The Trump administration’s recent pledge to transform kidney care is cause for hope for late-stage kidney disease patients languishing on transplant lists and in dialysis clinics. However, the administration has not publicized the details of its plans to make at-home dialysis more accessible and to encourage development of artificial kidneys, leaving patients and doctors with many questions.
The focal point of the administration’s plan to improve kidney disease treatment, which has been stagnant for over 40 years, is to increase access to in-home dialysis. The rate of patients undergoing dialysis in the comfort of their own homes remains low but is gradually increasing, thanks in part to the portable, easy-to-use NxStage home dialysis machine.
Each year, dialysis in clinics costs Medicare about $34 billion. The Centers for Medicare and Medicaid Services released a plan as part of the executive order to adjust payments for home dialysis claims to randomly-chosen clinics based on performance. If a clinic makes at-home dialysis accessible effectively, the clinic receives more funding. CMS said the model will cut Medicare spending overall, while providing better care for patients, but has not yet announced which clinics will participate.
Those who have begun at-home dialysis say it’s the best treatment available and that the administration is right to prioritize access to the program. Nieltje Gedney, treasurer of the advocacy group Home Dialyzors United, told the Washington Examiner that when you get comfortable using the NxStage machine at home, it becomes a normal part of your life. “It’s like brushing your teeth,” she said. Rather than go to a clinic three times each week for four-hour sessions hooked up to a machine, Gedney is able to tailor her treatment schedule to fit her life and allow her to save time and even travel.
Gedney had managed her chronic kidney disease for about 20 years since her diagnosis in 1997 and was adamant about avoiding in-center dialysis at all costs, even though in 2007 a nephrologist told her that “if you don’t get on dialysis in a year, you will be dead.”
“I fully planned to go into hospice. There was no way I was going to a center,” Gedney said.
When her disease progressed, she dreaded the thought of spending 12 hours each week in a clinic, tied to a chair, unable to move about freely or go to the bathroom. But her physician recommended home hemodialysis — the same treatment as in a clinic that can be done on the patient’s schedule in his or her home. She trained to self-administer the treatment for about five months, and she hasn’t looked back.
Gedney can plan her treatment schedule to fit into her lifestyle, altering the number of hours and days spent filtering impurities out of her blood. The NxStage, she said, “is foolproof. Pretty soon you push the button and bingo.”
Gedney is pleased with the executive order, saying it’s a step in the right direction. She refers to chronic kidney disease patients like her as “the orphan stepchild” and is glad that kidney disease has become a focal point for the administration.
She worries that innovative, accessible at-home dialysis programs will come too late for many with end-stage renal disease. Gedney wants dialysis treatments at home to become available to all as quickly as possible. The executive order neglects to offer a time frame in which the administration will carry out its plans.
“I am hopeful, but it won’t happen overnight,” she said. “Our work is just beginning.”
John Bayton, a former home dialysis patient and two-time kidney transplant recipient, is optimistic about the plans to prioritize treatment innovations, but his optimism is tempered with uncertainty about how Trump’s plans will materialize.
He was diagnosed with kidney disease in 2004, underwent dialysis in a clinic, and received his first transplant in September 2009. All was well until 2016, when his body rejected the donated kidney, and Bayton required more dialysis until he could get a new kidney. This time, though, he opted for dialysis at home.
Home hemodialysis, Bayton says, “was awesome.” His training was administered in a comfortable setting. He learned how to use the dialyzer and where to insert the needles and tubes through which his blood would flow, because, as the technician told him, the patient knows where in the body the needle can be best inserted better than a technician.
He underwent home treatments on his own schedule and was able to pursue jobs as an individual contractor to make enough money to support himself. He received his second transplant in February 2019 and hasn’t had any health complications.
Home dialysis in the U.S. is very uncommon compared to the number of patients who receive dialysis in clinics, which is 93%, even though most would be willing to take on the task of treating themselves, according to a 2016 survey of patients, rather than receiving dialysis in clinics. More than half of those surveyed felt comfortable addressing problems, including high blood pressure or troubles with inserting a cannula (a small tube) into their veins, on their own.
Most nephrologists and patients favor at-home dialysis as long as clinics provide patients with training. Bayton said that it would be a challenge for the administration to figure out how to provide patients the tools to treat themselves at home.
Another key part of the executive order that lacks details is encouraging the development of a potential medical breakthrough: the artificial kidney.
Researchers behind several attempts to create artificial kidneys have been working on shoestring budgets for more than 15 years and are keen to hear how the administration plans to fund their research.
The current kidney transplant waitlist has 100,000 people. The development of an artificial kidney could make a huge dent in that list and save lives.
The kidney would be bioartificial, created in a lab, and the same size as a kidney from a deceased or living donor. The artificial kidney, like a donated organic kidney, would be surgically implanted. Because of a lack of funding, researchers haven’t gotten close to introducing the bioengineered organs to operating rooms.
Dr. Shuvo Roy, director of the Kidney Project, has been working to create an implantable bioartificial kidney the size of a coffee cup for 15 years. Roy told the Washington Examiner that transplants should replace dialysis treatments, which have lower survival rates. Encouraging expanded access to dialysis, Roy said, would be “another Band-Aid,” rather than a solution to the underlying problem.
Like the Kidney Project, the lab behind the Wearable Artificial Kidney with California nephrologist Dr. Victor Gura at its helm, faces a money shortage that is slowing the project’s progress. His team has worked on a rechargeable battery-powered device for 19 years that travels with kidney disease patients. With the proper funding, the device could become available in about two years. “But we do not have the money to do it right now,” Gura told the Washington Examiner.
Some, like Gedney, have chosen to continue at-home dialysis rather than undergo the stress of waiting for a transplant that may never come.
“I’m doing so well and I’m so healthy,” Gedney said. “I wouldn’t trade that for the unknown. A transplant is a treatment, not a cure.”
Researchers agree that Trump’s executive order, which includes a kidney disease awareness campaign that may garner funding from private investors, offers more reason to hope that artificial kidney development will proceed. Without that funding, labs working on these projects fear even longer delays in reducing the transplant waitlist.
Bayton said the executive order left more questions than answers. “Things always looks great on paper but what’s the execution and plan to deliver on it? We have to factor in the 2020 election. The administration may change, and if it changes, will it still be a priority?”
The White House declined to comment.
