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Centers for Medicare & Medicaid Services

MEDCAC Meeting 4/12/2000 - Urinary Incontinence (Medical and Surgical Procedures Panel)

 Biofeedback for Urinary Incontinence

Biofeedback is defined as a therapy that uses electronic or mechanical instruments to relay visual and/or auditory evidence to assist a person to gain pelvic muscle awareness to improve physiologic activity and bladder function.

Currently, §35-27 of the Coverage Issues Manual states that biofeedback is covered under Medicare only when it is reasonable and necessary for the individual patient for muscle re-education of specific muscle groups or for treating pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or weakness, and more conventional treatments have not been successful. Therefore, coverage of biofeedback for the treatment of urinary incontinence is determined at the carrier level. HCFA will evaluate whether the current literature supports a national position on the use of biofeedback for the treatment of urinary incontinence.

Pelvic Floor Electrical Stimulation for Urinary Incontinence

Pelvic Floor Electrical Stimulation (PFES) for urinary incontinence refers to the use of a non-implantable electrical device that delivers variable rates of current through the pelvic floor with the intent of strengthening pelvic floor musculature.

Currently, §65-9 (C) of the Coverage Issues Manual states that the effectiveness of these devices is unproven, and therefore cannot be covered under §1862(a)(1) of the Social Security Act as a "reasonable and necessary" treatment. HCFA is currently evaluating this issue to determine whether sufficient scientific evidence exists to allow for a reconsideration of this national policy.

Federal Register Notice

Agenda for April 12-13, 2000 Meeting

The Baltimore Convention Center, Room 321
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

Wednesday, April 12, 2000

8:00 - 8:30 a.m.

Registration

8:30 - 9:00 a.m.

Opening Remarks - Summary of MCAC Executive Committee Recommendations

9:00 - 9:30 a.m.

Overview and Management of Urinary Incontinence

BIOFEEDBACK THERAPY FOR THE TREATMENT OF URINARY INCONTINENCE

9:30 - 9:45 a.m.

Opening Questions

9:45 - 10:45 a.m.

Open Public Comments & Scheduled Commentaries

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.

10:45 - 11:00 a.m.

BREAK

11:00 - 12 noon

Open Public Comments & Scheduled Commentaries

12 noon - 1:15 p.m.

LUNCH (On Your Own)

1:15 - 2:00 p.m.

HCFA Presentation

2:00 - 3:00 p.m.

Open Committee Deliberation

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

3:00 - 3:15 p.m.

BREAK

3:15 - 3:45 p.m.

Open Public Comments

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

3:45 - 4:45 p.m.

Open Committee Deliberation

4:45 - 5:15 p.m.

Final Panel Recommendations

5:15 p.m.

Ajourn

Thursday, April 13, 2000

PELVIC FLOOR ELECTRICAL STIMULATION THERAPY FOR THE TREATMENT OF URINARY INCONTINENCE

8:00 - 8:15 a.m.

Opening Remarks

8:15 - 8:30 a.m.

Opening Questions

8:30 - 10:00 a.m.

Open Public Comments & Scheduled Commentaries

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.

BREAK

10:15 - 11:00 a.m.

HCFA Presentation

11:00 - 12:00 noon

Open Committee Deliberation

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

12 noon - 1:15 p.m.

LUNCH (On Your Own)

1:15 p.m. - 1:45 p.m.

Open Public Comments

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

1:45 - 2:30 p.m.

Open Committee Deliberation

2:30 - 3:00 p.m.

Final Panel Recommendations

3:00 p.m.

Ajourn

Minutes for April 12-13, 2000 Meeting

April 12, 2000
Biofeedback for Urinary Incontinence

April 13, 2000
Pelvic Floor Electrical Stimulation for Urinary Incontinence

Biofeedback for Urinary Incontinence
April 12, 2000

Attendees

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

Michael D. Maves, M.D.
Vice-Chairperson

Constance A. Conrad, R.N.
Executive Secretary

Voting Members
Angus M. McBryde, M.D., FACS
H. Logan Holtgrewe, M.D., FACS
Kenneth P. Brin, M.D., Ph.D.
Les J. Zendle, M.D.
Linda D. Bradley, M.D.
James P. Rathmell, M.D.
Arnold M. Epstein, M.D.

Temporary Voting Member
Lisa Landy, M.D.

Consumer Representative
Phyllis E. Greenberger, M.S.W.

Industry Representative
Marshall S. Stanton, M.D.

Carrier Medical Director
Michael Riisager, M.D.

Non-Voting Guest
Diane Smith, R.N.

