The Evolution and Direction of OPTN Oversight of Live Organ Donation and Transplantation in the United States

For more than 20 years, the Organ Procurement and Transplantation Network (OPTN) has developed policies and bylaws relating to equitable allocation of deceased donor organs for transplantation. United Network for Organ Sharing (UNOS) operates the OPTN under contract with the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS). Until recent years, the OPTN had little defined authority regarding living donor organ for transplantation except for the collection of data relating to living donor transplants.
Beginning with the implementation of the OPTN Final Rule in 2000, and continuing with more recent announcements, the OPTN's role in living donation has grown. Its responsibilities now include monitoring of living donor outcomes, promoting equity in nondirected living donor transplantation and ensuring that transplant programs have expertise and established protocols to promote the safety of living donors and recipients. The purpose of this article is to describe the evolving mandates for the OPTN in living donation, as well as the network's recent activities and ongoing efforts.     

Lung and Heart Allocation in the United States

Lung and heart allocation in the United States has evolved over the past 20–30 years to better serve transplant candidates and improve organ utilization. The current lung allocation policy, based on the Lung Allocation Score, attempts to take into account risk of death on the waiting list and chance of survival posttransplant. This policy is flexible and can be adjusted to improve the predictive ability of the score. Similarly, in response to the changing clinical phenotype of heart transplant candidates, heart allocation policies have evolved to a multitiered algorithm that attempts to prioritize organs to the most infirm, a designation that fluctuates with trends in therapy. The Organ Procurement and Transplantation Network and its committees have been responsive, as demonstrated by recent modifications to pediatric heart allocation and mechanical circulatory support policies and by ongoing efforts to ensure that heart allocation policies are equitable and current. Here we examine the development of US lung and heart allocation policy, evaluate the application of the current policy on clinical practice and explore future directions for lung and heart allocation.     

Direction of the Organ Procurement and Transplantation Network and United Network for Organ Sharing Regarding the Oversight of Live Donor Transplantation and Solicitation for Organs

The Organ Procurement and Transplantation Network (OPTN) operated by United Network for Organ Sharing (UNOS) has taken recent steps to address public solicitation for organ donors and its oversight of live donor transplantation. This report provides the direction of the OPTN regarding deceased donor solicitation. The OPTN has authority under federal law to equitably allocate deceased donor organs within a single national network based upon medical criteria, not upon one's social or economic ability to utilize resources not available to all on the waiting list. The OPTN makes a distinction between solicitations for a live donor organ versus solicitations for directed donation of deceased organs. As to live donor solicitation, the OPTN cannot regulate or restrict ways relationships are developed in our society, nor does it seek to do so. OPTN members have a responsibility of helping protect potential recipients from hazards that can arise from public appeals for live donor organs. Oversight and support of the OPTN for live donor transplantation is now detailed by improving the reporting of live donor follow-up, by providing a mechanism for facilitating anonymous live kidney donation, and by providing information for potential live kidney donors via the UNOS Transplant Living website.     

Perspectives on donor lung allocation from both sides of the Atlantic: The United States

Donor lung allocation in the United States focuses on decreasing waitlist mortality and improving recipient outcomes. The implementation of allocation policy to match deceased donor lungs to waitlisted patients occurs through a unique partnership between government and private organizations, namely the Organ Procurement and Transplantation Network under the Department of Health and Human Services and the United Network for Organ Sharing. In 2005, the donor lung allocation algorithm shifted toward the prioritization of medical urgency of waitlisted patients instead of time accrued on the waitlist. This led to the Lung Allocation Score, which weighs over a dozen clinical variables to predict a 1-year estimate of survival benefit, and is used to prioritize waitlisted patients. In 2017, the use of local allocation boundaries was eliminated in favor of a 250 nautical mile radius from the donor hospital as the first unit of distance used in allocation. The next upcoming iteration of donor allocation policy is expected to use a continuous distribution algorithm where all geographic boundaries are eliminated. There are additional opportunities to improve donor lung allocation, such as for patients with high antibody titers with access to a limited number of donors.     

