The Centers for Medicare & Medicaid Services again have failed to endorse PET beta-amyloid imaging for Medicare coverage.
In its proposed decision memo July 3, CMS called the evidence "insufficient" to conclude that PET beta-amyloid imaging improves health outcomes for Medicare beneficiaries with dementia or neurodegenerative diseases.
In January, a CMS advisory panel declared it had less than "intermediate confidence" that amyloid PET imaging can improve patient health outcomes.
However, CMS did agree to cover the image in certain, limited circumstances.
In last week's memo, CMS said it envisions two scenarios in which the imaging could be promising, such as excluding Alzheimer's disease in "narrowly defined and clinically difficult differential diagnoses," such as Alzheimer's versus frontotemporal dementia, and in clinical trials seeking better treatments or prevention strategies for Alzheimer's, by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors.
Consequently, CMS said it would cover one PET scan to exclude Alzheimer's disease under a CED (coverage with evidence development) program as part of a clinical study, with certain stipulations. These stipulations include that the 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. The radiopharmaceuticals used in the PET scans must be approved by the U.S. Food and Drug Administration.
Additionally, the studies must be designed to ask the following:
- Do the results of PET amyloid imaging lead to improved health outcomes? Meaningful health outcomes of interest include: avoidance of futile treatment or tests; improving, or slowing the decline of, quality of life; and survival?
- Are there specific subpopulations, patient characteristics or differential diagnoses that are predictive of improved health outcomes in patients whose management is guided by the PET amyloid imaging?
- Does using PET amyloid imaging in guiding patient management, to enrich clinical trials seeking better treatments or prevention strategies for AD, by selecting patients on the basis of biological as well as clinical and epidemiological factors, lead to improved health outcomes?
To learn more:
- read the proposed decision memo