Organ Transplantation Affinity Group (OTAG): Strengthening accountability, equity, and performance

Improving the organ transplantation system is a priority for the Biden-Harris Administration.  In 2021, the Department of Health and Human Services Secretary Becerra established a coordinated effort to improve organ donation, procurement, and transplantation.  Led by the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA), this collaborative seeks to drive improvements in donations, clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight. 

The organ transplantation system consists of:

• A national body – called the Organ Procurement and Transplantation Network (OPTN) – whereby clinical experts, patients, donor families, and community stakeholders review, propose, seek public comment on, and develop OPTN policies on patient safety, organ allocation, and other donation, procurement, and transplant-related activities;
• Transplant hospitals that provide comprehensive medical care to patients and living organ donors;
• Organ procurement organizations (OPOs) that work with donor and recipient families and are responsible for the procurement of organs for transplantation;
• Histocompatibility laboratories that provide blood, tissue, and antibody testing which is critical to the organ matching process; and   
• Most importantly, people in need of a transplant, their families and caregivers, and living and deceased donors.

HRSA oversees the national procurement and transplantation system through the OPTN,  invests in public education and outreach to increase the supply of deceased donor organs available for transplant, and works to remove financial disincentives to living organ donation to ensure the safety of living organ donors. 

CMS establishes standards for OPOs and contracts with quality improvement entities such as the End Stage Renal Disease (ESRD) Networks and Quality Improvement Organizations to provide technical support to providers and patients seeking improvements in the system related to Medicare coverage.  Additionally, Medicare covers some transplant-related services when provided at a Medicare-approved facility.  Medicare also establishes and monitors compliance with the conditions of participation that establish clinical standards for health and safety for hospitals and transplant programs. 

Organ Transplantation Affinity Group

This federal collaborative, called the Organ Transplantation Affinity Group (OTAG), is a coordinated group working together to strengthen accountability, equity, and performance to improve access to organ donation, procurement, and transplantation for patients, donors, families and caregivers, and providers.

This joint work leverages recent actions by both agencies to strengthen accountability and transparency:

• On April 28, 2023, CMS reinforced its strategy for oversight of OPOs with the release of the 2023 OPO Public Performance report reflecting the first full year of operations following the publication of the December 2020 Conditions for Coverage final rule.  This report uses the new outcome measures and tier status, reflecting OPO performance data from 2021.
• On March 22, 2023, HRSA launched the OPTN Modernization Initiative to better serve the needs of patients and families. This Initiative is focused on strengthening accountability, equity, and performance in the organ donation and transplantation system through five key areas: technology, data transparency, governance, operations, and quality improvement and innovation.  

To further improvements in transplantation system accountability, equity, and performance, Congress passed the Securing the U.S. Organ Procurement and Transplantation Network Act on July 27, 2023 and the President is expected to sign this bill soon.  The Act supports HRSA’s efforts to implement changes to the OPTN through expanded authority to award grants, contracts, or cooperative agreements and the removal of an annual cap on appropriations, making it easier to ensure best-in-class operations and technology and achieve the aims of OPTN Modernization.  

Need to Improve System Performance and Equity

We know that the need for organs continues to outpace the number of organs available for transplantation.

• Every 10 minutes, another person is added to the national transplant waiting list and as of March 2023, more than 104,000 individuals (men, women, and children) remained on the national transplant waiting list;[1]
• Seventeen people die each day waiting for an organ transplant;[1] and
• Approximately 36 million adults suffer from chronic kidney disease and as of 2020, more than 808,000 suffer from end-stage kidney disease—two of the most common conditions that can be treated with a kidney transplant.[2]

Access to organ transplantation varies not only by geography, but also by factors such as race, ethnicity, disability status, and socioeconomic status.

• Data from the OPTN database show that in 2022, 32.9 percent of Black people on the waiting list received organ transplants, while 52.6 percent of White people on the waiting list received organ transplants.[4]
• Data from the OPTN database also show that in 2022, White people disproportionately use living organ transplants.  White people receive 48.6 percent of deceased donor transplants and 62.7 percent of living donor transplants respectively.  In comparison, Black people receive 24.3 percent deceased donor transplants and 11.9 percent living donor transplants respectively.[4]

Furthermore, the performance of the organ transplantation system is highly variable.  For example, data indicate there is wide variation among OPOs in the procurement of organs from donations after a circulatory death determination.[3]

The Organ Transplantation Affinity Group (OTAG) Improvement Strategy

OTAG builds on and complements the agency-specific efforts of CMS and HRSA, aiming to improve patient access, patient and family/caregiver experience, and organ transplantation outcomes.  This collaborative seeks to maximize the​ impact of government efforts to​ advance health equity, quality, ​safety, and outcomes in organ​ donation, procurement, and transplantation.

