CMS oversight,OPOs and transplant centers and the law of unintended consequences

Abstract: The Health Resources and Services Administration launched collaboratives with the goals of increasing donation rates, increasing the number of organs transplanted, eliminating deaths on the waiting list and improving outcomes. The Center for Medicare and Medicaid Services (CMS) recently published requirements for organ procurement organizations (OPOs) and transplant centers. Failure to meet CMS performance measures could result in OPOs losing their service area or transplant centers losing their CMS certification. CMS uses analyses by the Scientific Registry of Transplant Recipients (SRTR) to evaluate a transplant center’s performance based on risk‐adjusted outcomes. However, CMS also uses a more liberal (one‐sided) statistical test rendering more centers likely to qualify as low performing. Furthermore, the SRTR model does not incorporate some important patient variables in its statistical model which may result in biased determinations of quality of care. Cumulatively, there is much unexplained variation for transplant outcomes as suggested by the low predictive ability of survival models compared to other disease contexts. OPOs and transplant centers are unlikely to quietly accept their elimination. They may take certain steps that can result in exclusion of candidates who might otherwise benefit from transplantation and/or result in fewer transplants through restricted use of organs thought to carry higher risk of failure. CMS should join with transplant organizations to ensure that the goals of the collaborative are not inhibited by their performance measures.     

Comparison of recipient outcomes following transplant from local versus imported pancreas donors

The shortage of deceased donor organs for solid organ transplantation continues to be an ongoing dilemma. One approach to increase the number of pancreas transplants is to share organs between procurement regions. To assess for the effects of organ importation, we reviewed the outcomes of 1014 patients undergoing deceased donor pancreas transplant at a single center. We performed univariate and multivariate analyses of the association of donor, recipient and surgical characteristics with patient outcomes. Organ importation had no effect on graft or recipient survival for recipients of solitary pancreas transplants. Similarly, there was no effect on technical failure rate, graft survival or long-term patient survival for simultaneous kidney-pancreas (SPK) recipients. In contrast, there was a significant and independent increased risk of death in the first year in SPK recipients of imported organs. SPK recipients had longer hospitalizations and increased hospital costs. This increased medical complexity may make these patients more susceptible to short-term complications resulting from the longer preservation times of import transplants. These findings support the continued use of organ sharing to reduce transplant wait times but highlight the importance of strategies to reduce organ preservation times.     

Optimizing the Program‐Specific Reporting of Pancreas Transplant Outcomes

The Scientific Registry of Transplant Recipients is charged with providing program‐specific reports for organ transplant programs in the United States. Monitoring graft survival for pancreas transplant programs has been problematic as there are three different pancreas transplant procedures that may have different outcomes, and analyzing them separately reduces events and statistical power. We combined two consecutive 2.5‐year cohorts of transplant recipients to develop Cox proportional hazards models predicting outcomes, and tested these models in the second 2.5‐year cohort. We used separate models for 1‐ and 3‐year graft and patient survival for each transplant type: simultaneous pancreas–kidney (SPK), pancreas after kidney (PAK) and pancreas transplant alone (PTA). We first built a predictive model for each pancreas transplant type, and then pooled the transplant types within centers to compare total observed events with total predicted events. Models for 1‐year pancreas graft and patient survival yielded C statistics of 0.65 (95% confidence interval, 0.63–0.68) and 0.66 (0.61–0.72), respectively, comparable to C statistics for 1‐year patient and graft survival for other organ transplants. Model calibration (Hosmer–Lemeshow method) was also acceptable. We conclude that pooling the results of SPK, PAK and PTA can produce potentially useful models for reporting program‐specific pancreas transplant outcomes.     

