Dialysis treatment in USA: High costs, high death rates

By Rita Rubin, USA TODAY

Deb Lustman was late getting to work a few days every week, and often felt she wasn't thinking as clearly as she once did.

The reason: Lustman, 50, was spending four hours a day, three days a week, undergoing kidney dialysis at a dialysis center, where a machine filtered toxins and fluids from her blood. Normally, that's the job of the kidneys, but for reasons doctors have never figured out, hers had failed.

Steve Lustman helps his wife, Deb, as she inserts a needle into her arm to start dialysis at home in Magnolia, N.J. Only 8% of dialysis patients in the USA treat themselves at home.

Nine months into her treatment, as soon as her doctor raised the possibility of home dialysis, Lustman decided to switch. So, in July 2008, after she and her husband learned the ins-and-outs from a nurse, she began dialyzing five evenings a week at her Magnolia, N.J., home, with her two Maltese, Sophie and Jake, often lounging next to her. Now Lustman, an optician, dialyzes on her own schedule, not the center's, and she's not late for work anymore. And, she says, "I'm healthier."

Thanks to more frequent dialysis, totaling 15 or 16 hours a week, "I feel not only physically better but … mentally better" and no longer "loopy," she says.

Lustman is a rarity, however: Only 8% of U.S. dialysis patients treat themselves at home. The vast majority of the more than 350,000 Americans on dialysis are treated in centers, where three treatments a week, three or four hours each, is the norm — not because it's optimal but because that's the way it has been done for nearly four decades.

A growing body of evidence suggests that longer and/or more frequent dialysis treatments, either at home or in a dialysis center, are far superior to the status quo. Although the USA spends more per dialysis patient than other countries, that does not result in higher survival rates or even, many argue, a better quality of life.

"The standard of care is really inappropriate," says Brenda Kurnik, Lustman's doctor, who practices in Marlton, N.J. "Basically, it prevents people from dying, and that's about all it does."

So why doesn't the USA do better? Many blame Medicare's End Stage Renal Disease Program. Launched in 1973, it's the only federal program that entitles people of all ages to health-care coverage on the basis of a single diagnosis: chronic kidney failure. By paying for lifesaving care for hundreds of thousands of Americans, the program is a testament to what health insurance reform might achieve if Congress were to adopt it.

But it also may be a cautionary tale: Its cost has far exceeded initial projections, and some doctors and other analysts question whether Medicare get its money's worth and whether patients get the best treatment. Less than one-quarter of dialysis patients ages 18 to 54 are well enough to work or go to school.

In 2007, Medicare spent $8.6 billion on the treatment and medications of dialysis patients, from babies to the elderly, according to the Medicare Payment Advisory Commission's March report to Congress.

In addition, Medicare pays billions each year for the hospitalization of dialysis patients. Although they are younger on average than most Medicare beneficiaries, who must be 65 to qualify for coverage, "this is an incredibly sick population," says epidemiologist Paul Eggers of the National Institute of Diabetes and Digestive and Kidney Diseases. Such patients, Eggers says, enter the hospital six times more often than Medicare beneficiaries who don't have chronic kidney failure.

Despite the costs, a substantial proportion of dialysis patients die every year. In 2006, 20.1% of U.S. dialysis patients died, most often of heart disease or infections. In Japan, the death rate was about half that; Australia's rate was halfway between the USA's and Japan's.

Explanations for why the USA has the highest dialysis death rate in the world vary. Some U.S. kidney doctors say that countries with national health programs, such as Britain, withhold dialysis from the oldest, sickest patients, while the Medicare program takes all comers. But foreign doctors deny that their countries ration dialysis. They — and many of their U.S. colleagues — attribute the higher U.S. death rate in part to Medicare's own payment system and the resulting "one-size-fits-all" treatment.

The standard of care has become the three treatments a week for which Medicare pays, usually in a dialysis center, and no longer than four hours each. Home dialysis, which allows for longer, more frequent treatments, is more common in most countries with better survival rates.

'Capable of doing better'

http://www.usatoday.com/news/health/2009-08-23-dialysis_N.htm

The status quo has many critics. In June, a group of nephrologists, or kidney doctors, who had met at a Harvard teaching hospital to discuss the issue sent a letter to White House and Medicare officials urging "substantial changes in the delivery and financing of care … to improve patient outcomes" for those with chronic kidney failure.

"We are capable of doing better," they wrote to White House health policy czar Nancy-Ann DeParle and Barry Straube, chief medical officer at the federal Centers for Medicare & Medicaid Services, or CMS. "Small, incremental improvements in the outcomes for patients with kidney failure are no longer acceptable."

