End Stage Renal Disease
Coordinated Registry Network
Kidney disease is the ninth leading cause of death in the US with more than 726,000 people living with end-stage renal disease (ESRD). Annually, about $114 billion of Medicare funding is spent to care for ESRD patients but there is a major variation in outcomes. Based on the 2018 annual data report from the United States Renal Data System (USRDS), the adjusted mortality rate for ESRD overall was 134 per 1,000 patient-years and 164 per 1,000 patient-years for dialysis patients. Given the critical state of care for Americans with kidney disease, there are various national efforts set forth to improve care for patients with kidney disease and reduce healthcare costs, among which is the ESRD Network Program organized by CMS to promote quality and cost-effective healthcare in kidney disease. CMS maintains the Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb), assisted by ESRD networks for data quality. This data is used for both payment for performance programs and quality improvement activities. All regional networks receive CROWNWeb Data from the central ESRD National Coordination center.
There are various other programs that collect data in ESRD. The University of Michigan runs the Kidney Epidemiology and Cost Center (KECC), which supports many CMS and Center for Medicare & Medicaid Innovation programs for ESRD data collection and analysis. The U.S. Chronic Kidney Disease Surveillance System is a collaborative effort among KECC, the Centers for Disease Control and Prevention (CDC), and UCSF. Moreover, Veterans Affairs (VA) maintains several ESRD programs through coordination with CMS and the University of Michigan. In addition, a proposal was set forth for a national registry of patients requiring vascular access and other resources relating to renal replacement therapy (RRT). A comprehensive ESRD-CRN would further enable examination of more clinical and broader research questions to improve patients’ quality of care and outcomes.
The objective of the ESRD CRN is to establish an infrastructure to capture RWE of patients’ interactions with medical devices. The Kidney Health Initiative (KHI), a public-private partnership between the FDA and American Society of Nephrology (ASN) has developed a Technology Roadmap that defines the priorities and opportunities for innovative RRT. The Kidney Innovation Accelerator (KidneyX), a public-private partnership between the US Department of Health and HHS and the ASN through its prize programs provides the funding mechanism for innovative RRT. Through these collaborative efforts, ESRD CRN aims to ensure the engagement of a variety of key stakeholders including patients in the healthcare ecosystem and a commitment to platform sustainability over time.
The ESRD CRN is a collaborative effort that engages organizations such as the ASN, through its public-private partnerships, KHI and KidneyX, FDA, CMS, and Weill Cornell Medicine. The CRN leverages relationships and contacts with industry, patients, and professional medical societies, both in the U.S. and abroad. Patient organizations will be an important part of the collaboration.
The MDEpiNet Coordinating Center is in the process of establishing MOUs with all participating partners. After the ESRD CRN membership is finalized, MOUs will be finalized with CRN’s leadership.
The patient population for this CRN includes individuals with ESRD.
ESRD CRN data sources include claims and administrative data, as well as registry and other data sources. One of the potential data sources for the CRN is the USRDS, which is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and currently housed by the Chronic Disease Research Group in Minneapolis. This national data system collects, analyzes, and disseminates information on chronic kidney disease (CKD) and ESRD. USRDS produces comprehensive annual reports on dialysis and CKD-related metrics for researchers, regulators, and clinicians. The USRDS works collaboratively with CMS and the United Network for Organ Sharing.
Furthermore, dialysis organizations have a network of multisite electronic medical record (EMR) data. Three large dialysis EMRs, which include DaVita, Fresenius Medical Care, and Dialysis Clinic, Inc., encompass 80% of US dialysis patients, while 14 smaller EMRs comprise the rest of the market. These independent dialysis organizations’ data are consolidated though the National Renal Administrators Association health information exchange.
Existing core data sets for chronic kidney disease include the following: (1) Standardized Outcomes in Nephrology, which is an international initiative that aims to establish core outcomes in CKD; (2) the International Consortium for Health Outcomes Measurement Standard Set for CKD, which are recommendations established by a group of physicians, measurement experts, and patients; and (3) the European Association of Rehabilitation in CKD recommendations on measurement and interpretation of physical function.
Current Projects and Plans
Patient Preference Information Pilot Study: This effort aims to develop innovative methodology for patient engagement and input to build a patient-centered CRN. Specifically, a pilot study will be conducted that develops and incorporates patient preference information data into a core data elements set for ESRD. As one of the prime uses of the data and evidence generated by the CRN is for regulatory decision making, it is vital that PPI regarding benefit/risk trade-offs is captured as valid scientific evidence that can be used by regulators as well as payers, providers, and patients. The CRN platform will capture and expand capacity to identify outcomes most important to patients and aid in the design of clinical trials to reduce the time and cost of execution. Data developed from rapid-cycle clinical trials and linked to sources of real-world data will generate evidence for a variety of decision-making and improve patient care.
Collaboration with KHI: The ESRD prioritizes collaborating with KHI to ensure the engagement of a variety of key stakeholders including patients in the healthcare ecosystem and a commitment to platform sustainability over time. The KHI developed a “Technology Roadmap for Innovative Approaches to RRT,” which defines the priorities and opportunities for innovative RRT and allocates 2019-2022 for the establishment of the ESRD CRN.