On Friday October 13, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a formal change to their coverage policy for amyloid PET imaging. Previously, with limited exceptions, patients were required to be enrolled in a clinical study known as “Coverage with Evidence Determination” for the scan to be reimbursed. Now, that requirement has been removed and the door has been opened for more patients to get the scan and result in savings of thousands of dollars for patients and their families. In fact, patients may have the opportunity to receive multiple covered scans as part of their routine care for Alzheimer’s disease.
The decision follows through on an announcement earlier this summer, which was sparked by the full approval of lecanemab for the treatment of early Alzheimer’s disease. Appropriate use of lecanemab is limited to those in whom an amyloid PET scan or another biomarker test confirms that Alzheimer’s disease is the likely cause of cognitive impairment. Now, those scans will be more readily available for patients as part of their diagnostic work up, including determining whether lecanemab or other treatments are an option for them. CMS may also pay for subsequent scans, to see if treatments are working and potentially to see if treatments should be stopped. This was the approach taken in clinical trials of another drug, donanemab, which was halted in patients whose amyloid was lowered to “not elevated” levels in the trials but continued to show benefit compared to those who never received the drug and instead received placebo. Donanemab is widely expected to be granted full FDA approval within the next year.
Importantly, the scan (and other biomarker tests) has value beyond determining whether treatments are appropriate. It is key to giving patients and families information they desire, that helps them move past a diagnostic phase and into an active phase of managing that diagnosis.
The news that CMS will cover these scans comes at a time when research advances are yielding opportunities for improved clinical practice. Research will remain key to developing improved options, determining the optimal uses of new options, and ensuring that these new advances are made widely available in an equitable way.