Intensive Cardiac Rehabilitation (ICR) Program - Benson-Henry Institute Cardiac Wellness Program

I was a Member of the U.S. House of Representatives from 1983-2013 (R-Indiana). I was Chairman of the House Oversight and Government Reform Committee from 1997-2003.

I am posting this comment in response to the "Proposed Decision Memo for Intensive Cardiac Rehabilitation (ICR) Program- Benson-Henry Institute Cardiac Wellness Program (CAG-00434N)."

Recently, CMS has been reviewing the Benson-Henry program to determine if it is eligible for intensive cardiac rehabilitation (ICR) coverage. During this review process, it became clear to me that the eligibility language in the 2008 MIPP A bill (Public Law 110-275) is ambiguous and needs to be clarified in order to maintain the integrity of the ICR benefit category.

I am writing to provide guidance to CMS about the intent of the language in Section 144, paragraph (4)(A). I am very familiar with the intention of the language in this section of the MIPP A bill, as I helped co-author it.

This section states:

It was always my intention that the category of intensive cardiac rehabilitation was for programs proven to reverse the progression of coronary heart disease. It takes more intensive changes in diet and lifestyle to reverse the progression of coronary heart disease (intensive cardiac rehabilitation programs), whereas more moderate changes in diet and lifestyle may just slow its progression (traditional cardiac rehabilitation programs).

Thus, the language, "positively affected the progression of coronary heart disease" requires that a program have research from at least one clinical trial published in a peerreviewed journal showing that it can cause statistically significant regression (reversal) of coronary artery blockages when compared to a randomized control group.

The Benson-Henry program has not cited any data published in peer-reviewed journals showing it can reverse heart disease. It claims that it can reduce mortality as a surrogate for "positively affecting the progression of coronary heart disease," but (a) it was not a statistically significant reduction, so it didn't significantly reduce mortality, and (b) traditional cardiac rehabilitation (TCR) may reduce mortality without necessarily showing reversal of coronary heart disease-even moderate changes in diet and lifestyle are better than doing nothing. In other words, TCR may reduce mortality compared to no intervention by just slowing the rate at which heart disease gets worse, in contrast to programs proven to reverse heart disease in which the heart disease gets better over time.

The Benson-Henry program also has not cited any data published in peer-reviewed journals showing it can reduce the need for coronary bypass surgery or reduce the need for percutaneous coronary interventions, in contrast to both the Pritikin and Ornish programs which have done so.

Therefore, I strongly recommend that the Benson-Henry program be covered under the traditional cardiac rehabilitation guidelines. Thank you.

Representative Dan Burton

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The classification of the Benson-Henry program as an “Intensive Cardiac Rehabilitation” program appears to be based on a “trend towards” decreased mortality (quoted as P=0.07 in the abstract, but as 0.08 in the text, p. 790).

First, this does not represent a statistically significant association (conventionally set by virtually all medical journals at P=0.05). A P-value greater than 0.05 is not significant. This 0.05 cut-point is conventional and a priori; there is no such thing as a “trend” towards significance. A result is significant by definition, or it is not. Here, it is not.

Also, the comparison of intervention to control groups within the Benson-Henry program is not valid due to a failure to show that these groups were comparable at baseline.

Despite “heavy” matching (which the authors acknowledge could well have been incomplete due to “limitations of Medicare claims data in assessing the severity of cardiac disease”), both total and cardiac hospitalizations were significantly lower in the Benson-Henry intervention group than in the control group patients before the program even began (Table III).  That is, these groups were not comparable at baseline. 

In other words, these data suggest that the control group patients were sicker than the Benson-Henry patients at baseline.  Thus, the finding that the Benson-Henry patients had fewer subsequent hospitalizations than those in the control groups may have reflected, at least in part, the fact that the Benson-Henry patients weren’t as sick to begin with.  In contrast, there were no significant differences in these measures between patients in the intervention and control groups and those in the Ornish group at baseline.

