National Coverage Analysis (NCA) View Public Comments

Microvolt T-wave Alternans

Public Comments

Commenter Comment Information
Sodowick, MD, Bradford Title: Director of Electrophysiology
Organization: The Arrhythmia Institute
Date: 01/21/2006
Comment:

Generally, CMS is to be commended for its proposal to provide national coverage for reimbursement of Microvolt T-wave Alternans (MTWA). However, restricting coverage of MTWA testing to the spectral analytic method (thus limiting coverage to a single company’s product) is short-sited and does not allow coverage of other MTW systems that the FDA may approve for clinical use in the future.

As you are aware, MTWA is simply a natural phenomenon of the heart that can be used by

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Zappacio, Rick Date: 01/21/2006
Comment:

I feel this has incredible potential at reducing the risk for those patients with cardiac disease and it should be on the list for covered expenses by medicare.

Grudman, M.D., Mark Date: 01/20/2006
Comment:

MTWA tsting appears to be a new modality present to help risk stratify our patients appropriately.

Marangoni, Daniele Title: M.S. Editor
Organization: www.alternans.org
Date: 01/20/2006
Comment:

I am the editor of the European Web page on MicroVolt T Wave Alternans www.alternans.org

I am also author and co-author of several clinical papers on MTWA on PACE (1), Annals of Noninvasive Electrocardiology (2), Italian Heart Journal (3)and Italian Electrophysiology Journal (4).

This webpage is the reference for European cardiologists using MTWA alternans systems ( visited by 11.350 visitors in the last 5 years).

I am receiving several comments and requests of help

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chengot, mathew Title: physician
Organization: amityville heart center
Date: 01/20/2006
Comment:

this technology helps patients tremendously and shold be availabe for all patients prior to aicd therappy.thie will select patients who will benefit high risk patients appropriate care and avoid unnecessay device placements. mathew chengot.

Mahmood, Syed Title: M.D.
Date: 01/20/2006
Comment:

I applaud CMS for proposing national coverage for Microvolt T-wave Alternans using the Spectral Analytic Method. By utilizing this non-invasive, risk stratifying test; I have one more data point to decide if my high-risk patients will benefit from ICD therapy.

Brahmbhatt, M.D., Bimalkumar Date: 01/20/2006
Comment:

MTWA testing is a modality by which all patients whom are at risk for SCD may be stratified and subsequently treated appropriately. This technology is essential.

Cohen, M.D., Ph.D., Richard Title: Whitaker Professor
Organization: Harvard-MIT Division of Health Sciences & Technology
Date: 01/20/2006
Comment:

I write in strong support of the CMS proposed decision to provide national coverage for the use of microvolt T-wave alternans (MTWA) testing to evaluate patients at risk of sudden cardiac death. As detailed in the CMS review, this technology has been demonstrated to be an effective means of identifying patients at lost and high risk of sustained ventricular tachyarrhythmia. This decision will have a significant impact on improving the quality of the care of Medicare

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Colasacco, M.D., James Date: 01/20/2006
Comment:

I firmly believe that MTWA testing should be a standard screening diagnostic test for any patient whom is at risk for SCD. EP and MTWA may co exist and compliment one another. National Coverage is essential so that this technology may be available to all whom would benefit from it.

Costantini, Ottorino Title: Director, Arrhythmia Prevention Center
Organization: Case Western Reserve University
Date: 01/20/2006
Comment:

I am an electrophysiologist, and the director of the Arrhythmia Prevention Center at the MetroHealth Campus of Case Western Reserve University.

I wish to congratulate CMS for the proposed coverage decision acknowledging the importance of further risk stratification for patients at risk for SCD.

The SCD HeFT and MADIT II study, as important as they are, have put physicians in the uncomfortable position of recommending an expensive therapy (ICD) knowing full well that only a

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Eadie MD, Reginald Date: 01/20/2006
Comment:

This sounds innovative and promising. I am very impressed.

Fletcher, M.D., Ross Title: Chief of Staff
Organization: VAMC Washington DC
Date: 01/20/2006
Comment:

I am writing to register my opinion that T-wave alternans (TWA) could be useful in identifying patients in sudden death and thereby may prove helpful in guiding ICD implantation in Medicare and Medicaid patients.Clearly, too many devices are being implanted unnecessarily, and there is great need to rectify this costly state-of-affairs appropriately.

