President Trump, as part of his administration’s efforts stated goal to promote American kidney health, recently unveiled his initiative “Advancing American Kidney Health.” The initiative paves the way for what could be major changes to the treatment of end-stage renal disease (ERSD).
According to HHS, 37 million patients have chronic kidney disease, while 726,000 of those have ESRD. The kidney transplant waiting list has over 100,000 patients and kidney disease is the ninth leading cause of death in the U.S. There are about 750,000 Medicare members with ESRD (about 1% of the Medicare population), but those members make up about 7% of the Medicare budget.
HHS has three goals for improving kidney health:
- Reduce the number of Americans developing end-stage renal disease by 25% by 2030
- Have 80% of new ESRD patients in 2025 either receiving dialysis at home or receiving a transplant
- Double the number of kidneys available for transplant by 2030
In light of this, Trump’s initiative could, as Jesse Sussell, PhD, associate director, Policy and Economics, Precision Xtract, says, “introduce fairly substantial, mostly positive changes in the treatment of patients ESRD.”
“Over the last several decades,” Sussell says, “there has been relatively little innovation in the care model for patients with ESRD,” but “the administration is now seeking to significantly alter the way we provide care to patients with ESRD.”
Sussell says the order largely falls into three major aspects:
- Alter incentives for organ procurement organizations (OPOs)
- Remove barriers to kidney donation
- Explore models to shift patients from clinic-based dialysis to home dialysis.
One of the major goals of the executive order is to increase the number of available organs and close that waiting list gap.
Sussell points to evidence that there are not enough organs harvested due to “suboptimal evaluation metrics.”
“Currently,” Sussell continues, “OPOs are incentivized to maximize the number of organs procured per eligible death, and they can do this either by procuring a larger number of organs, or by being unnecessarily restrictive in defining eligible deaths. The executive order directs the secretary of Health and Human Services (HHS) to recommend alternative metrics which are less vulnerable to gaming by OPOs.”
Barriers to donation
One of the major barriers to kidney donation by healthy people, according to Sussell, is that organ donation is a major surgery—meaning that donors face not insignificant post-op recovery times that can affect if/how they can work or care for dependents.
"At present," Sussell says, "our system does not do a very good job of helping donors overcome these barriers, and the result is a reduction in the available organ pool. The executive order directs the secretary to create a proposal for expanding the set of donor costs which are reimbursable by HHS, to include things like lost wages, childcare, and elder care. Somewhat surprisingly, there is evidence from overseas that implementing this kind of policy change can have a big impact on voluntary organ donation rates.
“Both of these changes would benefit patients. Right now, the average wait time on a kidney transplant is roughly five years. Patients on waitlists are undergoing chronic dialysis, which has a large impact on quality of life and is also very costly. Increasing the available supply of organs would reduce average wait times, which means less time spent on dialysis. Because many patients die while waiting for organs, this policy change would also likely save lives.”
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Another possibility to save lives, Sussell points out, is that patients who receive live-organ donation have better long-term outcomes than patients who receive organ from deceased donors. Because of this, an increase in live-organ donation could have a positive impact on graft failure.
In the United States, most dialysis occurs in clinics. In the rest of the world, home dialysis is much more common.
According to Sussell, “this could have a potentially large impact on Medicare costs, because home dialysis is cheaper than in clinic dialysis, and ESRD is one of the major cost drivers for CMS.”
Hemodialysis costs about $89,000 per patient annually, for a total cost of about $42 billion per year.
A changing healthcare landscape?
While the executive order could ESRD care, perhaps most important is what it could mean for how the administration approaches healthcare going forward.
“The most interesting thing here,” says Sussell, “is the signal that the administration is interested in flexible experimentation with health policy to improve patient outcomes. While we've seen some previous efforts to influence pharmaceutical pricing, this is one of the first instances where the White House is seeking to directly influence the way care is provided for a specific patient population.”
Sussell adds, “these changes may signal an openness to health policy experimentation in other areas.”