Sacral Nerve Stimulation for Urge Urinary Incontinence (Medical and Surgical Procedures Panel)

Sacral nerve stimulation, or sacral nerve neuromodulation, is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder function by delivering controlled electrical impulses to the sacral nerves.

Currently, no national coverage decision is in place; and, therefore, coverage of this item and service is determined at the carrier level. HCFA will evaluate whether the current literature supports a national coverage policy for the use of sacral nerve stimulators.

Agenda for October 17-18, 2000 Meeting

One West Pratt Street
Baltimore, MD 21201

Chairperson: Alan M. Garber, MD, PhD
Vice-Chairperson: Michael D. Maves, MD, MBA
Executive Secretary: Constance A. Conrad, RN

8:00 - 8:30 a.m.

8:30 - 9:00 a.m.

9:00 - 9:30 a.m.

9:30 - 9:40 a.m.

9:40 - 9:50 a.m.

9:50 - 10:10 a.m.

10:10 - 10:20 a.m.

10:20 - 10:35 a.m.

10:35 - 12 noon

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.

12 noon - 1:00 p.m.

1:00 - 1:45 p.m.

1:45 - 2:15 p.m.

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

2:15 - 2:30 p.m.

2:30 - 3:30 p.m.

Public Observers May Not Participate Except at the Specific Request of the Chairperson.

3:30 p.m.

4:00 p.m.

8:00 - 8:05 a.m.

8:05 - 8:15 a.m.

8:15 - 10:00 a.m.

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.

10:00 - 10:15 a.m.

10:15 - 11:00 a.m.

11:00 - 12:00 noon

Public Observers May Not Participate Except at the Specific Request of the Chairperson.

12 Noon - 1:00 p.m.

1:00 - 1:30 p.m.

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

1:30 - 2:15 p.m.

2:15 - 2:30 p.m.

2:30 p.m.

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:

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 approve the minutes of this meeting
as recorded in this summary.

______________________________
Alan M. Garber, M.D., Ph.D.
Chairperson

Questions for panel

1. Is the evidence adequate to draw conclusions about the effectiveness of sacral nerve stimulation (SNS), in the Medicare population, for the following two indications: refractory urinary urge incontinence and refractory urgency-frequency syndrome? Please consider the following points when answering this question:

   Adequacy of study design:

   Is there evidence that the studies do not over or underestimate the effect of the intervention? For example, do the patients who received the intervention differ systematically from those in the control group in ways that might affect outcomes?

   Do the studies permit conclusions about the health outcome effects of the technology?

   Consistency of results: Are the results of the studies consistent or are they contradictory?

   Applicability to the Medicare population: Are the results of the studies applicable to the various Medicare populations?

   Generalizability beyond the research setting: Are the results likely to apply in routine clinical settings?

   Expert testimony, public comments, etc. should be considered with respect to the above considerations.

2. If the evidence is adequate to draw conclusions, what is the size, if any, of the overall health effect of SNS, compared with alternative treatments for refractory cases? These alternatives tend to be surgical. Please place the size and direction of effectiveness into one of the seven categories listed in Attachment A.

Attachment A: Categories of Effectiveness

Breakthrough technology: The improvement in health outcomes is so large that the intervention becomes standard of care.

More effective: The new intervention improves health outcomes by a significant, albeit small, margin as compared with established services or medical items.

As effective but with advantages: The intervention has the same effect on health outcomes as established services or medical items but has some advantages (convenience, rapidity of effect, fewer side effects, other advantages) that some patients will prefer.

As effective and with no advantages: The intervention has the same effect on health outcomes as established alternatives but with no advantages.

Less effective but with advantages: Although the intervention is less effective than established alternatives (but more effective than doing nothing), it has some advantages (such as convenience, tolerability).

Less effective and with no advantages: The intervention is less effective than established alternatives (but more effective than doing nothing) and has no significant advantages.

Not effective: The intervention has no effect or has deleterious effects on health outcomes when compared with "doing nothing," (e.g., treatment with placebo or patient management without the use of a diagnostic test).