Intensive Cardiac Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease

June 11, 2010

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national coverage decision (NCD) Intensive Cardiac Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease (CAG-00419N). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
AHIP and our member plans support CMS's efforts to ensure that Medicare beneficiaries receive access to safe and effective preventive health services, procedures, and treatments that can improve health outcomes, as determined by current and robust clinical evidence. While AHIP knows that a small number of health insurance plans have had success implementing Dr. Ornish's Program for Reversing Heart Disease for their members, there are several issues that CMS should address prior to determining coverage for this intensive cardiac rehabilitation (ICR) program.

Many of our members have questions regarding the evidence available to support the effectiveness of the Ornish program in reducing the cardiovascular risk criteria, as required within the proposed NCD. There is concern that it is not sufficiently robust to distinguish it from or recommend it over other commercial weight and dietary interventions, such as Weight Watchers or Jenny Craig. A direct comparative study on four commercially branded weight loss programs (Ornish, Atkins, Weight Watchers, and Zone Diets), found that weight loss and impact on cardiac risk factors was similar with the Ornish Program as with the other popular diet programs¹. The authors also noted that the compliance with all these programs was low. This is worthy of note, as there are also program completion concerns regarding the Ornish program.

Other commercially available weight loss and lifestyle change programs are widely available, in most geographic areas, and have distinct programmatic components that are easy to implement and track. As the evidence is based on tightly controlled programs and environments, the replication and implementation of the Ornish program, nationally and in other providers' offices and facilities is questionable. Our members also have concerns regarding how CMS will be able to manage both quality control and ensure that all Medicare beneficiaries had equal access to the program, ensuring that the program components are equitable in different areas and for different beneficiary populations.

The Ornish Program is multi-faceted, and CMS does not clarify within the proposed NCD which components would be covered. CMS should clearly state which components of the program would be covered and available. Our members are also concerned that it is not clear how an entity would become a "licensed" or "certified" provider of this program, and how CMS would ensure that beneficiaries are receiving all the services that are being reimbursed.

The Ornish Program requires participants to maintain a very strict diet and lifestyle changes, which can be difficult for many people, and has resulted in reported low enrollment and adherence to the program. In 2009, CMS published a study by Brandeis University, which evaluated CMS's Medicare Lifestyle Modification Program Demonstration, Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit². The purpose of the demo was to test the efficacy and cost-effectiveness of two cardiovascular lifestyle modification programs: the Ornish Program and the Cardiac Wellness Program of the Benson-Henry Mind/Body Medical Institute (M/BMI). In addition, the authors also compared outcomes with the standard Medicare cardiac rehabilitation program. The authors found that it was extremely difficult to sign up enrollees in the Ornish program; less restrictive programs had much greater enrollment. In addition, it was determined that, overall, only twelve percent of eligible Medicare beneficiaries enrolled in cardiac rehabilitation programs despite available evidence of their benefits and the recommendations by their personal physician, professional societies and organizations for their use.

When the authors compared cost effectiveness among the programs, the cost for the year-long Ornish program was $5,650 (Medicare paid 80%); traditional cardiac rehabilitation lasted for 18 weeks and cost Medicare $683. However, when looking at the following outcomes rehospitalization (12 month follow-up), mortality (36 month follow-up), or time to first cardiovascular hospitalization Ornish program participants did not show statistical improvements compared to matched patients, either those who had participated in traditional cardiac rehabilitation or those who did not participate in any cardiac rehabilitation,.³

AHIP would like to reiterate that there is evidence that Dr. Ornish's Program for Reversing Heart Disease is capable of producing some of the outcomes required within the proposed NCD, and that there are several health insurance plans that have implemented and operationalized this program successfully for their members. However, given the number of unresolved issues (as stated above) and the need for clarification on multiple issues regarding implementing this program nationally, additional information including a cost impact analysis to assess the cost of implementing this program vs. the potential to improve patient outcomes is needed for us to comment on the proposed Medicare coverage determination for Dr. Ornish's Program for Reversing Heart Disease.

Thank you for the opportunity to review this proposed national coverage decision.

Sincerely,

Carmella Bocchino
Executive Vice President, Clinical Affairs and Strategic Planning

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CAG-00419N

The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) agrees that published reports, including those listed in the Proposed Decision Memo for ICR, published May 14, 2010, provide evidence of the beneficial outcomes from the Ornish Program for the select group of coronary artery disease patients they have studied.

We applaud efforts in comprehensive risk-reduction interventions that demonstrate the importance of lifestyle in the secondary prevention of cardiovascular disease. The Ornish Program represents an alternative and beneficial approach for a select segment of Medicare beneficiaries who live with this chronic disease. AACVPR therefore supports the CMS designation of Intensive Cardiac Rehabilitation to the Ornish Program with the anticipation that other models of “intensive cardiac rehabilitation” that achieve similar outcomes will also be granted ICR-designation in the future.

