On September 27, the agency released its decision that there is not enough evidence to conclude that PET beta-amyloid imaging is "reasonable and necessary" to diagnose or treat the afflictions or improve functioning. The announcement is the final version of a proposed decision memo on PET coverage released on July 3.
CMS did state, however, that there is sufficient evidence to suggest that PET beta-amyloid imaging could be used to exclude Alzheimer's disease in narrowly defined and clinically difficult differential diagnoses, such as Alzheimer's disease versus frontotemporal dementia. The modality is also promising for use in clinical trials exploring better treatments or prevention strategies for Alzheimer's by helping to select patients based on biological, clinical, and epidemiological factors.
CMS is therefore upholding its proposal to cover one PET beta-amyloid scan per patient through the agency's coverage with evidence development (CED) regulatory structure.
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