Addressing two pressing issues in kidney care, equity and innovation, the Centers for Medicare & Medicaid Services (CMS) took decisive action Friday, October 29, releasing the final rule for the calendar year (CY) 2022 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and modifications to the ESRD Treatment Choices (ETC) Model. Both steps—addressing equity in the ETC Model and approving the first device for add-on innovation payment in kidney care—were first time moves by CMS and advocated for by the American Society of Nephrology (ASN). 

EQUITY

In the ETC Model, Medicare finalized plans to provide participants in the mandatory model higher scores if they increase home dialysis and kidney transplantation rates among both individuals in their care who are Medicare-Medicaid dual eligible and who are low-income individuals. These statuses are frequently used as proxies for socioeconomic status and race. One part of Medicare’s approach is to stratify nephrologists and dialysis facilities that serve a higher proportion of these individuals to avoid penalizing them. These steps make the ETC Model one of the first-ever CMS Innovation Center models to directly address health equity.

According to CMS Office of Minority Health’s studies on racial, ethnic, and socioeconomic factors, disadvantaged Medicare beneficiaries have higher rates of ESRD.¹ They are also more likely to experience higher hospital readmissions and costs,²  as well as more likely to receive in-center hemodialysis (vs. home dialysis). Studies also indicate non-white ESRD patients are less likely to receive pre-ESRD kidney care, become waitlisted for a transplant, or receive a kidney transplant.³ 

In a letter to CMS while the rule was under review, ASN President Susan E. Quaggin, MD, FASN, urged the agency to act on equity writing, “Black Americans are 3.7 times more likely to develop kidney failure than white Americans, and Latinx Americans are 1.5 times more likely to develop kidney failure than non-Hispanic or non-Latinx Americans. Further, Black, Indigenous, and Latinx Americans are less likely to initiate home dialysis when requiring dialysis for kidney failure or receive a kidney transplant.  These and other factors are why the Medicare ESRD program and the ETC Model, Kidney Care Choices (KCC) Model, as well as other models and reforms, are so vital for achieving health equity.”⁴ 

ASN’s broader recommendations on equity can be found in multiple sources, including the society’s letter to the White House Office of Management and Budget on steps to address inequities and barriers to kidney care⁵ and the recommendations of the National Kidney Foundation-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease in the Journal of the American Society of Nephrology.⁶ 

INNOVATION

Payment for innovative devices and equipment in the delivery of dialysis was seen by CMS as a complimentary step to addressing the disparities in access to dialysis modalities. In the same final rule, CMS approved an application from Outset Medical for its Tablo® System to receive a transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES). The Tablo® System is the first device to receive TPNIES status since the payment policy was finalized in 2019—a policy ASN and other members of the kidney community advocated for over many years. 

“ASN’s members, leadership, staff, and I are thrilled to see Medicare approve the first device for payment under the innovative add-on pass through in the ERSD bundle—TPNIES,” remarked Dr. Quaggin. “Nephrologists and other kidney health professionals know that the lack of payment for innovation has been one of the major factors stifling breakthroughs in kidney care. ASN and the kidney community have advocated for the development of this special payment and were delighted to see the first device receive approval. There is still a great deal of work to be done to create a stable payment pathway for innovation, but this decision by CMS is a major step forward and a huge win for the millions of Americans with kidney diseases.”

CMS wrote in its approval, “we strongly support health equity and believe that the approval of the Tablo® System under the criterion of § 413.236(b) will encourage uptake of home HD for vulnerable patients with ESRD” and “we believe that approval of the Tablo® System supports the goals of the ETC model by expanding beneficiary access to and retention of home HD.”⁷ 

In its application to Medicare, Outset stated that the Tablo® System features:

• Guide users through treatment using step-by-step instructions with simple words and animation on its touchscreen interface.
• Allow for flexibility in treatment frequencies, durations, and flow rates as the Tablo® System did not have a pre-configured dialyzer. 
• Eliminate the need for industrial water treatment rooms that are required to operate traditional HD machines due to an all-in-one system with integrated water purification and on-demand dialysate production.
• Leverage two-way wireless connectivity and data analytics provide the ability to continuously activate new capabilities and enhancements through wireless software updates.⁸ 

ASN has long maintained that the lack of payment support for innovative products has hampered innovation in kidney care. In ASN’s letter to CMS while the rule was under review, ASN wrote that Medicare must ensure the Substantial Clinical Improvement (SCI) criteria in TPNIES to allow for common sense solutions by: 

• Making home dialysis easier for people disadvantaged due to smaller homes, living alone, poor vision, challenges with dexterity or other physical limitations.
• Supporting modality longevity with a machine that helps more people dialyze at home with reduced drop out, including technologies that are easier for patients and care partners to use, more reliable than current machines, and boost communication between patients and care teams.⁹ 

The criterion that CMS used to review the device included renal device purpose, newness, commercial availability, HCPCS Level II code application, and innovation that meets the CSI criteria.  

On the innovation front, ASN has made its own $25,000,000 commitment to KidneyX (the Kidney Innovation Accelerator), a public-private partnership between the US Department of Health and Human Services (HHS) and ASN to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. Since its launch in 2018, KidneyX has run five prize competitions and supported innovators in 22 states. By accelerating the development of drugs, devices, biologics, and other therapies across the spectrum of kidney care, KidneyX seeks to improve the lives of the 850,000,000 people worldwide currently afflicted with kidney diseases, including 37,000,000 Americans. ASN believes payment policies within the ESRD bundle have long been a disincentive for innovation in dialysis care delivery.

References*

1. https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/ESRD-Infographic.pdf
2. https://www.cms.gov/about-cms/agency-information/omh/downloads/omh_readmissions_guide.pdf
3. https://www.cms.gov/files/document/chronic-kidney-disease-disparities-educational-guide-primary-care.pdf
4. https://www.asn-online.org/policy/webdocs/ESRD.PPS.QIP.Comment.Letter.and.Appendix.Final.pdf
5. https://www.asn-online.org/policy/webdocs/ASNOMBFinal.pdf
6. https://jasn.asnjournals.org/content/early/2021/09/22/ASN.2021070988
7. https://public-inspection.federalregister.gov/2021-23907.pdf
8. Ibid
9. https://www.asn-online.org/policy/webdocs/ESRD.PPS.QIP.Comment.Letter.and.Appendix.Final.pdf