Criterion
Threshold
Observed/expected
˃3
Observed/expected
˃1.5
P value
Two-sided P < 0.05
The criteria identified are used to scrutinize a center’s performance and outcomes closely. Oversight is provided by the UNOS Department of Member Quality (formerly the Evaluation and Quality Department) and by the OPTN/UNOS MPSC, which is made up of volunteers from the field of transplantation medicine who donate their time to ensure the integrity of the transplant system in the USA. This strict monitoring, as well as any action necessary to bring a member back into compliance, has fostered a high level of trust among transplant professionals (Abecassis et al. 2015).
The MPSC generally designates a group of reviewers to investigate the reasons for poor outcomes and report back to the MPSC. This process involves direct communication with the member and, if warranted, a formal interview before the entire committee. The MPSC may take no action, or it may issue a letter of uncontested violation, warning, or reprimand (OPTN Bylaws Appendix L, Section 15D). It also can recommend adverse actions to be taken by the OPTN board, which may lead to the member being placed on probation, necessitating a formal corrective action plan, or being declared a “member not in good standing,” with formal notice to the HHS secretary (OPTN Bylaws Appendix L, Section 15E). The MPSC also can make a recommendation to the OPTN board and HHS secretary regarding higher adverse actions, including but not limited to removal of one or more of the member’s transplant programs, termination of the member’s reimbursement under Medicare and Medicaid, and termination of the transplant hospital’s participation in Medicare or Medicaid. These actions would effectively shut down a program as it no longer would be eligible to attract referrals, patients, and payors.
The MPSC and OPTN must balance the safety of and access to transplantation for patients on a program’s transplant waiting list within the OPTN (OPTN Bylaws Appendix L, Section 16). A member in violation is given the opportunity for a formal hearing before the entire MPSC before a formal recommendation is made to the board. In addition, the member may appeal for a review by the OPTN board of directors if the MPSC proceeds with the recommendation (OPTN Bylaws Appendix L, Section 18). HHS approval is required for any of the higher-level adverse actions.
The peer review process is rigorous, and members understand its importance and consequences, as even lesser adverse actions require members to develop a corrective action plan, implement the plan, and undergo follow-up before regular membership status is restored. MPSC, along with OPTN, has addressed the concerns of patient safety aggressively and adopted recommendations in 2006–2007 from its review initiated in 2005.
Centers for Medicare and Medicaid Services and Transplantation
The Centers for Medicare and Medicaid Services (CMS) is the largest single payor in the USA for health care services in general and for transplant services in particular. It also acts as a regulator. As CMS plays an important role in end-stage renal disease (ESRD), it also plays an important role in transplant services. All individuals in the USA who develop ESRD are eligible for Medicare benefits, including kidney transplantation, at a center approved by CMS to perform kidney transplants. For nonrenal transplants, individuals in need of transplantation should show evidence of permanent medical disability or be at least 65 years of age to qualify for Medicare benefits.
Transplant centers must be certified by CMS for each organ type. Certification is based on meeting a certain volume and patient and/or graft survival rate requirements. Nonrenal transplant centers are required to submit an application to CMS for review by an expert panel. In 2005 and 2006, the media highlighted inadequacies in the oversight of transplant centers by OPTN and CMS with respect to patient safety and patients not receiving transplants despite being allocated organs. These reports resulted in a congressional review, leading CMS to propose Conditions of Participation (CoPs) in 2005 for the transplant centers. A joint task force comprising members of the American Society of Transplant Surgeons (ASTS), the American Society of Transplantation, and the International Society for Heart and Lung Transplantation examined the proposed CoPs and met with CMS; subsequently, a final rule was published in the Federal Register in 2007 (Federal Register: Center for Medicare and Medicaid 2007). Under this final rule, the CMS CoPs comprise several sections, including notification of transplant program changes, data submission, outcome review, initial approval, patient and living-donor selection, organ recovery and receipt, patient and living-donor management, quality assessment and performance improvement (QAPI), human resources, organ procurement, and patient and living-donor rights (Abecassis et al. 2008). QAPI is mandated and detailed by CMS, and transplant centers are required to track and monitor performance and also to take action for performance improvements. The CMS CoPs follow the same three criteria used to assess centers but with one difference: it uses a one-sided P value, which is more stringent (Table 2).
Table 2
CMS noncompliance thresholds to determine transplant center performance
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