Should Both UNOS and CMS Provide Regulatory Oversight in Kidney Transplantation?

Since publication of the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation Final Rule in 2007, there has been dual regulation of transplant centers by the Organ Procurement and Transplantation Network (OPTN) contractor the United Network for Organ Sharing (UNOS) and CMS. Herein, we summarize the environment leading to the development of the present regulatory framework and identify significant and unintended consequences of the current regulations.