The Centers for Medicare & Medicaid Services (CMS) issued a decision on September 27, 2013, in which it held that positron emission tomography (PET) amyloid-beta (Aβ) imaging would be covered only in limited circumstances based on CMS’s determination that there is insufficient evidence that use of this imaging is “reasonable and necessary” for diagnosing or treating Medicare beneficiaries with dementia or neurodegenerative disease. PET Aβ imaging is an Alzheimer’s Disease (AD) diagnostic tool used to determine if the brain contains Aβ, an indicator of AD.1

CMS did acknowledge, however, that there is sufficient evidence that the use of PET Aβ imaging offers promise as a way to exclude AD in narrowly defined and clinically difficult differential diagnoses and to allow for the selection of patients in clinical trials based on biological, clinical, and epidemiological factors in order to seek better treatment or prevention strategies for AD As a result, CMS stated that it will cover one PET Aβ scan per patient through coverage with evidence development (CED) in clinical trials that must be approved by CMS and that meet certain criteria, including:

  • The trial’s objectives must be to develop better AD treatments or prevention strategies, identify subpopulations at risk for developing AD, or “resolve clinically difficult differential diagnoses where the use of PET Aβ imaging appears to improve health outcomes;”
  • The trial must be comparative and longitudinal, and involve subjects from appropriate populations;
  • If appropriate, the study should be prospective, randomized, and use postmortem diagnosis as the endpoint;
  • The trial must address at least one aspect of a certain list of questions, e.g., does the PET Aβ imaging result in “improved health outcomes,” which include avoidance of futile treatment or tests, improving or slowing the decline of quality of life, and survival; and
  • The trial should adhere to the timeframe listed in the approved clinical study protocol and follow certain standards of scientific integrity and relevance to the Medicare population, e.g., the study is well supported by available scientific and medical information or is intended to clarify or establish the health outcomes of interventions already in common use. The full decision is available here.2