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CMS releases proposed decision for PET amyloid-beta (Aβ) imaging in dementia and neurodegenerative disease

On July 3, the Centers for Medicare & Medicaid Services released a memo proposing a rule that positron emission tomography amyloid-beta (Aβ) imaging not be covered for Medicare beneficiaries with dementia or neurodegenerative disease in most cases. CMS proposes that the evidence is insufficient to conclude that the use of PET amyloid-beta (Aβ) imaging improves health outcomes for Medicare beneficiaries with dementia or neurodegenerative disease, and thus PET Aβ imaging is not reasonable and necessary under the Social Security Act.

CMS does state that there is sufficient evidence that the use of PET Aβ imaging could be promising in two scenarios: to exclude Alzheimer's disease in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia; and to enrich clinical trials seeking better treatments or prevention strategies for AD, by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors. CMS proposes to cover one PET Aβ scan per patient through coverage with evidence development, in clinical studies that meet certain criteria. Clinical study objectives must be to (1) develop better treatments or prevention strategies for AD, or, as a strategy to identify subpopulations at risk for developing AD, or (2) resolve clinically difficult differential diagnoses (e.g., frontotemporal dementia (FTD) versus AD) where the use of PET Aβ imaging appears to improve health outcomes. more


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