Kidney,Pancreas and Liver Allocation and Distribution in the United States

Kidney transplant and liver transplant are the treatments of choice for patients with end‐stage renal disease and end‐stage liver disease, respectively. Pancreas transplant is most commonly performed along with kidney transplant in diabetic end‐stage renal disease patients. Despite a steady increase in the numbers of kidney and liver transplants performed each year in the United States, a significant shortage of kidneys and livers available for transplant remains. Organ allocation is the process the Organ Procurement and Transplantation Network (OPTN) uses to determine which candidates are offered which deceased donor organs. OPTN is charged with ensuring the effectiveness, efficiency and equity of organ sharing in the national system of organ allocation. The policy has changed incrementally over time in efforts to optimize allocation to meet these often competing goals. This review describes the history, current status and future direction of policies regarding the allocation of abdominal organs for transplant, namely the kidney, liver and pancreas, in the United States.     

Simultaneous Liver–Kidney Allocation Policy: A Proposal to Optimize Appropriate Utilization of Scarce Resources

The introduction of the Mayo End‐Stage Liver Disease score into the Organ Procurement and Transplantation Network (OPTN) deceased donor liver allocation policy in 2002 has led to a significant increase in the number of simultaneous liver–kidney transplants in the United States. Despite multiple attempts, clinical science has not been able to reliably predict which liver candidates with renal insufficiency will recover renal function or need a concurrent kidney transplant. The problem facing the transplant community is that currently there are almost no medical criteria for candidacy for simultaneous liver–kidney allocation in the United States, and this lack of standardized rules and medical eligibility criteria for kidney allocation with a liver is counter to OPTN's Final Rule. Moreover, almost 50% of simultaneous liver–kidney organs come from a donor with a kidney donor profile index of ≤0.35. The kidneys from these donors could otherwise be allocated to pediatric recipients, young adults or prior organ donors. This paper presents the new OPTN and United Network of Organ Sharing simultaneous liver–kidney allocation policy, provides the supporting evidence and explains the rationale on which the policy was based.     

Scientific Registry of Transplant Recipients: Collecting,analyzing, and reporting data on transplantation in the United States

Founded in 1987, the Scientific Registry of Transplant Recipients (SRTR) operates under a contract from the US government administered by the Health Resources and Services Administration (HRSA). SRTR maintains a database of comprehensive information on all solid organ transplantation in the US. The registry supports the ongoing evaluation of the clinical status of solid organ transplantation, including kidney, heart, liver, lung, intestine, pancreas, and multi-organ transplants. Data in the registry are from multiple sources, but most are collected by the Organ Procurement and Transplantation Network (OPTN) from hospitals, organ procurement organizations, and immunology laboratories. The data include information on current and past organ donors, transplant candidates, transplant recipients, transplant outcomes, and outcomes of living donors. SRTR uses these data to create reports and analyses for HRSA, OPTN committees that make organ allocation policy, and the Centers for Medicare & Medicaid Services to carry out quality assurance surveillance activities; SRTR also creates standard analysis files for scientific investigators. In addition, SRTR and OPTN produce an Annual Data Report and provide information upon request for the general public. Thus, SRTR supports the transplant community with information services and statistical analyses to improve patient access to and outcomes of organ transplant.     

National landscape of HIV+ to HIV+ kidney and liver transplantation in the United States

The HIV Organ Policy Equity (HOPE) Act, enacted on November 21, 2013, enables research on the transplantation of organs from donors infected with human immunodeficiency virus (HIV) (HIV+) into HIV+ individuals who, prior to transplantation, are infected with HIV. In 2015, the Organ Procurement and Transplantation Network revised organ allocation policies on November 21, and on November 23, the Secretary of Health and Human Services published research criteria and revised the Final Rule accordingly. The HOPE Act appears to be underutilized to date. As of December 31, 2018, there were 56 donors recovered (50 donors transplanted) resulting in 102 organs transplanted (31 liver, 71 kidney). As of December 31, 2018, 212 registrations were indicated on the waiting list as willing to accept an HIV+ kidney or liver, most of which were waiting in active status. Due to the limited number of transplants performed to date, definitive safety conclusions cannot be reached at this time, though current data suggest that 1‐year patient and graft survival does not deviate in a major way from that observed in HIV+ recipients of non‐HIV+ organs or non‐HIV+ recipients. As safety data are reviewed and disseminated, it is anticipated that HOPE participation will increase should safety signals remain low.     

