Imaging advocates are expressing concern after the Centers for Medicare & Medicaid Services proposed granting limited payment approval for the controversial, $28,000-a-year Alzheimer’s drug Aduhelm and corresponding brain imaging.
CMS said Tuesday that Medicare will pay for any such Food and Drug Administration-approved monoclonal antibodies in the context of clinical trials. The agency’s determination does not require a beta-amyloid PET scan before or after treatment. But Medicare will cover one such imaging exam for beneficiaries participating in CMS-approved studies, or those supported by the National Institutes of Health.
The Society of Nuclear Medicine & Molecular Imaging expressed dismay with the decision on Wednesday. Leaders with the Reston, Virginia-based group have hoped for a broad, national coverage determination for beta-amyloid PET, either through an official NCD process or by granting Medicare Administrative Contractors discretion to do so. They believe the present payment pathway will prevent patient access to diagnosis and treatment.
“We are concerned that CMS did not significantly change their [Coverage with Evidence Development] requirement for beta-amyloid PET scans,” SNMMI said in a Jan. 12 update. “In addition, the current limited CMS coverage pays the provider far less than the cost of the imaging agent, a situation that limits access to the scans for our most vulnerable populations.”
If its proposal is finalized, CMS said it will review each submitted clinical trial to determine whether it meets criteria outlined in the policy. Stakeholders have 30 days to comment on the proposal, which the feds hope to finalize by April 11. SNMMI said it continues to review the announcement and plans to submit more detailed feedback in the coming weeks.
“Our preliminary thoughts are that CMS’ decision to cover Alzheimer’s therapy under CED is an incomplete solution rather than a productive resolution that would allow widespread and equitable patient access to monoclonal antibody therapy or clinical trials of that treatment,” the society added. “We hope CMS will change its position in its final decision.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.