NKF Clarifying Statement on the Proposed OPO Conditions for Coverage (CfCs)

October 9, 2020

The National Kidney Foundation (NKF) has been a longtime proponent of reforming and modernizing our organ transplantation system.  Our position is driven by our obligation to the almost 100,000 patients currently awaiting a lifesaving kidney transplant.  Unfortunately, as only about 23,000 transplants take place each year, 12 kidney patients die each day on the transplant waitlist. 

Stakeholders from all corners of the transplant community generally agree that there are numerous gaps in the transplant system: deceased donor organs that go unprocured, supply chain failures, rejections of clinically valuable organs, and unjustifiable kidney discards. Due to the interdependent nature of our system, however, it is not optimal to hold any single stakeholder responsible for wholesale improvements to the transplant process. NKF is committed to advocating for greater accountability that drives all stakeholders to be high performers on behalf of patients. 

Earlier this year, NKF supported the Administration’s proposed revisions to the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs). In our formal comments to the Centers for Medicare and Medicaid Services (CMS), we acknowledged that several elements of the proposed rule are problematic and need to be revised in the final rule. We made several observations, suggestions and comments to the rule, but of particular note to the OPO community are our suggestions that CMS:

• Pair proposed measures with an organ acceptance rate at transplant centers
• Reconsider its proposal for assessing OPO performance to ensure that programs have enough time to implement and see the results of quality improvement initiatives
• Consider a “phase in” or “transition period” to ensure that decertification does not result in disruption to the transplant system

We understand that the OPO community has other concerns and has recommended its own slate of changes the proposed rule.  While we may not share all those concerns, NKF is committed to understanding the nuance and complexity of the issues so that we can identify common-sense, workable solutions.

However, we believe that reforms are necessary and will result in an increase in donor volumes. While there may be disagreement on the size and scope of the problem and the impact of proposed changes, true reform cannot be achieved if the rule is delayed.  We urge CMS to give due consideration to stakeholder feedback and finalize the rule expeditiously. 

If the final rule requires additional refinement, we will continue to advocate for subregulatory guidance, clarifications, and other policy changes.

We also stand ready to work with OPOs, transplant centers, donor hospitals, and other stakeholders to increase the number of kidneys available for transplantation from deceased donors. NKF has led the way in urging improvements to the transplant system. In 2016, NKF convened a panel of transplant patients, professionals, OPO leaders, policymakers, and other transplant stakeholders to identify gaps and policy barriers in the transplant system that contributed to unnecessary kidney discards.  That convening prompted NKF to issue a report outlining 14 comprehensive recommendations for improving the allocation of discarded kidneys which was published in the journal Clinical Transplantation, the Journal of Clinical and Translational Research. It also served as the basis for the July, 2019 Organ Procurement and Transplantation Network (OPTN) launch of the Kidney Accelerated Placement Project (KAPP) to assess whether accelerating the placement of extremely hard-to-place kidneys via the Organ Center can increase their utilization. Working together to operationalize and build upon these recommendations, we can achieve our shared objective of collecting more organs, transplanting more organs, and saving more lives.  

Questions regarding this statement can be directed to Sharon Pearce, Senior Vice President, Government Relations, National Kidney Foundation: Sharon.pearce@kidney.org. 

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: diabetes, high blood pressure, heart disease, obesity, 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.