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National Coverage Analysis (NCA) View Public Comments

Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program

CAG-00418N

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Total Comments: 9

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Lehr, Paul T.	Title: President Organization: Pritikin Research Foundation Date: 06/12/2010 Comment: June 13, 2010 BY ELECTRONIC DELIVERY Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: C1-09-06 7500 Security Blvd. Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: The Pritikin Research Foundation (Pritikin) appreciates this opportunity to comment on the proposed decision memorandum (the “Proposed Decision”) recently released by the Centers for Medicare & Medicaid Services (CMS) regarding approval of the Pritikin Program as an intensive cardiac rehabilitation (ICR) program.¹ We agree with CMS’s conclusion that the Pritikin Program “meets the ICR program requirements set forth by Congress” and “should be added to the list of approved ICR programs,” and we urge CMS to finalize this decision, as proposed. The Pritikin Program helps prevent and reverse heart disease and other health problems through its focus on daily exercise and an eating plan based on natural, whole foods like fruits, vegetables, whole grains, seafood rich in omega 3s, and limited lean animal protein. More than 110 studies in prestigious medical journals like The New England Journal of Medicine, Archives of Internal Medicine and Circulation have documented the Pritikin Program’s success in helping patients dramatically reduce total and low density lipoprotein (LDL) cholesterol, lower blood pressure to the point where medication is no longer necessary, eliminate the need for bypass surgery and angioplasty, and substantially reduce the risk of heart disease, hypertension, obesity, diabetes, and risk factors for cancers of the breast, colon, and prostate. As shown by the peer-reviewed published research discussed in the Proposed Decision, the Pritikin Program achieves the outcomes specified in the statute as requirements for ICR programs under Medicare. Specifically, the Pritikin Program reduced the need for coronary bypass surgery and achieves statistically significant reductions in five or more of the following measures: (1) low density lipoprotein; (2) triglycerides; (3) body mass index; (4) systolic blood pressure; (5) diastolic blood pressure; or (6) the need for cholesterol, blood pressure, and diabetes medications. To support the conclusion that the Pritikin Program reduces the need for coronary bypass surgery, CMS cites a significant study by Barnard et al. that followed 64 patients with documented coronary artery disease who had been recommended for bypass surgery before participation in the Pritikin Program.² Within five years of completing the program, only 12 of those patients (19%) had bypass surgery, and 81% had successfully avoided the surgery.³ This study clearly demonstrates that the Pritikin Program reduced the need for coronary bypass surgery. CMS also cites five studies to support its conclusion that the Pritikin Program achieves a statistically significant reduction in five or more of the specified measures: low density lipoprotein, triglycerides, body mass index, systolic blood pressure, diastolic blood pressure, and medication use.⁴ We agree with these conclusions and we strongly recommend that CMS finalize its decision to add the Pritikin Program to the list of ICR programs recognized by Medicare.⁵ Finally, we would like to take this opportunity to request clarification about the requirement for physician offices and hospital outpatient departments to provide ICR using an approved ICR program. In Transmittal 126, CMS revises the Medicare Benefit Policy Manual by adding a new section 232 to chapter 15. This section states, CR/ICR services must be furnished in a physician’s office or a hospital outpatient setting (for ICR, the hospital outpatient setting must provide ICR using an approved ICR program).⁶ This statement may lead to confusion regarding the need for ICR in a physician’s office to be furnished through an approved ICR program. The regulation at 42 C.F.R. § 410.49(a) states that “intensive cardiac rehabilitation sites” may be “a hospital outpatient setting or physician's office that is providing intensive cardiac rehabilitation utilizing an approved ICR program.” We ask CMS to clarify that both physician offices and hospital outpatient departments that provide ICR must use an approved ICR program. Pritikin greatly appreciates the opportunity to comment on the Proposed Decision regarding approval of the Pritikin Program as an ICR program, and we thank CMS for the time and effort it has dedicated to reviewing the evidence to reach this conclusion. Please feel free to contact me at (305) 935-7122 or via e-mail at plehr@pritikin.com if you have any questions regarding these comments. Thank you for your attention to this very important matter. Respectfully submitted, /s/ Paul T. Lehr President, Pritikin Research Foundation ¹ Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N), May 14, 2010, http://www.cms.gov/mcd/viewdraftdecisionmemo.asp?id=239. ² Barnard R, Guzy P, et al. Effects of an intensive exercise and nutrition program on patients with coronary artery disease: five-year follow-up. J Cardiac Rehab 3:183-190, 1983. ³ Id. at 186. ⁴ Proposed Decision, at 6. ⁵ We also agree with CMS’s conclusions for the reasons stated in our prior comment letter on CMS’s National Cover Analysis, which is incorporated herein by reference. ⁶ Transmittal 126, Change Request 6850, May 21, 2010. Less June 13, 2010 BY ELECTRONIC DELIVERY Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: C1-09-06 7500 Security Blvd. Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: The Pritikin Research Foundation (Pritikin) More