However, I disagree with the proposal to use the spectral method exclusively.I was concerned that a peer-reviewed study conducted in

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Melnick, Amy Title: Vice President, Health Policy
Organization: Heart Rhythm Society
Date: 01/20/2006
Comment:

The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. The Heart Rhythm Society’s mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards. The Heart Rhythm Society’s 3,800 members are physicians, scientists and their support personnel who implant and/or follow

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Sanaullah, Shezad Date: 01/20/2006
Comment:

I wanted to comment on how valuable this mode of testing has been for my practice. I am a cardiologist in a rural area and nearly a 100 miles from the next “big” medical center. I see a large number of patients that are older and don’t either have the capacity or the means to go a 100 miles unless it is absolutely necessary. T wave alternans allows me to risk stratify those patients who are at high risk and therefore must be further studied and need to be convinced to make

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Shalaby, Alaa Title: Director, Cardiac Electrophysiology
Organization: Pittsburgh Veterans Affairs Healthcare System
Date: 01/20/2006
Comment:

The microvolt TWA measurement by spectral analysis method as afforded by Cambridge Heart instruments has now withstood the test of time. Different trials involving at risk populations of both ischemic and nonischemic cardiomyopathy have elucidated a good discriminatory power for the test in terms of risk stratification for sudden death. The test is easy to use, with an easy learning curve for application and interpretation and is thus widely applicable. The discriminatory value supercedes

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Teich, Kris Title: Director, Health Economics and Reimbursement
Organization: Guidant Corporation
Date: 01/20/2006
Comment:

Guidant Corporation welcomes the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) national coverage analysis regarding Microvolt T-wave Alternans, CAG – 00293N.

Headquartered in Indianapolis, Indiana, with manufacturing and/or research and development facilities in the states of Minnesota, California and Washington, as well as in Puerto Rico and Ireland, Guidant Corporation is a leading designer and manufacturer of medical technologies

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Thompson, MS., MA, Bob Title: Director, Reimbursement, Economics and Health Poli
Organization: Medtronic, CRM
Date: 01/20/2006
Comment:

Medtronic, Inc. is the world’s leading medical technology company specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to research and development necessary to produce high quality products and to support innovative therapies that improve patients' lives. We appreciate the opportunity to comment on the Proposed National Coverage Determination (NCD) for Microvolt T-wave Alternans (MTWA).

Medtronic

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Walker, Susan Title: Director, Reimbursement
Organization: St. Jude Medical, Inc.
Date: 01/20/2006
Comment:

St. Jude Medical, Inc., a developer, manufacturer, and a distributor of innovative medical devices including implantable cardioverter defibrillators (ICDs), appreciates the opportunity to comment on the proposed National Coverage Decision Determination (NCD) for the use of Microvolt T-wave Alternans (MTWA).

The literature has identified MTWA as a promising predictor of ventricular arrhythmias and sudden cardiac death (SCD), and as such, a potential risk stratification tool for

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Strobel, John Title: Cardiac Electrophysiologist
Organization: IMA, Inc.
Date: 01/19/2006
Comment:

I feel strongly that the use of T wave alternans testing can help determine which patients who are candidates for ICD implantation are at greatest risk for sudden cardiac death. Because it has a very good negative predictive value, a negative test provides reassurance to both the patient and physician that ICD implantation is unlikely to provide additional mortality benefit. Thus, it saves the patient the risk and expense of an invasive procedure and the associated long-term complications.

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Armoundas, Antonis Title: Instructor in Medicine
Organization: Harvard Medical School
Date: 01/19/2006
Comment:

I am writing to support the CMS's draft decision to provide national coverage for microvolt T-wave alternans (MTWA) testing.

I have been the author of many papers that involve the use of MTWA in risk-stratifying patients susceptible to ventricular tachycardia and sudden cardiac death, including two major review articles (references 6 and 8 below):

1. Esperer HD, Armoundas AA, Rosenbaum DS, HU Klein, Cohen RJ. Specificity of T-wave alternans in individuals without organic

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Piscopiello, M.D., Michael Date: 01/19/2006
Comment:

I have been part of a practice that has incorporated MTWA testing for their arrythmic patients and have seen first hand the huge benefit of this brilliant diagnistic test. I am strongly in favor of national coverage to ensure that all patients whom are at risk for SCD may be tested. I feel as though MTWA testing should be a standard screening diagnostic test for all patients whom are being considered for EP referral.

Senft, M.D., Adolf Title: Clinical Cardiologist
Date: 01/19/2006
Comment:

I have been using MTWA testing in my practice for the last 2 years and have single handedly seen the unparalleled benefit of this diagnostic test. It's negative and positive predicted values are staggering and should not be ignored any longer! National coverage should be available so that all at risk for SCD may be tested.

Hutchinson, Leigh Ann Title: Cardiologist/Electrophysiologist
Organization: Long Island Arrhythmia Associates
Date: 01/19/2006
Comment:

I am in favor for the new policy. It will better help me treat my patients.

Lofaro, Marc Title: President
Organization: MasterLogic Research
Date: 01/19/2006
Comment:

I believe this National proposal has been long over due. The validity of the T-Wave Alternans through years of rigerous testing by the company has been proven.