When Medicare's kidney-failure program started in the early 1970s, "the science was such that somewhere between three and six hours of dialysis three days a week was sufficient. Things sort of settled into that pattern," says Dallas nephrologist Thomas Parker III, co-organizer of the conference at Harvard's Beth Israel Deaconess Medical Center.

But normal kidneys work 24/7, not a few shifts a week, so the standard treatment replaces only 10% to 13% of their function, Parker says. How much dialysis is enough isn't clear, he says, because few studies have randomly assigned patients to different amounts to test which approach is more effective.

In his July 22 prime-time press conference, President Obama endorsed the use of such studies, called comparative effectiveness research, to ensure that the U.S. health-care system gets the most value for its money. The economic stimulus package has earmarked $400 million for such research. "If doctors and patients have the best information about what works and what doesn't, then they're going to want to pay for what works," Obama said.

In a report issued June 30, the Institute of Medicine listed its top 100 priorities for comparative effectiveness research. Dialysis and kidney transplantation were high on the list.

Parker said Friday that the nephrologists had received a "very promising" response from Straube, indicating that federal officials "are open to further communications" about the future of dialysis.

Only the wealthy had dialysis

When President Nixon signed the 1972 bill establishing the End Stage Renal Disease Program, only 10,000 Americans were on dialysis, and more than one-third were doing it at home. Only the wealthy could afford long-term treatment.

The world's first outpatient dialysis center, the three-bed Seattle Artificial Kidney Center, predated Medicare by 11 years. There wasn't enough money or machines to go around. So an anonymous committee of Seattle community leaders decided which candidates would get dialysis and live and which would not and die.

The Medicare program opened up treatment to thousands who would have died without it. "We were naive in estimating how much this was going to cost," says Brandeis University professor Stuart Altman, an economist who advised Nixon on health policy and now advises Obama. "People didn't realize how many more people were going to go on it, how much longer we were going to keep these people alive."

It soon became clear: If you pay for it, they will come. "All of a sudden, large numbers of people who were not traditionally on Medicare qualified," Altman says. "We created this giant money machine that made a lot of nephrologists and entrepreneurs rich."

Dialysis became big business, with free-standing centers established in hundreds of cities by corporations, not hospitals. The number of U.S. centers has increased 4% every year, according to a June report by the Medicare Payment Advisory Commission. In 1998, there were 3,394; in 2008, 4,957. About 60% are owned by Denver-based DaVita, a Fortune 500 company, and Fresenius Medical Care North America, a Waltham, Mass.-based subsidiary of a German company that operates centers in 28 countries and also sells dialysis machines and other supplies.

And about 70% of Medicare dollars spent on dialysis and injectable drugs goes to DaVita, which runs more than 1,500 U.S. dialysis centers, and Fresenius, which runs more than 1,700. In the first quarter of this year, DaVita's revenues were $1.45 billion, up more than 8% from the first quarter of 2008. Fresenius' revenues from dialysis in North America were $1.57 billion, up 5% over the first quarter of 2008.

Since 1983, Medicare has paid dialysis providers, whether for-profit centers, non-profit centers or hospitals, a "composite rate" per treatment, which averaged about $155 in 2007. And because Medicare pays the same amount no matter how long the treatment, there's no financial incentive to dialyze patients longer than a few hours at a time.

On top of the composite rate, Medicare pays extra for newer, expensive injectable drugs — namely erythropoietin, or EPO, a hormone that stimulates red blood cell production, and vitamin D, which plays a role in bone health — and lab tests. These extras added an average of $75, or 50%, to the cost of each treatment in 2007. Countries with national health systems don't use the injectables nearly as much. They use less EPO and prescribe oral vitamin D pills that cost about one-quarter of the injectable versions but, their doctors say, are equally effective.

Longer, more frequent dialysis

Longer and/or more frequent dialysis can improve quality of life and survival and reduce hospitalizations, some doctors and patients believe, although the government isn't yet convinced.

"If you ever see patients who are dialyzing six or seven times a week, they are totally different" from those who receive the standard three treatments, says nephrologist Christopher Blagg, a University of Washington professor emeritus who for many years served as director of the Northwest Kidney Centers in Seattle.

Besides improved blood pressure control and lower use of EPO, they generally feel better, with more energy. And chances are they live longer, Blagg says. As he told the House Committee on Ways and Means in March, "dialysis patient deaths and cardiac incidents are significantly more frequent on the day after the two-day gap between treatments that occurs with three dialyses in the seven-day week."

From Medicare's point of view, though, the End Stage Renal Disease Program "is a pretty expensive program, and it needs the best justification imaginable that more dialysis would be better," says Eggers, the kidney disease institute epidemiologist.

Most of the evidence that longer and/or more frequent dialysis is superior has come from observational studies, in which patients decided on their own to try it. Perhaps some characteristic of the patients who choose to dialyze at home or overnight in a center — and not the dialysis itself — explains why they feel better and require less hospitalization than patients at centers.