HCFA Representative
Hugh F. Hill, M.D., J.D.

Wednesday, April 12, 2000, 8:30 a.m.

The Medical and Surgical Procedures Panel met on April 12, 2000, to discuss biofeedback therapy for the treatment of urinary incontinence. The meeting began with the introduction of the panelists, a reading of the conflict of interest statement, and the call to order.

Summary of MCAC Executive Committee Recommendations. The Chairman discussed the Executive Committee Subcommittee report entitled "Interim Recommendations for Evaluating Effectiveness," and advised the panel that the panel would follow all operational recommendations of the Executive Committee, and encouraged panelists to consider this document when evaluating the evidence in support of the treatment in question.

Overview of Evidence Based Methodology. The HCFA Representative introduced Deborah A. Zarin, M.D., Director of Technology Assessment at the Agency for Health Research and Quality. Dr. Zarin presented the panelists information on how to effectively review and evaluate studies. Following Dr. Zarin’s remarks, a panelist made a statement noting that, while the panel is charged only with evaluating evidence, the panel’s recommendations will be a key factor in HCFA’s ultimate coverage decision.

Presentation of Questions. A representative from the coverage and analysis branch from HCFA presented the questions the panel was being asked to deliberate and vote upon.

  1. Is the scientific evidence adequate to draw conclusions about the effectiveness of biofeedback as an adjunct to pelvic muscle exercises (PME) in routine clinical use in the Medicare populations for the following three indications: 1) stress incontinence, 2) urge incontinence, and 3) post-prostatectomy incontinence? Points of adequacy of study design, consistency of results, applicability to the Medicare population, applicability beyond the research setting were points for panelists to consider.

  2. If the evidence is adequate to draw conclusions, what is the size, if any, of the overall health effect of the addition of biofeedback to PME compared to PME alone?

Following Dr. Zarin’s presentation, several panelists raised questions concerning the standard the panel was being asked to evaluate by the Executive Committee, and the procedural method of voting on the questions. It was made clear to the panel that if the answer to Question No. 1 were no, they would not move to consider Question No. 2.

Open Public Comments and Scheduled Commentaries. The panelists heard from 13 scheduled speakers, 2 of whom were speaking as individuals, 2 representing firms producing equipment for use in biofeedback therapy, and 9 representing professional organizations.

The individual speakers presented results of various clinical trials, reporting on efficacy and the importance of providing patients with urinary incontinence treatment options through the use of biofeedback.

Industry speakers presented information relating to the efficacy of biofeedback utilizing either a vaginal or rectal probe.

The speakers representing professional organizations presented the panel findings of literature review of studies related to biofeedback treatment modalities, and their respective organizations’ conclusions arising therefrom. These speakers also noted the current policy published in AHCPR’s 1996 guidelines.

Recess. Following the scheduled speakers, the meeting recessed for lunch from 12:03 until 1:25 p.m.

HCFA Presentation. Dr. Ken Simon presented the panel with the definitions of various treatment modalities, and the criteria used for articles that were included in the evidence based literature review.

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 deliberations began with a review by Dr. Landy and Dr. Zendle of the information presented to the panel . The chairman again encouraged the panelists to adhere to the questions posed by HCFA in the discussion.

Open Public Discussion. Prior to voting on the questions presented, the panel heard from speakers who were not included in the schedule, as well as scheduled speakers that had additional comments to make. The panel heard from a total of 7 speakers during this phase of the session.

Open Committee Deliberation. The consumer representative expressed frustration at what she perceived in the panel soliciting public comments and letters, if they have no effect in the panel’s decision because they are not scientific evidence. The chariman reminded the panel that the entire MCAC process is a work in progress, and encouraged any panel member who had concerns about the form of the questions or the standard of evidence to either write to the Executive Committee, or appear at the next Executive Committee meeting, but that today the panel was only considering the questions posed by HCFA.

Final Panel Recommendations. The panel voted on the following questions:

Is the scientific evidence adequate to draw conclusions about the effectiveness of biofeedback as adjunct to pelvic muscle exercises in routine clinical use in the Medicare population for stress incontinence?

Drs. Bradley and Landy voted in the affirmative; all other panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of biofeedback as adjunct to pelvic muscle exercises in routine clinical use in the Medicare population for urge incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of biofeedback as adjunct to pelvic muscle exercises in routine clinical use in the Medicare population for post-prostatectomy incontinence?

All panelists voted no with no abstentions.

