Home Hemodialysis Industry Poised for Growth

The market for home-based hemodialysis is growing and is poised to expand, nephrologists and industry representatives reported. Changes required by the Medicare Improvements for Patients and Providers Act (MIPPA), the Centers for Medicare and Medicaid Services (CMS), and a trend toward home health care may all help shift the winds in favor of home dialysis.

Currently limiting dialysis in the home are Medicare reimbursement levels, reimbursement for training, and the ability of patients and caregivers to perform the tasks necessary for the hemodialysis. But several factors are converging to encourage more home dialysis. For example, many patients still don’t know about home dialysis as an option, but MIPPA and the CMS’s new Conditions for Coverage now require that patients be informed of all the modalities for treating kidney damage, including home dialysis.

About one percent of dialysis patients are now dialyzing at home, said Christopher R. Blagg, MD, professor emeritus of medicine at the University of Washington, and a pioneer and supporter of home dialysis since the 1960s.

The total number of home hemodialysis patients in the United States is about 4000 currently, compared with roughly1000 in 2005, said Joe Turk, senior vice president of commercial operations for NxStage, which manufactures the most frequently used home dialysis machine.

That number is set to change. With the number of all dialysis patients in the United States growing 2 to 3 percent per year, “by 2020, it’s estimated that about 800,000 people with kidney disease will either undergo dialysis or have a transplant,” according to Rajnish Mehrotra, MD, of the David Geffen School of Medicine at the University of California-Los Angeles and a member of the ASN Dialysis Advisory Group.

Some of these individuals will no doubt choose home dialysis. In fact, Mehrotra predicted that the home hemodialysis market will grow more quickly than other markets in the short term “as more centers open these programs and more nephrologists start to offer it.”

Findings from a pair of NIH clinical trials may spur more interest in dialysis at home, though the results of the trials are delayed because of slow recruitment.

NIH studies on home dialysis

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and CMS have funded two related clinical trials, one to study the results of daily hemodialysis at centers and the other the results of night-time dialysis done at home. In both cases, these more frequent forms of dialysis will be compared with outcomes from conventional, three-times-a-week dialysis in centers.

The endpoints of the trials will be evaluations of patients for their physical health scores on an established index (SF-36 Physical Health Composite score) and the size of the left ventricle of the heart (imaged by magnetic resonance imaging). Thinner walls of the ventricle are a desirable outcome.

Paul W. Eggers, program director for Kidney and Urology Epidemiology at NIDDK, said that the trials are enrolling more slowly than expected. “I’m afraid we’ve had to extend the trials due to slow recruitment,” he said. Both trials are scheduled to end recruitment in 2009 and end the one-year follow-up in 2010. Results will be available in 2011.

All observational trials thus far support a benefit to patients. “I cannot think of a reason why the NIH trials would have different results,” said Lynda Szczech, MD, chair of the ASN Dialysis Advisory Group and associate professor of medicine at Duke University Medical Center in Durham, N.C.

Studies tout benefits of nontraditional dialysis

A preliminary study by Bruce Culleton, MD, and colleagues at the University of Calgary, Calgary, Alberta, and other sites found that, compared with thrice-weekly hemodialysis, frequent nocturnal hemodialysis improved left ventricular mass, reduced the need for blood pressure medications, improved some measures of mineral metabolism, and improved selected measures of quality of life [J Am Med Assoc 2007; 298:1291–1299)].

“I think that the challenge will be how to implement the upcoming NIH results to a larger population of potential patients,” said Szczech. “The fact that only 10 percent of available patients were interested in participating in the study by Culleton might signal that those who choose this therapy will continue to be a self-selected group.”

In 2008, NxStage announced results of its FREEDOM (Following Rehabilitation, Economics and Everyday Dialysis Outcome Measurements) trial. Comparing data from 500 Medicare patients in the NxStage database with a matched group of 5000 patients from the U.S. Renal Data System database who had conventional dialysis, they found lower depression rates, higher physical and mental health composite scores, and much shorter recovery time after home dialysis—one hour versus eight hours for patients dialyzing in centers.

“The home patients can dialyze more often, which means that their toxin build-up is lower, and the fluid build-up in their system is less. Less fluid is removed at one sitting, reducing the physical strain,” said Turk of NxStage.

The University of Washington’s Blagg, who is executive director emeritus of Northwest Kidney Centers in Seattle, concluded with co-authors in a study published in Kidney International that home dialysis had lower mortality compared with in-center dialysis, even after adjusting for co-morbid conditions, age, and diabetes [Kidney International 1996; 49:1464–1470].

“The biggest benefit is survival,” Blagg said. “There are international data showing that with short daily dialysis, five to six times per week for three to three and a half hours or so, the survival rate is about double what it is for typical patients in the U.S. Renal Data System.”

Nocturnal home dialysis appears to lend some of the biggest benefits, according to Andreas Pierratos, MD, of Humber River Regional Hospital in Toronto.

“Patients don’t have to drive to the hospital (or center), and nocturnal home dialysis is a much higher quality dialysis,” Pierratos said. “Because the dialysis is slow and long, when dialysis is over, these people are ready to start their day. Patients can attain good blood pressure control, and many come off medications or take only one pill a day. Their diets are not restricted.”