AACVPR would appreciate clarification on the approval process for other cardiac rehabilitation programs that provide virtually the same structural services, achieve the same/similar goals, and rely on the same published data to meet the legislative criteria for approval. While we have indicated our support for the Ornish Program, we are unclear as to the specific process and supportive data that need to be submitted to CMS for intensive cardiac rehabilitation programs that are not specifically affiliated with the Ornish Program.

AACVPR believes it is reasonable to require a program to submit its unique outcomes data and rely on the peer reviewed data that has been used to approve the Ornish programs. After all, we surmise that each individual program with the Ornish imprimatur will not submit, nor were they required to submit, data unique to their specific program (site).

We believe the intent of the statute is to encourage not only Ornish programs but also programs that achieve the same clinical thresholds mandated by the statute. To rely on distinctly unique peer reviewed literature that addresses a specific rehabilitation program seemingly closes the door to independent programs.

Specific guidance and clarification from CMS would be appreciated.

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Dear Medicare:

The recent passage of healthcare access reform (Patient Protection and Affordable Care Act) will now require rigorous application of public health lifestyle interventions from k thru 12 in our school systems as well as lifestyle medicine interventions including re-education of physicians regarding the clinical evidence for primary prevention and secondary remediation of chronic, complex illnesses. Dr. Ornish''s program for reversing heart disease using the personalized lifestyle medical interventions well documented in his research is both compelling and proven efficacious. Our costly and often ineffective pharma/surgery-based interventions must be replaced where less expensive and clinically proven modalities are available, such as Dr. Ornish’s program. With patient-empowering medical interventions based on the clinical science of lifestyle medicine comes the added benefit of personal empowerment and sustain changes in behaviors.

David S. Jones, MD,FABFP
President, Institute for Functional Medicine

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I strongly support the CMS proposal to add the Ornish Program for Reversing Heart Disease to the list of approved ICR programs. The Ornish Program has been refined over the years but continues to focus on comprehensive lifestyle modifications, including exercise, a low-fat diet, smoking cessation, stress management training and group support.

It is clear that health and disease are a continuum and we know the fundamental elements that move us along that continuum. The basic elements of health promotion can slow and prevent chronic disease progression and enhance function, productivity and well-being. No matter what the illness or stage of life, we now know that the same components of human health behavior and productivity optimization apply. Those components are stress management and resilience, physical exercise and sleep, optimum nutrition and appropriate substance use, and social integration. These components are also at the core of the Ornish Program.

It is through approaches like the Ornish Program that the Nation will be able to proactively prevent disease and illness, promote health and productivity, and create well-being and flourishing for the people of America. In fact, such approaches are the only hope to bend the nation’s health care cost curve and change our current health care system that costs too much and is delivering less health and little care to fewer people.

It is for these reasons that I strongly endorse the Ornish Program.

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June 1,2010

The Honorable Kathleen Sebelius
Secretary, U.S. Department of Health & Human Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 61S-F
Washington, DC 20201

Dear Secretary Sebelius:

I write to lend my support for the Centers for Medicare & Medicaid Services' May 14 national coverage determination for the Ornish Program for Reversing Heart Disease to be included under the intensive cardiac rebabilitation (ICR) program.

Lifestyle changes are less expensive but medically effective treatments of chronic diseases, not just prevention. As you know, the health reform debate is not about continuing the status quo, but about changing our health care system and the way care is delivered. There is a great need in this country for innovative programs that hold the potential of moving our system to one that emphasizes health care, rather than sick care. Health reform is about giving individuals more choices and individuals should be given the option to engage in a lifestyle treatment program instead of surgery and pills.

As you know, chronic diseases account for approximately 75 percent of the $2.1 trillion in America's annual health care costs. I strongly believe that covering lifestyle changes as treatment holds potential to significantly reduce health care Costs while improving quality of care. For this reason, I introduced the bipartisan Take Back Your Health Act of 2009 (S. 1640) to help Congress deliver on its pledge to reduce health care costs and improve Americans' health.

Thank you for your consideration.

Sincerely,

CC: Marilyn Tavenner, Acting Administrator, Centers for Medicare and Medicaid Services .

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I am Director of the Center for Human Nutrition at the University of Colorado Denver and have been continuously funded by the National Institutes of Health since 1891 to study lifestyle and health. I am enormously enthusiastic about the decision to recommend that the Ornish Program for Reversing Heart Disease meets the intensive cardiac rehabilitation (ICR) program requirements set forth by Congress in §1861(eee)(4)(A) of the Social Security Act and in regulations at 42 C.F.R. §410.49(c) and, as such, should be added to the list of approved ICR programs. Backed by a large body of peer-reviewed research, the Ornish Program for Reversing Heart Disease has the potential to delay or prevent progression of heart disease in many people. Approval of this program is an important milestone in recognizing the power of lifestyle modification to impact health and prevent and delay chronic disease. While Dr. Ornish has published a large body of research demonstrating the efficacy of his specific program, other research, such as the results of the Diabetes Prevention Program and early results of the Action for Health in Diabetes (LOOK Ahead) study also strongly support the power of lifestyle modification in preventing type 2 diabetes in those at high risk and in improving CVD risk factors in those with type 2 diabetes. Approving this program will, in my opinion, encourage more health care professionals to engage in lifestyle modification to prevent and manage chronic diseases. This decision represents a strong leap forward in impacting overall health in the population.