Furthermore, the data are not presented in a clear manner or in a way which allows for replication (despite the authors’ statement that comparisons are based on descriptive summaries). No actual numbers are given; the presentation of per-person hospitalization rates and cumulative rates of mortality make it impossible even to duplicate the results/conclusions they have presented here.

Finally, “decreased mortality”—even if it were significantly associated with the Benson-Henry program (which it is not, in this study)—is not a valid surrogate for regression of cardiac disease, since slowing the progression of coronary heart disease (getting worse more slowly) in an intervention compared to a non-intervention control group is not the same as reversing heart disease (getting better over time).  Since traditional cardiac rehabilitation (TCR) programs have been shown to reduce mortality in intervention compared to a non-intervention control groups, covering a program under ICR guidelines simply because it reduced mortality (if it did, which in this study, it did not) would undermine the integrity of the ICR benefit category, as any TCR program could then claim ICR coverage. 

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TO:  Marilyn Tavenner, MHA, RN
        Administrator
        Patrick Conway, MD, MSc.
        Chief Medical Officer
        Tamara S. Syrek Jensen, JD
        Acting Director, Coverage and Analysis Group
        Centers for Medicare & Medicaid Services

FROM:  Dean Ornish, M.D.

I am writing to comment on the provisional decision memo regarding the eligibility of coverage under the category of intensive cardiac rehabilitation for the Benson-Henry program.

Before addressing the specific points of this decision memo, some historical context may be helpful.  Beginning in 1977, 37 years ago, my colleagues and I at the medical school and later at the non-profit Preventive Medicine Research Institute began directing and conducting a series of randomized controlled trials and demonstration projects demonstrating, for the first time, that the progression of coronary heart disease can be reversed by making intensive lifestyle changes.  These include a whole foods, plant-based diet low in refined carbohydrates; regular moderate exercise; stress management techniques; and group psychosocial support. 

These studies were published in leading peer-reviewed journals, including:  the Journal of the American Medical Association; The Lancet; American Journal of Cardiology; the Journal of the American Dietetic Association; Annals of Behavioral Medicine; Proceedings of the National Academy of Sciences; The New England Journal of Medicine; the American Journal of Public Health; the Journal of Cardiovascular Nursing; The Lancet Oncology; and others. 

A review article summarizing these findings, “Intensive lifestyle changes in the management of coronary heart disease,” was published in Harrison’s Principles of Internal Medicine (online), edited by Eugene Braunwald et al., in 1999.  I co-authored an article summarizing these findings, “Intensive Risk Factor Modification,” in Clinical Trials in Cardiovascular Disease, the companion book to Heart Disease, the Braunwald standard cardiology textbook.

In each of these articles, I discussed the scientific evidence that intensive lifestyle changes alone can reverse the progression of even severe coronary heart disease. 

I also presented various aspects of this scientific evidence on multiple occasions at the national scientific sessions of the American Heart Association and the American College of Cardiology.  I also presented a keynote lecture that included a summary of our research findings at the Institute of Medicine’s first “Summit on Integrative Medicine” at the National Academy of Sciences.  In each of these presentations, I discussed the scientific evidence that intensive lifestyle changes alone can reverse the progression of even severe coronary heart disease. 

In 1994, I began a dialogue with CMS (then HCFA) about providing Medicare reimbursement for our program for reversing heart disease.  CMS spent 16 years reviewing our lifestyle program, including numerous meetings at CMS, a Medicare Coverage Advisory Commission hearing, and two national coverage determinations.  In each of these presentations, I discussed the scientific evidence that intensive lifestyle changes alone can reverse the progression of even severe coronary heart disease.

I was invited to provide testimony at several U.S. Congressional hearings.  These included the U.S. House of Representatives Oversight and Government Reform Committee on February 24, 1999; the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropriations, U.S. Senate on March 28, 2000; again on May 16, 2002; again on February 17, 2003; and again on July 15, 2004; before the Subcommittee on Consumer Affairs and Product Safety, Commerce Committee, U.S. Senate on September 30, 2003; before the U.S. Senate Finance Committee on June 16, 2008; and before the U.S. Senate Committee on Health, Education, Labor and Pensions on February 26, 2009.  In each of these presentations, I discussed the scientific evidence that intensive lifestyle changes alone can reverse the progression of even severe coronary heart disease.