This national coverage proposal is clearly beneficial for all individuals and for C.M.S. as well.

An expedited approval, simply makes sense to the health and pockets of all Americans.

Stein, Kenneth Title: Associate Professor of Medicine
Organization: Weill Medical College of Cornell University
Date: 01/19/2006
Comment:

I am writing to strongly support the proposed NCD regarding MTWA testing for patients at risk for sudden cardiac death.

I am Associate Director of Cardiac Electrophysiology at the Weill Medical College of Cornell University and have extensive clinical and research experience with TWA testing. I agree wholeheartedly with the evidence-based conclusions that: 1)"MTWA is a useful risk stratification tool" and that there is strong evidence suggesting that patients with normal MWTA

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Urrutia M.D, Ellen Title: cardiologist
Date: 01/18/2006
Comment:

MTWA testing has been an intergral component in our practice. I am extremely impressed with it's unmatched predictive value. MTWA testing should be made available to all patient's whom may benefit from it, not just those fortunate enough to have a participating insurance provider. National coverage is essential!

Alfonso, M.D., Carlos Title: Cardiologist
Date: 01/18/2006
Comment:

MTWA testing is essential and vital to help stratify patient's whom are at risk for SCD. I am a strong advocate for the national coverage of this diagnostic test. I have seen first hand in my practice the benefit of this technology. National Coverage is the only logical decision.

Stoupakis M.D., George Date: 01/18/2006
Comment:

My practice has been doing MTWA testing for 2 years and I am extremely pleased with the sensitivity of this diagnostic test. I am an interventional cardiologist and my practice does nuclear stress testing in our imaging center and soon will be doing CT angiography. We consider ourselves to be very progressive and have icorporated MTWA testing into our pactice. I am a strong advocate for this essential diagnostic test and feel that it should be covered nationally so more people can benefit

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De Gregorio, M.D., Bart Organization: Bart De Gregorio , M.D. LLC
Date: 01/18/2006
Comment:

My name is Bart De Gregorio we have been doing MTWA testing for approximately 2 years. It has become an important part of our arrythmia work up and inturn has helped many patients. I firmly believe that a great number of patients are still walking around because of the effectiveness of this modality. I strongly support national coverage for this vital diagnostic test so that it's benefit can be extended to a larger segment of our population

Mariano, Domenic Title: Cardiologist
Date: 01/18/2006
Comment:

While we purchased our T wave alternans unit two years ago, it has only been in the last 6 months that we really have seen the benefit of T wave evaluation! We had at least one patients who was given an ICD after positive T wave evaluation - whose device went off only several weeks after implantation! At least one life saved!

-Domenic Mariano

Giles, Robert Title: Emergency Physician
Date: 01/18/2006
Comment:

I am very excited about the availabilty of Microvolt T wave alternans testing. This is a great tool to protect our patients from sudden cardiac death. Also, we could direct our attention to higher risk patients. R Giles, MD

Prystowsky, M.D.,, Eric Title: Director, Electrophysiology Laboratory
Organization: St. Vincent Hospital, Indianapolis, Indiana
Date: 01/18/2006
Comment:

The data on MVTW alternans have been building for years, and at present the test seems very reasonable to use for risk-stratification. Its false-negative rate is very low, and I can imagine situations where a negative test could be useful. For example, in an ICD recall situation, a negative MVTW alternans test would suggest that a borderline patient would be a reasonable candidate for observation in lieu of device replacement. I do not think the data are sufficient to use the test to

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Hoseth, Brett Date: 01/18/2006
Comment:

Great Lakes Heart and Vascular Institute in St. Joseph Michigan has been utilizing the Microvolt T wave Alternans test for approximately 2 years now. We initially started using the test for a Medtronic sponsered Masters Study. We have found this test useful for several situations. One situation that has occured is using the test to help convince skeptical patients about their high risk for sudden death when the patient already meets Madit II criteria. We also use it in patients that

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Nearing, Bruce Date: 01/18/2006
Comment:

As an engineer, software designer, and inventor, I am pleased that CMS is proposing to approve national coverage for T-wave Alternans (TWA) as a parameter for evaluating risk for sudden cardiac death. However, I think that it is not appropriate to exclude the use of the Modified Moving Average method and to restrict coverage only to the spectral analytic method.

