Back pain and related problems have substantial public health impact within the Medicare population each year, including discomfort, loss of mobility, and serious morbidity. CMS has identified this important issue for long-term examination.   Disease conditions interest include disc degeneration, spinal stenosis, spondylolisthesis, and vertebral compression fractures.   

Vertebral body compression fractures of the spine are among the most common fracture types in patients who have osteoporosis.  Compression fractures of the spine are also caused by osteolytic destruction, secondary to malignancy.  Pain and loss of function are the most common symptoms.

Percutaneous vertebroplasty is a minimally invasive treatment that inserts bone cement into the compressed and fractured vertebrae to provide mechanical stabilization.  Kyphoplasty is a variation of vertebroplasty.  Kyphoplasty uses an inflatable balloon to expand the compressed vertebral body, in an attempt to restore its natural height before injecting a cement-like substance into the vertebral cavity.

As an initial step, CMS will review the scientific evidence on the effectiveness of surgical management of vertebral compression fractures, particularly vertebroplasty and kyphoplasty procedures, in the Medicare population.  We will refer this issue to the Medicare Coverage Advisory Committee (MCAC).  Committee members will be given presentations on the current literature and also receive public comments to aid in the discussions and recommendations regarding the quality of the evidence on verterbroplasty and kyphoplasty procedures.

We expect to hold additional future meetings of the Medicare Coverage Advisory Committee regarding other back pain treatments and will post future notices in the Federal Register. 

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

Attendees

Barbara J. McNeil, M.D., Ph.D.
Vice-Chairperson

Kimberly Long
Executive Secretary

Voting Members
Harry B. Burke, M.D., Ph.D.
Mark Fendrick, Ph.D.
Alexander H. Krist, M.D.
Stephen L. Ondra, M.D.
Mary Starmann-Harrison, B.S.N., M.H.S.A.
Jonathan P. Weiner, Ph.D.

CMS Liaison
Steve Phurrough, M.D., M.P.A..

Consumer Representative
Charles J. Queenan, III

Guest Expert Panelists
James Weinstein, M.D.
Sean D. Sullivan, Ph.D.
Richard G. Fessler, M.D., Ph.D.
Daniel K. Resnick, Ph.D.
David F. Kallmes, M.D.
Jeffrey G. Jarvik, M.D., M.P.H.

Tuesday, May 24, 2005, 8:06 a.m.

The Medicare Coverage Advisory Committee met on May 24, 2005, to discuss the evidence, hear presentations and public comment, and make recommendations regarding the treatment of vertebral body compression fractures.

The meeting began with a reading of conflict of interest issues and an introduction of the Committee.

CMS Summary and Presentation of Voting Questions. A CMS representative presented the panel with a general overview of vertebral body compression fractures, their treatment by percutaneous vertebroplasty and kyphoplasty, CMS's coverage position regarding these treatments, as well as questions for the MCAC committee.

Presentation of the Technology Assessment. Dr. David Mark presented a summary of the technology assessment performed by the Blue Cross Blue Shield Technology Evaluation Center.

Presentations. The panel heard a presentation by Dr. Isador Lieberman, one by Dr. Ken Saag and Dr. John Bian, and one by Dr. Stephen M. Belkoff. Dr. Lieberman presented to the panel some of his thoughts on vertebral augmentation and summarized work by himself and his colleagues at the Cleveland Clinic. Dr. Saag and Dr. Bian highlighted what they perceived to be a major gap in the evidence and discussed a current study that they are participating in. Dr. Belkoff gave the panel a summary of his literature review related to vetebral augmentation. At the end of each presentation, the panelists were given the opportunity to ask questions.

Scheduled Public Comments. Fifteen speakers addressed the panel concerning treatment for vertebral body compression fractures and the state of the current evidence regarding those treatments. These speakers included representatives of five professional associations concerned with treatment of the spine, as well as researchers clinicians, and representatives of Kyphon, a device manufacturer.

Questions to Presenters. The panel was given the opportunity to pose questions to the presenters, and those who had made scheduled comments.

Open Public Comments. One additional speaker, the vice president for reimbursement for a device manufacturer, addressed the panel.

Open Panel Discussion. Following a lunch break, the panel engaged in a general discussion, including some further questioning of the presenters.

Final Remarks and Vote.

Following discussion, the panel voted as follows on the questions presented:

PERTAINING TO VERTEBROPLASTY

QUESTION 1: Responses ranging from 1(poorly) to 5 (very well); How well does the evidence address the effectiveness of vertebroplasty for patients with compression fracture as compared with conservative care, going from one, poorly, to five, very well? All six voting members voted two; of nonvoting members, four voted two, one voted three, and two voted four.

QUESTION 2 (acute and subacute): Responses ranging from 1(no confidence) to 5 (high confidence); How confident are you in the validity of the scientific data on the following outcomes with respect to vertebroplasty for patients with acute and subacute compression fractures?

1. Short-term morbidity. Among the voting members, one voted 1 and five voted 2; of nonvoting members, one voted 1, one voted 2, three voted 3, and two voted 4.