Panel Comments on Their Votes. The HCFA representative informed the panel that HCFA was interested in not only the votes, but the reasons for their votes. Panelists expressed views that if the questions had been posed to suggest a decision based on belief from clinical experience rather than scientific evidence, the results of the voting may have been different. Several panelists offered the feeling that if this were a coverage decision, their votes would have been different as well., because biofeedback does seem to be an efficacious treatment that is being used widely in a clinical setting. The panelists did not believe that there was sufficient evidence that adding biofeedback to exercises was effective; some panelists indicated that they believed that the combination of exercise and biofeedback was better than no treatment at all. Some panelists seemed to think that this was a possibility but that the appropriate studies had not been performed.

Adjournment. The meeting adjourned at 4:30 p.m.

I certify that I attended the meeting
of the Medical and Surgical Procedures Panel
on April 12, 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

Pelvic Floor Electrical Stimulation for Urinary Incontinence
April 13, 2000

Attendees

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

Michael D. Maves, M.D.
Vice-Chairperson

Constance A. Conrad, R.N.
Executive Secretary

Voting Members
Angus M. McBryde, M.D., FACS
H. Logan Holtgrewe, M.D., FACS
Kenneth P. Brin, M.D., Ph.D.
Les J. Zendle, M.D.
Linda D. Bradley, M.D.
James P. Rathmell, M.D.
Arnold M. Epstein, M.D.

Temporary Voting Member
Lisa Landy, M.D.

Consumer Representative
Phyllis E. Greenberger, M.S.W.

Industry Representative
Marshall S. Stanton, M.D.

Carrier Medical Director
Michael Riisager, M.D.

Non-Voting Guest
Diane Smith, R.N.

HCFA Representative
Hugh F. Hill, M.D., J.D.

Thursday, April 13, 2000, 8:00 a.m.

The Medical and Surgical Procedures Panel met on April 13, 2000, to discuss the use of pelvic floor electrical 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 branch of HCFA presented the questions the panel was being asked to deliberate and vote upon.

  1. Is the scientific evidence adequate to draw conclusions about the effectiveness of:
    • PFES compared to placebo
    • PFES compared to pelvic muscle exercises (PME) or alternative non-surgical techniques
    • PFES + PME compared to PME alone - in routine clinical use in the Medicare populations for the following three indications: 1) stress incontinence, 2) urge incontinence, and 3) post-prostatectomy incontinence? Points to be considered in deliberation were adequacy of study design, consistency of results, applicability to the Medicare population and applicability beyond the research setting.

Open Panel Discussion. Though not on the agenda, several panel members expressed their feelings of frustration resulting after the session on biofeedback held April 12. Non-voting members who voiced opinions were Industry Representative, Marshall Stanton, M.D., Consumer Representative, Phyllis Greenberger, M.S.W. and Guest, Diane Smith, R.N. Voting members who participated were Linda Bradley, M.D. and James P. Rathwell, M.D. The Chairman allowed a discussion concerning panelists’ feelings and opinions, and again encouraged them to write to the Executive Committee and/or to appear at the next meeting of the Executive Committee to voice their concerns over the formulation of questions and the standard of evidence to be applied to panel deliberations; these recommendations were echoed by the HCFA representative.

Open Public Comments and Scheduled Commentaries. The panelists heard from 13 scheduled speakers, 5 of whom were speaking as individuals, 2 representing firms producing equipment for use in pelvic floor electrical stimulation, and 6 representing professional organizations.

The individual speakers presented results of various studies, reporting on efficacy, cost effectiveness and the importance of providing patients and clinicians with the option of pelvic floor electrical stimulation as an adjunct treatment option for urinary incontinence, as well as some input from patients who felt they had benefited from the use of PFES in their treatment.

Industry speakers presented information relating to the efficacy of PFES, and pointed out the different settings for current and length of stimulation, and types of devices that are currently in use.

The speakers representing professional organizations presented the panel findings of literature review of studies related to PFES treatment, and their respective organizations’ conclusions arising therefrom. These speakers also noted the current policy published in AHCPR’s 1996 guidelines.

HCFA Presentation. Dr. John Whyte informed the panel that the definition of PFES used in the evidence based literature review was: The use of a non-implantable electrical device that delivers variable rates of current to the pelvic floor, with the intent of strengthening pelvic floor musculature. He also noted the selection criteria used to choose the articles reviewed.

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 deliberations began with a review by Dr. Landy and Dr. Zendle of the information presented to the panel . The Chairman again encouraged the panelists to adhere to the questions posed by HCFA in the discussion.

Open Public Discussion. Prior to voting on the questions presented, the panel heard from speakers who were not included in the schedule, as well as scheduled speakers that had additional comments to make. The panel heard from a total of 10 speakers during this phase of the session.

