MEDCAC Meeting

Positron Emission Tomography (FDG) for Alzheimer's Disease/Dementia (Executive Committee)


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Positron emission tomography (PET) is a non-invasive imaging procedure used for measuring the concentrations of positron-emitting radioisotopes within the tissue of living subjects. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is a radiopharmaceutical that is attracted to higher areas of metabolism. On December 15, 2001, CMS published a Decision Memorandum on a request for broad coverage (CAG-00065) of all oncological indications, heart disease, and neurological disorders. The December 15th decision memorandum stated that CMS had insufficient evidence to support coverage for the indication of Alzheimer's disease/dementia at that time but would refer the issue to MCAC.

Actions Taken


Agenda for April 16, 2002 Meeting

8:00 AM - 3:30 PM
Baltimore Convention Center- Rooms 321-322

Harold C. Sox, M.D., Chairperson
Robert H. Brook, M.D., Vice Chairperson
Sean R. Tunis, MD, MSc, Director, Coverage and Analysis Group
Janet A. Anderson, Executive Secretary

8:00 - 8:30 AM


8:30 - 8:35 AM

Opening Remarks - J. Anderson / S.Tunis

8:35 - 8:45 AM

Charge to the Committee - H.Sox

8:45 - 9:10 AM

Summary of Diagnostic Imaging (DI) panel findings
FDG Positron Emission Tomography (PET) imaging for diagnosis and patient management of Alzheimer's Disease
Frank Papatheofanis, M.D., Chairperson DI panel
Barbara McNeil, M.D., Vice-Chairperson DI panel

9:10 - 10:00 AM

Scheduled Public Comments

10:00 - 10:15 AM

Open Public Comments

10:15 - 10:30 AM


10:30 - 11:30 AM

Discussion and Vote concerning DI panel findings

11:30 - 12:30 PM


12:30 - 12:45 PM

Use of decision modeling in coverage policy (Introduction)- H. Sox

12:45 - 1:05 PM

Decision Modeling in policy-making - General Observations - David Matchar, M.D.

1:15 - 1:45 PM

Open Public Comments

1:45 - 2:45 PM

Committee Discussion on Decision Modeling

2:45 - 3:30 PM

Proposed changes to discussion and voting questions for MCAC panels - S. Tunis/ Perry Bridger

3:30 PM



Minutes of April 16, 2002 Meeting

Baltimore Convention Center
100 W. Pratt Street
Baltimore, Maryland


Harold C. Sox, M.D.

Robert H. Brook, M.D.
Vice Chair (voting)

Janet Anderson
Executive Secretary

Voting Members

Leslie P. Francis, J.D.
John H. Ferguson, M.D.
Alan M. Garber, M.D.
Frank J. Papatheofanis, M.D.
Thomas Holohan, M.D.
Barbara J. McNeil, M.D.
Daisy Alford-Smith, Ph.D.
Wade Aubry, M.D.

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

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

Consumer Representative
Linda Bergthold, Ph.D.

Tuesday, April 16, 2001. The Executive Committee (EC) of the Medicare Coverage Advisory Committee (MCAC) met on April 16, 2002, to act upon the findings of the MCAC Diagnostic Imaging (DI) Panel on FDG-PET imaging for diagnosis and patient management of Alzheimer’s disease (AD); to discuss the use of decision modeling in policy-making; and to discuss proposed changes to questions presented to MCAC panels.

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

Review of the Recommendations of DI Panel. Before hearing the summary of the January 10, 2002 meeting from the DI Panel chair and co-chair, Dr. Sox informed the committee that the EC’s purpose was not to question the panel’s review of the evidence, but to determine whether the process used by the panel was consistent with MCAC process as set forth in the guidelines for evaluating effectiveness. Frank Papatheofanis, M.D. and Barbara McNeil, M.D. presented the EC a summary of the panel’s recommendations, including what they perceived to be some of the thoughts that went into the reconstruction of the voting question from that which was originally presented to the panel by CMS. The DI panel chair noted that the meeting minutes detail the reasons for the change in wording of the voting question and that these minutes are available to the public.

Scheduled Public and Open Comments. The committee heard comments from five scheduled public speakers, after which three members of the public also addressed the panel. The scheduled public speakers were: Gary Small, M.D.; Dan Silverman, M.D.; Kirk Frey, M.D.; Peter Conti, M.D.; and Marilyn Albert, M.D.

Action of the Executive Committee on the DI Panel Recommendations. During discussion, the chair and co-chair of the DI Panel stated their opinions that in the revised language voted upon by the panel, the phrase possible or probable AD included the four scenarios expressed by Gary Small, M.D. and others concerning suspected AD. Dan Silverman, M.D. asserted that this still leaves out of consideration those who have dementia but don’t have possible or probable AD under current American Academy of Neurology (AAN) guidelines, and explicitly does not include people who have age associated memory impairment and so forth. During an ensuing discussion, Dr. McNeil and Dr. Papatheofanis reiterated that the intent of the committee was to conclude that there was not adequate evidence to show that there was a benefit to having a PET scan in patients with either mild cognitive impairment or probable or possible Alzheimer’s disease. Following the discussion, each member of the Executive Committee voiced their individual feelings about the issue before the committee.

A motion was then made by Tom Holohan, M.D. and seconded by Daisy Alford-Smith, Ph.D. to “accept the recommendations of the Diagnostic Imaging Panel regarding the use of positron emission tomography (PET) for the diagnosis and patient management of Alzheimer’s disease and other dementias.” The motion passed unanimously with no abstentions.

Use of Decision Modeling in Coverage Policy

Hal Sox, M.D. opened the discussion of decision modeling use in policy decisions with an introductory presentation on analytic decision-making. David Matchar, M.D. then presented a more comprehensive summary of ways to use decision modeling in reaching or recommending clinical health policy decisions. Following the two presentations, the Executive Committee held a discussion that generated a consensus that quantitative decision modeling is a tool that the MCAC should have available when needed in reaching their coverage recommendations. The panel also expressed the opinion that the decision to use models should be made on a case-by-case basis. Members also expressed the opinion that modeling could be used early in a device or technology’s development so that the developers would know what types of data will be most important to capture from clinical trials, thereby enhancing the value of the clinical evidence needed for making coverage recommendations. Members also voiced the opinion that decision models should not replace well-designed clinical trials when those trials are feasible. The members warned against an over-reliance on decision modeling which could result in researchers using modeling instead of conducting valuable research trials. Two members of the public commented that it is their hope that MCAC will somehow integrate the use of analytic decision modeling into their evaluation and recommendation process.

Proposed Changes to Discussion and Voting Questions for MCAC Panels. Sean Tunis, M.D. invited the committee to comment concerning changes to the formation of questions for the panels. Following discussion by the committee, Dr. Tunis said that he may reconvene the methods study group to make a recommendation to be voted on by the Executive Committee on these issues.

Remarks of Jeffrey Kang, M.D.. Jeffrey Kang, M.D., Director of the Office of Clinical Standards and Quality, thanked the committee for their work, and informed them that he would be leaving his post at CMS as of May 3rd.

Adjournment. The meeting adjourned at 3:16 p.m.

I certify that I attended the meeting
of the Executive Committee on
April 16, 2002, and that these
minutes accurately reflect what
Janet Anderson
Executive Secretary
I approve the minutes of this meeting
as recorded in this summary.
Harold C. Sox, M.D.

Panel Voting Questions

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