Alex M. Azar II
Described by HHS Secretary Alex M. Azar II as possibly the most significant step for treating kidney disease since Congress approved legislation in 1973 to create the ESRD Program, President Donald J. Trump signed an executive order this week to launch Advancing American Kidney Health, a new initiative to increase earlier intervention in chronic kidney care, incentivize dialysis providers to direct more patients to treatments at home and increase the number of kidneys available for transplantation. Goals include reducing the number of Americans developing ESRD by 25% by 2030; having 80% of new patients with ESKD in 2025 either receiving dialysis at home or having a transplant; and doubling the number of kidneys available for transplant by 2030.
More than a dozen kidney organizations, dialysis providers and members of industry responded to the plan, indicating they supported changes that would improve the care of kidney patients.
“The administration’s commitment to charting a new course for kidney health will help revolutionize transplantation and dialysis and advance new innovations, therapies and treatments which patients everywhere have been waiting on for far too long,” Kevin Longino, CEO of the National Kidney Foundation and a kidney transplant patient, said in a release. “Kidney care is, for the first time in decades, experiencing a renaissance that can transform the lives of millions of Americans while also saving taxpayers billions of dollars. NKF is grateful to the administration and our bipartisan Congressional champions who are elevating kidney disease as a national priority.”
In a release, Richard A. Knight, president, and Paul T. Conway, chair of policy and global affairs, for the American Association of Kidney Patients, said the organization, “enthusiastically endorses President Donald Trump and his health policy team in their bold and bipartisan efforts to fully empower kidney patient consumers and save kidney patient lives through greater care choice and innovations aimed at preventing and better managing kidney diseases.”
Medical societies also showed their support for the plan.
“Today’s announcement gives me hope for our patients — the 37,000,000 Americans impacted by kidney diseases,” Mark Rosenberg, MD, FASN, president of the American Society of Nephrology, said in a statement. “I hope these policy changes help us be better aligned to slow progression of kidney diseases, spur more innovation in treating kidney diseases, and offer more choices when dialysis is necessary, such as home therapy or more portable dialysis. Hope is long overdue for our patients,”
Advancing American Kidney Health includes five new treatment models, released by CMS through its Center for Medicare and Medicaid Innovation and to be implemented next year, that will eventually include more than 200,000 patients in demonstration projects to test whether the payment changes improve outcomes. Kidney Care Partners, an advocacy group made up of kidney organizations, providers and manufacturers, said the Trump plan includes “bold steps and fresh thinking about this important and often overlooked segment of health care patients.
“The administration’s proposal closely aligns with KCP’s Kidney Care FIRST initiative – which is a comprehensive framework for dramatically improving critical areas including prevention and awareness; patient empowerment; quality and access; and research and innovation ... we look forward to achieving our mutual goals of improving the lives of individuals with kidney disease, kidney failure and transplant,” KCP said.
Azar said part of the Trump plan includes covering expenses for organ donors, including lost wages, costs for childcare, medical costs not covered by the recipient’s health care insurance, and other expenses incurred by donors. In addition, the proposal calls for reducing disparities in performance among organ procurement organizations (OPOs) and transplant centers with the goal of increasing recovery of kidneys by OPOs and use of kidneys by transplant centers.
“We’ll establish more transparent, enforceable, and objective metrics for identifying potential kidneys for transplant. The result will be more and faster transplants for those in need,” Trump said during his speech. “By streamlining rules to help patients and by incentivizing the supply of kidneys — very substantially incentivizing, I have to add — an estimated 17,000 additional Americans could receive kidneys that they desperately need. We think that’s going to happen. We think that number is very doable, and it could even be higher than that.”
Using compromised organs in the current regulatory environment can present a challenge for transplant surgeons, Alfredo Fabrega, MD, director of Kidney and Pancreas Transplant Programs at Banner - University Medicine Transplant Institute, told Healio.com/Nephrology.
”The current environment does not encourage use of high [kidney donor profile index] KDPI kidneys (lower quality kidneys),” he said. “The emphasis is on patient/graft survival and on cost. All these are negatively affected by high KDPI ... If I have excellent patient/graft survival at low cost, no one questions how selective I am; on the other hand, if I save many more lives with high KDPI kidneys but have lower patient/ graft survival and higher costs, my program is flagged for poor outcomes and insurance companies shun me. Unless we de-emphasize cost and survival of patients transplanted and give equal weight to cost and survival of patients on dialysis, transplant centers are forced to be conservative if they want to survive.”
In a statement, the American Association of Organ Procurement Organizations, which represents all 58 OPOs in the United States, said, “OPOs support the goal of enhanced performance metrics that improve the ability to recover and deliver organs to those who need them. OPOs also embrace the goal of ensuring that every generously donated organ finds a suitable transplant recipient. Removing regulatory and financial disincentives to transplant centers using organs from medically complex donors and donors after circulatory death would accelerate the increase of transplantation over time. This is a significant issue.”
The association added, “There are many variables that determine the medical suitability of kidneys from deceased donors. Any metric must provide for an accurate estimate of true organ donation potential through the collection of timely, consistent and relevant data across all hospitals. Unless a potential donor is in the hospital and on a ventilator at the time of death, the organs cannot be donated and transplanted. Additionally, a metric should be flexible to adjust for advances in medical science and transplant program acceptance practices.” – by Mark E. Neumann
Disclosure: Fabrega reports he has no relevant financial disclosures.