This view is based on considerable evidence regarding signal processing principles, and basic and clinical scientific

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Chow, Theodore Title: EP Research Director
Organization: Lindner Center; Ohio Heart & Vascular Center
Date: 01/17/2006
Comment:

I support the decision to extend coverage for MTWA testing in all MADIT II/SCD-HeFT eligible patients. The excellent negative predictive value in this patient population provides an effective method for identifying patients at low risk who may not require ICD implantation, and a rational approach for containing health care costs. Moreover, recent data suggests that prophylactic ICD implantation in MTWA negative MADIT-II type patients may not be clinically effective, and certainly not cost

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ALI, SHAIK Title: CARDIOLOGIST
Date: 01/17/2006
Comment:

MTWA IS AN EXCELLENT TOOL TO PREDICT FUTURE CARDIAC EVENTS. IN ADDITION, IT IS ALSO AN EXCELLENT SCREENING TOOL FOR CARDIAC ARRHYTHMIAS SO THAT WE CAN PREVENT UNNECCESSARY EPS.

Benditt MD FACC FRCPC FHRS, David G Title: Professor of Medicine, Co-Director Cardiac Arrhyth
Organization: University of Minnesota
Date: 01/17/2006
Comment:

This comment is provided in response to the request for public comment regarding the pending decision to approve Microvolt T-wave Alternans testing (MTWA) as a useful technique for sudden death risk (SCD) stratification. My opinions are based on approximately 25 years of clinical experience caring for patients believed to be at high risk of SCD employing various 'risk stratification' strategies, and more recently as a principal investigator and participant of a multicenter trial

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Agyekum, Linda Title: MD
Organization: Advanced Cardiology Centre
Date: 01/17/2006
Comment:

I do believe that there is sufficient evidence to employ MTWA testing for evaluation of Medicare beneficiaries at risk of sudden death. I work in a Cardiology Practice and am very aware of the fact that cardiovascular disease, in particular CAD, is the Number 1. cause of death here in the U.S.A. Any method of pre-determining those at risk of SCD would be welcome. Thank you.

green, jeffrey Title: Physician
Organization: The Heart Physicians
Date: 01/16/2006
Comment:

I hope that MTWA is going to be an integral part of the decision making process in my practice over the foreseeable future. It is noninvasive and easy to perform. I am impressed by the negative predictive value that will allow me to better risk stratify both ischemic and nonischemics. Furthermore, I practice in a sophisticated community, and especially in patients who meet MADIT 2 or ScDHeFT criteria but have not had an arrhythmic event, an abnormal study will allow me to provide the

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Chauhan, Vinod Date: 01/16/2006
Comment:

MTWA is a very helpful tool in risk stratification for SCD. It also helps asymptomatic patient in making decision for ICD implant. Very helpful in situation where EP studdies are not reliable.

Jamnadas, Pradip Organization: Cardiovascular Interventions
Date: 01/16/2006
Comment:

Not every patient with poor Left Ventricular Function requires an implantable cardioversion device (ICD), and the Microvolt T-Wave Alternans (MTWA) aids in identifying those patients that are high risk. Recent trials have shown that only 20% of all ICD firings are appropriate. There is no doubt that MTWA would increase the percentage of appropriate ICD firings by creating a more accurate patient selection, thus saving lives in a more cost effective manner.

The negative predictive

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Sheinberg. MD. FACC, Jonathan Title: Cardiologist
Organization: Texas Cardiovascular
Date: 01/15/2006
Comment:

I applaud CMS for their consideration regarding the potential re-imbursement for Microvolt T-wave alternans. I believe the data reported are excellent and by utilizing this technology we can reduce the risk of SCD, and actually save our health care resources as we look to better identify those patients who are high risk.

I agree with many of my colleagues, when I point out that I am very troubled regarding some of the language in the proposed decision memo. By restricting

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Exner, Derek Organization: Libin Cardiovascular Institute of Alberta
Date: 01/15/2006
Comment:

I am a Canadian clinical electrophysiologist with a research interest in device therapy for patients at risk of sudden death. It is clear that the identification of patients at risk for sudden death via noninvasive methods is necessary in order to better identify those who might benefit from a prophylactic implantable defibrillator. Although the decision of CMS will not directly affect my practice, it will profoundly impact the lives of tens of thousands of patients in the United States. I

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niazi, imran Title: Director, Clinical Research,
Organization: Arrhythmia Center S. Wisconsin
Date: 01/13/2006
Comment:

We believe that T wave alternans analysis is a valuable clinical tool and should be compensated by CMS. Although initial studies are promising, the clinical utility of this test remains to be confirmed in large randomized trials in patients with severely depressed LVEF. In this patient population numerous large randomized trials have proven the efficacy of the implantable defibrillator, and more evidence is needed before this treatment modality is abandoned for a subset of this

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Verrier, Richard Title: Associate Professor of Medicine
Organization: Harvard Medical School, Beth Israel Deaconess Medical Center
Date: 01/13/2006
Comment:

This comment is intended to convey my support for CMS’s decision to recommend coverage for TWA testing for sudden death risk stratification. I am writing to provide peer-reviewed evidence of the accuracy and clinical value of Modified Moving Average method of TWA analysis in order to address a gap cited on page 14 of the proposed decision memorandum. Given the information below, it would be inappropriate to exclude coverage for the Modified Moving Average approach for TWA analysis.

