Medicare and bariatric surgery

Surgery for Obesity and Related Diseases 1 (2005) 35– 63

Review article

Medicare and bariatric surgery John G. Kral, M.D., Ph.D., Nicolas V. Christou, M.D., Ph.D., David R. Flum, M.D., M.P.H., Bruce M. Wolfe, M.D., Philip R. Schauer, M.D., Michel Gagner, M.D., Christine Ren, M.D., Sasha Stiles, M.D., Thomas A. Wadden, Ph.D., Stella Tanner, Col. Robert Stratiff, Walter J. Pories, M.D., Harvey J. Sugerman, M.D.* American Society for Bariatric Surgery, Gainesville, Florida

On November 4, 2004, Central Medicare Services (CMS) organized a Medicare Coverage Advisory Committee (MCAC) meeting to evaluate the safety and effectiveness of bariatric surgery. Several questions were posed, and the American Society for Bariatric Surgery (ASBS) submitted an organized response to these questions. Henry Buchwald, M.D., F.A.C.S., Professor of Surgery, University of Minnesota; Harvey Sugerman, M.D., F.A.C.S., Emeritus Professor of Surgery, Virginia Commonwealth University and President, ASBS; and Samuel Klein, M.D., Professor of Medicine and Gerontology, Washington University School of Medicine were invited experts on the topic and were nonvoting members of the MCAC panel.

ment Center, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland; Jed Weissberg, M.D., The Permanente Federation, LLC, Oakland, California. Clinical leads: Michael Abecaassis, M.D., Division of Organ Transplantation, Northwestern Memorial Hospital, Chicago, Illinois; Kieran P. Knapp, D.O., Jacobus Medical Center, Jacobus, Pennsylvania; William F. Owen, Jr., Chief Scientist, Baxter Healthcare, McGaw Park, Illinois. Consumer representative: Nancy Loving, WomenHeart, Washington, DC. Industry representative: G. Gregory Raab, Ph.D., Independent Health Policy Consultant, Raab and Associates, Inc., North Bethesda, Maryland.

Voting members of the MCAC panel

CMS questions to the MCAC panel

Chairperson: Ronald M. Davis, M.D., Director, Center for Health Promotion & Disease Prevention, Henry Ford Health System, Detroit, Michigan. Vice-Chairperson: Barbara J. McNeil, M.D., Ph.D., Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts. Methodologists: David J. Margolis, M.D., Ph.D., University of Pennsylvania School of Medicine, Department of Dermatology, Philadelphia, Pennsylvania; Clifford Goodman, Ph.D., Senior Scientist, The Lewin Group, Falls Church, Virginia; Brent J. O’Connell, M.D., Vice President and Medical Director, High Mark Blue Shield, Camp Hill, Pennsylvania. Policy experts: Jonathan P. Weiner, Ph.D., Professor and Deputy Director, Health Sciences Research and Develop-

Obese patients with comorbidities

*Reprint requests: Harvey J. Sugerman, M.D., American Society for Bariatric Surgery, 100 SW 75th Street, Gainesville, FL 32607. E-mail: [email protected]

1. How well does the evidence address the effectiveness of bariatric surgery in the treatment of obesity in patients with comorbidities compared to nonsurgical medical management? 2. How confident are you in the validity of scientific evidence available with respect to bariatric surgery in regard to outcomes in obese patients with comorbidities? ● Weight loss (sustained) ● Long-term survival ● Short-term mortality ● Comorbidities 3. How likely is it that the following procedures will affect the outcomes listed in Question 2 in obese patients with comorbidities? ● Open Roux-en-Y gastric bypass (RYGB) ● Laparoscopic RYGP ● Open vertical banded gastroplasty ● Laparoscopic adjustable gastric banding

1550-7289/05/$ – see front matter © 2005 American Society for Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2004.12.003

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J.G. Kral et al. / Surgery for Obesity and Related Diseases 1 (2005) 35– 63

