The American College of Radiology® (ACR®) recently sent a letter to relevant committees in the U.S. House of Representatives and Senate in support of a legislative solution for a radiopharmaceutical reimbursement issue related to the Imaging Dementia – Evidence for Amyloid Scanning (IDEAS) Study and the forthcoming “New IDEAS” study.
The original study, sponsored by the Alzheimer’s Association and managed by the ACR, sought to assess whether, in diagnostically uncertain cases, amyloid PET helps clinicians diagnose the cause of cognitive impairment and provides the most appropriate treatments and recommendations.
Phase 1 of the IDEAS Study evaluated the impact of three PET imaging drugs, which were designated for “pass-through” payment status as part of the study’s “Coverage with Evidence Development” design. The initial pass-through designation expired for one of the relevant drugs in 2017, with the other two drugs falling off pass-through in 2018. Throughout its duration, the IDEAS Study provided access to PET imaging at 343 imaging facilities in the U.S. for over 18,000 patients, ages 65 or older, for whom there was ambiguity about the cause of their cognitive decline/dementia.
Unfortunately, and as part of an unrelated effort, Congress included language in its fiscal year 2018 omnibus appropriations bill to extend the pass-through payment status for only one of the relevant three IDEAS Study drugs, therefore creating a payment disparity that could impact New IDEAS, the forthcoming second phase of the study. Hospitals using the one drug will receive approximately three times more reimbursement for the drug and PET scan, while facilities using either of the other drugs will receive a bundled payment and can expect to lose a significant amount of money per procedure.
Stakeholder organizations, as well as a handful of members of Congress, have aptly pointed out that the unequal payment, if not corrected, will potentially impact the availability and distribution patterns of the amyloid PET scans and will distort data collection on a geographical basis. In addition, the ability to sample data and compare it with the results of the first study could be skewed, undermining the scientific validity of the data.
Given the positive results from the initial IDEAS Study, the ACR and other stakeholders are committed to ensuring the strength of the forthcoming New IDEAS Study. The ACR will continue to work with members of Congress to ensure payment equity for the three radiopharmaceuticals utilized in this critical research.