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Lauer, Michael Title: Professor of Medicine, Epidemiology, Biostatistics
Organization: Cleveland Clinic and Case Western Reserve University
Date: 01/13/2006
Comment:

My understanding is that other methods of measuring TWA exist that do not require expensive electrodes. The cost implications are substantial.

The literature supporting T-wave alternans to date are based on small studies of biased samples (e.g. mainly patients referred for EPS studies). No published RCTs have shown that TWA improve outcome.

Pending the results of very large observational studies based on less biased samples and properly performed RCTs, TWA, in my

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Machado, M.D., Christian Date: 01/12/2006
Comment:

I am a Electrophysiologist inmetro DetroitI implant more than 250 ICD's per year and though I have a obvious monetary insentive to expansion of ICD implant coverage , In my opinion is is wasteful to apply ScHeft criteria to all patients we see in our daily practice so I welcome the strong scientific evidence avilable to us that strongly suggest TWA testing as a inexpensive screening test to better choose true patients at risk when properly used this test will reduce the number of unnecesary

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Gutterman, David Date: 01/12/2006
Comment:

There are multiple ways to measure T-wave alternans. CMS should consider more than just spectral analysis that may be just as or more robust. I encourage you to consider other alternatives as well in a more comprehensive and balanced decision.

Schwartz, Peter J. Title: Professor of Physiology
Organization: The University of Oklahoma Health Sciences Ctr.
Date: 01/12/2006
Comment:

The following are my thoughts and opinions, which are offered to address your request for comment on the pending decision to utilize T-wave alternans (TWA) in sudden death risk stratification in Medicare and Medicaid patients. I have had a longstanding interest in this phenomenon. More than 30 years ago, I published an article. “Electrical alternation of the T- wave: Clinical and experimental evidence of its relationship with the sympathetic nervous system and with the long Q-T

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HUNTER, JASON Title: EXERCISE PHYSIOLOGIST
Organization: ADVANCED CARDIOVASCULAR HEALTH SPECIALISTS
Date: 01/12/2006
Comment:

I AM A TECH THAT PERSONALLY SUPERVISED 67 T-WAVE ANALYSES AND CAN ATTEST TO THEIR EFFICACY AS WELL AS THEIR EASE OF ADMINISTERING. THE PATIENTS ARE RELIEVED THAT THERE ARE NO INJECTIONS, ONLY 14 ELECTRODES AND THAT THE TREADMILL PORTION IS A LOW LEVEL PROTOCOL. IT IS A FAST AND EASY TEST WITH INSTANT INTERPRETIVE VALUE. THE RESULTS OF THE TEST ARE EASILY INTERPRETED, THERE ARE ONLY THREE OPTIONS: POSITIVE, NEGATIVE AND INDETERMINATE AND INDETERMINATE CAN BE RECTIFIED WITH AN IMMEDIATE

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Chazanovitz, David Title: President and CEO
Organization: Cambridge Heart, Inc.
Date: 01/11/2006
Comment:

This comment is submitted in support of the Proposed National Coverage Determination for Microvolt T-Wave Alternans (MTWA). Cambridge Heart is pleased that CMS has recognized the importance of Microvolt T-Wave Alternans concluding that there is sufficient evidence to determine that the use of Microvolt T-Wave Alternans is reasonable and necessary for the evaluation of Medicare beneficiaries at risk for sudden cardiac death (SCD). The decision memorandum correctly recognizes that MTWA

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Rojas, M.D., Juan Carlos Title: Cardiologist
Organization: Cardiovascular Associates, P.C.
Date: 01/11/2006
Comment:

By utilizing Microvolt T-wave Alternans in my practice, I have been able to risk stratify those patients who are at the highest risk for sudden cardiac death and those whose risk is minimal. The tests high negative predictive value provides me, and most importantly, my patients, the peace of mind that I am giving them the most thorough cardiac management possible.

Reynolds, Matthew Title: Electrophysiologist
Organization: Beth Israel Deaconss Medical Center
Date: 01/11/2006
Comment:

I am writing in response to the solicitation for public comments following release of your draft decision regarding the National Coverage Analysis on the use Microvolt T-wave Alternans testing (CAG-00293N) for the evaluation of patients at risk for sudden cardiac death. I am a clinical electrophysiologist and clinical researcher affiliated with New England’s major Veteran Administration EP program, Beth Israel Deaconess Medical Center, and Harvard Medical School.

