Nation’s Kidney Community Expresses Deep Disappointment on CMS Proposed Rules on Prospective Payment System and ESRD Quality Incentive Program

June 28, 2023

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 issued the following statement expressing disappointment with the Centers for Medicare & Medicaid Services (CMS) proposed rule on 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):

KCP is extremely concerned that the CMS ESRD PPS proposed rule fails to heed calls from the kidney care community for meaningful relief to address the ongoing workforce crisis. The lack of attention and action on these labor issues, which impact the availability of vital healthcare services, is dismaying and short-sighted. With ESRD inflation-related labor costs around four percent nationally, CMS flatly rejected calls from providers, patients, and bipartisan Members of Congress to provide resources necessary to keep dialysis clinics open and ensure access to care for the individuals with ESRD, who, in the rule’s preamble, CMS, itself, recognized as among the most vulnerable of all beneficiaries.

Further, CMS’s rule doesn’t address policies that result in insufficient payment and instead proposes inadequate reimbursement for innovative treatment options, contributing to significant barriers to patient access and exacerbating already existing health equity concerns. Together, these provisions widen disparities for individuals living with kidney disease or failure, who are disproportionately from communities of color.

Due to a number of factors that make transplant – the ideal treatment – difficult to obtain, most individuals with kidney failure rely upon life-sustaining home or in-center dialysis sessions three or more times each week. Providing these services requires a highly trained and skilled healthcare workforce consisting of a diverse and knowledgeable team to develop and implement an individualized plan of care. These care teams include nephrologists, advanced practitioners (such as nurse practitioners or physician assistants), nephrology nurses, renal nutritionists, nephrology social workers, patient care technicians, renal technologists, administrative support, and financial counselors. Unfortunately, because of the ongoing healthcare labor crisis, many facilities cannot hire sufficient staff needed to support individuals receiving dialysis. Reductions in treatment capacity and closures of facilities altogether are some of the grave risks presented by the proposed rule’s policy choices.   

Federal data from the Bureau of Labor Statistics (BLS) showed an 8.3 percent increase in the cost of labor between the first quarter of 2020 and the first quarter of 2022. In contrast, the Medicare rates were increased by only 3.0 percent for Calendar Year 2023, which is more than 5 percentage points less than the Administration’s own labor statistics. The recently proposed rate is just 1.7 percent. By statute, the annual Medicare payment increase is supposed to capture not only increases in labor costs, but also increased costs related to equipment, supplies, medication, and devices.

KCP is disappointed that CMS has refused to adopt the forecast error policies that it applies in another Medicare payment system for the ESRD PPS. While this policy might not solve the payment adequacy problems in its entirety, it is an important step to help make sure that patients have access to the life-sustaining services they need.

Patient advocate Lori Hartwell of Renal Support Network said, “We can’t expect the kidney care treatment landscape to improve without access to innovation and a kidney care professional workforce. This rule doesn’t consider that without a workforce, people with kidney failure are denied access to care.  It’s disappointing that this rule inadequately addresses these issues, as it’s ultimately people living with kidney disease who will suffer.”

KCP continued,

Given the options outlined in the Request for Information (RFI) and strong community and Congressional comments submitted as a result of that RFI in 2022, KCP is particularly disappointed in the proposed payment methodology for post-transitional drug add-on payment adjustment (TDAPA) drugs. We applaud CMS for recognizing that additional resources should be added to the payment rate for innovative drugs or biologicals that received TDAPA when the TDAPA period ends and for understanding the need to update the add-on amounts to reflect inflationary costs. 

However, the proposal to add funding across all treatments will create significant access concerns for patients when the drug or biologic is medically needed for only a small percentage of patients. This approach simply will not provide adequate reimbursement to facilities when the product is used. Moreover, the proposal to limit the new funding only to three years creates a payment cliff that provides no sustainable pathway for the continued use of the product after the post-TDAPA period ends. These policies, coupled with limitations in utilization and the proposal to pay 65 percent of total drug expenditures rather than to use a more accurate offset calculation, result in a payment rate of a mere nine cents per treatment to the payment for the only TDAPA drug currently in use. Particularly concerning is that despite the agency’s assertion that it seeks to address health inequity for underserved communities, underfunding these treatments post-TDAPA will continue to expand the divide between those who can access new innovations and who cannot.  

KCP Chair, John P. Butler noted, “It is crucial to ensure that changes in the payment system reflect the needs of the kidney care community and support the delivery of high-quality care. We urge CMS to thoroughly consider the community’s concerns and look forward to providing more specific feedback in our forthcoming comments.”