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. An injected radioactive tracer gives 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. Certain tracers allow for imaging of beta-amyloid plaques in the brain of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes cognitive decline.
Section 220.6 of the National Coverage Determination Manual identifies ammonia N-13, fluorodeoxyglucose F-18, rubidium Rb-82 and sodium fluoride F-18 as the only nationally covered radioisotopes for certain defined uses in PET. Certain uses of PET with these radioisotopes are covered only when performed under Coverage with Evidence Development (CED) in clinical studies. 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 Eli Lilly and Company that coverage for PET tracers be expanded to include those agents that image beta-amyloid plaques in the context of the diagnosis of dementia.
CMS is soliciting public comment relevant to this request. We are particularly interested in comments that include scientific evidence.
