External Counterpulsation (ECP) Therapy

God gave man the ability to grow collateral vessels and capillaries. EECP merely harnesses this God-given ability. A surgeon cannot do this. A drug cannot do this. Should the American people be denied reimbursement for this non-invasive, life-enhancing procedure simply because man is not able to figure out how God created the body to work and explain it all to you scientifically? The empirical evidence is overwhelming. You need to look in your hearts and do the right thing for the millions of Americans with failing hearts. The only reimbursed treatment regimes you currently provide all lead to death sentences within five years.

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To whom it may concern: I am a board certified cardiologist who has treated over 300 patients with EECP since April, 1999. Our clinic was the first in the Pacific Northwest to offer EECP therapy, and virtually 100% of our patients are referred in to us by outside cardiologists or cardiothoracic surgeons. Our overall success rate is in the range of 80%, with the vast majority of patients coming to us with FC III - IV angina symptoms truly refractory to maximal medications, interventional techniques, and surgical approaches to their disease.

References in the medical literature that support EECP in heart failure and angina are mentioned in several of the comments already posted on this site. I would like to add our clinical experience. We have observed dramatic improvement in patients who were incapacitated by their symptoms prior to treatment with EECP, some of whom had previously been told that they should basically go home and get their affairs in order. Most of these patients are able to resume activities of daily life and in some cases even fairly vigorous exercise which they had not been able to do for years.

We have treated patients with ejection fractions as low as the mid-teens who improved not only their angina symptoms, but also their ejection fraction, pulmonary congestion, and dyspnea. One patient who was treated for debilitating angina while on a transplant waiting list improved to the point where he wanted to take himself off the list because of his improvement with EECP (we advised him against this and he was subsequently successfully transplanted months later). In fact, we have had success using EECP as a "bridge" to achieving optimal dosing of beta blocker therapy in heart failure patients who were previously intolerant (even in low doses) of those drugs despite numerous attempts. Independent of the symptomatic improvement seen with EECP alone, success in maximizing beta blocker therapy should result in a morbidity and mortality benefit that otherwise could not have been attained in these patients.

Finally, we have successfully treated patients with FC II angina. Some of these patients were initially referred in that condition. Others had previously had successful EECP but returned for a repeat course of therapy before their recurrent symptoms had progressed back to their pre-EECP FC III-IV baseline. As would be hoped, in both situations these patients generally experienced similar if not greater benefits as those presenting with worse symptoms.

In summary, I would urge you to change your preliminary decision and expand coverage for EECP to include heart failure and FC II angina. Our clinical experience supports the findings in the published literature that EECP is an effective, safe, lasting therapy which can be highly cost-effective when used appropriately.

Thank you for your consideration.

Ronald W. Schutz, MD, FACC

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We are members of an advisory group referred to as the EECP Scientific Council engaged by Vasomedical, Incorporated to promote and guide appropriate research investigating the effects of EECP therapy. As such, we periodically review results of published and unpublished research relevant to this therapy, advise the company with regard to on-going investigations and participate in the design of new research. We serve no role in the promotion of this therapy for commercial purposes and are particularly interested in translational research aimed at elucidating the mechanism(s) of action of this unique therapy.

Moreover, each of us has been involved with the provision of EECP therapy on a clinically indicated basis at our respective institutions and has personal experience in observing the therapy’s effects on our own and colleagues’ patients. This letter is meant to convey our expert opinion regarding the data available pertaining to EECP therapy, buttressed with our own personal experience as practicing cardiologists.

Based upon our review of the published literature (see below) and our personal experience with EECP therapy, we accept the findings of reports published in the peer-reviewed literature and strongly advocate that CMS expand the indications for EECP therapy to include patients symptomatic with CCS class II angina and NYHA class II/III heart failure with an EF≤35% already on appropriate medical therapy. Enhanced external counterpulsation treatment can improve exercise tolerance and symptoms in patients with ischemic heart disease and recent studies have demonstrated similar benefits in patients with stable heart failure. Many patients with heart failure have myocardial ischemia and no symptoms of angina, and are responsive to treatment aimed at improving the function of viable tissue. Furthermore, while we understand the need for mortality data to describe the benefit of costly life-long drug and complex interventional therapies, we do not believe that it is relevant in the evaluation of EECP therapy. No claim of mortality benefit has ever been made and its symptomatic and functional benefits have been documented in large numbers of patients who have failed or are obtaining inadequate relief and/or are intolerant to maximal medical and interventional therapies.

If, after careful review, it is still deemed appropriate to limit the additional use of this therapy to not include all patients with Class II angina or chronic, stable Class II/III heart failure, then we recommend that its use be expanded to include such patients who are not obtaining adequate relief from or who are unsuitable for maximal medical or interventional therapies. This promising therapeutic technique has already been shown to benefit thousands of patients annually who have advanced cardiac disease and very limited treatment options. We believe that CMS should implement a policy that enables the further development of this safe, effective, less complex and less costly therapy.

The seminal study of EECP in patients with angina is known as the MUST-EECP study, a multicenter, prospective, randomized, blinded, controlled trial conducted in seven university hospitals in 139 outpatients with CCS class I to III angina, documented coronary artery disease (CAD) and positive exercise treadmill test. Patients were given 35 hours of active counterpulsation (active CP) or inactive counterpulsation (inactive CP) over a four- to seven-week period. Outcome measures were exercise duration and time to ≥1-mm ST-segment depression, average daily anginal attack count and nitroglycerin usage. The study found improvements in exercise duration, time to ST-segment depression, the occurrence of angina episodes and nitroglycerin usage in the active CP group, with significant between-group differences in time to ST-segment depression and anginal episodes. The authors concluded that EECP therapy reduces angina and extends time to exercise-induced ischemia in patients with symptomatic CAD.

We recently participated in a multicenter study of EECP therapy conducted in six U.S. university hospitals in patients with CCS class II to IV angina who had exercise-induced myocardial ischemia. Pursuing our interest in translational research, we sought to evaluate the effect of EECP on myocardial perfusion using symptom-limited, quantitative SPECT imaging, as previous case-series reports had demonstrated improvement in those parameters. Thirty-seven patients were enrolled (mean age 61, 81% male, 78% prior revascularization, and 68% 3-vessel disease) and 34 patients completed pre- and 1- month post-EECP stress testing. Mean angina class decreased from 2.7 at baseline to 1.7 after EECP (p 9.1 minutes at baseline to 10.2 minutes post-EECP (p=0.03), while the average percentage of tracer uptake, magnitude of reversibility, average thickening fraction, and the left ventricular ejection fraction remained unchanged after EECP. We concluded that results of this study confirmed that EECP therapy reduces angina and improves exercise capacity, even in the absence of improvements in radionuclide imaging measures of myocardial perfusion. Based on these findings, we believe that much of the effect of the therapy can be attributed to a peripheral training effect.

Bonetti et al at the Mayo Clinic examined the effect of enhanced external counterpulsation (EECP) on endothelial function by noninvasively measuring reactive hyperemic response in 23 patients with refractory angina. Measurements were performed before and after the first, at midcourse, and last EECP session, with additional measurements made one month after completion of EECP therapy. The study showed that enhanced external counterpulsation therapy led to symptomatic improvement (≥1 Canadian Cardiovascular Society class) in 17 (74%) patients and was associated with a significant immediate increase in reactive hyperemia index after each treatment (p also sustained at one-month follow-up (p Moreover, when patients were divided by their clinical response, endothelial function improved at one-month follow-up only in those patients who experienced clinical benefit.

Shechter et al (Chaim Sheba Medical Center, Tel Aviv, Israel) investigated the influence of external counterpulsation therapy on flow- mediated dilation (FMD) in patients with coronary artery disease using high-resolution ultrasound to assess whether it resulted in modification or reversal of endothelial dysfunction. They prospectively assessed endothelial function in 20 consecutive patients with CCS class III to IV refractory angina pectoris who were unsuitable for coronary revascularization, before and after therapy, and compared them with 20 age- and gender-matched controls. They found that external counterpulsation therapy resulted in significant improvement in post-intervention FMD compared with controls (p=0.01 vs. p=0.78), in anginal symptoms assessed by reduction in mean sublingual daily nitrate consumption compared with controls (p post-treatment CCS angina class compared with controls (p that external counterpulsation significantly improved vascular endothelial function in CAD patients with refractory angina pectoris, suggesting that improved anginal symptoms may be the result of such a mechanism.

Numerous other studies have delineated beneficial changes in measures of hemodynamics, , collateral development, , myocardial perfusion , , , and neurohormonal milieu, , , , suggesting that the effects of EECP therapy may be mediated through multiple factors.

Clinical reports of the effects of EECP therapy are notable for their consistency in demonstrating symptomatic and functional improvement in patients. Bonetti et al in a thorough review of published literature provides a succinct overview of the results of clinical investigations of EECP therapy prior to their 2003 publication.

More recently, Michaels et al reported results observed in a large cohort of patients followed in the International EECP Patient Registry (IEPR) for two years after completion of therapy. These authors found seventy-three percent of 1,097 patients studied had a reduction by ≥1 angina class at the end of treatment, with more than 50% reporting an improvement in the quality of life assessment. Most notably, these results were sustained at 2-year follow-up. Cumulative 2- year clinical outcomes showed that 9% of patients died, 22% had unstable angina, 9% had myocardial infarction, 12% had heart failure exacerbation, 41% had cardiac hospitalization, and 15% underwent revascularization with either PCI or CABG. The improvements seen in these patients are even more impressive given the advanced coronary artery disease, multiple risk factors, frequent comorbidities, and very high percentage of prior interventional revascularizations in this cohort.

As expected, significant numbers of patients receiving EECP therapy for angina symptoms suffer from heart failure and/or left ventricular dysfunction (LVD). In a very recent publication, Soran et al report the 2-year clinical outcomes, event-free survival rates, and the incidence of repeat EECP in a cohort of 363 patients with refractory angina enrolled in the IEPR who had severe LVD (EF≤35%) at entry. After treatment, angina severity improved significantly (p severe angina to no angina or mild angina and 52% discontinued nitroglycerin use. Quality of life also improved substantially. At 2-year follow-up, the decrease in angina was maintained in 55% of patients. Notably, the 2-year survival rate was 83% and the major adverse cardiovascular event-free survival rate was 70%, with 43% reporting no cardiac hospitalization and 81% no congestive heart failure events. Repeat EECP was performed in 20%, with the only significant independent predictor being failure to complete the first EECP treatment course. Improvements in angina symptoms and quality of life were maintained at 2 years. The authors conclude that for patients who have significant LV dysfunction, this treatment offers an effective, durable therapeutic approach for refractory angina.

A significant concern associated with the use of EECP therapy in patients with heart failure is that the increase in venous return could overwhelm the capacity of the heart to respond to the increase in preload, putting them at high risk for pulmonary congestion, oxygen desaturation and worse. Based on analyses of patients in the IEPR and personal experience in patients with angina symptoms and concomitant systolic heart failure, investigators undertook to evaluate EECP therapy as a potential adjunctive treatment for patients with a primary diagnosis of heart failure.

Soran et al reported the results of a feasibility study of EECP therapy in 26 patients with chronic, stable congestive heart failure, NYHA Class II/III symptoms, a left ventricular ejection fraction ≤35%, and without fluid overload. The primary parameter was safety as reflected by adverse events and secondary end points included changes in exercise capacity and quality of life 1-week and 6-months after completion of therapy. There were no clinically significant problems associated with the administration of enhanced external counterpulsation. Mean peak oxygen uptake increased significantly at 1-week (14.99 vs. 15.98 mL/kg/min, p=0.05) and at 6-months (14.78 vs. 18.41 mL/kg/min, p mean exercise (627.63 vs. 732.96 sec, p 637.13 vs. 715.17 sec, p=0.028, at 1-week and 6- months after completion of treatment, respectively). These parameters increased similarly regardless of whether heart failure was of idiopathic or ischemic etiology. Quality of life was also improved in these patients.

Based upon this feasibility study demonstrating that EECP therapy could be safely administered to selected patients with heart failure and significant improvements in functional capacity could be achieved, a randomized, controlled trial was initiated in similar patients. Dr. Arthur Feldman presented the results of the Prospective Evaluation of EECP on Congestive Heart Failure Trial (PEECH) at a Late Breaking Clinical Trials session of the Annual Scientific Session of the American College of Cardiology in March 2005 and a manuscript is awaiting publication.

