Impact of outcomes monitoring on innovation and risk in liver transplantation.

1. The reporting of liver transplant center outcomes is required by the final rule of the Department of Health and Human Services. The reported patient and graft survival outcomes are risk-adjusted for specific donor and recipient factors, and the observed survival is compared to the expected survival. Both the Centers for Medicare and Medicaid Services and the Organ Procurement and Transplantation Network flag programs for corrective action when the observed survival is significantly less than the expected survival. Both agencies can take action up to the closure of a center. In the last 5 years, the Organ Procurement and Transplantation Network has not taken an adverse action that required the closure of a liver transplant center because of outcomes. 2. Center survey data suggest that centers may try to select donors and recipients to minimize poor outcomes. This strategy may not be effective if centers stop accepting donors or recipients according to factors that are included in the risk adjustment model. For example, limiting recipients to those less than 65 years old may improve the observed outcomes, but the expected outcomes will also improve because a recipient 65 years or older is included in the model's risk adjustment. 3. For factors such as cardiovascular risk that are not included in the model, it may be reasonable to exclude patients in an attempt to improve the observed outcomes without affecting the expected outcomes. Other examples of these types of factors are smoking, nutritional status, and donor liver biopsy findings. 4. Currently, there is no exemption for patients undergoing experimental protocols. Down-staging for hepatocellular carcinoma, transplantation for human immunodeficiency virus-positive recipients, and the use of left lobe grafts with inflow modification are relatively recent areas of innovation in liver transplantation. Because innovation is frequently associated with a learning curve and, therefore, poor outcomes, the inclusion of patients in innovative protocols potentially could lead to centers being subjected to an adverse action by the Organ Procurement and Transplantation Network or the Centers for Medicare and Medicaid Services. Active consideration is being given to the exclusion of patients in innovative protocols from center-specific outcomes.