For several years, researchers believed that positron emission tomography (PET) beta amyloid imaging was an important tool to aid the diagnosis of Alzheimer's disease. The use of this diagnostic test is now expected to become more widespread due to a policy change announced last week by the Centers for Medicare & Medicaid Services (CMS).
Since 2013, CMS has authorized reimbursement of positron emission tomography (PET) beta amyloid imaging for Alzheimer patients by the means of “coverage with evidence development” (CED), meaning that payment for amyloid PET scans was limited to use in clinical trials.
In a decision memo issued on October 13, “Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease,” CMS has announced permission for Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors (MACs) under § 1862(a)(1)(A) of the Social Security Act.
The coverage action by CMS was anticipated following the approval this summer by the U.S. Food and Drug Administration (FDA) of an antibody intravenous (IV) infusion therapy that targets and removes beta-amyloid from the brain called Lecanemab. The drug slows progression of the disease when taken in the early stages of Alzheimer's, giving individuals more time to participate in daily life and live independently. In 2021, the FDA approved a drug called Aducanumab that reduces beta-amyloid plaques.
Under the new authority, the MACs can determine whether beta amyloid PET imaging is “reasonable and necessary” if they conclude it is safe and effective; not experimental or investigational; and medically appropriate. Coverage determinations by the MACs for these PET imaging services are expected.
This is wonderful news for Alzheimer's patients and their families. It is also good news that CMS has removed the current limitation of one scan per lifetime.