The PEECH trial was a controlled, randomized, single-blind, parallel-group, multicenter study of 187 patients with symptomatic but stable HF (NYHA classes II and III) and an LV ejection fraction ≤35% designed to assess the efficacy of EECP in patients with stable HF. Medical therapy was optimized in all patients based on the recommendations of the Heart Failure Society of America, and they were then randomized between 2 treatment groups, with 1 group receiving EECP therapy (35 hours over 7 weeks) in addition to optimal medical therapy (ACE inhibitors or angiotensin receptor blockers and beta blockers). Measures of efficacy reported to date include standard exercise tolerance tests on a treadmill (modified Naughton protocol), with measurements of peak oxygen uptake and exercise duration time, quality of life questionnaires, and NYHA classification at 1-week and 6-months following completion of treatment. The summary findings of the trial, as described in the published summary available at the Cardiosource web site, include the following:

Concomitant Medications
ACE inhibitors (76%), ARBs (19%), and beta-blockers (85%)

Principal Findings
Baseline characteristics were well balanced between treatment groups. Ischemic etiology was present in 69% of patients and 65% had New York Heart Association (NYHA) class II. Baseline ejection fraction was 26%. Increase in exercise duration by at least 60 seconds at six months occurred more frequently in the EECP group compared with control (35.4% vs. 25.3%, p=0.016).

There was no difference in the co-primary endpoint of increase in peak VO2 of at least 1.25 ml/min/kg between groups (22.8% for EECP vs. 24.1% for control, p=NS). Change in exercise duration was longer in the EECP group compared with control as early as one week (26.4-secondincrease vs. 10.0-second decrease, p=0.01) and maintained through six months (24.7-second increase vs. 9.9-second decrease, p=0.01). Improvement in NYHA class was more common in the EECP group compared with control at one week (33.3% vs. 11.4%, p six months (31.3% vs. 14.3%, p Change from baseline in Minnesota Living with Heart Failure score was greater in the EECP group at one week (-8.9 vs. -3.4, p=0.01) and three months (-7.1 vs. -2.9, p=0.01), but did not differ at six months (-3.7 vs. -2.9, p=NS). Serious adverse events were reported in 30.3% of the EECP group and 29.5% of the control group (p=NS).

Interpretation
Among patients with systolic dysfunction, stable heart failure symptoms, and treated with optimal pharmacologic therapy, use of EECP was associated with improvements in exercise duration, NYHA classification, and quality of life, but no difference in change in peak VO2 compared with optimal pharmacologic therapy alone.

EECP therapy has previously been shown to be beneficial for increased time to exercise-induced ischemia and decreased anginal frequency in patients with stable angina. However, data in patients with heart failure are limited to a registry and a pilot trial. The present study demonstrated improvements in exercise duration and quality of life despite optimal medical therapy.

Importantly, results shared with CMS in the application for expansion of coverage include a sub-group analysis of patients in the PEECH trial ≥65 years of age in which both co-primary endpoints were achieved. This is a critical piece of information to consider when evaluating the data pertaining to heart failure patients dependant on Medicare coverage.

We are aware that there are skeptics in the physician community many of whom do not have a deep knowledge of the relevant published literature or personal experience with this therapy. There are still many issues to be explored, but we have spent considerable time assessing the strength and breadth of evidence available and also have personal, clinical experience with it. We hope that CMS will adopt a policy to support this promising therapy so that it can be offered to more patients.

Sincerely,

George A. Beller, MD, FACC
Ruth C. Heede Professor in Cardiology
University of Virginia Health System
Cardiovascular Division
P.O. Box 800158
Charlottesville, Virginia 22908-0158

C. Richard Conti, MD, MACC, FESC
Eminent Scholar (Cardiology)
Professor of Medicine
Director, Cardiovascular Clinic
University of Florida
Health Sciences Center
1600 SW Archer Road
Room M-438
Gainesville, FL 32610-0277

Arthur M. Feldman, MD, PhD
Magee Professor and Chairman
Department of Medicine
Jefferson Medical College
Thomas Jefferson University
1025 Walnut Street, Suite 822
Philadelphia, PA 19107

David R. Holmes, Jr., MD
Mayo Clinic
200 First Street SW
Saint Marys Hospital,MB4-523
Consultant, Cardiovascular Diseases
Professor of Medicine, Mayo Clinic College of Medicine

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Congestive Heart Failure has a poorer prognosis than most cancers. Not only do its victims increase strain on our health care system, but the toll that it takes in dampening the human spirit by degrading the quality of life cannot be measured in monetary terms. During my three decades as a cardiologist, I have participated in and witnessed great strides in cardiovascular disease. Treatment of the severely symptomatic CHF patient has slowly progressed. EECP has a special place in the treatment of the severely ill ischemic heart disease patient with and without CHF.I would urge that the use of EECP for refractory CHF be approved for CMS reimbursement. This will facilitate further refinements in the procedure and give CHF patients reason for guarded optimism. The goal in patients with CHF should be to enhance their quality of life, and if possible, its duration. EECP as an ancillary to medical and surgical therapy helps to achieve this goal.

Robert B. Vranian, MD, FACC
Medical Director for EECP
Mary Washington Hospital
Fredericksburg, Virginia

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I have been treating patients for 3 ½ years with EECP. EECP has proven to be a extremely safe and effective therapy for patients with angina, and Congestive Heart Failure. Our patients have went from being admitted into the hospital monthly to staying at home and doing outpatient follow-ups. This makes EECP therapy extremely cost efficient and actually returns most patients to a more normal life.Please reconsider the proposal to expand the coverage for EECP on class II angina patients, and class II & III Congestive Heart Failure patients. This will allow patients to seek help before the disease advances, causing much more damage and cost. Thank you.

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The American College of Cardiology is a 30,000 member non-profit professional medical society and teaching institution whose mission is to advocate for quality cardiovascular care—through education, research promotion, development and application of standards and guidelines—and to influence health care policy. The College represents more than 90 percent of the cardiologists practicing in the United States.

The ACC appreciates the opportunity to comment upon the Proposed Decision Memo for External Counterpulsation (ECP) Therapy (CAG-00002R2). CMS proposes to retain the national coverage policy for ECP in its current form. The ACC supports this decision and believes that it is consistent with currently available evidence.

We are grateful for CMS’s continued willingness to work cooperatively with the physician community to develop reasonable and effective coverage policies for the Medicare program. If you have any questions or if the College can be of further assistance in this matter, please contact Rebecca Kelly, ACC’s Director of Regulatory Affairs at 301-493-2398 or rkelly@acc.org.
Again, thank you for the opportunity to comment.

Sincerely,

Pamela S. Douglas, MD, FACC
President

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I HAVE BEEN A PROVIDER AND A LONG TERM INVESTIGATOR FOR EECP THERAPY. I HAVE PERSONALLY TREATED HUNDREDS OF PATIENTS FOR CLINICAL NEED AND FOR INVESTIGATIONAL PURPOSE. WHILE EECP IS AN OUTSTANDING CLINICAL DEVISE FOR REFRACTORY ANGINA, ITS EMERGING APPLICATIONS FOR CHF, WILL BE AN IMPORTANT ADJUNCTIVE TOOL FOR SYMPTOMATIC HEART FAILURE, IN THIS DIFFICULT ARENA. THE DATA, FROM IEPR REGISTARY, PEECH STUDY AND HEMODYNAMIC STUDIES SUGGEST IMPORTANT BENEFICIAL HEMODYNAMIC EFFECTS IN CHF. WE BELIEVE ITS APPROVAL BY MEDICARE WILL BE IMPORTANT STEP TO OFFER THIS THERAPY FOR HF PATIENTS.

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I support expanding coverage of EECP treatment for Class II angina patients and Class II-IV CHF. I have been involved in both EECP research and its clinical use since 1996. The burden of suffering with CCII angina and CHF is significant. PCI and CABG offer some recourse, but maximal pharmacologic therapy doesn't seem to meet the need completely. EECP has been demonstrated with statistical significance to improve the quality of life as well as reduce or eliminate angina and ischemia in CCIII. It is logical that if EECP were applied earlier in the disease process or in the CHF population, much suffering could be spared. This therapy is virtually free of adverse effects and has sustained benefits. Please re-consider the initial decision to deny this expansion of coverage.

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Commentor: Golovchinsky, Vladimir. M.D., PhD.

Title: M.D., PhD., Physical Medicine and Rehabilitation.

Organization: BRS Comprehensive Medical Group, Los Angeles

Date: 01-15-2006

I think that the decision of CMS not to allow EECP payment for treatment of congestive heart failure is outrageous. Presently there is no effective treatment for this condition, and one-third of the patients with congestive heart failure treated with traditional methods die within one year of their first hospitalization. The EECP is the best kind of treatment of congestive heart failure available, with excellent rate of recovery, and essentially there are no contraindications. Treatment like implanted heart stimulator (left ventricular assist device) is much more expensive (about $ 200,000.) and it corrects arrhythmia caused by congestive heart failure but not this condition itself. Medications for CHF are essentially ineffective and only slow the disease progression.It is hard to understand why this unique, inexpensive (about $ 5,000) and the only effective treatment of heart failure was not approved for treatment of this deadly condition, unless financial interests of some third party rather than interests of patients were taken into consideration.

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dear gentlemen, i have been treating patients with class III and IV angina with enhanced external couterpulsation for over 5 years. Many of these patients were status post 2 or 3 bypass surgeries with numerous occluded grafts! many of them had had frequent bouts of congestive heart failure! during this time i have tabulated 96 patient' s ejection fraction measured by 2 dimensional echocardiogram. not only were the vast majority of hse paients clinicly improved with greater exercise capacity , buheir cardiacejecion fracions improved an average of 12 points!this is a sriking improvement and rivals the results seen with bientricular pacers costing 5 times as much!most of the paients have never had recurrent myocardial infarctions or admissions for chfthe benefits of ECP to our cardiac patients is incredible especially in light of its low cost compared to cabg surgery and angioplasty/stent therapy.I beg you... approve ECP therapy for class 2 angina and congestive heart failure. not only will our patients benefit greatly but also it will save health care dollars!
Sincerely
Bartholomew J. Bonazinga MD. FACC

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Dear CMS Evaluators

Prior to retirement more than 5 years ago, Ioversaw the clinical development of EECP.

Considering the historic paucity of properclinical trialwork with most medical devices,especially non-invasive instruments, the volume ofdata available on EECP is highly creditable by any reasonable measure. I make this point because ofthe remarks of Dr. Pamela Douglas of the ACC andof Dr. Donna Raziano, Medical Director forElder Care of PA. The comment of the former isformulaic in nature but prefering to avoid theissue, she fails to take into account herorganization's pursuit of better therapy. Thesecond-mentioned comment seems to represent amindset that prefers personal opinion to studyingthe literature. It shows disregard for any benefitof doubt that should be accorded patients in needof help. To be sure, some component of practicallyall therapeutics is placebo but to speak of allEECP's effects as being placebo at this timedemonstates ignorance both of vascular physiologyand the liturature.

You have heard from a wide range of physicians,nurses, therapists and patients. In lookingthrough the list I find that I know quite a few ofthem. They are sincere and concerned individualswhose stories are typical of everyone withexperiece of EECP including those overseas.

Many of the physicians who offer comment,including past-presidents of the American Collegeof Cardiology, are highly accomplished academicswho would not allow themselves to be associatedwith anything less than that of utmost scientificlegitimacy. Despite all this, and the decades ofclinical and study experience with both ECP andEECP, one cannot help but detect a resistanceamong CMS contractors to what is both clinicallyand scientifically obvious EECP in its currentform provides an uncommonly safe, effective andtruly cost-beneficial treatment compared to whatis presently available.

Scientific work on ECP and EECP has beenpublished since the late 50's. The literature asa whole is extensive. New technology in the 90'senabled the develpoment and production ofcomforable and reliable equipment. It was onlythen that large clincal trials could be begun.

Like virtually all exploratory trialwork thesestudies are not without fault but neither are theywithout significant merit. I should point out thatthe results (both adverse effects and efficacymeasures) of this study-work as a whole areremarkably uniform. Only those studiesinvestigating modes of action have had somecontradictory results. Whereas it might beimprudent to conclude without question thatherein lies proof of clinical efficacy it wouldequally be unwise to ignore the strong implicationthat these data represent clincial truth.

