HHS Unveils Kidney Initiative with Bold Goals to Increase Home Dialysis, Transplants

Capture_title.PNGLast month, the Trump administration announced ambitious new plans for a kidney health initiative that seeks to improve care for people with kidney diseases by significantly increasing the number of Americans receiving home dialysis, reducing the incidence of kidney failure, and hastening and increasing access to kidney transplants.

Although the details of how the initiative will achieve these goals have not yet been fully revealed, industry leaders say the broad language set forth in the President’s July 10, 2019, Executive Order aligns with a growing shift toward providing greater consumer choice in kidney care and the need for a greater focus on prevention.

The Advancing American Kidney Health initiative established by the executive order calls for reducing the number of Americans developing ESKD by 25% by 2030, ensuring that 80% of new ESKD patients in 2025 receive home dialysis or a transplant, and doubling the number of kidneys available for transplant by 2030. It aims to achieve these goals by loosening restrictions and raising incentives for organ donation, launching a public awareness campaign to increase knowledge of CKD and encourage greater use of home dialysis, and instituting a set of five new payment models.

Industry leaders say these plans have the potential to accelerate growth and innovation in kidney care, but the devil will be in the details. The initiative is also expected to jumpstart the work of some of the smaller players in the industry.

“We’re in the middle of analyzing what’s been released so far,” said Frank Maddux, MD, Global Chief Medical Officer for Fresenius Medical Care. “I think it’s really a question of how the [Centers for Medicare and Medicaid Services] adjusts the delivery system and care models to achieve such aspirational goals.”

“[Starting in 2006], we invested in many different areas that have led to our alignment with the administration’s direction with this Executive Order,” Maddux said. For example, Fresenius has been investing in monitoring devices that make it safer for patients to receive dialysis at home or other locations outside a dialysis center and has educated more than 45,000 patients and physicians on home therapy modalities and techniques. “Those are really only starting points,” he said. “There’s much more to be done.”

Likewise, “DaVita’s strategy is very much aligned with the aspirational goals of President Trump’s Executive Order,” said DaVita Chief Medical Officer Allen Nissenson, MD, FACP. Nissenson noted that 12% of DaVita’s dialysis patients receive treatments outside a dialysis center. “We have had an intense focus on this for many years. At DaVita, we’ve been really trying to push the envelope, but we’ve been constrained because of the way the system is organized,” he said.

Reimbursement for kidney care has historically focused on the end stages of disease, ever since Congress extended Medicare coverage to anyone with kidney failure in 1972.

“That was the right thing to do then, because we didn’t know a lot about the earlier stages of kidney disease at the time and because it provided life-saving therapy regardless of ability to pay,” said Carmen Peralta, MD, a professor of medicine at the University of California, San Francisco, and chief medical officer for Cricket Health, a specialty care provider for patients with CKD and ESRD. “But in trying to do a good thing, it then sort of created a monster. We put a pot of gold at the end of the journey for our patients. If you reached kidney failure, Medicare paid for your dialysis and all your associated care.”

“Now the conversation is shifting to prevention,” she said, “and clinicians are out there trying to stop the progression of the disease and do the best for patients with no payment infrastructure to support it. Seeing patients every three to six months pays nothing compared to what physicians get when the patients are on dialysis. Allowing for payment to happen when the patient presents earlier on, that’s where I see the win.”

The push toward preventive care, upstream of the need for kidney replacement therapy, could be a boon for new providers such as Cricket. With just 300 patients nationwide, Cricket approaches kidney care with a multidisciplinary team that aims to treat all of a kidney patient’s needs, especially during the earlier stages of disease before dialysis becomes necessary, Peralta said. The preventive approach outlined in the new initiative, she said, “validates the Cricket clinical model, which is based upon the best available evidence.”

“This opens up economic opportunities for us,” said Peralta. “It’s good for the business, because the new financial incentives allow us to expand our clinical model to serve more patients.”

She’s hopeful the new payment models will remove barriers to better preventive care and encourage other payors to follow the government’s lead, especially in providing greater coverage of chronic conditions that lead to kidney failure. “Kidney disease never travels alone,” she said. “It travels with heart disease and diabetes. We need to treat the patient as a whole. We can slow the progression of kidney disease by treating all of these other diseases.”

CVS Kidney Care, a division of CVS Health launched a year ago, is also positioned to gain from the provisions of the Advancing American Kidney Health initiative.

CVS Kidney Care is devoted to early identification of kidney disease, targeted patient engagement and ongoing education to slow disease progression, and expansion of kidney transplantation and home dialysis. The company has just begun clinical trials of a home dialysis system it hopes to have on the market by 2021.

“With successful completion of the clinical trial and FDA approval, we plan to also provide a comprehensive home dialysis program,” said Bruce Culleton, MD, Vice President and Chief Medical Officer for CVS Kidney Care.

Culleton said the home dialysis system was just one of “a series of comprehensive solutions focused on improving health and outcomes for people living with kidney diseases and kidney failure” that CVS Kidney Care is beginning to provide, and that the company’s objectives align with the president’s goals.

“We have an existing CKD education program available in several markets today. As we expand our CVS Kidney Care programs and services, we will continue to offer all-inclusive education to diagnosed patients, and will soon offer face-to-face, personalized support and therapy education, as well as other proven patient engagement strategies,” Culleton said. “This begins with helping patients better understand the treatment options available to them, as well as educating them on critical factors such as kidney health, diet, comorbidities, and prescription management.”

Whether the goals of the administration’s initiative—particularly getting 80% of new patients transplanted or on home dialysis by 2025—are overly ambitious remains to be seen. Some in the industry are skeptical, but hopeful that the changes will result in at least making progress toward this goal.

“I think this combined transplant/home dialysis goal of 80% is very aspirational,” said DaVita’s Nissenson, noting that countries with high percentages of patients on home dialysis, such as Hong Kong, require patients to use home therapy unless there is a medical reason not to do so. “I think that’s not really practical here. It goes against our core principle of choice. It’s great to aspire to and stimulate people to work toward the goal, yet it will take time.”

Even if the industry can’t reach the 80% goal, Nissenson and others said they believe a substantially greater number of patients can be shifted to home dialysis if both patients and physicians are educated about the value of doing so. When educated early in the progress of their disease, he said, many kidney patients say they would prefer to be treated at home. DaVita’s growth rate in home dialysis is four times that of its in-center dialysis growth.

“We need to make sure we partner with our nephrologists, who are really the people who are driving the clinical care of the patient,” Nissenson said. “I think nephrologists are ready to step up to the plate, but we need to make sure they get sufficient training.”

Fresenius Medical Care’s Maddux said greater competition is sure to emerge as a result of the initiative, but it would ultimately result in better patient care. “I am much in favor of many people contributing to this dialogue,” he said. “The obligation is not just to demonstrate a novel approach to care, but to build that at scale so that everybody gets a chance to benefit from these therapeutic advances.”

“It’s all about the patients and the real epidemic of kidney disease in this country that has not gotten the attention from the public or regulators that it needs,” said Nissenson, “and now this is happening. Finally, the stars are aligning.”

August 2019 (Vol. 11, Number 8)