Articles and Blogs

On March 11, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a Quality, Safety & Oversight (“QSO”) memorandum and related updates to the State Operations Manual (“SOM”) interpretive guidance clarifying and reinforcing existing responsibilities of organ procurement organizations (“OPOs”) and donor hospitals throughout the organ donation process. While the memorandum largely reiterates... READ MORE

On January 30, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would substantially revise portions of the Conditions for Coverage for Organ Procurement Organizations (“OPOs”) (the “Proposed Rule”). According to CMS, the Proposed Rule is characterized as building on changes in the 2020 OPO Conditions for Coverage rule... READ MORE

The U.S. Department of Health and Human Services (“HHS”) recently announced a major reform initiative aimed at strengthening oversight of the organ transplant system for donations after circulatory death (“DCD”). This announcement follows an investigation by the Health Resources and Services Administration (“HRSA”) that uncovered instances where HRSA found potentially preventable harm to neurologically... READ MORE

Since the Health Resources and Services Administration’s (“HRSA”) announcement of its modernization initiative for the nation’s Organ Procurement Transplantation Network (“OPTN”) in March 2023, the OPTN has undergone five key changes, including technology infrastructure modernization, enhanced data transparency and analytics, sweeping governance changes, operational refinement and greater promotion of quality improvement and innovation among... READ MORE