HRSA Pushes OPTN Reforms as Criticism of US Organ Transplantation System Increases
Year: 2023
Type: article
Abstract: Congress passed the 1984 National Organ Transplant Act to unify organ donation, recovery, and allocation. Blaming a system they say fails to provide organs promptly, efficiently, and fairly, observers fear organ transplantation in the United States is in peril as demand expands and the number of patients dying on waiting lists increases.1 The National Organ Transplant Act created the Organ Procurement and Transplantation Network (OPTN) to contract with a private nonprofit organization to establish and maintain a list of individuals requiring transplantation and a computerized system to match organs and potential recipients, especially those considered hardest to match. The United Network for Organ Sharing (UNOS) has held the contract since 1986. Critics see the root of the problem in UNOS’s perceived monopoly2 and call for UNOS’s functions to be broken into separate contracts. Amid ongoing criticism of the system, the US Senate Committee on Finance concluded in August 2022 hearings that the OPTN inadequately oversees the nation's 57 Organ Procurement Organizations (OPOs). Senators charged that the lack of UNOS’s oversight caused errors in tests, organs lost or destroyed in transit, and patient lives lost. They said that UNOS’s outdated computing system led to failures and delays in allocating organs (UNOS Hearing Memo). In response to these concerns, the US Health Resources and Services Administration (HRSA), the government agency entrusted with overseeing the national organ transplantation system, launched the OPTN Modernization Initiative. We discuss the Initiative in this Perspective, supporting the need for improvement but suggesting that the Initiative must not inadvertently disrupt the system while the OPTN and UNOS work to reform organ recovery and organ allocation. HRSA needs to make clear how reforms will make the system more transparent, accountable, and efficient in placing organs. The HRSA Initiative focuses on technology, data transparency, governance, operations, and quality improvement and innovation. It proposes data dashboards with specifics from individual transplant centers and OPOs on organ retrieval, waitlist outcomes, and transplants. HRSA intends to seek multiple contract bids for awards to manage the OPTN and grant more independence to the OPTN Board of Directors, arguing that “robust competition” will help the OPTN modernize the system, and HRSA created a website to track progress (OPTN Modernization [HRSA.gov]).3 We need to define transparency and public trust to prevent them from becoming buzzwords. Transplant centers must give prospective transplant patients clear, easily accessible information about the steps from referral through evaluation and transplantation to offer them the best chance of obtaining an organ.4 At the system level, critics call for open software to replace UNOS's proprietary software to allow for better data entry and better organ tracking after recovery. Increasing public trust in the transplant system requires a robust discussion about the rights of donors and recipients. This includes reassurances that donation was not the cause of death and removing barriers to transplant due to systemic inequity. A major complaint centers on the ongoing shortage of organs. Critics blame OPO underperformance for the number of organs wasted after recovery. The Centers for Medicare & Medicaid (CMS) in its 2022 final rule on OPOs estimate that 22 OPOs would fall into the lowest tier for meeting organ retrieval standards, but that 5600 more organs could be transplanted a year if all OPOs increased their performance to the top 25%. CMS calculates potential donors as people aged 75 years or younger who die in hospitals and have no contraindication to donating. Using more kidneys from older donors will require detailed discussion between transplant professionals and patients about using organs with reduced expected survival in exchange for time off dialysis. Society needs to discuss its willingness to accept techniques like normothermic regional perfusion, which improves the quality of recovered organs and likelihood of transplantation, but may risk violating the dead donor rule once perfusion is restored after cardiovascular death.5 Organ allocation has moved from regional allocation to acuity circles and is headed toward continuous distribution nationally.6 This will require increased computing power, logistical agility, and cooperation between OPOs and transplant centers. Computing and transportation seem the ideal starting points for transforming the transplant network. Legislators have introduced measures authorizing HRSA to put out competitive bids for organ transportation and computing. For now, HRSA has extended UNOS's contract for 6 months. HRSA needs to show how separate UNOS and OPTN boards will improve accountability. Ideally, the OPTN would retain overall say on establishing policy and oversight of UNOS, other contractors, and UNOS members through its Membership Professional Standards Committee. UNOS would retain authority to carry out policy and supervise OPOs and member hospitals but would need increased enforcement powers from CMS to remove poorly performing OPOs from the network or merge them with better organized ones. UNOS has called for more data to identify OPOs that fail to meet minimum performance standards to identify where specific hospitals and OPOs could improve practices to recover more organs. UNOS could improve organ placement by encouraging OPOs to identify transplant programs that are willing to transplant potentially distressed organs if notified early that an organ is available. Those centers would need well-curated waiting lists with patients ready to accept the offers. UNOS has introduced a new quality metric to judge center performance by organ offers accepted as a percentage of organs offered. In response to critics of the current information technology system, UNOS has invited the US Digital Service to audit its IT infrastructure.7 The Digital Service recommended that HRSA bid for open systems that rely more on cloud computing.8 Other authors argue for the need to balance greater information security with systems that allow wide access to data9. Recent initiatives seek to increase equity and overcome racial injustice in kidney transplantation by requiring centers to calculate the estimate GFR with a race-neutral equation and restore waiting time to people who lost it because the race-based correction factor overestimated function.10 The National Academies of Sciences, Engineering, and Medicine recommended in its reports on fairness, transparency, and efficiency in the organ transplantation network11 that UNOS remove Black race from calculating the Kidney Donor Risk Index. Recognizing the cost of reforms, President Biden's administration proposed changes in the Fiscal Year 2024 Budget to double financial support for HRSA's organ transplantation programs, including the OPTN Modernization Initiative, to $67 million. The transplant system has not stood still. UNOS topped 1 million transplants in 2022. However, as the 70th anniversary of the first successful human kidney transplant approaches in 2024, much work remains to get more organs to people in need. We must improve organ recovery and use, improve the technology for matching donors and recipients, and improve the transport network. We must increase equity by removing disparities in rates of transplant because of race, sex, and geography. We must increase accountability by involving more patients and families of recipients and donors on the OPTN and UNOS boards to help shape and carry out policy.
Authors: Eli Y. Adashi, George Bayliss
Institutions: Brown University, Rhode Island Hospital
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4385322694