This effort builds upon the recent Organ Procurement Organizations’ Conditions for Coverage (CfCs) final rule to help thousands of patients on waitlists 

The U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) to solicit stakeholder and public feedback that will be used to inform potential changes and future rulemaking to improve the organ transplantation system and seek to enhance the quality of life of those living with organ failure. This is part of the Biden-Harris Administration’s ongoing efforts to improve the health outcomes of the more than 106,000 people who are waiting to receive a life-saving or life-enhancing organ transplant. CMS is focused on identifying potential system-wide improvements that would increase organ donations, improve transplants, enhance the quality of care in dialysis facilities, increase access to dialysis services, and advance equity in organ donation and transplantation. 

Critical to these system-wide improvements is the close, collaborative relationship among Organ Procurement Organizations (OPOs), donor hospitals, transplant programs, and End-Stage Renal Disease (ESRD) facilities to ensure that organs are successfully recovered and transplanted. These providers and suppliers are integral to the nation’s transplant ecosystem and the health of patients across the nation.   

“Today’s announcement supports the President’s Executive Orders to advance health equity and improve health outcomes for people in need of a life-saving transplant and dialysis,” said Health and Human Services Secretary Xavier Becerra. “We want to hear from diverse stakeholders, especially the patients and their families. Your feedback is essential to our work in ensuring equal access to vital resources.”

Communities of color have much higher rates of high blood pressure, diabetes, obesity, and heart disease, all of which increase the risk for kidney disease. Black Americans are almost four times more likely, and Latinos are 1.3 times more likely, to have kidney failure compared to White Americans. Despite the higher risk, data shows that Black and Latino patients on dialysis are less likely to be placed on the transplant waitlist and have a lower likelihood of transplantation. Because of these stark inequities, CMS’ RFI asks the public for specific ideas on advancing equity within the organ transplantation system, particularly on potential changes to the health and safety standards for transplant programs, ESRD facilities, and OPO operations.  

“Organ donation is a precious gift, and we owe it to recipients, donors, those awaiting organs, and their loved ones to ensure our transplantation system is safe, efficient, and equitable,” said CMS Administrator Chiquita Brooks-LaSure. “We are seeking input on ways to improve organ donation and transplantation and are committed to engaging all stakeholders throughout our policy development process. This effort is extremely important for supporting organ transplants for communities of color, individuals with disabilities, and other historically underserved populations.”

This RFI seeks feedback from those on organ transplant waitlists, transplant recipients, their families, living donors and those who sign up to be posthumous donors, families of donors, chronic kidney disease and ESRD patients. This feedback will help inform future regulatory requirements that transplant programs, OPOs, and ESRD providers and suppliers would need to meet to participate in the Medicare and Medicaid programs. 

The RFI is posted here: https://www.federalregister.gov/public-inspection/2021-26146/request-for-information-health-and-safety-requirements-for-transplant-programs-organ-procurement Comments must be submitted by February 1, 2022.