Positron Emission Tomography (PET) is a minimally invasive diagnostic imaging procedure used to evaluate normal tissue as well as 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 of cognitive decline.
Currently NCD 220.6.20 covers one PET amyloid-beta (Aß) scan per patient in CMS approved studies under coverage with evidence development (CED).
CMS internally generated the opening of this NCD analysis based on stakeholder feedback, including public comments received during the finalization of the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305) because clinical study protocols may involve more than one PET Aß scan per patient.
The purpose of this NCD reconsideration is to determine if the current policy of one scan per patient per lifetime should be revised.
