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Date Printed: June 23, 2017: 06:24 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-93000-23

Original Effective Date: 09/15/02

Reviewed: 06/23/11

Revised: 11/01/15

Subject: T-Wave Alternans

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

T-wave alternans refers to a beat-to-beat variability in the amplitude of the T wave and ST segment in an electrocardiogram (EKG, ECG). A routine EKG cannot detect these small fluctuations. T-wave alternans requires specialized sensors to detect the fluctuations and computer algorithms to evaluate the results.  T-wave alternans is a provocative test that necessitates gradual elevation of the heart rate to above 110 beats per minute. T-wave alternans can be performed in conjunction with an exercise tolerance stress test (treadmill). Test results are reported as the number of standard deviations by which the peak signal of the T-wave exceeds the background noise. This number is referred to as the "alternans ratio." An alternans ratio of 3 or greater is typically considered a positive result, an absent alternans ratio is considered a negative result, and anything in between is considered indeterminate.

The presence of T-wave alternans has been investigated as a risk factor for fatal arrhythmias and sudden cardiac death in high-risk patients with a history of myocardial infarction (MI), congestive heart failure (CHF), or cardiomyopathy. High-risk patients may be treated with drugs to suppress the emergence of arrhythmias or undergo implantation of cardiac defibrillators to terminate life-threatening arrhythmias. Sudden cardiac death is one of the most common causes of death after a MI or in patients with dilated cardiomyopathy; there is interest in risk stratification to target therapy for high-risk patients. Patient groups are categorized into those who have not experienced a life-threatening arrhythmia (i.e., primary prevention) and those who have (i.e., secondary prevention). Those who have already experienced an arrhythmia are already at high risk and probably do not require testing. T-wave alternans is one of many risk factors that have been investigated for identifying candidates for primary prevention. Others include left ventricular ejection fraction, arrhythmias detected on Holter monitor or electrophysiologic studies, heart rate variability, and baroreceptor sensitivity. T-wave alternans has also been investigated as a diagnostic test for patients with syncope of unknown origin and as a non-invasive test to identify candidates for further invasive electrophysiology testing of the heart.

This diagnostic test is performed by placing highly sensitive electrodes on a patient's chest prior to a period of controlled exercise. The electrodes detect tiny beat-to-beat changes, on the order of one-millionth of a volt, in the ECG T-wave. These minute voltage changes are calculated by use of spectral analysis, which is a sensitive mathematical method of measuring and comparing time and the EKG signals. A Computer software program is then used to analyze the microvolt changes and produces a report that is interpreted by a physician.

POSITION STATEMENT:

T-wave alternans is considered experimental or investigational as a technique of risk stratification for prevention of fatal arrhythmias and sudden cardiac death in patients with a history of myocardial infarction, congestive heart failure, cardiomyopathy or other cardiac disorders such as long-QT syndrome (e.g., Brugada syndrome).

The scientific data for T-wave alternans is insufficient to permit conclusions on health outcomes or whether it is as beneficial as any established alternatives. Observational studies performed on ICD-eligible patients with negative MTWA tests show variation in mortality and arrhythmic event outcomes. It is uncertain what level of risk of events precludes benefit from ICD therapy. There are no clinical trials of ICD therapy in patients not currently eligible for ICD therapy who have been selected using MTWA testing.

BILLING/CODING INFORMATION:

CPT Coding:

93025

Microvolt T-wave alternans for assessment of ventricular arrhythmias (investigational)

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Microvolt T-Wave Alternans (MTWA) (20.30) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Microvolt T-wave Alternans (L5944) located at fcso.com.

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.

DEFINITIONS:

Arrhythmia: an alteration in rhythm of the heartbeat either in time or force.

Cardiomyopathy: any structural or functional disease of heart muscle that is marked especially by hypertrophy of cardiac muscle, by enlargement of the heart, by rigidity and loss of flexibility of the heart walls, or by narrowing of the ventricles but is not due to a congenital developmental defect, to coronary atherosclerosis, to valve dysfunction, or to hypertension.

Electrocardiogram (EKG, ECG): the tracing made by an electrocardiograph.

QRS complex: the series of deflections in an electrocardiogram that represent electrical activity generated by ventricular depolarization prior to contraction of the ventricles.

ST segment: the part of an electrocardiogram between the QRS complex and the T wave.

Syncope: loss of consciousness resulting from insufficient blood flow to the brain.

T wave: the deflection in an electrocardiogram that represents the electrical activity produced by ventricular re-polarization.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report T-wave alternans:

Cambridge Heart alternans Processing System
Electrical Alternans
Heartwave Alternans Processing System (APS)
Microvolt T-Wave Alternans

REFERENCES:

1. American College of Cardiology (ACC)/American Heart Association (AHA)/European Society of Cardiology (ESC) 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (09/05/06).

2. Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction), 2004.

