Unintended Effects of the CMS Final Rule on Transplantation: A Patient Welfare Question

Effective on June 28, 2007, the Centers for Medicare and Medicaid Services (CMS) has established a new accountability policy by defining a set of Conditions of Participations (CoPs) for transplant centers. Centers’ performances, under the CoPs, are evaluated against three non-compliance thresholds for total patient survival and total graft survival outcomes. Centers performing below standards are flagged for non-compliance and are eligible for a quality review by the CMS and the potential loss of Medicare certification. The intent of this policy was to improve patient quality services. These stringent conditions of participation were also aimed at reducing re-transplantation rates. Nonetheless, the regulation could affect organ utilization rate and exacerbate the current shortage problem. In this article, we investigate the impact of the CMS Final Rule policy change.

We attempt to estimate, a causal relationship between the regulation change and health outcomes through response of transplant centers to more accountability. Although there have been positive responses with slightly higher quality transplants in the period post regulation, transplant centers have also  reacted to the new accountability policy in less than desirable ways. We make use of variations across transplant programs between 2002 and 2009 in a difference in difference framework; using biannual SRTR reports cards for 15 periods and UNOS patient registration information between 2003 and 2010, and find persuasive evidence that CMS Final Rule adversely affects patients’ welfare.

The estimated decrease in graft failures for centers subject to a quality review for low performance is negated by a decline in access to transplantation, creating a tradeoff between quality and access in the provision of transplant services. We estimate a sizeable reduction of about 4 less transplants per 6-month period at low performing centers on both graft survival and patient survival outcomes after the regulation. We augment our analysis by implementing a quantile regression of the effect of the CMS regulation on transplants volume and our results do not provide support for heterogeneity in treatment effects. Finally, our estimates on the policy effect on transplants volume for low performing centers on total graft survival outcomes are reinforced by results from a difference-in-difference propensity score matching.