WASHINGTON -- President Trump signed an Wednesday aimed at improving care and expanding treatment options for patients with chronic kidney disease (CKD).
"This action will also dramatically improve prevention and treatment of this life-threatening illness, while making life better and longer for millions of Americans," said Trump at the signing ceremony held at the Ronald Reagan Building and International Trade Center. "We will be changing the way that we reimburse Medicare providers, encouraging them to diagnose and treat patients earlier -- very important, the word 'earlier' -- allow for home care; and increase the rate of transplants."
The executive order does three things, Health and Human Services (HHS) Secretary Alex Azar explained on a conference call with reporters Wednesday morning. "The President's executive order calls for specific solutions to deliver on three goals: fewer patients developing kidney failure, fewer Americans receiving dialysis in dialysis centers, and more kidneys available for transplant," Azar said.
"We need to slow the progression of kidney disease by addressing risk factors like diabetes and hypertension," he continued, noting that the administration's goal is to reduce the incidence of kidney disease 25% by 2030. "The executive order calls for incentives for preventing kidney disease and a nationwide awareness campaign for Americans with diseases that lead to kidney failure." He added that 40% of those with some stage of kidney disease don't know they have it.
In addition to increasing awareness, "we need to provide patients with kidney failure more treatment options," Azar said. That includes making it easier to get dialysis at home. "We aim to have 80% of new American ESRD [end-stage renal disease] patients in 2025 receiving dialysis in the home or receiving a transplant ... Currently, only 12% of American dialysis patients receive it at home. That would compare to 56% in Guatemala and 85% in Hong Kong." Spending on kidney disease takes up 20% of the Medicare budget, he added.
Transplantation is another focus of the initiative, Azar said. "We aim to double the number of kidneys available for transplant by 2030," as well as to decrease barriers to kidney donations.
New Medicare Payment Models
As part of Wednesday's announcement, the Center for Medicare and Medicaid Innovation (CMMI) -- a division of the Centers for Medicare & Medicaid Services (CMS) that was created as part of the Affordable Care Act -- unveiled five new payment models aimed at improving prevention, care, and treatment of kidney disease:
- The "proposed required" ESRD Treatment Choices (ETC) Model would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD in order to preserve or enhance their quality of care while reducing Medicare expenditures. This mandatory model, which would take effect in 2020 and cover treatment providers in half the states, would adjust certain Medicare payments to ESRD facilities and clinicians managing ESRD beneficiaries ("Managing Clinicians") that are selected for participation in the model, through upward or downward payment adjustments based on their home and transplant rates to increase utilization of home dialysis and rates of kidney and kidney-pancreas transplants, CMS (More information on this model is available ).
- In the optional Kidney Care First (KCF) Model, participating nephrology practices will receive adjusted fixed payments on a per-patient basis for managing the care of patients with late-stage CKD patients and ESRD patients. The payments will be adjusted based on health outcomes and utilization compared to the participating practice's own experience and national standards, as well as performance on quality measures. In addition, participating practices will receive a bonus payment for every patient aligned to them that receives a kidney transplant based on the transplant remaining healthy for up to 3 years after the surgery (More information on this model is available ).
- The three optional Comprehensive Kidney Care Contracting (CKCC) models include the Graduated, Professional, and Global Models -- in which capitated payments will be similar to the capitated payments under the KCF Model, but the "Kidney Contracting Entities" -- which consist of nephrologists, transplant providers, and other healthcare providers including dialysis facilities – will take responsibility for the total cost and quality of care for their patients, and in exchange, can receive a portion of the Medicare savings they achieve (More information on these models is available ).
Savings are Expected
Administration officials mostly stuck to generalities when MedPage Today asked about the cost of the initiatives. "There are some costs just in terms of evaluating the model and setting it up. But those are included as part of our projections and the potential savings that these models could have," replied CMS administrator Seema Verma.
"When we looked at the numbers, we think over time we are going to save money in Medicare," said Joe Grogan, director of the president's Domestic Policy Council. "Again, that's not our primary focus right now. But if we were spending $114 billion a year and getting great outcomes, we might be willing to pay the price. But we think there's plenty of opportunities to improve outcomes, improve quality, and save money."
