December 19, 2019

Pass-Through Payments for IDEAS Study Extended in Approved Appropriations Bill

The omnibus appropriations packages passed by Congress this week included a hard-fought provision to restore and extend pass-through payment status for two radiopharmaceutical drugs used in the “Imaging Dementia—Evidence for Amyloid Scanning (IDEAS)” Study and deemed critical for the forthcoming “New IDEAS” effort.

This important research study, managed by the American College of Radiology® (ACR®), is assessing whether, in diagnostically uncertain cases, amyloid PET imaging can help guide clinicians with care planning to attain better health outcomes for patients with mild cognitive impairment, dementia and/or Alzheimer’s disease.

The initial IDEAS Study utilized three PET imaging drugs that received “pass-through” payment status as part of the trial’s “coverage with evidence development” design. The initial pass-through designation expired for one of the relevant drugs in 2017. The designation ended for the other two in 2018.

Unfortunately, and as part of an unrelated effort, Congress included language in its 2018 fiscal year (FY18) 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. In this scenario, hospitals using the one pass-through drug would receive approximately three times more reimbursement than facilities using either one of the other drugs and receiving bundled payments resulting in a significant monetary loss per procedure.

Since discovering the payment disparity, the ACR government relations team collaborated with various stakeholders — on and off Capitol Hill — to secure a legislative “fix” to re-establish pass-through for the two omitted drugs. The relevant provisions included in the FY 2020 appropriations package achieve this goal by re-establishing the pass-through payment status through Oct. 1, 2020.