Organ Transplant Programs: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain
Published: 2008-04-29T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Organ transplantation has become increasingly common, with over 28,000  organ transplants performed in the United States in 2007. Over 250 U.S.  hospitals have organ transplant centers. Many of these centers operate  multiple transplant programs that each specialize in the transplantation of  a specific organ, such as the kidneys, heart, liver, lungs, intestines, or  pancreas. Despite increases in organ donations, the demand for organs  continues to exceed the available supply. Over 6,000 people die each year  in the United States while waiting for organ transplants. The scarcity of  organs relative to demand emphasizes the need to ensure both the  equitable allocation of organs and proper oversight of the organ  transplantation system, including the programs that perform organ  transplants.
Two agencies within the Department of Health and Human Services (HHS)  are involved in overseeing the organ transplantation system. These two  agencies have responsibilities that differ in some respects but overlap in  others.
HHS’s Health Resources and Services Administration (HRSA) is  responsible for overseeing the Organ Procurement and Transplantation  Network (OPTN), a nonprofit network of transplant centers and others in  the transplant community that was established in 1984 to manage the  nation’s organ allocation system. The OPTN’s responsibilities include  maintaining a list of individuals waiting for transplants, operating a  computerized system for matching donated organs with individuals on the  waiting list, and developing policies for how organs are to be allocated.  The OPTN is administered by a nonprofit organization that has a contract  with HRSA. Historically, the OPTN’s primary focus has been ensuring the  equitable allocation of donated organs, and its policies include detailed  allocation rules for matching donated organs with individuals on the  waiting list. Its policies also address other areas related to  transplantation, such as the training and experience of key transplant  personnel and performance standards for transplant programs related to  patient survival rates and transplant activity. More recently the OPTN’s  activities expanded to include monitoring members’ compliance with  federal regulations and OPTN policies. The OPTN monitors its members’  compliance through various mechanisms, such as on-site reviews of  transplant programs and regular reviews of organ allocations, and is  responsible for reporting member noncompliance and any other issues  affecting patient health or public safety to HRSA.
HHS’s Centers for Medicare & Medicaid Services (CMS) is responsible for  regulating transplant programs that receive reimbursement under the  Medicare program. CMS oversees fewer transplant programs than the  OPTN because not all transplant programs participate in Medicare. In  addition, CMS’s range of requirements for Medicare-approved transplant  programs differs from the OPTN’s; for example, CMS does not have  specific requirements for organ allocation procedures. At the same time,  CMS’s requirements address some areas in common with the OPTN, such  as minimum qualifications for some transplant program personnel and  patient survival rates. CMS has monitored some transplant programs by  contracting with state agencies to conduct routine on-site inspections,  known as surveys.
In 2005 and 2006, media reports of problems at several organ transplant  programs drew attention to possible shortcomings in federal oversight,  noting that some problems were not detected or addressed by the OPTN  or CMS in a timely fashion. Three cases that occurred at different facilities  in California received particular attention because of the seriousness of  the problems involved. The OPTN’s oversight brought one of the cases to  light, while individuals alerted federal agencies or the media to the other  cases.
In 2003, a liver transplant program used one patient’s high position on the  waiting list to obtain a liver for someone else who was lower on the  waiting list, bypassing more than 50 patients who had higher priority for  the liver than the actual recipient. Medical records were falsified to  conceal the switch, and the patient who had the highest priority for the  liver later died without a transplant. A routine OPTN on-site review in 2005  led the transplant program’s staff to review the case and self-report the  problem to the OPTN.
At another facility, the liver transplant program did not have a full-time  transplant surgeon on staff even though it had led the OPTN and patients  to believe otherwise. From mid-2004 until the program closed over a year  later, the program lacked a full-time surgeon and had been turning down  organs offered for patients on the waiting list at rates markedly higher  than regional and national averages. A patient complaint in 2005 led to a  CMS investigation that first uncovered the situation.
In 2004, a health maintenance organization (HMO) notified over 1,500 of  its enrollees waiting for kidney transplants that it would no longer pay for  their transplants unless they were performed at a new kidney transplant  program it was about to open. The new transplant program, however, was  unable to properly handle the large influx of patients and did not provide  contingency plans for patients to receive transplants through other  programs. As a result, patients’ access to transplants was impeded. A  whistleblower contacted the media, and in May 2006, media articles about  the situation alerted the OPTN and CMS to the problem.
Concerned that these recent issues at organ transplant programs could  indicate more systemic problems, you asked us to examine federal  oversight of the organ transplantation system. This report discusses   (1) federal oversight of transplant programs at the time the high-profile  cases came to light in 2005 and 2006 and (2) the changes that federal  agencies have made or planned since then to strengthen their capacity to  detect and resolve compliance problems at organ transplant programs.
Our review encompassed the OPTN’s and HRSA’s activities to oversee  organ transplant programs and CMS’s activities to oversee Medicare- approved organ transplant programs. To examine the OPTN’s, HRSA’s,  and CMS’s oversight activities, we reviewed relevant laws, regulations,  policies, and other documents and interviewed OPTN and HRSA officials  and officials from CMS’s central office and from the 5 (of 10) regional  offices responsible for overseeing the largest numbers of transplant  programs. We also reviewed case files from the OPTN detailing the  OPTN’s review of and actions taken on compliance cases that occurred  from 2003 through 2006, including the three high-profile cases; the OPTN’s  data on transplant programs that did not meet OPTN performance  standards for clinical outcomes or transplant activity from January 2003  through October 2006; the OPTN contract with HRSA; CMS data on  surveys of renal (kidney) transplant programs; CMS data on reviews of  extra-renal (heart, liver, lung, and intestine) transplant programs  conducted in 2006 and 2007; CMS complaint investigations of the three  high-profile cases; and a CMS draft proposal for sharing information with  HRSA. We examined the reliability of the data used in this report by  performing appropriate electronic data checks and checks for obvious  errors, such as missing data and data outside of expected ranges. We also  interviewed officials who were knowledgeable about the data. We  determined that the data we used were sufficiently reliable for our  purposes. In addition, we conducted interviews with experts from  associations representing transplant professionals about both CMS’s and  the OPTN’s oversight of transplant programs. We conducted this  performance audit from August 2006 through April 2008 in accordance  with generally accepted government auditing standards. Those standards  require that we plan and perform the audit to obtain sufficient, appropriate  evidence to provide a reasonable basis for our findings and conclusions  based on our audit objectives. We believe that the evidence obtained  provides a reasonable basis for our findings and conclusions based on our  audit objectives.