In 2008, Congress provided the statutory authority to CMS in the Medicare Improvements for Patients and Providers Act (MIPPA) bill to create a new benefit category, “intensive cardiac rehabilitation.”  The MIPPA bill states [paragraph 4(A), italics added]:

This language has since been adopted by CMS in judging eligibility of programs for coverage under intensive cardiac rehabilitation.

The Benson-Henry program meets none of these three criteria in the proposed decision memo:

1. “Positively affected the progression of coronary heart disease.”

   In the proposed decision memo, CMS presents in section VIII, “CMS Analysis,” that the Benson-Henry program had significantly reduced mortality compared to a nonrandomized control group, and that this reduced mortality is evidence that this program fulfills the criterion of “positively affected the progression of coronary heart disease.”

   However, this is not accurate.  The difference in mortality rates between the Benson-Henry program patients and “rigorously matched controls” was not statistically significant (P=0.08) as described on page 790 of the cited article by Zeng et al.  Therefore, this program did not fulfill the criterion of “positively affected the progression of coronary heart disease” even if a reduction in mortality were a surrogate for this, since the reduction was not statistically significant.  

   Even if the Benson-Henry program had shown a significant reduction in mortality rates, which it did not, traditional cardiac rehabilitation programs also significantly reduce mortality, so reducing mortality is not sufficient to qualify for coverage as an intensive cardiac rehabilitation program.

   A Cochrane Review of traditional cardiac rehabilitation concluded, “Exercise-based [traditional] cardiac rehabilitation is effective in reducing total and cardiovascular mortality (in medium to longer term studies) and hospital admissions (in shorter term studies).”  [http://www.ncbi.nlm.nih.gov/pubmed/21735386]

   Thus, it is not enough for a program to reduce total or cardiovascular mortality to be eligible for intensive cardiac rehabilitation, as traditional cardiac rehabilitation programs show this reduction in mortality.  This is not surprising, since exercise and moderate changes in diet have benefits compared to doing nothing at all; however, these changes do not go far enough to reverse the progression of coronary heart disease. 

   If CMS were to cover the Benson-Henry program on the basis of reduced mortality, then virtually any traditional cardiac rehabilitation program would also be eligible for intensive cardiac rehabilitation coverage, thereby threatening the integrity of the intensive cardiac rehabilitation benefit category.  Otherwise, there would be no meaningful distinction between traditional cardiac rehabilitation and intensive cardiac rehabilitation programs.

   What makes intensive cardiac rehabilitation unique is that it reverses the progression of coronary heart disease using direct measures of the severity of coronary heart disease.  There are no published studies indicating that the Benson-Henry program can cause regression (reversal) of coronary atherosclerosis using studies that measure the degree of coronary heart disease (e.g., coronary angiography).

   The other two articles cited in the proposed decision memo (one by Stason, one by Shepard) have not been published “in peer-reviewed published research,” which is one of the criteria in the MIPPA language/CMS guidelines and thus should not have been considered in the CMS analysis in the proposed decision memo. 

2. “Reduced the need for coronary bypass surgery.”

   The proposed decision memo provides no evidence that the Benson-Henry program reduces the need for coronary bypass surgery other than speculation.  It states, “While specific hospital diagnoses were not reported, the need for coronary artery bypass surgery may have been reduced as well, and a specific presentation of bypass hospitalizations would be informative.”  Of course, there are many reasons for a patient being hospitalized other than to undergo surgery, and no data were presented to support this speculation. 

3. “Reduced the need for percutaneous coronary interventions.”

   The proposed decision memo provides no evidence that the Benson-Henry program reduced the need for percutaneous coronary interventions.

Thus, the Benson-Henry program does not fulfill any of these three essential criteria necessary to be eligible for coverage as stated in the MIPPA bill and in CMS’ proposed decision memo.

It has always been my understanding, and the understanding of Congress when writing the MIPPA bill, that lifestyle programs covered under intensive cardiac rehabilitation must have been proven in peer-reviewed journals to reverse the progression of coronary heart disease.