2. Long-term morbidity. Of the voting members, one voted 1 and five voted 2; of nonvoting members, one voted 1, three voted 2, and three voted 3.

3. Mortality. Of the voting members, three voted 1 and three voted 2; of nonvoting members, one voted 1, four voted 2, and two voted 3.

4. Mobility and functional status. All voting members voted 2; of nonvoting members, three voted 2, three voted 3, and one voted 4.

5. Pain relief. Of the voting members, five voted 2, and one voted 3; of nonvoting members, one two voted 2, two voted 3, and three voted 4.

QUESTION 2 (chronic): Responses ranging from 1 (no confidence), to 5 (high confidence); How confident are you in the validity of the scientific data on the following outcomes with respect to vertebroplasty for patients with chronic compression fractures?

1. Short-term morbidity. All voting members voted 2; of nonvoting members, four voted 2, three voted 4.

2. Long-term morbidity. Of the voting members, one voted 1 and five voted 2; of nonvoting members, one voted 1, five voted 2, and one voted 3.

3. Mortality. Of the voting members, three voted 1 and three voted 2; of nonvoting members, two voted 1, three voted 2, and two voted 3.

4. Mobility and functional status. All voting members voted 2; of nonvoting members, six voted 2 and one voted 3.

5. Pain relief. Of the voting members, five voted 2 and one voted 3; of nonvoting members, four voted 2, two voted 3, and one voted 4.

QUESTION 3 (acute and subacute). Responses ranging from 1 (not likely) to 5 (very likely); How likely is it that vertebroplasty, in the following circumstances, will positively affect the following outcomes when compared to conservative care for patients with acute and subacute compression fractures?

1. Short-term morbidity. Of the voting members, two voted 3, three voted 4, and one voted 5; of nonvoting members, one voted 3, one voted 4, and five voted 5.

2. Long-term morbidity. Of the voting members, one voted 2, three voted 3, and two voted 5; of nonvoting members, one voted 1, two voted 3, and four voted 4.

3. Mortality. Of the voting members, two voted 1, one voted , and three voted 3; of nonvoting members, one voted 1, four voted 3, and two voted 4.

4. Mobility and functional status. Of the voting members, one voted 3, four voted 4, and one voted 5; of nonvoting members, three voted 3 and four voted 5.

5. Pain relief. Of the voting members, one voted 3, two voted 4, and three voted 5; of nonvoting members, one voted 3, two voted 4, and four voted 5.

QUESTION 3 (chronic). Responses ranging from 1 (not likely) to 5 (very likely); How likely is it that vertebroplasty, in the following circumstances, will positively affect the following outcomes when compared to conservative care for patients with chronic compression fractures?

1. Short-term morbidity. Of the voting members, one voted 3 and five voted 4; of nonvoting members, five voted 3 and two voted 4.

2. Long-term morbidity. Of the voting members, four voted 3 and two voted 4; of nonvoting members, one voted 1, five voted 3, and one voted 4.

3. Mortality. Of the voting members, one voted 1, three voted 2, and two voted 3; of nonvoting members, one voted 1, one voted 2, four voted 3, and one voted 4.

4. Mobility and functional status. Of the voting members, four voted 3 and two voted 4; of nonvoting members, five voted 3 and two voted 4.

5. Pain relief. Of the voting members, one voted 3 and five voted 4; of nonvoting members, two voted 3 and five voted 4.

QUESTION 4. Responses ranging from 1 (no confidence) to 5 (high confidence); How confident are you that vertebroplasty will produce a clinically important net health benefit for patients with compression fracture compared to conservative care, for patients with:

1. Acute or subacute compression fracture. Of the voting members, one voted 2, three voted 3, and two voted 4; of nonvoting members, one voted 2, two voted 3, one voted 4, and three voted 5.

2. Chronic compression fracture. Of the voting members, three voted 2 and three voted 3; of nonvoting members, one voted 2, three voted 3, and three voted 4.

QUESTION 5. Responses ranging from 1 (not likely) to 5 (very likely); Based on the literature presented, how likely is it that the results of vetebroplasty in the treatment of relief of pain and improvement in ability to function for patients with a compression fracture can be generalized to:

1. The Medicare population (aged 65+). Of the voting members, three voted 2, one voted 3, and one voted 4; of nonvoting members, four voted 4 and three voted 5.

2. Providers (Facilities/physicians) in community practice. Of the voting members, three voted 2, one voted 3, and two voted 4; of nonvoting members, one voted 2, one voted 3, four voted 4, and one voted 5.

PERTAINING TO KYPHOPLASTY

QUESTION 1: Responses ranging from 1(poorly) to 5 (very well); How well does the evidence address the effectiveness of kyphoplasty for patients with compression fracture as compared with conservative care? All six voting members voted 2; of nonvoting members, three voted 2, two voted 3, and two voted 4.

QUESTION 2 (acute and subacute): Responses ranging from 1 (no confidence) to 5 (high confidence); How confident are you in the validity of the scientific data on the following outcomes with respect to kyphoplasty for patients with acute and subacute compression fractures?

