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.
There has been a formal request for reconsideration of FDG PET for broad coverage of all oncological indications, heart disease, and neurological disorders. Evidence that supports FDG PET broad-based coverage has been submitted to the Health Care Financing Administration (HCFA).
HCFA must evaluate whether the current empirical scientific literature and the potential value of PET in clinical practice supports that FDG PET is a "reasonable and necessary" diagnostic imaging procedure for all cancers, heart diseases, and neurological disorders.
July 10, 2000
July 21, 2000
August 7, 2000
August 15, 2000
September 26, 2000
October 17, 2000
Referred to the Medicare Coverage Advisory Committee (MCAC) for further consideration by the Executive Committee on November 7. Internal review of the data and the EPC report raise concerns about methodological limitations in the empirical scientific evidence provided, however, HCFA is aware of the clinical and theoretical support for expanded coverage within the imaging community. Given this difference of opinion, HCFA would like input from the MCAC. Current members of the MCAC are Harold C. Sox, MD (Chairperson); Thomas V. Holohan, MD (FACP); Leslie P. Francis, JD, PhD; John H. Ferguson, MD; Robert L. Murray, PhD; Alan M. Garber, MD, PhD; Michael D. Maves, MD, MBA; Frank J. Papatheofanis, MD, PhD; Ronald M. Davis, MD; Daisy Alford-Smith, PhD; Joe W. Johnson, DC; Robert H. Brook, MD, ScD; Linda A. Bergthold, PhD; Randel E. Richner, MPH. To augment the panel's consideration of PET coverage issues, HCFA has asked Dr. Richard Klausner, Director of the National Cancer Institute (NCI) to designate a representative to participate in the MCAC review. Dr. Ellen Feigal, Deputy Director of the Division of Cancer Treatment and Diagnosis of the NCI, will serve as the NCI representative. Prior to the MCAC meeting, the requestors are encouraged to respond to the issues identified in the EPC report and to work with HCFA staff in formulating the questions to be considered by the MCAC. After receiving the input of the MCAC, HCFA will make a coverage decision by December 15, 2000.
The initial coverage request and the EPC report are available upon request. You may contact Mary Stojak of HCFA at (410) 786-6939.
December 15, 2000