September 16, 2004
The following is a summary of the coverage criteria/guidelines posted by the Centers for Medicare & Medicaid Services (CMS) in their "Decision Memorandum for Positron Emission Tomography and Other Neuroimaging Devices for Suspected Dementia." While the coverage decision memorandum did not specifically state the implementation date, the SNM contacted CMS official Stuart Caplan who confirmed an implementation date effective with the publication of the decision memorandum, September 15, 2004.
CMS has made the following determinations regarding the use of FDG-PET in the diagnosis and treatment of mild cognitive impairment (MCI) and early dementia in elderly patients:
1) The evidence is adequate to conclude that a 2-deoxy-2- [F-18] fluoro-D-glucose Positron Emission Tomography (FDG-PET) scan is reasonable and necessary in patients with documented cognitive decline of at least six months and a recently established diagnosis of dementia who meet diagnostic criteria for both Alzheimer's disease (AD) and fronto-temporal dementia (FTD), who have been evaluated for specific alternate neurodegenerative diseases or causative factors, and for whom the cause of the clinical symptoms remains uncertain. The following additional conditions must be met:
In addition, the billing provider must furnish upon request a copy of the FDG-PET scan result for use by CMS and its contractors in Medicare quality assessment and improvement activities.
2) The evidence is not adequate to conclude that FDG-PET is reasonable and necessary for the diagnosis of patients with MCI or early dementia in clinical circumstances other than that specified above absent safeguards that would be present in formal, protocol-driven clinical investigations. Their trials must compare patients who do and do not receive an FDG-PET scan and have as its goal to monitor, evaluate, and improve clinical outcomes, and must meet the following basic criteria:
For purposes of this coverage decision, CMS will determine whether specific clinical trials meet these criteria. CMS will continue to work with the National Institute on Aging, Agency for Healthcare Research and Quality, Alzheimer's Association, device manufacturers, and experts in AD and imaging to develop a large practical clinical trial to address these questions.