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.
September 12, 2012
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.
on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html
submit a comment, please use the orange "Comment" button at the top
of the page. Enter comments directly into the “Submit A Public Comment”
March 13, 2013
April 12, 2013
June 11, 2013