The Trump administration unveiled several new rules Tuesday that aim to boost access to transplants for patients with kidney disease.
The Centers for Medicare & Medicaid Services issued a rule that overhauls oversight of organ procurement organizations (OPOs). The measures were last updated significantly in 2006, and the new proposed rule would change the recertification cycle for these organizations from every four years to annually.
CMS also wants to include new performance measures for these groups, such as donation and transplantation rates. The changes, if finalized, would take effect in 2022.
On a call with reporters Tuesday morning, CMS Administrator Seema Verma said the agency estimates the changes would lead to an additional 5,000 kidney transplants.
“Our proposed rule represents a fundamental shift in the way we assess OPOs,” Verma said.
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The changes are borne out of an executive order signed by President Donald Trump in July that included a slew of initiatives to improve kidney care for patients and address the high costs associated with the disease.
Also as part of that order, CMS released five new payment models designed to drive greater use of home dialysis and increase access to transplants. Under one of the models, called End-Stage Renal Disease Treatment Choices, CMS said it will adjust participating providers’ payments up or down depending on their transplant and home dialysis rates.
Kidney care has been a focus for the administration for some time, as the Department of Health and Human Services launched a nephrology-centric accelerator, called KidneyX, in April 2018 and Secretary Alex Azar has spoken about how kidney care has “some of the worst incentives in healthcare.”
In addition to the rule from CMS, the administration also released a rule from the Health Resources and Services Administration (HRSA) that aims to ease some of the financial barriers to becoming a living kidney donor.
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HRSA’s proposed rule would offer greater coverage for expenses associated with the donation, such as lost wages, childcare or eldercare. Kidneys transplanted from living donors typically produce better outcomes than those from deceased donors or compared to dialysis, according to HRSA.
HRSA Administrator Tom Engels said on the press call that the changes could lead to a notable increase in living kidney donations. About 96,000 people are on the waiting list for a kidney transplant, he said.
“Many potentially living donors may be willing and available to donate an organ to a family member, friend or an unknown recipient, but would be unable to afford the loss in income while out of work during the transplant process, which include pre-transplant evaluation, surgery, subsequent recovery time and follow up appointments,” Engels said.
“This proposed rule would remove this potential barrier to living organ donations,” he said.