CMS’s Role and Responsibilities

CMS is responsible for overseeing organ transplant programs that receive  Medicare reimbursement for transplant services. Limitations Existed in Federal Oversight at the Time High-Profile Problems Came to Light

CMS’s and, to a lesser extent, the OPTN’s oversight of transplant programs  was not comprehensive at the time high-profile problems came to light in  2005 and 2006. CMS monitored  renal transplant programs through contracts with state agencies, but the  surveys reviewed compliance with requirements that had not been  substantially updated in decades and were limited in scope; also, not all  programs were actively monitored. At the same time, the OPTN actively  monitored transplant programs and took action to resolve identified  problems, but its oversight activities fell short in some respects—the  OPTN’s monitoring did not include methods capable of promptly detecting  problems at transplant programs that prolonged the time that patients  waited for transplants, and the OPTN did not always meet its goals for  conducting on-site reviews. CMS Did Not Actively Monitor Extra-Renal Transplant Programs

At the time high-profile problems came to light in 2005 and 2006, CMS was  not actively monitoring the ongoing compliance of Medicare-approved  extra-renal transplant programs with the criteria specified in the NCDs,  which included performing a minimum number of transplants per year and  achieving a minimum patient survival rate. While helpful in detecting completely inactive programs, this  particular method did not identify more subtle problems, such as a  transplant program that was understaffed and was turning down organs  offered for patients at markedly high rates. CMS, HRSA, and the OPTN Have Acted to Strengthen Oversight, but the Full Effect of These Actions Will Depend on Implementation and Further Information Sharing

Since the high-profile cases came to light, CMS, HRSA, and the OPTN have  made some changes and planned others to improve federal oversight of  organ transplant programs; however, the full effect of these changes  remains to be seen. The OPTN and HRSA are  working to develop and implement a set of indicators to help the OPTN  better identify problems that prolong the time patients wait for  transplants. Implementation of CMS’s new requirements is in its early  stages, however, and CMS has not resolved the extent to which on-site  surveys will be performed as part of its periodic reviews of programs for  Medicare reapproval. In March 2007, CMS made a more fundamental change to its oversight by  publishing final regulations establishing a new set of Medicare  requirements specifically for organ transplant programs. In addition, the new  regulations both update and expand upon previous requirements. As of January 2008,  CMS officials said that the agency had not decided how many reapproval  surveys it would conduct or how it would choose which programs to  survey among those that meet the aforementioned requirements. CMS, HRSA, and the OPTN Are Sharing Basic Data on Transplant Programs, but How They Will Share Additional Information from Their Oversight Activities Has Not Been Resolved

CMS, HRSA, and the OPTN have recognized the importance of sharing  data on transplant programs with one another and have taken initial steps  to share basic data. It will be important for CMS and  HRSA to determine specifically what information they will share from  their oversight activities. A more difficult challenge that CMS and  HRSA face is agreeing when to share information about potential  problems at transplant programs. Not conducting on-site  reapproval surveys may limit CMS’s ability to monitor these transplant  programs’ compliance with other Medicare CoPs, for example, whether  transplant programs are providing required protections for living donors,  and to detect problems like those involved in some of the high-profile  cases. Recommendations for Executive Action

To improve federal oversight of organ transplant programs, we  recommend that the Secretary of Health and Human Services:  (1) 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.
Why GAO Did This Study

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.

What GAO Found

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.