But doctors and large dialysis corporations are seeking to remove or reduce proposed financial penalties for underperforming clinics. The new plan was supposed to take effect Jan. 1, but now the timetable is unclear.
“We have to work through those issues, no doubt,” Joseph Grogan, director of the White House Domestic Policy Council, told The Washington Post. “But we’ll get there, and we aren’t delaying for any other reason than to get it right.”
Delays in federal rulemaking are not unusual. But the administration’s hesitancy — six months after Trump signed an executive order in July to advance kidney care — signals the clout of Washington's potent health-care lobbies , which have managed in the past two yearsto fend off promises from Trump and Congress to lower drug costs and end surprise medical bills.
Under a 1972 law, anyone with end-stage renal disease, regardless of age, is eligible for Medicare insurance coverage, with the biggest expense coming from dialysis, a lifesaving procedure requiring sessions three times a week. Health advocates and academics have raised concerns for years about high mortality, low rates of home dialysis, racial disparities in transplant waiting lists and other problems in the nation’s outpatient dialysis clinics.
Hoping to improve the system, the Centers for Medicare and Medicaid Services (CMS), acting on Trump’s executive order, devised a carrot-and-stick approach. It proposed bonuses of up to 10 percent for doctors and clinics that oversee a larger number of patients on home dialysis and receiving transplants. Payments would be reduced by up to 11 percent for doctors and by 13 percent for dialysis clinics that fall short of expectations.
The mandatory pilot program would affect clinics serving half of all patients in the country and span six years.
Health and Human Services Secretary Alex Azar initially received plaudits for what the president called “long-overdue reform” to increase the use of home dialysis.
But the administration hit the pause button after lobbying groups for doctors and clinic operators warned of business disruptions and the potential for inappropriate care. They warned the proposed rules would financially incentivize doctors to push patients into home dialysis — even if they are not appropriate candidates for home therapy and do not want to undertake home dialysis.
Kidney Care Partners, an industry group whose members include the two large corporations that dominate the U.S. dialysis business, Fresenius Medical Care and DaVita, said in a letter to CMS that the plan could make patients “feel forced” into undergoing dialysis at home instead of in a clinic.
Kidney Care Partners said it amounts to the government “telling nephrologists and facilities to have patients use modalities that are either clinically not appropriate for them . . . or that are expressly against their will to use.”
Those industry arguments are off the mark, said Adam S. Boehler, until last fall the director of the federal Center for Medicare and Medicaid Innovation and the key architect of the Trump plan.
“I think it’s just the opposite. When you look at the United States today, we’re just at about 10 percent rates of home dialysis. You’ve got Hong Kong at 85 percent. You have got Guatemala in the 50s. We’re way behind,” Boehler said. “We’re nowhere close to reaching a point where somebody is clinically taken and put home when they are not appropriate to be home.”
“Industries don’t like change,” added Boehler, now the chief executive of the U.S. International Development Finance Corp., a federal agency. “What the Trump administration is doing here is taking a bold stance to push an industry toward change that needs change, because that’s how you’re going to help people.”
Other supporters of the government plan said doctors and clinics are not giving patients enough information and education about home dialysis and transplants under the current system.
“Their choice is limited unbelievably now,” said Robert Lockridge, an independent nephrologist in Lynchburg, Va., who is a leading proponent of home dialysis. “These things have got to change.”
He said Medicare’s earlier efforts to encourage alternatives to in-center dialysis have not had a major impact. “Everybody knows that home therapy is better, but they don’t know how to get there,” he said.
Only about 12 percent of dialysis patients in the United States receive dialysis treatments at home, even though, when kidney doctors are surveyed, most say it would be the choice for them or a family member. Instead, most patients are treated three times a week for three to four hours a session at dialysis centers, a grueling regimen that has changed little in decades.
Industry groups say they support the goals of the rules but they have different ideas on how to get there.
The American Society of Nephrology said its member doctors worry the threat of an 11 percent penalty would “cloud” the conversation between kidney doctors and their patients about the best treatment choice. It said a 2 percent penalty would be more appropriate to encourage home dialysis. The smaller threat “would have the effect of driving pretty positive change on behalf of patients . . . without being too onerous,” said Rachel Meyer, the society’s director of policy and government affairs.
The National Kidney Foundation, which draws up physician guidelines for kidney treatment, raised questions about “choice and access for some patients, as well as patient safety.”
The CMS proposal is a “retrograde” effort to influence outcomes using raw economic incentivesrather than the more holistic proposals for total patient care being tried across the country for a variety of chronic conditions, said Jackson Williams, director of government affairs for Dialysis Patient Citizens, an industry-funded, nonprofit advocacy group that claims 32,000 patient members.
“They weren’t really looking at what the unique problems are for getting people on transplants and home dialysis,” he said.
The industry also objected to using transplant rates to measure clinic performance before a national system of nonprofit, regional organ procurement organizations is improved and more kidneys are made available. The administration in December unveiled new rules intended to bring more accountability to organ procurement.
Transplantation is the preferred treatment for survival and quality of life, but a shortage of organs has left tens of thousands of patients stuck on waiting lists. Many die without receiving a transplant.
The industry was not the only source of objections. A bipartisan group of 74 members of the House of Representatives said thatdoctors and clinics should be measured differently than proposed and that the plan should take into account patients’ ability and willingness to use home dialysis. The Medicare Payment Advisory Commission, an independent government watchdog, also found fault with multiple aspects of the payment formula.
About 85 percent of the roughly 500,000 dialysis patients in the United States receive their treatments from just two large corporations, Fresenius and DaVita. Fresenius, a global company based in Germany, had $3 billion in North American profits in 2018. DaVita, based in Denver, logged profits of $1.5 billion.
The companies said they want reform efforts to succeed.
“The goals need to be realistic and inclusive of patient choice and shared decision-making between patients and their doctors,” said Bryan Becker, chief medical officer for DaVita Integrated Kidney Care.
In dialysis, a patient’s blood is extracted from blood vessels in their arm, pumped through a machine that removes toxins and excess fluid, and streamed back into their arm. Health outcomes and quality of life have been proved to be better when patients undergo dialysis at home, do it overnight while they sleep or use a different home method called peritoneal dialysis, which relies on daily exchanges of dialyzing fluid that is introduced directly into the patient’s abdomen.
Longer dialysis sessions using a slower rate of toxin and fluid removal improves survival, studies have shown.
But treating patients in a central dialysis clinic is more efficient and easier to manage for doctors and the dialysis companies, and critics say that is why it has become the default pattern of practice for decades.
Dialysis clinics have a short-term financial incentive to keep people in their facilities, because they may be able to treat a greater volume of patients using the same staff and equipment, the Government Accountability Office, a federal watchdog agency, found in 2015. Housing uncertainty, lack of space in the home, absence of a spouse or someone else to help, and a learning curve for patients are among other reasons cited for low U.S. home dialysis rates.
End-stage renal-disease patients represent 1 percent of the Medicare population, but covering all their care — from transplants to dialysis and hospitalizations — accounts for 7.2 percent of Medicare’s annual fee-for-service expenditures, or about $36 billion.