I agree

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MORGAN M.D., KERRY Title: MD
Organization: MorganCadiovascular
Date: 01/11/2006
Comment:

I find that t-wave alternan testing in our office, is a valuble tool in the treatment of our patients.

Kleiger, M.D., Robert E. Title: Professor of Medicine
Organization: Washington University School of Medicine
Date: 01/11/2006
Comment:

I strongly support the CMS decision on payment for micro T wave alternans testing. This test can substantially improve clinical decisions on ICD placement. There is now substantial documentation that a negative micro T wave alternans test predicts a very low risk of cardiac arrest in patients who otherwise meet the usual criteria for ICD placement for primary prevention suggesting that these patients should not have ICD placement. On the other hand, a non-negative test substantially

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Tang, Chuen Title: Cardiac Electrophysiologist
Organization: Minneapolis Heart Institute, Abbott Northwestern Hosp
Date: 01/10/2006
Comment:

The specificity of the test will help to identify patients not at high risk for malignant ventricular tachyarrhythmia and therefore provide a more cost effective use of our limited healthcare resources.

Deming, Wood Title: M.D., FACC, FSCAI
Date: 01/10/2006
Comment:

I have had MICROVOLT T-Wave Alternans testing in the office for about three years. I find it very, very helpful in decision making regarding AICD implants. We have not had a sudden cardiac death in a negative T-Wave Alternans patient in our practice here at Regional Cardiology Consultants.

I think the technology should be used to a much wider extent. It is most helpful in a patient with limited lifespan and decision making regarding AICD and for decisions regarding arrythmic

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sacher, howard Title: CArdiologist
Organization: Cardiology and Internal Medicine of Long Island
Date: 01/10/2006
Comment:
The negative predictive value of MTWA has greatly enhanced my ability to decide who will benefit or not benefit from an AICD.
Tombul, Selcuk Title: President
Organization: Selcuk A. Tombul, DO, PA
Date: 01/10/2006
Comment:

As a physician already utilizing MTWA testing in my practice, I know the positive impact on patient outcomes MTWA testing can have. The positive predictive value of MTWA helps me identify those patients most likely to benefit from ICD therapy. MTWA testing is a clinical proven risk stratifier that enables me to openly discuss a patient's level of risk and need for an ICD. CMS should extend coverage to Medicare beneficiaries and expand access to MTWA testing.

Hughes, Patrick Title: MD, FACC, FASCI - Director Noninvasive Services
Organization: Aspirus Wausau Hospital
Date: 01/10/2006
Comment:

I am a member of a large group practice in cardiology and the medical director for non-invasive services at Aspirus Wausau Hospital and The Wausau Heart Institute. For roughly 2 years my partners and I have used the Cambridge Heart MTWA system as a risk stratification tool for patients potentially at risk for sudden cardiac death from malignant ventricular arrythmias. After a careful review of available literature we were reasonably confident that the results of the MTWA test could be used

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HASSINE, BRIAN Date: 01/10/2006
Comment:

I came to know of MTWA only recently, and what I found astounded me...For years the ability to predetermine, with a reasonable degree of error, the chances of sudden cardiac death..and not only in the positive but to exclude as well...Yet, as we sit here today, 9 yrs since Mr. Cohen working with NASA discovered the predictive value of MTWA, we are still discussing the reasonableness and necessaryness of MTWA..Why?...Guidant, Medtronic, St. jude, J J,,,,Yes, their products save lives, and

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Choudhry, Abdul Sattar Date: 01/09/2006
Comment:

Microvolt T-wave Alternans has been extremely beneficial to my practice as it has allowed me to identify those patients most likely to benefit from ICD therapy. Knowing that only 20% of ICDs fired appropriately in the SCD-HeFT trial, this risk stratifier has helped me to differentiate those patients at the highest risk from those that I can manage medically.

Evangelista, Jose Title: M.D.
Organization: Livonia Diagnostic Center
Date: 01/09/2006
Comment:

I applaud the CMS proposal to expand the indications for MTWA testing using the Analytic Spectral Method.

MTWA provides me with a noninvasive diagnostic tool that allows me to assess my patients' risk of sudden cardiac death. This will ensure that the most appropriate primary prevention patients will be referred out for ICD therapy. In addition the negative predictive value has held up across all of the clinical data.

Please approve asap. Thank you for allowing me to

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Magnano, Anthony Title: Asst Professor of Clinical Medicine, Attending MD
Organization: EP/Cardiology Division at Columbia Univ Med Ctr
Date: 01/09/2006
Comment:

I strongly commend and support the CMS decision regarding reimbursement for MTWA testing. Multiple well performed prospective research trials support its value. I use MTWA testing routinely, but often struggle with payment issues in the current circumstances. Reimbursement for this test would help us offer an affordable noninvasive test to many patients instead of an expensive, invasive and only possibly beneficial ICD. It will result in better care and most likely overall cost savings.

