Positron Emission Tomography

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.

July 11, 2012

December 13, 2012

March 7, 2013