Health Outcomes After Bariatric Surgical Therapies in the Medicare Population

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=74 | meeting_date=2017-08-30

On August 30, 2017, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development &Coverage Advisory Committee (MEDCAC). This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding the appraisal of the state of evidence for health outcomes in the Medicare population for surgical and endoscopic procedures. Obesity affects over one-third of the Medicare population and can be a serious medical condition causing numerous complications, many of which are highly prevalent in the Medicare population. The MEDCAC panel will examine the scientific evidence for health outcomes resulting from bariatric therapies, including open and laparoscopic surgeries and endoscopic procedures, in the Medicare population with obesity. This meeting will also identify evidence gaps related to treatment of obesity and related co-morbidities with these interventions and discuss efforts aimed at patient-centered care. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS in regards to these therapies in the Medicare population. MEDCAC panels do not make coverage determinations. The MEDCAC panel judges the strength of the evidence and makes recommendations to CMS based on that evidence. CMS will use the MEDCAC recommendations to inform future coverage policies.

Actions Taken: June 28, 2017 CMS posts MEDCAC meeting announcement. July 3, 2017 Posted FR Notice announcing meeting July 7, 2017 Posted questions to panel. July 19, 2017 Posted Revised MEDCAC Questions to the Panel Deadlines for Written Comments, Speaker Registration, and Presentation Materials have been extended to 5:00 p.m., EDT on Friday, July 28, 2017 August 24, 2017 Posted agenda , roster and speaker list for meeting. Also posted presentations ( A-H , I-L , M-Q ), written comments , and written stakeholder statements . August 31, 2017 Posted scoresheet from meeting. October 26, 2017 Posted minutes and transcript from meeting. Webcast of meeting (registration is not required to view the webcast) Registration Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee August 30, 2017 7:30 AM – 4:30 PM CMS Auditorium Aloysius Cuyjet, MD, MPH , Acting Committee Chair Lori Ashby, MA, Director, Division of Medical and Surgical Services, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:15 AM Opening Remarks - Maria Ellis/Lori Ashby, MA/Aloysius Cuyjet, MD 8:15 - 8:30 AM CMS Presentation & Voting Questions – Sarah Fulton, MHS 8:30 – 9:10 AM Eric DeMaria, MD, FACS, FASMBS, Secretary/Treasurer, American Society for Metabolic and Bariatric Surgery, Bariatric Surgeon, Bon Secours General Surgery at St. Mary's Hospital 9:10 – 9:55 AM TA Presentation: Orestis Panagiotou, MD, PhD, Assistant Professor of Health Services, Policy & Practice, Brown University School of Public Health and Thomas Trikalinos, MD, PhD, Director, Center for Evidence Synthesis in Health, Associate Professor in Health Services, Policy & Practice, Brown University 9:55 – 10:20 AM Joe Nadglowski, President/CEO, Obesity Action Coalition 10:20 – 10:45 AM Kimberly Marschhauser, PhD, Program Officer, Research Infrastructure Patient-Centered Outcomes Research Institute and David Arterburn, MD, MPH, FACP , Senior Investigator, Kaiser Permanente, Washington Health Research Institute, General Internal Medicine, Washington Permanente Medical Group, Affiliate Professor, Department of Medicine, University of Washington 10:45 – 10:55 AM BREAK 10:55 – 11:50 AM Scheduled Public Comments (Refer to Speaker List) ******************************************************************************************* Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. ******************************************************************************************* 11:50 – 12:00 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 12:00 – 1:00 PM LUNCH (on your own) 1:00 – 2:00 PM Questions to Presenters 2:00 – 3:00 PM Initial Open Panel Discussion: Dr. Cuyjet 3:00 – 4:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 4:00 – 4:20 PM Final Open Panel Discussion: Dr. Cuyjet 4:20 – 4:30 PM Closing Remarks/Adjournment: Lori Ashby & Dr. Cuyjet Issue: On August 30, 2017, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development &Coverage Advisory Committee (MEDCAC). This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding the appraisal of the state of evidence for health outcomes in the Medicare population for surgical and endoscopic procedures. Obesity affects over one-third of the Medicare population and can be a serious medical condition causing numerous complications, many of which are highly prevalent in the Medicare population. The MEDCAC panel will examine the scientific evidence for health outcomes resulting from bariatric therapies, including open and laparoscopic surgeries and endoscopic procedures, in the Medicare population with obesity. This meeting will also identify evidence gaps related to treatment of obesity and related co-morbidities with these interventions and discuss efforts aimed at patient-centered care. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS in regards to these therapies in the Medicare population. MEDCAC panels do not make coverage determinations. The MEDCAC panel judges the strength of the evidence and makes recommendations to CMS based on that evidence. CMS will use the MEDCAC recommendations to inform future coverage policies. Minutes: Download meeting minutes . Other Material: Transcript 1 Technology Assessment: Short and Long Term Outcomes after Bariatric Surgery in the Medicare Population Panel Voting Questions: Download scoresheet . Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Health Outcomes After Bariatric Surgical Therapies in the Medicare Population August 30, 2017 The panel will examine the scientific evidence for health outcomes after bariatric therapies, including open and laparoscopic surgeries and endoscopic procedures, in the Medicare population with obesity. This meeting will also identify evidence gaps related to treatment of obesity and related co-morbidities with these interventions and discuss efforts aimed at patient-centered care. Obesity is an increase in the size and amount of fat cells in the body and is typically diagnosed and measured by body mass index (BMI) and waist circumference. It affects over one-third of the Medicare population. It can be a serious medical condition causing complications such as metabolic syndrome, high blood pressure, atherosclerosis, heart disease, diabetes, high blood cholesterol, cancers and sleep disorders [1] . Paralleling obesity, these associated conditions are all highly prevalent in the Medicare population. Treatments for obesity include diet and exercise, Food and Drug Administration (FDA)-approved weight-loss medicines, and surgical and endoscopic therapies that result in alterations of the anatomy of the gastrointestinal (GI) tract. Based on recommendations from a National Institute of Health panel, a number of Medicare beneficiaries are eligible for surgical or endoscopic procedures [2] . Studies on bariatric surgeries have focused on weight loss. Other outcomes have included mortality, postoperative complications, diabetes and metabolic outcomes, cardiovascular outcomes and musculoskeletal outcomes. These procedures are not without harms; some harms appear to be significant. The benefits and harms of open and laparoscopic surgery, as well as newer endoscopic techniques with and without devices, will be discussed. Voting Questions For each voting question, please use the following scale identifying your level of confidence with a score of 1 being low or no confidence and 5 representing high confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence How confident are you that the following are meaningful primary health outcomes in research studies of bariatric surgery: Weight loss; Postoperative complications; Diabetes and metabolic outcomes; Cardiovascular outcomes; Respiratory outcomes; Musculoskeletal outcomes; and Quality of life. How confident are you that there is sufficient evidence for an intervention (to include open and laparoscopic surgeries and endoscopic procedures) where the benefit outweighs the harm for: Short term (2 years or less from surgery) weight loss? Mid-term (more than 2 but 5 or less from surgery) weight loss? Long-term (more than 5 years after surgery) weight loss? For those outcomes listed in Question 1 with a voting score >2.5, how confident are you that there is sufficient evidence for an intervention (to include open and laparoscopic surgeries and endoscopic procedures) where the benefit outweighs the harm for: Short term (2 years or less from surgery) outcomes? Mid-term (more than 2 but 5 or less from surgery) outcomes? Long-term (more than 5 years after surgery) outcomes? How confident are you that the predictors of success in the Medicare population (such as patient characteristics and pre and post procedure standards of care) for any bariatric therapy is known? Discussion: List the predictors of success and the correspondent strength of evidence. Additional Discussion Topics Discuss important evidence gaps that have not been previously or sufficiently addressed. Discuss any known treatment disparities. Considering both existing and new procedures and devices as well as potential barriers to care, discuss any mechanisms that might be supported by CMS that would more quickly generate an improved evidence base that would underpin improved care and decision-making for the Medicare population affected by obesity. [1] https://www.nhlbi.nih.gov/health/health-topics/topics/obe - Accessed 5/9/2017 [2] https://www.nhlbi.nih.gov/files/docs/guidelines/ob_gdlns.pdf Roster: Acting Committee Chair Aloysius B. Cuyjet, MD, MPH Medical Director HealthCare Partners, IPA Acting Committee Co-Chair (voting) Marcel Salive, MD, MPH Medical Officer National Institute on Aging National Institute of Health MEDCAC Members Karen Albright, DO, MPH Associate Clinical Professor University