Proceedings of the AST heart allocation meeting at the American Transplant Congress,Philadelphia, Pennsylvania,May 4, 2015

Ensuring fair and equitable allocation of donor hearts in the US is the charge of the Organ Procurement and Transplantation Network (OPTN). However, the recent increase of candidates waiting without a corresponding increase in available donors, higher waitlist mortality rates in higher status patients, the presence of disadvantaged subgroups, and the changing management of heart failure patients with increased VAD usage, has necessitated review of allocation policy. Therefore, the Heart Subcommittee of the OPTN/UNOS Thoracic Committee is exploring a further‐tiered allocation system, devising a “straw man” model as a starting point for modeling analyses and public discussion. On May 4, 2015, an American Society of Transplantation (AST)‐endorsed forum to discuss these potential proposed changes took place. Attendees included 41 people, mostly highly experienced transplant cardiologists and cardiothoracic surgeons, representing 19 heart transplant centers across the US, UNOS, and the Scientific Registry of Transplant Recipients (SRTR). There was unanimous agreement that the potential proposed policy will require careful wording to avoid ambiguity and “gaming” of the system, and strong support for abolishment of local organ sharing in favor of geographic sharing. However, contention existed concerning the appropriate prioritization levels of ECMO, temporary VAD/TAH patients as well as the 30‐day LVAD listing.     

Long-Term Graft Outcome Analyzed From a National Registry Point of View

It has been 10 years since the “Taiwan Organ Registry and Sharing Center” (TORSC) was founded by the Department of Health in June 2002. The mission of TORSC is to build a fair organ sharing and registration network and also a national database collection and analysis mechanism. TORSC is also dedicated to improving the organ donation rate and shortening the waiting times for patients to improve the effective usage of donated organs. The first organ was formally allocated on April 1, 2005. In this article, we will present the initial 8-year results of this allocation system focusing on kidneys. From the first organ shared on April 1, 2005 to March 31, 2013, there were 1502 donors allocated by TORSC. There were 1063 males and 439 females, with a mean age for males of 42.41 and for females of 41.99. Total organs they donated were hearts 642, livers 688, kidneys 1626, lungs 50, pancreas 88, and cornea 1973. The overall nation-wide 3-year survival rate of kidney recipients was 93.72% for patients and 83.08% for kidney grafts. In comparison, the 3-year graft survival rate presented in the 2008 Organ Procurement and Transplantation Network/Scientific Registry of Transplant Recipients (OPTN/SRTR) annual report was 82.4% for kidney. According to our data, graft survival is not inferior to OPTN/SRTR, although the patient numbers are not comparable.     

The trials and tribulations of liver allocation

Allocation policies are necessary to ensure a fair distribution of a scarce resource. The goal of any liver transplant allocation policy is to achieve the best possible outcomes for the waiting list population, irrespective of the indication for transplant, whilst maximizing organ utilization. Organ allocation for liver transplantation has evolved from simple centre-based approaches driven by local issues, to complex, evidence-based algorithm prioritizing according to need. Despite the rapid evolution of allocation policies, there remain a number of challenges and new approaches are required to ensure transparency and equity on the decision-making process and the best possible outcomes for patients on the waiting list. New ways of modelling, together with novel outcome criteria, will be required to enable a dynamic adaptability of the allocation policies to the ever changing demographics of the donor population and the changing landscape of indications for transplantation.     

The OPTN Deceased Donor Potential Study: Implications for Policy and Practice

The Organ Procurement and Transplantation Network (OPTN) Deceased Donor Potential Study, funded by the Health Resources and Services Administration, characterized the current pool of potential deceased donors and estimated changes through 2020. The goal was to inform policy development and suggest practice changes designed to increase the number of donors and organ transplants. Donor estimates used filtering methodologies applied to datasets from the OPTN, the National Center for Health Statistics, and the Agency for Healthcare Research and Quality and used these estimates with the number of actual donors to estimate the potential donor pool through 2020. Projected growth of the donor pool was 0.5% per year through 2020. Potential donor estimates suggested unrealized donor potential across all demographic groups, with the most significant unrealized potential (70%) in the 50–75‐year‐old age group and potential Donation after Circulatory Death (DCD) donors. Actual transplants that may be realized from potential donors in these categories are constrained by confounding medical comorbidities not identified in administrative databases and by limiting utilization practices for organs from DCD donors. Policy, regulatory, and practice changes encouraging organ procurement and transplantation of a broader population of potential donors may be required to increase transplant numbers in the United States.     