As an immediate action, the group established a common understanding of the organ transplantation landscape including the roles and responsibilities of each agency, areas that would benefit from better alignment, opportunities to strengthen oversight of the organ transplantation system, and areas that would improve patient experiences with living and deceased organ donation and transplantation.  

The needs of patients and families remain at the center of OTAG’s purpose; OTAG has sought to gain an understanding of their experiences to utilize in the development of a comprehensive action plan.  Through listening sessions, meetings, conferences, and journey maps, OTAG benefitted from the voices of patients, families, and the organ transplantation system that identified how federal authority could address areas for improvement.

OTAG’s vision is a transformed organ donation, procurement, and transplantation system that​ equitably and successfully​ procures and transplants organs to save and enhance lives.  To improve the performance and equity of the U.S. organ transplantation system, OTAG established five goals:

1. 1. Reduce variation of pre-transplant and referral practices.
   2. Increase the availability and use of donated organs.
   3. Increase accountability for organ procurement and matching.
   4. Promote equitable access to transplants.
   5. Empower patients, families, and caregivers to actively engage in the transplant journey.

A Plan of Action

OTAG’s 2023-2028 Action Plan serves as a roadmap to improve the performance and equity of the U.S. transplantation system to meet the five national goals listed above.  Each of the OTAG national goals is supported by strategies that will be implemented by CMS and HRSA.

Action Plan At-A-Glance 

A Whole of Government Approach

Through OTAG, CMS and HRSA are collaborating to strengthen federal oversight and support of the organ transplantation system. Both agencies are committed to working closely with our colleagues at other HHS agencies and external interested parties to ensure a strategic and comprehensive approach to improving federal oversight, alignment, and support of the organ donation, procurement, and transplantation system. 

CMS and HRSA will collaborate on the following joint activities to achieve the above goals:

• Enhance collaboration on federal policy development, implementation, and communication to improve transparency and advance progress on national goals.
• Harmonize data across the organ transplantation system to improve system performance and develop a core set of national organ transplantation system performance metrics.
• Further strengthen accountability to patients, families, and the public by:
  • Advancing equitable access to transplantation by collecting data and establishing criteria for standardization and transparency of waitlist practices;
  • Ensuring a transparent process for intake of stakeholder complaints and ensuring that concerns and recommendations are addressed in a timely manner; and
  • Promoting patient safety and engagement.

Interested parties are encouraged to contribute best practices for quality improvement, continue to respond to agency-published Requests for Information as applicable, engage in upcoming listening sessions, and review other resources as they are made available.  Future CMS rulemaking will also allow the public to comment on proposed changes as described in the action plan. 

Through these efforts, we will continue to identify and refine improvement activities, collect data toward goals, and share the feedback received with the healthcare community to enhance the ability of patients and providers to make informed, shared decisions.  Overall, HHS will strive to achieve the vision of a transformed organ donation, procurement, and transplantation system that is​ equitable, transparent, efficient, and effective at providing the patient-centered, high-quality lifesaving, and life-enhancing care that Americans expect and deserve.

[1] Health Resources and Services Administration website accessed on July 13, 2023. Organ Donation Statistics. https://www.organdonor.gov/learn/organ-donation-statistics.

[2] Centers for Disease Control and Prevention (2023). Chronic Kidney Disease in the United States, 2023. Centers for Disease Control and Prevention. https://www.cdc.gov/kidneydisease/pdf/CKD-Factsheet-H.pdf.

[3] Sonnenberg, E., Hsu, J., Reese, P., Goldberg, D., & Abt, P. (2021). Wide variation in the percentage of donation after circulatory death donors across donor service areas – a potential target for improvement. Transplantation. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170761/.

[4] Report generated on July 13, 2023, from the Organ Procurement and Transplantation Network website https://optn.transplant.hrsa.gov/data/view-data-reports/build-advanced/.

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