subsections: section_title: Background
paragraphs: Organ transplants are becoming increasingly common. The 28,352 organ  transplants performed in the United States in 2007 represent an increase of  about 40 percent since 1997. (See fig. 1.) Kidney transplants are the most  common procedure, accounting for almost 60 percent of transplants. Most  transplanted organs come from deceased donors, but a significant portion  (22 percent in 2007) come from living donors who may donate, for  example, a kidney or a segment of liver or lung.
As of January 2008, 254 U.S. hospitals had a transplant center; collectively,  these centers operated 844 individual transplant programs. (See table 1.)  Nearly all states had at least one transplant center, but some types of  transplant programs, such as lung or intestine transplant programs, were  located in a limited number of states.
subsections: section_title: Organ Transplantation Process
paragraphs: The organ transplantation process involves the following steps.
Step 1: The process begins when a patient’s physician determines that an  organ transplant may be necessary and refers the patient to a transplant  program for evaluation.
Step 2: If the transplant program determines that the patient is a candidate  for transplantation, the individual is registered on the national organ  transplant waiting list maintained by the OPTN.
Step 3: When an organ becomes available, the local organ procurement  organization enters information about the donor organ into a national  computer system operated by the OPTN. The computer system generates a  ranked list of potential recipients based on how closely their medical  characteristics—such as blood type, organ size, and genetic makeup— match the donor’s, as well as on the urgency of their medical conditions,  their time spent on the waiting list, and their proximity to the donor.
Step 4: Transplant programs whose patients appear on the list are  contacted. The decision whether to accept an organ rests with the  patient’s transplant team. Because the length of time organs can viably be  kept outside the body is limited, the transplant team has 1 hour to make its  decision. If the organ is not accepted, it is offered to the center with the  next patient on the list until the organ is placed.
Step 5: Once the organ is accepted for a potential recipient, a surgical team  comes to the donor hospital to recover the organ. The recovered organ is  transported from the donor to the recipient hospital for transplantation  into the patient.
section_title: The OPTN’s Role and Responsibilities
paragraphs: The OPTN was created pursuant to the National Organ Transplant Act,  which called for HHS to provide by contract for the establishment and  operation of the OPTN to manage the nation’s organ allocation system.  Prior to that time, national policies regarding transplantation did not exist  and organ allocation was carried out on an ad hoc basis. The OPTN’s  functions include maintaining a list of patients waiting for transplants,  operating a system for matching donated organs with individuals on the  list, establishing medical criteria for allocating organs, collecting and  analyzing data on organs donated and transplanted, and conducting work  to increase the supply of donated organs. The OPTN’s members include all  transplant centers and organ procurement organizations in the country;  tissue-typing laboratories; professional scientific and medical  organizations; and other organizations and individuals interested in organ  donation or transplantation, such as organ donors, recipients, and their  families. The OPTN’s Membership and Professional Standards Committee  (MPSC) is responsible for overseeing the compliance of OPTN members  with applicable federal regulations and OPTN policies. The OPTN collects  most of the funding to cover its operating costs (estimated to be about   $25 million in 2006) from candidate registration fees paid by OPTN  members; HRSA’s funding for the OPTN is capped at $2 million a year.
From early in its history, the OPTN has been responsible for operating an  equitable nationwide system of organ allocation. The OPTN develops  detailed policies that govern the distribution of organs and other issues  related to transplantation, such as the specific credentials required of  transplant surgeons and physicians. HHS clarified the OPTN’s oversight  responsibilities in regulations implemented in 2000. The regulations  require the OPTN to design plans and procedures for conducting ongoing  and periodic reviews of all member transplant centers for compliance with  the regulations and OPTN policies. The regulations also require the OPTN  to advise the Secretary of Health and Human Services when the results of  its reviews indicate noncompliance with the regulations or OPTN policies  or otherwise indicate a risk to patient health or public safety.
While the OPTN is required to monitor transplant programs’ compliance  with its policies, OPTN policies are considered voluntary or advisory. To  promote transplant programs’ voluntary compliance with OPTN policies,  the OPTN employs a confidential review process in which OPTN members  evaluate the medical care provided by colleagues to determine compliance  with OPTN policies and regulations. The OPTN emphasizes that its  confidential review process focuses on corrective action rather than  punishment and is aimed at continuous quality and performance  improvement. On its own, the OPTN can impose certain sanctions against  noncompliant transplant programs, such as issuing a letter of warning or  placing a program on probation. The OPTN can also request that the  Secretary of Health and Human Services impose stronger enforcement  actions, including terminating a program’s ability to receive organs or  reimbursement under Medicare.