Time for reform in transplant program–specific reporting: AST/ASTS transplant metrics taskforce

In accordance with the National Organ Transplant Act and Department of Health and Human Services’ Final Rule, the Scientific Registry of Transplant Recipients (SRTR) publicly releases biannual program‐specific reports that include analyses of transplant centers’ risk‐adjusted waitlist mortality, organ acceptance ratios, transplant rates, and graft and patient survival . Since the inception of these center metrics, 1‐year posttransplant graft and patient survival have improved, and center variation has decreased, casting uncertainty on their clinical relevance. The SRTR has recently modified center evaluations by ranking centers into 5 tiers rather than 3 tiers in an attempt to discriminate between programs performing within a tight range, further exacerbating this uncertainty. The American Society of Transplantation/American Society of Transplant Surgeons convened an expert taskforce to examine both the utility and unintended consequences of transplant center metrics. Estimates of center variation in outcomes in adjacent tiers are imprecise and fleeting, but can result in consequential changes in clinician and center behavior. The taskforce has concerns that current metrics, based principally on 1‐year graft and patient survival, provide minimal if any benefit in informing patient choice and access to transplantation, with the untoward effect of decreased utilization of organs and restriction of research and innovation.     

The effect of center volume on pancreas transplant outcomes

BACKGROUND: Caseload often correlates with improved outcomes for several surgical procedures, including solid organ transplantation. Given the unique nature of pancreas transplantation and large variation in transplant center volumes, this study aims to determine whether center volume affects patient and graft survival after pancreas transplantation. METHODS: Registry data on all forms of whole organ pancreas transplants performed between 1995 and 2000 were obtained from the United Network for Organ Sharing. Patient and graft survival rates were followed until 2002. Center volume then was categorized as: low (< 10/year), medium (10-20/year), high (21-50/year), and very high (< 50/year). Cox proportional hazard regression models were developed to evaluate factors affecting pancreas transplant outcomes. RESULTS: Very-high-volume centers were more likely to do pancreas after kidney transplant, pancreas transplant alone, pancreas with kidney transplant, and repeat transplants, while other centers more frequently performed simultaneous pancreas-kidney transplants (P < .001). Very-high-volume centers were more likely to transplant older recipients and less likely to transplant minority or Medicaid patients. Low-volume centers tended to accept pancreatic allografts from younger donors and had the longest waiting times. In models adjusting for differences in patient population, there were no differences in patient survival. However, low-volume centers had a slightly increased risk of graft loss compared to other centers. Early graft loss was similar among all centers, but medium-volume centers were at increased risk for late graft loss. CONCLUSIONS: Low center volume is not associated with increased mortality after pancreas transplantation. Other factors appear to be more important than center volume in determining pancreas transplant outcomes.     

Transplant tourism to China: the impact on domestic patient‐care decisions

Abstract: Organ procurement in China has been criticized because of its reliance on executed prisoners as donors. We aimed to assess the influence of perceptions about organ procurement practices in China on domestic patient‐care decisions. Methods: An anonymous internet administered case‐based questionnaire was used to survey a sample of healthcare professionals with affiliations to hepatology and transplantation professional societies. Results: Of 674 completed surveys, the vast majority (93%) of the respondents were physicians, surgeons or allied transplant professionals actively caring for liver transplant patients and 81% practiced in the US. A strong majority believed procurement practices were ethically sound in the US and Europe (87% and 73%) but fare fewer believed that procurement practices were ethically sound in China (4%, p < 0.001). In case‐based questions, lack of confidence in the ethical standards of organ procurement in China predicted patient‐care decisions. The majority would provide post‐transplantation care for patients who underwent liver transplantation at another domestic center, in a foreign country and in China (90%, 78%, and 63%, respectively, p < 0.001) yet respondents who suspected unethical procurement practices in China were more reluctant to do so (p < 0.001). Conclusions: Transplant professionals expressed concern about organ procurement practices in China which influenced their patient‐care decision‐making.     

