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WASHINGTON -- Medicare beneficiaries with end-stage renal disease (ESRD) may soon have easier access to home dialysis and kidney transplants under a by the Centers for Medicare & Medicaid Services (CMS).

"Today we're announcing two major steps forward in our efforts to advance American kidney health," Health and Human Services Secretary Alex Azar said Friday morning on a conference call with reporters. "It's not just because center-based dialysis is one of the most draining procedures in modern medicine and we believe hundreds of thousands of American patients could benefit from better options ... It's also because kidney care represents maybe the most egregious example of how American healthcare pays for sickness and procedures rather than health and outcomes."

Under the rule, Medicare will implement a "mandatory model" called the ESRD Treatment Choices (ETC) model, enrolling about a third of its ESRD patients "in a system that rewards more convenient, comfortable options like home dialysis and incentivizes rather than discourages transplants," Azar continued. The rule also "significantly expands support for living organ donation to include compensation for lost wages, child care, and elder care, because no generous American who wants to save a life by becoming a kidney donor should face barriers to doing so."

He added that he had seen many kidney care challenges firsthand through his father, who died from chronic kidney disease in April. "I saw the progression of chronic kidney disease, and I saw how draining center-based dialysis could be," Azar said. "I also saw the unbelievable generosity of the living donor who gave him his kidney, but also the challenges that the living donor faced because of bureaucratic rules and restrictions."

CMS Administrator Seema Verma noted that although ESRD patients comprise only 1% of Medicare beneficiaries, they cost the program $35.9 billion per year, or 7% of Medicare spending, and they have the highest rate of COVID-19 among Medicare beneficiaries. Nationwide, more than 37 million Americans -- about 11% of the population -- have chronic kidney disease, and 800,000 have progressed to ESRD, she said. Currently, only about 12% of dialysis patients receive their care at home, while the other 88% go to dialysis centers.

The nation also is not doing well with transplants, which give patients nearly a 70% better chance of survival within 4 years. "America falls in the bottom half of comparison countries when it comes to transplantation rates," Verma said, noting that as of Friday, 92,000 people were waiting for an available kidney. "Our healthcare system is not adequately incentivizing the modes of treatment -- home dialysis and transplantation -- most likely to deliver the best health outcomes."

The new model encourages home dialysis and kidney transplants, improving ESRD patients' quality of life and saving an estimated $23.5 million over 5 ½ years, she continued. "The model increases home dialysis payment rates from 2021 to 2023 to incentivize a change. We will also increase or decrease the amount we pay dialysis facilities and nephrologists starting in July 2022 based on their relative performance increasing rates of home dialysis, transplant wait-listing, and living donor transplants."

In addition, "we're expanding access to kidney disease education for beneficiaries by letting nephrologists and providers create a curriculum tailored to their patients," said Verma. The payment model, which will begin in January 2021, will be tested with about 30% of treatment providers and will affect an expected 120,000 beneficiaries with ESRD. CMS and the Health Resources and Services Administration also will operate a learning collaborative bringing together organ procurement organizations, transplant centers, large hospitals, and other stakeholders to share best practices for increasing availability and use of donor kidneys, Verma said.

Kidney Care Partners, a coalition of patient advocates, dialysis professionals, care providers, researchers, and manufacturers, applauded the rule but also expressed some concerns. "The administration's efforts to improve patient access and choice, namely encouraging use of home dialysis and access to – and better coordination of -- available organs for transplants, has long been a top priority of the kidney community," the group said in a statement. "Incentivizing living kidney donors by providing financial support for recovery time, child care and elder care expenses is critical to improve the pool of available organs for transplant, which are in very short supply in this country for the 100,000 individuals on the transplant waiting lists."

However, the statement continued, regarding the ETC model, "while we appreciate the decision to reduce the scope of the model from the proposed 50% to 30%, we remain concerned over fears voiced by patient organizations and providers about patients who do not select home dialysis being disadvantaged by the model." The group -- which includes several large dialysis center operators such as DaVita, U.S. Renal Care, and Fresenius -- noted that the waivers for providing kidney disease education "do not include dialysis facilities and their multi-disciplinary care teams, which is something that members of Congress have specifically sought to do in The Chronic Kidney Disease Improvement in Research & Treatment Act."

The group added, "It remains critical that the patient and physician voice be in the forefront regarding access and choice for care settings -- such as home care -- that are most desirable and appropriate for the patient given the healthcare needs and associated co-morbidities, their home support and the home environment itself."

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