PRESS STATEMENT FOR IMMEDIATE RELEASE

Contact Information:
Jenny Daigle | [email protected]

AOPO Urges Congressional Action to Address Key Concerns in U.S. Organ Transplant System Reform

McLean, VA (July 20, 2023) – The Senate Finance Committee (SFC) Subcommittee on Health Care held a hearing today, “The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System,” which addressed critical issues concerning the organ donation and transplantation system. As the national non-profit organization representing 48 Organ Procurement Organizations (OPOs) across the U.S., the Association of Organ Procurement Organizations (AOPO) reiterates its steadfast commitment to pursuing comprehensive reform within the system to increase life-saving opportunities. 

CMS OPO Performance Metrics

AOPO has voiced concerns regarding the Centers for Medicare & Medicaid Services’ (CMS) metrics and their ability to accurately evaluate OPO performance. Despite having one of the world’s leading donation and transplantation systems, with notable advancements in deceased organ donation rates, organs recovered and made available for transplant, as well as successful transplantations, it is concerning that a record number of OPOs (42%) are disproportionately ranked in the lowest performance category, according to the latest released data. This is alarming as these OPOs will face automatic decertification with no opportunity for remediation when new CMS regulations take effect in 2026. Furthermore, CMS has not provided any guidance regarding the transition of OPO donation service areas, leaving OPOs without necessary details to prepare for future operations and minimize disruptions to saving lives. Urgent action from policymakers and federal regulators is imperative to address these concerns promptly and provide an implementation plan to safeguard the highly successful U.S. organ donation and transplantation system, ensuring patient lives are not compromised.  

HRSA OPTN Modernization Initiative

AOPO supports the goals of the Health Resources and Services Administration (HRSA) Modernization Initiative to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN). As HRSA progresses towards its goals, AOPO suggests several recommendations. Firstly, the policy portion of the OPTN contract should be overseen by a non-profit entity with proven experience in complex operations. Secondly, it is essential to ensure that the OPTN Board’s policy committees reflect diversity in race, ethnicity, profession, and gender. Lastly, the implementation of efforts should be conducted in a step-wise manner, involving collaboration with key stakeholders to address process changes and establish clear timelines.    

Organ Non-Utilization

The non-utilization of organs recovered by OPOs and declined by transplant centers poses the most critical challenge to the donation and transplantation system today. In 2022, the non-utilization rate reached a record high of 19%, resulting in the loss of thousands of viable organs that could have saved lives. This issue is concerning, both due to unnecessary deaths and the impact on OPOs, which are evaluated based on transplantation rates influenced by a multitude of factors, including proper use of organ acceptance filters, unintended consequences of the allocation system, and organ acceptance practices. Research reveals that the U.S. non-utilization rate for procured organs is nearly double that of other developed countries, such as France, where 62% of kidneys declined in the U.S. would have been successfully transplanted. AOPO supports the SFC’s discussion on aligning performance metrics for OPOs and transplant centers, in order to promote the increased use of organs from older and medically complex donors. However, urgent attention and examination are warranted to address this issue promptly and save more lives through enhanced utilization.

Pancreas for Research

The inclusion of pancreata allocated to research in an OPO’s donation rate and performance evaluation has raised concerns. AOPO previously expressed apprehension to CMS during the initial rulemaking process, highlighting the potential for skewed comparisons and inaccurate conclusions resulting from this inclusion. Despite the ongoing uncertainty surrounding this issue, OPOs have diligently complied with the adopted rule. They actively recover pancreas for transplantation purposes and explore research options when an organ cannot be placed with a recipient, ensuring the gift is honored and waste is avoided. Donating pancreata to research is essential for studying human islet cells, which play a vital role in expanding scientific knowledge and developing effective treatments for patients with diabetes. Progress in this field has the potential to reduce the number of patients requiring pancreas transplants. AOPO urges policymakers to closely monitor this matter to ensure fair assessment of OPOs’ life-saving capabilities in organ donation and transplantation.  

NASEM Report

AOPO reaffirms its support for the National Academies of Science, Engineering, and Medicine (NASEM) report titled “Realizing the Promise of Equity in the Organ Transplantation System.” This report provides data-driven recommendations for donor hospitals, OPOs, transplant centers, federal policymakers, and the Organ Procurement and Transplantation Network (OPTN) to enhance system-wide performance, equity, and organ utilization. The NASEM report, requested by Congress, serves as a valuable blueprint for driving productive system reform. The report underscores the implementation of strategies to tackle disparities in organ donation and transplantation, including enhancing transplantation access in underserved communities and fostering greater patient involvement in their transplant journey and decision-making process. The SFC can leverage these insights to guide their action in promoting meaningful improvements.

Despite repeatedly sharing our concerns with Congress and CMS, AOPO and its members have not received due consideration or attention for our input which is based on the extensive knowledge of OPO professionals with decades of experience in the field. Following today’s hearing, we urge the SFC to broaden its examination of the system by actively engaging all stakeholders in advancing reform efforts. This collaborative approach will be advantageous for donors, donor families, and patients who rely on the collective dedication of all entities involved in the organ donation and transplantation process.