section_title: HRSA’s Oversight of the OPTN
paragraphs: The OPTN contract with HRSA includes several requirements related to  the oversight of transplant programs. For example, the contract requires  the OPTN to conduct on-site reviews of heart, liver, and lung transplant  programs at least once every 3 years and to perform ongoing analyses of  organ allocations. The OPTN is also required to submit monthly reports  to HRSA describing transplant program-specific instances of  noncompliance with OPTN policies and the status of corrective action  plans. To ensure that the OPTN is fulfilling its responsibilities to monitor  transplant programs’ compliance, HRSA officials participate as ex officio  nonvoting members on the OPTN’s Board of Directors and committees,  including the MPSC. According to HRSA officials, the agency’s presence  on OPTN committees helps ensure that the committees’ recommendations  are consistent with federal laws and regulations. In addition, HRSA  officials said that they and OPTN officials communicate regularly about all  aspects of the OPTN’s performance, including monitoring transplant  program compliance.
section_title: CMS’s Role and Responsibilities
paragraphs: CMS is responsible for overseeing organ transplant programs that receive  Medicare reimbursement for transplant services. At the time the high- profile cases came to light, CMS had different criteria and procedures for  overseeing extra-renal and renal transplant programs participating in  Medicare.
Extra-renal transplant programs participated in Medicare by meeting the  criteria set forth in various national coverage determinations (NCD)  published beginning in 1987. The NCDs provide that transplants of extra- renal organs for Medicare beneficiaries will be considered reasonable and  necessary and therefore reimbursable under Medicare if they are  performed in a facility that CMS approves as meeting specified criteria.  For example, heart, liver, and lung transplant programs were required to  have written patient selection criteria, perform a minimum number of  transplants each year, and meet minimum patient survival rates. The NCDs  for these programs did not include criteria for reevaluating the ongoing  performance of Medicare-approved programs.
Renal transplant programs participated in Medicare by meeting regulatory  standards for facilities furnishing end-stage renal disease (ESRD)  services. ESRD facilities include those providing dialysis services and  renal transplant services. CMS monitored renal transplant programs’  compliance with Medicare requirements by contracting with state survey  agencies—generally state departments of health—to conduct routine on- site inspections known as surveys. If a survey found a facility to be out of  compliance and if it had a major deficiency that went uncorrected, then  the facility was subject to termination from the Medicare program.
In 2005, recognizing the need to update existing requirements for extra- renal and renal transplant programs and that the NCDs did not include  criteria for reassessing the performance of extra-renal transplant  programs, CMS promulgated proposed regulations to establish a single set  of Medicare requirements for both renal and extra-renal transplant  programs.
section_title: Limitations Existed in Federal Oversight at the Time High-Profile Problems Came to Light
paragraphs: 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 did not actively monitor extra-renal transplant  programs’ compliance with criteria for Medicare approval. 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.
subsections: section_title: CMS’s Oversight Was Limited and Inconsistent
paragraphs: CMS’s oversight varied between extra-renal and renal transplant programs  and was not comprehensive even for renal transplant programs, which  received more oversight.
subsections: section_title: CMS Did Not Actively Monitor Extra-Renal Transplant Programs
paragraphs: 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. Instead, CMS’s procedure was  to conduct only an initial review of an extra-renal program to determine if  it met the criteria in the NCDs at the time the program applied for  Medicare approval. Once an extra-renal transplant program received  Medicare approval, CMS generally did not assess the program’s continued  compliance with NCD criteria. Although the NCDs for heart and liver  transplant programs called for programs to submit an application for  Medicare reapproval every 3 years, the NCDs did not specify and CMS did  not otherwise establish a process for doing so, and programs continued to  retain Medicare approval without reapplying.
To oversee extra-renal transplant programs’ ongoing compliance with  criteria for Medicare approval, CMS relied on programs to self-report  significant changes and complaints from Medicare beneficiaries and others  that would alert CMS to a potential problem. CMS officials or state  surveyors conducted complaint investigations after receiving complaints  against transplant programs or otherwise becoming aware of potential  problems, such as through media reports. CMS officials in three of the five  regions we contacted reported that they or state surveyors had  investigated nine complaints against extra-renal transplant programs  during the period of 2000 through 2006. For example, one of the three  high-profile cases initially came to light after CMS received a patient  complaint about a liver transplant program. CMS officials investigated the  complaint and discovered that this transplant program had not had a full- time surgeon on staff in over a year. After completing the complaint  investigation, CMS withdrew Medicare approval from the transplant  program, which closed shortly thereafter.
section_title: CMS Had a Process in Place to Monitor Renal Transplant Programs, but Some Programs Still Were Not Actively Reviewed
paragraphs: CMS’s oversight of renal transplant programs was more active than its  oversight of extra-renal transplant programs, although it also had  limitations. CMS contracted with state agencies to periodically perform  on-site surveys of renal transplant programs for compliance with Medicare  requirements and had a process in place to resolve problems identified  during these surveys. When state surveyors identified compliance  problems with requirements during their reviews of renal transplant  programs, CMS generally acted to resolve these problems by requiring  programs to submit corrective action plans for coming back into  compliance with requirements. According to CMS data, major problems  were generally corrected within 90 days, and only one of the five CMS  regional offices we contacted reported that CMS had withdrawn Medicare  approval from a renal transplant program in its region since 2000 for  failure to comply with Medicare requirements. This instance was the high- profile case involving an HMO that was unable to properly handle a large  influx of patients to its program.
Although CMS had a process in place to periodically review renal  transplant programs through state agency surveys of ESRD facilities, the  surveys reviewed compliance with requirements that had not been  substantially updated in decades and were limited in scope. Medicare  regulations for ESRD facilities, including renal transplant programs, were  initially published in 1976 and, according to CMS officials, had not been  substantially updated since then. For example, the regulations did not  include a requirement that renal transplant programs achieve a minimum  patient survival rate. Experts in the transplantation field have since  recognized the importance of patient-centered, outcome-oriented  performance measures, such as survival rates, and recommended their  use. In addition, while the Medicare requirements specified that renal  transplant programs should perform a minimum number of transplants per  year, CMS instructions to state surveyors did not call for them to verify  that these numbers were achieved.