The upshot of all this is that your decision toexpand the covered indications for ECP will effectthe lives of many patients in great need of help. As a citizen and taxpayer, I hope you will lookunbiasedly to the evidence of benefit and wherethere is incomplete evidence bare in mind Carl Sagan's admonishment: " absence of evidence is not evidence of absence".

Faithfully,

Anthony E. Peacock

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As a consultant to Vasomedical, I have been personnally involved in many of the clinical research sponsored by the company, including two major trials, MUST-EECP and PEECH. In this capacity, I am familiar with the evidence, its strengths, and its weakenesses. After reading the proposed decision memo released December 20, 2005, I feel compelled to take advange of the public comment period to express my opinion. I am doing so on my own time and initiative, and without input from my client, Vasomedical, because I personnally believe that CMS is taking a stance that is hard to support in its decision not to extend coverage to CCSC class II angina and to heart failure as defined in the PEECH trial. My comments focus mostly on coverage for angina pectoris.

The purpose of this comment is not to discuss all aspects of the proposed decision. Many aspects of the review are pertinent, and it is clear that it would be very useful to have more research performed on the device. However, it seems clear also that decisions can made today with confidence that there is little risk of mistake.

In the introduction, CMS states that “ideally, the goal of external counterpulsation treatment should be to reduce symptoms, decrease morbidity, and potentially improve mortality by reducing ischemia through favorably impacting myocardial oxygen supply and demand.” It should be noted that the treatment goals stated in the ACC/AHA guidelines for the treatment of stable angina specifically state that the primary therapeutic goal is to alleviate symptoms and improve functional capacity (the guidelines are available on the web). ECP is providing these benefits. The context is important: percutaneous interventions (PCI) are reimbursed by CMS in the treatment of refractory angina pectoris, although the benefits of the intervention are also limited to symptomatic relief without effect on morbidity and mortality. According to Katritsis, “In patients with chronic stable CAD, in the absence of a recent myocardial infarction, PCI does not offer any benefit in terms of death, myocardial infarction, or the need for subsequent revascularization compared with conservative medical treatment. (Circulation. 2005;111:2906-2912). Furthermore, the benefits are not universal or forever lasting. Thus, the benefits that results from these two treatments (ECP and PCI) have qualitatively much in common, with the advantage for PCI of more immediate effectiveness while EECP is not invasive and can be repeated over time at a lower cost. Outside of coronary artery disease, biventricular pacing obtained reimbursement prior to the submission of evidence that this intervention had a positive effect on clinical outcomes.

The clinical outcomes assessed in studies of ECP reflect the primary goals defined in the ACC/AHA guidelines for the treatment of stable angina pectoris. Symptom reduction is the primary treatment goal. However, CMS seems to discount the value of assessing angina on the grounds that “pain is subjective”. CMS goes on with a discussion regarding general aspects of pain assessment, but does not provide references demonstrating how these statements apply to angina pectoris. Although the assessment of pain intensity is usually the result of a subjective assessment using variations of visual analog scales, recording the occurrence of pain independent of its intensity is much less subject to the problems raised by CMS in its discussion. In the context of angina pectoris, angina counts as a measure of the frequency of angina are a good indication of disease severity. Indeed, increasing frequency of angina is the clinical basis for stepping up medical therapy or for revascularization, and when uncontrolled, the sole criteria for the diagnosis of unstable angina, a condition that requires emergency care. Therefore, its seems that improvement in CCSC class and a decrease in angina counts are good criteria to assess the effectiveness of a treatment. This particularly true when exercise testing results are consistent with symptom relief and functional improvement.

The lack of correlation between functional class (e.g., CCSC) and the severity of coronary artery disease when defined using objective measures (angiography) is well known. However, CMS seems not to acknowledge that the severity of coronary artery disease by angiography is not necessarily a good measure of the effect of the disease on the patient or of its prognosis. For instance, some patients with severe angina (CCSC class IV) are free of atherosclerosis. Many pharmaceutical interventions that provide symptom relief (e.g., calcium channel blockers, nitroglycerin) do not affect the severity of arthrosclerosis. Yet, nobody ever suggested to deny patients the benefit of these treatments, which over time, remain costly, especially calcium channel blockers. And again, PCI is reimbursed without clear benefits on clinical outcomes, and while the intervention alters the anatomy of the target vessel, it does not affect other vessels or the progression of atherosclerosis, and is subject to restenosis.

In its review of MUST-EECP (evidence summary, indication 1: stable angina), CMS correctly states that the population was of CCSC classes I, II and III. To date, there is no controlled trial of ECP in CCSC IV. Thus, this trial supports the extension of reimbursement to CCSC II patients.

The evidence provided by the IEPR registries seems to be discounted too. However, registries are powerful studies when it comes to evaluating the effectiveness and safety of treatments in real-life practice. Indeed, all patients treated at participating sites are enrolled, with very few if any exclusions. Therefore, registries remain virtually immune to selection biases and provide invaluable information on the actual performance of medical interventions. For example, the limits of Nesiritide in the treatment of heart failure were revealed recently thanks to large registries.

In my opinion, it seems that evidence supportive of an extension of coverage should be considered again and given proper weight on its own merits and by reference to other decisions made by CMS in the past (PCI, biventricular pacing). The result of the proposed decision would be that a cost effective therapy for stable angina pectoris and heart failure is denied to the many patients who would benefit from this treatment. Such decision would be made despite the available and highly supportive evidence. Other comments made on this site support this opinion while confirming research data with real-life experience.

I thank CMS for providing this opportunity to comment on its decisions in due time, and hope that the final decision will reflect more positively on the existing evidence.

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I have been a therapist for 3 1/2 years. I wish all heart patients could have this treatment once a year. We have doubled Ejection Fractions & I do have proof. You not only improve or stop their angina, the great side effects from this treatment tremendously improve our patients quality of life. Just a few are, improve or stop having SOB, improved exercise tolerance (patient can split & stack wood with diagnosis of angina & CHF after recieving 35 treatments), lowers blood pressure (some have had meds reduced or stopped), improved kidney functions, better vision, can sleep better at nite, improve speech in a patient who, had also had a CVA, helped ED, hair growth & one 86 y/o patient resumed driving after 1 1/2 years. I could go on & on but, you would have a book. This would make it possible for more patients to recieve this treatment. Thank you for reading!

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I am a Registered Nurse who has served my community as the EECP Clinical Coordinator for the EECP Heart Center of Ks since our start up in May of 2001.

Recently, I became aware that the proposal to expand coverage for Medicare beneficiaries for EECP Therapy was denied and that you are seeking public comment on the proposed determination. Please allow me to share with you some of my experiences as an EECP health care provider.

First of all the bulk (27 years) of my nursing career has been entrenched in the cardiac field. I began in the 1980’s as a Surgical Intensive Care nurse in a unit extending post-op care to patients who received bypass surgery and valve replacement. Our unit’s average census made up 12-14 post-op heart patients on a daily basis. I also had the privilege of assisting in the initial setup of our local Transplant team, both as a retrieval nurse and a transplant team member. For the next 12 years I worked in Coronary Care settings spanning our nation; i.e. Kansas, California, Illinois, and Indiana.

My intention is not to bore you with my resume; I am trying to point out my vast experience in the care of Cardiac patients, while expressing the extreme need for EECP Therapy.

In 2000 I was approach by a local Cardiologist about setting up an EECP Clinic. He provided me with a vast amount of research requesting that I look into the procedure from a clinical aspect and from a potential business aspect. I will admit I was suspicious of a Non-Invasive rocedure due to my vast experience on the Invasive side working not only in post-op settings but in Heart Catheterization Labs.

What I discovered was an effective Non-Invasive procedure which offered patients an option, in many cases the only option they had left. I also discovered that from a business aspect EECP was not and I repeat was not a money maker.

I am blessed to work for a Cardiologist who is more concerned about the quality of his patients’ lives than his income. Our EECP Clinic opened with the full knowledge that it would not make a profit for many years but most importantly we would be able to provide an inexpensive treatment for our most severely ill patients that actually worked.

Nothing frustrates a health care provider more than to be forced to tell a patient; “I’m sorry but there are no more procedures we can safely provide. You have made all the lifestyle changes we’ve requested, your medications have been maximized, and the most I can suggest is limiting your daily activities to prevent your symptoms.”

My patients represent a population who has chest pain on a daily basis. In many cases they are unable to do simple activities such as cooking a meal, bathe, get dressed, walk out to the mailbox, or climb a flight of stairs without suffering from chest discomfort, fatigue, and shortness of breath.

Can you place yourself in their situation?

Since 2001 we have improved the quality of over 600 lives in the state of Kansas with EECP Therapy; however there are many more patients with CCSC Class II angina and NYHA Class II/III stable heart failure with an ejection fraction of less than 35% who could benefit from this inexpensive therapy if the proposal to expand coverage for Medicare beneficiaries was passed.

It is a well known fact that heart related disorders eat up the majority of health care cost in the United States. The number of admission on a daily basis for heart patients remains staggering.

The number of patients that are told there are no options left makes me want to cry!

EECP Therapy truly changes the quality of my patients’ lives. In some cases they are able to return to work, be removed from the transplant list, travel, play with their grandchildren, go out to dinner with family and friends, reduce their hospital admissions, in short do the things we take for granted.

Please reconsider your recent decision and expand the coverage for Medicare beneficiaries providing more persons with the opportunity to have their life back.

Sincerely,

Linda Rae Rolfe, RN
EECP Clinical Coordinator
EECP Heart Center of KS

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Our ECP clinic has been in operation for the past three and a half years and has treated many angina patients that also have heart failure. We have seen much improvement in the functional capacity of the patients with heart failure as well. One patient was unable to walk from his garage to the curb to remove his refuse (less than 60 feet) due to chest pain and severe shortness of breath. Following a 35-day course of ECP this patient was riding his bike more than 20 miles per week. Another patient with both stable angina and heart failure was unable to drive herself to treatment because walking from the parking lot to the treatment room caused severe shorness of breath. This patient was using portable oxygen 24 hours a day. Near the end of the 35-day course of ECP this patient was driving herself to treatment, parking in the lot and no longer required any oxygen. We have seen most every one of our angina/heart failure patients show improvement in their level of shortness of breath and functional capacity following ECP treatments. We have prevented further readmissions to the hospital because of this improvement. In addition this therapy provides the opportunity for extensive education of our patients regarding their medications, diet, signs and symptoms of angina/heart failure. As the patient begins to understnad their own individual response to their plan of care, they feel empowered to handle their chronic conditions.Since the purpose of this treatment is to create collateral blood vessel growth in angina patients, the opportunity to experience the same effects and possibly slow the progression of the coronary heart disease should be afforded to patients that have class II angina and heart failure.

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I have provided treatment for patients with chronic angina using enhanced counterpulsation since 1995. I have used it for patients with angina and EF less than 35% and found it safe and effective improving their quality of life, improving function, angina episodes, exercise capacity and showing improvements in areas of ischemia as well as EF after treatment as evidenced by nuclear studies and echocardiography. Often these patients have no alternatives and are nearly always on maximum standard angina and heart failure medications. My colleagues abroad have sent me abstracts which appear to show improvement in EF with their chronic angina patients with low EF as well. I implore the Center for Medicare and Medicaid to serve their patient well by approving the use of enhanced counterpulsation in patients with EF less than 35% who have ischemic cardiomyopathy with demonstrable areas of reversible ischemia by stress testing.

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we are running EECP centers in Pakistan (karachi lahore, Isalmabad)we treated more than 100 patients and success rate is 85- 90% .we are facing problems like unawreness among Pakistani cardiologists and cardiac surgeons .otherwise the patients are quite co- oprtatine as they are awared through internet and media which was marketed by Macter International (Pvt) Limited. it is requested to the forum to arrange awareness strategies for the doctors. we are thankful to the Vasomedical inc.as we are the only EECP running centers in Pakistan.

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ScottCare Corporation appreciates the opportunity to comment on expanded coverage for External Counterpulsation (ECP) therapy.

