Minutes of October 18, 2000 Meeting
OPEN SESSION
Baltimore Convention Center
Baltimore, Maryland
Attendees
Alan M. Garber
Chairperson
Michael D. Maves
Vice-Chairperson
Constance A. Conrad
Executive Secretary
Voting Members
Michael D. Maves
Angus M. McBryde
H. Logan Holtgrewe
Kenneth P. Brin
Les J. Zendle
Bruce Sigsbee
Michael D. Maves
Consumer Representative
Phyllis E. Greenberger
Industry Representative
Eileen Helzner
Non-Voting Guest
Adrian Oleck
HCFA Representative
Sean R. Tunis
Wednesday, October 18, 2000, 8:30 a.m.
The Medical and Surgical Procedures Panel met on October 18, 2000, to discuss the use of sacral nerve stimulation for the treatment of urinary incontinence. The meeting began with a reading of the conflict of interest statement, and the call to order.
Presentation of Questions.
A representative from the Coverage and Analysis Group of HCFA presented the questions the panel was being asked to deliberate and vote upon.
Open Public Comments and Scheduled Commentaries.
The panelists heard from 11 scheduled speakers, 5 of whom were speaking as individual clinicians, 3 representing firms producing equipment for use in SNS, and 3 representing professional organizations.
The speakers presented results of various studies and clinical experience, reporting on efficacy, cost effectiveness and the importance of providing patients and clinicians with the option of sacral nerve stimulation as an adjunct treatment option for urinary incontinence.
HCFA Presentation and Blue Cross/Blue Shield TEC.
Dr. Mitchell Burken discussed definitions that HCFA had used when sending the questions to the panel.
Dr. Frank Lefevre presented the results of the technology assessment performed by the Blue Cross/Blue Shield Association’s Technology Evaluation Center (TEC).
Open Committee Deliberation.
The panel noted that neurological patients had been excluded from the primary study, but agreed that was an appropriate exclusion. The panel also discussed the definition of the term "refractory" incontinence; the sense of the panel was that the precise definition would be best left to HCFA, and their opinions were included in the record of the panel meeting. The panel also noted that use of the intervention for urinary retention had not been adequately evaluated at this point in time, but invited HCFA to take a look at the forthcoming study results in making a coverage decision.
Open Public Discussion.
Prior to voting on the questions presented, the panel heard again from three of the scheduled speakers that had additional comments to make.
Final Panel Recommendations. The panel voted on the following questions:
Is the evidence adequate to draw conclusions about the effectiveness of sacral nerve stimulation in the Medicare population for two indications, refractory urinary urge incontinence, and refractory urge frequency syndrome?
There was a unanimous affirmative vote on the question.
In terms of level of health effect, the panel voted unanimously to assign the sacral nerve stimulation to Category 2, more effective than alternative treatments.
Panel Comments on Their Votes.
The HCFA representative informed the panel that HCFA was interested in not only the votes, but also the reasons for voting as they did. The panelists felt their opinions were adequately set forth in the record.
Adjournment. The meeting adjourned at 11:57 a.m.
I certify that I attended the meeting
of the Medical and Surgical Procedures Panel
on October 18, 2000, and that these minutes
accurately reflect what transpired.
_________________________________
Constance A. Conrad, R.N.
Executive Secretary, HCFA |
I approve the minutes of this meeting
as recorded in this summary.
______________________________
Alan M. Garber, M.D., Ph.D.
Chairperson
|