Variation in Organ Quality between Liver Transplant Centers

A wide spectrum of quality exists among deceased donor organs available for liver transplantation. It is unknown whether some transplant centers systematically use more low quality organs, and what factors might influence these decisions. We used hierarchical regression to measure variation in donor risk index (DRI) in the United States by region, organ procurement organization (OPO) and transplant center. The sample included all adults who underwent deceased donor liver transplantation between January 12, 2005 and February 1, 2009 (n = 23 810). Despite adjusting for the geographic region and OPO, transplant centers’ mean DRI ranged from 1.27 to 1.74, and could not be explained by differences in patient populations such as disease severity. Larger volume centers and those having competing centers within their OPO were more likely to use higher risk organs, particularly among recipients with lower model for end‐stage liver disease (MELD) scores. Centers using higher risk organs had equivalent waiting list mortality rates, but tended to have higher post‐transplant mortality (hazard ratio 1.10 per 0.1 increase in mean DRI). In conclusion, the quality of deceased donor organ patients receive is variable and depends in part on the characteristics of the transplant center they visit.     

The Prognostic Value of Kidney Transplant Center Report Cards

SRTR report cards provide the basis for quality measurement of US transplant centers. There is limited data evaluating the prognostic value of report cards, informing whether they are predictive of prospective patient outcomes. Using national SRTR data, we simulated report cards and calculated standardized mortality ratios (SMR) for kidney transplant centers over five distinct eras. We ranked centers based on SMR and evaluated outcomes for patients transplanted the year following reports. Recipients transplanted at the 50th, 100th and 200th ranked centers had 18% (AHR = 1.18, 1.13?1.22), 38% (AHR = 1.38, 1.28?1.49) and 91% (AHR = 1.91, 1.64?2.21) increased hazard for 1‐year mortality relative to recipients at the top‐ranked center. Risks were attenuated but remained significant for long‐term outcomes. Patients transplanted at centers meeting low‐performance criteria in the prior period had 40% (AHR = 1.40, 1.22?1.68) elevated hazard for 1‐year mortality in the prospective period. Centers' SMR from the report card was highly predictive (c‐statistics > 0.77) for prospective center SMRs and there was significant correlation between centers' SMR from the report card period and the year following (ρ = 0.57, p < 0.001). Although results do not mitigate potential biases of report cards for measuring quality, they do indicate strong prognostic value for future outcomes. Findings also highlight that outcomes are associated with center ranking across a continuum rather than solely at performance margins.

     

A novel patient‐centered “intention‐to‐treat” metric of U.S. lung transplant center performance

Despite the importance of pretransplantation outcomes, 1‐year posttransplantation survival is typically considered the primary metric of lung transplant center performance in the United States. We designed a novel lung transplant center performance metric that incorporates both pre‐ and posttransplantation survival time. We performed an ecologic study of 12 187 lung transplant candidates listed at 56 U.S. lung transplant centers between 2006 and 2012. We calculated an “intention‐to‐treat” survival (ITTS) metric as the percentage of waiting list candidates surviving at least 1 year after transplantation. The median center‐level 1‐year posttransplantation survival rate was 84.1%, and the median center‐level ITTS was 66.9% (mean absolute difference 19.6%, 95% limits of agreement 4.3 to 35.1%). All but 10 centers had ITTS values that were significantly lower than 1‐year posttransplantation survival rates. Observed ITTS was significantly lower than expected ITTS for 7 centers. These data show that one third of lung transplant candidates do not survive 1 year after transplantation, and that 12% of centers have lower than expected ITTS. An “intention‐to‐treat” survival metric may provide a more realistic expectation of patient outcomes at transplant centers and may be of value to transplant centers and policymakers.     

SRTR Program-Specific Reports on Outcomes: A Guide for the New Reader

Differences in outcomes indeed exist among transplant programs and organ procurement organizations (OPO). A growing set of tools are available from the Scientific Registry of Transplant Recipients (SRTR) to measure and assess these outcomes in the different phases of the transplant process. These tools are not intended to compare two individual programs, rather to help identify programs whose practices may need further scrutiny, to be either avoided, corrected or emulated.
To understand which differences in outcomes might be due to underlying differences in populations served and which might be due to differences in treatment, it is important to compare outcomes to 'risk-adjusted' expected values. Further, it is important to recognize and assess the role that random chance may play in these outcomes by considering the p-value or confidence interval of each estimate. We present the reader with a basic explanation of these tools and their interpretation in the context of reading the SRTR Program-Specific Reports.
We describe the intended audience of these reports, including patients, monitoring and process improvement bodies, payers and others such as the media. Use of these statistics in a way that reflects a basic understanding of these concepts and their limitations is beneficial for all audiences.     

