This national coverage determination was issued on September 15, 2004. The NCD establishes specific clinical indications under which CMS will cover FDG Positron Emission Tomography (FDG PET) imaging for Alzheimer’s disease and other identified neurodegenerative diseases.
CMS determined that such coverage must be provided in a protocol-driven clinical research study that meets the following criteria:
- Written protocol on file;
- Institutional Review Board review and approval;
- Scientific review and approval by two or more qualified individuals who are not part of the research team;
- Certification that investigators have not been disqualified.
Study Title: Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
Sponsor: University of California, Los Angeles
Clinicaltrials.gov Number: NCT00329706
CMS Approval Date: 05/24/2006