The US Organ Transplantation System: HRSA’s Modernization Initiative

Abstract

The 1984 National Organ Transplant Act (NOTA) saw to the establishment of a national Organ Procurement and Transplantation Network (OPTN). As envisaged by the law’s congressional sponsors, the Secretary of the US Department of Health and Human Services (HHS) was to institute a “central registry linking donors and potential recipients.” In addition, the Secretary was to see to the institution of a “scientific registry of organ recipients” as well as “designate and maintain an identifiable unit in the Public Health Service to coordinate Federal organ transplant programs and policies.” Forty years later, over 103,000 patients remain on the organ transplant waiting list for an average of 3–5 years during which time 17 die every day. It is against this backdrop that the Senate Committee on Finance (SCF) launched a sustained inquiry in 2020 with an eye towards assessing the status quo and potential remedies thereof. A Health Resources & Services Administration (HRSA) Modernization Initiative followed suit in March 2023. In this Perspective, we review the state of OPTN, discuss its recent oversight by the SCF, and describe its future reform as conceived and enunciated by HRSA.

It was the 1984 enactment of the National Organ Transplant Act (NOTA) by President Ronald W. Reagan which saw to the establishment of a national Organ Procurement and Transplantation Network (OPTN).¹ As envisaged by NOTA’s lead sponsor, Sen. Orrin G. Hatch [R-UT], the Secretary of the US Department of Health and Human Services (HHS) was to institute a “central registry linking donors and potential recipients.”¹ In addition, the Secretary of HHS was to see to the institution of a “scientific registry of organ recipients” as well as “designate and maintain an identifiable unit in the Public Health Service to coordinate Federal organ transplant programs and policies.”¹ Finally, the Secretary of HHS was to “publish an annual report on the scientific and clinical status of organ transplantation.”¹ Forty years later, over 103,000 patients remain on the organ transplant waiting list for an average of 3–5 years during which time 17 die every day.² It is against this backdrop that the Senate Committee on Finance (SCF) launched a sustained inquiry in 2020 with an eye towards assessing the status quo and potential remedies thereof.³ A Health Resources & Services Administration (HRSA) Modernization Initiative followed suit in March 2023.⁴ In this Perspective, we review the state of OPTN, discuss its recent oversight by the SCF, and describe its future reform as conceived and enunciated by HRSA.

OPTN, a public-private partnership, is tasked with the management of the US organ donation system as well as with its allocation, transportation, and transplantation responsibilities.⁵ With an eye towards discharging its task, OPTN comprises all of the elements of the organ transplantation universe replete with the 56 regional Organ Procurement Organizations (OPOs) and their cognate transplant hospitals.⁵ In so doing, OPTN links the various professionals involved with organ donation, transportation, and transplantation for which it seeks to establish equitable policies and procedures.⁵ In its present form, OPTN is home to 11 geographic US regions which assume operational responsibility for the states in question.⁵ Ever since its inception, OPTN has been and remains the subject of management by the United Network for Organ Sharing (UNOS), a private nonprofit organization that has heretofore been the sole awardee of a HRSA-issued contract.⁵ Ongoing concerns of HRSA as to the chronic performance problems of UNOS have variably focused on outdated information technology infrastructure, inefficient organ allocation, and organ transportation challenges.

Congressional concerns as to the quality of the oversight exercised by UNOS over OPTN came into sharp focus on February 10, 2020, via a letter sent by SCF Chairman Charles E. Grassley (R-IA) and Ranking Member Ron L. Wyden (D-OR) to the CEO of UNOS.³ The letter in question made note of alleged oversight gaps by UNOS as they relate to the OPOs which “are failing to recover or transplant thousands of eligible organs.”³ Note was also made of “serious patient safety.” A subsequent report released by the SCF on August 3, 2022, concluded that “OPTN is failing to provide adequate oversight of the nation’s 57 OPOs, resulting in fewer organs available for transplant.”⁶ Further note was made of the fact that “lack of oversight by UNOS causes avoidable failures in organ procurement and transplantation resulting in risks to patient safety.”⁶ The SCF further contended that “UNOS lacks technical expertise to modernize the OPTN IT system, resulting in risk of system interruption or technical failure with the potential to harm patients across the country.”⁶

