Minutes of February 21, 2001 Meeting
OPEN SESSION
Baltimore Convention center
Baltimore, Maryland
Attendees
Harold C. Sox
Chairperson
Patricia Brocato-Simons
Executive Secretary
Voting Members
Willarda V. Edwards
Karl A. Matuszewski
Wade M. Aubry
Temporary Voting Member
Kenneth P. Brin
Temporary Nonvoting Guest
Parker J. Staples
Consumer Representative
Christine M. Grant
Industry Representative
Eileen C. Helzner
HCFA Representative
Sean R. Tunis
Wednesday, February 21, 2001, 8:30 a.m.
The Medical Devices and Prosthetics Panel (Panel), of the Medicare Coverage Advisory Committee (MCAC), met on February 21, 2001, to discuss the use of ambulatory blood pressure monitoring (ABPM). The meeting began with a reading of the conflict of interest statement, and the call to order.
Charge to Committee. Dr. Harold Sox, Panel chairperson, presented the charge to the Committee, to advise the Health Care Financing Administration (HCFA) on the quality of evidence concerning the use of ABPM for patients with white coat hypertension (WCH), patients with symptoms of low blood pressure while on treatment, and patients with treatment-resistant hypertension. Dr. Sox also presented an analytical framework proposed for use in guiding the Panel discussions.
Overview of ABPM. Dr. Thomas Pickering, American College of Cardiology (ACC), presented the Panel with an overview of the clinical use of ABPM, including definitions of WCH and white coat hypotensive. Following his presentation, Dr. Pickering fielded a number of questions from the Panel.
HCFA Presentation. Ms. Poppy Rotter, HCFA, explained the information presented to the panelists in their review packets, and encouraged the Panel to note that although there may be consistencies between position and consensus statements concerning the general use of ABPM, there is a lack of information as to for whom and exactly how the procedure should be used.
Scheduled Public Comments. Dr. Frank Lefevre, Blue Cross/Blue Shield Association Technology Evaluation center (BCBSA/TEC) presented an overview of its assessment. A total of 18 studies were included in the assessment, all of which were cross-sectional. The conclusion of the assessment was that white coat hypertensives do have a risk profile that differs from normotensives, but the magnitude of increased risk is undefined, and prospective studies would be helpful.
Mr. Wayne Powell, ACC, and Ms. Sandy Sherman, American Medical Association (AMA), presented statements reflecting their groups’ opinions. The ACC position is that it believes the use of ABPM is supported by evidence for the evaluation of patients with suspected WCH, evaluation of clinically normotensive patients with evidence of hypertension related to target organ damage, and evaluation of autonomic dysfunction. The AMA encouraged the Panel to give serious consideration to Spacelabs, Inc.’s request and the corresponding ACC letter of support.
Dr. Grant Bagley, Arnold & Porter, presented a statement supporting the use of ABPM, and encouraging the Panel to consider the data from the Syst-Eur study and the NIH-VI report, neither of which were included in the BCBSA/TEC assessment.
Four individuals who utilized ABPM as part of their treatment regimens addressed the Panel concerning their personal experiences. All of them commented that ABPM was of great medical benefit to their treating physicians in controlling their hypertension symptoms.
Dr. William White, University of Connecticut, spoke to the Panel. He supported the use of ABPM for assessment of patients for WCH, those with borderline hypertension with target organ damage, treated hypertension patients with resistance to anti-hypertension medication, and those who are symptomatic.
Dr. Stephen Northrup, Medical Device Manufacturer’s Association, urged the Panel to look at the broad range of evidence on ABPM and not restrict themselves to the published evidence alone.
Open Panel Discussion. After Dr. Sox presented a framework for evaluating ABPM, the Panel discussed the use of ABPM to confirm WCH, and the potential effect on health outcomes, if any. Most of the evidence consists of studies which evaluate the degree of left ventricular hypertrophy (and other markers of left ventricular function) in patients with WCH, normotensives, and patients with sustained hypertension. These intermediate outcomes predict cardiovascular disease endpoints in patients with sustained hypertension. Left ventricular function in patients with WCH is intermediate between normotensives and patients with sustained hypertension. Thus, WCH is not an innocuous condition, at least for some patients.
There is no satisfactory body of evidence about the effect of treating WCH, and therefore, no empirical basis for deciding which patients require treatment. Consequently, although ABPM is useful in defining a group of hypertensive patients who may require different treatment goals than sustained hypertensives, there is not as yet a satisfactory body of evidence to guide further management or to conclude that treatment alters cardiovascular outcomes.
The Panel agreed that the evidence was much weaker for the use of ABPM in patients with symptoms of low blood pressure while on treatment, and for patients with treatment-resistant hypertension.
Unscheduled Public Comments. The Panel heard additional comments from four individuals who commented earlier in the day.
Final Panel Recommendations. The Panel voted, and unanimously approved, the following statement and recommendations: "The Panel believes the evidence from cross-sectional studies indicates that people with WCH have intermediate harmful health outcomes (left ventricular hypertrophy, nephropathy, retinopathy) compared with normotensive people. Although higher quality evidence (e.g., randomized control trials) is lacking and data on true health outcomes (e.g., mortality, cardiovascular disease morbidity) are sparse and of relatively low quality, the Panel believes the use of ABPM in diagnosing WCH can help guide individualized treatment of persons with WCH (e.g., whether and when to initiate medication, deciding which medication(s) to use), which may in turn improve overall health outcomes. Therefore, the Panel supports ABPM for diagnosis of WCH in patients with suspected WCH, if guidelines are developed for selecting patients for ABPM and managing WCH. The Panel recommends that studies be performed to better define WCH and low-risk patients."
The individual panelists, including nonvoting members and guests, stated their reasons for supporting the vote.
The Panel agreed that it had not been presented with evidence to consider concerning the use of ABPM in sorting out symptoms of low blood pressure in patients on treatment. Therefore, the Panel did not take a formal vote on that issue.
Dr. Willarda Edwards left the meeting early, and Dr. Harold Sox participated in the remaining vote in order to ensure a quorum.
The Panel voted, and unanimously approved, the following statement and recommendation: The Panel believes the evidence is inadequate to make a clear judgment about the use of ABPM in the management of treatment-resistant hypertension.
HCFA Announcements/Adjournment. Dr. Sean Tunis, HCFA, announced a meeting of the Executive Committee for February 22, 2001. He also noted that as of
October 2001, MCAC medical specialty panels would be empowered to make recommendations directly to HCFA without prior EC ratification. Until that time, the EC will continue to ratify Panel recommendations.
The meeting adjourned at 3:43 p.m.
I certify that I attended the meeting of
the Medical Devices and Prosthetics Panel
on February 21, 2001, and that the above minutes
accurately reflect what transpired.
_________________________________
Patricia Brocato-Simons
Executive Secretary
I approve the minutes of the February 21, 2001,
meeting of the Medical Devices and Prosthetics
Panel as recorded in the above minutes.
______________________________
Harold C. Sox, M.D.
Chairperson