The ECP community is naturally disappointed in CMS’s preliminary decision not to expand coverage for ECP therapy. Providers of ECP therapy believe in this technology and its ability to improve patient’s functional status and quality of life. Your message board is filled with testimonials from physicians and clinicians who have all seen and experienced the benefits of ECP therapy, and want nothing more then to be able to offer ECP to a broader patient population. Our experience mirrors theirs, and we have found our users to be strong proponents of its application to patients with angina and heart failure for whom other treatment alternatives are limited.

Providers of ECP therapy support evidence-based medicine and the development of sound evidence to support medical interventions. Over 40 years of ECP research have provided clinical evidence of ECP’s effectiveness, as documented and published in numerous peer-reviewed journals. However, we are concerned that CMS may be focusing on physiological parameters at the expense of quality of life measurements. And it is certainly clear that ECP has been shown to improve quality of life.

As you know, Medicare’s current policy allows ECP reimbursement only for patients with refractory angina who are not amenable to surgery. What this means is that patients are not being prescribed for ECP therapy until they have “disabling” angina and have no other options. These patients typically have long standing coronary artery disease as well as multiple other underlying disease states. Even so, the research shows that 80% of these patients show significant improvement in their angina symptoms and quality of life measurements. In addition, these improvements are comparable to, if not greater than, those attributed to surgical procedures (bypass and angioplasty), and last just as long. It stands to reason that if ECP can work for patients who have long standing coronary artery disease who are refractory to other treatments, how much more could it benefit those with Class II angina? And, how much more money could it save our healthcare system to try ECP before expensive invasive cardiac procedures? Therefore, we feel coverage of ECP should be extended to include treatment for all patients with clinically significant, medically refractory angina.

Heart failure is a major medical problem in the United States and is increasing substantially because of the progressive aging of the population. The annually mortality rate for heart failure is also increasing steadily, especially among certain subsets of patients…particularly the elderly. Current medications and treatment modalities frequently fail to provide adequate symptom control and improved quality of life.

Among its findings, the Vasomedical PEECH trial showed that ECP can improve a heart failure patient’s quality of life. Because of that, I would implore CMS to consider reimbursement for patients who continue to have symptoms related to heart failure, and who are already on optimal drug therapy. If ECP can improve the quality of life for such patients, CMS needs to consider it as a viable treatment option. ECP is a safe alternative to other treatment modalities available to these patients. Since the FDA cleared the indication for heart failure in 2002, ECP providers have treated heart failure patients with tremendous success (significant symptom reduction, functional improvement, and reduction of re-hospitalizations) as well as an absence of unfavorable side effects.

Finally, I would also call attention to the alternative treatment regimens recommended by Vasomedical (standard therapy pressures up to 310 mm Hg) and Cardiomedics (graduated lower pressures) related to treatment of heart failure patients. While every patient requires evaluation and consideration of his or her unique medical condition, ScottCare’s treatment guidelines/protocols recommend the same “higher treatment” pressure (240 – 310 mm) requirements that Vasomedical does. This is because the arterial system lies deeper within the patient’s limbs and requires more pressure to effectively alter the patient’s arterial blood flow. The venous system does not rely on a tighter squeeze to preload the heart, as it lies closer to the surface of the body. Higher pressure enhances the critical aspect of systolic unloading and decreases the likelihood of pulmonary congestion. This protocol is supported by the clinical experience of our users in treating angina patients who also suffer from HF.

I hope that CMS will reconsider their preliminary decision and grant expanded reimbursement for ECP therapy for angina and heart failure.

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I have been a Registered Nurse for 18 years and have never seen the results the external counterpulsation gives. I have been an EECP therapist for 3 years and have seen many positive results. Many of our patients have numerous procedures(at great cost to you) to no avail and find positve results with EECP. Many patients have debilitating angina with numerous admissions to the hospital for suspected MI to find again the diagnosis of Angina. I have seen improvement not only in Angina but in renal functions, Diabetes, Erectile dysfunction, Glaucoma, Macular Degeneration, cardiac ejection fraction, Congestion Heart Failure and COPD. In conclusion, I am requesting that the coverage for external counterpulsation be expanded as I believe that with the usage of EECP, the cost of procedures and hospital admissions will decrease..

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As an EECP therapist (CET) for over 3 years, I have seen some amazing results. Many of the patients we see are severely debilitated and have no other revascularization options. Many find themselves short of breath or have anginal symptoms just from walking into the therapy room from the parking lot. After ECP therapy, the majority of our patients are able to do more basic activites of daily living symptom free. They appear vibrant and happier after 7 weeks of therapy. ECP therapy has provided patients with a new lease on life. ECP therapy has affected me, by observing patients on their first day compared to their last day of therapy, it makes me realize that there is something that can be done to help these so called "cardiac cripples".

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Our EECP Center has treated 450 patients over the past 7 years. Usually our daily census includes at least one patient with the concomitant diagnosis of CHF with stable angina. We have seen undeniable improvements in these individuals and have witnessed the patients' elation when they realize that they have had a weekend of comfort and ease just with activities of daily living. It gives them hope and a renewed interest in hobbies, travel, community service and enjoyment in living. This may mean that they can plan on visits with family and grandchildren without the worry and anxiety of that possible trip to the ER or that they can enjoy holidays at home instead of in the hospital. Individuals who suffer with the symptoms of CHF should have one more choice of noninvasive, non-drug treatment. ECP has proven to improve exercise ability, decrease symptoms, enhance quality of life and extend the life of individuals with CHF. We have documented improved ejection fractions post 35 hours of therapy. Please reconsider your decision by allowing coverage of ECP for patients with the diagnosis of CHF. Thank you for your consideration.

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I have worked with patients in EECP for 7 years and have seen so much improvement in their angina status. This coverage needs to be expanded to CCSC class II and NYHA Class II/III stable HEART FAILURE!!! There is no question that there would be less hospitalization of these patients and increased quality of life. Please reconsider this coverage. Patients under going EECP are very closely monitored and many MD visits can be avoided and many hospitalization averted because of the treatment and the close surveillance by capable eecp trained nurses.

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I am a physician in private practice in western Pennsylvania who has integrated ECP into my practice for over three years. I have seen dramatic improvements in my patients' functional capacity, remarkable reduction in suffering from ischemic heart disease, and consistent reduction of reliance on cardiac drugs with concurrent reduction in their inherent adverse effects. Those patients who are fortunate enough to become aware that ECP is every bit as effective as the more dangerous invasive interventions so popular in our disease care system for treatment of not only ischemic heart disease but also for treatment of the failing myocardium, are often precluded from access to ECP because of a restrictive system of reeimbursement led by the Medicare example. When a safer, less expensive, yet equally effective treatment is available to patients, it is mind boggling that Medicare would favor a system that encourages invasive and costly interventions (both in terms of dollars and human suffering) by unquestioningly reimbursing their gross over-utilization in a cardiology arena where all decisions are made in a closed loop, with neither "checks and balances" nor any accountability for outcomes.

It's time to stop the madness and recognize what is obvious: when properly implemented ECP is a safe, effective therapy that produces highly predictable benefits for an extremely low cost. We must stop squandering our precious resources on therapies that generate dollars for hospitals and cardiology centers but only marginally benefit patients. We must recognize that ECP is a physical intervention with a tremendous potential for patient benefit and cost savings with minimal potential for harm. When compared to the prevailing invasive interventions and polypharmaceutical interventions, ECP should be the first choice with the others only used should ECP either fail or the patient not be a candidate. In no small part due to our cookbook overuse of toxic drugs such as Beta blockers and others that interfere with repair processes and normal metabolism, there is a burgeoning epidemic of Congestive Heart Failure in this country. ECP has been proven to support repair processes that enhance myocardial function without drugs, or in spite of drugs. The international registry for ECP at the University of Pittsburgh documents a track record of safety and efficacy around the world. If Medicare shows the foresight and compassion to permit coverage for treatment of CHF with ECP, surely the short term increase in expenditures for ECP reimbursement will be far outweighed by the long term savings in reduced invasive interventions and saved human suffering. This is a win/win situation and a likely means to slow the hemorrhage of Medicare funds. Do the right thing for Medicare and mankind cover ECP for CHF.

Ralph A. Miranda, MD

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Every patient that we have put on EECP therapy has noticed an improvement. A few were modest but most were dramatic improvements. Many patients that took Nitro pills for chest pain were able to stop taking them. Several patient improved so much, that when nearing the end of treatments, asked if they could start doing things that they had been unable to do for over a year, such as bowling, hunting, chopping wood. Several have offered to talk to our other patients about the benefits of EECP. This therapy definitely enhances the Quality of Life.

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I am writing to provide feedback regarding your recent decision to deny expanded coverage for the use of enhanced external counterpulsation (EECP). I have been in practice as a board- certified cardiologist for over 20 years now, working both as a general cardiologist, as well as an interventional cardiologist performing balloon angioplasty procedures in the cardiac catheterization laboratory.

In the last year or two we have been offering EECP as a treatment for patients with refractory angina. I know you are well aware of the efficacy of EECP treatment in this group of patients, but I want to reiterate those results with our own findings. By definition, these patients have been refractory to every other form of treatment for angina and have been severely incapacitated by their symptoms. The results from the EECP treatments have been impressively positive providing marked symptom improvement in these frequently desperate patients. These are the most grateful patients I have ever seen in my career.

There is no question that EECP is an effective treatment for angina. I think it is a mistake to relegate the treatment only to patients with the most severe, refractory angina. It is a completely noninvasive, relatively cheap treatment option, and I cannot fathom why it would not be considered an alternative first- line treatment comparable with either long-term medical therapy or invasive revascularization procedures. Clearly many patient with mild angina would become symptom-free after EECP treatment and would therefore enjoy a markedly improved quality of life without the need to take long-term expensive medications or undergo expensive interventional procedures sometimes requiring prolonged hospital stays and recovery times.

I would also like to comment on the use of EECP for treatment of heart failure. There is solid clinical evidence that it is effective in this group of patients. As you are well aware, we have some excellent pharmacologic treatments for congestive failure, but nevertheless, many people end up with refractory symptoms resulting in a markedly poor quality of life, as well as multiple hospitalizations for exacerbation of their heart failure. This again represents a rather desperate group of patients for whom all other treatment options may well have been exhausted. If the EECP can be helpful for these patients, why would we want to withhold the treatment? Again, it represents a relatively simple, noninvasive, cost-effective treatment option. Even if a given patient did not obtain much benefit, nothing has really been lost in terms of hurting the patient with invasive procedures, and from a cost perspective realistically not much money has been spent.

Not to become overly melodramatic about this, but each and every one of us should consider at a personal level the treatment options we would like to have available for ourselves or our loved ones should these sorts of illnesses occur. It clearly represents a relatively simple, noninvasive, treatment option that is both medically effective as well as cost- effective, and should remain a viable option for our cardiology patients.

I strongly urge you to reconsider your decision.

Sincerely,
DONALD R. PACINI, MD

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As a provider of ECP therapy I would like to share some of the experiences with patients I have had over the last 3 years. The majority of my patients came to me after suffering through multiple surgeries, catherizations and on an abundance of medications. Their quality of daily life was poor and many did not feel anything would help them to enjoy many of the things they had previously done. Some of these things were cooking a meal, cleaning the house, gardening or just trying to get to the bathroom without the fear of chest pain. Their sedentary lifestyle had also begun interfering with other areas of their health. Simple tasks such as climbing a flight of stairs or playing with their grandchildren were now becoming too difficult.Along came a therapy that was for them kind of strange but by then they were willing to try anything. I too was not much of a believer when I first started administering ECP therapy. It just did not seem likely that something simple, safe and inexpensive (in comparison to many of the procedures and hospitalizations the patients had gone through prior) could actually help them in any way. BUT IT DID!!!! Time and time again I have seen patients who came in with no quality of life to speak of, walk out of therapy doing many of the things they had given up long ago. It didn't take long before I too realized just how much of a difference this therapy made in the lives of so many patients. To see the improvement first hand was what made me a believer and for the patients it was how much better they felt. Less angina or none at all, a decrease in their shortness of breath, an ability to do more, such as exercise, fewer trips to the Emergency Room and an overall better quality of life. The thing that I hear most often is "Why wasn't I able to have this before I had all of the catherizations and surgeries that were hard on me and dangerous? If this is safer and seems to work why did I have to go through with all of those dangerous expensive procedures before I could qualify for this therapy? Why couldn't I have tried this first and maybe not have had to risk my life so many times with invasive, dangerous procedures?" I am never quite sure what to tell them. WHAT WOULD YOU SUGGEST I TELL THEM!!! NOW AN OPPORTUNITY HAS COME FOR YOU TO ALLOW PATIENTS TO HAVE A SAFER, PROVEN THERAPY. PLEASE DON'T TURN YOUR BACKS ON THE PATIENTS WHO WILL NOT BE ALLOWED TO TRY THIS THERAPY AND WILL JUST CONTINUE TO SUFFER AND BE HOSPITALIZED TIME AND TIME AGAIN. ALL PATIENTS SHOULD HAVE THE OPPORTUNITY TO REGAIN A QUALITY OF LIFE WE TAKE FOR GRANTIT.

