On Thursday, November 7, 2019, Health and Human Services (HHS) Secretary Alex Azar spoke at the American Society of Nephrology Kidney Week. Secretary Azar spoke about American kidney health and the future.
Azar first commended all those who support kidney patients: from health professionals to researchers to patients themselves. He noted that those individuals and their “dedication to American kidney health, are one of the main reasons” he has hope that “a major revolution” is in the works when it comes to how America cares for kidney disease.
Secretary Azar reminded attendees that the Trump Administration initially laid out its vision for kidney care at the National Kidney Foundation’s patient gathering earlier this year. Since that time, President Donald Trump signed an executive order on Advancing American kidney health and an initiative was launched within HHS.
The overall plan has three parts: first, more efforts to prevent, detect, and slow the progression of kidney disease; second, more options for treating kidney failure, from both today’s technologies and those of the future; and third, more organs for transplants.
Each part of the plan has a corresponding goal: first, reducing the number of Americans developing end-stage renal disease by 25 percent by 2030; second, reducing the number of Americans receiving dialysis in a dialysis center, from 2019 levels, by 80 percent by 2025; and third, doubling the number of kidneys available for transplant by 2030.
Secretary Azar used his speech as a way to provide an update on the initiatives, starting with a partnership with the American Society of Nephrology (ASN) and the National Kidney Foundation. This partnership will focus on educating Americans on how they can improve their kidney health, which will lead to early identification, treatment, and management of kidney disease.
KidneyX, the partnership with ASN, has made awards to 15 teams across the country to redesign dialysis. Submissions for the second phase of Redesign Dialysis, bringing products to prototype, will open November 18th.
HHS is also issuing a request for information about how KidneyX can bring advances to human trials. The RFI includes a summary of regulatory, coverage, and payment options for a wearable or implantable artificial kidney, including the availability of Fast Track programs at FDA.
National Institutes of Health
The National Institutes of Health (NIH) has also opened applications to its small-business innovation research program to develop new technologies that may advance society towards the goal of an artificial kidney.
Optional Payment Models
Four optional payment models have been launched, known as Kidney Care Choices, and Requests for Applications for these models were recently posted. It’s anticipated that more than 200,000 Medicare patients will be enrolled in arrangements with new incentives to prevent the progression of kidney disease and manage kidney patients’ health. Azar noted that within each of those models, there will be patient-centered prevention and dialysis, as well as new incentives to encourage transplants.
Azar also announced a new step the Administration is taking: in mid-November, the Health Resources and Services Administration (HRSA) will issue a Request for Information about 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 is particularly interested in hearing from a variety of entities that can develop a system that is more effective than the one in existence today.