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Centers for Medicare & Medicaid Services

MEDCAC Meeting 6/6/2000 - Urinary Incontinence (Executive Committee)

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 June 6, 2000 Meeting

The Baltimore Convention Center
One West Pratt Street
Baltimore, MD 21201

Chairperson: Harold C. Sox, MD
Vice-Chariperson: Robert H. Brook, MD, ScD
Executive Secretary: Constance A. Conrad, RN

8:00 - 8:30 am

Registration

8:30 - 8:35 am

Opening Remarks – Connie Conrad

Review of Comments on MCAC Interim Operating Procedures

8:35 - 8:50 am

Summary of MCAC Interim Operating Procedures Recommendations - Harold Sox, MD

8:50 - 9:00 am

HCFA Presentation

9:00 - 10:00 am

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.p

10:00-10:15

BREAK

10:15 - 11:00 am

Open Committee Deliberation

Public observers may not participate except at the specific request of the chariperson

11:00 - 11:15 am

Open Public Comments

11:15 - 11:30 am

Final Recommendations

11:30 - 12:45 pm

LUNCH (On Your Own)

Presentation and Review of Medical Surgical Procedures Panelp

12:45 - 1:00 pm

HCFA Presentation

1:00 - 1:15 pm

Report of the Chair - Alan Garber, MD, PhD

1:15 - 2:15 pm

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 tothe 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.

2:15 - 3:00 pm

Open Committee Deliberation

Public observers may not participate except at the specific request of the chairperson

3:00 - 3:10 pm

Open Public Comments

3:10 - 3:20 pm

Final Recommendations/Ratification

3:20 - 3:30 pm

HCFA Announcements/Information

Minutes of June 6, 2000 Meeting

Baltimore Convention Center
One West Pratt Street
Baltimore, Maryland

Attendees

Harold C. Sox, M.D.
Chairperson

Robert H. Brook, Ph.D.
Vice-Chairperson

Constance Conrad, R.N.
Executive Secretary

Voting Members
Thomas V. Holohan, M.D.,
Leslie P. Francis, J.D.
John H. Ferguson, M.D.
Robert L. Murray, Ph..D.
Alan M. Garber, M.D.
Michael D. Maves, M.D.
Frank J. Papatheofanis, M.D.
Ronald M. Davis, M.D.
Daisy Alford-Smith, Ph.D.
Joe W. Johnson, D.C.

HCFA Liaison
Hugh F. Hill, III, M.D.

Consumer Representative
Linda A. Bergthold, Ph.D.

Industry Representative
Randel E. Richner, M.P.H.

Tuesday, June 6, 2000, 8:35 a.m.

The Executive Committee of the Medicare Coverage Advisory Committee met on June 6, 2000, to discuss the MCAC Interim Operating Procedures and to review the recommendations of the Medical and Surgical Procedures panel coming from its April 12 and 13, 2000 meeting. The meeting began with the introduction of the Committee, a reading of the conflict of interest statement, and the call to order.

Summary of MCAC Interim Operating Procedures. The Chairperson summarized the Interim Operating Procedures document that was approved by the Executive Committee at their meeting of March 1, 2000.

HCFA Presentation. Dr. Hill informed the Executive Committee that the Agency had received many comments, that were collated in the operations procedures mailing sent to the Executive Committee members. Dr. Hill remarked that HCFA remains strongly supportive and very appreciative of the MCAC and Executive Committee work. He noted that a recurrent theme in correspondence was a question of whether HCFA wants the MCACs to provide specific coverage advice, but at present, HCFA is looking to the MCACs for recommendations relating to their analyses of scientific evidence. In response to comments received which suggest the MCAC and Executive Committee may be setting the evidentiary bar too high, Dr. Hill reiterated that the threshold determination for level of evidence, and the ultimate coverage decision, remains with HCFA. Finally, Dr. Hill advised the Executive Committee that HCFA had issued a Notice of Intent to publish a proposed rule, which the Executive Committee would not be specifically asked to respond to, but that the comment period on that notice had been extended, and comments from members of the Executive Committee would be welcomed and appreciated.

Remarks from Director, Office of Clinical Standards and Quality. Dr. Jeffrey L. Kang announced that Dr. Sean Tunis has been selected as the new director for the Coverage and Analysis Group, and thanked Dr. Hill for his service as acting director.