Hare, M.D., F.A.C.C., Joshua M.	Title: Louis Lemberg Professor of Medicine Organization: Leonard M. Miller School of Medicine Date: 06/11/2010 Comment: June 12, 2010 BY ELECTRONIC DELIVERY Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: C1-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: My name is Dr. Joshua M. Hare. I am the Louis Lemberg Professor of Medicine (Cardiology) at the University of Miami Miller School of Medicine. I also am the Director of the Universityfs Interdisciplinary Stem Cell Institute. Previously, I was the Chief of Cardiology at the University of Miami Miller School of Medicine, and Professor of Medicine and Director of the Cardiac Transplant and Heart Failure program at Johns Hopkins University School of Medicine. I specialize in the areas of heart failure, heart transplantation, myocarditis, cardiomyopathy, and stem cell therapy. My work has been published in The New England Journal of Medicine, Nature, Proceedings of the National Academy of Sciences, Journal of Clinical Investigation, Journal of American College of Cardiology, Circulation, and Circulation Research. Currently, I am the principal investigator on a National Institutes of Health Specialized Center for Cell- Therapy funded stem cell study for patients with congestive heart failure. I have just published a seminal paper on the use of bone marrow derived stem cells for patients with acute myocardial infarction. Among other things, my research interests include the aging cardiovascular system and the pathophysiology of and therapy for congestive heart failure. I am grateful to have the opportunity to comment on proposed decision memorandum (the "Proposed Decision") by the Centers for Medicare & Medicaid Services (CMS) regarding approval of the Pritikin Program as an intensive cardiac rehabilitation (ICR) program.¹ The Pritikin Program provides patients with invaluable health benefits through an eating plan based on natural whole foods like fruits, vegetables, whole grains, seafood, and limited lean meat; daily exercise; and education that focuses on practical real-world training such as reading food labels and cooking healthfully, as well as skills for managing stress. I have closely followed the clinical literature related to cardiovascular disease, which has clearly established the valuable role such lifestyle modification program elements can have in helping prevent and reverse heart disease and other health concerns, reduce total and low density lipoprotein (LDL) cholesterol, lower blood pressure to the point where medication is no longer necessary, and eliminate the need for bypass surgery and angioplasty. I also personally have treated several patients that have participated in the Pritikin Program and have seen first-hand the benefits of the Program in improving health outcomes in patients with cardiovascular disease and helping to avoid more invasive treatments. I am a strong advocate that lifestyle modification serves as an essential adjunct to medical therapy to improve outcomes for patients with coronary artery disease, metabolic syndrome, and congestive heart failure. Congress recognized the benefits that ICR programs like the Pritikin Program can have for Medicare beneficiaries and provided coverage for such programs by statute. I commend CMS for recognizing the benefits of the Pritikin Program in the Proposed Decision. CMS's extensive review of the peer-reviewed published research concludes that the Pritikin Program has been shown to reduce the need for coronary bypass surgery and achieve a statistically significant reduction in the following measures: low density lipoprotein cholesterol (LDL); triglycerides (TG); body mass index (BMI); systolic blood pressure (SBP); diastolic blood pressure (DBP); or the need for medications. Because the statutory requirements have been met, and to ensure that Medicare beneficiaries have access to this proven ICR program, I agree that CMS should recognize the Pritikin Program as an approved ICR program. If you have any questions about these comments, please feel free to contact me at 305 243 1999. Thank you for your time and consideration. Sincerely, /s/ Joshua M. Hare, MD Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute ¹ Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N), May 14, 2010, http://www.cms.gov/mcd/viewdraftdecisionmemo.asp?id=239. Less June 12, 2010 BY ELECTRONIC DELIVERY Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: C1-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: My name is Dr. Joshua M. Hare. I am the More