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I have worked intimately with this program in the past and have been involved in training health professionals to provide this program for patients with heart disease, diabetes, cancer and obesity. This is an excellent, tested method for guiding people to make comprehensive lifestyle changes. I have seen hundreds of people benefit from this approach both in terms of improvement in health and quality of life, without expensive and life threatening procedures and medications. This approach has allowed patients to return to their normal activities, reduce their medications, avoid costly and expensive procedures. In addition, I have seen improvement in vitality and reduction in depression and anxiety.

The time has come in health care to value and support preventive, behavioral and integrative approaches to medical care. Kudos to Dr. Ornish and to you for making this an integral part of the CMS philosophy and policy.

Thank you and congratulations.

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May 28, 2010

Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services

Re: Proposed Decision for Intensive Cardiac Rehabilitation (ICR) Program – Dr. Ornish’s Program for Reversing Heart Disease (CAG-00419N)

Dear Centers for Medicare and Medicaid Services:

As a physician and founder of the Physicians Committee for Responsible Medicine, I am pleased to see your proposed decision to add the Ornish Program for Reversing Heart Disease to the list of approved ICR programs.

A low-fat vegetarian diet, along with other healthful lifestyle changes, not only leads to significant weight loss and improved cholesterol levels, but also reverses heart disease (1). Dr. Ornish showed that as arteries reopened and blood flow improved, chest pain disappeared, and participant’s quality of life changed for the better without drugs or surgery. The heart attacks that had threatened Dr. Ornish’s patients were much less likely to ever occur (2). The changes were evident in 82 percent of patients in the first year. On a five-year follow up, their risk of any sort of heart complication was cut by 56 percent (1,2).

Dr. Ornish’s program brings an alternative to expensive and potentially dangerous surgical procedures and chronic medication use. The Ornish Program for Reversing Heart Disease is a simple yet proven effective change in lifestyle. The change is doable and makes sense economically.

As Dr. Ornish’s studies progressed over the decades, he showed this dietary change can be done by individuals in a wide variety of geographic areas. In his study of 2,974 people in 24 different locations, he showed that the vast majority of people can and will stick with a healthful diet and lifestyle. People reap enormous benefits in cholesterol, blood pressure, and functional capacity (3). He showed that his program worked just as well for people with diabetes, and even had a favorable effect on men with prostate cancer.

In 2003, Dr. David Jenkins from the University of Toronto published a study in the Journal of the American Medical Association reporting that a “portfolio” diet – a vegetarian diet incorporating soluble fiber, soy protein, almonds, and plant sterol ester-enriched margarine – lowers serum cholesterol concentrations about as effectively as cholesterol-lowering statin drugs (4).

Vegetarian diets also lower blood pressure significantly. Observational studies have shown that hypertension is significantly less common among vegetarians, and subsequent clinical trials showed that such diets lower blood pressure in individuals with either normal or high blood pressure (5).

A few years ago National Institutes of Health funded our study that showed low-fat, plant-based diets are more effective than the American Diabetes Association dietary guidelines at controlling blood sugar (6). The research also showed that by adopting a low-fat vegetarian diet individuals can lower their cholesterol, reduce their blood pressure, and lose weight.

Diet and lifestyle changes have a profound effect, not just on the body, but on the mind, too. Many people with heart disease show signs of serious depression. Because of extent of illness, heart disease patients are often unable to engage in exercise. But in a large research study, Dr. Ornish found that people with significant depression who improved their diet, began modest physical activity, and learned stress management techniques not only felt better physically, but their moods lifted, too (7). Patients described how sleep habits and appetite that had been disrupted finally normalized.

Following Dr. Ornish’s research, it is clear that diet and lifestyle changes are not just the answer for individuals with heart disease. They are the answer for whole communities burdened by health problems, and for nations laboring under massive health-care costs.

Making this scientifically-proven program available through CMS is a wonderful collective step toward health. This life-saving and life-altering program should be available to everyone.

Thank you for your consideration.

Sincerely,

Neal Barnard, M.D.
President and Founder, Physicians Committee for Responsible Medicine Adjunct Associate Professor, The George Washington University Medical Center

References:

1. Ornish D, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990;336:129-133.

2. Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998;280:2001-2007.

3. Silberman A, Banthia R, Estay IS, et al. The effectiveness and efficacy of an intensive cardiac rehabilitation program in 24 sites. Am J Heath Promot. 2010;24:260-266.

4. Jenkins DJA, Kendall CWC, Marchie A, et al. Effects of a dietary portfolio on cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003;290:502-510.

