Adult and child holding kidney shaped paper on textured blue background.

New Regulation Aims at Accountability for Organ Procurement Organizations

By James W. Lytle and Abe Sutton

Facing a looming deadline for the adoption of pending proposed rules, the Trump Administration finalized a host of healthcare regulations, including highly anticipated regulations addressing drug pricing and Stark Law/anti-kickback rules. Within this flurry of regulatory activity, the Centers for Medicare & Medicaid Services (CMS) also finalized an important, but not as widely discussed, proposal that seeks to hold Organ Procurement Organizations (OPOs) more accountable for their performance.

While some of these last-minute actions by the outgoing administration may ultimately be reversed or revised by the Biden Administration, this rule was associated with a well-regarded Advancing American Kidney Health initiative that has been “widely hailed by health care groups, patient advocacy organizations and Democrats,” making it “the most broadly popular health initiative of Trump’s presidency.” While its fate is not entirely certain, the recently issued final rule may be one of the few last-minute legacies of the Trump Administration likely to be more warmly received by its successor.

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