Health Outcomes After Bariatric Surgical Therapies in the Medicare Population

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.

June 28, 2017

July 3, 2017

July 7, 2017

July 19, 2017

August 24, 2017

August 31, 2017

October 26, 2017

• Webcast of meeting (registration is not required to view the webcast)
• Registration
• Information about visiting CMS
• Driving directions to CMS
• Recommended hotels

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

8:00 – 8:15 AM

8:15 - 8:30 AM

8:30 – 9:10 AM

9:10 – 9:55 AM

9:55 – 10:20 AM

10:20 – 10:45 AM

10:45 – 10:55 AM

10:55 – 11:50 AM

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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.

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11:50 – 12:00 AM

12:00 – 1:00 PM 

1:00 – 2:00 PM

2:00 – 3:00 PM

3:00 – 4:00 PM

4:00 – 4:20 PM

4:20 – 4:30 PM

Download scoresheet.

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.             

1. How confident are you that the following are meaningful primary health outcomes in research studies of bariatric surgery:
   
   1. Weight loss;
   2. Postoperative complications;
   3. Diabetes and metabolic outcomes;
   4. Cardiovascular outcomes;
   5. Respiratory outcomes;
   6. Musculoskeletal outcomes; and
   7. Quality of life.


2. 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:
   
   1. Short term (2 years or less from surgery) weight loss?
   2. Mid-term (more than 2 but 5 or less from surgery) weight loss?
   3. Long-term (more than 5 years after surgery) weight loss?


3. 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:
   
   1. Short term (2 years or less from surgery) outcomes?
   2. Mid-term (more than 2 but 5 or less from surgery) outcomes?
   3. Long-term (more than 5 years after surgery) outcomes?


4. 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

1. Discuss important evidence gaps that have not been previously or sufficiently addressed.


2. Discuss any known treatment disparities. 


3. 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

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

• 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