Open Committee Deliberation. The panel discussed how the vote would be conducted and decided to vote on nine separate questions as part of Question No. 1, voting individually on each efficacy comparison called for with each indication of urinary incontinence.

Final Panel Recommendations. The panel voted on the following questions:

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES compared to placebo in stress incontinence?

Dr. Landy voted in the affirmative; all other panelists voted no, with the exception of Dr. Epstein, who abstained.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES compared to placebo in urge incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES compared to placebo in post-prostatectomy incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES compared to pelvic muscle exercises or alternate nonsurgical techniques for the indication of stress incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES compared to pelvic muscle exercises or alternate nonsurgical techniques for the indication of urge incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES compared to pelvic muscle exercises or alternate nonsurgical techniques for the indication of post-prostatectomy incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES and pelvic muscle exercises, compared to pelvic muscle exercises alone, for the indication of stress incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES and pelvic muscle exercises, compared to pelvic muscle exercises alone, for the indication of urge incontinence?

All panelists voted no, with no abstentions.

Is the scientific evidence adequate to draw conclusions about the effectiveness of PFES and pelvic muscle exercises, compared to pelvic muscle exercises alone, for the indication of post-prostatectomy incontinence?

All panelists voted no, with no abstentions.

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.

On the issue of PFES compared with placebo in stress incontinence, Dr. Landy voted in the affirmative stating trouble understanding what is adequate and referred back to earlier discussions. Dr. Rathmell voted in the negative citing inconsistencies in the devices used and outcomes shown. Dr. Epstein abstained based inconsistencies in the studies and that he was not sure which evidence standard would be appropriate.

On the issue of PFES compared to placebo for urge incontinence, Dr. Landy offered it was hard to make a decision due to the fact that the Brubaker study had limitations and the panel had not seen the Yamanishi trial of 2000.

On the question of PFES compared with placebo for the indication of post-prostatectomy, Dr. Holtgrewe stated that the evidence was anecdotal and not scientific.

There was a negative vote on the question of the effectiveness of PFES compared to PMEs or alternative non-surgical techniques for the indication of stress incontinence. Dr. Landy stated that there may be efficacy in the use but there was only one trial to support it.

Dr. Hill thanked the panel members and invited them to send HCFA comments and suggestions on the questions developed by HCFA and the Executive Committee's interim recommendations for evaluating effectiveness and adequacy of evidence.

Adjournment. The meeting adjourned at 1:30 p.m.

I certify that I attended the meeting
of the Medical and Surgical Procedures Panel
on April 13, 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

Questions for panel

NOTE: The panel was asked to vote on the following sequence of questions during the final panel recommendations period.

Biofeedback for Urinary Incontinence

  1. Is the scientific evidence adequate to draw conclusions about the effectiveness of biofeedback as an adjunct to pelvic muscle exercises (PME) in routine clinical use in the Medicare populations for the following three indications: 1) stress incontinence, 2) urge incontinence, and 3) post-prostatectomy incontinence? 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?

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

  2. If the evidence is adequate to draw conclusions, what is the size, if any, of the overall health effect of the addition of biofeedback to PME compared to PME alone. Please place the size and direction of effectiveness into one of the seven categories listed in Attachment A.

Pelvic Floor Electrical Stimulation for Urinary Incontinence

  1. Is the scientific evidence adequate to draw conclusions about the effectiveness of:
    • PFES compared to placebo
    • PFES compared to pelvic muscle exercises (PME) or alternative non-surgical techniques
    • PFES + PME compared to PME alone

    in routine clinical use in the Medicare populations for the following three indications: 1) stress incontinence, 2) urge incontinence, and 3) post-prostatectomy incontinence? 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 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?

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

  2. If the evidence is adequate to draw conclusions, what is the size, if any, of the overall health effect of PFES compared to placebo for the treatment of urinary incontinence? Please place the size and direction of effectiveness into one of the seven categories listed in Attachment A.

  3. If the evidence is adequate to draw conclusions, what is the size, if any, of the overall health effect of PFES compared to pelvic muscle exercises (PME) or alternative non-surgical techniques for the treatment of urinary incontinence? (Refer to Attachment A)

  4. If the evidence is adequate to draw conclusions, what is the size, if any, of the overall health effect of the addition of PFES to PME compared to PME alone? (Refer to Attachment A)

Attachment A: Categories of Effectiveness

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

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

  3. 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.

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

  5. 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).

  6. 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.

  7. 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).


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