Improving the diagnosis and treatment of kidney disease while enhancing their affordability and adding incentives for preventive care are among goals of an executive order signed this week by President Donald Trump.

The executive order declares the policy of the U.S. to “prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care.”

U.S. policy, according to the order, also includes expanding affordable alternative treatment options for end-stage renal disease (ESRD) by educating patients on treatment alternatives, encouraging development of artificial kidneys—and encouraging “higher value care.”

High-value care has been defined by the American College of Physicians as healthcare that balances clinical benefit with costs and harms with the goal of improving patient outcomes—and by the Institute of Medicine as “the best care for the patient, with the optimal result for the circumstances, delivered at the right price.”

The order also directs officials to increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.

“We’re taking groundbreaking action to bring new hope to millions of Americans suffering from kidney disease,” Trump said at a signing ceremony for the order held in Washington, DC, at the Ronald Reagan Building and International Trade Center. “This action will also dramatically improve prevention and treatment of this life-threatening illness, while making life better and longer for millions of Americans.”

According to Trump and the executive order, nearly 100,000 Americans are awaiting kidney transplants. The order cited several additional statistics on kidney disease:

  • Approximately 37 million Americans have chronic kidney disease and more than 726,000 have ESRD.
  • More than 100,000 begin dialysis each year for ESRD, of which 20% die within a year and 50%, within five years.

Creating payment models

U.S. Secretary of Health and Human Services Alex M. Azar II.

Within 30 days of its signing on Wednesday, or August 9, the order directs Secretary of Health and Human Services Alex M. Azar II to create two payment models.

One model is intended to encourage “innovations” by providers to deliver kidney care services at reduced patient cost and increased quality outcomes by expanding Medicare payment options for care that succeeds in “delaying or preventing the onset of kidney failure, preventing unnecessary hospitalizations, and increasing the rate of transplants.”

The other payment model required by the order would create incentives for greater use of home dialysis and kidney transplants for Medicare beneficiaries on dialysis: “The model should adjust payments based on the percentage of a participating provider’s attributed patients who either are on home dialysis or have received a kidney transplant and should include a learning system to help participants improve performance.”

One of the nation’s two largest operators of dialysis care centers, DaVita Kidney Care, said in a statement it was “energized by the focus from the Administration on kidney health.”

“We’ve been investing in capabilities to deliver holistic care that addresses our patients’ needs beyond kidney disease, such as mental health, social services, and nutrition. We will continue to work with the Administration and Congress to launch programs that address broader care opportunities,” DaVita CEO Javier Rodriguez said.

The other large dialysis center operator, Fresenius Medical Care, also praised the executive order.

“We share the U.S. Administration’s commitment to expanding access to home dialysis, transplantation, and new models of value-based care for chronic kidney disease, and we see it as an endorsement of our initiatives,” Fresenius CEO Rice Powell stated. “We invest constantly in innovation and will continue to do so in order to further develop the healthcare system. The proposed reimbursement models and new incentives will help foster further innovation and support a healthcare delivery system structure that is closely attuned to the needs of our patients.”

Developing artificial kidneys, therapies

Within 120 days of the order’s signing, or November 7, the order directs Azar to encourage development of artificial kidneys.

One component calls for enhanced cooperation between developers of wearable or implantable artificial kidneys and the FDA. HHS plans to announce it will consider requests for FDA premarket approval for those artificial kidneys.

The other component will be a new strategy designed to promote innovation in new therapies through the Kidney Innovation Accelerator (KidneyX), a year-old public-private partnership between HHS and the American Society of Nephrology created to accelerate development of drugs, devices, biologics, and other kidney therapies.

In April, KidneyX held a summit at which the partnership announced the 15 winners of $75,000 each in its inaugural prize competition, Redesign Dialysis Phase I. Participants were tasked with creating “designs of possible solutions or solution components that can replicate normal kidney functions and improve patient quality of life.”

KidneyX plans a Phase II competition in which participants will need to develop and demonstrate prototype solutions, with up to three innovators set to be awarded $500,000 each.

Azar was also directed within 120 days to promote kidney disease awareness through support programs and patient education efforts.

“The initiative shall develop proposals for the Secretary to support research regarding preventing, treating, and slowing progression of kidney disease; to improve kidney transplantation; and to share information with patients and providers to enhance awareness of the causes and consequences of kidney disease,” according to the order.

NIH kidney disease spending

The NIH has estimated that its spending on kidney disease research for federal fiscal year 2020, which begins October 1 of this year, at $536 million. That would be a 13% decrease from the $619 million estimated to be spent during the current 2019 federal fiscal year, which would be 3.5% higher than the $598 million actually spent on kidney disease in FY 2018.

However, FY 2020 spending will likely be higher than estimated since both the House of Representatives and the Senate have supported greater spending for NIH than the budget proposal submitted by Trump to Congress earlier this year. Trump proposed a 12% cut in NIH funding, to $34.368 billion, in his proposed $4.75 trillion budget.

On June 19, the House approved a four-bill spending package (H.R. 2740) that includes a $2 billion increase for NIH. The bill has advanced to the Senate, where it has been read a second time and placed on its legislative calendar.

Under other provisions of the Executive Order, Azar was directed to:

  • Propose a regulation within 90 days, or by October 8, revising Organ Procurement Organization (OPO) rules and evaluation metrics in order to increase procurement and use of organs available through deceased donation.
  • Propose a regulation within 90 days aimed at removing financial barriers to living organ donation by expanding the definition of allowable costs that can be reimbursed under the Reimbursement of Travel and Subsistence Expenses Incurred Toward Living Organ Donation program.
  • Reduce the discard rate of kidneys in transplants within 180 days, or by January 6, 2020, by speeding up kidney matching and delivery by “removing process inefficiencies.”

At the signing ceremony, Trump included in his remarks a commitment to kidney disease patients, including those in attendance: “We are fighting by your side, and we’re determined to get you the best treatment anywhere in the world.”

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