Kidney transplantation is a heavily regulated medical procedure with the Secretary of HHS ultimately responsible for oversight and authority derived from the NOTA and the Final Rule. Transplant Programs undergo publicly reported evaluations every 6 months based on outcomes from a 2-and-a-half-year period. The current Bayesian metrics for kidney transplant programs were created such that over ten percentage of programs are deemed underperformers, or ‘flag’, every 6 months. Newly suggested transplant metrics have been released for public comment in Summer 2021. In addition to graft outcomes, waiting list mortality and organ acceptance rate ratios are proposed.
Under the newly proposed kidney transplant metrics, over 10% of programs are expected to be deemed underperformers or ‘flagged’. Transplant Center flagging is well correlated with decreased transplantation due to the transplant centres move to more conservative organ and patient acceptance. Death on the waiting list is a proposed metric over which transplant centres have little influence.
In the USA, the harsh regulation continued by Health Resources and Services Administration (HRSA) through the national organ procurement and transplant network (OPTN) and Scientific Registry for Transplant Recipients (SRTR) leads directly to high organ discard rates and limitations to transplanting patients with perceived unadjusted risks. Instead of loosening regulation in a highly functioning industry that achieves remarkable outcomes in end stage kidney patients, the OPTN with the SRTR persist in increasing potential penalties through more proposed metrics that continue to deem 10% of US kidney transplant programs as underperformers. HRSA must establish a reasonable regulatory environment that allows for innovation and increased transplant opportunities for US end-stage renal disease patients.

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