Some thoughts on the future of home hemodialysis
Home hemodialysis (HD) for chronic renal failure began some 46 years ago, and was primarily intended to provide dialysis at a lower cost so that more patients could be treated with the very limited funds available at the time. In the Seattle program, patients dialyzed three times a week during the day or evening, but this was inconvenient. After Stanley Shaldon introduced overnight home HD in October 1964, thrice-weekly 6- to-8-hour overnight dialysis became the norm in many programs.
Early Seattle experience with HD in both the hospital and the Seattle Artiﬁcial Kidney Center showed facility patients easily became dependent upon their nurses, doctors, and the machine. It was recognized that when patients lose control of factors that can gratify or hurt them they are soon reduced to a state that the psychologist Martin Seligman later described as “learned helplessness”—a condition in which an individual has learned to behave helplessly, even when they may have the opportunity to help themselves.
To achieve independence, it is important that dialysis begin early to avoid hospitalization and debility. Nurses and doctors are crucial in fostering independence and educating patients that home HD is safe for appropriately motivated, trained, and supported patients. Any reinforcement of a “sick image” in the patient must be avoided. Belding Scribner noted early on that the involvement of patients in their own care is important with all chronic diseases, and particularly for dialysis patients, wherever they dialyze (personal communication).
The advantages of home HD soon became obvious. It provided the best patient survival, quality of life and opportunity for rehabilitation, encouraged patient independence, responsibility, and conﬁdence, gave freedom from the need to travel to a dialysis facility three times a week and enforced socialization with others, allowed the patient to set their own ﬂexible scheduling, provided increased comfort and convenience, reduced the risk of infection, and considerably reduced the cost of care.2 The Boston program estimated costs at $5,000 to $7,000 a year, and the Seattle program as between $4,000 and $5,000 a year excluding training costs. As a result, by 1972, the year before the Medicare End-Stage Renal Disease Program began, there were about 7,500 dialysis patients in the U.S., 35% of whom were on home HD.3
What Happened to Home HD?
Since 1972, the number of home HD patients in the U.S. has steadily declined until, in 2002, it reached a nadir of 1,758 patients (0.57% of all dialysis patients).4 There were a number of reasons for this.5 Perhaps most important was that, since the Medicare ESRD Program is an entitlement program, almost all U.S. patients with chronic kidney failure are entitled to treatment. As a result, the proportion of diabetic patients and elderly patients increased rapidly, many of whom were not good candidates for home HD. At the same time, the availability of, what was at the time, very generous federal funding, led to a rapid proliferation of dialysis units, and for-proﬁt dialysis units in particular were uninterested in home dialysis. One of the other reasons was that because there had been few dialysis units previously, most nephrologists had little or no experience with dialysis for chronic renal failure and even fewer had any experience with home HD and its beneﬁts.
As noted earlier, the cost of dialysis in the home is very signiﬁcantly less than the cost of dialysis in a facility primarily because of much lower stafﬁng costs. However, the Medicare reimbursement for home HD training has always been woefully inadequate at an extra $20 per training dialysis. As a result, there was no incentive for facilities or companies concerned with cost to consider home HD as it took one to two years after the patient went home to offset the costs of training. Also, in order to staff and support an effective training program it was necessary to have at least 12 to 15 patients at home.
In the late 1990s, with the introduction of more frequent overnight (nightly) home HD and shorter more frequent (daily) HD, interest in home HD began to revive in the U.S. and elsewhere. By 2007, according to the U.S. Renal Data System Annual Report, there were 2,999 home HD patients in the U.S. (0.81% of all dialysis patients).3 Unofﬁcial estimates are that by the end of 2010 the number will be some 5,000 patients. Currently, the two largest for-proﬁt dialysis corporations in the U.S. have begun to offer home HD as an option at some of their units. Even so, 11 countries in the world have a higher percentage of home dialysis patients than the U.S., particularly Australia (9.8%) and New Zealand (15.5%).6 This may reﬂect the absence of major for-proﬁt programs in these two countries, salaried physicians, dialysis units that are generally related to teaching and other major hospitals, and state and national governments that have very close working relationships with nephrologists and actively encourage home HD.
