Centers for Medicare & Medicaid Services

10/6/2005 - Treatments for Bone Fractures That Fail to Progress to Union

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].

Federal Register Notice

Agenda

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].

Transcript

Panel Voting Questions

Download Questions to Panel [PDF, 62KB].

Voting Results [PDF, 837KB]

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	Alexander Emyr Khan Ommaya, ScD, MA Director, Clinical Research Roundtable Institute of Medicine, The National Academies Bethesda, MD
Voting Member/Patient Advocate: Leslie B. Fried, JD American Bar Association Commission on Law & Aging Washington, D.C. 20005	Deborah Shatin, PhD Senior Researcher Director Center for Health Care Policy & Evaluation UnitedHealth Group Minneapolis, MN
Voting Members: Lishan Aklog, MD Department of Cardiothoracic Surgery Mount Sinai Medical Center New York, New York	Industry Rep: Kim K. Kuebler, MN, RN Palliative Care Nurse Practitioner Private Practice: Adjuvant Therapies Atlanta, GA
Wade M. Aubry, MD Senior Advisor Health Technology Center San Francisco, CA	Consumer Rep: Linda A. Bergthold, PhD Watson Wyatt Worldwide Santa Cruz, CA
Marc L. Berger, MD Vice President Outcomes Research & Management Merck & Co., Inc. West Point, PA	Guest Expert Panelists: John S. Kirkpatrick, MD, FACS Associate Professor Department of Surgery Division of Orthopaedics University of Alabama Birmingham, AL
Kim J. Burchiel, MD Department of Neurological Surgery Oregon Health & Science University Portland, OR	Sean D. Sullivan, PhD Professor of Pharmacy, Public Health, and Medicine Director, Pharmaceutical Outcomes Research and Policy Program University of Washington Seattle, WA
Harry B. Burke, MD,PhD Associate Professor of Medicine George Washington University School of Medicine Washington, D.C.	Kenneth Koval, MD Dartmouth – Hitchcock Medical Center Orthopaedic Surgery Lebanon, NH
Robert H. Christenson, PhD Professor of Pathology; and Research Technology Director, Rapid Response Laboratories University of Maryland School of Medicine Baltimore, MD	Barbara D. Boyan, Ph.D Georgia Institute of Technology Institute of Bioengineering and Bioscience Atlanta, GA
Mark Fendrick, MD Professor, Internal Medicine and Health Management & Policy Co-Editor in Chief, American Journal of Managed Care Ann Arbor, MI	CMS Liaison: Steve Phurrough, MD, MPA Director, Coverage and Analysis Group 7500 Security Boulevard, C1-09-06 Baltimore, MD 21244
Robert S. McDonough, MD Aetna Hartford, CT	Executive Secretary: Kimberly Long Coverage and Analysis Group

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