National Coverage Analysis (NCA) View Public Comments

Microvolt T-wave Alternans

Public Comments

Commenter Comment Information
Nearing, Bruce Title: Assistant Professor of Medicine, Harvard Med Schl
Organization: Beth Israel Deaconess Medical Center
Date: 03/15/2008
Comment:

I am writing to comment on CMS’s proposed decision to exclude the Modified Moving Average (MMA) method from coverage. My training and experience are in signal processing. In collaboration with Dr. Verrier, I developed an early spectral technique to measure T-wave alternans, and we published our study in Science in 1991 (1). We selected the spectral method of “complex demodulation” approach over the spectral Fast Fourier Transform (FFT) method because it is inherently more dynamic and

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Dove, M.D., F.A.C.C., James T. Title: President
Organization: American College of Cardiology
Date: 03/14/2008
Comment:

March 15, 2008

Steve E. Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, MD 21244-1850
Re: Proposed Decision Memo for Microvolt T-wave Alternans (CAG-00293R).

Dear Dr. Phurrough:

The American College of Cardiology (ACC; the College) appreciates the opportunity to comment on the Centers for

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Ancona MD FACC, David Title: Cardiologist, Chief of Staff
Organization: Memorial Hospital West
Date: 03/14/2008
Comment:

I would like to speak to the comparative value of the MMA and spectral methods for TWA measurement from the perspective of a cardiologist in an active private practice in Florida. I have used the MMA method during routine exercise stress testing for several years. Although I do not have direct experience with the spectral method, what I gather from my colleagues is that they do not find it as useful as I find the MMA. If the MMA is markedly positive, I have elected to treat with

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Exner, Derek Title: Associate Professor, Medicine
Organization: Libin Cardiovacular Institute of Alberta
Date: 03/14/2008
Comment:

I am writing related to the recent CMS decision onreimbursement for repolarization alternanstesting. Thank you for the opportunity to comment.As a clinician and researcher who has used andstudied both the spectral method and the modifiedmoving average (MMA) method I feel that I canprovide useful insight to assist in your decisionmaking. I am also the Principal Investigator forthe Risk Evaluation Following Infraction,Noninvasive Evaluate or REFINE study, a trial thatcompared a variety of

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Albrecht, Paul Date: 03/14/2008
Comment:

Having spent many years working with the mathematical methods of T-wave alternans analysis, I’d like to make the following point: The MMA and Spectral Analytic Method are substantively different, and should not be confused as equivalent methodologies. A key difference between the two methodologies is the measurement of the statistical significance of the alternans. The spectral method has a built-in measure to assess the significance of the measured alternans. This makes the spectral

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HASSINE, BRIAN Date: 03/14/2008
Comment:

I share my comments not through a doctorate nor degree. I am an investor in mtwa technology and have studied every aspect of the science behind it, its potential market, and most importantly, "market acceptance". All have relevance in the discussion ,you have asked for, here in this forum, and my knowledge on this subject grants me a voice on behalf of the 400,000 victims of SCD this year..I maintain cms is the only Pure Patient Advocate, who''s decisions , while Not affecting practice

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Honigberg, Robert Title: Chief Medical Officer
Organization: Global Medical Affairs & Clinical Strategy, GE Healthcare
Date: 03/14/2008
Comment:

GE Healthcare appreciates the opportunity to provide public comment on the CMS proposed decision for MTWA involving the modified moving average (MMA) method. Our letter outlines a number of issues that we urge CMS to consider with respect to the proposed decision. These include the following:

1) Lack of discussion of two key publications by Exner and Schusterman in the CMS memorandum;
2) Clarification of MTWA MMA technology attributes; and
3) Responses to CMS reservations

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Josephson, Mark Title: Herman Dana Professor of Medicine, Harvard Medical
Organization: Harvard School of Medicine, Beth Israel Deaconess Medical Center
Date: 03/14/2008
Comment:

This letter is to express my opinion regarding CMS’s proposed decision memorandum that declines to reimburse physicians when they use the Modified Moving Average (MMA) method for T-wave alternans analysis to assess their patients’ risk for sudden cardiac death. The major emphasis of my clinical work has been the problem of sudden cardiac death and the use of ICDs for prevention of life-threatening arrhythmias.

