Organ Transplant Programs: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain

In April 2008 we recommended that the Secretary of Health and Human Services direct the Administrator of the Centers for Medicare & Medicaid Services (CMS) to develop a methodology for conducting on-site surveys of transplant programs seeking Medicare reapproval that ensures that at least some transplant programs meeting data submission, clinical experience, and outcomes requirements receive on-site surveys. These key requirements comprise one of the Conditions of Participation (CoP) with which transplant programs must comply to receive approval for Medicare participation. This approval lasts for 3 years under Medicare's March 2007 transplant programs regulations, at which point programs need to be reapproved. We noted that under these regulations, CMS may choose not to conduct on-site reapproval surveys for transplant programs meeting data submission, clinical experience, and outcomes requirements. However, we concluded that the lack of conducting on-site reapproval surveys for transplant programs meeting these requirements may limit CMS's ability to monitor compliance with other CoPs and that problems with transplant programs unrelated to these requirements could go undetected. In response to our inquiry about actions taken relevant to this recommendation, CMS provided us with applicable provisions in guidance for states. In guidance for fiscal year 2011--the first year in which transplant programs approved in fiscal year 2008 are seeking reapproval under the regulations--CMS is directing state agencies, which conduct initial and reapproval surveys, to include on-site surveys for a targeted sample of transplant programs that have had significant program changes or are at-risk for providing poor care. Further, all transplant program are to have an on-site survey at least every 4 years. Therefore, the methodology addresses our recommendation in that it ensures at least some transplant programs that have met data submission, clinical experience, and outcomes requirements will receive an on-site survey.

In April 2008, we reported that two Department of Health and Human Services (HHS) agencies--the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) had started sharing basic data on transplant programs, but had not resolved how they would share additional information resulting from their oversight activities. Although the agencies recognized the importance of sharing such information, they had not reached an agreement or established a time frame to finalize such an agreement. We recommended that the Secretary of HHS direct the Administrators of CMS and HRSA to establish a time frame for finalizing an agreement for the agencies to share information resulting from CMS's and HRSA's oversight activities and that the agreement should at a minimum specify the types of information the agencies would share and at what point in the oversight process they would share it. HHS agreed with our recommendation, noting that CMS and HRSA have been working to develop and finalize such an agreement. In July 2008, CMS and HRSA finalized an agreement to share information resulting from their oversight on organ transplant programs. Under the agreement, the agencies will share information on serious events (such as incidents of immediate threat to public health and safety) and incidents of potential policy violations. The agreement also specifies at which point in the oversight process the agencies will share this information.