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Dear CMS,

Over the past 8 years I have treated over 800 patients with EECP. Nearly all have responded favorable, and for many, EECP 'gave them their life back'. Post-EECP, hospitalization and event rates have also fallen (I can document this). Thus with EECP I have been able to help patients who could not be helped by other means and reduce their health care expenditures.

My only frustration has been CMS's position to cover EECP only in patients with advanced symptoms who are not candidates for further revascularization. This sounds like a good policy and makes sense on paper, but in the real world of medical practice it means that patients don't make it in to EECP until they have undergone multiple unsuccessful invasive procedures. By this point many are really too far gone to be turned around. A change in the wording of CMS's policy to cover EECP in individuals not felt to be good candidates for invasive revascularization or who have not been helped by an initial revascularization procedure would allow us to treat people before they become too far gone. I also feel that such a policy shift would save CMS a lot of money. Along this line, extending coverage to individuals with class II symptoms would also allow us to help more people, before they get to the too far gone point, and here again we would save on cost. I don't know the exact cost of a day in the hospital, but my hunch is that two to three hospital days costs as much as 35 hours of EECP. I have helped many patients with heart failure, just as the literature would predict. These patients paid for their EECP out of pocket or had insurance other than CMS. I feel strongly that a CMS policy to cover EECP in heart failure will not only improve the status of our patients but will reduce hospital utilization rates and conserve health care dollars.

I thus urge CMS to change its EECP coverage policy along the lines of Vasomedical's suggestion to include EECP therapy for use in the treatment of patients with Class II stable angina and in patients with stable NYHA Class II/III congestive heart failure symptoms with an EF „T 35% as a primary indication. EECP is a great technology. By expanding coverage to CHF and Class II angina, CMS will allow us to help more patients and reduce health care costs.

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I strongly encourage the expansion of ECP coverage for Class II angina and CHF with EF < 35, and patients post MI. I have been performing ECP at three centers for the past 7 years and have observed significant improvements in many patients.

My facilities also provides Phase II and Phase III cardiac rehabilitation with many patients continuing in these program for over 10 years. The improvement that I have seen in ECP patients compares with those patients that have exercised for two years. There have been several whose angina and de-conditioning was so limiting that they could not start rehab until they completed their ECP.

Other patients, especially diabetics that may not feel chest pain but have very ischemic stress test and are not good candidates for invasive procedures have also had excellent outcomes.

A recent patient in his 80's was having angina that was probably considered Class II. His physician opted for bypass surgery and the result was a post surgical stroke that has now disabled him. This patient and many more like him would greatly benefit from ECP as a primary course of treatment. A much better outcome for the patient and dramatic cost savings for Medicare.

CHF patients that have angina have also greatly increased their exercise capacity and based on the results of the PEACH study, I know that CHF patients without angina will also improve.

Please add these conditions for coverage.

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As EECP Medical Director for The Cardiology Group, P.A. I am very concerned about the recent CMS decision to not utilize EECP in the treatment of Stage II/III CHF.

Stage II and III heart failure are levels of heart failure not covered at this time by biventricular pacemakers, therefore, we only have drug therapy and lifestyle modification as a treatment option in this subgroup of CHF patients. EECP has clearly been shown to work nearly as effectively and, sometimes, more effectively than PTCA and anginal patients including those with significantLV dysfunction.

I am perplexed that Medicare continues to pay for angioplasties done multiple times on patients with little success. It is performed many times outside of accepted criteria, mainly in those patients with asymptomatic ischemia. I have found, personally, that EECP many times is a preferable treatment over PTCA. There is certainly a significant cost savings and no decrease in survival rates. The results of the PEACH Trial show as good a result as any standard drug therapy programs have shown in the past.

I would suggest that you reconsider your decision on EECP therapy for patients with CHF. Savings can be made in other areas such as the explosion of diagnostic testing and imaging which does not offer any therapeutic nefits to patients and is many times redundant and overpaid.

It is clear to me that CMS can decide the future of treatment options with their decisions in the past to decrease payments for EECP. It can be very difficult to treat enough patients in a day to break even. I have seen a decrease in the centers where EECP is performed because of that reason and I think we will see continued decline in that treatment modality, primarily because of the decions of CMS.

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As Clinical Operations Director for The Cardiology Group, P.A., I have managed EECP since the program began March 1, 2001. We currently treat 10 patients/day and the patient outcomes measured at the end of 35 treatments reveal a significant improvement in each patient's Quality of Life, level of energy and measureable changes in anginal and breathing symptoms. In addition, the hospital re-admission rate has decreased significantly, as well. As one of the premier providers of cardiac care in Burlington County, New Jersey, The Cardiology Group, P.A. has been recognized for the quality of care provided to patients with CHF and the decision not to approve Class II/III CHF for EECP, at this time, is both disappointing and frustrating. These are the patients we should and must be targeting for EECP Therapy, as CHF is the #1 re-admission diagnosis and one that is very costly for all Insurance providers.

With the number of CHF patients in our practice, it is very clear that we need to vigorously pursue other treatment modalities, including EECP, to better assist our patients in being able to live a more productive and healthy lifestyle. On behalf of our patients, I ask you to support and approve EECP for Class II/III CHF, as well as Class II stable angina. Thank you for your consideration.

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2006-ECP:CMS Decision to Expand Coverage for CHF Patients: I have been involved with ECP from the late 60s with Dr. Soroff at Stoneybrook. I have followed ECP all these years and felt it to be beneficial, and introduced it to Miami Heart Institute in Miami, FL, and JFK in West Palm Beach, FL. There is no question in my mind, and will be demonstrated by the PEECH Trail, that it will be beneficial to all patients in CHF. This should economically be very cost savings to Medicare in keeping people out of the hospital and out of CHF.

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I have been an EECP therapist for nearly 10 years, and never in the 28 eight years I have been in the medical profession has one single treatment been more effective or offered more hope where there was none previously. Do we send our soldiers to war ill equipped to fight the enemy. NO!! Why tie the hands of the professionals to fight this enemy? Congestive heart failure is the primary co-morbid condition these patients have presented with for treatment. They do extremely well. Less shortness of breath, less discomfort, more energy, better quality of life. That is all they want and this treatment is the in the front lines helping these people back to life. It’s not a lot to ask. I have witnessed numerous patients over the years have their ejection fraction improve from 25 up to40 %. This in not anecdotal information these are facts. I have seen improvements in perfusion in nuclear studies, patients who can’t walk to their treatment and after a couple of weeks have left their wheelchairs at home. Patients who have been admitted to hospital monthly, are able to continue a life at home without problems, patient’s who central lines with daily dobutamine infusions have it discontinued and are riding bicycle with their grandchildren. I have treated patients with history of V-Tach arrest, present for treatment with numerous multi focal PVCs, couplets, salvos, Bigeminy, Trigeminy, ….have one or two PVC’s on a 24 hour holter post EECP treatment. So why is it so hard for decision makes to understand that this is a viable treatment option for patients with primary congestive heart failure. The PEECH trial has proven the efficacy. Lets move forward and not backward. EECP is a viable option for patients with primary congestive hear failure . Listen to the patients and help those of us who are out in the trenches fighting off disease. Give us the ammunition we need to be good healthcare providers. In 10 my years of EECP practice over 700 patients are proof positive. Please reconsider your decsion,for all congestive heart failure patients and ClassII angina.
Louanne Tempich
Supervisor for EECP, EECP Center of Pittsburgh, President Interantional EECP Therapists Association

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Gentlemen:

I wish to make some comments on the CMS determinations on coverage for EECP Therapy.

The case for Chronic Angina Pectoris:

The current criteria for evaluation and determination for coverage for EECP seems to be bias and under a double standard of criteria when compared to other approved modalities to treat chronic stable angina pectoris.

PTCA, stents and in general PCI are been covered with no clear benefit of their use when compared to medical therapy in general terms. Forrester and Shah argued as early as 1977, that performing PTCA immediately after making a diagnosis of stable coronary artery disease (CAD) provides little or no benefit over medical therapy.( Forrester et al, Circulation 1977,96:1360)

The Duke databank followed over 9000 patients from 1984 to 1990. Among patient with 1 vessel disease and less severe 2 vessel disease, neither of the mechanical interventions proved superior to medical therapy. (Califf et al, Semin Thorac Cardiovasc Surg. 1994;6:120)

In 2003 the RITA-2 trial showed that in patients with angina class 2 or less there were no difference between medical therapy and PTCA. (Henderson et al, J Am Coll Cardiol. 2003;42:1161)

Another study in patients 80 years and older , TIME trial, showed that 1 year outcomes in these elderly patients were similar with regard of symptoms, quality of life, and death or nonfatal myocardial infarction. ( Pfisterer et al, JAMA 2003;289:117)

Even with the above mentioned evidence, CMS continues to approve PTCA and PCI in general, with no limitations. When it comes to EECP coverage then limitations applied, even so the evidence is overwhelming that EECP is better than medical therapy for the same cohort of patients above described. This is a double standard and a bias one against a non invasive therapy that if anything may save millions of dollars to the Medicare fund.

“As a noninvasive treatment it should perhaps be considered the first-line treatment with invasive revascularization reserved for EECP failures or high-risk patients. The International EECP Patient Registry was used to analyze a cohort of patients with prior percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) (n = 4,454) compared with a group of patients (PUMPERS) who were candidates for PCI and/or CABG and chose EECP as their initial revascularization treatment (n = 215). The PUMPERS responded to treatment with EECP with decreased anginal episodes and nitroglycerin use and with improvement in their Canadian Cardiovascular Society functional class, similarly to previously revascularized patients. Treatment with EECP resulted in sustained, and often progressive, reduction in angina over the succeeding 6 months. Given the findings of this study, it is interesting to speculate on the possibility of using EECP as the primary revascularization intervention after medical therapy proves unsatisfactory”. ( Fitzgerald et al Cardiology. 2003;100(3):129-35.)

By easing up on the current requirements for coverage of EECP therapy with a register you may be able to show the enormous saving this therapy may provide.

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I have been an EECP therapist for about 3 1/2 years. I am very disappointed with Medicare's decision to not expand coverage for EECP. I have seen remarkable changes in patients. Befor treatments they were unable to carry on activities of daily living. After treatments they are able to do activities that they couldn't do because of angina, shortness of breath, and fatigue. We have treated some angina patients that have also had some heart failure, and the majority of them have had good results. They can do their housework, play with grandkids, go to church, walk a block, accomplish more, cooking,etc. The list could go on & on. Angina & heart failure are a crippling disease and this treatment can help them. Please reconsider your decision.
Brenda Wehr

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Realizing that protocol must be followed in order for a decision to become policy,we cannot ignore the fact that PEECH demonstrated overwhelming proof that CHF improved with EECP. You must be proactive with your decision to provide insurance coverage for this group of cardiac patients. Many CHF patients no longer have a good quality of life because of their labile symptoms. Repeated hospital stays and the ever increasing cost of medication make for a miserable life for these patients.As the supervisor of a 3 bed EECP center, greater than 450 patients have successfully been treated at our site. They constantly testify to the improved quality of life that EECP has given them. We repeadedly hear "if it weren't for EECP I'd be dead". Many, many of these patients carry a concomitant diagnosis of CHF in addition to angina. They would not have been offered EECP if it were not for the diagnosis of angina, as this is the only insurance approved diagnosis. Despite the very reasonable cost (compared to hospitalization and medicines), these patients are now exhausting their life savings, trying to stay alive.It behooves you to approve insurance coverage for this vast group of people.Thank you for the opportunity to voice my opinion and observations.