Drawbacks such as clotting of the central venous catheter (treated with low-dose warfarin) and catheter infections have largely been addressed, he said.

Reimbursement issues

Reimbursement has limited the growth of home dialysis. But in 2008, Congress and CMS worked to remove roadblocks to dialysis at home.

Medicare pays for thrice-weekly dialysis in any setting, whether at home or in a center. However, “if you are going to go to five- to six-day-a-week dialysis at home, you probably need the equivalent of reimbursement at the current rate for four and a half days,” Blagg said. Home dialysis costs about 55 percent of what in-center dialysis costs, he said, because “you don’t have all of the nursing tasks a center must pay for.”

Under the new outpatient bundling rules in MIPPA (HR 6331), what had been separately billable drugs will become part of a new bundled payment for dialysis patients. Bundling these charges is set to begin in 2011.

Bundling drug costs into the dialysis reimbursement may encourage more home dialysis, said NxStage’s Turk. “Chairman Stark specifically wrote into the Congressional Record that home dialysis should be appropriately reimbursed and encouraged.”

From a nephrologist’s standpoint, the payments from Medicare are the same for monthly monitoring of patients in any setting, said Edgar Lerma, MD, clinical associate professor of medicine at the University of Illinois at Chicago College of Medicine and a member of the ASN Dialysis Advisory Group. “Right now in the United States, from the CMS standpoint, any form of dialysis—peritoneal, in-center, or at-home—is still more expensive than renal transplant.”

Payment for training patients and care partners for home dialysis remains poor given the costs of nursing time, just $20 above the rate of payment for a dialysis session, Blagg and Lerma said. This figure has not changed in decades.

MIPPA would require Medicare to pay for training patients about their treatment options and for increased education funding to help patients manage other medical conditions. The law states that all patients who are on the cusp of dialysis (stage 4 chronic kidney disease patients) need to be educated about their potential options, including home hemodialysis.

The new Conditions for Coverage from CMS state that patients must receive information about home dialysis as an option for care. In addition, they must be told where they can get training if it is not offered in their facility. Caregivers need to record annually in a patient’s record why a patient would not be a candidate for home dialysis.

Equipment advances keep market growing

Fresenius, with about 1700 North American dialysis centers, is now devoting more resources to the home market. The company purchased Renal Solutions, Inc. (RSI) in 2007. This is “a further promising acquisition and an important step toward expanding our technology leadership in the high-growth area of home dialysis,” said Ben Lipps, CEO and chairman of the Management Board of Fresenius, based in Bad Homburg, Germany.

NxStage makes the portable NxStage System One™, which has helped to make daily and home therapy more accessible, said Alvin Armer, area manager for NxStage in Southern California. Turk said NxStage systems are used in the homes of 3000 of the 4000 patients doing home hemodialysis.

DaVita Dialysis, with more than 1400 dialysis centers in 43 states and Washington, DC, has teamed with NxStage to expand home hemodialysis opportunities. “Home (dialysis) is becoming very popular,” Armer said. “It is important that we keep the home therapies going, because we’ve seen the benefits in patients from day to day.” Fresenius and B Braun companies also make home dialysis equipment.

Dori Schatell, executive director of the Medical Education Institute, a clearinghouse of information for patients who are on dialysis at home, said her organization counts the number of programs that offer home therapy. Since 2004 there has been a 1200 percent growth in home hemodialysis, particularly in programs offering nocturnal dialysis, which had a growth of 300 percent, she said. “Peritoneal dialysis at home has grown by 20 percent.”

Limitations of home hemodialysis

Although there are not many clear drawbacks to home dialysis, there are limitations. Several sources mentioned the same aphorism: “If you can drive, you can do home dialysis.” Not everyone can drive, however.

Patients must have a certain level of cognitive ability to perform dialysis at home, Blagg said. Some patients have a fear of needles and do better in centers where nurses or others can do the needle management, Lerma said. Anecdotally, one patient said she chose not to dialyze at home because she did not want her home to take on the hallmarks of a treatment center. She didn’t want her small children to think “Mommy is always sick,” Lerma said.

Each person also should have a care partner who can attend in case of any problems. These care partners need to have the time to be trained and to participate.

Home dialysis isn’t trouble free. With nocturnal dialysis, “sleep can be disturbed because of alarms,” Lerma said. It’s not unusual for people to be awakened once or twice during the night. “Home dialysis affects everyone in the home.”

Looking ahead

Blagg said he foresees a bump from 1 percent to 5 percent of dialysis patients dialyzing at home in the next three to four years. This number, of course, will depend on the NIH outcomes, favorable reimbursement changes, and identifying and training patients and their caregivers who want the advantages of dialyzing at home.

If the NIH trials confirm that morbidity and mortality are diminished by this therapy, Szczech said, we will need to ask why more patients aren’t doing this at home “and also how do we increase patient enthusiasm so that more can benefit?”

Said Lerma: “As nephrologists, we can appreciate that in-center dialysis accounts for about 12 hours per week. Normal kidneys work 24 hours per day. The big question is: ‘What can we do to get kidney function as close as possible to physiological levels?’”