Accelerate Trials Enrollment (NAVIGATE), a partnership between the VA and the NCI to facilitate enrollment of veterans with cancer into NCI-funded clinical trials. Page 17 | Advancing American Kidney Health ▶ In May 2019, FDA issued final guidance that industry should consider when utilizing animal studies to evaluate organ preservation devices. This guidance will help support the development of next-generation organ preservation devices and systems, potentially capable of increasing the supply of transplantable kidneys by salvaging and maintaining more kidneys. In addition to recommendations that could be considered relevant for most animal studies such as developing animal study protocols with consideration of the applicability of anatomical, physiological, and immunological factors for humans, studies should include a control group as a comparator. Specifically, for kidney preservation devices, animal studies should consider three phases of the organ for transplantation: procurement, preservation, and reperfusion. Following these recommendations will speed the review of kidney preservation devices, as well as potentially improving the quality and functionality of these devices. Find the FDA’s final guidance at: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/utilizing-animal-studies-evaluate-organ-preservation-devices Goal 3: Increase Access to Kidney Transplants OBJECTIVE 1. Increase the utilization of available organs from deceased donors by increasing organ recovery and reducing the organ discard rate From 2007 through 2017, the annual rate of kidneys procured but not transplanted has ranged between 18-20 percent. In 2017, the discard rate of 18.9 percent reflected 3,534 kidneys that were procured but not transplanted into waiting patients.45 Some donor kidneys are not transplanted due to medically justifiable reasons; however, it is estimated that thousands of discarded kidneys could provide benefit to people on dialysis.46 Education about the appropriate clinical use of kidneys would help maximize the limited supply of donated organs used.47,48 Addressing the availability and utilization of kidneys is one of the ways HHS can help people living with ESRD through transplantation. ▶ HRSA supported a Collaborative Innovation and Improvement Network (COIIN) pilot project through the Organ Procurement and Transplantation Network (OPTN) with a limited number of participating kidney transplant programs. The goal was to increase transplantation and reduce the number of discarded kidneys, with a particular focus on increasing utilization of kidneys deemed to be moderate-to higher-risk due to their clinical characteristics. In addition to supporting education of transplant program staff, patients, and referring physicians on the effective use of these organs, the COIIN pilot also modified OPTN performance monitoring criteria to reduce the risk-avoidance behaviors associated with the current monitoring system. Initial results suggest that the COIIN pilot has resulted in increased utilization of kidneys among the first cohort of participating transplant programs. It is possible that a recent decline in the discard rate of moderate-risk kidneys may in part be related to the COIIN pilot. Find more information on the HRSA COIIN at: https://optn.transplant.hrsa.gov/resources/coiin/ ▶ The OPTN implemented a policy change in June 2018 to expedite the process of allocating organs and improve the efficiency of organ placement. This change reduces the amount of time a transplant program has to accept or refuse an organ offer, as well as reduces bottlenecks in the system by limiting the number of organ offers a program can accept for any candidate at the same time. ▶ CMS added a transplant waitlist measure to the ESRD Quality Incentive Program (QIP) for dialysis facilities via rulemaking in 2018 as a measure of dialysis center performance. The goal of the ESRD QIP is to promote high-quality services in ESRD facilities treating patients with ESRD. Under this value-based purchasing program, CMS pays for ESRD treatment by linking a portion of payment directly to dialysis facilities’ performance on quality of care measures. A list of CMS quality measures for ESRD care is included in the Appendix. Page 18 | Advancing American Kidney Health Looking forward, HHS plans to take a number of actions directly aimed at increasing the utilization and availability of organs. ▶ HHS is updating the PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation. The goal of the existing 2013 Guideline was to reduce risk of unintended HIV, HBV, and HCV transmission, while preserving availability of high quality organs: Since 2013, however, shifts in the composition of the donor pool, as well as advances in testing and treatment technologies, have created opportunities to revise the Guideline. The current initiative will re-evaluate and, where warranted, revise elements of the Guideline based on current risks to patients and improvements in technology. HHS is also considering the April 2019 recommendations of the Advisory Committee on Blood and Tissue Safety and Availability concerning revising the Guideline. The revised Guideline is intended to strengthen the overall process for assessing, communicating, and