What is the Future for Home HD?
Home HD should continue to grow in the U.S., although gradually, and there are a number of reasons it should grow. Congress, MedPac, the General Accounting Ofﬁce, and the Centers for Medicare and Medicaid Services have all expressed the view that there should be more patients treated by home dialysis in the future.
There is an increasing number of nephrologists rediscovering the beneﬁts of home HD as a result of the steadily increasing number of presentations and publications about the beneﬁts of home HD generally, and about more frequent HD speciﬁcally. Home HD enthusiasts over the years have always claimed that conventional thrice-weekly home HD provides better survival than conventional center dialysis. A study using USRDS data published in 1996, before more frequent HD came to the U.S., showed an unadjusted risk of death with home versus center HD of 0.37 (p < 0.01) and controlled for age, race, sex, cause of renal failure, and comorbid conditions a relative risk of 0.58 (p = 0.03).7 Similarly, in a matched case cohort study reported in 2005 from Switzerland, survival at 5, 10, and 20 years for home HD patients was 93%, 72%, and 34% compared with that of center patients of 64%, 48%, and 23%.8
More recently, two reports have shown that short daily HD had a standardized mortality ratio of 0.39 (p < 0.005) and 0.34 (p > 0.001), and a matched cohort study showed survival with long nightly dialysis had a hazard ratio of 0.51 (95% conﬁdence interval: 0.28–0.91).9–11 Survival with both short daily and long nightly HD has been shown to be comparable with that following a successful deceased-donor transplant and better than with breast and prostate cancer,9, 10 and some suggest these ﬁgures should be given to patients to help them with treatment option decisions. It would be interesting to compare survival using conventional thrice-weekly home HD with that of the various forms of more frequent home HD as well as center HD, but this is unlikely to occur.
Patients too are becoming more interested and knowledgeable about home HD, as shown in recent articles and blogs, but at this time most U.S. dialysis units do not provide this treatment modality. This is beginning to change, and it is encouraging that the two largest dialysis corporations recently have started to develop home HD programs. Another important development is that Medicare's Conditions of Coverage will now require documentation that all patients are made aware of all dialysis modalities, and if home HD or peritoneal dialysis is not available at the facility the patient must be informed where they could get these treatments.11
As it is unlikely that the 5,000 or so dialysis units in the U.S. will each develop a successful home HD program because of the need for specialized training and support staff, a better approach might be to encourage regionalization of home HD training rather like transplantation. Also, with more funding becoming available for pre-dialysis education, it is to be hoped that many more potential patients will have greater opportunities in the future to learn about their options well prior to starting dialysis and—most importantly—will have the opportunity to meet with successful patients who are using all modalities of treatment as well as their families.
Another factor is the recent development of new machines speciﬁcally designed to be patient-friendly and for use in the home. Although the ﬁrst such machine, the Aksys PHD, was very innovative and was approved by the FDA in 2002, it was ﬁnancially unsuccessful and withdrawn from the market several years later. This was unfortunate as the device had properties that made it probably the nearest approach to an ideal home HD machine yet available. In 2005, the FDA approved the NxStage System One for home HD. This device is relatively portable, weighing about 70 pounds, and the company's marketing to the dialysis industry and to patients has been very successful and has been a major factor in the increased use of home HD in the U.S. today. NxStage is now beginning operations outside the U.S. In addition, Fresenius recently purchased Renal Solutions Inc., a company that had developed an interesting sorbent-based machine for home HD, and are in process of incorporating it into their existing home machines. This would have the advantage of not needing a water treatment system in the home. A number of other innovative home machines are being developed in the U.S. and Europe and are beginning the process of obtaining FDA approval, and so the market for home HD machines is likely to become much more competitive over the next few years.
