(125,000). In July 2019, President Trump issued an Executive Order (EO) aimed at improving the care of patients with Chronic Kidney Disease. In 2020, the Department of Health and Human Services (HHS) published final rules that attempt to streamline the renal care system by removing regulatory barriers, increasing oversight of organ procurement organizations (OPOs), and encouraging living donations.3 HHS estimates that their changes to the OPO system alone could generate up to 4,500 additional kidney transplants per year by 2026. While HHS notes that there is uncertainty regarding the number of kidney 3Medicare Program, Specialty Care Models To Improve Quality of Care and Reduce Expenditures, 85 FR 61114 ; Removing Financial Disincentives to Living Organ Donation, 85 FR 59438; Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations, 85 FR 77898. CEA • Increasing the Number of Kidney Transplants to Treat End Stage Renal Disease 3 transplants these rules will engender, HHS has set a goal of doubling the number of kidneys available for transplantation by 2030. CEA estimates that even comparatively modest improvements to the United States renal care system could generate significant societal benefits. Specifically, CEA estimates that if the United States matched Spain’s best in the world rate of deceased donor kidney transplants on a per million population (pmp) basis—an increase of roughly 7,300—and increased the number of living donors by 900, then these changes would produce societal benefits with a net present value of $16 billion per year. The Problem of Kidney Disease Chronic Kidney Disease (CKD) is a major health problem in the United States. The prevalence of CKD – i.e., the total number of people with the condition - in the U. S. adult population is 14.8 percent (USRDS 2018) or about 37 million people (CDC 2019). Kidney disease is the 9th leading cause of death in the United States, causing more deaths than breast or prostate cancer (National Kidney Foundation 2019). CKD is more prevalent among the elderly than among younger adults – 38 percent of people 65 and older have CKD as compared with 13 percent in people aged 45-64 years and 7 percent in people aged 18-44 years (CDC 2019). It is more common in women (15 percent) than men (12 percent) and more common in Blacks/African Americans (16 percent) and Hispanics (14 percent) than non-Hispanic whites (13 percent) (CDC 2019). CKD is classified along a continuum of disease severity ranging from Stage 1 (mild renal dysfunction) through Stage 5.4 Patients with Stage 5 whose disease is so severe that they would die without dialysis or kidney transplantation have End Stage Renal Disease (ESRD) (Agarwal 2016), 5 defined as a substantial and irreversible failure of the kidneys’ essential function–filtering the blood and removing waste products from the body while maintaining fluid and mineral balance (Wei et al. 2016). 6 At the end of 2016, there were 726,331 prevalent cases of ESRD. The incidence for 2016 – the number of newly reported cases – was 124,675 (USRDS 2018). ESRD is more common among males than females and far more common among minorities. The probability over a lifetime or lifetime cumulative incidence of having ESRD in males ranged from a low of 3.43 percent in whites to a high of 8.09 percent Blacks/African Americans. Similarly, in women, the lifetime cumulative incidence of ESRD ranged from a low of 2.32 percent in whites to 6.83 percent in Blacks/African Americans (USRDS 2018). 4 The staging is based on the patients’ level of glomerular filtration rate (GFR) which measure the kidneys’ filtering capacity and the level of protein in the urine. In general, Stage 1 is a normal GFR greater than 90 ml/min but with protein in the urine. Stage 2 CKD has GFR of 60-89 ml/min.; Stage 3 has GFR 30-59 ml/min and are often anemic; Stage 4 has GFR of 15-29 ml/min; and Stage 5 is GFR less than 15 ml/min. Protein in the urine, indicating kidney damage, is present in all stages of CKD. 5 Also known as End Stage Kidney Disease or ESKD. Everyone with ESRD has Stage 5 CKD but not everyone with Stage 5 CKD has ESRD. ESRD is defined by the need for renal replacement therapy (dialysis or transplant). While CKD 5 has specific laboratory parameters, ESRD can be a bit subjective, i.e., when the nephrologist determines renal replacement therapy is necessary. 6 The kidneys also have an endocrine function producing the hormones erythropoietin (involved in red blood cell production) and renin (involved in blood pressure regulation). Kidneys also synthesize multiple substances important for bone development, remodeling and repair. CEA • Increasing the Number of Kidney Transplants to Treat End Stage Renal Disease 4 Treating End Stage Renal Disease People with ESRD need renal replacement therapy - dialysis or transplantation of a functioning kidney – or they will die. There are two basic types of dialysis: hemodialysis uses a machine, usually at a dialysis center, much less frequently at home, to pass the blood through a filter called a dialyzer to remove waste products and regulate fluid and minerals. Treatment is usually 3-4 times per week with each session lasting 3-4 hours. Peritoneal dialysis uses the lining