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At Baptist Hospital, we are the only facility that provides ECP in our area. We are pleased to say that many patients commute from nearby cities and states to participate in a treatment regimen that has been proven time and time again to reduce cardiac symptoms that compromise day to day activities. Over the past five years, we have treated over 100 patients with a 95% success rate in regards to overall quality of life. It is hard to imagine Medicare denying coverage for a treatment that could improve the health of so many angina and CHF patients. Many patients have CHF related problems and symptoms without necessarily have class III or IV angina but cannot undergo EECP because insurance will not cover it. Hopefully, the feedback and testimonials being provided will be overwhelming evidence that Medicare should join in the efforts to keep our citizens well. Maybe the deciding committee should open their hearts to the patient testimonials and think what if one of their family members needed this treatment but could not afford it because insurance would not cover it.

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The reason that I feel the diagnosis of CHF should be extended to be covered under Medicare for ECP patients is the following: the affects of the treatment on patients with stable angina that I have witnessed since our program started approximately 3 years ago has been tremendous. After completion of the ECP program, these patients are able to function at a higher Met level with fewer or no angina symptoms, and this not only gives them a better quality of life but a more productive one at that. Not only is their physical status improved, but their mental status is also affected by their ability to be more productive and independent. This is not to mention the decrease in physician office visits, emergency room visits and inpatient stays. I as a health care provider feel that we are doing patients with a diagnosis of CHF an injustice by denying them the chance to improve their quality of life by having this treatment done.

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I find it very disheartening to hear that Centers for Medicare and Medicaid Services has decided not to expand the reimbursement coverage of EECP therapy. As a nurse who has worked with the EECP program for the last 5 years, I have seen our patients achieve so much benefit as almost everyone has relief of chest pain, SOB, and an improvement in energy. They appreciate having another option instead of having to go through an invasive procedure. EECP is also a cheaper option vs. Bypass procedures, or numerous Primacore infusions for CHF patients (not including all the other meds, and potential hospitalizations that go along with that diagnosis.) I believe that EECP is a proven valuable option. I find it a shame and disservice that we can not offer it to CHF pt's and Class II chest pain pt's. How wonderful it would be to build collateral circulation for the chest pain pt's before they get to Class III/IV. Who knows, maybe if they had the treatment earlier, they would not have to see Class III/IV angina. I hope that you reconsider this denial, as EECP is a wonderful, very beneficial alternative, that patients deserve to have.

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Coverage of EECP should be extended to include the treatment of all patients with clinically significant, medically refractory CCS II-IV angina and NYHA class II-III heart failure.

In the CAD patient with chronic disabling angina (CCS II-IV) refractory to medical therapy a 35 hour course of EECP has been demonstrated to have the following durable benefits:

I have been the coordinator of the EECP program at JFK medical center since February 1998. I am amazed at the positive outcomes that I have seen. I strongly encourage the CMS to expand the coverage for angina and heart failure patients. I have been working in the cardiology field for over 25 years and this treatment has positivley changed the quality of life for so many patients. It is a shame that EECP is not offered sooner to our clients. Why not improve their quality of life and prevent future angina and heart failure admissions. Why wait until someone is disabled by their symptoms? EECP prevents patients from numerous hospital admissions. Just imagine the savings to our healthcare system. One of the best things about EECP is that it is non-invasive and safe. I can honestly say that I have not seen any adverse outcomes associated with EECP therapy. Can that be said of other invasive treatment options?We were involved in the IEPR data and the PEECH trial. Unfortunatley heart failure patients do not have alot of treatment options. We have seen first hand the improved outcomes stated in the literature. EECP is truely an amazing treatment option!Thank you for allowing me to state my opinion.

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I would like to comment that I believe it is important to change the existing coverage for EECP. I believe additional cardiac conditions would greatly benefit from the treatment. Most importantly I believe patients with congestive heart failure would show significant benefit from this treatment. The treatment is a wonderful non-invasive way for patients to see results in the management of their CHF. By not covering these patients under the current coverage we are not optimizing their care. Thanks you for your comsideration of my comments.

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I have read many of the letters submitted to your office supporting increased coverage for EECP. I am not going to parrot the requests quoting clinical outcomes as I believe the more than 100 peer review journals document the clinical needs.

As a hospital administrator, a long term health care administrative consultant to numerous hospitals throughout the US and as a private citizen my concern reflects the financial consequences of a CMS denial for increased coverage and not the clinical.

The traditional clinical pathway for CHF/Angina/Chest Pain/CHD patients for whom invasive procedures are no longer a viable alternative allows for EECP therapy for some of these patients. In many cases without increased CMS coverage the patient is limited to 'Drug Therapy' which leaves these patients symptomatic.

The traditional pathway for these patients includes admission to the acute care hospital 3-4 times per year, frequent ER visits (with 5-50 per year not uncommon), utilization of expensive drugs and unnecessary utilization of physician services 12 visits per year or more is not uncommon. With many hospitals facing nursing shortages particularly intensive care and emergency room RNs the unnecessary utilization of this scarce resource leads to a spiraling increase in their salaries and increased costs to the healthcare system. Moreover, many hospitals are at or near capacity in their intensive care units and emergency rooms. The failure to eliminate unnecessary utilization of intensive care units and emergency rooms leads to very costly construction projects.Expansion of an ER and or ICU department can easily cost $5 million or more with total replacement costing even more.

The cost to the system of caring for the CHF/Angina/Chest Pain/CHD patients under the traditional clinical pathway described above often times exceeds $50K/patient/year. By contrast a clinical pathway utilizing EECP therapy costs the system $4-$7K for those that are successful and require no further care beyond their EECP therapy.

When the savings described above is multiplied by the 450,000 patients for whom EECP services would be appropriate under increased coverage the direct system savings would be expected to exceed $18 Billion per year. This savings does not even take into account the reduction in the need to expand existing over utilized hospital emergency rooms, hospital intensive care units or the ability to re-utilize the ICU nurses, ER nurses, EMS providers who would no longer be needed to care for these patients for whom EECP has provided a new and improved life style.

Since there is no evidence what-so-ever that the non-invasive EECP treatment protocol can in anyway harm a patient, CMS should examine the financial consequences of denying increased coverage. Our healthcare delivery system should consider every alternative which can reduce costs.

If I can provide any additional information, please do not hesitate to contact me.

Respectfully submitted by,

Michael L. Schwartz, FACHE

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As a provider of ECP for several years, I have seen the amazing improvement in quality of life that has been achieved in patients with heart failure undergoing ECP for dyspnea as a serogate for angina. Many of these patients had poor EF and were experiencing angina due to small but intense areas of ischemia on nuclear scan - intense enough to cause frequent angina but not large enough to likely effect LV function. These patients had as much benefit in quality of life as those with much larger ischemic burden but better EF's. I think the PEECH trial addresses just this issue, improvement in quality of life in patients with chronic stable CHF - an improvement similar to those undergoing ECP for current indications. I strongly advise CMS to provide ECP benefit for CHF patients. They deserve the same consideration as those suffering from angina, as they usually obtain the same quality of life benefit.

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As a board certified cardiologist, I have treated approx. 80 patients c EECP. Approximately 10 of my patients have had class 2 anginal symptoms are were not covered by Medicare quidelines. These patients by and large beneifited greatly from their treatment. By aggressive risk factor reduction and EECP we were able to avoid very expensive revascular-ization procedures which address only one or two critical blockages, and instead treat the entire coronary vascular tree. The patients now have an axcellent long term prognosis because they are helping themselves rather than relying on a surgical fix which in only temporary. In the end, MediCAr approval for type II angina would prevent many cases of angiograms and stenting which costs much more that EECP and in the long term actaully does less for the patients.

Treatmaent for congestiave heart failure is also beneficial as documented by the PEEP trial. Ibelieve treatment of these patients is more crictical if the underlying etiology of their CHF is ischemia. EECP does inprove nitric oxide levels which leads to improved vascular function in these patients. Certainly by keeping these patients out of the hospital for exacerbations of CHF we are again reducting overall medical expenditures.Therefore, I strongly urge that the indications for EECP be expanded to include patients with class II angina, and patients with CHF due to ischemia cardiomyopathy.

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I have in my practice in the last two years two patients with left ventricular ejection fractions of less than 35% who were NYHeart Association class III (shortness of breasth)on maximum medications and could not have further revascularization. Both of them benefited greatly from ECP therapy in terms of improved exercise tolerance and improved quality of life. I think it is inappropriate not to approve ECP for individuals with heart failure symptoms related to coronary artery disease who are in Functional Class III. Please reconsider.

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The research we have done on EECP at the University of Iowa has included some Class II angina patients and patients with ejections fractions less than 35%; it has demonstrated a significant improvement in functional capacity. It is counterintuitive to wait to perform this noninvasive, cheaper treatment until patients are out of options. While we have not studied heart failure patients receiving EECP here, I am well aware of the PEECH trial soon to be published, that clearly demonstrates improvement in this patient population. Certainly, we have treated patients who have had heart failure accompany their Class III angina and we have seen comparable improvement.As a taxpayer, I am interested in providing cheaper, noninvasive, earlier treatments instead of very expensive invasive treatments.I strongly urge you to include Class II angina and heart failure patients as candidates for EECP.
Patricia Lounsbury, RN, BC, MEd, CCRN, FAACVPR
Advanced Practice Nurse and Program Director
University of Iowa Cardiovascular Health,
Assessment, Management, and Prevention Services
(CHAMPS)

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I am a cardiologist providing EECP therapy in a large multispecialty organization for the past year. Although initially skeptical, I became convinced of the benefit of EECP for patients with intractable angina. Regardless of the mechanism of angina, functional class II patients may be benefitted by undergoing EECP. Additionally, the PEECH trial data is supportive of a role for EECP in improving CHF symptoms and may prove to be an important cost effective option for otherwise difficult to manage patients. The data was sufficient not only to convince me but also another branch of the federal government, the FDA. I urge CMS to approve EECP for reimbursement.

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As a physician who has treated many cardiac patients with EECP, I would like to comment on the use of EECP for class II/III CHF. These pts have severely impaired quality of life and often have no further treatement options (medications, CRT-D, transplant have been exhausted). Given the safety and efficacy results in CHF patients, I believe that EECP is an important option for relief of symptom in patients on optimal medical therapy. Please consider extending coverage to this pt population.

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This comment is in favour of expanding coverage of EECP treatment for Class II angina patients and Class II-IV CHF. I have been involved in both EECP research and its clinical use since 1996. About 75-80% of patients with angina have had dramatic reductions in requirement of antianginal medications. These effects have been sustained over a period of years as well. The benefits of EECP in CHF has been clearly demonstrated by the PEECH trial. With over 75% of patients with CHF having Coronary disease as its etiology stand to benefit from this single therapy which is virtually free of adverse effects and has sustained benefits.

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Although initially I was skeptical of the benefits provided by EECP for both angina and CHF, after personal experience I have found this therapeutic modality to be very helpful for both angina of CCSC Classes II-IV and modest to severe CHF of NYHA Class III and IV patients. The good results reported in the studies in the literature caused me to reassess my opinion of this treatment method and our results have justified my change in opinion. I urge the CMS to strongly reconsider their decision not to expand the coverage of this treatment modality to include less severe forms of angina and CHF. In contrast to other forms of angina treatment EECP has essentially a zero mortality rate, trivial morbidity risk, and an excellent success rate. The downside risks of EECP are far less than those of a number of other currently covered forms of therapy and the documented benefits are quite similar.

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Please allow this noninvasive effective treatment to be administered to CHF patients. I have been working with Refractory angina patients as primary diagnosis and some have had CHF as secondary diagnosis entering EECP lab for the past 2 1/2years. These patients have also had positive outcomes as a result of this treatment option. Many patients with coronary diseases have a poor quality of life secondary to limitations of the disease as well as effects of meds on board. They are hypotensive/bradycardic and listless yet without meds end up in ER over and over or may indeed die. Why not rethink the process and allow a treatment option that can do more with positive results. I think many centers would be willing to partipate in any study for Medicare showing benefits of EECP tx.

