National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography for Initial Treatment Strategy in Solid Tumors and Myeloma



Positron emission tomography (PET) is a non-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. The radioisotope commonly used in oncologic PET imaging procedures is 2-[F18] fluoro-2-deoxy-D-glucose (FDG).

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 as indicated by the glucose metabolism of adjacent tissues.

Section 220.6.17 of the National Coverage Determination (NCD) Manual establishes coverage for only one FDG PET scan for guiding initial antitumor treatment strategy for beneficiaries who have solid tumors and myeloma that are biopsy proven or strongly suspected of being cancer based on other diagnostic testing, when the beneficiary's treating physician determines that the FDG PET study is needed to determine the location and/or extent of tumor for various therapeutic purposes.

The requestors have asked CMS to reconsider Section 220.6.17 to remove the restriction that only one FDG PET scan may be performed as part of guiding the initial antitumor treatment strategy.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
See Actions Taken View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
11/09/2009 - 12/09/2009
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
05/06/2010 - 06/05/2010
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Stuart Caplan, RN, MAS
Lead Medical Officers
Jeffrey Roche, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

November 9, 2009


Timothy J. McCarthy, PhD
Academy of Molecular Imaging

Harvey L. Neiman, MD, FACR
Executive Director
American College of Radiology

Laura I. Thevenot, CAE
Chief Executive Officer
American Society for Therapeutic Radiology and Oncology

Jay A. Harolds, MD, FACNP
American College of Nuclear Medicine

Michael M. Graham, PhD, MD
President Society of Nuclear Medicine

CMS initiates this national coverage analysis. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.

CMS is requesting public comment on the health benefit outcomes of performing more than one PET scan as part of the initial antitumor treatment strategy for solid tumors and myeloma in the Medicare population.

CMS considers all public comments, and is particularly interested in comments regarding clinical studies and other scientific information about the technology under review and the short and long term outcomes.

Instructions on submitting public comments can be found at You can also submit a public comment by clicking on the highlighted word COMMENT in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

May 6, 2010

CMS posts the Proposed Decision Memorandum. The 30-day public comment period on the proposed decision begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in new evidence relevant to the technology under review.

Instructions on submitting comments can be found at

August 4, 2010