At the outset, I would like to express my concern that in the present

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Bocchino, Carmella Title: Executive Vice President, Clinical Affairs and Str
Organization: America’s Health Insurance Plans (AHIP)
Date: 03/13/2008
Comment:

March 14, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage decision (NCD), Microvolt T-wave Alternans (CAG-00293R). America's Health Insurance Plans (AHIP)

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Haghighi-Mood, Ali Title: Chief Executive Officer
Organization: Cambridge Heart, Inc.
Date: 03/13/2008
Comment:

Dear Dr. Phurrough,

Cambridge Heart appreciates the opportunity to comment on the proposed decision memorandum for Microvolt T Wave Alternans (MTWA) diagnostic testing. We support the proposal to continue coverage of MTWA for patients at risk of sudden cardiac death, only when the spectral analytic method is used.

Since the original request to consider inclusion of the modified moving average (MMA) method in August 2007, two publications on MMA-TWA have emerged which

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Swiryn, Steven Title: Professor of Medicine
Organization: Northwestern University
Date: 03/13/2008
Comment:

The following comments are offered in response to your Proposed Decision Memo for Microvolt T-wave Alternans (CAG-00293R). I am a Professor of Medicine at Northwestern University Medical School and also Adjunct Professor in the Department of Electrical Engineering and Computer Science. I have practiced clinical cardiac electrophysiology since finishing my fellowship in that field in 1979 and am Board of Internal Medicine certified in that field as well as Cardiology and Internal

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Nieminen, Tuomo Date: 03/13/2008
Comment:

I am writing in response to the proposed decision memo by the Centers for Medicare and Medicaid Services regarding the use of the Modified Moving Average method for T-wave alternans to assist in risk stratification for life-threatening arrhythmias. We have extensive experience with this analytical approach and employed it in our prospective analysis of more than 1000 patients, making it one of the largest investigations of TWA. As the memo indicates, our study was published in a leading

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Huikuri, Heikki Title: Professor of Medicine
Organization: Institute of Clinical Medicine. Centre of Excellence in Research
Date: 03/13/2008
Comment:

Our research group has been working both with the spectral and MMA method in the analysis of TWA. A methodological problem of spectral method has been that many of the patients with heart disease (post-AMI) are not able to reach a target heart rate (>90-105 bpm)needed for analysis of TWA. So far, our two studies (Tapanainen et al, published in the Journal of Cardiovascular Electrophysiology, and Huikuri et al, CARISMA study presented in thge Late-Breaking Trial Sessions of HRS in Denver

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Rowlandson, Ian Title: Chief Engineer, Diagnostic Cardiology
Organization: GE Healthcare - Clinical Systems
Date: 03/12/2008
Comment:

Below is a letter that was sent by GE Healthcare to CMS on 21 September 07. It is with regards to comments made by Professor Cohen on 16 Sep 07, the last day of the first comment period.

This letter is in response to the public comments regarding the National Coverage Analysis for Microvolt T-Wave Alternans (CAG-00293R). After reviewing the comments, we feel there are a number of comments the require clarification. We appreciate the opportunity to respond to these public

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Passman, Rod Date: 03/12/2008
Comment:

It is with great interest that I read the CMS decision on MMA TWA. The broad exclusion by the reviewers of studies not involving ICD-eligible patients appears arbitrary and ignores the well recognized fact that the majority of sudden deaths occur in post-MI patients with EF > 35%. Such a decision is also inconsistent with the CMS coverage decision on spectral TWA, which states that “Microvolt T-wave Alternans diagnostic testing is covered for the evaluation of patients at risk for

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Verrier, Richard Title: Associate Professor of Medicine
Organization: Harvard Medical School
Date: 03/12/2008
Comment:

I am writing to comment on the proposed CMS decision memo regarding coverage for T-wave alternans (TWA) testing using the Modified Moving Average (MMA) method. As a co-inventor together with Dr. Bruce Nearing (1), I would like to address misconceptions about the clinical literature as well as the technology.

First, it has been stated that there are no prospective clinical studies supporting MMA-based TWA analysis for sudden death risk stratification. In fact, three prospective

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mirro, michael Title: Medical Director: Parkview Clinical Research
Organization: Parkview Health Systems
Date: 03/09/2008
Comment:

I am a Cardiac Electrophysiologist in a privatepractice setting(single specialty group)and wouldlike to comment on CAR-00293R. I am the MedicalDirector of a Clinical Research center and haveused MTWA for the past 8 years both in clinicaltrial work as well as routine practice.

I would like to support the CMS decision not torevise the MTWA NCD.