Furthermore, CMS’s process to review renal transplant programs did not  ensure that all of these programs were actively monitored in practice. Our  analysis of CMS data as of May 2007 showed that 31, or about 1 in 8,  active, Medicare-approved renal transplant programs had been mistakenly  classified as no longer participating in Medicare in CMS’s survey database  or had been mistakenly excluded from the database. According to CMS  officials, these programs would not have been surveyed again after these  mistakes occurred. Our analysis showed that as of May 2007 the length of  time since the 31 programs had last been surveyed ranged from about 4 to  over 20 years; over three-quarters of these programs had not been  surveyed in the previous 10 years. By comparison, most correctly  classified programs had been surveyed in the previous 4 years, although 34  programs had not, and 9 of those programs had not been surveyed in the  previous 10 years. CMS did not have survey frequency goals specific to  renal transplant programs. However, CMS has acknowledged that not all  state agencies achieved CMS goals for conducting surveys of all ESRD  facilities (of which renal transplant programs are a subset). CMS officials  emphasized that the CMS survey and certification budget had not been  fully funded during fiscal years 2005 through 2007.
section_title: The OPTN’s Oversight Was Active and Multipronged but Was Not Sufficient to Detect All Problems
paragraphs: The OPTN’s oversight, while more active and extensive than CMS’s  oversight, also had limitations; most notably, its monitoring methods were  insufficient to promptly detect problems affecting patients waiting for  transplants.
subsections: section_title: The OPTN Actively Monitored for Many Types of Problems
paragraphs: The OPTN monitored transplant programs on an ongoing basis for  numerous types of potential problems. The OPTN’s oversight was  conducted by both OPTN staff and by its MPSC, which includes OPTN  members who are medical professionals from the field of transplantation.  The OPTN’s numerous activities to monitor compliance with OPTN  policies included reviewing information on patients placed on transplant  waiting lists, allocations of organs from deceased donors, physician  credentials, and timely submission of required data. These reviews were  generally scheduled to occur weekly or quarterly. The OPTN also  monitored on a quarterly basis two key indicators of potential  performance problems at transplant programs—lower-than-expected  patient and organ survival rates and failure to perform any transplants  during a specified period of time. In addition, the OPTN conducted  periodic routine on-site reviews of heart and liver transplant programs to  review patient medical records; the OPTN’s goal was to conduct these on- site reviews once every 3 years.
The OPTN’s monitoring activities identified many problems, ranging from  minor anomalies with organ allocations to more significant problems,  including one of the three high-profile cases. The case came to light after a  routine OPTN on-site review led staff at the transplant program to self- report that a recipient of a liver transplant had inappropriately received  the transplant ahead of others on the waiting list and that the program had  falsified patient medical records in order to conceal its actions. Our  review of a sample of compliance cases showed that the OPTN most often  identified members’ noncompliance with OPTN policies through its  routine on-site reviews (15 of 43 cases).
Our review of OPTN compliance cases and performance data and  discussions with OPTN officials indicated that the OPTN took steps to  resolve compliance and performance problems it identified during its  monitoring activities. As explained below, the OPTN’s process for  resolving members’ noncompliance with OPTN policies differs from its  process for resolving members’ performance problems, such as lower- than-expected survival rates.
Noncompliance with OPTN policies. OPTN officials emphasize that the  OPTN works to resolve most cases of noncompliance without resorting to  strong enforcement actions. Our review of a sample of compliance cases  showed that the length of time for cases to be fully resolved varied and  depended on the nature of the case. For example, a relatively minor case  involving an organ allocation discrepancy was resolved within 4 months,  while a case involving problems with medical record documentation took  about 3 years to resolve. The three high-profile cases are examples of  cases in which the OPTN took strong enforcement actions. After the  individual transplant programs involved in these cases had announced that  they would voluntarily close, the OPTN continued to review the cases and  eventually declared two of the transplant centers that operated these  transplant programs “Members Not in Good Standing” and imposed a  lesser sanction of probation on the third transplant center.
Performance problems. The OPTN flags for the MPSC’s review  transplant programs that are not achieving OPTN performance standards  for survival rates or transplant activity, but these programs are not  considered to be out of compliance with OPTN policies. Instead, the OPTN  works with these programs until they meet the standards, sometimes  sending peer review teams on-site to consult with the programs, or until  problems are otherwise resolved (for example, if a program closes  voluntarily). OPTN officials said that programs with low survival rates  typically need to show improvement in outcomes before being released  from review by the MPSC and emphasized that this can take some time. Of  72 cases the OPTN flagged for low survival rates in 2005, about 40 percent  remained under review by the MPSC as of August 2007.
section_title: The OPTN’s Monitoring Did Not Detect All High-Profile Cases and Was Not Always Timely
paragraphs: Although the OPTN conducted numerous types of monitoring activities,  these activities did not incorporate methods capable of promptly detecting  problems at transplant programs that prolonged the time that patients  waited for transplants. For example, the OPTN regularly flagged programs  for review that did not perform any transplants in a specified period of  time. 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. At the two transplant programs  with high-profile problems affecting patient access to transplants, enough  transplants were conducted that the programs were not flagged as inactive  programs. In addition, the transplants that did occur were successful  enough that the programs were not flagged as experiencing performance  problems at the time the problems came to light. However, far fewer  transplants were conducted than would be expected given the numbers of  patients on the waiting list, reflecting problems with understaffing that  ultimately affected patients’ access to transplants at these programs.