Restructuring the Organ Procurement and Transplantation Network contract to achieve policy coherence and infrastructure excellence

The Organ Procurement and Transplantation Network (OPTN) went up for competitive bid again this year, yet this contract has been held by only 1 entity since its inception. The OPTN's scope has grown steadily, and it now embraces several disparate missions: to operate the computing and coordination infrastructure that maintains waitlists and makes organ offers in priority order, to regulate transplant centers and organ procurement organizations, to follow and protect living donors, and to decide organ allocation policy in concert with the many voices of the transplant community. The contracting process and performance work statement continue to discourage both innovative approaches to the OPTN and competitive bids outside of United Network for Organ Sharing (UNOS), with evaluation criteria that either disqualify or strongly disadvantage new applicants. The performance work statement also emphasizes bureaucratic tasks while obligating the OPTN contractor to the specific committee structure that has impeded decision‐making and tended to preserve the status quo in controversial matters. Finally, the UNOS computing infrastructure is antiquated and requires months to years to implement small changes. Restructuring the OPTN contract to separate the information technology requirements from the policy/regulatory responsibilities might allow more nimble and effective specialty contractors to offer their capabilities in service of the national transplant enterprise.     

Medicine and ethics. How to allocate transplantable organs

Organ transplantation has made tremendous strides in the last decade. The demand for transplantable organs has far outstripped the supply; waiting lists have grown long and patients are dying for want of vital organs. Therefore policies and criteria that guide the allocation of transplantable organs become ever more important. Over the years, allocation policies have evolved by including both medical and ethical considerations, and much work has gone into defining and analyzing components of such policies. However, they have often grown by accretion, and a parallel analysis of both sets of approaches did not occur. This article attempts to integrate medical and ethical considerations, and to develop a schema that will permit review, redefinition, and--it is hoped--development of a fairer, more equitable and responsive allocation system.     

Organ Donation and Utilization in the United States, 1997–2006

Deceased organ donation has increased rapidly since 2002, coinciding with implementation of the Organ Donation Breakthrough Collaborative. The increase in donors has resulted in a corresponding increase in the numbers of kidney, liver, lung and intestinal transplants. While transplants for most organs have increased, discard and nonrecovery rates have not improved or have increased, resulting in a decrease in organs recovered per donor (ORPD) and organs transplanted per donor (OTPD). Thus, the expansion of the consent and recovery of incremental donors has frequently outpaced utilization. Meaningful increases in multicultural donation have been achieved, but donations continue to be lower than actual rates of transplantation and waiting list registrations for these groups. To counteract the decline in living donation, mechanisms such as paired donation and enhanced incentives to organ donation are being developed. Current efforts of the collaborative have focused on differentiating ORPD and OTPD targets by donor type (standard and expanded criteria donors and donors after cardiac death), utilization of the OPTN regional structure and enlisting centers to increase transplants to match increasing organ availability.     

Donor‐Transmitted Malignancies in Organ Transplantation: Assessment of Clinical Risk

The continuing organ shortage requires evaluation of all potential donors, including those with malignant disease. In the United States, no organized approach to assessment of risk of donor tumor transmission exists, and organs from such donors are often discarded. The ad hoc Disease Transmission Advisory Committee (DTAC) of the Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) formed an ad hoc Malignancy Subcommittee to advise on this subject. The Subcommittee reviewed the largely anecdotal literature and held discussions to generate a framework to approach risk evaluation in this circumstance. Six levels of risk developed by consensus. Suggested approach to donor utilization is given for each category, recognizing the primacy of individual clinical judgment and often emergent clinical circumstances. Categories are populated with specific tumors based on available data, including active or historical cancer. Benign tumors are considered in relation to risk of malignant transformation. Specific attention is paid to potential use of kidneys harboring small solitary renal cell carcinomas, and to patients with central nervous system tumors. This resource document is tailored to clinical practice in the United States and should aid clinical decision making in the difficult circumstance of an organ donor with potential or proven neoplasia.     