5. Berkow SE, Barnard ND. Blood pressure regulation and vegetarian diets. Nutr Rev. 2005;63:1-8.

6. Barnard ND, Cohen, J, Jenkins DJ, et al. A low-fat, vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006;29:1777-1783.

7. Pischke CR, Frenda S, Ornish D, Weidner G. Lifestyle changes are related to reductions in depression in persons with elevated coronary risk factors. Psychol Health. 2010, in press.

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The Silverton Hospital Network strongly supports Centers for Medicare and Medicaid Services (CMS) proposed ruling to include the Dr. Dean Ornish Program for Reversing Heart Disease as a covered program for Intensive Cardiac Rehabilitation (ICR). We commend CMS in taking steps to provide coverage for comprehensive lifestyle intervention, which we have found to be a successful, evidence based intervention for those wishing to have a long term positive effect their cardiovascular disease (with the benefit of also impacting other co-existing chronic conditions). This program has proven to be a cost-effective treatment to help people halt or reverse the development of heart disease while significantly improving their quality of life.

To ensure long term financial viability, we also request serious consideration to increasing payment rates for cardiac rehabilitation services as suggested in RTI International’s July 2008 report to CMS entitled “Refining Cost to Charge Ratios for Calculating APC and MS-DRG Relative Payment Weights”. Without adequate payment for ICR, healthcare institutions will be financially challenged to provide these much needed and efficacious services, which in turn may limit the availability of such services to Medicare beneficiaries.

William Winter
CEO & President
Silverton Hospital Network

Terri Merritt-Worden, MS, FAACVPR
Vice President- Wellspring Division
Silverton Hospital Network

Frank Lord, MD
Medical Director
Silverton Hospital Network

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I''ve been a practicing registered nurse for 30 years and I''ve worked with the Ornish lifestyle modification program for 7 years. I''ve witnessed first hand how powerful and transformational these comprehensive lifestyle changes can be.

This program is a comprehensive and scientifically proven approach to preventing and treating lifestyle-related disease. This program expands choice for patients, providing a much needed non-invasive and pro-active treatment option.

I fully support the CMS decision to cover the Ornish program for reversing heart disease.

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May 25, 2010

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services
200 Independence Avenue, SW
Wash ington, DC 2020 I

Dear Dr. Jacques:

Cleveland Clinic (CC) is a not-for-profit, integrated healthcare system dedicated to patient care, teaching and research. Our health system is comprised of a main campus, ten community hospitals and 14 family health centers with over 2,100 salaried physicians and scientists. Last year, our system had more than four million patient visits and over 165,000 hospital admissions. We are pleased to have the opportunity to comment on the Proposed Coverage Decision Memo for Intensive Cardiac Rehabilitation Program - Or. Ornish' s Program for Reversing Heart Disease. (CAG-00419N)

We agree with the conclusion in the decision memo which states "The Ornish program for Reversing Heart Disease meets the intensive cardiac rehabilitation (lCR) program requirements set forth by Congress in 1861(eee)(4)(A) of the Social Security Act and in your regulations at 42 C.F.R 410.49:' It is clear that CMS conducted a thorough and rigorous review of the peer reviewed research in order to make this determination. We believe that the research demonstrates that the Ornish progmm is a viable and important treatment for patients with coronary artery disease. It is clear that t is ICR program enables patients to make positive life changes that result in positive health outcomes.

One of our physicians, Dr. Michael Roizen had the opportunity to visit two of Ihe Ornish programs. During these visits he was able to meet with patients who were in the early phases of the program, as well those with years of experience. His visit was both informative and inspiring as he was able to see firsthand the positive effects of The Ornish Program. We thoroughly support the position taken by CMS for reimbursement of this program as we feel it is in best interests of patients for their longterm health and wellness.

Thank you for conducting a thoughtful process that allows us to provide input on such an important issue. and for your consideration of this information. Please do not hesitate to contact me if you need additional information.

Sincerely,

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Thank you for your decision to cover Dr Ornish''s Program for Reversing Heart Disease.

We are in the process of building an Accountable Care Organization in Sacramento with a health plan and a hospital system - adding an Intensive Cardiac Rehabilitation Program is an essential piece to help slow stop and reverse heart disease.

When given the right support, as in an intensive cardiac rehabilitation program, patients are able to better self manage their health.
Glenn Perelson
Hill Physicans Medical Group
San Ramon, California

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Comments for Memo for Intensive Cardiac Rehabilitation (ICR) Program – Dr. Ornish’s Program for Reversing Heart Disease (CAG-00419N)

To: CMS Comments

From: Mehmet Oz, M.D.

Date: May 19, 2010

Re: Comments for Memo for Intensive Cardiac Rehabilitation (ICR) Program – Dr. Ornish’s Program for Reversing Heart Disease (CAG-00419N)

My team and I would just like to support the decision for the proposed coverage decision of Louis B. Jacques, M.D., et al of May 14, 2010 and believe that your excellent review is completely on target. The Ornish program has repeatedly demonstrated the ability to be a crucial treatment for patients with atherosclerotic disease. The studies strongly reflect that such a program not only can meet the criteria set forth by Congress in 1861 (EEE) (4) (A), but would be a less expensive choice.

