How We’re Making the Organ Transplant System Safe and Equitable

Improving the U.S. organ transplant system continues to be a priority for the Department of Health and Human Services (HHS). In 2021, the HHS Secretary established the Organ Transplantation Affinity Group (OTAG), a federal collaborative led by the Health Resources and Services Administration (HRSA) and the Centers for Medicare & Medicaid Services (CMS) to improve organ donation, procurement, and transplantation in the United States. As described in our September 15, 2023, blog, “Organ Transplantation Affinity Group (OTAG): Strengthening accountability, equity, and performance,” OTAG, HRSA, and CMS are collaborating in several areas, including: (1) coordinating federal policy development, (2) improving national organ transplantation system performance, (3) establishing more consistent and transparent waitlist practices, (4) promoting equitable access to transplants, (5) enhancing data harmonization, and (6) establishing efficient and transparent processing of stakeholder complaints.

We are pleased to provide updates on OTAG’s progress toward producing impactful outcomes and demonstrating value in support of HHS' Strategic Initiatives. We have greatly enhanced our efforts in coordinating federal policy development. While some of the activities discussed are implemented within a single agency, OTAG has served as a coordinating body to jointly review policies to foster greater alignment, collaboration, and integration of federal organ transplantation-related initiatives and activities. OTAG also continues to work on overall improvement of the national organ transplantation system performance, as discussed below.

Organ Procurement and Transplantation Network (OPTN) Modernization Initiative

On March 22, 2023, HRSA launched the OPTN Modernization Initiative to better serve the needs of patients and families. The Initiative will strengthen accountability, equity, and performance in the organ donation and transplantation system by focusing on five key areas: technology, data transparency, governance, operations, and quality improvement and innovation. A comprehensive look at the Initiative’s progress to date can be found on HRSA’s OPTN Modernization Initiative website; highlights of recent activities are provided below.

Bipartisan legislation — Securing the U.S. Organ Procurement and Transplantation Network Act — improved the governance and operations of the OPTN, reforming the decades-old statute and enabling system transformation. The newly enacted Public Law 118-14 authorizes HRSA to make multiple awards to support the operation of the OPTN and eliminates a cap on the funding available for supporting the network.

Recent modernization activities include: (1) issuing and awarding a multi-vendor contract solicitation to support broad competition and best-in-class vendors for critical OPTN functions, which will better serve the needs of patients, families, and their care teams; (2) launching the discovery and development phase of the transition to a modernized OPTN IT matching system that leverages industry-leading IT standards and practices; and (3) incorporating the OPTN Board of Directors as a distinct entity separate from the Board of any contractor involved with the operations of the OPTN itself and awarding a Board support contract to ensure the OPTN’s Board has the necessary support to fulfill its responsibilities. A newly incorporated Board entity was implemented in July 2024; the process for selecting new Board members has begun, and a new OPTN Board will be seated in 2025.

Consistent and Transparent Waitlist Practices

OTAG continues to promote equitable access to transplantation by increasing the OPTN’s data collection to inform HRSA and CMS’ efforts to ensure transparency of waitlist practices. To increase transparency and accountability of pre-waitlist and organ procurement practices, HRSA announced efforts to expand OPTN data collection in February 2024, and a notice was published in the Federal Register in November describing these new data collection forms. These data will facilitate the OPTN’s ability to improve access to organ transplantation, monitor OPO performance, and assess overall system performance.

Proposed CMS Innovation Center Model

CMS is taking meaningful action to address system inequities through its newly proposed payment model, the “Increasing Organ Transplant Access (IOTA) Model,” for testing by the Center for Medicare and Medicaid Innovation (Innovation Center). The model aims to increase access to life-saving transplants for patients living with kidney disease and reduce Medicare expenditures by encouraging transplant hospitals to use more kidneys that become available for transplantation and facilitate more transplants from living donors. The IOTA Model is designed to support greater care coordination, improved patient-centered processes for those being waitlisted for (and receiving) kidney transplants, and more equitable access to kidney transplants. Through the model’s payments and policies, CMS aims to increase the care delivery capabilities and efficiency of participating kidney transplant hospitals selected to take part. The IOTA Model is a proposed six-year model that would be mandatory for approximately half of all eligible kidney transplant hospitals across the country. For information on the model, please visit CMS’ website; for information on the proposed rule regarding the IOTA Model, please visit the Federal Register. The comment period closed July 16, 2024, and CMS has received robust comments from stakeholders. CMS is reviewing those comments as we continue working on the final rule. Consequently, we are anticipating a later start date for the model than the previously proposed date, January 1, 2025.

