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President Orders Overhaul of Kidney Transplant, Dialysis Systems

Move is designed to save Medicare money and improve patient care

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In a move aimed at saving Medicare money and saving the lives of people with kidney disease, President Trump signed an executive order Wednesday that emphasizes early detection, more patient choice and increased numbers of transplants.

About 1 in 7 adults in the United States have chronic kidney disease, according to the federal Centers for Disease Control and Prevention (CDC). Of the 37 million estimated to have the condition, 9 in 10 don't know it.

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“We aim to reduce the number of Americans developing end-stage renal disease by 25 percent by 2030,” said Alex Azar, secretary of health and human services. “We need to provide patients who have kidney failure with more options for treatment from both today's technologies and future technologies such as artificial kidneys, and make it easier for patients to receive care at home or in other flexible ways."

Kidney disease ranked ninth among causes of death in the United States in 2017, the most recent year for which CDC figures are available. Women are more affected than men, and people of African American, Native American, Asian and Hispanic descent die from kidney problems more often than do non-Hispanic whites.

spinner image chart of percentage of total deaths in each ethnic, racial category. Non-Hispanic blacks is 2.8 percent, Asian is 2.1 percent, Hispanic is 2.0 percent, Native American is 1.7 percent, and non-Hispanic whites is 1.6 percent.
Non-Hispanic whites die from kidney disease in greater numbers than do all minorities combined. But members of other racial and ethnic groups account for disproportionately high percentages of kidney disease deaths. (Source: Centers for Disease Control, 2017 data, the most recent available)

Diabetes and high blood pressure are the two leading causes of kidney failure, the CDC says. The good news: Not all people diagnosed with kidney disease end up in kidney failure. Diagnosing the problem early, controlling the chronic conditions that caused the illness and making healthy lifestyle changes are important to stop the need for dialysis and a new kidney.

“We need awareness, earlier detection and more treatment in a primary setting,” with primary-care physicians overseeing diet and exercise plans to help delay or prevent the need for dialysis, and with patients who need dialysis doing it themselves at home, said Tonya Saffer, vice president of health policy for the National Kidney Foundation.

Part of the intent of Trump's executive order is to launch an awareness campaign that focuses on early diagnosis and incentives for health care providers to keep the disease from progressing to kidney failure.

Kidney disease coverage under Medicare

Since 1972, Medicare has covered people of any age diagnosed with permanent kidney failure that requires dialysis or a kidney transplant, called end-stage renal disease. A diagnosis of end-stage kidney failure usually happens when a patient has just 10 to 15 percent of kidney function remaining, according to the National Kidney Foundation.

The government-funded health care plan also covers those age 65 and older who have chronic kidney disease, lasting damage to the kidneys that can get worse over time.

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Together, Medicare spending for chronic kidney disease and end-stage renal disease topped $114 billion in 2016, 23 percent of all Medicare spending, according to the U.S. Renal Data System. The number of people diagnosed with kidney problems and the costs per person have been increasing substantially since 2011 because of an aging population, more obesity and higher rates of diabetes.

So the government is looking for alternatives. “Our commitment is to improving health care outcomes” and lessening costs, Seema Verma, administrator for the Centers for Medicare and Medicaid Services (CMS), said in an interview with AARP. “We want to make sure the program is sustainable for future generations."

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Moving to in-home dialysis

In 2016, nearly 8 of every 9 end-stage renal disease patients started dialysis, generally a filtering of the blood called hemodialysis, in freestanding clinics, U.S. Renal Data System figures show.

In-home peritoneal dialysis, which uses the lining of the abdomen and a cleansing fluid to absorb waste products from blood, was the choice of most of the rest of the kidney-failure patients. The process often can be done at night while a patient is sleeping and imposes fewer dietary restrictions.

People who use peritoneal dialysis often like it better than hemodialysis if they can handle having a catheter permanently inserted in their abdomen and can keep the area around the catheter as well as the home dialysis equipment clean. Failure can mean a patient develops peritonitis, an infection of the lining of the abdomen.

"Quality of life is actually better for those who can do this at home,” said Deidra Crews, a nephrologist at Johns Hopkins Medicine in Baltimore. Those who have the therapy while they sleep can wake up in the morning, “unclamp it, tuck their catheter away and go on with their day.”

Many patients feel less fatigued after peritoneal dialysis because the process is considered more gentle, she adds. By 2025, health officials want 4 of every 5 new kidney dialysis patients using this home care or receiving a transplant, Azar said.

Peritoneal dialysis is less expensive in part because it eliminates the need for a separate clinic and staff. The patient and at least one caregiver are trained in the process, Crews said.

The number of people enrolled in Medicare who have end-stage renal disease topped half a million in 2017, according CMS. So a change in the preferred method of dialysis could save more than $25 billion a year without taking into account that health care costs have risen at about three times the general rate of inflation in the past decade.

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More organs for transplants

For people already in end-stage kidney failure, a transplant is the best option, Crews said.

But as of Wednesday, almost 95,000 people were on the kidney transplant waiting list, the most for any organ. Close to 15,000 patients have been waiting for five or more years.

"Fifteen percent of those with end-stage renal disease die every year,” many awaiting a transplant, Crews said. “That's higher than most cancers. But kidney disease has not gotten the kind of exposure like breast cancer."

Crews said she hopes the exposure from Wednesday's announcement will make families more aware of organ donation. Even though people might designate themselves as organ donors on driver's licenses, their survivors are the ones who determine whether the organ donation will happen, she said.

Saffer of the National Kidney Foundation said she hopes that more people from minority groups, who often provide a better match within their own race and ethnicity, will consider becoming living donors as well as donors when they die.

"My order supports the selfless individuals who donate kidneys by granting them reimbursement for extra expenses associated with organ donation such as lost wages and child care,” Trump said of living donors.

Saffer also said living donors sometimes fear future discrimination from health insurers, so she's hoping for action on that front as well. Both Saffer and Crews also see an opportunity for some kidneys that transplant centers reject and are later discarded.

"It's an issue of a kidney being offered and not being taken up because it is less than perfect,” Saffer said. Sometimes a transplant center rejects it without telling the patient it's available.

Federal officials anticipate 17,000 more kidney transplants because of the incentives for living kidney donors and an additional 11,000 heart, lung and liver transplants because of new organ procurement rules. Because kidney transplants cost less than long-term dialysis, the additional transplants would translate into $4.2 billion in savings.

For the longer term, researchers are working on wearable and implantable artificial kidneys that would filter impurities in the body 24/7. At least one wearable artificial kidney, which weighs about 11 pounds in its current version, has had a human clinical trial, according to the American Society of Nephrology.

One of the bigger impediments to the research has been money. But in September, the Department of Health and Human Services and the American Society of Nephrology committed more than $2.2 million in prizes to develop better treatment options for kidney failure, and Trump's executive order puts the technology on a fast track for availability before Food and Drug Administration final approval.

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