Lung Transplant Center Volume Ameliorates Adverse Influence of Prolonged Ischemic Time on Mortality

The influence of prolonged ischemic time on outcomes after lung transplant is controversial, but no research has investigated ischemic time in the context of center volume. We used data from the United Network for Organ Sharing to estimate the influence of ischemic time on patient survival conditional on center volume in the post–lung allocation score era (2005–2015). The analytic sample included 14 877 adult lung transplant recipients, of whom 12 447 were included in multivariable survival analysis. Patient survival was improved in high‐volume centers compared with low‐volume centers (log‐rank test p = 0.001), although mean ischemic times were longer at high‐volume centers (5.16 ± 1.70 h vs. 4.83 ± 1.63 h, p < 0.001). Multivariable Cox proportional hazards regression stratified by transplant center found an adverse influence of longer ischemic time at low‐volume centers but not at high‐volume centers. At centers performing 50 transplants in the period 2005–2015, for example, 8 versus 6 h of ischemia were associated with an 18.9% (95% confidence interval 6.5–32.7%; p < 0.001) greater mortality hazard, whereas at centers performing 350 transplants in this period, no differences in survival by ischemic time were predicted. Despite longer mean ischemic time at high‐volume transplant centers, these centers had favorable patient outcomes and no adverse survival implications of prolonged ischemia.     

Overview of Guidelines for Establishing a Face Transplant Program: A Work in Progress

Since 2005, nine face transplants have been performed in four countries: France, the United States (US), China and Spain. These encouraging short‐term outcomes, with the longest survivor approaching 5 years, have led to an increased interest in establishing face transplant programs worldwide. Therefore, the purpose of this article is to facilitate the dissemination of relevant details as per our experience in an effort to assist those medical centers interested in establishing a face transplant program. In this article, we address the logistical challenges involved with face transplantation; including essential program requirements, protocol details, face transplant team assembly, project funding, the organ procurement organization and the coroner. It must be emphasized that face transplantation is still experimental and its therapeutic value remains to be validated. All surgical teams pursuing this endeavor must dedicate an attention to detail and should accept a responsibility to publish their outcomes in a transparent manner in order to contribute to the international field. However, due to its inherent complexity, facial transplantation should only be performed by university‐affiliated medical institutions capable of orchestrating a specialized multidisciplinary team with a long‐term commitment to its success.     

Center variation in long-term outcomes for socioeconomically deprived children

Neighborhood socioeconomic deprivation is associated with adverse outcomes after pediatric liver transplant. We sought to determine if this relationship varies by transplant center. Using SRTR, we included patients <18 years transplanted 2008–2013 (N = 2804). We matched patient ZIP codes to a deprivation index (range [0,1]; higher values indicate increased socioeconomic deprivation). A center-level patient-mix deprivation index was defined by the distribution of patient-level deprivation. Centers (n = 66) were classified as high or low deprivation if their patient-mix deprivation index was above or below the median across centers. Center quality was classified as low or high graft failure if graft survival rates were better or worse than the overall 10-year graft survival rate. Primary outcome was patient-level graft survival. We used random-effect Cox models to evaluate center-level covariates on graft failure. We modeled center quality using stratified Cox models. In multivariate analysis, each 0.1 increase in the patient-mix deprivation index was associated with increased hazard of graft failure (HR 1.32; 95%CI: 1.05, 1.66). When stratified by center quality, patient-mix deprivation was no longer significant (HR 1.07, 95%CI: 0.89, 1.28). Some transplant centers care for predominantly high deprivation children and maintain excellent outcomes. Revealing and replicating these centers’ practice patterns should enable more equitable outcomes.     