In all of my discussions with CMS and Congress, I emphasized that the raison d’être and sine qua non of intensive cardiac rehabilitation is for programs of comprehensive lifestyle changes that have been proven in peer-reviewed journals to reverse the progression of coronary heart disease.

In this context, it was always my understanding that “…positively affected the progression of coronary heart disease…” is another way of saying it “causes regression (reversal) of coronary heart disease.”

This requires direct measures of the degree of coronary artery blockages (atherosclerosis) using coronary angiography or other similar tests.  Our ICR program has been proven to significantly reverse the progression of coronary heart disease as measured with quantitative coronary angiography, cardiac PET scans, and other direct measures of coronary heart disease in the leading peer-reviewed journals.

Traditional cardiac rehabilitation (TCR) programs are based primarily on 36 sessions of supervised exercise plus a 30% fat diet.  While TCR programs have several benefits—e.g., slowing the progression of coronary heart disease compared to those making no lifestyle interventions—these moderate diet and lifestyle changes do not go far enough to reverse the progression of coronary heart disease.  Coronary arteries tend to get more and more clogged over time but at a slower rate than if they had made no changes in diet and lifestyle.  Thus, TCR programs may reduce mortality compared to those making no lifestyle changes by slowing the rate at which heart disease worsens.

In contrast, our intensive cardiac rehabilitation (ICR) program has been scientifically proven to reverse the progression of coronary heart disease.  Instead of getting more and more clogged over time, the coronary arteries of patients who go through intensive cardiac rehabilitation programs tend to get less and less clogged over time as measured by quantitative coronary arteriography.  Cardiac PET scans revealed that 99% of the experimental group patients were able to stop or reverse the progression of their coronary heart disease. 

In order to reverse heart disease, ICR programs are much more intensive than TCR programs.  They include a whole foods, plant-based diet with only 10% of calories from fat; moderate exercise; intensive stress management techniques including meditation; and support groups.

As described in the published article by Zeng et al, the diet recommended in the Benson-Henry program is based on the traditional cardiac rehabilitation American Heart Association 30% fat diet, which slows the progression but has not been shown to go far enough to reverse the progression of coronary heart disease in several randomized controlled trials.

A 30% fat diet is only sufficient to slow the rate at which arteries become increasingly clogged over time, not to reverse it.  The control groups in our randomized controlled trials were following the traditional 30% fat AHA guidelines, yet they showed continued progression (worsening) of their coronary heart disease after one year and even more progression after five years.  Also, the randomized control groups of most cholesterol-lowering drug trials (e.g., statins) were on a 30% fat diet yet showed worsening (progression) of coronary atherosclerosis over time.

In contrast, both the Pritikin program and the Ornish program for reversing heart disease are based on a predominantly whole foods, plant-based diet that has only 10% of calories from fat and is low in refined carbohydrates.  This diet and lifestyle program has been proven to significantly reverse the progression of coronary heart disease as noted above.

Also, it was not appropriate in the proposed decision memo to directly compare outcomes of the Benson-Henry program and the Ornish program since the patient selection criteria during the demonstration project were different.

Patients were allowed to enroll in the Ornish program who were choosing it as a direct alternative to revascularization (bypass surgery or angioplasty) because it had been proven to reverse the progression of even severe coronary heart disease.  In contrast, patients were only eligible for enrollment into the Benson-Henry program if they were not considered candidates for revascularization.  It was not considered ethical to enroll patients in the Benson-Henry as a direct alternative to revascularization since that program has not been proven to reverse heart disease.

Thus, the patients who went through the Ornish program were not comparable to the Benson-Henry patients because they had different enrollment criteria.  Although no direct measures of the severity of coronary heart disease were provided, patients in the Ornish program were likely sicker than those in the Benson-Henry program.

This is supported by the finding reported in Table 3 of the Zeng paper that both total and cardiac hospitalizations were significantly lower in the Benson-Henry intervention group than in the control group patients at baseline.  In contrast, total and cardiac hospitalizations were not significantly different in the Ornish group than in control group patients at baseline.