In addition, the Ornish program demonstrates remarkable retention rates as reflected in the reviewed article of Ornish in JAMA 1998, and is the most reported treatment program that reverses symptomatic lesions.

I have reviewed in detail the Ornish program and discussed them with patients in the different phases of the program. This program offers a substantial role in medicine’s armamentarium and will fit the criteria of the law. I believe that your decision to approve the Ornish program for Medicare Coverage will remove the major barrier of patients to this approach. While this approach may not be suitable or fit everyone, a substantial portion of patient will benefit from this at a lower cost than alternative treatments.

I wanted to weigh in as an individual with no financial interest in this decision, but as a front line clinician who has watched patients use it and believes that this is an important advance that provides a reasonable choice for a lower cost program that materially slows or reverses coronary disease.

Sincerely,

Mehmet Oz, M.D.

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Mark Hyman, MD
Chairman, Institute for Functional Medicine
45 Walker Street
Lenox, MA 01240

To Center for Medicaid and Medicare Services:

Comment on: Intensive Cardiac Rehabilitation (ICR)Program - Dr. Ornish''s Program for Reversing HeartDisease: (CAG-00419N)

Most of the chronic diseases that affect 160million Americans and accounts for 78% of ourhealth care costs are caused by a few lifestyleand environmental factors – namely our diet,sedentary lifestyle, smoking and chronic stressand environmental toxins.

Lifestyle factors leading to chronic diseases suchas heart disease, diabetes, obesity and cancer arethe domain of doctors and not merely a “publichealth problem.” Lifestyle is not only a public health issue; it isalso a medical and clinical care issue.

Lifestyle medicine is not just about preventingchronic diseases but also about treating them,often more effectively and less expensively thanrelying only on drugs and surgery. Nearly all themajor medical societies recently joined inpublishing a review of the scientific evidence forlifestyle medicine both for the prevention andTREATMENT of chronic disease.http://www.acpm.org/LifestyleMedicine.htm. Thereis strong evidence that this approach works andsaves money. Unfortunately, insurance doesn’tusually pay for it. No one profits from lifestylemedicine, so it is not part of medical educationor practice. It should be the foundation of ourhealth care system.

For example, the recent “EPIC” study published inthe Archives of Internal Medicine studied 23,000people’s adherence to 4 simple behaviors (notsmoking, exercising 3.5 hours a week, eating ahealthy diet [fruits, vegetables, beans, wholegrains, nuts, seeds, and low meat consumption],and keeping a healthy weight [BMI <30]). In thoseadhering, 93% of diabetes, 81% of heart attacks,50% of strokes and 36% of all cancers wereprevented.

This study is only one among a large evidence basedocumenting how lifestyle intervention is oftenmore effective in reducing cardiovascular disease,hypertension, heart failure, stroke, cancer,diabetes and all cause mortality than almost anyother medical intervention. It is becauselifestyle addresses not only risk factormodification or reduction. Our lifestyle andenvironment influences the fundamental biologicalmechanisms leading to disease: changes in geneexpression, which modulate inflammation, oxidativestress and metabolic dysfunction.

This distinction between risk factors and causesis an important one. High blood pressure,dyslipidemia, elevated C-reactive protein, orglucose are not in and of themselves the realcauses of chronic disease, but simply surrogatemarkers that are the EFFECTS of how we eat, howmuch we exercise, how we respond to stress, andthe effects of environmental toxins.

The future of medical care must be to transformgeneral lifestyle guidance (eat a healthy diet,get regular exercise) that many physicians try toprovide to their patients intoindividually-tailored lifestyle prescriptions forboth prevention and treatment of chronic diseases. Lifestyle is often the best medicine when appliedcorrectly.

“Prevention” therapies as written into currenthealth care bills are public health and communitybased wellness initiatives, or payment for earlydetection of disease with mammograms,colonoscopies and other screening tests. As theCongressional Budget Office recently indicated,early detection without treating the majorunderlying causes of chronic diseases—ourlifestyle choices may actually add to costs.

For example, a mammogram does not prevent breastcancer; it may find it sooner when it is moreeasily treated, but hundreds or thousands of womenmust be tested to find one cancer. The argumentfor this type of “prevention” is necessary andmoral, but not economic. The center of the health care debate must changeto what is covered, not just who is covered, if weare to make current treatments more effective andless costly.

The lifestyle factors leading to these chronicdiseases are the domain of doctors and not just a“public health problem”. Doctors must “do”lifestyle medicine and receive adequatereimbursement, otherwise the cost of chronicdisease will bankrupt Medicare by 2017.

