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Centers for Medicare & Medicaid Services

MEDCAC Meeting 6/14/2001 - Ambulatory Blood Pressure Monitoring (Executive Committee)

Ambulatory blood pressure monitoring (ABPM) is a diagnostic test used to measure blood pressure when isolated clinical blood pressure measurements are suspected to be inaccurate. These suspected inaccuracies in blood pressure measurement generally only occur in defined populations. ABPM is conducted under the supervision of a physician and does not entail patient intervention; it is not considered a self-monitoring device. HCFA must evaluate whether current literature supports the clinical use of ABPM and whether or not ABPM is a "reasonable and necessary" for the Medicare population.

Federal Register Notice

Agenda for June 14, 2001 Meeting

8:00 AM - 4:00 PM
Baltimore Convention Center-Room 339

Harold C. Sox, M.D., Chairperson
Robert H. Brook, M.D., Vice Chairperson
Sean R. Tunis, M.D., M.Sc., Director, Coverage and Analysis Group
Constance A. Conrad, Executive Secretary

8:00 - 8:30 AM

Registration

8:30 - 8:35 AM

Opening Remarks - C.Conrad / S.Tunis

8:35 - 8:45 AM

Charge to the Committee - H.Sox


8:45 - 9:00 AM

HCFA Presentation on FDG-PET Alzheimer's disease and dementia

9:00- 9:45 AM

AHRQ Presentation

9:45- 10:15 AM

Scheduled public comments

10:15-10:30 AM

BREAK

10:30 - 11:15 AM

Committee Discussion

11:15 - 11:30 AM

Open Public Comments

11:30 - 12:15

Discussion and Conclusions

12:15 - 1:00 PM

LUNCH


1:00 - 1:15 PM

Summary of Medical Devices and Prosthetics Panel findings/Ambulatory Blood Pressure Monitoring - H. Sox, Chairman

1:15 -1:30 PM

Open Public Comments

1:30 - 2:15 PM

Discussion and Decision Concerning Panel findings

2:15 - 2:30 PM

BREAK


2:30 - 2:40 PM

Explanation of Recommendations for Evaluating Effectiveness that provide guidance to MCAC specialty panels-Methods Subgroup

2:40 - 3:10 PM

Scheduled public comments

3:10 - 3:30 PM

Discussion of Recommendations for Evaluating Effectiveness: scientific evidence and summary of practice guidelines


3:30- 4 PM

Future Role of the Executive Committee-S.Tunis nomination/ process and expertise needed

4:00 PM

ADJOURN

Minutes of June 14, 2001 Meeting

Baltimore Convention Center
One West Pratt Street
Baltimore, Maryland

Attendees

Harold C. Sox, M.D.
Chairperson

Constance Conrad
Executive Secretary

Voting Members
Leslie P. Francis, J.D.
Robert L. Murray, Ph.D.
Alan M. Garber, M.D.
Frank J. Papatheofanis, M.D.
Ronald M. Davis, M.D.
Joe W. Johnson, D.C.
Thomas Holohan, M.D.
Barbara J. McNeil, M.D.

HCFA Liaison
Sean R. Tunis, M.D.,M.Sc.

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

Thursday, June 14, 2001.

The Executive Committee of the Medicare Coverage Advisory Committee met on June 14, 2001, to discuss the framework to be used in the Technology Assessment (TA) commissioned by the Agency for Healthcare Research and Quality (AHRQ) to evaluate the available evidence for the use of FDG-PET in Alzheimer's disease and dementia; to ratify the findings of the MCAC Medical Devices and Prosthetics Panel on ambulatory blood pressure monitoring; review recommendations for evaluating effectiveness that provide guidance to MCAC specialty panels; and discuss the future role of the Executive Committee.

The meeting began with the introduction of the Committee, a reading of the conflict of interest statement, and the call to order.

Opening Remarks and Charge to the Executive Committee.    The Chairperson informed the Executive Committee that they would first discuss giving advice to HCFA and to the EPC that will prepare the evidence report for FDG-PET on Alzheimer's disease and other dementias, before the evidence report is performed. Second, the Executive Committee would hear a report from the Medical Devices and Prosthetics Panel about ambulatory blood pressure monitoring, and then vote to ratify that report. Third, the Executive Committee would go over the major changes to the interim guidelines for evaluating effectiveness, and to give the public an opportunity to comment on the changes. Finally, Dr. Tunis would present roles that HCFA is considering for the Executive Committee following the implementation of BIPA, and panelists' comments would be welcomed.

HCFA Presentation on FDG-PET in Alzheimer's disease and dementia.    Dr. Carlos Cano presented the Executive Committee with an overview of the history of the request for coverage of FDG-PET in the work-up for dementia, informed the Committee of the materials that had been provided prior to this meeting, and informed the Committee of the contents of the formal request to AHRQ. Following Dr. Cano's presentation, Dr. Tunis informed the Executive Committee that HCFA was seeking their advice concerning actual wording of the questions for AHRQ to submit to the Evidence-based Practice Center (EPC), as well as the possibility of broadening the questions to include other forms of neuroimaging.

AHRQ Presentation.   Dr. Deborah Zarin informed the committee that AHRQ would serve as a liaison to ensure that the EPC prepares a report that will be helpful to the Diagnostic Imaging panel and the Executive Committee in making their recommendations to HCFA. She went over the time line for consideration by the MCAC panel in November. Dr. Zarin then presented the committee with background on the diagnosis and treatment of dementia, the potential uses of PET, MCAC criteria for evaluating diagnostic tests, a proposed model for the EPC to use, and other issues for the MCAC to consider. The issues Dr. Zarin asked the committee to consider were: does MCAC agree with the basic broad approach proposed by AHRQ; how much consideration should be given to other diagnostic imaging procedures; what are acceptable reference standards when evaluating operating characteristics of these tests; and how should the psychological, legal or other consequences of different PET outcomes be considered.