In any event, to be eligible for ICR coverage, the Benson-Henry program must meet the stated MIPPA guidelines on its own terms, not in comparison to other programs. 

Costs are not a criteria for determining eligibility for intensive cardiac rehabilitation coverage, so these data should be irrelevant in the coverage decision process.  Also, cost savings from avoiding bypass surgery or angioplasty by patients who went through the Ornish program as a direct alternative were not included in the cost analysis. 

Nevertheless, it may be worth noting that Highmark Blue Cross Blue Shield found that adherence to the Ornish program has been 85-90% after one year in almost 4,000 patients in 24 sites.  They reported a 50% reduction in overall health care costs in the first year and a 400% reduction in the high-utilization patients.  Mutual of Omaha found that 77% of patients who were eligible for revascularization were able to safely avoid it by enrolling in the Ornish program, and they saved almost $30,000/patient in the first year (published in the American Journal of Cardiology).

Also, from a safety standpoint, it’s important to maintain a distinction between TCR and ICR programs.  As noted above, traditional cardiac rehabilitation only slows the progression of coronary heart disease, whereas intensive cardiac rehabilitation reverses the progression of coronary heart disease.  If the Benson-Henry program is covered as intensive cardiac rehabilitation, then it may be potentially unsafe for patients with severe coronary heart disease to enter an intensive cardiac rehabilitation program believing that it has been proven to reverse the progression of coronary heart disease when it only slows its progression, especially if the patient is choosing to make comprehensive lifestyle changes in lieu of revascularization or reducing cardiac medications.

Thus, it would be inappropriate to cover a program under intensive cardiac rehabilitation that is based on the traditional cardiac rehabilitation dietary guidelines and would likely be confusing to both health care professionals and to CMS beneficiaries about what makes intensive cardiac rehabilitation programs different from traditional cardiac rehabilitation programs.  It would threaten the integrity of the ICR category. 

Support groups, nutrition counseling, and stress management techniques may be part of traditional cardiac rehabilitation programs, according to CMS.  The primary distinction is the degree of dietary change required to reverse heart disease (i.e., a 10% fat plant-based whole foods diet low in refined carbohydrates in ICR programs vs. a 30% fat non-plant-based diet in TCR programs).

My colleagues and I welcome coverage of other lifestyle programs that have been proven to reverse the progression of coronary heart disease under intensive cardiac rehabilitation guidelines, but the Benson-Henry program does not.

I have long admired the work of Dr. Benson.  He has been a respected pioneer of mind/body medicine and was one of the first researchers to document that meditation could lower blood pressure.  However, Dr. Benson and his colleagues have never published research in a peer-reviewed journal proving that his lifestyle program can reverse the progression of coronary heart disease or significantly reduce mortality. 

In summary, it is important to preserve the integrity of the intensive cardiac rehabilitation benefit category.  Therefore, the Benson-Henry program should be covered as a traditional cardiac rehabilitation program, which it is, not as an ICR program, which it is not.  Otherwise, there would be no meaningful distinction between traditional cardiac rehabilitation and intensive cardiac rehabilitation programs.

Dean Ornish, M.D.
Founder and President, Preventive Medicine Research Institute
Clinical Professor of Medicine, University of California, San Francisco

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I had an opportunity to participate directly in CMS decision-making on intensive cardiac rehabilitation guidelines, including evaluation of the Ornish Program as well as the Benson-Henry Program during my time as medical officer and as Acting Division Director from 1998-2003. I think it is important to understand the historical perspective, and take it into consideration when issuing a final decision.

During these discussions and evaluations, the focus was always on reversing heart disease. This was the critical component for evaluation. It was and remains a high standard, yet was of paramount concern if Medicare dollars were going to be spent. The goal was to consider a new benefit category for programs proven to reverse the progression of coronary heart disease. The reason why reversal was so important was that there was the need to make sure that Medicare would not be paying for programs that were simply more expensive and would be additive to costs, with no value-added than traditional cardiac rehabilitation. Reduction in morbidity and mortality was not the threshold during these discussions. If the Benson-Henry program were covered under intensive cardiac rehabilitation guidelines, it would undermine the validity of the ICR category.

