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National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (CAG-00065R2)

PET is a minimally-invasive diagnostic imaging procedure used to evaluate normal tissue as well as in diseased tissues in conditions such as cancer, ischemic heart disease, and some neurologic disorders. Injected radioactive tracers give off subatomic particles, known as positrons, as they decay. PET uses a positron camera (tomograph) to measure the decay of these radioisotopes. The rate of tracer decay provides biochemical information on the tissue being studied.

Section 220.6 of the National Coverage Determination Manual identifies fluorodeoxyglucose F-18, rubidium Rb-82, ammonia N-13, and sodium fluoride F-18 as the only nationally covered radioisotopes for certain defined uses in PET. Certain other uses of PET with these radioisotopes are covered only when furnished in clinical studies under Coverage with Evidence Development (CED) or are specifically nationally noncovered. All remaining uses of PET are nationally noncovered. CMS is reconsidering Section 220.6 of the National Coverage Determination (NCD) Manual pursuant to a request from the Medical Imaging & Technology Alliance that coverage of these remaining uses of PET be determined locally by Medicare Administrative Contractors (MACs) when PET is furnished with new FDA approved radioisotopes, including those that may be approved by FDA in the future.

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. We remind the reader that local determination of coverage would not preclude CMS from accepting internal or external requests to open a national coverage analysis (NCA) on any uses of PET.

Diagnostic Tests (other)
Requestor Name(s)Medical Imaging & Technology Alliance
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated07/11/2012
Expected NCA Completion Date03/13/2013
Public Comment Period07/11/2012 - 08/10/2012
Proposed Decision Memo Released12/13/2012
Proposed Decision Memo Public Comment Period: 12/13/2012 - 01/12/2013 
Decision Memo Released03/07/2013
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • Jeffrey Roche MD, MPH

July 11, 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" webpage.

December 13, 2012

March 7, 2013

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