Moore, Michael	Date: 06/11/2010 Comment: June 12, 2010 Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mailstop: C1-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: Thank you for the opportunity to comment on the Centers for Medicare & Medicaid Services' proposed decision memorandum regarding approval of the Pritikin Program as an intensive cardiac rehabilitation program. My name is Michael Moore and I am a filmmaker and concerned citizen. I have attended the Pritikin Longevity Center and one of my films, entitled Sicko, was based in part on some of the inspiring education I received while at Pritikin. It is imperative that we focus more on health care and fixing the source of the problems, rather than just disease management, and Pritikin can not only prevent but reverse serious health issues. Pritikin dramatically improves the lives of people who go through the program and there are no side effects to learning and adopting the healthy lifestyle taught by Pritikin. I urge CMS to finalize its decision to recognize the Pritikin Program as a Medicare reimbursable intensive cardiac rehabilitation program. Pritikin can help to improve and save millions of lives and I urge Medicare to make this valuable program more widely available to the American people. Respectfully submitted, Michael Moore Less June 12, 2010 Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mailstop: C1-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: Thank you for the opportunity to comment on the Centers for Medicare & Medicaid Services' More
Bocchino, Carmella	Title: EVP, Clinical Affairs and Strategic Planning Organization: America's Health Insurance Plans (AHIP) Date: 06/10/2010 Comment: 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 - Pritikin Program (CAG-00418N). 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. AHIP is not aware of any health insurance plans that currently provide coverage for the Pritikin Program. Our members have also noted, along with CMS within the proposed decision memo, that the evidence base for the Pritikin program is not as substantial as other lifestyle modification programs. While there is some evidence that the Pritikin Program positively affects the clinical outcomes required within the proposed NCD, the studies have had small numbers of participants, with generally no control populations. Most of our members have concerns that the evidence available to support the effectiveness of the Pritikin program in reducing the cardiovascular risk criteria, as required within the proposed NCD, 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. These commercially available weight loss and lifestyle change programs are widely available, in all geographic areas, and have distinct programmatic components that are easy to implement and track. Questions remain regarding the replication and implementation of the Pritikin Program, nationally and in other providers' offices and facilities, as the available evidence is based on research in Pritikin centers, having tightly controlled programs and environments. Our members also have concerns regarding how CMS will be able to manage both quality control and ensure that Medicare beneficiaries have equal access to the program, and that the program components are identical in different areas and for different beneficiary populations. Especially as there is limited detail available, either within the CMS proposed NCD or through readily available sources, on the specific Pritikin Program's programmatic components and expectations of patients participation. The Pritikin program is multi-faceted, as mentioned above, and CMS does not clarify within the proposed NCD which components would be covered. Prior to advancing this program for consideration as a benefit, CMS should articulate exactly which components the program would provide to beneficiaries. Our members are also concerned that it is not clear how an entity would become a "licensed" or "certified" provider of the Pritikin program, and how CMS would ensure that beneficiaries are receiving all the services that are being reimbursed. In light of the above stated concerns, and our request to CMS to provide clarification on multiple issues regarding implementing this program nationally, we do not support the Pritikin Program becoming a covered benefit for Medicare beneficiaries, at this time. Thank you for the opportunity to provide comments at this time. Sincerely, Carmella Bocchino Executive Vice President, Clinical Affairs and Strategic Planning Less 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 - Pritikin Program (CAG-00418N). More
