The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed coverage of amyloid PET scans for diagnosing and managing patients with Alzheimer's disease, with a 30-day public comment period that opened July 17.
CMS initiated a reconsideration of its national coverage determination (NCD) for amyloid PET in June 2022. Currently, CMS limits Alzheimer's disease patients eligible for monoclonal antibody treatments to a single PET scan, if they are enrolled in a clinical trial. The proposal also follows CMS's recent decision to cover new drugs for the disease.
"With the recent development of treatments directed against amyloid, the PET scan would help to confirm the presence of brain amyloid, to alter the course of treatment for the patient, and to demonstrate treatment results," CMS said.
Evidence for the decision came from pivotal trials and other major studies that aimed to demonstrate that interventions guided by amyloid PET imaging can lead to improved health outcomes for Medicare beneficiaries, CMS noted.
Ultimately, the proposal would allow Medicare to cover amyloid PET for people at the discretion of Medicare administrative contractors (MACs).
"We propose to remove the NCD PET beta amyloid imaging, which would allow local MACs to make coverage determinations regarding the use of Aêžµ PET imaging, to include, covering more than one scan per patient's lifetime and use within or outside the context of a CMS approved study," CMS stated.
The previous lack of clarity over coverage of amyloid PET scans had been criticized by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the Medical Imaging and Technology Alliance (MITA).