Dr. Kang stated that the period for comments on the Notice of Intent had been extended until mid-July and that HCFA was planning a town meeting to address the notice. He also informed the Executive Committee and the public that he is keenly aware of the interests in having the MCAC and panels give advice as to actual coverage as opposed to the narrow issue of evidence, and that broadening the scope of the MCAC and its panels would be one of the first issues addressed by Dr. Tunis.

Final Recommendations. It was moved and seconded that a methods subcommittee be established to deal with the current MCAC process, to include addressing modification of the interim procedures, interim recommendations, to assist in the formulation of questions from HCFA, and to discuss and develop procedures for the broader issues raised by an expanded assignment to give coverage advice to HCFA. Following discussion by the panelists, a vote was taken. The motion carried, with all voting members except Dr. Brook voting in the affirmative, and Dr. Brook abstaining.

Recess. The meeting recessed for lunch at 11:44 a.m., and resumed at 1:00 p.m.

Presentation and Review of the Medical and Surgical Procedures Panel. The Chairman informed the panelists that the afternoon would be spent discussing the panel’s recommendations regarding the treatment of urinary incontinence, from its April 12 and 13 panel meeting.

HCFA Presentation. Dr. Whyte explained how the topic of urinary incontinence was arrived at, how the two topics discussed at the panel were decided upon, the process used relating to the technology assessment, and the formulation of the assessment questions.

Report of the Chair. Dr. Alan Garber commented on his role in forming the questions presented to the panel, use of subject matter experts as reviewers for the panel, and his feelings regarding the panel’s deliberations. The panelists made a good faith effort to answer the questions that HCFA posed to the panel. They were free to consider all kinds of evidence and in fact, the evidence presented to them was not limited to controlled clinical trials. Following Dr. Garber’s comments, Dr. Michael Maves, vice-chair of the panel, spoke to the Executive Committee, concurring with Dr. Garber’s opinions.

Open Public Comments and Scheduled Commentaries. The panelists heard from four speakers, one representing a coalition of professional organizations, two representing firms involved in the manufacture of related devices, and an independent clinical consultant. All public speakers voiced the opinion that the panel had given too much weight to the Blue Cross/Blue Shield TEC report in their deliberations, and had discounted the evidence presented by clinicians and professional organizations. One speaker opined that if the panel’s recommendations were ratified and a national noncoverage policy were adopted, it would withdraw the coverage currently granted by 35 states for biofeedback treatment. Another speaker asked the Executive Committee not to use these therapies as the subject of experiments as the evolving coverage process within MCAC and HCFA matures.

Open Committee Discussion and Public Comments. The Chairman asked for a motion that the Committee could discuss and the public could comment on. Two motions were made and seconded:

One, that the Executive Committee ratify the recommendations of the panel.

Two, that the Executive Committee encourage HCFA to open a dialogue with appropriate funding agencies to discuss the need for good research on the treatment of incontinence, that would help inform future decisions and actions on Medicare coverage.

Following discussion by panelists, members of the public were given the opportunity to address the panel.

Final Recommendations and Ratification.

Following the open committee discussion and public comments, the first pending motion was voted on. The vote resulted in Dr. Brook being absent, Dr. Ferguson and Dr. Johnson voting in the negative, and the rest of the voting members voting in the affirmative. The motion carried.

Dr. Davis, based on the discussion and a suggestion from another panelist, amended his second motion, to read as follows: That the Executive Committee encourage HCFA to open a dialogue with appropriate funding agencies to discuss the need for support for good research on treatments for incontinence, to better inform future decisions by HCFA on Medicare coverage of those treatments. The motion carried on a unanimous vote of the members present, Dr. Brook still being absent.

HCFA Announcements/Information. Dr. Hill made announcements concerning future panel schedules, and informed the Executive Committee of different actions taken on prior panel findings.

Adjournment. The meeting adjourned at 3:15 p.m.

I certify that I attended the meeting
of the Executive Committee on
June 6, 2000, and that these
minutes accurately reflect what
transpired.
_________________________________
Constance Conrad
Executive Secretary, HCFA

I approve the minutes of this meeting
as recorded in this summary.
______________________________
Harold C. Sox, M.D.
Chairperson

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