The ER/hospital/nation wide healthcare costs is the secondary reason to consider this treatment. The primary reason is the person behind that failed beating heart.

Thank you for your consideration. Kim

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I am a RN and EECP coordinator in a large heart facility on Staten Island. I am very confident in the results of EECP treatments from an increase in energy,decrease in SOB, and freedom from chest pains. One particular patient comes to mind, this patient has a history of CABG,several cardiac caths, stents, and many hospital admissions due to severe angina. Shortly after beginning EECP this patient has been free from CP and had his first NORMAL Ekg in years. This is a patient who could easily take 3 nitro's with each episode of angina, and had many episodes and often. To both of our suprise, he was able to respond to an emergency situation at work and RAN up the stairs free of pain and SOB. I support the recommendation of EECP for both angina AND CHF, because I have seen the improvement week after week. I am hoping this letter will keep this treatment available to those who need it and can truly benefit from it.
Sincerely,
Sharon Guibelondo RN,BSN

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My practice has been offering ECP treatment since June 2005. In that time, I have treated fifteen patients. 14 of those patients had significant improvement and the 15th patient choose to stop the treatment prior to completing the seven week session. I am absolutely sold on this treatment modality. And it is my beleif that most everyone who is able to take this treatment will benefit from it.I request that you approve reimbursement for those patients with CHF, acute MI, and cardiogenic shock.

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The reason that I feel the diagnosis of CHF should be extended to be covered under Medicare for EECP patients is the following: the affects of the treatment on patients with stable angina that I have witnessed since our program started approximately 1 1/2 years ago has been tremendous. After completion of the EECP program, these patients are able to function at a higher Met level with fewer or no angina symptoms, and this not only gives them a better quality of life but a more productive one at that. Not only is their physical status improved, but their mental status is also affected by their ability to be more productive and independent. This is not to mention the decrease in physician office visits, emergency room visits and inpatient stays. I as a health care provider feel that we are doing patients with a diagnosis of CHF an injustice by denying them the chance to improve their quality of life by having this treatment done.

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We would like for CMS to reconsider reimbursementfor CHF and acute myocardial infarction. We have done several patients for angina in our facility and secondary to this they have CHF. We have noticed great improvements in these patients. They were wearing oxygen prior to treatments, were continually short of breath, edema, and fatigued. Each of the patients after finishing 35treatments of ECP went off their oxygen, had improved heart function, from 10-15%, to 30-40%EFs, and improved their quality of life tremendously. If we need to provide documentation to help you make your decision please feel free to contact me. Thank you for the opportunity to share some information with you.

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I am a cardiology nurse practitioner and I refer patients to EECP at the hospital where I work. I have had many patients tell me how much better they feel after this treatment. Many had tried multiple medical therapies with no improvement in their physical abilities. Most patients experience improved exercise tolerance and decreased symptoms. I realize that this is anectodal, however, over the period of time that we have been able to offer EECP (3 years), I have seen many patients benefit from it. I would like to see the indications for EECP expand to include stable NYHA class II and III heart failure. Please give this information consideration when making future decisions and establishing policy.

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I provide ecp therapy to patients in a small rural hospital. The patients I treat have said, "Why did I have to wait until I had gotten this bad to do this? It would have saved so much and I could have felt better and been able to do things so much sooner." One patient had been hospitalized with chest pain 7 times in 7 months at tremendous cost. After ecp it was another 7 months until he had any reoccurance. Please provide ecp therapy to the many patients that cannot adequately function in their homes, cannot walk to their mailboxes or climb stairs without episodes of chest pain, shortness of breath or fatigue stopping them. Patients tell me that after ecp, they are able to do normal household functions that they haven't done in months or years.
Please reconsider,
Sincerely, Sue Barley,RN BS

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When I sit down and research EECP and read published studies, it seems that nearly all studies include classes II-IV angina and/or heart failure patients. I cannot understand that if the research clearly indicates significant improvements in class II angina patients as well as heart failure patients, why CMS would not cover these patients. It does not seem logical to me. I think it would be extremely beneficial to expand EECP to a wider variety of patients. At our institute, patients at the lower end of class III angina and patients with an EF < 40% have seen significant improvements in QOL and exercise capacity. These improvements are very comparable to the improvements seen in class IV angina patients.

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Dear CMS, I'm a Cardiology Technician working directly in connection with ECP Therapy. I've seen tremendous beneficial results from the therapy such as decreased hypertension and improved overall cardiovascular circulation. I have seen patient's suffering from angina, chf, and diabetes and their symptoms have decreased dramatically, thus showing marked improvements in their quality of life. It would be a shame and an outrage to deny anyone especially those with CHF the opportunity of receiving this therapy which I guarantee will improve their lifestyle. I advocate that everyone no matter what their health status is should receive the benefits of ECP. Therefore, CMS you just act even more so with urgency to approve this therapy for these patient's with CHF who have very limited therapy options already.
Sincerely
Benson Gilliard

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Bottom line, this is a proven therapy for Heart Failure patients. It would be a crime not to make this therapy available to those who so desperately need a way to improve their quality of life. I challenge those who are in a decision making position to ask themselves if they are looking merely at short-term dollars and cents or are they truly considering patients' well being?

In actuality, this therapy is a long-term cost- avoidance tool for Medicare and other insurers. Do the right thing. Help make this treatment more accessible. Support this therapy for heart failure.

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I have been an ECP Therapist since 2001, and have treated many patients that have had truly remarkable outcomes. I was also involved in the treatment of some of the heart failure patients in the PEECH trial. I think patients should have the option to get the benefits of this treatment before they get so sick, suffer through sometimes years of poor quality of life and often spend all their savings on medicines and other therapy. It should be offered much sooner in the course of their disease, in order to improve their quality of life as well as their outlook.

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I was very surprised to read all the comments of the Medical Directors, Directors of Clinics, Cardiologists, various Medical Doctors, Nurses, Therapists and affected patients, ALL expressing their disappointment, surprise and indeed outrage, over CMS' decision NOT to extend coverage for Congestive Heart Failure to ECP. After reading their comments, one must wonder if these experts could, somehow, all be unanimously and completely wrong, or if CMS itself is on the verge of some colossal blunder, which will cost Billions of unneccessary and wasted Tax Dollars, and result in Thousands of painful, yet easily preventable deaths. After reading the collection of comments on the CMS website, it is clear the ball is now in CMS' Court, because the Jury, has most definetely, Spoken! And, all they appear to Ask, is that you Listen.

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Most of our patients that go through the EECP treatment in our clinic see a huge difference in what physical activity they can enjoy after the treatment is completed. One of our first patients had to be brought into oure clinic fronm the parking lot by wheelchair when she first started the treatments. Before she finished she was driving herself to the clinic and walking all the way from the parking lot down a long hall to get her treatment.EECP provides a quality of life many patients have not enjoyed for years.

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this therapy has already benefitted many of our patients with angina and concomitant heart failure improving both objective and subjective functional parameters of close to 80% of patients with these conditions.. the safety of ecp is unparalleled and it is very very cost effective therapy...we have now 3 yrs experience with ecp and can state unequivocally it should be covered for class 2,3,4 chf as it is such a safe "assist device" equivalent to if not more sensible than a balloon pump..please reconsider

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This is in response to CMS decision to not expand coverage of ECP to include Angina class II and Congestive Heart Failure. I have treated patient for ~ 3 years and have seen first hand the dramatic improvements my patients make in their lifestyle, ability to stay out of the hospital. ECP is extremely cost efficient and numerous studies shows it WORKS! One patient was being hospitalized every month and has been out of the hospital for six months at this writing. Please reconsider the expanded coverage of ECP, people across America are depending on you.

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To whom it may concern,

I have been using EECP therapy in my clinical practice for several years. Without a doubt, I can present an endless number of clinical situations where a paient recieved EECP therapy for incalcitrant angina and have found that the patient's concomitant congestive heart failure dramatically improved as well as their angina. This scenario has been seen clinicaly multiple timed and I believe is directly related to EECP's afterload reducing effect.

On a humanitarian basis I highly reccommend that you approve EECP theray for the CHF indication. This has long been overdue.

Sincerely,

Mason Weiss MD FACC

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I have personnally witnessed the benefits of this procedure on a an individual with conjestive heart failure (only 25% of heart funtional). When drugs and invasive surgical procedures were no longer an option, ECP provided the only solution and has given this indivdual nine wonderful years to spend with his family. The Cardio-thoracic specialists gave him a window of two years with a poor quality of life. The studies of this procedure are well documented and understood. If CMS had not accepted and covered the cost of this procedure ($5,000), well below heart surgery this individual would be dead now. Alot of Americans cannot afford the high cost of invasive heart surgery and life long medications so this should be used as a last resort. Please continue to support this treatment and provide additional funding as the technology changes to provide better health care for Americans. Thank You!

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January 2, 2006

Dear Sirs:

I would like to present the following points regarding CMS’s recently published Assessment of EECP and their conclusions regarding the “quality” of existing RCCT evidence demonstrating the clinical effectiveness of the treatment in patients with angina and heart failure. In my view, EECP has been shown to have dramatic physiological impact on coronary perfusion, endothelial function, neurohormonal withdrawal, and central hemodynamics in a number of focused studies over the last 5-8 years. With regard to the clinical effects of treatment of patients with either chronic coronary disease, angina and/or congestive heart failure I would offer the following points for consideration.

Angina
1. As noted in the ACC/AHA 2002 Guideline Update for Chronic Angina, the treatment of chronic stable angina has two primary objectives: - Reduce mortality and morbid events - prevent MI and death- Reduce symptoms of angina and occurrence of ischemia The goals of angina treatment are elimination of pain and reduction in angina symptoms. Targeted health outcomes of treatment should be the complete or nearly complete elimination of anginal pain, return to normal activity, and return to a functional capacity as close to CCS Class I as possible. Treatment plans should be designed to reduce symptoms, improve function and QOL. (Gibbons et al. ACC/AHA 2002 Guideline Update for the Management of Patients with Chronic Stable Angina: A Report for the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, p. 48, 59.)
2 Angina clinical evidence derived from published studies including MUST and the International EECP Patient Registry (IEPR) consistently demonstrate that EECP therapy provides benefits that are sustained 2-years post treatment, and include a reduction in angina symptoms, improvement in functional status, and improvement in quality of life indicators. A peer reviewed publication authored by Michaels et al. reported 2-year health outcomes in a cohort of 1,097 patients from 28 sites and revealed a significant change in functional classification with 73% of patients in all angina classes maintaining an improvement of greater than or equal to 1 angina class at two years post-treatment. Additionally there were significant changes in the number of angina episodes per week experienced by patients immediately and 2 years post treatment compared to baseline at both time points (p< 0.001). Changes in Quality of Life measures showed a significant improvement from baseline in all patients for all three quality of life measures at both time points. (Source: Michaels AD, et al. Am J Cardiol 2004; 93:461-464)
3. Benefits of EECP compared to alternative treatments for Angina and Heart Failure–

Chronic Angina: A decision analysis by Aequitas was designed to evaluate the cost- effectiveness of EECP plus optimal medication for chronic stable angina by comparing the clinical benefits for improvements in angina class and health related quality of life to patients treated with medication alone. The outcomes of the cohort receiving medical therapy alone were modeled from the Mediator of Social Support Study (MOSS), by Kandzari et al (2001). Using Markov analysis, the results showed that EECP therapy along with standard guideline-compliant medical therapy is a cost effective strategy for treatment of chronic angina, and when compared to standard medical therapy alone, demonstrated an incremental cost effectiveness of $3,126 per QALY at 2 years. The authors concluded that EECP therapy was highly cost–effective, patients experienced fewer MACE, and enjoyed less rescue nitrate use and overall better quality of life. (Source: Aequitas, San Diego, CA. 2004).

Heart Failure: The goals of heart failure treatment are to prolong active life and improve or maintain the quality of life by improving symptoms, retarding disease progression, reducing major morbidity and subsequent disability, and avoiding negative iatrogenic effects of management. (Source: Cleland et al., Heart Failure, p. 49).

