CMS coverage decision for Alzheimer's drug, related PET scans sparks concern in imaging community

The Medical Imaging and Technology Alliance (MITA) recently expressed their displeasure with the Centers for Medicare and Medicaid Services (CMS) coverage decision regarding access to diagnostic testing and treatment of Alzheimer’s Disease. 

In a statement released on April 14, the alliance cautioned that the coverage decision will “severely limit patient access” to amyloid PET diagnostics and anti-amyloid monoclonal antibodies treatment. The limited access they were referring to pertains to the final CMS determination that restricts coverage of PET nuclear imaging and monoclonal antibodies directed against amyloid. The final determination states that coverage with evidence development (CED) will be granted only to those who are enrolled in CMS-approved clinical studies. 

“Limiting coverage to randomized controlled trials (RCTs) for the existing FDA-approved mAB will significantly restrict and delay access for patients and families,” said Patrick Hope, executive director of MITA. “Removing the hospital outpatient-only requirement is one of the only positive changes in the final decision. Limiting amyloid PET scans to the outpatient setting would have exacerbated already severely restricted patient access due to existing Medicare payment policy.” 

The Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease national coverage determination came after CMS considered more than 10,000 stakeholder comments and 250 peer-reviewed documents. Before the final determination was made, many prominent organizations in the medical imaging community, such as MITA, the American College of Radiology (ACR) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI), had publicly advocated for expanded coverage, citing the benefits of beta-amyloid PET scans.