3. Armoundas AA, Hohnloser SH, Ikeda T, Cohen RJ. Can microvolt T-wave alternans testing reduce unnecessary defibrillator implantation? Nat Clin Pract Cardiovasc Med. 2005 Oct; 2(10): 522-8.

4. Baravelli M, Salerno-Uriarte D, Guzzetti D, Rossi MC, Zoli L, Forzani T, Salerno-Uriarte JA. Predictive significance for sudden death of microvolt-level T wave alternans in New York Heart Association class II congestive heart failure patients: a prospective study. Int J Cardiol. 2005 Oct 20; 105(1): 53-7.

5. Bloomfeld DM, Steinman RC, Namerow PB et al. Microvolt T-wave alternans distinguishes between patients like likely and not likely to benefit from implanted cardiac defibrillator therapy: a solution to the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II conundrum. Circulation. 2004 Oct 5; 110(14): 1885-9.

6. Bloomfield DM, Bigger JT, Steinman RC, Namerow PB, Parides MK, Curtis AB, Kaufman ES, Davidenko JM, Shinn TS, Fontaine JM. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006 Jan 17; 47(2): 456-63.

7. Blue Cross and Blue Shield Association. Medical Policy Reference Manual. 2.02.13 T-Wave Alternans, (02/10/11).

8. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Microvolt T-Wave Alternans Testing to Risk Stratify Patients Being Considered for ICD Therapy for Primary Prevention of Sudden Death. TEC Assessments 2005. Volume 20, No. 9.

9. Blue Cross and Blue Shield Association. Technology Evaluation Center (TEC). Microvolt T-Wave Alternans Testing to Risk Stratify Patients Being Considered for ICD Therapy for Primary Prevention of Sudden Death. TEC Assessments 2006. Volume 23, No. 2.

10. Cantillon DJ, et al. Predictive value of microvolt T-wave alternans in patients with left ventricular dysfunction. J Am Coll Cardiol. 2007 Jul 10; 50(2): 166-73. Epub 2007 Jun 21.

11. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 1, Section 20.30 – Microvolt T-Wave Alternans (MTWA), (08/25/08).

12. Chan PS, Stein K, Chow T, Fendrick M, Bigger JT, Vijan S. Cost-effectiveness of a microvolt T-wave alternans screening strategy for implantable cardioverter-defibrillator placement in the MADIT-II-eligible population. J Am Coll Cardiol. 2006 Jul 4; 48(1): 112-21.

13. Chan PS, Brahmajii K, Nallamothu BK, et al. Impact of Age and Medical Comorbidity on the Effectiveness of Implantable Cardioverter-Defibrillators for Primary Prevention. Circ Cardiovasc Qual Outcomes. 2009;2:16-24.

14. Chow T, Kereiakes DJ, Bartone C, Booth T, Schloss EJ, Waller T, Chung ES, Menon S, Nallamothu BK, Chan PS. Prognostic utility of microvolt T-wave alternans in risk stratification of patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2006 May 2; 47(9): 1820-7.

15. Chow T, Kereiakes DJ, Bartone C, Booth T, Schloss EJ, Waller T, Chung E, Menon S, Nallamothu BK, Chan PS. Microvolt T-wave alternans identifies patients with ischemic cardiomyopathy who benefit from implantable cardioverter-defibrillator therapy. J Am Coll Cardiol. 2007 Jan 2; 49(1): 50-8.

16. ClinicalTrials.gov. T-Wave Alternans clinical trials. Accessed at website.

17. ECRI. Custom Hotline Response. T-Wave Alternans Measurement for Predicting Arrhythmias. Plymouth Meeting, PA: ECRI. 06/27/07.

18. Costantini O, Hohnloser SH, Kirk MM, Lerman BB, Baker JH 2nd, Sethuraman B, Dettmer MM, Rosenbaum DS; ABCD Trial Investigators. The ABCD (Alternans Before Cardioverter Defibrillator) Trial: strategies using T-wave alternans to improve efficiency of sudden cardiac death prevention. J Am Coll Cardiol. 2009 Feb 10;53(6):471-9.

19. Cutler MJ, Rosenbaum DS. Risk stratification for sudden cardiac death: is there a clinical role for T wave alternans? Heart Rhythm. 2009 Aug;6(8 Suppl):S56-61. Epub 2009 Jun 23.

20. De Ferrari GM, Sanzo A. T-wave alternans in risk stratification of patients with nonischemic dilated cardiomyopathy: Can it help to better select candidates for ICD implantation? Heart Rhythm, Vol 6, No 3S (Heart Rhythm 2009;6:S29.

21. First Coast Service Options. Local Coverage Determination Coding Article (02/02/09).

22. First Coast Service Options. Local Coverage Determination. L5944 93025 Microvolt T-wave Alternans, (02/02/09).

23. Fuchs T, Torjman A. The usefulness of microvolt T-wave alternans in the risk stratification of patients with hypertrophic cardiomyopathy. Isr Med Assoc J. 2009 Oct;11(10):606-10.