In the proposed decision memo posted online, the Benson-Henry program is said to satisfy the requirement of “positively affected the progression of coronary heart disease” because there was a “trend” towards decreasing mortality. However, reducing mortality is not equivalent to reversing heart disease, since traditional cardiac rehabilitation programs have been shown to reduce mortality compared to no intervention.

In addition, as someone trained in health services research who was intimately involved in the new coverage decision process that is now in effect, I am concerned about scientific and clinical rigor of proposed national coverage decisions. Given that we have an established scientific standard of statistical significance—i.e., P< 0.05 it is not acceptable to accept as evidence data that does not meet that standard. To suggest that data trends towards significance are evidence of benefit simply does not hold weight. At a minimum, there should be statistical significance which can then lead to a discussion of clinical significance - it’s not the other way around. CMS should not lower its standards in reviewing evidence that serve as the basis for national coverage decisions.

The Benson-Henry program does have merit and value; however, it does not meet the standard of intensive cardiac rehabilitation. Instead, it meets the standard of traditional cardiac rehabilitation and should be covered on that basis.

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To Whom It May Concern at CMS:

I am writing to comment on the proposed coverage decision for Intensive Cardiac Rehabilitation (ICR) Program – Benson-Henry Institute Cardiac Wellness Program (CAG-00434N).

I am a physician who has worked in Cardiovascular medicine for many years, and someone who is focused upon prevention and wellness as well as current efforts at bringing forth Intensive Cardiac Rehabilitation (ICR). I have reviewed the clinical literature cited in the proposed decision to grant Benson-Henry Cardiac Wellness Program ICR status. In my opinion, it does not meet ICR requirements set forth in the statute.

Under the law, as articulated, a program needs to demonstrate, through peer-reviewed published research, that it has accomplished one or more of the following for its patients:

The proposed decision memo cites only one peer-reviewed published study (Zeng W, Stason WB, Fournier S, Razavi M, Ritter G, Strickler GK, Bhalotra SM, Shepard DS. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013 May;165(5):785-92.).

I have reviewed this study. It does not appear to have addressed the criteria listed above.

There is a demonstrated reduction in the number of cardiac hospitalizations. However, there is no specificity in identifying causes for those hospitalizations. As a consequence, the study does not seem to meet the statute requirements for recognition of the program as an “ICR program”.

While I laud the Benson-Henry Institute Cardiac Wellness Program for its efforts in reducing readmissions and its attention and focus on prevention, I must once again state that it does not appear to meet the criteria articulated under the law.

Therefore, I would suggest that CMS not expand ICR benefit coverage to include this program at this time.

Thank you for your consideration of these points.

Sincerely,

Ronald Riner, MD

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I appreciate the opportunity to comment on the proposed coverage decision for ICR Program - Benson-Henry Institute Cardiac Wellness Program (CAG-00434N). As a scientist with knowledge and experience in cardiac rehabilitation programs, I reviewed the literature cited in the proposed decision, and I respectfully disagree with its conclusion that the Benson-Henry Institute Cardiac Wellness Program meets the ICR program requirements set forth in the statute. Under the law, a program needs to demonstrate through peer-reviewed, published research that it has accomplished one or more of the following for its patients: 1) positively affected the progression of coronary heart disease; 2) reduced the need for coronary bypass surgery; and 3) reduced the need for percutaneous coronary interventions. The proposed decision cites only 1 peer-reviewed published paper (Zeng et al. Am Heart J. 2013 May;165(5):785-92.) It does not address the effect of the program on the progression of coronary heart disease, the need for coronary bypass surgery, or the need for percutaneous coronary interventions. Instead, it addresses reductions in cardiac hospitalizations, without identifying specific causes for hospitalizations. This study clearly does not demonstrate the results that the statute requires for recognition of an ICR program. Due to the lack of peer-reviewed, published data on whether this program has positively affected the progression of coronary heart disease, reduced the need for coronary bypass surgery, and/or reduced the need for percutaneous coronary interventions, CMS should not expand the ICR benefit to include this program.

