Do Federal Regulations Have an Impact on Kidney Transplant Outcomes?

Transplantation is one of the most highly regulated fields in health care. An important component of transplant oversight is the performance assessment of transplant centers as measured by 1-year patient and graft survival outcomes. The use of the Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients flagging mechanism for quality improvement as criteria for Center for Medicare and Medicaid Services certification has resulted in greater importance in transplant program operations. Although supporters of this program of encouraging Quality Assurance and Performance Improvement point to improved survival outcomes for more than the decade, others assert that the oversight is unnecessarily punitive, results in tremendous resource utilization, and discourages innovation. Data exist to support an inhibitory effect on national transplant volume. Although survival outcomes are risk adjusted, limitations on national data collection prevent several important risks from being incorporated into the models. This has led to the consensus that many transplant centers have become increasingly risk averse in this environment, which may indirectly reduce access to transplant for candidates who could still benefit from transplantation. Recently enacted modifications to performance evaluation by Center for Medicare and Medicaid Services and the Organ Procurement and Transplantation Network appear to acknowledge these concerns and have the potential to recalibrate transplant center focus away from first-year outcomes and more toward expanding transplant volume, innovation, and overall improvements in care.