24. Gehi AK, Stein RH, Metz LD, Gomes JA. Microvolt T-wave alternans for the risk stratification of ventricular tachyarrhythmic events: a meta-analysis. J Am Coll Cardiol. 2005 Jul 5; 46(1): 75-82.

25. Gold MR, et al. Role of microvolt T-wave alternans in assessment of arrhythmia vulnerability among patients with heart failure and systolic dysfunction: primary results from the T-wave alternans sudden cardiac death in heart failure trial substudy. Circulation. 2008 Nov 11; 118(20): 2022-8. Epub 2008 Oct 27.

26. Hayes, Inc. HAYES Medical Technology Directory. “Microvolt T-Wave Alternans to Identify Risk of Ventricular Arrhythmias and Sudden Cardiac Death”. Lansdale, PA: Hayes, Inc.; March 2004. Update performed, 05/13/06.

27. Hohnloser SH, Ikeda T, Cohen RJ. Evidence regarding clinical use of microvolt T-wave alternans. Heart Rhythm. 2009 Mar;6(3 Suppl):S36-44. Epub 2008 Oct 11.

28. Ikeda T, Yoshino H, Sugi K, Tanno K, Shimizu H, Watanabe J, Kasamaki Y, Yoshida A, Kato T. Predictive value of microvolt T-wave alternans for sudden cardiac death in patients with preserved cardiac function after acute myocardial infarction: results of a collaborative cohort study. J Am Coll Cardiol. 2006 Dec 5; 48(11): 2268-74. Epub 2006 Nov 9.

29. Jorge A. Salerno-Uriarte, MD, Gaetano M. De Ferrari, MD, et al. Prognostic Value of T-Wave Alternans in Patients With Heart Failure Due to Nonischemic Cardiomyopathy. Results of the ALPHA Study. J Am Coll Cardiol 2007;50:1896–904.Merriam Webster Medical Dictionary, web edition 2002.

30. Narayan SM, Smith JM, Lindsay BD, Cain ME, Davila-Roman VG. Relation of T-wave alternans to regional left ventricular dysfunction and eccentric hypertrophy secondary to coronary heart disease. Am J Cardiol. 2006 Mar 15; 97(6): 775-80.

31. Narayan SM. T-wave alternans and the susceptibility to ventricular arrhythmias. J Am Coll Cardiol. 2006 Jan 17; 47(2): 269-81.

32. Nieminen T, Verrier RL. Usefulness of T-wave alternans in sudden death risk stratification and guiding medical therapy. Ann Noninvasive Electrocardiol. 2010 Jul;15(3):276-88.

33. Parade U, Klingel K, Kandolf R, Gawaz M, Schreieck J. [Risk stratification in non ischemic cardiomyopathy: a case report--Case 5/2010]. Dtsch Med Wochenschr. 2010 Jun;135(22):1122. Epub 2010 May 31.Salerno-Uriarte JA, De Ferrari GM, Klersy C, Pedretti RF, Tritto M, Sallusti L, Libero L, Pettinati G, Molon G, Curnis A, Occhetta E, Morandi F, Ferrero P, Accardi F; ALPHA Study Group Investigators. Prognostic value of T-wave alternans in patients with heart failure due to nonischemic cardiomyopathy: results of the ALPHA Study. J Am Coll Cardiol. 2007 Nov 6; 50 (19): 1896-904. Epub 2007 Oct 22.

34. U.S. Food and Drug Administration (FDA) 510(k) Summary #K001034-Cambridge Heart, Inc; Heartwave Alternans Processing System (APS), 01/01.

35. van der Avoort CJ, Filion KB, Dendukuri N, Brophy JM. Microvolt T-wave alternans as a predictor of mortality and severe arrhythmias in patients with left-ventricular dysfunction: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2009 Jan 28;9:5.

36. Verrier RL, Kumar K, Nearing BD. Basis for sudden cardiac death prediction by T-wave alternans from an integrative physiology perspective. Heart Rhythm. 2009 Mar;6(3):416-22. Epub 2008 Nov 27.

37. Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). J Am Coll Cardiol. 2006 Sep 5; 48(5): e247-346.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 06/23/11.

GUIDELINE UPDATE INFORMATION:

09/15/02

New Medical Coverage Guideline.

09/15/03

Annual review; definitions added, description updated – investigational.

09/15/04

Review and revision of guideline; consisting of updated reference and maintain investigational status.

09/15/05

Review and revision of guideline consisting of updated references.

05/15/06

Review and revision of guideline consisting of updated references.

06/15/07

Review and revision of guideline consisting of updated references.

07/15/08

Review and revision of guideline consisting of updated references.

07/15/09

Scheduled review; no change in position statement; updated references.

07/15/11

Annual review; position statement unchanged; references updated.

05/15/14

Revision; Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 23, 2017: 06:24 PM