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Dear Administrator Tavenner and Dr. Conway,

First, let me reiterate what I have said to many others.  You are doing an outstanding job.

Many of us are deeply grateful for your leadership and commitment to our nation’s health.

I want to comment briefly on the matter before you pertaining to the clarification of the intention of the language in the Medicare Improvements for Patients and Providers Act (MIPPA. I  have no professional relationships on the matter.  But want to take a minute to add my voice to those who have commented both publicly and privately on the need for clarification of the clear difference between traditional and intensive cardiac rehabilitation.

I share the view of many of my former colleagues who were involved in the enactment of the law that intensive rehabilitation can only be documented by proving a reversal of coronary heart disease.  The law lays out clear criteria by which such documentation can be presented.  Mere reduction in mortality or morbidity cannot be equated with disease reversal or regression.

Traditional cardiac rehabilitation programs can play an important role in slowing progression of the disease.  But they do not necessarily reverse it.  That distinction is critical.

For any lifestyle program to be considered  eligible for Intensive Cardiac Rehabilitation (ICR) reimbursement, I would strongly urge you to insist that scientific evidence be provided and documented demonstrating that the program clearly has the capacity to reverse the progression of coronary heart disease.

Thank you for consideration of this matter and for all that you continue to do.

All the best.

Tom Daschle

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As U.S. Senate Majority Leader in 2005 and 2006 when the language of MIPPA was being considered, I was involved in discussions with CMS and administrator Mark McClellan. In discussing the language used to define “intensive cardiac rehabilitation” we intended to distinguish it from “traditional cardiac rehabilitation.” I would like to provide clarification as to the intention of the language.

MIPPA states [paragraph 4(A)]:

“The term ‘intensive cardiac rehabilitation program’ means a physician-supervised program (as described in paragraph 2) that furnishes the items and services described in paragraph 3 and has shown, in peer-reviewed published research, that it accomplished one or more of the following:

• positively affected the progression of coronary heart disease; or
• reduced the need for coronary bypass surgery; or
• reduced the need for percutaneous coronary interventions.”

Our intention was that the language “positively affect the progression of coronary heart disease” meant “reversal of disease.” To prove reversal of disease, a program needed to have been shown, in at least one peer-reviewed study, to significantly reduce the degree of lesions of coronary artery disease when compared to a randomized control group (P=0.05 or less). To show a reduction in coronary lesions, the study would need to evaluate patients post intervention using follow-up coronary angiography or CT scans that could quantify the degree of coronary atherosclerosis before and after an intervention.

Showing an intervention or program results in a reduction in morbidity and mortality does not necessarily equate to a reversal or regression of disease. Reduction in morbidity and mortality is correlative in these instances, but does not prove the intervention or rehabilitation program was causative. While many lifestyle programs may halt or slow progression of disease, they do not necessarily “positively affect the progression of coronary heart disease,” as we intended an actual reversal or regression in coronary artery disease. For example, traditional cardiac rehabilitation programs reduce mortality when compared to a non-intervention control group, but this may occur by slowing the rate at which coronary heart disease worsens rather than actually reversing the progression of coronary heart disease.

In following, to qualify as “intensive cardiac rehabilitation” under the language “positively affected the progression” of coronary heart disease, the program would need to have published peer-reviewed studies with diagnostic tests proving reversal of coronary artery disease.

