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October 14, 2024
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To reach optimal kidney care, funding for innovation is necessary

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“The historic underfunding of the ESRD payment system has created disincentives for the development of new drugs, biologicals, devices and innovative treatment options ... ”

from Kidney Care First, June 2019, Kidney Care Partners

The Congressionally mandated Prospective Payment System, implemented more than 10 years ago, was built with cost containment in mind.

The premise was to “bundle” services and drugs needed to treat patients with end-stage renal disease that were previously billed separately by dialysis providers. But the Medicare Prospective Payment System (PPS) has little room for funding innovation.

Mark E. Neumann

“It will be difficult, if not impossible, to translate research ... into actual patient care if there is not a viable payment pathway that recognizes the need for additional funding in the PPS,” the authors of the Kidney Care First report wrote.

KidneyX, launched in April 2018 as a private-public partnership between the American Society of Nephrology and HHS, has awarded $17 million in grants to companies developing new technologies.

Congressional supporters are seeking another $20 million this year.

Suzanne Watnick, MD, FASN, agreed with the Kidney Care Partners report that the efforts to push cost containment has strangled the chances of new technologies that could improve the lives of patients with kidney disease.

“The bundle actually started developing as far back as 2008,” Watnick, a professor of medicine in the division of nephrology at the University of Washington and the ASN Health Policy Scholar in Residence, told Healio | Nephrology News & Issues. “But it is outdated now. It needs to be modernized.”

High cost, mortality

Costs for kidney care in the United States have increased. The most recent annual report of the U.S. Renal Data System (USRDS) showed Medicare spent $52.3 billion on patients with end-stage kidney disease in 2021. For Medicare beneficiaries with chronic kidney disease not on dialysis, spending was $86.1 billion that year. Combined, the tally is more than $138 billion.

While the COVID-19 pandemic can be blamed for high mortality earlier in this decade among patients with ESKD – the USRDS showed a 17% increase in patient deaths in 2020 vs. the previous year, including a high rate of death among kidney transplant recipients – dialysis providers have expressed concern that the rate of mortality among patients has continued.

“We have been talking to our physician community in trying to understand what is driving [high mortality],” DaVita Inc. CEO Javier Rodriguez told investors during a recent earnings call. “The reality is people come up with hypotheses, ... but the real quantifiable answer is not one that we can say with confidence ... ,” he said.

Due in part to a lower-than-expected patient census, DaVita has closed more than 200 dialysis clinics in the last few years, company executives have said.

Quality of life

But “living longer” should not be the only goal of any medical therapy, and a lack of funding for new innovative products, such as new vascular access methods or wearable dialysis devices, may offer dialysis care defined as adequate, not optimal. A recently published study by Maria E. Montez-Rath, MS, PhD, from Stanford University School of Medicine and colleagues showed that dialysis treatment offered only “modest gains” in life span – 9.3 days – compared with patients who chose medical management.

“ ... [B]y focusing on the life-extending effects of dialysis, treatment decision-making for older adults with kidney failure often ignores or downplays the potential harms of dialysis, including exposure to invasive procedures, hospitalizations and time spent in health care settings,” Montez-Rath and colleagues wrote.

While the payment bundle has had some victories, like containing the cost and use of erythropoiesis-stimulating agents while maintaining good outcomes, Watnick said patients deserve access to new innovative therapies. “Whatever the future is, we should make sure that we are providing the value we set out to, and make sure that the quality of life of patients is improving,” she said.