Even though a targeted method for detecting these problems was not in  place, separate pieces of information, if pieced together, could have  alerted the OPTN to at least one of the high-profile incidents. The OPTN,  however, missed opportunities to link these separate sources of  information. For example, OPTN staff who handle patient transfers were  aware that an HMO was attempting to transfer hundreds of patients to its  new transplant program at an unprecedented rate and was experiencing  problems with the transfers. However, they did not alert other appropriate  OPTN staff to the possible need for a compliance review or to look into  the situation by, for example, reviewing available data that indicated far  lower-than-expected numbers of transplants at the new program. The  problem eventually came to light after a whistleblower alerted the news  media.
In addition to having insufficient methods to detect some of the high- profile cases, the OPTN was not always timely in conducting those  monitoring activities that it performs on-site, namely routine on-site  reviews and peer review site visits. Although the OPTN’s goal was to  conduct routine on-site reviews of heart and liver programs once every   3 years, it had fallen behind this schedule. In December 2006, 50 percent of  continuously active heart and liver transplant programs had not been  reviewed on-site in the previous 3 years and 38 percent had not been  reviewed on-site in the previous 4 years. OPTN and HRSA officials  attribute the delay in routine on-site reviews to HRSA’s directive to the  OPTN to study a new lung allocation policy. Additionally, in our review of  performance data we observed that in some cases peer review site visits  were not conducted on a timely basis. For about three-fourths of  transplant programs (17 of 22) for which the MPSC recommended a peer  review site visit from July 2005 through July 2006, the site visit had not yet  occurred a year after being recommended. According to OPTN officials, a  contributing factor in the delay was that the number of programs  recommended to receive a peer review site visit significantly increased  during 2005, resulting in a backlog.
section_title: 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
paragraphs: 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. CMS has begun monitoring extra-renal transplant  programs and has finalized regulations that expand and unify Medicare  requirements for all types of transplant programs and establish procedures  for periodic review of transplant programs. 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. Also, the OPTN’s and HRSA’s set of indicators has  not yet been implemented. Further, while CMS, HRSA, and the OPTN have  begun sharing basic transplant program data, how they will share  additional information resulting from their oversight activities has not  been resolved.
subsections: section_title: CMS Strengthened Oversight by Expanding Monitoring Efforts and Issuing New Regulations
paragraphs: CMS has made substantial changes to its oversight: the agency began  monitoring extra-renal transplant programs and, most significantly,  finalized new regulations that apply to all types of transplant programs and  that require on-site surveys of all transplant programs applying for  Medicare approval.
subsections: section_title: CMS Began Monitoring Extra- Renal Transplant Programs and Took Steps to Withdraw Medicare Approval from the Most Problematic Programs
paragraphs: After high-profile problems came to light, CMS began monitoring extra- renal transplant programs’ compliance with existing Medicare NCD  criteria in 2006. According to CMS officials, the agency’s initial monitoring  effort revealed that nearly all 242 Medicare-approved programs were  complying with NCD criteria for meeting minimum survival rates. A  number of programs, however, were not in compliance with the NCD  annual transplant volume criteria, which specify that programs must  conduct a minimum number of transplants each year. CMS continued to  monitor extra-renal transplant programs and ultimately found that a total  of 49 extra-renal transplant programs did not meet the NCD transplant  volume criteria in 2005, 2006, or both. As a result, CMS notified 11  programs that agency officials viewed as the most problematic that they  could lose Medicare approval for failure to comply with NCD criteria.  Ultimately, CMS withdrew Medicare approval from 1 of the 11 programs;  of the remaining 10 programs, 2 withdrew voluntarily and 8 programs were  implementing corrective action plans as of December 2007. (See table 2.)
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. The regulations  include 13 core requirements known as Medicare conditions of  participation (CoP). Whereas renal and extra-renal transplant programs  were previously subject to different requirements and regulatory  procedures, the new regulations provide a single set of CoPs and review  procedures for all types of transplant programs. In addition, the new  regulations both update and expand upon previous requirements. For  example, the new CoPs incorporate an updated method for calculating  survival rates that reflects current best practices. The CoPs also include  entirely new requirements, such as those related to the protection of living  donors. (See app. I for more information about the 13 CoPs.)
The new regulations also bring CMS requirements into substantial  alignment with OPTN policies. Specifically, 10 of the 13 CoPs pertain to  areas addressed in OPTN policies. In some instances, CMS incorporated  OPTN policies into its requirements such that these policies are now  enforceable under federal regulation for Medicare-approved transplant  programs. In some areas, the new regulations impose additional  requirements not covered by the OPTN. For example, while OPTN policies  require transplant programs to provide social support services, CMS’s  regulations further require that social support services be furnished by a  qualified social worker, as defined by CMS. In other areas, the new CMS  requirements cover matters not addressed in existing OPTN policies. For  example, one CoP requires programs to implement formal quality  assessment and performance improvement programs—a requirement not  paralleled in OPTN policies. There are also areas of OPTN policies, largely  pertaining to organ allocation, which the CMS regulations do not address.
section_title: New Regulations Also Established Procedures for Reviewing Transplant Programs
paragraphs: In addition to updating and expanding requirements and more closely  aligning them with OPTN policies, CMS’s new regulations also subject  transplant programs to initial and periodic reviews for compliance with  the Medicare CoPs. Under the new regulations, all transplant programs  seeking Medicare approval are required to apply for initial approval;  programs that were previously Medicare approved must reapply. As part  of determining compliance with the CoPs, each transplant program that  applies for Medicare approval will undergo an on-site survey. Transplant  programs that are in compliance with all CoPs will be approved for  participation in Medicare for 3 years. Prior to the end of the initial 3-year  approval period, CMS plans to reexamine data on three key requirements,  which together compose one of the CoPs:  Data submission: Transplant programs must submit OPTN-required data to  the OPTN within specified time frames.