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I am writing to comment on the eligibility of the Benson-Henry program for intensive cardiac rehabilitation under CMS. Most important is that the B-H program did not fulfill the CMS criterion of having a positive effect on the progression of coronary heart disease. The difference in mortality rates between the B-H program patients and their controls was not significantly different (p=0.08). All medical journals of which I am aware, including The American Journal of Cardiology of which I am editor in chief, consider statistically significant to be p< 0.05. Even if the B-H program showed a statistically significant reduction in mortality, which it did not, that should not be sufficient to qualify for ICR coverage since traditional cardiac rehabilitation (TCR)programs have been shown to reduce mortality rates - because even moderate changes in exercise and diet are better than making no changes at all. Otherwise, virtually any TCR program would qualify for intensive cardiac rehabilitation (ICR) thereby threatening the integrity of the ICR category and substantially increasing CMS expenses without corresponding benefits. A cardiac rehabilitation program must have proof that it can reverse the progression of coronary heart diseasee to be eligible for coverage as an ICR program! Furthermore, it is important to maintain the integrity of the ICR benefit category because it would be unfair,indeed potentially harmful, for patients with severe coronary heart disease to enter an ICR program believing that it would reverse the progression of their heart disease if it had not been proven to do so. Also, the 30% fat non-plant based diet (the one used in the B-H program) does not reverse the progression of coronary heart disease, but a 10% plant-based diet with 10% of calories from fat does reverse heart disease. I addvocate the the B-H program be covered by CMS under the category of TRC, not ICR. Thank you.

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In response to your request for comments on the proposed coverage decision for Intensive Cardiac Rehabilitation (ICR) Program - Benson-Henry Institute Cardiac Wellness Program (CAG-00434N) I reviewed the clinical literature cited in the proposed decision, and as a scientist with numerous publications in the area of cardiac function/rehabilitation I disagree with the conclusion that the Benson-Henry Institute Cardiac Wellness Program meets the ICR program requirements set forth in the statute.

The proposed decision memo cites only one peer-reviewed published study, (Zeng W, Stason WB, Fournier S, Razavi M, Ritter G, Strickler GK, Bhalotra SM, Shepard DS. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013 May;165(5):785-92.) I have reviewed this study and found that it does not address the effect of the program on the progression of coronary heart disease, the need for coronary bypass surgery, or the need for percutaneous coronary interventions. Instead, it addresses reductions in cardiac hospitalizations, without identifying specific causes for hospitalizations. Although the decision memo states that the reductions in hospitalizations is important it was not statistically significant as it did not reach the p< 0.05 level of significance. This study clearly does not demonstrate the results that the statute requires for recognition to qualify for an ICR program.

Due to the lack of peer-reviewed, published data on whether the Benson-Henry Institute Cardiac Wellness Program has positively affected the progression of coronary heart disease; reduced the need for coronary bypass surgery; and/or reduced the need for percutaneous coronary interventions as required by the law CMS should not expand the ICR benefit to include the Benson-Henry Program program.

Respectfully,

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March 27, 2014

To Whom It May Concern:

I appreciate the opportunity to comment on the proposed coverage decision for Intensive Cardiac Rehabilitation (ICR) Program- Benson-Henry Institute Cardiac Wellness Program (CAG-00434N). As a cardiovascular scientist with knowledge and experience in cardiac rehabilitation programs, and a past president of the AACVPR and ACSM, I reviewed the clinical literature cited in the proposed request, and respectfully disagree with the proposition that the Benson-Henry Institute Cardiac Wellness Program meets the ICR program requirements set forth in the statute.

Under the law, an ICR needs to demonstrate through peer-reviewed, published research that it has accomplished one or more of the following outcomes:
(1) positively affected (i.e., attenuated) the progression of coronary heart disease;
(2) reduced the need for coronary bypass surgery; and/or
(3) decreased the need for elective or emergent percutaneous coronary interventions.

The proposed decision memo cites only one substantiating peer-reviewed published study (Zeng W, eta/. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J 2013 May;J65(5):785-92.) I have reviewed this study and fouud that it does not address the above-referenced outcomes and that the fmdings were limited by numerous potential confounding variables (e.g., subject motivation, adjunctive pharmacotherapies/medication dosages, ejection fraction and/or cardiorespiratory fitness data were lacking, and dietary approaches were markedly different). Only hospitalization rates were addressed. Accordingly, this report does not demonstrate the outcomes that the statute requires for recognition of an ICR program.

Due to the lack of peer-reviewed, published data on whether the Benson-Henry Institute Cardiac Wellness Program has positively affected the above-referenced outcomes, CMS should not expand the ICR benefit to include this program at the present time.

Thank you for your consideration of my sentiments regarding this issue.

Sincerely,

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