Statement from Kidney Care Partners on CMS Proposed ESRD Rule Changes

August 5, 2019

WASHINGTON, DC— Today Kidney Care Partners (KCP) responded to the Centers for Medicare & Medicaid Services (CMS) proposed changes to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Incentive Program (QIP) proposed rules. KCP cautions that without addressing the sustainable, long-term payment changes for the current payment systems and Value-Based Purchasing Program, and incorporating new advances in patient care and treatment, the proposed rules will negatively impact stability, as well as affect the quality of care in Medicare’s End-Stage Renal Disease (ESRD) program for individuals living with kidney disease.

While KCP is pleased that CMS has established a transitional add-on for truly innovative devices, members remain concerned that after the two-year transition ends for these devices, as well as drugs and biologics defined to be within an ESRD “functional category,” the products will be folded into the bundle without the option for additional resources.

The policies under this proposed rule come despite several recent independent Medicare Payment Advisory Commission (MedPAC) reports indicating negative-to-flat payment margins for dialysis care over the past few years for Medicare ESRD beneficiaries, of which nearly 85% of the entire dialysis population rely upon for their care. Thus, while CMS continues to voice support for innovation in kidney care, the Agency is asking the community to spur innovation in a payment system that does not even cover the cost of the current standards of care.

Additionally, KCP is disappointed that this latest CMS proposed ESRD rule did not take into consideration these concerns around ESRD payment and quality measures brought to their attention back in April in a joint bipartisan letter by Senators Roy Blunt (R-MO) and Ben Cardin (D-MD).

Given the importance of these issues to this at-risk patient population, the following reflects the kidney community’s response to specific items contained in the CMS Proposed Rule:

Quality: KCP is pleased that CMS has recognized its concerns about the validity of the Standardized Transfusion Ratio measure. However, we continue to believe that CMS needs to look at all of the QIP measures and make sure that those being used meet the National Quality Forum’s (NQF) measure criteria for scientific acceptability. For example, KCP strongly supports transplantation as the best treatment for kidney failure for most patients. However, KCP also expressed concern that, despite CMS’ Meaningful Measures Initiative, the proposed rule focuses on transplantation of dialysis patients by maintaining transplant waitlist measures that have already been rejected by the NQF as not meeting these criteria. Instead of adopting recommendations developed by patients, physicians, nurses, dialysis facilities, and others in the kidney care community, CMS has ignored NQF’s recommendations and adopted flawed transplant waitlist measures.

KCP has made several concrete recommendations about how to address structural problems in the ESRD QIP and the Dialysis Facility Compare (DFC) Five Star Program so that the two programs can provide transparent and accurate information to patients. If implemented, these recommendations would provide both the QIP and DFC with a truly meaningful set of measures that would improve a patient’s care and quality of life.

Payment: KCP believes that CMS has missed an opportunity to  sustain innovation for patients living with kidney disease and receiving dialysis care. Despite growing patient demand for new ESRD related drugs and biologicals, and the potential for innovation in devices, CMS has instead chosen a “no new money” policy for ESRD related drugs that fall into existing functional categories and devices. This means that after only a two-year transitional payment, such new products will be added to the bundle without any adjustment. As a result, the proposed rule fails to provide a stable pathway for the sustained adoption of new products. We also remain very concerned that Transitional Drug Add-on Payment Adjustment (TDAPA) products will be reimbursed at ASP+0 and not ASP+6% like Part B drugs are reimbursed in other settings of care.

Innovation and new technologies are critical in addressing patient needs and reducing overall spending for patients with kidney failure. This requires strategic investments and sustainable pathways for new drugs, biologicals, medical devices, and other technologies and transformative services. Unfortunately, chronic underfunding of the ESRD payment system has caused innovation in ESRD to lag far behind other therapeutic areas and virtually stalled provider quality improvement initiatives. In order to remove the barriers which have undermined the development of important innovations that will advance patient care, KCP urges CMS to evaluate which products are truly innovative, as well as increase the ESRD PPS payment bundle.

In addition, KCP calls on CMS to expand access to chronic kidney disease education as a means to delay onset of dialysis, to encourage pre-emptive transplant, and prepare patients for the optimal therapy,  thus reducing expenditures for the program.

Last, KCP recently released a proposed comprehensive framework — Kidney Care FIRST — to significantly increase kidney care quality and access. KCP is also grateful to Senators Blunt and Cardin, as well as Representatives John Lewis (D-GA) and Vern Buchanan (R-FL), for working with the kidney community to help further many of these goals around improving payment reform and better aligning quality measures for ESRD and kidney disease as is evidenced in their recent legislation, S. 1676 and H.R. 3912. KCP looks forward to working constructively with CMS and Members of Congress to advance our mutual goal of improving the lives of individuals living with kidney disease, kidney failure and transplants.