Clinical experience: Transplant programs must generally perform at least  10 transplants over a 12-month period.
Outcomes: Transplant programs must achieve expected survival rates.
If a program is found to be in compliance with the three requirements of  this CoP, under the new regulations CMS may choose whether to conduct  an on-site reapproval survey of the program’s compliance with additional  CoPs.
CMS plans to complete on-site surveys for transplant programs seeking  initial Medicare approval over the course of 3 years. CMS officials  reported that on-site surveys of transplant programs had begun as of  August 2007. The agency is prioritizing the order in which these surveys  will be conducted, so that programs that do not currently meet the clinical  experience and outcomes requirements will receive the highest priority for  surveys. According to CMS officials, the agency plans to complete these  high-priority surveys by the end of fiscal year 2008; all initial surveys are  planned to be completed by the end of fiscal year 2010. Until a new  Medicare approval decision is made under the new regulations, currently  approved extra-renal and renal transplant programs will remain approved  under the NCDs and requirements for ESRD facilities, respectively.
section_title: The OPTN and HRSA Have Taken Steps to Address Shortcomings in Detection of Problems
paragraphs: To address shortcomings in the OPTN’s ability to detect problems  affecting patients waiting for transplants, such as understaffing, the OPTN  and HRSA, along with another HRSA contractor, are working to develop  and implement a set of activity-level indicators. The set of indicators  would be used to monitor programs for problems, such as understaffing,  indicated by lower-than-expected activity levels in a manner similar to  how the OPTN currently monitors programs for performance problems  indicated by lower-than-expected survival rates. The set of indicators  includes two existing indicators already developed by the OPTN, one of  which, although available, was not previously reviewed by the MPSC, and  a new organ acceptance rate indicator. The new indicator, which is  intended to identify programs exhibiting lower-than-expected rates of  organ acceptance, is a key component of the set of activity-level indicators  and has been under development since January 2006. According to the  OPTN, the organ acceptance rate indicator had been developed but not yet  implemented for kidney and liver transplant programs as of February 2008.
With HRSA’s encouragement, the OPTN has also taken steps to increase  its capacity to conduct on-site monitoring activities and to improve  internal communication. The OPTN substantially increased its staff in 2007  in order to get back on schedule in conducting on-site reviews once every  3 years. According to OPTN officials, the increase in staff will also help the  OPTN address its backlog of peer review site visits and achieve its goal of  conducting all peer review site visits within 3 months of the visit being  recommended by the MPSC. To improve internal communication, the  OPTN reported that since 2006, its leadership has emphasized the  importance of shared communication, particularly across departments. As  a result, according to the OPTN, staff responsible for managing the waiting  list, including handling patient transfers, now meet frequently with staff  responsible for monitoring policy compliance to share information about  potential policy violations.
section_title: CMS, HRSA, and the OPTN Have Yet to Fully Implement Several Measures to Improve Oversight
paragraphs: Although CMS, HRSA, and the OPTN have taken steps to improve  oversight of transplant programs since the high-profile cases came to light,  three important areas remain in progress.
One key unresolved question is the extent to which CMS will conduct on- site reapproval surveys of transplant programs (as part of its new review  procedures) after transplant programs gain initial Medicare approval  under the new regulations. According to CMS’s new regulations, CMS may  choose not to conduct on-site reapproval surveys for transplant programs  meeting data submission, clinical experience, and outcomes requirements.  This means that CMS could potentially choose not to conduct any  reapproval surveys for programs meeting these requirements. While CMS  officials said that they see value in conducting reapproval surveys, just  how CMS will apply its discretion remains unclear. 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. They  emphasized the agency’s need to carefully consider resource constraints in  making these decisions. A decision by CMS not to conduct an on-site  reapproval survey at a transplant program means that compliance with  some CoPs would not be reviewed unless there was a complaint  investigation. As a result, problems at transplant programs unrelated to the  data submission, clinical experience, and outcomes requirements—for  example, a transplant program failing to provide required protections for  living donors or to sufficiently staff its program—could go undetected. In  two of the high-profile cases, staffing problems that ultimately affected  patients’ access to transplants would not have been detected by the  outcomes indicator that CMS has now adopted, and the numbers of  transplants performed per year at these programs exceeded or were close  to CMS’s clinical experience requirement.
Additional questions remain regarding the extent to which CMS will  accurately track on-site surveys to avoid the misclassification errors we  identified in our review and complete the surveys on a timely basis. As a  result of the new transplant regulations, renal transplant programs will no  longer share Medicare identification numbers with dialysis facilities, and  previously misclassified renal transplant programs will at some point  receive a new accurate classification in CMS’s survey database once they  are approved. However, the potential for transplant programs to be  mistakenly classified may remain because transplant programs within the  same hospital will share one transplant center Medicare identification  number, according to CMS officials. CMS officials said that they were  highly aware of the need for their systems to accurately track the status of  each transplant program separately. They said that they plan to test for  this capability in their new tracking system for transplant programs, which  remains under development. What also remains to be seen is the extent to  which surveys will occur on a timely basis. Prior to the new regulations,  state agencies did not always meet CMS goals for surveying ESRD  facilities. Now, under the new regulations, the responsibilities of state  agencies that will be conducting on-site surveys of transplant programs  will increase, since they will be required to survey both renal and extra- renal transplant programs. With respect to initial approval surveys, CMS’s  stated plan is that high-priority surveys of transplant programs will be  completed by the end of fiscal year 2008, but as of January 2008, CMS  officials expressed some uncertainty about meeting this goal. Initial  surveys of transplant programs have been given a relatively high priority in  the state agency workload, but it is not definite that this high priority level  will continue because CMS has revised state agency workload priorities in  the past. Further, the priority level for reapproval surveys is not yet  known; a lower priority could affect how frequently surveys occur.