1. Short-term morbidity. Of the voting members, five voted tw2 and one voted 3; of nonvoting members, four voted 3 and three voted 4.

2. Long-term morbidity. All six voting members voted 2; of nonvoting members, one voted 1, four voted 2, one voted 3, and one voted 4.

3. Mortality. Of the voting members, three voted 1 and three voted 2; of nonvoting members, one voted 1, five voted 2, and one voted 5.

4. Mobility and functional status. Of the voting members, five voted 2 and one voted 3; of nonvoting members, three voted 2, two voted 3, and two voted 4.

5. Pain relief. Of the voting members, five voted 2 and one voted 3; of nonvoting members, two voted 2, two voted 3, and three voted 4.

QUESTION 2 (chronic): Responses ranging from 1 (no confidence) to 5 (high confidence); How confident are you in the validity of the scientific data on the following outcomes with respect to kyphoplasty for patients with chronic compression fractures?

1. Short-term morbidity. Of the voting members, five voted 2 and one voted 3; of nonvoting members, two voted 2 and five voted 3.

2. Long-term morbidity. All six voting members voted 2; of nonvoting members, one voted 1, four voted 2, and two voted 3.

3. Mortality. Of the voting members, three voted 1 and three voted 2; of nonvoting members, one voted 1, five voted 2, and one voted 5.

4. Mobility and functional status. All six voting members voted 2; of nonvoting members, four voted 2 and three voted 3.

5. Pain relief. All six voting members voted 2; of nonvoting members, three voted 2 and four voted 3.

QUESTION 3 (acute and subacute). Responses ranging from 1 (not likely) to 5 (very likely); How likely is it that kyphoplasty, in the following circumstances, will positively affect the following outcomes when compared to conservative care for patients with acute and subacute compression fractures?

1. Short-term morbidity. Of the voting members, two voted 3, three voted 4, and one voted 5; of nonvoting members, three voted 3, two voted 4, and two voted 5.

2. Long-term morbidity. Of the voting members, one voted 2, two voted 3, and three voted 4; of nonvoting members, one voted 2, four voted 3, and two voted 4.

3. Mortality. Of the voting members, one voted 1, two voted 2, one voted 3, and two voted 4; of nonvoting members, one voted 1, three voted 2, two voted 3, and one voted 4.

4. Mobility and functional status. Of the voting members, one voted 2 and five voted 4; of nonvoting members, six voted 3 and one voted 5.

5. Pain relief. Of the voting members, one voted 3, three voted 4, and one voted 5; of nonvoting members, one voted 3, three voted 4, and three voted 5.

QUESTION 3 (chronic). Responses ranging from 1 (not likely) to 5 (very likely); How likely is it that kyphoplasty, in the following circumstances, will positively affect the following outcomes when compared to conservative care for patients with chronic compression fractures?

1. Short-term morbidity. Of the voting members, two voted 3 and four voted 4; of nonvoting members, six voted 3 and one voted 4.

2. Long-term morbidity. Of the voting members, one voted 2, three voted 3, and two voted 4; of nonvoting members, one voted 1, five voted 3, and one voted 4.

3. Mortality. Of the voting members, two voted 1, three voted 2, and one voted 3; of nonvoting members, one voted 1, five voted 2, and one voted 4.

4. Mobility and functional status. Of the voting members, three voted 3 and three voted 4; all seven nonvoting members voted 3.

5. Pain relief. Of the voting members, two voted 3 and four voted 4; of nonvoting members, four voted 3 and three voted 4.

QUESTION 4. Responses ranging from 1 (no confidence) to 5 (high confidence); How confident are you that kyphoplasty will produce a clinically important net health benefit for patients with compression fracture compared to conservative care, for patients with:

1. Acute or subacute compression fracture. Of the voting members, one voted 2, three voted 3, and two voted 4; of nonvoting members, one voted 2, three voted 3, and three voted 5.

2. Chronic compression fracture. Of the voting members, two voted 2, three voted 3, and one voted 4; of nonvoting members, two voted 2, four voted 3, and one voted 4.

QUESTION 5. Responses ranging from 1 (not likely) to 5 (very likely); Based on the literature presented, how likely is it that the results of kyphoplasty in the treatment of relief of pain and improvement in ability to function for patients with a compression fracture can be generalized to:

1. The Medicare population (aged 65+). Of the voting members, three voted 2, one voted 3, and two voted 4; of nonvoting members, four voted 4 and three voted 5.

2. Providers (Facilities/physicians) in community practice. Of the voting members, two voted 2 and four voted 3; of nonvoting members, three voted 2, two voted 3, one voted 4, and one voted 5.

Remarks. Following the votes, each voting member and nonvoting panelist was given the opportunity to make a statement summarizing reasons for their opinions and voting.

Adjournment. The meeting adjourned at 3:21 p.m.

I certify that I attended the meeting
of the Executive Committee on
May 24, 2005, and that these
minutes accurately reflect what
transpired.


_________________________________
Kimberly Long
Executive Secretary, MCAC, CMS

Download Questions [PDF, 38KB].

Download Voting Results [ZIP, 38KB].