The Oversight of Solid Organ Transplantation in the United States

The publication of the Organ Procurement and Transplantation Network (OPTN) Final Rule in 2000 resulted in a new and different regulatory environment for solid organ transplantation in the United States. In this review the role of the OPTN in providing oversight is clarified, differentiating the powers of enforcement the OPTN and HHS possess compared to the importance of confidential peer review in promoting compliance with OPTN policies. The function of the OPTN's Membership and Professional Standards Committee (MPSC) in adjudicating center performance and investigating alleged violations is described as well as the type and impact of adverse actions that the MPSC can recommend. The role of the OPTN Board compared to that of the Secretary of HHS in determining adverse actions is differentiated. We describe MPSC's broad scope of work in the ongoing evaluation of performance of all transplant centers. Finally, the relationship between the OPTN oversight and other entities charged with safe health care practices in the United States is considered.     

Evolution in allocation rules for renal, hepatic, pancreatic and intestinal grafts

Organ transplantation is the victim of his own success. The results of transplantation are excellent and more patients are activated on the waiting list. The need for organs exceeds the supply. Which criteria are used to allocate available grafts to patients on the waiting list ? Organ allocation and finding the "best match" between donor and recipients, is the goal of Eurotransplant, the organ sharing organization for seven European countries (Austria, Croatia, Germany, Luxemburg, Slovenia, The Netherlands and Belgium). Last decade, the allocation system has switched from a "center-driven" (organ allocated to a center) to a "patient-driven" system (organ allocated to a particular patient). For the allocation of abdominal organs some general allocation rules are followed: blood group compatibility, priority for high urgencies. The allocation of kidneys is based on a point score system based on waiting time, HLA and donor location (to reduce the cold ischemia time). In addition to this standard allocation procedure, there are still specific procedures for pediatric recipients and for candidates > or = 65 year old. There is also an "acceptable" mismatch program for recipients at high immunological risk. The liver allocation system recently changed and is now based on the MELD score, a formula that calculates the probability of death within 3 months on the waiting list. For pancreas and intestine, the system is based on blood group, medical urgency, waiting time, donor region and weight (for intestine).     

Thoracic organ transplantation

This article presents an overview of factors associated with thoracic transplantation outcomes over the past decade and provides valuable information regarding the heart, lung, and heart-lung waiting lists and thoracic organ transplant recipients. Waiting list and post-transplant information is used to assess the importance of patient demographics, risk factors, and primary cardiopulmonary disease on outcomes.
The time that the typical listed patient has been waiting for a heart, lung, or heart-lung transplant has markedly increased over the past decade, while the number of transplants performed has declined slightly and survival after transplant has plateaued. Waiting list mortality, however, appears to be declining for each organ and for most diseases and high-severity subgroups, perhaps in response to recent changes in organ allocation algorithms. Based on perceived inequity in organ access and in response to a mandate from Health Resources and Services Administration, the lung transplant community is developing a lung allocation system designed to minimize deaths on the waiting list while maximizing the benefit of transplant by incorporating post-transplant survival and quality of life into the algorithm. Areas where improved data collection could inform evolving organ allocation and candidate selection policies are emphasized.     

Living kidney donors in need of kidney transplants: a report from the organ procurement and transplantation network

BACKGROUND: Our aim was to use the Organ Procurement and Transplantation Network (OPTN) database to determine the number of renal waitlist candidates who previously had been living donors. METHODS: All living renal donors in the OPTN database were cross-checked against the renal waitlist history files. Additionally, renal transplant programs were contacted that had listed candidates as qualified for four additional allocation points available to patients who previously had donated an organ. Confirmatory phone calls to transplant programs yielded additional cases previously unreported to the United Network for Organ Sharing. RESULTS: A total of 56 previous living donors were identified as having been subsequently listed for cadaveric kidney transplantation. Forty-three have received transplants; 36 currently have functioning grafts. One died after transplantation. Two candidates died while waiting. CONCLUSIONS: Living renal donation has long-term risks that may not be apparent in the short term. The numbers here reported underestimate the actual number of living donors with renal failure, because they include only patients listed for a kidney transplant. To determine risk factors for postdonation renal failure, long-term living-donor follow-up data are needed.