Blumenthal, MD, Roger S.	Title: Professor of Medicine, Division of Cardiology Organization: The Johns Hopkins University School of Medicine Date: 06/09/2010 Comment: June 8, 2010 Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mailstop: C1-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: Thank you for the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum (the “Proposed Decision”) regarding approval of the Pritikin Program as an intensive cardiac rehabilitation (ICR) program.¹ My name is Roger S. Blumenthal, MD and I serve as Professor of Medicine in the Division of Cardiology at the Johns Hopkins University School of Medicine. I also serve as Director of the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease. I have published more than 200 peer reviewed articles on treatment and prevention of cardiovascular disease. I was also Chairman of the American College of Cardiology Committee for Prevention of Cardiovascular Diseases for 4 years. Based on my clinical expertise and review of the pertinent medical literature, I urge CMS to recognize the Pritikin Program as an approved lCR program under the Medicare program. The Pritikin Program offers a sound, science-based integrated approach to cardiac rehabilitation that combines lifestyle education, structured exercise, and healthy eating that focuses on natural, nutrient-rich, high-fiber foods. A number of my friends and patients have had superb long-lasting results from their participation in the Pritikin program. Clearly the cornerstone of prevention is optimization of dietary and exercise habits and reduction in psychosocial stress. The Pritikin Program excels in this area. In light of my experience and the foregoing evidence, I urge CMS to finalize its decision to recognize the Pritikin Program as an ICR program, eligible for Medicare reimbursement. Not only will it improve clinical outcomes for Medicare beneficiaries suffering from cardiac conditions, but, as illustrated by a variety of studies, it will save Medicare money by reducing the use of costly medications and procedures. In case any questions should arise regarding my submission, I am available at 410-955-7376. Thank you for your consideration of this important matter. Respectfully submitted, /s/ Roger S. Blumenthal, MD Professor of Medicine, Division of Cardiology Director, The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease The Johns Hopkins University School of Medicine ¹ Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N), May 14, 2010, http://www.cms.gov/mcd/viewdraftdecisionmemo.asp?id=239. Less June 8, 2010 Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mailstop: C1-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: Thank you for the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed More
Goldschmidt, M.D., Pascal J.	Title: Senior Vice President for Medical Affairs and Dean Organization: Chief Executive Officer, University of Miami Health System Date: 06/09/2010 Comment: BY ELECTRONIC DELIVERY June 10, 2010 Louis Jacques, M.D. Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mailstop: CI-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-0041SN) Dear Dr. Jacques: I greatly appreciate this opportunity to comment on the proposed decision memorandum (the "Proposed Decision") released by the Centers for Medicare & Medicaid Services (CMS) regarding approval of the Pritikin Program as an intensive cardiac rehabilitation (ICR) program.^l My name is Dr. Pascal J. Goldschmidt and I currently serve as the Senior Vice President for Medical Affairs and the Dean for the Miller School of Medicine at the University of Miami. I also serve as the CEO of the University of Miami Health System. Previously, I was the chairman of the Department of Medicine at Duke University Medical Center, having first served as the chief of Duke's Division of Cardiology. Prior to my tenure at Duke, I also served as the director of cardiology at the Ohio State University College of Medicine and Public Health, where I founded the Heart and Lung Institute. My current research applies genomics and cell therapy to the prevention, diagnosis, and treatment of coronary altery disease. The Pritikin Program provides intensive cardiac rehabilitation through lifestyle education, structured exercise, and nutritional counseling. I have closely followed the clinical literature, which has clearly established the valuable role that the Pritikin Program can have in helping prevent and reverse heart disease and in treating other health problems. I believe that the Pritikin Program has proven that it effectively improves health outcomes for patients with cardiovascular disease and helps them avoid more invasive treatments. My observations are also supported by studies in the peer-reviewed literature, which demonstrate the Pritikin Program's ability to: reduce levels of low density lipoprotein (LDL) cholesterol, triglycerides, and blood glucose; produce long-term and sustainable weight-loss; lessen reliance on celtainmedications; and eliminate the need for bypass surgery. I strongly support CMS's Proposed Decision to recognize the Pritikin Program as an approved ICR program. CMS is correct to conclude that the Pritikill Program has been shown to reduce the need for coronary bypass surgery and to attain the requisite statistically significant reductions in the measures specified in the law. I recommend that CMS finalize this decision and recognize the Pritikin Program as an approved ICR program. Again, I greatly appreciate this opportunity to submit this comment on the Proposed Decision to determine whether the Pritikin Program qualifies for palticipation as an ICR program. Please feel free to contact me if you have any questions or concerns. Respectfully submitted, /s/ Pascal J. Goldschmidt, M.D. Senior Vice President for Medical Affairs and Dean Chief Executive Officer, University of Miami Health System ¹ Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N), May 14,2010, http://www.cms.gov/mcd/viewdraftdecisionlllemo.asp?id=239. Less BY ELECTRONIC DELIVERY June 10, 2010 Louis Jacques, M.D. Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Mailstop: CI-09-06 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-0041SN) Dear Dr. Jacques: I greatly appreciate this opportunity to comment on the proposed decision memorandum (the More
