Levocarnitine for End Stage Renal Disease & Positron Emission Tomography (FDG) for Breast Cancer (Executive Committee)

Levocarnitine for End Stage Renal Disease

Carnitine is an endogenous molecule that serves as a carrier in the transport of long-chain fatty acids across the inner mitochrondrial membrane, facilitating oxidation and energy production. Dialytic losses, combined with reduced renal synthesis and reduced intake of meat and dairy products, can cause carnitine deficiency in end stage renal disease (ESRD) patients. Levocarnitine injection has been approved by the Food and Drug Administration (FDA) for the "prevention and treatment of carnitine deficiency in ESRD patients who are undergoing dialysis. Levocarnitine injection was first approved by the in FDA 1992. The FDA approved the drug's indication for ESRD patients on December 15, 1999. Given inconsistencies among the fiscal intermediaries' local coverage policies for this drug, the Centers for Medicare and Medicaid Services (CMS) believes a national review is appropriate. Among other issues, CMS plans to examine, in this review, the clinical significance of carnitine deficiency and the issue of intravenous administration of carnitine supplementation versus oral administration.

Positron Emission Tomography (FDG) for Breast Cancer

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, 2000, HCFA 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 HCFA had insufficient evidence to support coverage for the indication of breast cancer at that time but would refer the issue to MCAC.

Minutes of October 17, 2001 Meeting

Attendees

Harold C. Sox, M.D.
Chairperson

Janet Anderson
Executive Secretary

Voting Members
Leslie P. Francis, M.D.
Robert L. Murray, Ph..D.
Alan M. Garber, M.D.
Joe W. Johnson, D.C.
Thomas Holohan, M.D.
Barbara J. McNeil, M.D.
Daisy Alford-Smith, Ph.D.
Wade Aubry, M.D.
Robert H. Brook, M.D.
John Ferguson, M.D.
Michael D. Maves, M.D.

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

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

Consumer Representative
Linda Bergthold, Ph.D.

Wednesday, October 17, 2001.

The Executive Committee of the Medicare Coverage Advisory Committee met on October 17, 2001, to ratify the findings of the MCAC Diagnostic Imaging Panel on FDG PET imaging for breast cancer diagnosis and staging; to ratify the findings of the MCAC Drugs, Biologics and Therapeutics Panel on levocarnitine injection for end-stage renal disease; to discuss the summary of CMS/NCI diagnostic imagining workshop; and to discuss other MCAC business.

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

Ratification of Recommendations of Diagnostic Imaging Panel. Barbara McNeil, M.D. presented the Executive Committee a summary of the panel's recommendations, including a summary of the discussions that went into their findings. Following extensive discussion by the committee and comments from public speakers, the Executive Committee took the following action: A motion was made to approve all recommendations of the Diagnostic Imaging Panel except number 4, and amend the question recommendation relative to question number 4 to state, "is it likely that PET improves health outcomes when used as an adjunct to standard staging tests in detecting locoregional recurrence or distant metastases recurrence for some patients when results from other tests are inconclusive." The motion passed unanimously, with one abstention.

Ratification of Recommendations of Drugs, Biologics and Therapeutics Panel. Thomas Holohan, M.D. presented the Executive Committee a summary of the panel's recommendations about levocarntine in chronic renal failure, including a summary of the discussion that led to the panels' findings. Following extensive committee discussion, with input from the public, the Executive Committee voted on the following motion: To approve the three recommendations of the Drugs, Biologics and Therapeutics Committee. The motion was passed unanimously.

Summary of CMS/NCI Diagnostics Imaging Workshop Following lunch, Dr. Tunis and Dr. Ellen Feigal reported on an interagency workshop convened jointly by CMS and NCI to discuss possible alternative approaches to evaluating diagnostic imaging tests, including modeling. Dr. Sox and Dr. Garber, who had attended the workshop, offered their comments. Following extensive discussion, it was the consensus of the Executive Committee that the committee should, by the next meeting, identity an issue that they would like to use in a decision modeling exercise. Interested members of the committee, especially those with analytic modeling expertise, would then proceed with the exercise and report the results to the committee at a later date.

Other MCAC Business. Dr. Tunis informed the panelists of several issues.

First, he reminded the panelists that they are under no obligation as an MCAC member to take any phone calls or respond to any letters promoting a particular position, whether from industry or other parties. Panelists were welcome to respond to phone calls and inquiries but are under no obligation to do so. Ms. Richner offered the option, for calls from industry, to refer them to the industry representative.

Second, the only topic that is scheduled to go to a panel at this time will be the FDG Positron Emission Tomography and other neuroimaging for Alzheimer's/Dementia which is scheduled for consideration by the Diagnostic Imaging panel on January 10, 2002.

Third, Dr. Tunis invited EC member input for the new Federal Register notice describing the MCAC process. Finally, he mentioned that CMS is considering restructuring the panels, specifically reducing the numbers of panels, having a pool of members who would be invited to participate in meetings based on expertise related to the issue before the panel, and adding more methodologists to the panels.

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

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