● Open biliopancreatic diversion (BPD) with/without duodenal switch ● Laparoscopic BPD diversion with/without duodenal switch ● No surgery 4. How confident are you that bariatric surgery will produce a clinically important net health benefit in the treatment of obese patients with comorbidities? 5. Based on the scientific evidence presented, how likely is it that results of bariatric surgery in obese patients with comorbidities can be generalized to the Medicare population (age ⱖ 65) and to providers (facilities/ physicians) in community practice? Obese patients without comorbidities 1. How well does the evidence address the effectiveness of bariatric surgery in the treatment of obesity in patients with comorbidities compared to nonsurgical medical management? 2. How confident are you in the validity of scientific evidence available with respect to bariatric surgery in regard to outcomes in obese patients with comorbidities? 3. How likely is it that the following procedures will affect the following outcomes in obese patients with comorbidities? ● Open RYGB ● Laparoscopic RYGB ● Open vertical banded gastroplasty ● Laparoscopic adjustable gastric banding ● Open BPD with/without duodenal switch ● Laparoscopic BPD with/without duodenal switch ● No surgery 4. How confident are you that bariatric surgery will produce a clinically important net health benefit in the treatment of obese patients with comorbidities? 5. Based on the scientific evidence presented, how likely is it that results of bariatric surgery in obese patients with comorbidities can be generalized to the Medicare population (age ⱖ 65) and providers (facilities/physicians) in community practice?

Final vote by the MCAC panel Obese patients with one or more comorbidities Question 1: How well does the evidence address the effectiveness of bariatric surgery in the treatment of obesity in patients with one or more comorbidities compared with nonsurgical medical management? Four voting members indicated “reasonably to very well” (level 4); five voting members and all four nonvoting panelists indicated “very well” (level 5).

Question 2: How confident are you in the validity of the scientific data for the following outcomes: ● Weight loss (sustained). Four voting members indicated “moderate to high confidence” (level 4); five voting members and all four nonvoting panelists indicated “high confidence” (level 5). ● Long-term survival. Three voting members indicated “moderate confidence” (level 3), six voting members and one nonvoting panelist indicated “moderate to high confidence” (level 4), and three nonvoting panelists indicated “high confidence” (level 5). ● Short-term mortality. Three voting member indicated “moderate confidence” (level 3), five voting members indicated “moderate to high confidence” (level 4), and one voting member and all four nonvoting panelists indicated “high confidence” (level 5). ● Comorbidities. One voting member indicated “moderate confidence” (level 3), six voting members indicated “moderate to high confidence” (level 4), and two voting members and all four nonvoting panelists indicated “high confidence” (level 5). Question 3: How likely is it that bariatric surgery, including RYGB, banding, and BPD, will positively affect the following outcomes in obese patients with one or more comorbidities compared with nonsurgical medical management? ● Weight loss (sustained). One voting member indicated “reasonably to very likely” (level 4); eight voting members and all four nonvoting panelists indicated “very likely” (level 5). ● Long-term survival. Three voting members indicated “reasonably likely” (level 3), five voting members and one nonvoting panelist indicated “reasonably to very likely” (level 4), and one voting member and three nonvoting panelists indicated “very likely” (level 5). ● Short-term mortality. Four voting members indicated “reasonably likely” (level 3), four voting members and one nonvoting panelist indicated “reasonably to very likely” (level 4), and one voting member and three nonvoting panelists indicated “very likely” (level 5). ● Comorbidities. One voting member indicated “reasonably likely” (level 3), two voting members indicated “reasonably to very likely” (level 4), and six voting members and all four nonvoting panelists indicated “very likely” (level 5). Question 4: How confident are you that the following bariatric surgeries will produce a clinically important net health benefit in the treatment of obese patients with one or more comorbidities? ● RYGB, open. Seven voting members and one nonvoting panelist indicated “moderate to high confidence” (level

