Dear Dr. Roche and Mr. Caplan:
As a practicing clinician with two decades of experience working with advanced imaging technologies, I write in strong support of lifting the national non-coverage language for new FDA approved PET diagnostic radiopharmaceuticals. For more than a decade now, significant data has been accumulated to demonstrate the clinical accuracy of FDG-PET and its impact on patient management.
There is increased urgency for CMS to act given the recent FDA approval of florbetapir injection for PET imaging of patients with cognitive impairment who are being evaluated for Alzheimer's disease. Amyloid deposition in the brain is one of the most important pathological hallmarks of Alzheimer's disease. Following the FDA approval, there is a high level of public and professional interest in amyloid imaging.
Johannes Czernin, M.D.
UCLA Medical Center