The last unresolved question concerns the OPTN’s and HRSA’s planned  organ acceptance rate indicator, which as part of a set of activity-level  indicators, could potentially improve the OPTN’s ability to detect  transplant programs experiencing problems that prolong the time patients  wait for transplants. According to the OPTN, the organ acceptance rate  indicator for kidney and liver transplant programs has been developed but,  as of February 2008, has not yet been implemented; HRSA officials expect  the indicator to be in place within 1 year. HRSA and OPTN officials  reported that they are considering developing organ acceptance rate  indicators for transplant programs for other organ types. Before extending  the indicator to other types of programs, however, the OPTN will first  assess the effectiveness of the indicator at detecting potential problems at  kidney and liver transplant programs, which perform larger volumes of  transplants, and determine the feasibility of developing an indicator for  programs with lower transplant volumes, such as heart and lung transplant  programs.
section_title: 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
paragraphs: 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. To help CMS assess programs’ compliance with its  new Medicare requirements, the OPTN (through HRSA) is now sending  CMS certain basic transplant program data on a quarterly basis. For  example, the new Medicare regulations require transplant centers to be  OPTN members, so the OPTN is providing data on the status of each  transplant center’s membership in the OPTN. (See table 3.)
While this basic data sharing represents progress, CMS, HRSA, and the  OPTN have additional information resulting from their oversight activities  that could be shared. The exchange of this information is important  because CMS and the OPTN conduct different monitoring activities and, as  a result, may have different information about transplant programs that  could be relevant to each other. For example, while both CMS and the  OPTN conduct on-site reviews of transplant programs, the OPTN’s on-site  reviews focus largely on medical records review while CMS’s on-site  surveys are more broadly scoped. If the OPTN determined during an on- site review that the medical urgency assigned to patients by a transplant  program was not supported by its medical records, this information could  be of interest to CMS if this practice inappropriately reduced the chances  of others on the waiting list to receive a transplant. As another example,  the OPTN and HRSA are working to put into place their organ acceptance  rate indicator, which CMS officials said they would be interested in using.  Information from CMS’s and the OPTN’s investigations could also be  potentially important to share. For example, if CMS investigated a  complaint from a patient about the length of time he or she had been  waiting for a transplant and determined that the delay was caused by the  program failing to update the patient’s health status, a violation of OPTN  policy, the OPTN might want to flag the program for closer monitoring.
CMS and HRSA have recognized the importance of sharing information  from their oversight activities, but the agencies have not yet reached  agreement on how they would do so. CMS submitted a draft proposal to  HRSA in April 2007 describing how CMS and HRSA could potentially share  information about organ transplant programs. CMS and HRSA officials  have since discussed the initial proposal, including possible revisions, but  their progress has been slow. As of February 2008, CMS and HRSA had yet  to reach agreement or establish a time frame for doing so. According to  HRSA officials it had taken the agencies several months to better  understand each other’s oversight processes, and both agencies needed to  further explore their information needs. CMS officials also indicated that  further issues would need to be resolved before an agreement could be  reached.
As part of any agreement to share information from their oversight  activities, CMS and HRSA will need to determine precisely what  information from their oversight activities they will share and at what  point in their oversight processes they will share it. CMS and HRSA have  discussed but not resolved these issues:    Nature of information to be shared. It will be important for CMS and  HRSA to determine specifically what information they will share from  their oversight activities. For example, while CMS’s initial proposal  addressed how CMS and HRSA could share information from CMS’s and  the OPTN’s investigations of serious complaints, such as those involving  threats to patient health and safety, CMS and HRSA officials have since  discussed whether to share information from all complaints. In addition,  CMS and HRSA have not determined to what extent information from  routine inspections, such as the OPTN’s on-site reviews and CMS’s on-site  surveys, will be shared and at what level of detail. For example, CMS’s  initial proposal called for CMS to notify the OPTN about its completed on- site surveys and to indicate whether the transplant program surveyed had  a plan of correction, but it did not call for CMS to provide information on  the deficiencies CMS found. HRSA officials have since expressed their  interest in having this more detailed information.
Timing of information sharing. A more difficult challenge that CMS and  HRSA face is agreeing when to share information about potential  problems at transplant programs. Officials from both CMS and HRSA  consider the severity of the identified problem(s) with a program to be a  key factor in determining the appropriate time for information sharing. In  this regard, officials from both agencies stated a willingness to promptly  share information on potentially serious problems. Agreeing on just when  to exchange information on less serious problems has been more  problematic for the agencies in part because of differences in their  approaches to oversight. On the one hand, CMS officials emphasize their  agency’s obligation to investigate any indications of noncompliance with  Medicare requirements and prefer to be notified as soon as possible if the  OPTN discovers a potential problem indicating noncompliance with  Medicare CoPs. On the other hand, HRSA officials have emphasized that  the viability and success of the OPTN’s performance improvement process  depends upon transplant programs sharing openly about their practices or  past events. HRSA officials contend that the possibility of such  information being shared with CMS, a regulatory agency, could cause  transplant programs to be less candid about discussing real or potential  problems, making it more difficult for the OPTN to help them return to  compliance.
section_title: Conclusions
paragraphs: CMS, HRSA, and the OPTN recognize the gaps in oversight that existed  when serious problems were exposed at transplant centers and have taken  significant steps to strengthen federal oversight. The actions they have  taken will help improve standards for transplant programs and should  improve detection of potential problems. These actions include CMS’s  issuance of new regulations that expand and update requirements for  transplant programs. In addition, CMS plans to conduct on-site surveys of  all transplant programs seeking initial Medicare approval under the new  regulations and to regularly review certain transplant program data, which  should reduce the chances of problems going undetected by the agency.  Similarly, if the OPTN’s and HRSA’s efforts to develop and implement a set  of activity-level indicators to detect problems that prolong the time  patients wait for transplants are successful, the indicators will likely result  in earlier detection of these more subtle problems.
