of death in the United States was kidney disease.2 Major risk factors for kidney disease include uncontrolled diabetes, high blood pressure, and a family history of kidney failure. In some individuals, kidney disease progresses to kidney failure, often referred to as end-stage renal disease (ESRD), which requires dialysis or transplantation to survive.3 ESRD is a life-threatening illness with a death rate (50 percent mortality in 5 years) worse than most cancers that significantly affects quality of life. Even ESRD that is well managed with dialysis can result in premature death or severe disability, heart disease, bone disease, arthritis, nerve damage, infertility, and malnutrition.4 Infections, including those related to the dialysis procedure, are frequent causes of hospitalization and death among persons with ESRD. Dialysis treatments also pose a risk of non-infectious complications. Currently, the only treatment alternative that can restore some or most of normal kidney function is transplantation, which requires immunosuppressive therapy (to prevent rejection of the kidney by the recipient’s body) and therefore places recipients at risk for infection and malignancy due to immunosuppression. Page 5 | Advancing American Kidney Health Another indicator of the burden of kidney disease is the financial cost of treatment. Most individuals with kidney failure are eligible for Medicare coverage, regardless of age.5 Many Medicare beneficiaries with kidney failure suffer from poor health status, often resulting from disease complications and multiple co-morbidities that can lead to high rates of hospital admissions and readmissions.6 Total Medicare spending for beneficiaries with chronic kidney disease (CKD) and ESRD, including spending on comorbidities and other health care services that may be unrelated to ESRD, was over $114 billion in 2016, representing 23 percent of total Medicare fee-for-service (FFS) spending, of which $35.4 billion was spent on beneficiaries living with ESRD.7 While less than 1 percent of the total Medicare population has ESRD, spending on ESRD beneficiaries accounts for approximately 7 percent of total Medicare FFS spending.8 Figure 1 (previous page) shows the proportion of Medicare FFS spending attributable to Medicare beneficiaries living with ESRD. Over the past 70 years, there has not been the same level of innovation in treatments for people living with kidney failure compared to treatments for other health conditions.9 To improve quality of life among people living with kidney failure, it is clear that new technological advances and alternatives to dialysis for renal replacement therapy are urgently needed. Additional information about kidney disease and its risk factors can be found in the Appendix. Examples of Key Initiatives to Achieve Goals of the Kidney Care Vision Efforts across HHS to advance kidney disease prevention and care in the United States include scaling programs nationwide to optimize screening for kidney diseases, educating patients on care options with coordinated care networks and other tools, supporting ground-breaking research to inform the next generation of targeted therapies, creating new payment models and financial incentives to encourage utilization of home dialysis and increase access to kidney transplants, encouraging accelerated development of innovative products such as an artificial kidney, and undertaking a variety of efforts to increase the number of kidneys available for transplant from both living and deceased donors. Goal 1: Reduce the Risk of Kidney Failure Examples of how HHS is addressing Goal 1 include the Indian Health Service’s (IHS’) efforts to adopt a person-centered approach to care to improve outcomes for American Indians and Alaska Natives (AI/ ANs) at risk for diabetes complications such as kidney failure. The incidence of diabetes-related ESRD (ESRD-D) among AI/AN populations decreased by over 40 percent between 2000 and 2015, resulting in lower levels of disease burden for patients and lower spending on ESRD care.10 The Centers for Disease Control and Prevention (CDC) is updating its Hypertension Control Change Package for Clinicians to improve CKD detection and care quality among persons at high risk for CKD progression. CDC is also investing in state and local efforts to develop a public health response to CKD risk factors such as diabetes and heart disease.11 Goal 2: Improve Access to and Quality of Person-Centered Treatment Options HHS’ efforts to address Goal 2 include the National Institutes of Health (NIH) Kidney Precision Medicine Project, which will use kidney biopsies to help redefine kidney disease into new molecular subgroups, paving the way for personalized treatments. The Office of the Assistant Secretary for Preparedness and Response’s (ASPR’s) programs are working to ensure individuals who need dialysis treatment have ready access to treatment in the aftermath of disaster situations, through the availability of portable dialysis technologies. The U.S. Food and Drug Administration (FDA) has cleared devices for home hemodialysis, and FDA actively supports innovative efforts to improve the quality of current dialysis treatment and to develop new alternatives to dialysis for renal replacement therapy through its Breakthrough programs and participation in KidneyX, the Kidney Innovation Accelerator. The Centers