WASHINGTON – Kidney Care Partners (KCP) – the nation’s largest non-profit, non-partisan kidney care coalition dedicated to protecting access and comprised of more than 30 organizations, including patients, dialysis professionals, physicians, nurses, researchers, therapeutic innovators, transplant coordinators, and manufacturers – today expressed deep disappointment and concern with the Centers for Medicare & Medicaid Services (CMS) final rule on End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)* which fails to address issues raised by the kidney care community in the hundreds of public comments submitted during the 60-day public comment period. Specifically, the final rule does not provide adequate support and reimbursement for innovative treatment options under the Transitional Drug Add-on Payment Adjustment (TDAPA) policy, nor does it provide support to address the workforce shortage crisis that has already resulted in widespread clinic closures and a substantial reduction in dialysis treatment shifts and patient access to care. Stakeholders from all sectors of the community, particularly patients and health care providers, have noted that the proposed policies CMS has finalized will have devastating consequences for the nation’s 30 million patients living with kidney disease.

“KCP is extremely disappointed that the ESRD PPS final rule fails to incorporate feedback provided by the kidney care community and bipartisan members of Congress and instead offers grossly insufficient reimbursement for vital kidney care services,” said Dr. Mahesh Krishnan, Chair-Elect of KCP. “The ` reimbursement increase is not enough to address the soaring labor and overhead costs that care providers face. CMS’ failure to include a forecast error adjustment to address incorrect estimates about inflationary costs will worsen access to dialysis care, ultimately harming patients living with ESRD nationwide, particularly people of color and those living in rural areas.”

“It is deeply concerning that policy in the final rule will stifle innovation,” said John P. Butler, Chair of KCP. “The payment cliff for new drugs and methodology for the limited adjustment to the base rate dilutes funding for innovative products across all treatments rather than targeting funding for patients with conditions that require innovative products. This policy fails to provide a patient-centric approach to supporting innovative treatment options. The stark contrast here to the agency’s supportive efforts to incentivize innovative products for other chronic conditions, such as cancer or heart disease, is disappointing and contradicts the efforts of the Administration’s KidneyX Initiative.”

 “As a physician, knowing that medications that could significantly improve a patient’s quality of life are just out of reach because of a well-intentioned but ultimately unsuccessful payment policy is heartbreaking,” said Dr. Dan Weiner, a practicing nephrologist at Tufts Medical Center in Boston. “Without reform, dialysis innovations will continue to remain limited, leaving the more than half million people who need dialysis dependent on technology and care that has barely changed in more than 30 years.”

In comments to HHS on the rule, patients and care partners echoed KCP’s concerns about staff shortages, clinics closing and limited access to innovations, including oral-only phosphate-lowering treatments. For those living with kidney failure, these concerns come on top of grappling with the already life-altering need for dialysis.  

To mitigate this rule’s impact on ESRD patients nationwide, KCP is asking members of Congress to step in and pass the Chronic Kidney Disease Improvement in Research and Treatment Act, which would aid the nationwide fight against kidney disease by expanding prevention, screening, and education resources, addressing ongoing workforce challenges through annual payment updates, and creating a long-term, sustainable pathway for innovative drugs and devices. Urgent action is needed, given that the first innovative drug will be subject to this flawed policy in April 2024.

“Now, more than ever, it’s essential that federal lawmakers step up and pass legislation to support our nation’s kidney care community before it’s too late,” Butler concluded.

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*The End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI), End-Stage Renal Disease Quality Incentive Program (QIP), and End-Stage Renal Disease Treatment Choices Model (ETC)