Scheduled Public Comments.    The committee heard from Dr. Marilyn Albert, representing the National Alzheimer's Association. She gave the committee an overview of the current clinical practice related to dementia and Alzheimer's disease. She recommended that in considering the effectiveness of PET, it is important to evaluate whether the data come from unselected individuals or individuals selected according to the stage of their disease; she commented that most studies were of people who had been carefully screened. Dr. Albert also emphasized the importance of a reference standard for the diagnosis of Alzheimer's.

Committee Discussion.   Following the presentations by Dr. Zarin and Dr. Albert, the committee had extensive discussions, including questions for both Dr. Zarin and Dr. Albert. There were no formal motions made or votes taken, but the members of the Executive Committee voiced opinions resulting in the following consensus:

That the model proposed by AHRQ is consistent with the model adopted by the Executive Committee for the evaluation of diagnostic tests.

Following discussion by committee members, the chair asked members of the public to address the committee. No speakers chose to address the committee.

Following a break, Dr. Holohan commented on the clinical guidelines used by the VA to determine whether to offer PET as a diagnostic procedure in dementia. The committee asked that this guideline be sent to AHRQ for inclusion in the materials provided to the EPC. The committee discussed the need, called for in the interim guidelines, to involve two panel members in preparing the EPC report; the Chair commented that it was his understanding that the reviewers were to contact the EPC team during the review itself, an approach used by the U.S. Preventive Services task force with great success. Dr. Papatheofanis, the chair of the Diagnostic Imaging panel, stated he would try to implement that policy for this review.

Ratification of first Recommendation of Medical Devices and Prosthetics Panel.   Dr. Sox presented a summary of the panel's findings. Following discussion by the committee and comments from two public speakers, a committee member proposed an amendment to the first recommendation of the panel, so that it reads:

The Panel believes that the evidence from cross-sectional studies indicates that people with White Coat Hypertension (WC HTN) have intermediate harmful health outcomes (LV hypertrophy, nephropathy, retinopathy) compared with normotensive people. Although higher quality evidence (eg, RCTs) is lacking and data on true health outcomes (eg, mortality, CVD morbidity) are sparse and of relatively low quality, the Panel believes that the use of ABPM in diagnosing WC HTN can help guide individualized treatment of persons with WC HTN (eg, whether and when to initiate medication, deciding which medication(s) to use), which may in turn improve health outcomes. Therefore, the Panel supports ABPM for diagnosis of WC HTN in patients with suspected WC HTN when guidelines are developed for selecting patients for ABPM and managing WC HTN. The Panel recommends that studies be done to better define WC HTN and low-risk patients.

A motion to ratify the amended recommendation was seconded and approved unanimously.

Explanation of Recommendations for Evaluating Effectiveness that provide guidance to MCAC specialty panels.   Dr. Sox informed the Executive Committee and the public of the major changes made to the interim guidelines. These changes include insertion of a section on the evaluation of diagnostic tests; making some process changes to deal with the status of unpublished studies which are used by EPCs in evaluating technology; and, introduction of a section of what to do if the evidence is inadequate. The comments from the public and Executive Committee members generally supported the changes.

Ratification of final two Recommendations of Medical Devices and Prosthetics Panel.   Dr. Sox informed the Executive Committee of the rationale behind the Medical Devices and Prosthetics Panel's last two recommendations on Ambulatory Blood Pressure Monitoring (ABPM), which were:

The evidence is inadequate to determine the effect of using APBM monitoring in patients with treatment-resistant hypertension. And,

The evidence is inadequate to determine the effect of using ABPM monitoring in patients with symptoms of low blood pressure on medication.

A motion was made, seconded and unanimously approved to ratify those two recommendations.

Future Role of the Executive Committee. Dr. Tunis informed the members that because Dr. Sox has accepted a position as the Editor of the Annals of Internal Medicine, he would be resigning as the chairperson of the Medical Devices and Prosthetics Panel, but would remain as the Chairman of the Executive Committee. Dr. Tunis further informed those present that Dr. Ronald Davis had agreed to assume the position as chairperson of that panel, and Dr. Wade Aubry will be the vice chair.

Dr. Tunis outlined the following seven functions that HCFA expects the Executive Committee to perform once the BIPA legislation takes effect:

  1. Continue to discuss recommendations of MCAC specialty panels but without formally ratifying them.
  2. Continue to work on needed updates or improvements to the recommendations for evaluating clinical effectiveness.
  3. Provide a forum for discussing overarching technical issues that may arise in the context of one technology but have applications to a number of technologies.
  4. Discuss complicated social, ethical, legal and allocation issues, not in the context of coverage policy, but as a general forum.
  5. Horizon scanning for new technologies.
  6. Identifying critical research priorities for evaluating health technologies.
  7. Help the Centers for Medicare and Medicaid (CMS), formerly HCFA, to develop questions for complicated technology assessments.

The Executive Committee felt that these suggested topics are appropriate for the Executive Committee, and that it should remain available to serve HCFA in whatever areas the Agency needs advice or service.

Terms of Service of Executive Committee Members.   Dr. Sox informed the Executive Committee that Connie Conrad would be stepping down and leaving Federal Service possibly prior to the next Executive Committee meeting. Following a question from a panelist, Ms. Conrad said she would provide a current list of expiration dates of each member's term, some of which have expired, although under the charter, an individual member's term continues until a replacement is named.

Adjournment.   The meeting was adjourned at 3:38 p.m.

I certify that I attended the meeting
of the Executive Committee on
June 14, 2001, 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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