Stone, Peter Title: Co-Director, Samuel A. Levine Cardiac Unit
Organization: Brigham & Women's Hospital
Date: 01/09/2006
Comment:

I am responding to your invitation to provide public comment regarding the pending decision to utilize T-wave alternans (TWA) in sudden death risk stratification in Medicare and Medicaid patients. This is a topic with which I am highly familiar, as Co-Director of the Coronary Care Unit and Director of the Ambulatory ECG Research Laboratory at the Brigham &Women’s Hospital in Boston, which is a teaching hospital of Harvard Medical School.

While I support the decision that

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Josephson, M.D., Mark E. Title: Prof. of Medicine, Chief of Cardiovascular Div
Organization: Beth Israel Deaconess Medical Center
Date: 01/09/2006
Comment:

I am writing to respond to the solicitation of public comment regarding the recent proposed decision for CMS coverage for T-wave alternans (TWA) testing for noninvasive sudden cardiac death risk stratification. My views derive from decades of experience in caring for patients at risk for arrhythmic death using both invasive and noninvasive techniques. I have personally evaluated many TWA tests using the Cambridge Heart system at our medical center, which is a teaching hospital of Harvard

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Ruskin, Jeremy Title: MD
Date: 01/08/2006
Comment:

I strongly support coverage for Microvolt T-wave Alternans testing in patients at risk for sudden cardiac death, to be used at the discretion of their cardiologist. The data strongly support the utility of this test, particularly with respect to its negative predictive value. I believe that MTWA can help select patients with left ventricular dysfunction who would ordinarily qualify for an ICD but who are not likely to benefit and do not need a prophylactic ICD.

RAMA, BHOLA Title: Cardiologist
Organization: Smith Clinic
Date: 01/07/2006
Comment:

MTWA testing removes the barrier to entry to insure the most appropriate primary preventions patients are referred to the implanting specialists.The positive predictive value of MTWA helps identify those patients most likely to benefit from ICD therapy.MTWA testing is a clinical proven risk stratifier that enables me to openly discuss a patient's level of risk and need for an ICD.Implanting every primary prevention ICD eligible patients is not a cost effective use of our valuable health

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kumar, p Date: 01/06/2006
Comment:

MTWA testing is important and help to insure most apppropriate primary preventionspts are referrd to implanting doctorit also has negative prdictive valuepositive prdeictive vlaue help pats most likerly benefit from ICDmtwa testing is a clinical proven rikd stratifier and help me discusee with my patients level of ridk and need for icdsince we know oly 20 % icd fired appropriately in trials use of mtwa testing will help differentiate those patients at highest riskplease contact if any

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mirro MD, michael Title: Senior Partner
Organization: Fort Wayne Cardiology
Date: 01/05/2006
Comment:

I would like to applaud CMS on providing acoverage decision that will result in allowingPhysicians to carefully screen patients who areat risk for Sudden Cardiac Death. This also maystimulate the adoption of a very useful,cost-effective, non-invasive technology that willlead to a more targeted approach to ICDimplantation. The patients will be the winner fromthis NCD. Thank you for looking at the science.

Michael J Mirro MD, FACC (EP Physician Indiana)

Akin, David Organization: Independence Cardiology Associates, PC
Date: 01/04/2006
Comment:

I am a cardiologist in private practice. We have a group of four cardiologists,none of whom are electrophysiologists. A very common problem in our practiceis the appropriate referral for implantation of implantable defibrillators. This concern is not small, as you know, with risk both ways; i.e., if we referpeople who are not candidates, they may end up with a defibrillator they don'tneed, thus facing the risk and the expense of the procedure. On the otherhand, if we don't refer patients

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Raval, Pramod Title: M.D.
Organization: Raval Medical Center
Date: 01/04/2006
Comment:

I would like to comment on CMS' draft decision on Microvolt T-wave Alternans testing. I am in strong agreement with CMS to utilize MTWA testing (from Cambridge Heart) to determine which patients are at risk for sudden cardiac death.

As an internist it is extremely important to me to be able to utilize MTWA testing in my practice. MTWA allows me to rule patients out for SCD with its high negative predictive value and identify the high risk patients who test positive. This way only

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sheth, viral Date: 01/04/2006
Comment:

Given the excellent negative predictive value, the microvolt T-wave Alternans test has helped my patients make more informed decisions on the need for an implantable defibrillator.

braby md, daniel Date: 01/03/2006
Comment:

This test should be required for all patients meeting criteria as a prerequisite for implantable defibrillator.