J.G. Kral et al. / Surgery for Obesity and Related Diseases 1 (2005) 35– 63

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4); two voting members and three nonvoting panelists indicated “high confidence” (level 5). RYGB, laparoscopic. Four voting members indicated “moderate to high confidence” (level 4); five voting members and all four nonvoting panelists indicated “high confidence” (level 5). BPD, open. Three voting members indicated “moderate confidence” (level 3), six voting members and one nonvoting panelist indicated “moderate to high confidence” (level 4), and three nonvoting panelists indicated “high confidence” (level 5). BPD, laparoscopic. One voting member indicated “moderate confidence” (level 3), six voting members indicated “moderate to high confidence” (level 4), and two voting members and all four nonvoting panelists indicated “high confidence” (level 5). Banding, open. One voting member indicated “no to moderate confidence” (level 2), four voting members indicated “moderate confidence” (level 3), four voting members and one nonvoting panelist indicated “moderate to high confidence” (level 5), and three nonvoting panelists indicated “high confidence” (level 5). Banding, laparoscopic. Three voting members indicated “moderate confidence” (level 3), five voting members indicated “moderate to high confidence” (level 4), and one voting member and all four nonvoting panelists indicated “high confidence” (level 5).

Question 5: Based on the scientific evidence presented, how likely is it that the results of bariatric surgery in obese patients with one or more comorbidities can be generalized to: ● The Medicare population (age 65⫹). Four voting member indicated “not to reasonably likely” (level 2), two voting members indicated “reasonably likely” (level 3), three voting members and one nonvoting panelist indicated “reasonably to very likely” (level 4), and three nonvoting panelists indicated “very likely” (level 5). ● Providers (facilities/physicians) in community practice. One voting member indicated “not to reasonably likely” (level 2), eight voting members and one nonvoting panelist indicated “reasonably likely” (level 3), one nonvoting panelist indicated “reasonably to very likely” (level 4), and two nonvoting panelists indicated “very likely” (level 5). Obese patients without comorbidities Question 1: How well does the evidence address the effectiveness of bariatric surgery in the treatment of obesity in patients without comorbidities compared to nonsurgical medical management? Four voting members and three nonvoting panelists in-

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dicated “poorly” (level 1); five voting members and one nonvoting panelist indicated “poorly to reasonably well” (level 2). Based on the vote as to question 1, it was the consensus of the panel not to proceed to vote on the other questions on this section.

Evaluation of bariatric surgery John G. Kral, M.D., Ph.D., F.A.C.S., Professor of Surgery and Medicine, SUNY Downstate School of Medicine, Brooklyn, New York To fairly evaluate antiobesity surgery, it is of vital importance at the outset to define the “playing field.” This is my task. Mind you, I use the word “vital” advisedly; severe obesity, today’s topic, is a deadly disease with many of the hallmarks of a cancer. And, tragically, throughout the careers of the surgeons assembled here, we have all encountered patients of all ages who have directly stated that they would gladly take the risk of dying from complex surgery rather than continuing to suffer with their terrible disease. For me to provide constructive suggestions regarding evaluation of bariatric surgery, I must first clarify biases or commonly held assumptions about obesity the disease, about surgery for obesity, and about the “quality” of evidence, while at the same time pointing out some faulty premises and flaws in the literature. Please bear with me, because the whole rationale for this meeting rests on these issues. The necessity for having today’s meeting in part springs from biases, and, as is often the case with biases, from ignorance. Rationale for treating obesity surgically: a changed perspective Bias has always surrounded the disease of obesity, and it continues to do so today. It is true that solid evidence for the molecular biological nature of this disease took a giant step forward in November 1994, and it is only during the last decade that the public (and the medical profession) has come to learn that obesity is not a sin, or a character disorder, or a cosmetic problem for which treatment is discretionary. Only recently has the medical profession acknowledged that obesity is a chronic, persistent, incurable disease of multifactorial etiology, similar to hypertension, diabetes, cardiopulmonary failure, and numerous other manifest and occult comorbidities of obesity. As is the case with hypertension and diabetes, obesity requires chronic, continuous, life-long treatment as long as the obese state persists, a concept that also has been accepted by physicians only recently. This new knowledge is a prerequisite for accepting the need for durable, effective treatment. It negates the very foundation of most studies of nonsurgical therapies, which rarely have extended beyond weeks or