National Coverage Analysis (NCA) Tracking Sheet

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.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Internally generated following University of California at Los Angeles (UCLA), School of Medicine initial request for broad coverage of FDG-PET N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
01/15/2001 - 02/14/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released


Lead Analysts
Mary Stojak
Stuart Caplan, RN, MAS
Lead Medical Officers
Mitchell Burken, MD

Medicare Benefit Category Determination Date

Actions Taken

March 7, 2001

Referred for technology assessment. HCFA expects to receive the finished technology assessment the end of May and present the issue to the MCAC Diagnostic Imaging Panel  on June 19, 2001.

May 30, 2001

Technology Assessment  and Questions posed to the MCAC for the June panel meeting posted.

June 19, 2001

Revised version of the Technology Assessment posted. This revised version incorporates late comments received from an external reviewer. The revisions do not change the substantive findings of the report.

June 19, 2001

MCAC Diagnostic Imaging Panel deliberated on the issue and made recommendation to be referred to the MCAC Executive Committee  for review.

December 17, 2001

MCAC Executive Committee Minutes received November 30, 2001. New due date: January 20, 2002.

February 5, 2002

The decision memorandum is complete. Awaiting final clearance. New due date: February 28, 2002.

February 27, 2002

The Decision Memorandum  posted.

May 2, 2002

Claims processing instructions issued and NCD updated