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National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (FDG) (CAG-00065N)

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.

Diagnostic Tests (other)
Requestor Name(s)University of California Los Angeles (UCLA), School of Medicine
Formal Request Accepted and Review Initiated07/10/2000
Expected NCA Completion Date12/15/2000
Public Comment Period08/10/2000 - 09/10/2000
Decision Memo Released12/15/2000
Lead Analyst(s)
  • Mary Stojak
  • Samantha Richardson

July 10, 2000

Accepted formal consideration request

July 21, 2000

HCFA Staff met with the Agency for Health Research and Quality (AHRQ) staff to discuss utilizing their assistance to review the large packet of evidence sent by UCLA School of Medicine.

August 7, 2000

HCFA staff met with National Cancer Institute (NCI) to discuss advancements in FDG PET.

August 15, 2000

HCFA sent literature to AHRQ for assistance with the evidence review.
  • Development of diagnostic test review criteria
  • Complete current literature review from 1990 - present
Note: AHRQ referred request to New England Medical Center Evidence-Based Practice Center (EPC).

September 26, 2000

Received New England Medical Center EPC report concerning PET request. The EPC report identifies significant limitations in the empirical evidence submitted on the performance and clinical utility of PET for all indications that are currently not covered.

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

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