NKF Statement Regarding the Administration’s Proposed Revisions to the OPO Conditions for Coverage

October 2, 2020 - Nearly 100,000 Americans with kidney failure are awaiting a lifesaving organ transplant[i]. Unfortunately, only about 23,000 transplants take place each year,[ii] and as a result, 12 Americans die each day on the transplant waitlist[iii]. At the same time, ten deceased donor kidneys are discarded each day in the United States.[iv] Regional disparities in transplantation are well documented, leaving many patients at the mercy of luck and geography. Simply put, the current transplant framework is not working well for patients.

In 2018, the National Kidney Foundation (NKF) published a comprehensive report outlining the reasons that donor kidneys are discarded and put forward a series of recommendations for reducing unnecessary discards. Among other factors, the study found that risk-aversion and financial disincentives cause many transplant centers and surgeons to refuse to accept viable organs – oftentimes without notifying the patient of their options.  

To address these issues, in December 2019, the Administration proposed changes to its regulatory framework for Organ Procurement Organizations (OPOs), the entities charged with managing the organ procurement and recovery process. Under these proposed changes, OPOs would have better incentives to seek out possible organs for transplant from a larger pool of deceased donors and ensure these organs are transplanted by transplant centers, rather than discarded. The proposal also includes new policies for holding OPOs accountable for their conduct by establishing performance benchmarks, more frequent assessments of performance, and an improved process for quality improvement for OPOs that do not meet these standards. 

The National Kidney Foundation is committed to advocating for greater accountability that drives all stakeholders to be high performers on behalf of patients. The proposed OPO rule would modernize the organ procurement process and drive coordination, transparency, and accountability.

We understand concerns voiced by some in the OPO community about the proposed data sources used to assess performance and the benchmarks in general. In our own comments to CMS, we acknowledged the challenges that some OPOs might have in meeting certain performance improvements in the timelines outlined in the rule. Overall, however, we believe that any concerns about major, immediate disruption to the transplant system are unfounded. The proposed rule allows underperforming OPOs up to four years to improve their systems and meet new requirements and would not take effect until 2022.

More than 3,500 Americans have died on the transplant waitlist since the proposed rule was issued. We cannot afford to wait another day. We call on Congress to resist any efforts to further delay implementation of this rule and encourage the Administration to finalize this rule as quickly as possible.



Kidney Disease Facts

In the United States, 37 million adults are estimated to have chronic kidney disease—and approximately 90 percent don’t know they have it. 1 in 3 adults in the U.S. are at risk for chronic kidney disease. Risk factors for kidney disease include: diabeteshigh blood pressureheart diseaseobesity, and family history. People of Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, or Native Hawaiian or Other Pacific Islander descent are at increased risk for developing the disease. Blacks or African Americans are almost 4 times more likely than White Americans to have kidney failure.  Hispanics are 1.3 times more likely than non-Hispanics to have kidney failure.


The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.