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MEDCAC Meeting

Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease

11/30/2006

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Issue

The incidence of low back pain at some time in a person’s lifetime in the U.S. population is reported to be as high as 90%.  There are numerous causes of low back pain and men and women are equally afflicted. The degenerative changes that occur in the intervertebral disc in the spine are thought to be part of the normal process of aging and do not always lead to low back pain.  Low back pain secondary to lumbar degenerative disc disease (DDD) can usually be successfully treated conservatively.  However, when conservative treatment is not successful, surgical intervention becomes an option to relieve the pain associated with DDD.

Since DDD is associated with the aging process, this is an affliction that is well represented in the Medicare population.  CMS has a significant interest in discussing the evidence for surgical interventions for lumbar degenerative disc disease, with a specific focus on spinal fusion for low back pain associated with lumbar DDD in the Medicare population.

The Medicare Coverage Advisory Committee (MCAC) will hear presentations and discuss evidence relative to indications for spinal fusion, clinical outcomes (including adverse events) and the persistence of outcomes over time, outcome measurement tools, and outcomes related to different surgical spinal fusion procedures, as well as, the generalizability of this evidence to the Medicare population.

Actions Taken

 August 25, 2006

 Federal Register notice is published announcing the Medicare Coverage Advisory Committee meeting on Thursday, November 30, 2006.

August 30, 2006

 Posted Federal Register notice [PDF, 84KB].

September 28, 2006

We are posting the questions [PDF, 38KB] that we expect to pose to the MCAC panel. Comments and presentations should focus on answers to these questions. Any modifications will be posted prior to the panel meeting.

October 12, 2006

CMS requested the Agency for Healthcare Research and Quality to provide a technology assessment (TA) for the MCAC. We are posting the TA questions the TA focuses on.

November 14, 2006

November 27, 2006

Posted the roster and agenda.

November 30, 2006

Medicare Coverage Advisory Committee has been renamed Medicare Evidence Development Coverage Advisory Committee.

December 01, 2006

Posted Score Sheet [PDF, 80KB].

February 23, 2007

Posted minutes [PDF, 6MB] and transcript [PDF, 576KB].

 

Note: For security reasons, individuals planning to attend must register by the close of business on November 23, 2006  by contacting Maria Ellis at (410) 786–0309; e-mail to Maria.Ellis@cms.hhs.gov; or by regular mail to Maria Ellis, Centers for Medicare& Medicaid Services, OCSQ-Coverage and Analysis Group, C1–09–06, 7500, Security Boulevard, Baltimore, MD 21244.

Agenda

Federal Register Notice
Agenda
Medicare Coverage Advisory Committee
November 30, 2006
7:30 AM - 4:30 PM
CMS Auditorium

Alex Krist, MD, Chairperson
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Michelle Atkinson, Executive Secretary

7:30 - 8:00 AM

Registration

8:00 - 8:10 AM

Opening Remarks—M. Atkinson / S. Phurrough, MD, MPA/Alex Krist, MD

8:10 - 8:20 AM

CMS Presentation of Background and Voting & Discussion Questions - Shamiram Feinglass, MD, MPH

8:20 - 9:00 AM

TA Presentation: Douglas C. McCrory, MD, MHS, Associate Professor of Medicine, Duke University Medical Center, Center for Clinical Health Policy Research

9:00 - 9:30 AM

Steven R.Garfin, MD, Professor and Chairman, Department of Orthopaedic Surgery, UCSD School of Medicine

9:30 - 10:00 AM

Sohail K. Mirza, MD, MPH, Associate Professor, Department of Orthopedics and Department of Neurological Surgery, University of Washington

10:00 - 10:50 AM

Scheduled Public Comments
(Refer to Speaker List)

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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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10:50 - 11:00 AM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunity

11:00 - 12:00 PM

Questions to Presenters

12:00 - 1:00 PM

LUNCH (on your own)

1:00 - 3:30 PM

Open Panel Deliberations: Dr. Krist

3:30 - 4:25 PM

Formal Remarks and Vote

The Chairperson will ask each panel member to state his or her position on the voting questions

4:25 - 4:30 PM

Closing Remarks / Adjournment: Dr. Phurrough, Dr. Krist

4:30 PM

ADJOURN

Minutes

Download minutes [PDF, 6MB]

Panel Voting Questions

Download questions [PDF, 38KB] to panel.

Download scoresheet [PDF, 80KB]

Contact Information

Other Material

Roster

Medicare Coverage Advisory Committee
Roster
November 30, 2006

Chair
Alexander H. Krist, MD
Family Physician
Fairfax Family Practice Center

Mark V. Boswell, MD, PhD
Associate Professor of Anesthesiology Chief, Division of Pain Medicine
Director, Pain Medicine Fellowship Program
Department of Anesthesiology
Case Western Reserve University and University Hospitals of Cleveland

Barbara D. Boyan PhD
Price Gilbert, Jr. Chair in Tissue Engineering
Wallace H. Coulter Department of biomedical Engineering at Georgia Tech and Emory University Georgia Institute of Technology Institute of Bioengineering and Bioscience

Kim J. Burchiel, M.D.
Department of Neurological Surgery, Oregon Health & Science University

A. Mark Fendrick, MD
The University of Michigan

David R. Flum, MD, MPH, FACS
University of Washington Medical Center
Department of Surgery

Jeffrey G. Jarvick, MD, MPH
Professor of Radiology and Neurological Surgery
University of Washington

Stephen L. Ondra, MD
Associate Professor of Neurological Surgery, Dept. of Neurological Surgery
Northwestern Medical Faculty Foundation

Laxmaiah Manchikanti, M.D.
Pain Management Center of Paducah

John S. Kirkpatrick, MD
Division of Orthopaedic Surgery
University of Alabama, Birmingham

Industry Representatives
Kim K. Kuebler, MN, RN
Associate Director
Medical Respiratory Publications Boehringer Ingelheim Pharmaceuticals

Consumer Representative
Charles J. Queenan, III
Independent Management Consultant

Guests
Tom Faciszewski, MD
Chairman, Dept. of Orthopaedic Surgery
Marshfield Clinic

Jon D. Lurie, MD, MS
Associate Professor of Medicine
Dartmouth Medical School

CMS Liaison
Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group

Michelle Atkinson
Coverage and Analysis Group

Associated NCA

Associated Technology Assessment

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