Miller, M.D., FACC, FAHA, Michael	Organization: University of Maryland School of Medicine Date: 06/09/2010 Comment: Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: Cl-09-06 7500 Security Boulevard Baltimore, MD 21244 June 10, 2010 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr Jacques: I am delighted to support the proposed Centers for Medicare & Medicaid Services (CMS) decision memorandum (the "Proposed Decision")¹ for the Pritikin Program to serve as an intensive cardiac rehabilitation (ICR) program. As Professor of Medicine, Epidemiology & Preventive Medicine and Director for the Center of Preventive Cardiology at the University of Maryland School of Medicine, I have served on committees at both the state and national level (i.e., American Heart Association), aimed at cardiovascular disease prevention. In addition, I am co-author of 2 textbooks, " The Practice of Coronary Disease Prevention" (lippincott, Williams & Wilkins, 1996) and "The American Medical Association Guide to Preventing & Treating Heart Disease" (Wiley & Sons, 2008). Having recently had the opportunity to visit the Pritikin Center, I was very impressed with their approach to intensive lifestyle measures that have been demonstrated to improve overall cardiovascular health. Therefore, I am writing to praise CMS's Proposed DeCision to recognize the Pritikin Program as an approved ICR program for Medicare payment based upon demonstrable reductions in weight, lipids, blood pressure and blood glucose, thereby reducing reqUIrements for medication and in some cases, bypass surgery. Consequently, it is important for CMS to finalize this decision, because approval of this program will ensure that Medicare beneficiaries enjoy access to cardiac rehabilitation services with proven results in the treatment of heart disease. Thank you for the opportunity to voice my opinion on this important issue and please do not hesitate to contact me at (410) 328-6299 if any questions arise regarding this matter. Sincerly, /s/ Michael Miller, MD, FACC, FAHA Professor of Medicine, EpidemIOlogy & Preventive Medicine ¹Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N), May 14, 2010, https://www.cms.gov/mcd/viewdraftdecisionmemo.asp?id=239. Less Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: Cl-09-06 7500 Security Boulevard Baltimore, MD 21244 June 10, 2010 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr Jacques: I am delighted to support the proposed Centers for Medicare & Medicaid More
Peck, M.D., William A.	Date: 06/09/2010 Comment: June 10,2010 Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: CI-09-06 7500 Security Blvd. Baltimore, MD 21244 Re: NCA Tracking Sheet for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: It is my understanding that the Centers for Medicare and Medicaid Services, as part of its national coverage analysis, has developed statutory criteria for an intensive cardiac rehabilitation program. As a recent Commonwealth Fund pointed out - the United States is losing ground on preventable deaths. It is not surprising at all that both the House of Representatives and the Senate health reform bills, in recognizing the crucial importance of prevention; provide supportive new resources to that end. My name is William A. Peck, MD. I have been an academic internist and endocrinologist for 45 years, a long career devoted to patient care, research, teaching and administration. Since 2003, I have served as the Alan A. and Edith L. Wolff Distinguished Professor of Medicine at Washington University and head of the University's Center for Health Policy. From 1989-2003, I was the Dean of Washington University School of Medicine, Vice Chancellor and Executive Vice Chancellor for Medical Affairs at Washington University, and President of the Washington University Medical Center, following a long faculty career at Washington University and the University of Rochester. I am a member of the Institute of Medicine and served on its Committee for Redesigning Health Insurance Benefits, Payment and Performance Improvement Programs, the report of which was published three years ago. I am writing to indicate my strong opinion that the Pritikin Program, with which you are now familjar, effectively improves health outcomes for patients with cardiovascular disease, thereby avoiding the need for more risky and expensive interventions. In my view, the literature regarding the impact of the Pritikin Program provides substantial evidence, published in journals that employ peer review of submitted manuscripts, that it yields significant improvements in reliable markers of cardiovascular disease and other conditions, reduces