Treating Causes Rather than Risk Factors

Let’s circle back to flaw in treatment of riskfactors and not causes. Typically doctors treat“risk factors” for disease such as giving alifetime of medications to lower high bloodpressure, elevated blood sugar, and highcholesterol. These, however, do not treat theunderlying causes of those risk factors; what andhow much we eat, if we smoke, how we exercise,manage stress, and the effects of environmentaltoxins. Since the underlying causes are notaddressed by medications, it’s somewhat likemopping up the floor around an overflowing sinkinstead of turning off the faucet, which is whymedications usually have to be taken for a lifetime.

Instead, when the underlying lifestyle causes areaddressed, patients are often able to stop takingthese medications (under their doctor’ssupervision, of course). Likewise, they can oftenavoid surgery as well. Presently, according to the American HeartAssociation, 1.3 million coronary angioplasty and448,000 coronary bypass operations are performedannually at a cost of more than $100 billion. Despite these costs, many studies, including onelast month in The New England Journal of Medicine,revealed angioplasties and stents do not prolonglife or even prevent heart attacks in stablepatients (i.e., 95% of those who receive them). Coronary bypass surgery prolongs life in less than2-3% of patients who receive it. In contrast, the INTERHEART study, published inThe Lancet, followed 30,000 people and found thatchanging lifestyle could prevent at least 90% ofall heart disease. Think about it. Heart disease accounts for morepremature deaths and costs Americans more than anyother illness and is almost completely preventablesimply by changing diet and lifestyle. The samelifestyle changes that can prevent or even reverseheart disease also can prevent or reverse manyother chronic diseases. Medicare and insurance companies currently paybillions every year for surgical procedures suchas angioplasties and bypass surgeries. These arehigh-risk invasive procedures fraught withcomplications, expensive and largely ineffective. In the large ACCORD study of over 10,000diabetics, aggressive blood sugar lowering withmedication actually caused more deaths. Highblood sugar is just a side effect poor lifestylechoices. The treatment isn’t insulin to lowerblood glucose, but healthy dietary choices,exercise, managing stress and quitting smoking. In contrast, the Diabetes Prevention ResearchGroup study showed that lifestyle changes are evenmore effective than diabetes drugs such asmetformin in reducing the incidence of diabetes inpersons at high risk, with lower costs and fewerside-effects, and is sustainable in a 10 yearfollow up study. At the same time, lifestyle medical treatmentincluding personalized, science basedprescriptions for diet, exercise and stressmanagement are not reimbursed or only partiallyreimbursed. These proven therapies are low riskand effective in reversing and preventing chronicdiseases. If we train and pay for doctors to learn how tohelp patients address the REAL causes of diseasewith lifestyle medicine –and not just treatdisease risk factors (simply the effects of poorlifestyle choices) with medications or surgery,then we can save almost $1.9 trillion over tenyears for just five major diseases: heart disease,diabetes, “pre-diabetes” or metabolic syndrome,prostate and breast cancer.

Congress recently passed a health insurance reformbill. However, the important questions remains asto whether we can both provide access to healthcare for all Americans and reduce costs at thesame time. We cannot reduce costs if we continueto provide the same type of health care basedprimarily on treating with medications and surgeryrather than lifestyle medicine. Giving 47 millionmore people access to our current methods oftreatment for chronic disease with medications,procedures and surgery will surely cost more andoffer less.

The lifestyle treatment program for cardiovasculardisease based on Dr. Dean Ornish’s researchrecently approved for reimbursement by CMS is agiant step forward, a game-changer that willfinally provide reimbursement for research proventreatments that will both improve outcomes andreduces costs. This approach of lifestyletreatment must also be extended to other lifestyledriven conditions including diabetes and metabolicsyndrome. Many argue, including the head of the AmericanMedical Association that lifestyle medicine is asocial, community and public health issue, not amedical care issue. Real doctors don’t “treat”patients with lifestyle medicine. While communitywellness programs and public health education dowork (tobacco use reduced by two-thirds since the1950’s, Americans reduced dietary fat by 4% andincreased carbohydrate by 6% on the urging of themisguided US Dietary guidelines of 1977, and morepeople use seatbelts, sunscreen and helmets), theyonly go part way. Doctors need to go the rest ofthe way.

Doctors Must Learn and Practice Lifestyle Medicine

The fundamental flaw in thinking right now inhealth care is that doctors don’t “do” lifestylemedicine. And that people don’t change. In partthat is true. Only 50% of patients take the drugstheir doctor recommends. The food and drugindustry, however, has been very successful inchanging our habits for the worse. The typicalAmerican now eats 680 more calories per day than30 years ago and 81% of the adult population takesat least one medication. Established financialinterests drive research and delivery of carebased on medication and surgery. There are noincentives to drive doctors to treat disease withlifestyle medicine. The recent approval of Dr.Ornish’s lifestyle program for cardiovasculardisease is a critical step forward in creatingincentives that will shift medical practice toaddress the drivers of both disease and cost. Changes in policy, reimbursement, research,education and clinical care encouraging doctors to“do” lifestyle medicine must continue as weproceed with health care reform. But you might argue that doing this for everyonemay cost more (and it might), so let’s begin withthose who ALREADY have chronic disease. Integrated health care teams led by physicianspracticing lifestyle medicine can save our healthcare system. Presently, however, physicians lacktraining and financial incentives to help peoplelearn how to eat a healthy diet, exercise, stopsmoking, manage their weight or address theeffects of environmental toxins. So they continueto do what they know how to do: prescribemedication and do surgery. Personalized lifestyle medicine is a high-science,high-touch, low-tech, low-cost treatment that ismore effective for the top five chronic diseasesthan our current approaches. Yet is it not taughtin medical schools, practiced by physicians, nordelivered in hospitals or healthcare settings. Infact, this treatment, if applied to all thepatients with cardiovascular disease, diabetes,metabolic syndrome (obesity), prostate cancer, andbreast cancer could reduce net health careexpenditures $930 billion over 5 years, and resultin dramatically better health and quality of life.

