Centers for Medicare & Medicaid Services

11/4/2004 - Bariatric Surgery for Treatment of Morbid Obesity

Issue

Morbid obesity is recognized as a significant health risk associated with physical problems that may increase morbidity and mortality among the Medicare population. According to the U.S. Preventive Services Task Force, “obesity is a risk factor for major causes of death, including cardiovascular disease, numerous types of cancer, and diabetes, and is linked with markedly diminished life expectancy.” The surgical management of morbid obesity, bariatric surgery, is a treatment that may result in dramatic weight loss. Several different surgical procedures have been used for people with morbid obesity, including biliopancreatic diversion, Roux-en-Y gastric bypass, and gastric banding.

The Agency for Health Research and Quality (AHRQ) recently issued a technology assessment entitled: Pharmacological and Surgical Treatment of Obesity. Evidence Report/Technology Assessment No. 103.* This, along with numerous other publications, indicate the need for a careful assessment of the evidence surrounding bariatric surgery.

CMS is referring the issue of surgical management of obesity to the Medicare Coverage Advisory Committee (MCAC). The MCAC will review the evidence related to the benefits, risks and costs of bariatric surgery in obesity.

Notice of this action is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).

This tracking sheet does not represent a National Coverage Analysis for bariatric surgery. It only serves to announce the upcoming MCAC meeting.

*Shekelle PG, Morton SC, Maglione MA, Suttorp M, Tu W, Li Z, Maggard M, Mojica WA, Shugarman L, Solomon V, Jungvig L, Newberry SJ, Mead D, Rhodes S. Pharmacological and Surgical Treatment of Obesity. Evidence Report/Technology Assessment No. 103 (Prepared by the Southern California - RAND Evidence-Based Practice Center, Santa Monica, CA, under contract Number 290-02-0003.) AHRQ Publication No. 04-E028-2. Rockville, MD: Agency for Healthcare Research and Quality. July 2004.

Actions Taken


September 2, 2004	A Medicare Coverage Advisory Committee meeting will be held on Thursday, November 4, 2004, from 7:30 a.m. until 4:30 p.m. EST at the Holiday Inn Inner Harbor, 301 West Lombard Street, Baltimore, MD 21201. The Committee will review the evidence related to the benefits, risks and costs of bariatric surgery in obesity. Formal announcement of this meeting in the Federal Register will be forthcoming. Questions to be addressed to the MCAC panel will be posted soon.
October 5, 2004	Publication of the Federal Register notice [PDF, 71KB] of the meeting and release of the questions [PDF, 98KB] to be addressed to the MCAC panel. Due to the late posting of the questions, the deadline for receiving public comments has been extended to close of business on October 14, 2004. Individuals wishing to make scheduled public comments should ensure that their presentations focus on these questions.
October 21, 2004	CMS is interested in the public's comment on the potential creation of a national registry for Medicare patients undergoing bariatric surgery. We encourage that discussion at the MCAC.
October 26, 2004	Additional information is available including the agenda, speaker list, and roster .
November 3, 2004	CMS is posting its summary of evidence [PDF, 1MB] on bariatric surgery.
February 7, 2005	CMS is posting the transcript [PDF, 1MB] of the November 4 meeting.

Federal Register Notice

Agenda

Medicare Coverage Advisory Committee
November 4, 2004
7:30 AM – 4:30 PM
Holiday Inn Inner Harbor
Agenda

Ronald M. Davis, MD, Chairperson
Barbara J. McNeil, MD, PhD, Vice-Chairperson
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Kimberly Long, Executive Secretary


7:30 – 8:00 AM	Registration
8:00 – 8:15 AM	Opening Remarks—K.Long / S. Phurrough, MD, MPA/R. Davis, MD
8:15 – 8:55 AM	CMS Summary of Evidence and Presentation of Voting Questions: Ross Brechner, MD, MS, MPH
8:55 – 9:45 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.
9:45 – 10:00 AM	BREAK
10:00 – 11:00 AM	Scheduled Public Comments (continued)
11:00 – 11:30 AM	Questions to Presenters
11:30 – 12:00 AM	Open Public Comments Public Attendees who wish to address the panel will be given that opportunity
* * * * * * * * * * * *
12:00 – 1:00PM	LUNCH (on your own)
* * * * * * * * * * * *
1:00 – 4:15 PM	Open Panel Deliberations: Dr. Davis Formal Remarks and Vote The Chairperson will ask each panel member to state his or her position on the voting questions
4:15 – 4:30 PM	Closing Remarks / Adjournment: K. Long /Dr. Phurrough
4:30 PM	ADJOURN

Minutes

Download Minutes [PDF, 293KB].