In addition to home machines developed for more frequent short daily or long nightly HD, for several years there has been gradually increasing interest in developing a wearable artiﬁcial kidney. While several ingenious new light-weight small devices have been or are being developed and tested at this time, blood access remains a major issue with a wearable device. In addition, many patients may not ﬁnd it acceptable to wear a device weighing a few pounds around their waist or on a limb for many hours at a time on most or all days of the week. Nevertheless, the technology used in the devices themselves may have distinct possibilities for home HD machines in the future. Another wearable device under development uses tidal peritoneal dialysis and has the advantage that peritoneal catheters have a greater likelihood of staying in place and functioning over the long-term. Again, weight will be an issue.
With more funding becoming available for pre-dialysis education, many more potential patients will have greater opportunities in the future to learn about their options well prior to starting dialysis.
In the U.S. we are currently waiting the Final Rule on bundling affecting reimbursement. The Proposed Rule included a higher bundled rate of 1,473 times the standard bundled rate for the ﬁrst four months of dialysis to account for the extra costs associated with stabilization of new patients and related administrative and labor costs, and also included “initial costs incurred to train patients and their caregivers to perform home dialysis.” However, according to the 2009 USRDS Annual Report, 43% of new patients have not seen a nephrologist before starting dialysis and so will need access surgery, time for a ﬁstula to mature, and time to learn how to needle their ﬁstula before training starts.4 Many home HD patients are center patients who decide to change to home HD after months or years on dialysis as they become aware of how successful and better rehabilitated home HD patients are.
In addition, there are occasions when patients already on home HD requite retraining on new equipment or for other reasons. A large numbers of comments have been made to the Center for Medicare and Medicaid Services about this, as the great majority of episodes of home HD training occurs later than a patient's ﬁrst four months of dialysis. Consequently the add-on for home HD training should be omitted from the per dialysis payment for treatments in the ﬁrst four months of treatment and should be applied to the regular bundle whenever training occurs. We shall see if this is changed in the Final Rule.
The other important issue in the Proposed Rule is that of paying for more frequent HD. As noted above, conventional home HD, “daily” and “nightly,” provide better survival than conventional facility dialysis as well as other beneﬁts. However there is little doubt that longer and/or more frequent HD provide further beneﬁts such as reduced hospitalizations, better blood-pressure control with fewer or no antihypertensive drugs, less or no need for phosphate binders, and possibly a reduction in erythropoietin requirements. It is certainly signiﬁcant that when asked what treatment they would prefer for themselves if they had kidney failure (and a transplant was not feasible), most nephrologists would opt for home HD ﬁve or six nights a week. My opinion is that, in increasing order of beneﬁt, are:
Conventional thrice-weekly in-center HD as practiced today in the U.S., where few patients receive treatments of longer than four hours;
Thrice-weekly overnight HD in a facility;
Thrice-weekly HD at home, preferably overnight;
Alternate night overnight HD at home;
Five or six times a week short dialysis at home; and
Five or six times a week overnight HD at home.
Currently, Medicare pays for a fourth dialysis in a week based on medical necessity but it remains to be seen if they will pay for dialysis more frequently than that and, if so, what the requirements may be. Unfortunately while savings with more frequent dialysis will be in parts A and D of Medicare, any necessary increase in payment would be in Part B and could not be offset by the savings of doing more dialysis.
What Is Important
All patients should be educated on the advantages of home HD and, if possible, this should be provided to all potential dialysis patients at least several months before dialysis begins. It must cover all options and include meeting with successful home patients and their families. If HD is the option, either at home or in a center, whenever possible an arteriovenous ﬁstula should be placed early so as to be mature by the time dialysis is necessary. The patient's nephrologist should be knowledgeable and supportive of home dialysis.
Physicians, dialysis facility staff, and administrators must be educated on the advantages of home HD, including the cost advantages.
Congress and CMS must continue to be educated about the advantages of home and longer and more frequent HD—including the savings related to less hospitalization and infections and reduced drug needs, and the need for reimbursement—so that more frequent home HD becomes much more readily available for patients.
There's no place like home!