The Intensive Cardiac Rehabilitation (ICR) Program- Dr. Ornish''s Program for Reversing HeartDisease: (CAG-00419N) is one of the most importantpolicy initiatives in health care today.

I have reviewed the same scientific studies aboutDr. Ornish’s program that CMS reviewed and Istrongly agree with your conclusion that this is ascientifically proven program. As is clear fromthe references included with the comment, theposition of the American College of Cardiologyquestioning whether there was enough science towarrant coverage is inaccurate, and frankly, wrong.

This program will reinvigorate primary caremedicine and drive the transformation of existinghealth care institutions, medical schools,postgraduate education and insurers to meet thedemand for interventional lifestyle treatment ofchronic disease. It will induce doctors to learn and practicelifestyle medicine, both because it works betterfor their patients, and physicians will be paid todo it. It will support the development of a wellness- andhealth-based economy rather than one based on sickness and chronic disease. If lifestyle medicine becomes central to the practice of medicine, our sick care system will be transformed into a health care system.

Ford ES, Bergmann MM, Kröger J, Schienkiewitz A,Weikert C, Boeing H.Healthy living is the best revenge: findings fromthe European Prospective Investigation Into Cancerand Nutrition-Potsdam study. Arch Intern Med. 2009Aug 10;169(15):1355-62.2 http://www.acpm.org/LifestyleMedicine.htm3
Mozaffarian D, Wilson PW, Kannel WB. Beyondestablished and novel risk factors: lifestyle riskfactors for cardiovascular disease. Circulation.2008 Jun 10;117(23):3031-8. Review.4
Boden WE, O''Rourke RA, Teo KK, et al; COURAGETrial Investigators.Impact of optimal medical therapy with or withoutpercutaneous coronary intervention on long-termcardiovascular end points in patients with stablecoronary artery disease (from the COURAGE Trial).Am J Cardiol. 2009;104(1):1-4.5
Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A,Lanas F, McQueen M, Budaj A, Pais P, Varigos J,Lisheng L; INTERHEART Study Investigators. Effectof potentially modifiable risk factors associatedwith myocardial infarction in 52 countries (theINTERHEART study): case-control study. Lancet.2004 Sep 11-17;364(9438):937-526
Action to Control Cardiovascular Risk inDiabetes Study Group, Gerstein HC, Miller ME,Byington RP, Goff DC Jr, Bigger JT, Buse JB,Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr,Probstfield JL, Simons-Morton DG, Friedewald WT.Effects of intensive glucose lowering in type 2diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-597
Knowler WC, Barrett-Connor E, Fowler SE, et al;Diabetes Prevention Program Research Group.Reduction in the incidence of type 2 diabetes withlifestyle intervention or metformin. N Engl J Med.2002;346(6):393-403.8
Diabetes Prevention Program Research Group,Knowler WC, Fowler SE, Hamman RF, Christophi CA,Hoffman HJ, Brenneman AT, Brown-Friday JO,Goldberg R, Venditti E, Nathan DM. 10-yearfollow-up of diabetes incidence and weight loss inthe Diabetes Prevention Program Outcomes Study.Lancet. 2009 Nov 14;374(9702):1677-86.9
Ornish D, Scherwitz LW, Billings JH, Gould KL,et al. Intensive lifestyle changes for reversal ofcoronary heart disease. JAMA 1998;280:2001-2007.10 Cleveland Clinic estimates for Take Back YourHealth Act of 2009

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It is with great pleasure that I recommend that CMS cover Dr. Dean Ornish’s pioneering lifestyle program for reversing heart disease. Dr. Ornish’s program is the most comprehensive and scientifically proven approach to preventing lifestyle-related disease in the country and I applaud your efforts to support it. Many lives and much heartache (both physically and emotionally) will be saved by CMS support.

As an educator who has worked for many years with at-risk children and their families, I have seen an increase in the devastating effects of lifestyle diseases affecting young children. Dean Ornish is unique in the medical field for his focus on multi-dimensional education as a preventive strategy. Dr. Ornish conducts brilliant scientific research that is patient-centered and deeply caring. I only wish that this approach was the prevailing standard in the United States. I cannot think of a better program for CMS to endorse.