Concurrent with the SCF inquiry, the National Academies of Sciences Engineering and Medicine concluded and released a Consensus Study Report focused on the national organ transplantation system.⁷ Titled “Realizing the Promise of Equity in the Organ Transplantation System,” the National Academies Report issued “recommendations for creating a more equitable, transparent, and efficient system for deceased donor organs.”⁷ Leading the Report’s 14 recommendations was a critical call to “ Develop national performance goals for the U.S. organ transplantation system.”⁷ Equally notable was the call to “Achieve equity in the U.S. transplantation system in the next 5 years.”⁷ In addition, the Report called for the modernization of “the information technology infrastructure and data collection for deceased donor organ procurement, allocation, and distribution” as well as for the embedding of “continuous quality improvement efforts across the fabric of the U.S. organ transplantation system.”⁷

On March 22, 2023, in response to growing Congressional concerns, HRSA launched the “OPTN Modernization Initiative” with an eye towards strengthening “accountability, equity, and performance in the organ donation and transplantation system.”⁴ To this end, HRSA was aiming to focus on “five key areas: technology; data transparency; governance; operations; and quality improvement and innovation.”⁴ Seeking to assist HRSA in its drive, Senator Ron L. Wyden [D-OR] and Representative Larry D. Buchson [R-IN-8] introduced the Securing the U.S. Organ Procurement and Transplantation Network Act which was signed by President Biden into law on September 22, 2023.⁸ Most notably, the law “authorizes HRSA to award multiple grants, contracts, or cooperative agreements to support the operation of the network,”⁸ thus ending the monopoly held by UNOS over the OPTN since 1986, and “eliminates a cap on the amount of funding available for supporting the network.”⁸ The law further specifies that “the network shall be operated through awards that are distinct from awards for supporting the operation of the network’s board of directors,”⁸ addressing concerns of conflicts of interest in the oversight of the OPTN by UNOS. Moreover, the law requires that the Government Accountability Office “review the historical financing of the network, including the use of registration fees.”⁸

In the year since the passage of the OPTN improvement act, HRSA has taken a number of steps to advance its modernization initiative.⁹ Most fundamentally, in July 2024, HRSA supported the incorporation of a new independent OPTN Board of Directors, and in August awarded the OPTN Board Support contract to American Institutes for Research; for the first time in 40 years, the oversight board and the managing board are not one in the same. In addition, HRSA awarded a wave of contracts designed to address key components of the modernization plan (see Table 1).

Table 1.

OPTN Modernization Contracts Awarded by HRSA¹⁰

HRSA Modernization Priority for OPTN	Contract Awardee	Targeted Improvement
Improving Patient Safety	Arbor Research Collaborative for Health	Will address patient safety and the policy compliance systems and processes overseen by the OPTN Board of Directors and the Membership and Professional Standards Committee to improve oversight of the multiple entities in the OPTN
Supporting OPTN IT Modernization	General Dynamics Information Technology, Inc.	Will focus on the opportunities to improve the OPTN organ matching IT system and inform HRSA’s Next Generation IT procurement and development work
Increasing Transparency and Public Engagement in OPTN Policy Development	Maximus Federal Services	Will advance opportunities to improve public visibility and engagement in the OPTN policy-making process including improving transparency around OPTN policy-making committees’ deliberations and actions
Strengthening Patient-Centered Communications	Deloitte Consulting	Will focus on improvements in communications from the OPTN, within the OPTN and, importantly, with patients and families
Improving OPTN Financial Management	Guidehouse Digital	Will address improvements for OPTN’s budget development and management systems and processes

Although an optimally functioning US organ transplantation system is yet to fully materialize, recent actions on the part of the legislative and executive branches of government bode well for just such an outcome. Changes to the oversight, data gathering, and transparency of the OPTN methodologies, administration, and operations can significantly address the inequity concerns raised by Congress and the other recent examinations of the system. “Certain groups of patients (e.g., patients of color, lower socioeconomic status, female gender) receive organ transplants at a disproportionately lower rate and after longer waiting times than other patients with comparable medical need.”⁷ Moreover, studies have indicated that the “organ donation system is failing patients and donor families of color through every phase of the process – from getting on the waitlist, to finding a match, to becoming a donor.”¹¹ The reforms identified by Congress and HRSA are intended to, among other things, improve data gathering so that timely and relevant data are available; eliminate the use of outdated data that places certain populations at a disadvantage; improve efficiencies in donation, procurement, and transportation of organs; improve accountability by measuring and evaluating performance across the system; and strengthen oversight and compliance. These steps can potentially lead to greater trust in the system overall and help ensure “that persons in equivalent medical circumstances actually receive equivalent medical care.”⁷

Declarations:

Conflict of Interest:

The authors declare that they do not have a conflict of interest.