L29227-LCD

Automated World Health

Local Coverage Determination (LCD) for Microvolt T-wave Alternans (L29227)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29227

LCD Title Microvolt T-wave Alternans

Contractor's Determination Number 93025

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 02/02/2009 Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (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 represents quotation from one or more of the following CMS sources: Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 20.30

Indications and Limitations of Coverage and/or Medical Necessity

Microvolt T-wave alternans (TWA) is an every other beat variation in the T-wave that is predictive of ventricular tachyarrhythmias associated with sudden cardiac death. Microvolt TWA is measured through sensors and electrodes placed in the standard 12-lead configuration as well as additional vector positions during a routine exercise stress test, pharmacologic stress test or cardiac pacing. Sustained alternans with an onset of the heart rate less than 110 bpm for a minimum of 2.5 minutes with alternans voltage measured at > 1.9 microvolts and alternans ratio of >3 is considered a positive t-wave alternans.

Medicare will consider microvolt TWA medically reasonable and necessary when performed for a clinical condition associated with a high risk of ventricular tachyarrhythmias (e.g., ischemic cardiomyopathy, unexplained syncope with suspected or known heart disease, etc.) only when the results of the test will be used in the management of the patient. For example, the results of the microvolt TWA will determine whether a patient will undergo an invasive electrophysiological study or treatment with antiarrhythmics when the results are positive.

Microvolt TWA is not covered for the general assessment of a patient with atherosclerotic heart disease, pre- surgical evaluation or other circumstances where the index of suspicion of ventricular tachycardia/fibrillation is low, or the knowledge of possible ventricular tachycardia/fibrillation will not alter the management of the patient. Also, the routine use of microvolt TWA as an add-on service to other cardiac evaluation tests such as electrocardiograms, stress testing, and electrophysiologic studies is not covered.

Effective for dates of service on or after March 21, 2006, Microvolt T-wave Alternans (MTWA) diagnostic testing is covered for the evaluation of patients at risk of sudden cardiac death (SCD), only when the spectral analysis method is used. Within patient groups that may be considered candidates for implantable cardioverter

defibrillator (ICD) therapy, a negative MTWA test may be useful in identifying low-risk patients who are unlikely to benefit from, and who may experience worse outcomes from ICD placement.

The test is performed by placing highly sensitive electrodes on a patient’s chest prior to a period of controlled exercise. These electrodes detect tiny beat-to-beat changes, on the order of one-millionth of volt, in the EKG T- wave. Spectral analysis is used to calculate these minute voltage changes. Spectral analysis is a sensitive mathematical method of measuring and comparing time and the EKG signals. Software then analyzes these microvolt changes and produces a report to be interpreted by a physician.

Limitations:

Microvolt T-wave Alternans diagnostic testing in non-covered for the evaluation of patients at risk for SCD if measurement is not performed employing the spectral analysis method for services performed on or after March 21, 2006.

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.

99999 Not Applicable

CPT/HCPCS Codes

93025 MICROVOLT T-WAVE ALTERNANS FOR ASSESSMENT OF VENTRICULAR ARRHYTHMIAS

ICD-9 Codes that Support Medical Necessity

402.01 MALIGNANT HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.11 BENIGN HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.91 UNSPECIFIED HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART

404.00 - 404.03 FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED - HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.10 - 404.13 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED - HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.90 - 404.93 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED - HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL EPISODE OF CARE

410.00 - 410.92 UNSPECIFIED - ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE

411.1 INTERMEDIATE CORONARY SYNDROME

411.81 ACUTE CORONARY OCCLUSION WITHOUT MYOCARDIAL INFARCTION

411.89 OTHER ACUTE AND SUBACUTE FORMS OF ISCHEMIC HEART DISEASE OTHER

412 OLD MYOCARDIAL INFARCTION

414.10 ANEURYSM OF HEART (WALL)

414.19 OTHER ANEURYSM OF HEART

414.8 OTHER SPECIFIED FORMS OF CHRONIC ISCHEMIC HEART DISEASE

425.0 - 425.9 ENDOMYOCARDIAL FIBROSIS - SECONDARY CARDIOMYOPATHY UNSPECIFIED

426.82 LONG QT SYNDROME

427.1 PAROXYSMAL VENTRICULAR TACHYCARDIA

427.41 VENTRICULAR FIBRILLATION

427.42 VENTRICULAR FLUTTER

427.5 CARDIAC ARREST

428.1 CONGESTIVE HEART FAILURE UNSPECIFIED

428.2 LEFT HEART FAILURE

428.20 - 428.23 UNSPECIFIED SYSTOLIC HEART FAILURE - ACUTE ON CHRONIC SYSTOLIC HEART FAILURE

428.30 - 428.33 UNSPECIFIED DIASTOLIC HEART FAILURE - ACUTE ON CHRONIC DIASTOLIC HEART FAILURE

428.40 - 428.43 UNSPECIFIED COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE - ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