"Nobel Laureate estimated that for every that occurs, for someone on Medicare that's $250,000 saved to Medicare over a 5-year period after that transplant," Azar told MedPage Today. "So this is lives saved, but it's also taxpayer resources saved."
The executive order outlined several steps for increasing the rate of kidney transplants. "Within 90 days ... the [HHS] Secretary shall propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO's performance," the order said.
It also called for HHS to "streamline and expedite the process of kidney matching and delivery to reduce the discard rate" and for HHS to propose a regulation to "remove financial barriers to living organ donation" by allowing for more travel costs of kidney donors to be reimbursed as well as lost-wage, elder care, and child care expenses.
Another part of the executive order called for encouraging the development of an artificial kidney by asking for premarket approval applications for wearable or implantable artificial kidneys, and by seeking innovation in new therapies through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology.
Praise for the Initiative
Reactions to the order and the other announcements were overwhelmingly positive. The Twitter hashtag #AdvancingKidneyHealth was flooded with celebratory posts and group selfies from nephrologists who attended Trump's speech.
High praise for the move also flowed from kidney-focused medical societies. Mark Rosenberg, MD, of the University of Minnesota Medical School in Minneapolis, and president of the American Society of Nephrology, said this was "one of the most exciting days in my 35-year nephrology career." This effort to realign the priorities and incentives in kidney care marks "one of the biggest policy transformations for advancing kidney health since the creation of the Medicare ESRD benefit in 1972 that took effect 46 years ago this month," he said.
Holly Kramer, MD, a nephrologist who is president of the National Kidney Foundation, praised the initiative's comprehensiveness. "What I'm really impressed about is that the initiative covers the entire spectrum of kidney disease, to the point of where it's trying to incentivize physicians to do early detection, screening, and treatment of kidney disease to prevent kidney failure, and then it's incentivizing people who have advanced kidney disease -- for the nephrologist who sees those patients to try to keep them off dialysis."
Primary care physicians often don't have time to address patients with early kidney disease -- which is often asymptomatic -- when patients have other, more symptomatic issues that they would prefer to discuss, Kramer said. "But in the long run, what happens is kidney disease progresses because it's not being addressed, and then by the time they come to a nephrologist, we're at a point where we can't really do too much except get the patient prepared for dialysis ... It's so disappointing. So to try to do better care before, to prevent progression, to me is the most exciting part of the whole initiative."
Nephrologist Rajnish Mehrotra, MD, MBBS, of the University of Washington School of Medicine in Seattle, said the policy change will "force care to be more patient-centric than it presently is."
"Many patients are not aware of the choice of doing dialysis at home, and even when they are, few have had their fears and concerns addressed adequately," he said. "Having done this for some time now, I think patients are the best judge of whether they can do dialysis at home successfully and we should let patients make this choice."
Adequately addressing patients' fears could be one challenge to getting more of them signed up for home dialysis, Mehrotra said, as is educating physicians about the therapy. Nephrology training programs have historically been "uneven in providing training [on] how to provide medical care to patients who do dialysis at home," he said. A nursing shortage -- especially of home dialysis nurses -- could also be a barrier to greater uptake of home dialysis, Mehrotra added.
There are also some challenges for referring more patients to transplant, said Christos Argyropoulos, MD, a transplant nephrologist at the University of New Mexico Health Sciences Center in Albuquerque. "The existing system doesn't help us utilize the available organs to the maximum possible extent," he said.
The two largest companies that run dialysis centers, DaVita and Fresenius, both said in statements that they are growing their investments in technologies that make it easier for patients to dialyze at home, such as remote monitoring and telehealth platforms. Fresenius, for instance, recently invested in a company that is developing a platform for remote patient monitoring, and it completed its acquisition of NxStage, which produces medical devices used in home dialysis.
Kristina Fiore, Director of Enterprise & Investigative Reporting at MedPage Today, contributed to this story.