National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer



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. Sodium Fluoride F-18 (NaF-18) is a radioisotope commonly used in oncologic PET imaging procedures to detect bone metastasis in cancer and is the focus of this national coverage analysis.

The rate of NaF-18 uptake provides information on the tissues being studied. NaF-18 PET evaluation can indicate the probable presence or absence of bone metastasis based upon observed differences in biologic activity of adjacent tissues.

Section 220.6.19 of the National Coverage Determination (NCD) Manual establishes the requirement for prospective data collection under Coverage with Evidence Development (CED) for NaF-18 PET for bone metastasis in cancer.

The requestors have asked CMS to end the prospective data collection requirements under CED for use of NaF-18 PET (CAG-00065R) imaging in intended patient management.

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.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Bruce E. Hillner, MD, Chair, National Oncologic PET Registry View Letter
Barry A. Siegel, MD, Co-chair, National Oncologic PET Registry N/A
Anthony F. Shields, MD, Co-chair, National Oncologic PET Registry N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
03/16/2015 - 04/15/2015
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
09/16/2015 - 10/16/2015
Decision Memo Released
Comments for this NCA
View Public Comments


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

Medicare Benefit Category Determination Date

Actions Taken

March 16, 2015

CMS opens this reconsideration of Section 220.6 of the NCD on NaF-18 Positron Emission Tomography. 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:

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" webpage.

March 18, 2015

Due to technical difficulties, the comment submission button is currently inoperable. Please submit your comments via

September 16, 2015

December 15, 2015