Fuchs, Kathleen Date: 01/03/2006
Comment:

Re: The Microvolt T-wave Alternans Test (from Cambridge Heart) used to determine which patient requires an ICD

I would like to express my strong agreement with CMS to utilize the Microvolt T wave Alternans Test (from Cambridge Heart) to determine which patients are at risk for sudden cardiac death. The high negative predictive value of this test will ensure that only those patients in absolute need of an ICD will receive one. What with the inherent problems of ICDs (not to

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Narayan, Sanjiv Title: Director of Electrophysiology, VAMC
Organization: University of California, San Diego
Date: 01/02/2006
Comment:

I applaud the CMS proposal to widen the scope of reimbursement for the T-wave alternans test.

TWA testing has been shown to substantially improve risk stratification for sudden cardiac arrest over existing methods. However, it has yet to be incorporated into Professional clinical pathways or guidelines for this purpose. Broadening the reimbursement for TWA testing removes a potential obstacle for wider use of this tool in prospective or registry studies. In turn, such studies

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Bull, Michael Date: 01/01/2006
Comment:

Please review and accept my comment on the upcoming decision by CMS related to national coverage for Microvolt T-wave Alternans testing.

It would seem to be a contradiction For CMS to currently provide national coverage for ICD therapy (costing tens of thousands of dollars) in patients who are candidates for primary prevention ICD therapy and to not provide national coverage for a test (well under a thousand dollars). The MTWA test has been shown in studies and commented on by

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johnson, eric Title: md
Date: 12/30/2005
Comment:

We use the test to evaluate (1) which patients with LVEF less than 35% are at risk for SCD (2) to evaluate patients post transmural MI and (3) for those patients with NSVT to dicriminate those at high or low rick before AICD.

Raeder, Ernst Title: Associate Professor of Medicine
Organization: SUNY at Stony Brook
Date: 12/29/2005
Comment:

There is compelling evidence that the MTWA test is a powerful predictor of sudden cardiac death risk. Its value lies not only in its positive, but perhaps more importantly, its negative predictive accuracy. The results of the recently NIH-sponsored trial of Bloomfield and coworkers are so strong that the proposed NCD is clearly justified. I believe, however, that a word of caution is in order. While there is little doubt about the ability of the MTWA test to identify a low-risk cohort, it

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Bigger, J. Thomas Title: Professor of Medicine (Cardiology)
Organization: Columbia University Medical Center
Date: 12/29/2005
Comment:

The cardiology community is grateful for the broad coverage decision for ICD prophylaxis (primary prevention) rendered by CMS in January 2005. Similarly, cardiologists will be grateful for coverage for microvolt T-wave alternans (MTWA) testing, which will permit better selection of patients for ICD prophylaxis. CMS is not proposing mandatory use of MTWA for selecting patients for ICD nor is it suggesting that the results of a MTWA should mandate a particular action. MTWA results are to be

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Bouier, Arthur Title: DO
Organization: Ascending Home Physicians
Date: 12/29/2005
Comment:

I am an Internal Medicine physician and have been using MTWA testing in my practice. MTWA has been extremely helpful in assessing my patients' risk of sudden cardiac death. MTWA gives me an inexpensive, non-invasive diagnostic tool to indentify low and high risk patients.

The clinical data clearly supports its use in patients with cardiomyopathy, as well as, syncope, post MI etc. The negative predicative value has held up in all of the clinical studies. This gives me confidence

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Zareba, Wojciech Title: Associate Professor of Medicine (Cardiology)
Organization: University of Rochester
Date: 12/29/2005
Comment:

Over last several years, there were several studies conducted indicating predictive value of T wave alternans testing. Importantly, negative predictive value is very high (above 90%) - indicating clinical usefulness of TWA for identifying patients at low risk of arrhythmic events at teh time of testing. Performing TWA testing in high-risk patients might help prioritizing patients for ICD therapy. Those with negative test could have ICD postponned and TWA test repeated either on periodic

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Zipes, Douglas Title: Distinguished Prof Medicine, Director Emeritus
Date: 12/29/2005
Comment:

I think there is sufficient data, particularly on the negative predictive accuracy of TWA, to make the test a part of the workup of candidates for an ICD.Note: I have been a consultant to Cambridge Heart in the past and am presently a consultant to Medtronic.

Lepor, Norman Title: Cardiologist
Organization: Westsdie Medical Associates of Los Angeles
Date: 12/28/2005
Comment:

My review of clinical data including recent article in Journal of the American College of Cardiology clearly supprot the use of this technology to assess in need assessment in patients with cardiomyopathy.

Taking into account all of the issues associated with AICD placement including implant and recalls... this will be an important part of the assessment of patients. As a cardioloigst, I will want to offer this to my patients who fit into the SCD-HeFT and MADDIT II populations