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National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R4)

Positron emission tomography (PET) is a minimally-invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues in the human body. Images are obtained by processing of emissions from positron-emitting radioisotopes that are usually administered intravenously. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is a radioisotope commonly used in oncologic PET imaging procedures and is the focus of this national coverage analysis.

The rate of FDG decay provides information on glucose metabolism of tissues being studied. As malignancies can cause abnormalities of glucose metabolism, FDG PET evaluation can indicate the probable presence or absence of malignancy based upon observed differences in biologic activity of adjacent tissues.

Section 220.6 of the National Coverage Determination (NCD) Manual establishes the requirement for prospective data collection under Coverage with Evidence Development (CED) for FDG PET used in the subsequent treatment strategy (i.e., restaging and monitoring response to treatment) of various cancers.

The requestors have asked CMS to end the remaining prospective data collection requirements under CED for all oncologic uses of FDG PET imaging.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

Diagnostic Tests (other)
Requestor Name(s)Bruce E. Hillner, MD, Chair, National Oncologic PET Registry; Barry A. Siegel, MD, Co-chair, National Oncologic PET Registry; Anthony F. Shields, MD, Co-chair, National Oncologic PET Registry
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated09/12/2012
Expected NCA Completion Date06/11/2013
Public Comment Period09/12/2012 - 10/12/2012
Proposed Decision Memo Released03/13/2013
Proposed Decision Memo Public Comment Period: 03/13/2013 - 04/12/2013 
Due to technical difficulties, the comment period has been extended. No comments will be accepted after 12:01 am on April 14.
Decision Memo Released06/11/2013
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • Jeffrey Roche, MD, MPH

September 12, 2012

CMS opens this reconsideration of Section 220.6 of the NCD on Positron Emission Tomography (FDG). The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” form.

March 13, 2013

April 12, 2013

Comment period extended due to technical difficulties.

June 11, 2013

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