WASHINGTON (CN) – Poised to shake up the multimillion-dollar industry for kidney care, President Donald Trump signed an executive order Wednesday aimed at expanding organ-transplant accessibility as well as at-home treatment options.
The U.S. has long lacked a sufficient inventory of transportable organs to meet demand. According to the United Network for Organ Sharing based in Richmond, Virginia, there are more than 113,000 people waiting for transplants in the United States alone.
Wednesday’s order strives to change that, to start, by streamlining the performance of the 58 nonprofit organizations that collect organs, ultimately reducing the amount of organs that are discarded.
All told, the White House estimates the plan will make roughly 17,000 healthy kidneys available for transplant, as well as 11,000 livers, hearts and other vital organs.
Before signing the executive order Wednesday, President Trump said the kidney has a “very special place” in his heart.
“It’s an incredible thing,” said Trump, whose wife, Melania, was hospitalized for kidney issues last year.
In an official statement following the signing, Trump said the order would give patients more options.
“We believe in giving patients choice and freedom in healthcare, ensuring access to the doctors they want, the treatments they need and the highest standard of medical care anywhere in the world,” Trump said.
The order also hopes to recoup losses to Medicare, which, according to the National Kidney Foundation, spent $35 billion in 2016 for dialysis, a treatment regimen where toxins and excess water are removed from the blood of people with malfunctioning kidneys.
Some 30 million Americans have a form of kidney disease and once a person reaches the most advanced stages of the disease, without a transplant or dialysis, the illness can be fatal. The CDC reported in 2017 that kidney disease was the ninth leading cause of death in the United States.
Ensuring that more Americans are treated with in-home dialysis, instead of frequenting a kidney center or hospital for treatment, has been pushed by members of the administration’s Health and Human Services Department since May.
The department did not immediately respond to request for comment Wednesday and does not generally comment on pending rulemaking. In a May speech delivered during the agency’s annual kidney health initiative, however, HHS Deputy Secretary Eric Hargan emphasized the administration’s wish to focus on more on “convenient” care.
“Too many Americans don’t shift to more convenient dialysis options and too many Americans never get a chance at a kidney transplant,” Hargan said.
In 2017, the National Institute of Health, with funding from the federal government, launched its Kidney Precision Medicine Project to better understand both kidney disease and treatment techniques. Enrollment for study participants will begin soon.
The current model of treatment relies heavily on patients receiving care at the hospital and the makers of dialysis machines are were shaken in the run up to the president’s announcement. Two of the nation’s top providers, DaVita and Fresenius Medical Care, saw a dip in their respective shares of 8.7% and 6.5% Tuesday. Dialysis centers across the U.S. reported a hefty $24 billion in revenue in 2018. DaVita and Fresenius Medical Care own the majority of machines in those centers.
According to Wednesday’s order, convenience will also be extended to donors not just recipients. Typically, only low-income donors have their travel expenses paid to and from the hospital and receive reimbursement for lost wages. Under the new order, people with middle and high incomes will also be eligible for reimbursement.
The order also outlines directives around deceased donors. Currently, the system set up to assess eligible donors through organ procurement organizations is based on a series of incentives. These centers are evaluated based on the number of organs are recovered from “eligible deaths.” But the organizations are also the only group making that determination, opening the door to a manipulation of reported donor numbers.
Under the new directive, that system would be exchanged for another process that the government touts as harder to manipulate. Procurement centers will now have to evaluate the number of deceased donors as part of the grand total of those people deceased at 75 years old or younger. It will also require evaluation of whether the cause of death lines up with the donation.
This, the White House argues, creates a baseline for agencies to work from that is more objective and accurate.
The order will also instruct kidney-treatment centers to reform how they accept provider payments and incentivize preventative care. The Food and Drug Administration has orders meanwhile to review advances in new medical breakthroughs and treatment methods that don’t immediately rely on costly care from a designated kidney treatment center.