The Regulatory and Legal Environment of a Contemporary Kidney Transplant Program

Abstract

Organ transplantation is one of the most complex sectors of healthcare available in only approximately 4% of hospitals nationwide. It is a high-risk and high-skill program utilizing scarce resources. As such, it is highly regulated with a number of different federal agencies enforcing regulations, policies, and bylaws. The Organ Procurement and Transplantation Network (OPTN) managed by contract agency the United Network for Organ Sharing (UNOS) enforces these rules concurrently with the Centers for Medicare and Medicaid Services (CMS) among other agencies. The governing rules are dynamic, layered, often repetitive, and sometimes open for interpretation by Transplant Centers putting the issue of compliance at the forefront of all decision-making at all levels. The OPTN’s primary focus has been the fair and equitable distribution of organs with focus on patient and donor safety, whereas CMS’s primary focus has been patient health and safety with a focus on nondiscrimination in practices. Given this complexity, Transplant Centers put forth a tremendous amount of resources ensuring compliance and often routinely employ Compliance Specialists/Managers. A number of resources are available to Transplant Centers to be informed about regulatory oversight and requirements.