The American College of Radiology is “strongly” urging the Centers for Medicare & Medicaid Services (CMS) not to leave positron emission tomography-related reimbursement decisions to the discretion of local Medicare Administrative Contractors.
ACR voiced its concerns in comments submitted to the lead medical officer of CMS on Tuesday. The agency in July proposed lifting the longstanding national coverage determination that limits patients to one amyloid-detecting PET scan in their lifetime. Instead, CMS would permit MACs to make the call.
“ACR strongly urges CMS to reconsider leaving coverage determinations to the discretion of the local MACs and instead implement a national coverage ruling,” CEO William T. Thorwarth Jr., MD, wrote Aug. 15. “If left to local determination, a final ruling for coverage of Aβ PET could be significantly delayed and highly variable across geographic regions, further [exacerbating] existing inequities to access. Swift and broad coverage of Aβ PET is imperative at this time when anti-amyloid therapies are being approved by the Food and Drug Administration and highly sought after by patients and their families.”
Thorwarth and the college believe there is sufficient evidence to end the ongoing “coverage with evidence development” determination and move instead to nationwide reimbursement for beta-amyloid PET. ACR wants CMS to ensure beta-amyloid PET payment both for initial diagnostic evaluation of Alzheimer’s and other cognitive decline, along with follow-up to gauge the new therapies’ effectiveness, where appropriate.
The college has worked with CMS over the last decade to strengthen evidence of the importance of PET in treating this patient population. It sponsored the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) study and the follow-up New Ideas analyses to help fulfill coverage requirements from the agency. Thorwarth and colleagues also want an update on the status of the latter, “as the proposed decision lists this study as inactive.” As of July 27, the study had enrolled 4,414 participants, of whom 3,539 had received scans.
“Without the insights provided by a diverse cohort [as New IDEAS intends to do], the clinical utility and effectiveness of beta-amyloid PET is less likely to be fully understood,” the letter stated.
ACR said it has worked with Medicare Administrative Contractors in the past on PET pay decisions, and it doesn’t want patients to experience any delays in receiving these crucial exams.
“We acknowledge that the MACs have experience with extending coverage for PET scans for non-oncologic indications,” Thorwarth wrote. “However, given the importance of the findings from beta-amyloid PET imaging studies, ACR is concerned about the potential delay in coverage decisions by MACs and variations in local coverage that may result in health equity-related access differences due to difference coverage decisions by each MAC.”
Read the whole letter from ACR here. CMS was accepting comments on the proposal until this week, with the college anticipating a final decision in October.