A randomized trial, in which patients are randomly assigned to a particular therapy, is generally considered the gold standard for comparing treatments. Eggers is the project manager for two such dialysis trials, funded by the National Institutes of Health. One is comparing traditional thrice-weekly, four-hour dialysis treatments with six short daily treatments, adding up to about 16 or 17 hours a week. The other is comparing the traditional in-center approach to six nocturnal, or overnight, treatments a week.

Yet, neither of the trials enrolled as many patients as had been hoped, Eggers says, and he figures he knows why. "You have to go to a patient and say, 'here is something that you do three times a week that you hate,' " he says, and then tell them that they might have to do it twice as often. "It's a pretty significant thing you're asking a patient to do without a huge guarantee."

Because of the studies' limited size, they won't be able to determine conclusively whether more dialysis saves lives, Eggers says. "We might show that patients feel a lot better and have better heart function."

Blagg says he is so convinced of the benefits of more dialysis that he felt it was unethical to enroll patients in Eggers' trials, in which they had a 50-50 chance of getting the standard treatment.

30% could be treated at home

Home is a convenient setting for longer or more frequent treatments. About 30% of U.S. dialysis patients are candidates for home treatment, though only 8% now do it, Blagg says. By comparison, about 55% of dialysis patients in New Zealand dialyze at home, as do 30% in Australia and 20% in Canada.

Some U.S. patients don't even know home dialysis is an option. To fix that, Congress passed a law last year requiring dialysis providers to tell patients about all dialysis methods, beginning Jan. 1.

Home dialysis may also be more cost-effective, according to a May report by the U.S. Government Accountability Office which collected information from the large for-profit chains and non-profit and hospital-based dialysis providers. All of them said their per-treatment costs are lower when patients dialyze at home.

Centers recoup the "serious upfront costs," mainly for the machine they provide, after the patient has been dialyzing at home for a year or 18 months, Blagg says.

J. Michael Lazarus, Fresenius Medical Care North America's chief medical officer, says he wishes more patients would dialyze at home, because it would cut his company's overhead and help it deal with a nursing shortage. But, he says, home dialysis is a hard sell to U.S. patients. "When you build enough dialysis units so there's one on every corner," Lazarus says, patients think " 'why should I go home when I can go to your dialysis unit that's 10 minutes away?' "

Some patients find home dialysis too disruptive for their families. After doctors in 2007 had to remove the kidney her oldest son had donated to her, Michelle Adams-Walton, 46, tried hemodialysis at her Seaside, Calif., home for a couple of months. Her youngest son, now 20, served as her dialysis partner, a requirement for home dialysis.

"That machine did not work out for me," Adams-Walton recalls. "We were both starting to feel the dialysis was taking over our entire lives." However, she says, she had seen enough evidence to convince her that the more dialysis, the better. For her, nocturnal dialysis has been the answer.

On Mondays, Wednesdays and Fridays, Adams-Walton, who works full time as a librarian, drives 90 minutes to one of the few centers set up to provide overnight treatment. She goes on the machine at about 8 p.m. and is taken off at 4 a.m. Then she drives home and tries to catch some more sleep.

Since starting nocturnal dialysis, she says, "I certainly feel so much better." Before, "I was able to function, but just function."

What happens next

Congress has ordered Medicare to revamp the current pricing system. Payments for injectable drugs and lab tests not currently covered by the composite payment are to be "bundled" into it, effective Jan. 1, 2011. Details aren't expected to be released for a few weeks, so the potential impact on dialysis care is difficult to predict.

The open questions:

• Will Medicare keep home dialysis training costs outside the composite payment? Home dialysis advocates fear that rolling such costs into the bundle will discourage centers from offering the home option.

• Will the expanded composite payment be based on what Medicare already pays for dialysis and injectable drugs? That wouldn't result in any savings but could lead to an excessive reduction in the drugs' use, says Bill Peckham, 45, a Seattle dialysis patient and blogger.

• Will Medicare start paying on a weekly or monthly basis, instead of per treatment? Peckham fears that would lead to fewer, not more, treatments.

Straube of CMS emphasizes that a "quality incentive program" will accompany the new payment structure. Instead of paying only on the basis of quantity, he says, Medicare will also begin rewarding dialysis providers on the basis of quality standards, such as how well they manage patients' side effects.

Lazarus, of Fresenius, predicts "a number of (dialysis) units will close because of the bundle. Where are they and who's going to be deprived?" If they're rural, for example, that could greatly impact some patients.

Still, expanding the composite payment is "the right move," Lazarus says. "We have to do something about cost. We have to do something with a system that's out of control. It's a broken system, and we need to fix it."

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