symptoms of coronary artery disease and diminishes the need for angioplasty and coronary bypass surgery in highly susceptible populations. [PHI Redacted] I learned first-hand of the incredible rigor with which it approaches the mission of health promotion and disease prevention through lifestyle education, structured exercise and health food consumption that features natural, nutrient-rich, high-fiber foods. The Pritikin Program experience can be transforming and even life-saving. I strongly support CMS' proposed decision to recognize the Pritikin program as an approved ICR program. Warmest regards, /s/ William A. Peck, M.D. Director, Center for Health Policy Alan A. and Edith L. Wolff Distinguished Professor of Medicine Emeritus Dean, Washington University School of Medicine Less June 10,2010 Louis Jacques, MD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: CI-09-06 7500 Security Blvd. Baltimore, MD 21244 Re: NCA Tracking Sheet for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N) Dear Dr. Jacques: It is my understanding that the Centers for Medicare and Medicaid Services, as part of More
Vogel. MD, Robert A.	Title: Professor of Medicine Organization: University of Maryland School of Medicine Date: 06/09/2010 Comment: BY ELECTRONIC DELIVERY Louis Jacques. MD Director. Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: CI -09-06 7500 Security Boulevard Baltimore, MD 21244 June 10, 2010 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-0041 8N) Dear Dr. Jacques: I appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision memorandum (the "Proposed Decision") regarding approval of the Pritikin Program as an intensive cardiac rehabilitation (ICR) program, ^l My name is Robert A. Vogel and I am Professor of Medicine and Director of Clinical Vascular Biology at the University of Maryland School of Medicine. I also am the Chief Medical Director of Pritikin. I have studied heart disease for more than 30 years and published numerous articles focusing on evaluating and preventing coronary heart disease. I have written study guides and guidelines for the American College of Cardiology covering the prevention of heart disease. I also assisted CMS in developing the Health Care Quality Improvement Initiative and documented the resulting improvement in the treatment provided to Medicare patients with acute myocardial infarction. which I co-authored with Dr. Stephen Jencks. former director of the Quality Improvement Group in the Office of Cl inical Standards and Quality at CMS.² I am writing to commend CMS's Proposed Decision to recognize the Pritikin Program as an approved ICR program for Medicare payment. Based on my own experience treating cardiac patients. I can state that the Pritikin Program improves health outcomes for patients with cardiovascular disease. Through the intensive lifestyle modification provided as part of the Pritikin Program. patients are able to improve their cardiac function. decrease their dependence on medications. and avoid risky and costly medical interventions. My individual experience is corroborated in the clinical literature. including the studies cited in the Proposed Decision. Based on its review oftbis literature, CMS correctly concludes that the Pritikin Program has been shown to achieve quantifiable results on importam metrics, such as reductions in LDL-cholesterol. triglycerides. blood pressure. blood glucose. and weight, that it reduces the need for bypass surgery. and reduces the need for medication. I urge CMS to finalize this decision . I greatly appreciate the opportunity to comment on the Proposed Decision to recognize the Pritikin Program as an ICR program. Approval of the Pritikin Program is important to ensure that Medicare beneficiaries have access to cardiac rehabilitation services with proven results in treating cardiovascular disease. Please feel free to contact me at (410) 328-8795 if you have any questions regarding these comments. Thank you for your attention to this very important matter. Respectfully submitted, /s/ Robert A. Vogel. MD Professor of Medicine University of Maryland School of Medicine ¹Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-00418N), May 14.2010. https://www.cms.gov/mcd/viewdraftdecisionmemo.asp?id=239. ²Ellerbeck E, Jencks S. Radford M. Kresowick T, Craig A, Gold J. Krumholtz. H, Vogel R. Treatment of Medicare patients with acute myocardial infarction: Report on a four state pilot of the Cooperative Cardiovascular Project. JAMA 273: 1509-15 14, 1995: Marciniak TA. Ellerbech EF, Radford MJ. Kresowik TF, Gold JA. Krumholz HM. Kiefe CI, Allman RM. Vogel RA Jencks SF. Improving the quality of care for Medicare patients with acute myocardial infarction. Results from the Cooperative Cardiovascular Project. JAMA 279: 1351-1357, 1998. Less BY ELECTRONIC DELIVERY Louis Jacques. MD Director. Coverage and Analysis Group Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop: CI -09-06 7500 Security Boulevard Baltimore, MD 21244 June 10, 2010 Re: Proposed Decision Memorandum for Intensive Cardiac Rehabilitation (ICR) Program - Pritikin Program (CAG-0041 8N) Dear Dr. Jacques: I appreciate the opportunity to More

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