kidney transplantation. The ETC Model will test the effectiveness of outcomes-based payment adjustments to health care providers to increase utilization of home dialysis and kidney/kidney-pancreas transplants. The Home Dialysis Payment Adjustment (HDPA) would be in effect for the first three years of the Model, and would increase payment for home dialysis and home dialysis-related services. The Performance Payment Adjustment (PPA) would decrease or increase payment for dialysis and dialysis-related services based on a participating ESRD facility or Managing Clinician’s rate of home dialysis and transplants. The goal of the Model is to increase the transplant and home dialysis rate across the country. ▶ The Innovation Center’s optional kidney care models (KCF and CKCC) include incentives for health care providers to better manage the care for beneficiaries with kidney disease including incentives for pre-emptive transplants, improving beneficiaries’ transition to dialysis, and ensuring dialysis initiation is appropriately timed. The Model also includes incentives to manage the total cost and quality of care for beneficiaries with kidney disease and kidney failure, and strong financial incentives to move beneficiaries through the transplant process. Together with the new ETC Model, the optional kidney care models demonstrate CMS’ commitment to supporting high quality, coordinated care for people living with ESRD. ▶ CMS is considering ways to encourage ESRD facilities to furnish new and innovative drugs and biological products for the treatment of ESRD. The Transitional Drug Add-on Payment Adjustment (TDAPA) is an add-on payment adjustment under the ESRD PPS intended to facilitate this goal for Page 16 | Advancing American Kidney Health Medicare beneficiaries. This is done by encouraging ESRD facilities to furnish certain qualifying new renal dialysis drugs and biological products by allowing additional payment for them while utilization data is collected. ▶ CMS recognizes that continual refinement of the ESRD PPS is necessary to benefit people living with ESRD, and is therefore working with an analytical contractor to perform payment analysis and develop potential refinements to the ESRD PPS. CMS plans to ask for stakeholder input on data collection. ▶ Based on comments received during and after the CY 2019 ESRD PPS rulemaking, CMS is considering issues related to payment for new and innovative supplies and equipment that are renal dialysis services furnished by ESRD facilities for ESRD beneficiaries. OBJECTIVE 3. Catalyze the development of innovative therapies including wearable or implantable artificial kidneys with funding from government, philanthropic and private entities through KidneyX, and coordinating regulatory and payment policies to incentivize innovative product development Ultimately, the best way to improve care for people living with kidney failure is to support the development of novel therapies extending beyond the choices available today. Investing in foundational research at the NIH, catalyzing rapid product development through public-private partnerships, and creating clear and forward-looking guidelines for marketing approval for emerging technologies like organ preservation may unleash innovation for years to come. ▶ KidneyX was officially launched in 2018 as a public-private partnership with the American Society of Nephrology to support the development of innovative therapies and diagnostics. KidneyX is designed to leverage rapidly emerging technologies in areas such as regenerative medicine, nanotechnology, and advanced materials to support early-stage development and lower the risk of commercialization. KidneyX’s first prize, Redesign Dialysis, offers $2.6M for kidney failure treatments beyond currently available options of dialysis and transplantation. Included among the 15 winning teams announced in April 2019, were companies developing advanced nanofiltration for toxin removal, miniaturized wearable dialyzers, real-time infection and clotting sensors, cell-based implantable dialyzers, and regenerative kidneys. The second phase currently underway will seek testable prototypes and announce winners in April 2020. Find more information on KidneyX at: https://www.kidneyx.org ▶ In June 2019, the HHS Chief Technology Officer signed an agreement with the heads of CMS, NIH, FDA, and CDC to work closely together on KidneyX to ensure that unnecessary barriers to patient access for innovative technologies are addressed. In July 2019, KidneyX is also launching a patient innovator prize focused on identifying and scaling new products and practices that patients and caregivers have developed for their own care, recognizing that innovation often happens at the frontlines of health. In 2020, KidneyX plans to launch Redesign Dialysis Phase III to advance new products into human clinical trials, another prize focused on helping dialysis patients manage fluids, a leading cause of ESRD hospitalizations, and a prize focused on spurring development of therapies to slow progression of kidney disease. ▶ HHS and the Department of Veterans Affairs (VA) are exploring a partnership to streamline and expedite clinical trials for kidney care-related treatments using the VA health system, similar to the National Cancer Institute (NCI) and VA Interagency Group to