On July 10, 2019, President Trump signed an Executive Order launching the Advancing American Kidney Health initiative, led by the Department of Health and Human Services. HHS Secretary Alex Azar issued the following statement:
“We have brought more change to American kidney policy in the last year than we saw in the past several decades. President Trump fights for forgotten Americans, and America’s kidney patients were forgotten for far too long—but no more. Since the President signed his executive order, HHS has launched models to improve kidney payments, proposed new ways to increase transplants and support organ donors, changed guidelines to expand the supply of organs, and launched a historic public awareness campaign to promote kidney health. Because of the hard work of the HHS team and kidney patients and advocates, American kidney care will change and improve dramatically in the years to come.”
Since the signing of the executive order, HHS has taken numerous actions to advance American kidney health, including the following:
- The Centers for Medicare & Medicaid Services launched the Kidney Care Choices payment model, a voluntary model to provide new incentives for delaying the need for dialysis in patients with chronic kidney disease, which is expected to enroll more than 200,000 Medicare beneficiaries.
- CMS proposed the ESRD Treatment Choices model, a mandatory model that aims to increase rates of home dialysis and transplants, and is currently considering comments on it.
- CMS proposed a rule to change the way organ procurement organizations (OPOs) are held accountable for their performance, estimating that the number of annual transplants would increase from about 32,000 to 37,000 by 2026, for a total of almost 15,000 additional transplants in that time.
- CMS finalized a change to increase the new technology add-on payment in Medicare and expand the eligibility for it, with the goal of supporting new technologies, including for kidney care.
- The Health Resources and Services Administration (HRSA) issued a proposed rule to remove financial barriers to living organ donation by expanding support for living donors.
- HRSA issued a request for information to begin exploring more effective ways in which modern IT systems may be able to manage allocating organs and handling patient and donor data on a national scale.
- HHS announced new guidelines for the donation of organs such as kidneys from patients with HIV, hepatitis B, and hepatitis C, using scientific advances to allow donations that previously would not have been possible.
- HHS launched a nationwide kidney risk awareness campaign with the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN).
- KidneyX, a public private partnership between HHS and ASN, made awards in the first-ever Patient Innovator Challenge. The KidneyX Summit 2020 on July 22 will award $3 million in prizes to six winners of the Phase 2 Redesign Dialysis Prize. KidneyX also issued a request for information to help shape a moonshot Artificial Kidney Prize, soon to be announced.
- HHS’s Office of the Assistant Secretary for Preparedness and Response deployed a new form of portable dialysis machines in March 2020 to New York City to help patients suffering kidney injury from COVID-19.
- The FDA awarded a contract to the Kidney Health Initiative, a public-private partnership between FDA and ASN, for a three-year project that will measure patient preferences and risk tolerance for novel treatments for kidney failure, allowing the FDA to better incorporate patient input into the development and review of new technologies.
- The NIH-funded Kidney Precision Medicine Project (KPMP) has been conducting research that will help improve identification of populations at risk and those in early stages of kidney disease. Since the summer of 2019, KPMP has collected renal biopsies from over 30 patients, and recent KPMP publications have demonstrated the utility of kidney tissue in optimizing research tools and defining discrete, disease state-specific cell types based on molecular profiles.
Read more about the administration’s bold vision for kidney health: https://aspe.hhs.gov/pdf-report/advancing-american-kidney-health