History of deceased organ donation, transplantation, and organ procurement organizations

The historical development of deceased organ donation, transplantation, and organ procurement organizations is reviewed. The concept of transplantation, taking parts from one animal or person and putting them into another animal or person, is ancient. The development of organ transplantation brought on the need for a source of organs. Although many early kidney transplants used kidneys from living donors, these donors could not satisfy the ever-growing need for organs, and extrarenal organs were recovered only from deceased donors. This need for organs to satisfy the great demand led to specialized organizations to identify deceased donors, manage them until recovery occurred, and to notify transplant centers that organs were available for their patients. The functions of these organ procurement organizations expanded to include other required functions such as education, accounting, and compliance with state and federal requirements. Because of the shortage of organs relative to the demand, lack of a unified organ allocation system, the perception that organs are a national resource and should be governed by national regulations, and to improve results of organ procurement organizations and transplant centers, the federal government has regulated virtually all phases of organ procurement and transplantation.     

Expanding transplant outcomes research opportunities through the use of a common data model

The volume of solid organ transplant in the United States is increasing, providing improved quality of life and survival for patients with organ failure. The growth of transplant requires a systematized management of transplant outcomes assessment, especially with the movement toward value‐based care. However, there are several challenges to analyzing outcomes in the current registry‐based, transplant reporting system: (1) longitudinal data points are difficult to capture in outcomes models; (2) data elements are restricted to those that already exist in the registry data; and (3) there is a delay in the release of outcomes report. In this article, we propose an informatics approach to solve these problems by using a “common data model” to integrate disparate data sources, data elements, and temporal data points. Adopting such a framework can enable multicenter outcomes analyses among transplant centers, nationally and internationally.     

The impact of COVID-19 on kidney transplantation and the kidney transplant recipient – One year into the pandemic

The COVID-19 pandemic has significantly changed the landscape of kidney transplantation in the United States and worldwide. In addition to adversely impacting allograft and patient survival in postkidney transplant recipients, the current pandemic has affected all aspects of transplant care, including transplant referrals and listing, organ donation rates, organ procurement and shipping, and waitlist mortality. Critical decisions were made during this period by transplant centers and individual transplant physicians taking into consideration patient safety and resource utilization. As countries have begun administering the COVID vaccines, new and important considerations pertinent to our transplant population have arisen. This comprehensive review focuses on the impact of COVID-19 on kidney transplantation rates, mortality, policy decisions, and the clinical management of transplanted patients infected with COVID-19.     

The association of candidate mortality rates with kidney transplant outcomes and center performance evaluations

Timely access to transplantation for eligible patients with end-stage renal disease (ESRD) is critical. However, pressures exist to improve efficiencies in transplantation and to achieve high center performance ratings, including the recently submitted "Final Rule" by Center for Medicare and Medicaid Services. This policy may affect the availability of public funding for as many as 10% of kidney transplant centers in the United States. This study examined adult solitary kidney transplant candidates from 1995 to 2005 using a national database. Mortality rates were calculated for candidates at individual centers prior to transplantation. Posttransplant survival and center's standardized mortality ratios were then calculated and compared to rates of candidate mortality. Candidate mortality rates varied substantially across centers (highest quartile with almost 2-fold elevated mortality). Recipients at centers with the highest candidate mortality rates had approximately 1.9 years reduced median graft survival for deceased donor transplants and decreased patient survival even after risk adjustment (adjusted hazard ratio=1.33, 95% confidence interval 1.25-1.41). This association was greater among living transplants (adjusted hazard ratio=1.49, 95% confidence interval 1.31-1.70). For 1-year outcomes, 19% (43/224) of centers met criteria for low performance for either graft loss or patient death in living or deceased donor transplants. Of these, 51% were among centers with the highest candidate mortality as compared to 7% of centers with the lowest candidate mortality. The health status of centers' transplant candidate pool is a significant determinant of outcomes and performance ratings. Centers with a higher risk candidate pool are significantly more likely to be identified for poor performance and could potentially lose public funding. Pressures to enhance outcomes may lead centers to exclude high-risk but otherwise viable transplant candidates.     