of Alabama at Birmingham Doug Campos-Outcalt, MD, MPA Medical Director Mercy Care Plan Marc Mora, MD Senior Medical Director Networks and Care Management Kaiser Permanente Washington Daniel A. Ollendorf, PhD Chief Scientific Officer Institute for Clinical and Economic Review Renee Williams, MD Physician Division of Gastroenterology Bellevue Hospital Center (New York) Assistant Professor of Clinical Medicine New York University School of Medicine Adolph J. Yates, Jr., MD Staff Presbyterian-Shadyside University of Pittsburgh School of Medicine Diana Zuckerman, PhD President National Center for Health Research Cancer Prevention and Treatment Fund Representative Robert L. Kormos, MD, FRCS(C), FACS Brack G. Hattler Professor Cardiothoracic Transplantation Director, Artificial Heart Program Co-Director, Heart Transplantation Department of Cardiothoracic Surgery Heart and Vascular Institute University of Pittsburgh Medical Center Due to unforeseen circumstances, Dr. Kormos is unable to attend the meeting. Industry Representative Robert J. Hilkert, MD, FACC, FAHA Vice President Global Program Medical Director Novartis Pharmaceutical Corporation Guest Panel Members Martha W. Betz, Ph.D. Biomedical Engineer & Senior Lead Reviewer Gastroenterology Devices Branch Division of Reproductive, Gastro-Renal & Urological Devices Office of Device Evaluation Center for Devices and Radiological Health U.S. Food and Drug Administration Samuel Klein, MD William H. Danforth Professor of Medicine and Nutritional Science Director, Center for Human Nutrition Washington University School of Medicine Dana A. Telem, MD, MPH, FACS, FASMBS Associate Professor of Surgery University of Michigan Bruce M. Wolfe, MD, FACS, FASMBS Professor of Surgery and Vice Chair of Research Department of Surgery Division of Bariatrics Oregon Health & Science University Invited Guest Speakers David Arterburn, MD, MPH, FACP Senior Investigator, Kaiser Permanente Washington Health Research Institute General Internal Medicine Washington Permanente Medical Group Affiliate Professor, Department of Medicine University of Washington Eric J. DeMaria, MD, FACS, FASMBS Secretary/Treasurer American Society for Metabolic and Bariatric Surgery Bariatric Surgeon Bon Secours General Surgery at St. Mary’s Hospital Kimberly Marschhauser, PhD Program Officer Research Infrastructure Patient-Centered Outcomes Research Institute Joe Nadglowski President/CEO Obesity Action Coalition CMS Liaison Lori Ashby, MA Director Division of Medical & Surgical Services Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Speaker List: Medicare Evidence Development & Coverage Advisory Committee August 30, 2017 SPEAKER LIST *4 MINUTES PER SPEAKER* Sidney Rohrscheib, MD , Champaign, Illinois John Gunstad, PhD , Department of Psychological Sciences, Kent State University Wayne J. English, MD, FACS , Associate Professor of Surgery, Director, Center for Surgical Weight Loss, Vanderbilt University, Medical Center Christopher D. Still, DO, FACN, FACP, FTOS, Medical Director, Center for Nutrition & Weight Management, Director, Geisinger Obesity Research Institute, Medical Director, Employee Wellness, Geisinger Health System Sigh Pichamol Jirapinyo, MD, Bariatric Endoscopy Fellow, Brigham and Women's Hospital – No PowerPoint Leslie Narramore, MPA, Director of Reimbursement, American Gastroenterological Association – No PowerPoint Shelby A. Sullivan, MD, Division of Gastroenterology, University of Colorado Denver – Representing: American Society for Gastrointestinal Endoscopy Matthew M. Hutter, MD, MPH, Director, Codman Center for Clinical Effectiveness in Surgery, Director, MGH Weight Center, The Codman Warshaw Endowed Chair of Surgery, Department of Surgery, Massachusetts General Hospital John D. Scott, MD, FACS, FASMBS , Division Chief, Minimally Access and Bariatric Surgery, Greenville Health System – Representing: American Society for Metabolic and Bariatric Surgery Ranjan Sudan, MD, FASMBS, Associate Professor of Surgery and Behavioral Medicine, Vice Chair, Education, Director of Surgical Education and Activities Lab, Department of Surgery, Duke University – Representing: American Society for Metabolic and Bariatric Surgery Peter Hallowell, MD, FACS, FASMBS, Director of Bariatric Surgery, Co-director MIS Fellowship, Medical Director Surgery Clinic, Associate Professor of Surgery, University of Virginia – Representing: American Society for Metabolic and Bariatric Surgery Teresa LaMasters, MD, FACS, FASMBS, Medical Director for Bariatric Surgery UnityPoint Clinic and Co-chair for Access to Care Committee ASMBS, UnityPoint Clinic Weight Loss Specialists – Representing: American Society for Metabolic and Bariatric Surgery Daniel Leslie, MD , Chief of Bariatric Surgery, University of Minnesota MC, and Fairview Hospital - Representing: Medtronic Anthony Petrick, MD, FASMBS, Director, Minimally Invasive and Bariatric Surgery, Surgical Fellowship at Geisinger Health System, Geisinger Health System – Representing: American Society for Metabolic and Bariatric Surgery