Purpose of review: Risks of regulatory scrutiny has generated widespread concern about increasingly risk averse transplant center behaviors regarding both donor and candidate acceptance patterns. To address potential unintended consequences threatening access to care, we discuss recent changes in regulatory metrics and potential improvements in quality oversight of transplant centers.
Recent findings: Despite many recent changes to one-year patient and graft survival regulatory criteria, the capacity to accurately identify true underperforming centers and avoiding false positive flagging remains an area of great concern. Numerous studies have demonstrated restrictions in transplant volume and access following transplant center flagging.
Summary: Current regulatory criteria are limited in their capacity to accurately identify poorly performing centers and potentially encourage risk-averse behavior by transplant centers. Efforts to address these concerns should focus on (1) improving risk-adjustment models with better data which captures the acuity of candidate and donor risk, (2) reconsidering primary outcomes measured to assess comprehensive transplant center performance, (3) improving education to address rational or perceived disincentives, and (4) using data more effectively to share best practices.
Keywords: Centers for Medicare and Medicaid Services; Membership and Professional Standards Committee; Organ Procurement and Transplant Network; Organ Transplantation; Performance metrics; Quality; Regulatory oversight.