- 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.
- Clinical studies must be approved by CMS, involve subjects from appropriate populations, be comparative, prospective and longitudinal, and use randomization and postmortem diagnosis as the endpoint where appropriate, and comply with other requirements as described in the proposed decision memo. Radiopharmaceuticals used in the PET Aβ scans must be FDA approved.
The Centers for Medicare & Medicaid Services (CMS) published a proposed decision memo (http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=265) on July 3. In summary, CMS proposes that the evidence is insufficient to conclude that the use of positron emission tomography (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 §1862(a)(1)(A) of the Social Security Act (“the Act”). However, there is sufficient evidence that the use of PET Aβ imaging could be promising in two scenarios: (1) to exclude Alzheimer’s disease (AD) in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia (FTD); and (2) 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 is proposing to cover one PET Aβ scan per patient through coverage with evidence development (CED) in clinical studies that meet the criteria outlined below.