1. 2 year outcomes of 363 angina patients enrolled in the International EECP Patient Registry (IEPR) with impaired LV function defined as having an ejection fraction less than or equal to 35% was studied. Immediately post EECP treatment, 77% reported improvement in 1 or more angina class, 15.6% had complete resolution of angina post treatment and during EECP treatment heart failure exacerbations or worsening heart failure was reported to be 5.4%. At 2 years post-EECP treatment, 265 patients completed follow-up and 55% had sustained improvement in angina class. Quality of Life measures indicated that 58% of patients improved their QOL post-EECP compared to baseline and at 2 years 63% reported improved QOL compared to baseline (p< 0.001). At 2 years post-EECP treatment, 70% of patients had event free survival. (Soran et al.: Two Year Clinical Outcomes, Event Free Survival, and Incidence of Repeat EECP in Refractory Angina Patients with Left Ventricular Dysfunction, Presented at HFSA 2004. In press American Journal of Cardiology, January 2006).

The considerable concordance of data from the IEPR which has successfully collected data on 7500 of the approximately 45000 patients treated to date in the US, and the two, positive, randomized controlled clinical trials for Angina (MUST-EECP) and Heart Failure (PEECH) create a considerable body of data proving the clinical efficacy of EECP therapy. While we still do not understand everything about the multiplicity of EECP effects in humans with heart disease, there is no question that it is efficacious for all the currently accepted treatment goals for patients with angina and/or heart failure. Therefore, I strongly urge CMS to take all the available data and published experience into account before deciding not to expand the indications for the clinical use of EECP in angina pectoris and heart failure.

Sincerely,

John E. Strobeck, MD, PhD
Director, Heart-Lung Center
297 Lafayette Avenue
Hawthorne, NJ 07506
Co-editor, Congestive Heart Failure

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I am Chief Technology Officer with a global manufacturing company. For many years I have followed with interest the advent of EECP/ECP and other cost reducing medical technologies. As a U.S. taxpayer I am greatly disappointed in your preliminary decision to not expand ECP for CCS Class II angina and NYHA Class II/III heart failure with ejection fraction <= 35%. I respectfully ask that you consider the following commentary in your final decision process:

ECP is currently relegated for use in patients with Class III/ IV angina that are not amenable to surgery, and who in some cases have already experienced multiple CABG/PCI and cannot survive additional surgery. This subset of ECP eligible patients may arguably be classified as the “sickest” of patients, and for many in this subset ECP provides a treatment of last resort. Dozens of published, peer reviewed studies of EECP have shown that a large majority of angina patients (and many diagnosed with heart failure) respond with significant symptom reduction and quality of life improvements. It is not unusual for some patients to experience “Lazarus like” recoveries.

While no individual study is ever statistically perfect, I would ask that CMS consider the totality of evidence from all the studies that ECP is a highly effective treatment in improving symptoms, physiology and quality of life in cardiac patients. Also, please consider a common sense perspective in the interpretation of the statistical data. Common sense strongly suggests that ECP, being effective in treating the “sickest” CCS Class III/IV patients, is at least as effective in treating the “less sick” Class II patients.

If you have not already done so, I also ask that you consider the compelling evidence presented in the recently published book “Heal Your Heart with EECP” by Debra Braverman, MD. This is an excellent reference that nicely summarizes the patient and health system benefits derived from the use of ECP.

The CMS Preliminary Decision Memo states that the reduction of angina symptoms (vis-à-vis Canadian Cardiovascular Class, daily angina counts and nitroglycerin use) are not alone sufficient outcomes for determination of “evidence of benefit”. Yet such measures have been used for many years to evaluate the success of other therapies. Is the “evidence of benefit bar” being raised for ECP as compared to other approved therapies, or even as compared to the earlier approval of ECP in Class III/IV angina?

CMS also raises questions about the possibility of the placebo effect. While placebo effects beyond 6 months are highly unlikely, EECP has demonstrated continued sustainability of angina class and quality of life improvements to as long as 3 years. Are surgical interventions held to the same level of scrutiny for placebo effect? What about the already approved use of ECP for Class III/IV angina? Is the “placebo effect bar” also being raised for the new ECP indications?

CMS did not appear to weigh the cost value of ECP as compared to currently approved treatment regimens. ECP is an extremely economical treatment. As a taxpayer I would insist on such consideration as being essential to the long term viability of our Medicare system. Also, there was no apparent safety comparison with other approved therapies. The totality of the documented studies clearly shows that ECP is very safe and does not carry the risk of invasive procedures.

It’s my opinion that Medicare must be pro-active in seeking and promoting less invasive, lower risk and more cost effective therapies to derive more benefit from taxpayer’s hard earned dollars, and that such considerations be factored into the determination for “reasonable and necessary”. On this basis, I urge CMS to approve EECP/ECP as a much needed, adjunctive therapy for the cited classifications.

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I was very surprised to hear the proposed decision not to expand reimbursement for ECP therapy for Heart Failure- NYHA Class II/III or IV stable heart failure with an ejection fraction of < 40%. The leading cause of heart failure being coronary artery disease - brings several patients who experience class III or IV angina and have an EF < 40% into our hospital for ECP therapy. These patients most often have been through CABG 2+ times, and absolutely have no other options. Their life is limited to a sedentary lifestyle, which in the long run only exacerbates their condition. ECP has given the patients we have treated improved quality of life, lower health care costs related to fewer hospitalizations, etc. The cost of 35 sessions of ECP is far less than one admission to the hospital for CHF, which nationally averages ~$15,000. This is 2X the cost of a complete series of ECP.

Because CHF diagnosis is growing at a very rapid pace, I cannot believe that ECP would be something you would not allow the CHF population to employ. It is an economical treatment - non-invasive with very few complications (we have had none). I believe coverage would be PROACTIVE instead of REACTIVE, and the result would be A healthier CHF population - improved quality of life and functional status/exercise tolerance - fewer health care dollars spent on this taxing population.

I can tell you that several of the patients we have treated had an EF < 40%. They had several ED visits per month with angina, dyspnea, etc. There lives were limited to sedentary lifestyles, and increasing medications to help them cope with their symptoms. Now they are able to be more active - hunting, ranching, volunteer services, golfing, exercise daily, and some just completing their ADL's independently with ease is an incredible improvement.

I encourage you to reconsider your decision and expand your reimbursement to include Class II/II or IV stable heart failure with an ejection fraction of < 40%, as well as CCSC II Angina. I am certain it will result in a huge savings in the health care dollars spent on the CHF population overall.

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After working with EECP for the past two years, I have seen many patients improve therapy. EECP is offered as a last resoprt when surgery or angioplasty is no longer an option. If the therapy could be done before the heart disease is not so extensive these patients would avoid many years of pain and failing health. This proposal would allow EECP to be given to those patients who are a Class II Canadian Classification as compared to Class III which is the current ruling. Suzan Johnson R.N.

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I appreciate the opportunity to offer comment to CMS. I am a Nephrologist in Santa Fe, NM. I am a limited participant in a EECP device brought here through a Cardiology group. As someone who specializes in extracorporeal therapy, I was impressed with EECP and became involved in its coming to town. Now, however, I am particularly a strong supporter based on the patient feedback and improvements, which for several patients with whom I am well familiar have been very impressive improvements in both symptoms of anigina and in level of function. I strongly believe that patinets with refractory congestive heart failure (CHF) could benefit from this therapy, which is non-invasive. AS a Nephrologist, I sometimes have to provide hemodialysis for refractory CHF, which is very invasive, higer risk, and high cost. I urge CMS to cover EECP for refractory CHF as an effective, non-invasive therapy for patients. Thank you.

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I am a Cardiovascular Technologist by training and have treated heart patients in many invasive procedures involving balloon angioplasty and stenting. I have had the pleasure to speak with many physicians, EECP therapists and most importantly, patients treated with this non- invasive yet extremely effective therapy called EECP. This therapy works!!!!! If you speak with these patients, many who have angina and heart failure, you become amazed at their improvement and how it changes their lives. The PEECH trial has proven that EECP works for NYHA class II and III patients and is safe. The trial was positive on a primary and multiple secondary endpoints. Give these Heart Failure patients an option where very few options exist. If CMS denies coverage for class II and III HF, they really need to go visit with some graduates of EECP therapy and hear their story first hand.

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To Whom It May Concern:

Since beginning ECP Therapy in Feb. of 2004, I have had the pleasure of treating 76 patients suffering from angina and CHF. These patients whose lives are burdened daily with the symptoms of CHF, seem to benefit the most. Normal tasks that healthy individuals take for granted, such as grocery shopping, having lunch with friends, or simply pushing a grandchild in a swing, may never be able to enjoy these delightful things with CHF. But with the help of ECP Therapy and Medicare we can give a parent or grandparent the quality of life they deserve. Sincerely, Rani Mills, B.S.

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PLEASE consider expanding Medicare coverage for EECP Therapy to include patients with Class II Stable Angina and in patients with stable NYHA Class II/III congestive failure symptoms with an EF =or < 35%. We need to treat these patients sooner than the current system allows!!!! If we treat these patients sooner, we will achieve better results, less dependency on expensive medications/treatments/testing and most importantly provide our patients with a better quality of life!!!! Please consider this change in EECP Coverage.

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This comment is written in support of the request to expand Medicare coverage of EECP to include patients with CHF and Class 2 angina. My colleagues and I have been providing EECP to patients with Class 3 and 4 angina for about 5 yrs. Our outcomes mimic those of the published literature with about 75-80% of pts improving at least 1 NYHA class...often more. About 40% of these pts also have ischemic cardiomyopathies with low ejection fractions. This group of pts is just as likely to report improvement of their congestive symptoms, including an improved exercise capacity as they are to notice improvement of their angina. These results are not surprising in light of the data recently reported in the PEECH trial. Although the exact mechanism of action derived from EECP remains uncertain, the observational data and the witnessed benefits are clear and compelling, and go far beyond what might be anticipated from a placebo effect. The science suggests potential answers including possible angiogenesis, improved endothelial function, an enhanced neurohumoral milieu and others. EECP would seem to be a remarkably cost effective adjunctive therapy for the treatment of both angina and CHF. If it were more widely available it has the potential of providing significant cost savings for these two very high cost groups of pts, especially those with CHF. I would like to encourage CMS to respond favorably to the request to expand reimbursement coverage to include patients with CHF as well as those with Class 2 angina. Thank-you for listening.
Alan Berrick, MD

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EECP therapy has been a wonderful adjunct to the therapy available for the cardiac patient. It is one of the many tools available in our arsenal to fight heart disease. I am the Director of Non Invasive Cardiology at Our Lady of Lourdes Medical Center in Camden NJ where we pride ourselves on providing state of the art care to the cardiac population. Patients who have been through the invasive procedures, the stents, the bypass, the biventricular pacemakers and have been through medical management and cardiac rehab have benefited from ECP therapy. The PEECH trial demonstrates the benefit of ECP. Please reconsider your decision to limit the patients who can benefit from this procedure.

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We are very disappointed and frankly quite surprised with the proposed decision released today. We have had 2 years of experience with treating patients with ECP, and this experience is consistent with that of other providers. Eighty some per cent of our patients have improved by at least one class and 40 some per cent have improved by at least two classes.

We are aware of the extreme pressure on CMS by the cardiologists and hospitals to suspress this inexpensive and non-invasive treatment for angina. It is beyond us why CMS favors the vastly more expensive and dangerous surgical alternatives considering that their results are marginal at best. This is a poor use of the taxpayers’ funds.

But more surprising is your decision not to reimburse for ECP treatment of CHF patients. Our experience and that of other providers has proven that ECP is the only treatment that can stop the deterioration of the heart. It is unconscionable to waste tens of billions of dollars on ineffective management of CHF patients when an inexpensive, effective therapy is readily available as a first line course of treatment.

We strongly and emphatically request that ECP be reimbursed as a first line therapy for both angina and CHF.

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This is regard to new coverage for ECP to treat CHF Class II&III and Angina Class II. Our center has been treating Angina with EECP for over 5 years and nearly always see improvement in angina symptoms. As an added bonus, our patients with a CHF componenet in their heart disease almost always also experience a significant improvement in CHF symptoms. I truly believe we could see a decrease in hospitalizations for CHF if we had the opportunity to also treat those CHF patients that don't have angina.As for our Class II angina patients, many ask for treatments in an attempt to slow the progression of disease early instead of waiting until it is crippling. I hope CMS will reconsider it's initial denial of coverage that we may provide this "life-quality" imporving therapy for many more deserving patients. Thank you.

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