Transcript

Panel Voting Questions

Download Qs and As [PDF, 98KB].

Summary of Evidence

Roster


Chairperson	Consumer Representative:
Ronald M. Davis, MD	Nancy Loving
Center for Health Promotion and	WomenHeart: The National Coalition for
Disease Prevention	Women with Heart Disease
Henry Ford Health System

Vice-Chairperson	Industry Representative:
Barbara J. McNeil, MD, PhDG.	Gregory Raab, PhD
Harvard Medical School	Raab & Associates, Inc.

Voting Members	Guest Panelists
David J. Margolis, MD, PhD	Madison Powers, JD, DPhil
Department of Dermatology	Georgetown University
Hospital of the University of Pennsylvania
	Sam Klein, MD, MS
Clifford Goodman, PhD	Department of Internal Medicine,
The Lewin Group	Washington University

Brent J. O’Connell, MD	Henry Buchwald, MD, PhD
High Mark Blue Shield	University of Minnesota

Jonathan P. Weiner, PhD	Harvey Sugerman, MD
Division of Health Services Research,	American Society of Bariatric Surgeons
Johns Hopkins School of Public Health
	CMS Liaison
Jed Weissberg, MD	Steve E. Phurrough, MD, MPA
The Permanente Federation LLC	Director, Coverage and Analysis Group
	Centers for Medicare & Medicaid Services
Michael Abecaassis, MD
Division of Organ Transplantation	Executive Secretary
Northwestern Memorial Hospital	Kimberly Long
	Centers for Medicare & Medicaid Services
Kieren P. Knapp, DO
Jacobus Medical Center

William F. Owen, Jr., MD
Duke University

Speaker List


8:55 – 9:45 AM	Walter Pories, MD, et al. John G. Kral, MD, PhD, FACS Nicolas V. Christou, MD, PhD David R. Flum, MD, MPH Bruce Wolfe, MD Philip R. Schauer, MD Michel Gagner, MD Christine J. Ren, MD Thomas Wadden, MD Sasha Stiles, MD Col. Robert Stratiff Mrs. Stella Tanner
10:00 – 10:04 AM	American Dietetic Association Mary H. Hager, PhD, RD, FADA
10:04 – 10:08 AM	American College of Surgeons Josef E. Fischer, MD, FACS
10:08 – 10:12 AM	John B. Dixon, MBBS, PhD Monash University, Australia
10:12 – 10:16 AM	Jeff W. Allen, MD, FACS University of Louisville, Dept. of Surgery
10:16 – 10:20 AM	David Provost, MD University of Texas Southwestern Medical Center at Dallas
10:20 – 10:24 AM	Barry L. Fisher, MD, FACS University of Nevada School of Medicine
10:24 – 10:28 AM	Douglas S. Hess, MD Private Practice; Bowling Green, OH
10:28- 10:32 AM	Robin Blackstone, MD, FACS Scottsdale Bariatric Center
10:32- 10:36 AM	Marc Bessler, MD New York Presbyterian Center for Obesity Surgery, Columbia University
10:36- 10:40 AM	Christopher D. Still, DO, FACN, FACP Geisinger Health System
10:40- 10:44 AM	Karen Schoelles, MD MetaWorks, Inc.
10:44- 10:48 AM	Robert A. Rabkin, MD, FACS Pacific Laparoscopy, San Francisco
10:48 10:52 AM	Sondra Albers, Patient
10:52 10:56 AM	Pamela Rogers, Patient
10:56 – 11:00 AM	Eldith Willis, Patient

Associated NCA

Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R)

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