The full effect of these planned improvements, however, is unknown at  this time, and much has yet to be accomplished. While surveyors have  begun conducting on-site surveys for initial Medicare approval, CMS  expects these surveys may take 3 years to complete. CMS is still in the  process of designing its tracking system for transplant programs, and it is  important that the system include mechanisms to check that transplant  programs remain accurately classified in the CMS survey database over  time. The OPTN and HRSA are working on implementing their set of  activity-level indicators for kidney and liver transplant programs. It will be  important for the OPTN and HRSA to implement the activity-level  indicators to the extent feasible to provide improved monitoring tools to  detect problems affecting patient access to transplants like those involved  in the high-profile cases in 2005 and 2006. Attending to these areas is  critical for effective oversight, and we encourage CMS, HRSA, and the  OPTN to continue their efforts to implement these initiatives.
Of more concern are two other issues. The first is how CMS will ultimately  conduct on-site surveys for transplant programs seeking reapproval under  the new Medicare regulations. Under the regulations, CMS may choose not  to conduct such surveys for transplant programs meeting data submission,  clinical experience, and outcomes requirements. 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. CMS has not yet developed a process to determine the scope of the  transplant programs (number or type) to be included in reapproval  surveys or the criteria for determining which, if any, transplant programs  that meet the three requirements will receive such surveys. Given the  potential importance of these reapproval surveys, we believe that having a  methodology that ensures that CMS conducts surveys of at least some  transplant programs meeting the three requirements is critical to maximize  CMS’s opportunities to identify potential problems in a timely manner.
We also have a concern about the pace of progress being made to share  information about the oversight activities of CMS, HRSA, and the OPTN.  Agency officials believe, as we do, that their ability to identify potential  problems could be enhanced by sharing information resulting from their  oversight activities. While CMS’s draft proposal for sharing such  information is an important first step in reaching an agreement on this  issue, CMS and HRSA have yet to finalize an agreement or establish a time  frame for doing so. Without a definitive time frame for reaching  agreement, there is increased risk that the negotiation process among  these agencies could languish, and they could miss opportunities to detect  and remedy problems with transplant programs. Furthermore, in  developing an agreement, CMS and HRSA will need to fully articulate what  types of information will be shared from their oversight activities and  when they will share it. While we agree that there are challenges  associated with reaching agreement on this issue, we also believe it is  important to settle these issues and finalize a clear written agreement that  maximizes information sharing as appropriate and better ensures that all  parties are aware of critical information in time to take appropriate action.  Once CMS and HRSA reach and implement an agreement, they may wish  to periodically assess how effectively it is working for each of them to  improve their oversight.
section_title: Recommendations for Executive Action
paragraphs: 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.  (2) 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,    specify the types of information CMS, HRSA, and the OPTN will share and    specify at what point in CMS’s and the OPTN’s oversight processes this  information will be exchanged.
section_title: Agency Comments
paragraphs: We received comments on a draft of this report from HHS. (See app. II.)  The department concurred with both of our recommendations and  commented that CMS recognizes the need to increase its oversight of  organ transplant programs.
HHS agreed with our recommendation that CMS develop a methodology  for conducting on-site surveys for Medicare reapproval to ensure that at  least some programs meeting certain Medicare criteria are surveyed,  noting that CMS has developed an initial framework for doing so but that  its implementation will depend on the resources available for survey and  certification activities. CMS highlighted several factors the agency may use  as part of a methodology to determine survey frequencies for individual  transplant programs, including prior survey results, program changes,  program indicators, and the time interval since the last survey.
HHS also agreed with our recommendation to establish a time frame for  finalizing the agreement between HRSA and CMS to share information  from their oversight activities, noting that HRSA and CMS have been  working to develop and finalize such an agreement. Specifically, the  department commented that CMS has conveyed a proposal to HRSA  regarding the criteria and process that CMS would use in sharing  information, and that CMS would like the agreement with HRSA to be  finalized by June 30, 2008. HHS also noted that even though a formal  agreement is not yet in place, CMS and HRSA have on several occasions  already shared oversight information about particular programs.
The department also provided technical comments, which we  incorporated as appropriate.
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If you or your staff members have any questions about this report, please  contact me at (202) 512-7114 or williamsonr@gao.gov. GAO staff who  made major contributions to this report are listed in appendix III.
section_title: Appendix I: Medicare Conditions of Participation for Transplant Centers
paragraphs: On March 30, 2007, the Centers for Medicare & Medicaid Services (CMS)  published a final rule promulgating requirements for Medicare approval  and reapproval of transplant centers to perform organ transplants. The  regulations, which became effective June 28, 2007, delineate Medicare  conditions of participation for heart, heart-lung, intestine, kidney, liver,  lung, and pancreas transplant centers. Table 4 presents a summary of the  key requirements for each condition of participation.
section_title: Appendix II: Comments from the Department of Health and Human Services
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: Acknowledgments
paragraphs: In addition to the contact named above, Kim Yamane, Assistant Director;  Emily Beller; Susannah Bloch; George Bogart; Manuel Buentello;   Linda McIver; Colin Smith; Stanley Stenersen; and Suzanne Worth made  key contributions to this report.