The aggressive phenotype: center-level patterns in the utilization of suboptimal kidneys

Despite the fact that suboptimal kidneys have worse outcomes, differences in waiting times and wait-list mortality have led to variations in the use of these kidneys. It is unknown whether aggressive center-level use of one type of suboptimal graft clusters with aggressive use of other types of suboptimal grafts, and what center characteristics are associated with an overall aggressive phenotype. United Network for Organ Sharing (UNOS) data from 2005 to 2009 for adult kidney transplant recipients was aggregated to the center level. An aggressiveness score was assigned to each center based on usage of suboptimal grafts. Deceased-donor transplant volume correlated with aggressiveness in lower volume, but not higher volume centers. Aggressive centers were mostly found in regions 2 and 9. Aggressiveness was associated with wait-list size (RR 1.69, 95% CI 1.20-2.34, p = 0.002), organ shortage (RR 2.30, 95% CI 1.57-3.37, p < 0.001) and waiting times (RR 1.75, 95% CI 1.20-2.57, p = 0.004). No centers in single-center OPOs were classified as aggressive. In cluster analysis, the most aggressive centers were aggressive in all metrics and vice versa; however, centers with intermediate aggressiveness had phenotypic patterns in their usage of suboptimal kidneys. In conclusion, wait-list size, waiting times, geographic region and OPO competition seem to be driving factors in center-level aggressiveness.     

American Society of Transplant Surgeons Transplant Center Outcomes Requirements—A Threat to Innovation

The transplant center regulations recently published by the Centers for Medicare and Medicaid (CMS) mandate that observed program-specific survival outcomes to fall within expected risk-adjusted outcomes. Meeting these outcomes is essential to continued participation in the Medicare program. Both donor and recipient variables not considered in current risk adjustment models can result in inferior outcomes and therefore may cause an overestimation of transplant center expected performance, precluding participation in the federally funded Medicare program. We reviewed the most recent four reporting periods published by the Scientific Registry for Transplant Recipients on their public website. We identified kidney, liver and heart transplant programs that were flagged for having outcomes statistically lower than expected as well as those that failed to meet CMS criteria. We also analyzed whether center volumes correlated with outcomes in these centers. We highlight the need for mitigating factors that could justify inferior outcomes under specific circumstances. Failure to reach consensus on such a mechanism for appeal may result in risk-averse behavior by transplant centers with respect to innovation and therefore hamper the ability to advance the field of transplantation. We propose a methodology that may address this emerging dilemma.     

Best practices to optimize utilization of the National Living Donor Assistance Center for the financial assistance of living organ donors

Living organ donors face direct costs when donating an organ, including transportation, lodging, meals, and lost wages. For those most in need, the National Living Donor Assistance Center (NLDAC) provides reimbursement to defray travel and subsistence costs associated with living donor evaluation, surgery, and follow‐up. While this program currently supports 9% of all US living donors, there is tremendous variability in its utilization across US transplant centers, which may limit patient access to living donor transplantation. Based on feedback from the transplant community, NLDAC convened a Best Practices Workshop on August 2, 2018, in Arlington, VA, to identify strategies to optimize transplant program utilization of this valuable resource. Attendees included team members from transplant centers that are high NLDAC users; the NLDAC program team; and Advisory Group members. After a robust review of NLDAC data and engagement in group discussions, the workgroup identified concrete best practices for administrative and transplant center leadership involvement; for individuals filing NLDAC applications at transplant centers; and to improve patient education about potential financial barriers to living organ donation. Multiple opportunities were identified for intervention to increase transplant programs’ NLDAC utilization and reduce financial burdens inhibiting expansion of living donor transplantation in the United States.