Pancreata for Islet Cell Research

One of the main OTAG goals is to listen and learn from those who provide feedback. Many stakeholders voiced their concerns about the reporting of pancreata for islet cell research, and a CMS review of the data found a significant increase in the number of pancreata reported as procured for research since this definition was revised in 2020. On January 18, 2024, to support implementation of the OPO final rule, CMS issued guidance clarifying the definition of “donor” in the OPO Conditions for Coverage. The guidance addressed the use of the pancreata for islet cell research that is included in the “donor” definition, consistent with the Pancreatic Islet Cell Transplantation Act of 2004. OPOs must maintain information on the disposition of pancreata and islet cells procured and used for pancreatic islet cell transplantation or research. CMS also worked with HRSA on system revisions necessary for the OPTN to collect and harmonize pancreata data on pancreata procured and used for islet cell research for more accurate reporting. On August 29, 2024, CMS issued data entry instructions to OPOs to differentiate between pancreata used for islet cell transplantation or research and pancreata used for non-islet cell research.

Strengthening Patient Safety & Quality

Patients and transplant community members have voiced their concerns about the process for filing complaints and registering concerns regarding the performance of transplant centers or organ transplant organizations. OTAG has implemented internal processes to improve information sharing among CMS, HRSA, and the OPTN at the complaint investigation phase to gain efficiencies and ensure that there is no “wrong door” to file a complaint. OTAG streamlined the process by which patients and other interested parties may report complaints regarding OPOs and transplant centers so that CMS, HRSA, and OPTN are able to coordinate their complaint investigations. While each entity determines its course of action via its authority, this coordination helps ensure alignment of complaint management, regardless of which agency initially receives the complaint.

Looking Forward

HHS remains committed to making organ procurement and transplantation more equitable, accessible, and transparent. To that end, OTAG will continue to identify and refine improvement activities, promote data collection to further OTAG goals, and share the feedback received with the health care community to enhance the ability of patients and providers to make informed, shared decisions.

HRSA will continue its efforts to improve the OPTN to better serve patients by modernizing the legacy approaches that have supported the nation’s organ allocation system.

Finally, HRSA and the HHS Office of the Assistant Secretary for Health published a notice of proposed rulemaking (NPRM) on September 12, 2024, to streamline requirements for transplantation of kidneys and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. These transplants are conducted under the standards provided by the HIV Organ Policy Equity Act (HOPE Act). If finalized as proposed, HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants, helping reduce the stigma and health disparities associated with HIV.

Following the December 3, 2021, Transplant System Modernization Request for Information (86 FR 68594), CMS also plans to propose clarifications and technical modifications to the standards used to evaluate and recertify OPOs. Revisions would continue to hold OPOs responsible for improved performance.

Additionally, CMS posts annual OPO performance reports on CMS’ QCOR website and anticipates posting 2024 reports later this year, once OPOs have resubmitted 2022 pancreata data to the OPTN and the dataset is updated. As outlined in the guidance issued on August 29, 2024, CMS’ analytic contractor will re-run the 2024 OPO Annual Individual Performance Reports using updated 2022 Scientific Registry of Transplant Recipients data. CMS will provide a new preview period for OPOs before the 2024 aggregate performance report is published.

Also, President Biden’s Budget calls for Congress to remove restrictions on the certification of new entities as organ procurement organizations and increase enforcement flexibility (see page 86 of the HHS FY 2025 Budget-In-Brief).

Engagement with the health care community is a cornerstone of OTAG’s success. To foster a culture of collaboration, CMS and HRSA will continue to host cross-agency meetings to share insights and strategies. Externally, OTAG will continue to engage industry leaders and key partners to share our goals and strategies and to help ensure they are both realistic and reflect key opportunities for improving the system. OTAG’s listening tour included the following stops: the American Society of Nephrology’s Kidney Week (November 2023), a webinar hosted by OTAG (January 2024), the Organization for Donation and Transplant Professionals (February 2024), the CMS Quality Conference (April 2024), the National Kidney Foundation’s Spring Clinical Meetings (May 2024), and the National Alliance for Caregiving: Uplifting Caregivers in Transplant Care (August 2024).

We are excited about these improvements, but there is much more to do to improve the transplant ecosystem. As we continue to navigate through the challenges and opportunities surrounding organ transplantation, we will leverage the new OTAG webpage to keep you apprised of OTAG’s efforts. We appreciate and look forward to our ongoing collaboration with all interested parties.