Organ Transplant Programs:

Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain

GAO-08-412: Published: Apr 29, 2008. Publicly Released: May 19, 2008.

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Media reports in 2005 and 2006 highlighted serious problems at organ transplant programs, calling attention to possible deficits in federal oversight. Two agencies in the Department of Health and Human Services (HHS) oversee organ transplant programs: the Centers for Medicare & Medicaid Services (CMS) oversees transplant programs that receive Medicare reimbursement, and the Health Resources and Services Administration (HRSA) oversees the Organ Procurement and Transplantation Network (OPTN), which manages the nation's organ allocation system. GAO was asked to examine (1) federal oversight of transplant programs at the time the high-profile cases came to light in 2005 and 2006 and (2) changes that federal agencies have made or planned since then to strengthen oversight. GAO interviewed CMS, HRSA, and OPTN officials and reviewed agency documents and data and a CMS draft proposal for sharing information with HRSA.

Limitations in federal oversight of organ transplant programs existed when high-profile problems came to light in 2005 and 2006. These high-profile cases included, for example, a transplant program that lacked a full-time surgeon for over a year and had been turning down organs offered for patients at markedly high rates. At that time, CMS did not actively monitor heart, liver, lung, and intestine transplant programs, relying instead primarily on complaints to detect problems. CMS periodically monitored kidney transplant programs through on-site inspections, known as surveys, but the surveys reviewed compliance with requirements that had not been substantially updated in decades and were limited in scope. In addition, some programs were not actively monitored. At the same time, the OPTN actively monitored transplant programs for many types of potential problems and worked with the programs to resolve identified problems. The OPTN's monitoring activities, however, were not sufficient to promptly detect certain problems that prolonged the time that patients waited for transplants, such as inadequate staffing at transplant programs. CMS, HRSA, and the OPTN have made or plan to make changes to strengthen their oversight of organ transplant programs, but the effectiveness of these changes will depend, in part, on implementation and information sharing by CMS, HRSA, and the OPTN. In 2006, after high-profile problems came to light, CMS began actively monitoring heart, liver, lung, and intestine transplant programs. In a more fundamental change, CMS published new regulations in 2007 that establish a single set of updated requirements for all Medicare-approved transplant programs and provide for periodic reviews of programs. The OPTN has been working with HRSA to develop and implement a set of indicators to better detect problems that prolong the time patients wait for transplants. However, neither CMS nor the OPTN has fully implemented these changes, and their full effect remains to be seen. In particular, CMS has not determined the extent to which it will conduct on-site surveys in its periodic reviews of programs for Medicare reapproval. Under the new regulations, CMS may choose not to conduct on-site reapproval surveys of programs meeting certain Medicare requirements. Not conducting these surveys may limit CMS's ability to monitor for compliance with other Medicare requirements and to detect problems like some of those involved in the high-profile cases. As of January 2008, CMS had not determined how it will choose which transplant programs to survey, if any, among those for which it has discretion. Further, while CMS, HRSA, and the OPTN recognize the value of sharing information about potential problems at transplant programs, how they will share additional information from their oversight activities has not been resolved. A definitive agreement between CMS and HRSA on this issue will better ensure that problems at transplant programs are detected and corrected in a timely manner.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To improve federal oversight of organ transplant programs, the Secretary of Health and Human Services should direct the Administrator of 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: To improve federal oversight of organ transplant programs, the Secretary of Health and Human Services should 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 the OPTN's oversight activities. The agreement should, at a minimum, (1) specify the types of information CMS, HRSA, and the OPTN will share and (2) specify at what point in CMS's and the OPTN's oversight processes this information will be exchanged.

    Agency Affected: Department of Health and Human Services

 

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