428.9 HEART FAILURE UNSPECIFIED

746.89 OTHER SPECIFIED CONGENITAL ANOMALIES OF HEART

780.2 SYNCOPE AND COLLAPSE

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation must clearly indicate the medical necessity of the service(s) being billed and that the results of the test are being used in the management of the patient. In addition, the documentation must support that the procedure was performed. The procedure report should include documentation and interpretation of spectral analysis for services performed on or after March 21, 2006. This information is normally found in the

office/progress notes, hospital records, and test results.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

Barron, H. (2000). Editorial Comment: T-wave alternans and serious ventricular arrhythmias: a tale of two t- waves. Journal of the American College of Cardiology, 36(7), 2254-2256. Supported validity of test for coverage.

Bloomfield, D.M. (2006). Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. Journal of the American College of Cardiology. 47(2): 456-63.

Cambridge Heart Inc. (2001). Microvolt T-wave alternans: A tool for predicting arrhythmia and sudden cardiac arrest. Retrieved October 10, 2001, from Cambridge Heart database on the World Wide Web: http//www.cambridgeheart.com/camh/professional/newtool.html. Used in the description of the service.

Cohen, R. (2001). Use of microvolt t-wave alternans testing in clinical practice to reduce cardiac arrest and sudden cardiac death. Scheduled for publication in EP Lab Digest, September, 2001. Used in description of the service and supports the clinical conditions for coverage.

Gold, M., Bloomfield, D., Anderson, K., El-Sherif, N., Wilber, D., Groh, W., Estes, M., Kaufman, E., Greenberg, M., & Rosenbaum, D. (2000). A comparison of t-wave alternans, signal averaged electrocardiography and programmed ventricular stimulation for arrhythmia risk stratification. Journal of the American College of Cardiology, 36(7), 2247-2253. Provided information regarding a positive test used in the description.

Hennersdorf, M., Perings, C., Niebch, V., Vester, E., & Strauer, B. (2000). T wave alternans as a risk predictor in patients with cardiomyopathy and mild-to-moderate heart failure. PACE, 23, 1386-1391. Supports potential indication for coverage.

Ikeda, T., Sakata, R., Takami, M., Kondo, N., Tezuka, N., Nakae, T., Noro, M., Enjoji, Y., Abe, R., Sugi, K., & Yamaguchi, T. (2000). Combined assessment of t-wave alternans and late potentials used to predict arrhythmic events after myocardial infarction. Journal of the American College of Cardiology, 35(3), 722-730. Supports potential indication for coverage.

Ikeda, T., Saito, H., Tanno, K., Shimizu, H., Watanobe, J., Ohnishi, Y., Kasamaki, Y., & Ozawa, Y. (2002). T-wave alternans as a predictor for sudden cardiac death after myocardial infarction. The American Journal of Cardiology, 89, 79-82. Indicates TWA could be used in the primary screening of patients for sudden cardiac death after MI.

Izzo, J.L. (2004). Mechanisms and management of hypertensive heart disease: from left ventricular hypertrophy to heart failure. Med Clinics North Am 88(5):1257-71.

Kitamura, H., Ohnishi, Y., Okajima, K., Ishida, A., Galeano, E., Adachi, K., & Yokoyama, M. (2002). Onset heart rate of microvolt-level t-wave alternans provides clinical and prognostic value in nonischemic dilated cardiomyopathy. Journal of the American College of Cardiology, 39(2), 295-300. Supports TWA as a risk stratifier for patients with DCM at risk for sudden cardiac death.

Klingenheben, T., Zabel, M., D’Agostino, R., Cohen, R., & Hohnloser, S. (2000). Predictive value of t-wave alternans for arrhythmic events in patients with congestive heart failure. The Lancet, 356, 651-652. Supports potential indication for coverage.

Tapanainen, J., Still, A., Airaksinen, K., & Huikuri, H. (2001). Prognostic significance of risk stratifier of mortality, including t wave alternans, after acute myocardial infarction: Results of a prospective follow-up study. Journal of Cardiovascular Electrophysiology, 12(6), 645-652. Indicates that additional studies are needed to assess the prognostic power of TWA in post AMI populations.

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.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

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

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29227) replaces LCD L5944 as the policy in notice. This document (L29227) is effective on 02/02/2009.

Reason for Change