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I wholeheartedly support the inclusion of the Ornish program under Medicare coverage. As a medical director for a health plan I have seen several seniors benefit immensely from participating in Ornish which is covered currently under Highmark''s Medicare Advantage plans SecurityBlue and FreedomBlue. Participant''s have had significant improvement in their cholesterol, LDL, HDL, improved quality of life, reduction of blood pressure and reduction of the need for medications. This coverage will significantly impact the health care cost curve by positively impacting the health life of Medicare participants

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I enrolled in Dr Ornish''s reversal program at CAMC in early 2004, after heart attack and 4 bypasses, and have followed the program since then. I am now 72 and feel fitter than before the heart attack. No hospitalization or other serious medical problems in this period. BMI now 25 and has been stable for several years. I have remained a member of the local self-directed group after the 12 month hospital program and believe that continuing contact with other participants has helped maintain my lifestyle changes. In speaking to individuals who have not started the program, the common complaint is that they could never give up eating meat. I suggest you investigate the feasibility of providing carefully-prepared Ornish food to all cardiac patients in hospitals, and perhaps an Ornish version of ''Meals on wheels'' for the first month after discharge. Anything which increases participation in this program has to be worthwhile.

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I am a Registered Nurse of 21 years and have been working in the Cardiac Rehab field for 13 years. In working with the Ornish Program for the past 8 years, I have seen incredible outcomes in patients who have participants in the ORnish Program. It has dramatically improved the lives of patients with heart disease as well as those who are at risk for heart disease. They are healthier because of their lifestyle changes. They are at less risk for coronary events as well as dramatically improving the quality of life. There are absolutely NO negative side effects when people are guided to make healthy lifestyle change! What other disease treatment can say there are no negative side effects? Providing Medicare coverage for the Ornish program will allow Medicare participants the opportunity to dramatically improve their health simply by changing their lifestyle. We have a large number of Medicare people that over the past 9 years have wanted to participate in the Ornish Program, but have been unable to because of the lack of coverage and inability to pay out of pocket. Covering this program will allow Medicare participants to CHOOSE to be healthier with a program that is at no risk to them. One of the best ''positive'' side effects of participation is that when they are healthier, their dollars spent on health care will be less!! Thank you for your decision to cover the Ornish Program as an Intensive Cardiac Rehab program. This will make a difference in many thousands of lives!

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Dear Sirs,

I have read the article by Dean Ornish. It is excellent. I have known Dr. Ornish for many years since he was a student of mine when I was Chief of Medicine at Harvard Medical School. I know very well the paper by Dr. Ornish of which you are requesting advice from experts in this field. His paper is excellent as I stated.

There is no question in my mind, but that his paper should be accepted as important and acurate.

I trust you will accept my evaluation of the importance of Dr. Ornish''s work and publications.

Sincerely,

Alexander Leaf, M.D.
Jackson Professor of Clinical Medicine, Emeritus
Harvard Medical School
Chief, Medical Services, Emeritus
Massachusetts General Hospital
Tel: 617-726-5908; Fax: 617-726-6144
E-mail: aleaf@partners.org

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I write is strong support of the Proposed Decision Memo-Dr. Ornish''s Program for Intensive Cardiac Rehilitation(ICR) Program for Reversing Heart Disease(CAG-00419N). This program and Dr. Ornish''s work and research have rewritten our understanding of the development of cardiovascular disease. Despite initial skeptisism, he has conclusively demonstrated the dynamic and reversible nature of coronary artery atherosclerosis. His program consisting of dietary modification, healthy life-style changes and stress reduction has been conclusively shown to minimize risk of cardiovascular disease. Indeed, compliance with his program actually reverses atherosclerosis. Dr. Ornish and others have not only shown striking clinical benefit, but have uncovered much of the underlying mechanistic explanation for why his program works.Dr. Ornish''s program exemplifies the best in preventative, personalized, patient-centered approaches to care. Noty only is his approach effective and compassionate, it is cost-effective.I applaud CMS for its proposal to fund this important approach. It''s implimentation will be a big step in rational health care reform.

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Dr. Ornish''s program is a lifesaver. I cannot give enough credit to Dr. Ornish and his program, and the life-changing benefits of nutrition and stress reduction. This should be a part of every medical school program - teaching nutrition and how food is medicine. The importance of reducing stress in our lives, especially with technology we live with today cannot be understated. How we can heal ourselves - this could help end the health care crisis - if we can get politics out of it. Thank you Dr. Ornish.

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I am in full support of Dr. Ornish''s program beingreimbursed. It is first and foremost in the bestinterests of the patient, as it is a less-invasiveand more sustainable, longer-term approach toachieving greater health. In addition, it is alsoin the best interests of government spending, ascurrent invasive/expensive treatment options thatdo not attempt to alter lifestyle are 1.) ordersof magnitude more expensive and/or anatomicallyintrusive, and 2.) will invariably fail if thesource of unhealthy behavior is not remedied.

100% in full support, and I applaud CMS'' decision.

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