Sec. 3. Findings
420 words·~2 min read·
/bill/117/hr/7506/ih/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Congress finds the following: Approximately 37,000,000 adults in the United States have a chronic kidney disease, and kidney diseases are the ninth leading cause of death in the United States. Each day in the United States, on average, 340 people begin dialysis and 13 people die waiting for a kidney transplant. Rare kidney diseases like focal segmental glomerulosclerosis and immunoglobulin A nephropathy are particularly difficult to treat, and there are no approved treatments for these diseases.
In the absence of approved treatment options, more than 100,000 people live with rare glomerular kidney disease and face dialysis, transplant, or death. Focal segmental glomerulosclerosis is associated with a 50 percent risk of end-stage kidney disease within 5 years of diagnosis if partial or complete remission is not achieved. Between 20 and 40 percent of individuals with immunoglobulin A nephropathy are expected to develop end-stage kidney disease within 20 years. Rare kidney diseases disproportionately affect Black Americans, who are 3.5 times more likely to develop end-stage kidney disease, and 5 times more likely than the general population to have focal segmental glomerulosclerosis.
Because approximately one-third of Black Americans with focal segmental glomerulosclerosis cases are associated with a particular gene, communities of color would benefit from additional resources to support earlier detection, including genetic and genomic testing and referrals to high-quality providers. The prevalence of end-stage kidney disease is exacerbated by diagnostic challenges, barriers to high-quality care, and lack of awareness of disease risks. Federal spending on end-stage kidney disease currently accounts for approximately 7 percent of Federal Medicare spending.
The total Medicare spending on both chronic kidney disease and end-stage kidney disease patients exceeded $120,000,000,000 per year in recent years. A focus on renal health and the prevention of end-stage kidney disease would improve patient outcomes, extend lives, mitigate racial health care disparities, and reduce government spending. Due in large part to the 21st Century Cures Act, new regulatory paradigms have unleashed a wave of clinical innovation in the rare kidney disease space.
In 2020, the first-ever Rare Kidney Disease Roundtable outlined urgent needs in the areas of diagnosis, education, communities of color, and patient support for rare kidney disease patients and their families in the United States. In 2021, there are over 30 ongoing clinical trials underway for treatments for a range of rare kidney diseases, offering the first hope for novel therapies for patients living with rare kidney diseases, a new era of preventing end-stage kidney disease and related Federal costs, and the possibility of improving chronic kidney care writ large.