The initial decision to provide MTWA coverage wasbased on review of over 10 years of scientificstudies on MTWA by the Spectral AnalyticMethod.The

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Chow, Theodore Date: 03/07/2008
Comment:

To whom it may concern,

I am writing this letter in response to the CMS request for public opinion and comment on the memo with respect to coverage for microvolt T-wave alternans testing (MTWA) using the spectral method. In that memo CMS asked for comment on more recent data, specifically citing the MASTER Trial. As you know, the MASTER Trial was a prospective multi-center study of MADIT-II indicated patients, all of whom underwent ICD implantation following MTWA testing. This

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Martinez, Juan Pablo Organization: Spain
Date: 03/07/2008
Comment:

I am a researcher in signal processing applied to ECG signal. Having worked in TWA detection and estimation, I would like to contribute to this discussion, highlighting some aspects of the proposed decision memo PDM from a signal processing point of view.

First, I found some misconception of the term "stationarity" on the PDM.

For instance, in the sentences "The spectral analytical method requires the patient to be stationary when obtaining the data, thus, this data cannot be

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Shusterman, Vladimir Date: 03/06/2008
Comment:

There seems to be some confusion in the comparison of the spectral and time-domain methods for the analysis of T-wave alternans. In particular, it is well known (Parseval''s theorem) that the spectral and time-domain representations (of a square or a power of a Riemann-integrable function) are identical. Thus, the spectral and time-domain methods, in theory, should provide identical results. However, in a real-life setting, the results are not identical, due to the presence of multiple

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Stein, Phyllis Title: Research Associate Professor of Medicine and Dire
Organization: Washington University School of Medicine
Date: 03/06/2008
Comment:

I would like to register my opinion regarding theproposed CMS decision not to cover the ModifiedMoving Average (MMA) method for TWA detection andmeasurement while continuing to cover theCambridge Heart Exercise-based spectral one. AsDirector of the Washington University School ofMedicine HRV Laboratory, I have been working inthe field of noninvasive arrhythmia riskstratification from ambulatory ECGs (AECGs) foralmost two decades. I have closely followed thedevelopment of the MMA method

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Hammill, Stephen Title: Professor of Medicine
Organization: Mayo Clinic
Date: 03/05/2008
Comment:

I am disappointed that CMS is not extending coverage of microvolt T-wave alternans (MTWA) to include the modified moving average (MMA)method. I am surprised that CMS did not use the REFINE study as part of their coverage determination (Exner et al. Noninvasive Risk Assessment Early after Myocardial Infarction. Journal of the American College of Cardiology 2007;50:2276). This study assessed MTWA in 322 high risk patients with reduced ejection fraction following myocardial infarction who

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Stone, M.D., Peter Title: Co-Director, Samuel A. Levine Cardiac Unit
Organization: Brigham & Women''s Hospital, Harvard Medical School
Date: 03/03/2008
Comment:

My area of expertise is assessment of cardiovascular risk in patients with ischemic heart disease. Ambulatory ECG and exercise stress testing are essential noninvasive tools for evaluating major characteristics of risk, including both functional ischemia and susceptibility to life-threatening arrhythmias.

Over recent years, I have been particularly impressed by the growing evidence suggesting that tracking repolarization abnormalities with T-wave alternans can add significantly to risk

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Schmidt, Georg Organization: Technische Universität München
Date: 02/29/2008
Comment:

I am writing to register my comments regarding thepreliminary decision memo for T-wave alternans(TWA) testing with the Modified Moving Average(MMA) method. I am Director of the Non-invasiveElectrophysiology Unit at 1. Medizinische Klinikand Poliklinik, Technische Universität München. My interest in sudden death risk stratificationwith noninvasive methodologies spans more than twodecades.

1. Left ventricular ejection fraction, which hasbeen regarded as the gold standard in guiding

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Cohen, Richard Title: Whitaker Professor
Organization: Harvard-MIT Division of Health Sciences and Technology
Date: 02/28/2008
Comment:

I am submitting this comment on the proposed decision memo for Microvolt T-Wave Alternans (CAG-00293R). I concur with the proposed decision to continue National Coverage for Microvolt T-Wave Alternans (MTWA) for the evaluation of patients at risk for sudden cardiac death (SCD) only when the spectral analytic method is used and non-coverage when MTWA is measured by any other method. In particular, I agree with CMS's assessment that evidence is lacking to support demonstration of

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Olgin, Jeffrey Date: 02/27/2008
Comment:

This seems like a very biased read of the literature, especially when comparing the comments to that of the previous decision limiting the technique to the spectral analysis. For example, when discussing the Finish study, the critique that the study population is different than the CMS population wasn''t levied against a German study cited in support of the first CMS decision.

Most importantly, a study that appeared in JACC (Exner et al. Noninvasive risk assessment early after a

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