The Centers for Medicare and Medicaid Services (CMS) has developed a set of regulations that spell out the Conditions of Participation (CoPs) for provider hospitals that wish to be certified (and thus eligible for reimbursement) by Medicare for transplant services. The American Society of Transplant Surgeons (ASTS) Council has played a major role in providing CMS with advice and guidance in the development and ongoing implementation of these conditions through a process of fruitful dialogue. In this report, we highlight the events that led to the development of the regulations and describe the process to date in implementing the CoPs. We have raised some important questions regarding the effectiveness of the regulations for improving safety, and we have highlighted the cost associated with their implementation. This report has been vetted by and represents the opinions of the Council of the ASTS.