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MEDCAC Meeting

Treatments for Bone Fractures That Fail to Progress to Union

10/06/2005

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Issue

Treatments for nonunion fractures are varied and there is no uniformly accepted method for diagnosis or appropriate treatment. Bone growth stimulating devices and orthobiologics are commonly used in the treatment of nonunion fractures.

CMS will review the scientific evidence on the effectiveness of various devices and orthobiologics used in treating nonunion fractures. We will refer this issue to the Medicare Coverage Advisory Committee (MCAC). Committee members will be given presentations reviewing current literature and will also receive public comments to assist in the discussions and recommendations regarding the net health outcomes of treatments for bone fractures that fail to progress to union.

Actions Taken

July 22, 2005

The Medicare Coverage Advisory Comittee will meet on Thursday, October 6, 2005 from 7:30 a.m. to 4:30 p.m. in the auditorium of the Centers for Medicare and Medicaid Services, located at 7500 Security Boulevard, Baltimore, MD 21244. A formal notice was published today in the Federal Register. We are also posting today the questions [PDF, 62KB] that the panel will address.

Posted Federal Register [PDF, 58KB] notice announcing meeting and Questions to Panel [PDF, 62KB].

September 06, 2005

The agenda and roster have been posted.

September 22, 2005

Posted Technology Assessment prepared for the meeting.

October 07, 2005

Posted Voting Results [PDF, 838KB].

November 22, 2005

Posted Transcript [PDF, 657KB] and Minutes [PDF, 2MB].

Agenda

Federal Register Notice
Medicare Coverage Advisory Committee
October 6, 2005
7:30 AM - 4:30 PM
CMS Auditorium
Agenda

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 - 8:20 AM

Opening Remarks—K. Long / S. Phurrough, MD, MPA/
B. McNeil, MD, PhD

8:20 - 8:40 AM

CMS Summary and Presentation of Voting Questions:
Shami Feinglass, MD, MPH

8:40 - 9:10 AM

Presentation of the TA: Karen Schoelles, MD; ECRI

9:10 - 9:35 AM

Presentation: David B. Carmack, MD; Eastern Maine Medical Center, Orthopaedic Trauma Surgery

9:35 - 10:00 AM

Presentation: Alan L. Jones, MD; Baylor University, Dept. of Ortho

10:00 - 10:15 AM

BREAK

10:15 - 11:15 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.

11:15 - 11:30 AM

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

11:30 - 12:30 PM

LUNCH (On your own)

12:30 - 1:00 PM

Questions to Presenters

1:00 - 3:15 PM

Open Panel Deliberations: Dr. McNeil

3:15 - 4:15 PM

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: Dr. Phurrough, Dr. McNeil

4:30 PM

ADJOURN

Minutes

Download Minutes [PDF, 2MB].

Panel Voting Questions

Download Questions to Panel [PDF, 62KB].

Voting Results [PDF, 837KB]

Contact Information

Other Material

Roster

Medicare Coverage Advisory Committee
October 6, 2005
Roster

Vice-Chair:
Barbara J. McNeil, MD, PhD
Department of Health Care Policy
Harvard Medical School
Boston, MA

Voting Member/Patient Advocate:
Leslie B. Fried, JD
American Bar Association
Commission on Law & Aging
Washington, D.C. 20005

Voting Members:
Lishan Aklog, MD
Department of Cardiothoracic Surgery
Mount Sinai Medical Center
New York, New York

Wade M. Aubry, MD
Senior Advisor
Health Technology Center
San Francisco, CA

Marc L. Berger, MD
Vice President
Outcomes Research & Management
Merck & Co., Inc.
West Point, PA

Kim J. Burchiel, MD
Department of Neurological Surgery
Oregon Health & Science University
Portland, OR

Harry B. Burke, MD,PhD
Associate Professor of Medicine
George Washington University
School of Medicine
Washington, D.C.

Robert H. Christenson, PhD
Professor of Pathology; and Research
Technology
Director, Rapid Response Laboratories
University of Maryland School of Medicine
Baltimore, MD

Mark Fendrick, MD
Professor, Internal Medicine and Health
Management & Policy
Co-Editor in Chief, American Journal of
Managed Care
Ann Arbor, MI

Robert S. McDonough, MD
Aetna
Hartford, CT

Alexander Emyr Khan Ommaya, ScD, MA
Director, Clinical Research Roundtable
Institute of Medicine, The National Academies
Bethesda, MD

Deborah Shatin, PhD
Senior Researcher Director
Center for Health Care Policy & Evaluation
UnitedHealth Group
Minneapolis, MN

Industry Rep:
Kim K. Kuebler, MN, RN
Palliative Care Nurse Practitioner
Private Practice: Adjuvant Therapies
Atlanta, GA

Consumer Rep:
Linda A. Bergthold, PhD
Watson Wyatt Worldwide
Santa Cruz, CA

Guest Expert Panelists:
John S. Kirkpatrick, MD, FACS
Associate Professor
Department of Surgery
Division of Orthopaedics
University of Alabama
Birmingham, AL

Sean D. Sullivan, PhD
Professor of Pharmacy, Public Health, and
Medicine
Director, Pharmaceutical Outcomes Research
and Policy Program
University of Washington
Seattle, WA

Kenneth Koval, MD
Dartmouth – Hitchcock Medical Center
Orthopaedic Surgery
Lebanon, NH

Barbara D. Boyan, Ph.D
Georgia Institute of Technology
Institute of Bioengineering and Bioscience
Atlanta, GA

CMS Liaison:
Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
7500 Security Boulevard, C1-09-06
Baltimore, MD 21244

Executive Secretary:
Kimberly Long
Coverage and Analysis Group

Associated NCA

Associated Technology Assessment

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