The Centers for Medicare & Medicaid Services (CMS) on Friday determined that there was insufficient evidence that imaging scans are ”reasonable and necessary” for diagnosing and helping treat individuals with Alzheimer’s disease or other related dementias, and therefore it would only consider coverage for the test in limited circumstances.
CMS said they will cover one beta-amyloid positron emission tomography (PET) scan per individual through coverage with evidence development (CED), only for clinical trials that they must pre-approve.
To gain approval, the clinical study’s objective must be to either develop better treatments or prevention strategies for Alzheimer’s disease, identify subpopulations at risk for developing the disease, or resolve clinically difficult differential diagnoses where the use of imaging test appears to improve health outcomes. Full guidelines are available in the CMS’ decision summary.
Several organizations were critical of the CMS ruling, hoping for broader coverage for the imaging scans. Many cited that the decision directly conflicts with the Department of Health and Human Services’ own National Plan to Address Alzheimer’s Disease, an extensive effort to find means to prevent and effectively treat Alzheimer’s by 2025 and improve the care of those suffering from the disease.
While a positive beta-amyloid PET scan is not definitive diagnosis for Alzheimer’s disease, it is used as a diagnostic tool to determine whether or not there is beta-amyloid in the brain, one of the neuropathological hallmarks of the disease. According to the FDA, it is “an adjunct to other diagnostic evaluations” – a tool to provide physicians with additional information to help make an accurate diagnosis.
Advocates say having wider access to the PET scans is critical – having a definitive diagnosis leads to better health outcomes for individuals with Alzheimer’s, helps families plan for long-term care, and increases enrollments in clinical trials that can develop future treatments.
Read the full decision: Decision Memo for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease.
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