Barry Siegel, MD, FACR, Co-Chair of the New Imaging Dementia – Evidence for Amyloid Scanning (New IDEAS) Study, contributed this piece.
Clinical research is pivotal in the advancement of the practice of radiology and care of our patients. As potential new treatments for Alzheimer’s are on the horizon, the urgency to support the clinical utility of amyloid PET imaging in dementia and neurodegenerative disease remains paramount. More specifically, metropolitan hospital amyloid PET imaging facility involvement in clinical research is critical for increasing the generalizability of research findings to patient populations historically underrepresented in research due to structural healthcare access barriers.
Sponsored and managed by the American College of Radiology® and directed by the Alzheimer’s Association, New IDEAS builds upon the results from the original IDEAS Study to address additional gaps in knowledge that are highly relevant to improve precision in future coverage decisions and implementation of amyloid PET in clinical practice. The overall purpose of the New IDEAS Study is to understand the association between amyloid PET imaging and patient-centered outcomes in a diverse population, specifically Black/African American and Hispanic/Latinx populations who were underrepresented in the original IDEAS Study and bear the greatest burden of dementia.
The ACR is currently seeking amyloid PET imaging facilities, particularly hospital facilities in major metropolitan regions, to participate in New IDEAS and provide Medicare beneficiaries with greater access to Alzheimer’s disease diagnostic services. Under coverage with evidence development approval, CMS provides reimbursement for amyloid-beta PET imaging scans provided to patients participating in New IDEAS. Reimbursement rates are subject to applicable CMS fee schedules based on the place of service. For imaging facilities that that bill under HOPPS, payment for the diagnostic radiopharmaceutical is packaged into the payment amount for the procedure. This bundled payment structure has led to many hospital-based imaging facilities to decline participation in New IDEAS due to the financial burden that comes with each scan performed, however, a lack of hospital-based facilities participating in the study has proven to create an access barrier for patients in certain geographic regions.
As a Professor of Radiology at Washington University in St. Louis, I collaborated with senior colleagues in our Memory Diagnostic Center and Alzheimer’s Disease Research Center to educate administrative personnel at Barnes-Jewish Hospital, the primary teaching hospital associated with the medical school, on the importance of participating in New IDEAS. We emphasized our substantial participation in the precursor IDEAS Study, with over 200 subjects accrued, and that our participation in New IDEAS was especially important given Washington University’s reputation as one of the world’s leading centers in Alzheimer’s disease research and patient care. Because there are no free-standing PET facilities in the St. Louis metropolitan area, where the amyloid PET studies could be performed with adequate coverage for the radiopharmaceutical, we posited that the hospital and the university jointly had a responsibility to allow for patients, and especially underserved minority patients, in our catchment to be able to participate in the study. We were extremely pleased to see that hospital leadership understood and shared this goal, and we received approval to accrue up to 50 patients to New IDEAS. Without the hospital’s collaboration, we would not have been able to participate in this important study.
In addition to allowing our participation in the study, the collaboration with our hospital is allowing us to contribute to the data that we hope will ultimately lead to Medicare coverage of amyloid PET for the evaluation of patients with cognitive impairment. Such coverage is especially important with the recent FDA approval of anti-amyloid therapies.
The key to our successful discussions with the hospital was the involvement of champions from both neurology and radiology, and we encourage others in a similar situation to encourage hospital participation in New IDEAS. Ultimately, inclusion of hospital-based PET facilities, even if only for limited numbers of subjects, is essential for New IDEAS to meet it accrual targets.
If your facility is interested in becoming a participating site, please complete the PET Imaging Facility questionnaire, and contact the New IDEAS Operations Team at firstname.lastname@example.org with any questions or concerns. We hope you’ll join us in the pursuit to increase access and enhance the future of dementia care for our patients.