee meeting as a coordinated New York/New Jersey LCD.

   -   This 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 Neurology, Internal
       Medicine and the State Medical Societies.

   -   This LCD was presented at the February 13, 2002, Carrier Advisory
       Committee meeting by Group Health Incorporated.

   -   This LCD does not reflect the sole opinion of the contractor or
       Contractor Medical Director.  Although the final decision rests with
       the carrier, this LCD was developed in cooperation with advisory
       groups, which includes representatives from Neurology, Internal
       Medicine and Endocrinology specialty societies, and the Medical
       Society of the State of New York.

End Date of Comment Period
12/11/2004

Start Date of Notice Period
05/12/2008

Revision History Number
1

Revision History Explanation
This LCD is end dated effective 04/25/2008 because it is no longer effective for educational purposes.

Revision #1: Changes have been made to the Indications and Limitations, Documentation Requirements, and Utilizations Guidelines sections. Added ICD-9-CM codes 337.1, 337.20, 337.21, 337.22, 337.29, 337.3, 337.9 as payable. Additional Sources of Information were added.

Conversion to a LCD was completed on 06/23/2005.

Does this LCD contain a "Least Costly Alternative" provision?
No