Reorganization of the U.S. Transplant System – October Update

Friday, September 22, President Biden signed the Securing the U.S. Organ Procurement and Transplantation Network Act into law. 

“Everybody knows the system has been broken for years with heartbreaking consequences. Now with the president’s signature, we are taking significant steps to improve it,” said White House press secretary Karine Jean-Pierre after President Biden signed the bill into law last month.

On September 15, 2023, CMS published an announcement about a coordinated effort with HRSA to improve organ donation, procurement, and transplantation through an Organ Transplantation Affinity Group (OTAG). The announcement describes efforts committed to by both agencies to drive improvements in donations, clinical outcomes, system improvement, quality measurement and transparency, and regulatory oversight. 

Link to full statement here: CMS Statement

The CMS announcement says, in part:

“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;

Seventeen people die each day waiting for an organ transplant; 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.

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.

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.

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.

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.”

Anticipated efforts of the collaborative working group include:

• Enhancing collaboration on federal policy development and implementation and communication to improve transparency and advance progress on national goals.
• Harmonizing data across the organ transplantation system to improve system performance and to 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.
• Promoting patient safety and engagement

Looking Forward

There is anticipation that the new system will take advantage of the AI revolution, creating a data-driven culture to promote quality improvement for better outcomes. The application of such a data-driven approach will be crucial to keeping systems up to date for a seamless integration. Modernizing the organ transplant system will also focus on improving post-transplant outcomes and recipients’ quality of life.

This reorganization of the transplant systems currently in place relies upon system participation from many organizations, with multiple contracts and grant awardees. As the OPTN replaces the once-single-vendor system, transparency across every party involved is crucial to its success. If this new system operates as promised, it will make transplants more accessible and equitable for all recipients.