Volume 14, Issue 3, Pages 290-296 (July 2007)

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ABSTRACT

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Should the Medicare ESRD Program Pay for Daily Dialysis? An Ethical Analysis

End-stage renal disease (ESRD) is a growing problem in the United States and has now reached epidemic proportions. The mortality rate and other complications related to conventional dialysis remain unacceptably high necessitating improvements in dialytic therapies. One strategy has been to increase dialysis frequency through daily dialysis since the Hemodialysis study showed that clinical outcomes are not improved by simply increasing delivered dialysis dose per session. Most studies of daily dialysis are observational and limited by small sample size, variable dialysis techniques, high patient dropout, and lack of adequate control group. These studies have shown consistent improvements in blood pressure and solute clearance, but improvements in patient survival, anemia, and health-related quality of life are less clear. The costs of providing daily dialysis on a large scale are likely to be substantial. However, if there are significant improvements in the outcome measures outlined earlier as well as decreased hospitalization rates, daily dialysis may prove cost-effective or budget neutral from a global standpoint. A scientific basis is needed to justify a change in the Medicare ESRD Program to fund daily dialysis. Decisions regarding the allocation of limited medical resources such as the Medicare budget should consider ethically appropriate criteria including likelihood of benefit, urgency of need, change in quality of life, duration of benefit, patient selection, equitable distribution, and the amount of resources required. In examining the evidence base on daily dialysis according to these ethical criteria, we find that there are not yet sufficient grounds to recommend funding of daily dialysis by the Medicare ESRD Program. Randomized controlled trials comparing conventional hemodialysis to short daily and long nocturnal hemodialysis are much needed.

Index Words: Daily dialysis, Medicare funding

Article Outline

• Abstract

• Likelihood Benefit

• Urgency of Need

• Change in Quality of Life

• Duration of Benefit

• Resources Required for Successful Treatment

• Economic Resources

• System/Capacity Requirements

• Patient Selection

• Equitable Distribution

• Conclusion

• References

• Copyright

Despite long experience with hemodialysis and a growing patient population, the mortality rate of conventional thrice weekly hemodialysis remains unacceptably high for US patients.1, 2 The rates of other complications related to end-stage renal disease (ESRD) such as cardiovascular disease, anemia, hypertension, bone disease, poor nutrition, and poor physical and cognitive function also remain high.2, 3, 4, 5, 6, 7, 8 Observational studies have suggested that inadequate hemodialysis dose may be responsible in part for the high mortality and morbidity of conventional hemodialysis.9, 10 However, as shown by the Hemodialysis study, attempts at improving clinical outcomes by increasing the dose of dialysis delivered at each session have not been successful.11 In the last decade, more attention has been directed at increasing dialysis frequency in the form of short daily and nocturnal hemodialysis.12, 13

More recently, there has been a renewed interest in daily (also termed quotidian) dialysis because in part of technologic advances and improved clinical outcomes with daily hemodialysis. As a consequence of the HEMO study, the focus has shifted from increasing the per-session dialytic dose to increasing treatment frequency or duration to improve clinical outcomes.12, 13 Most studies of daily dialysis are observational and are limited by small sample size, variable dialysis techniques, high patient dropout, and lack of adequate control groups.14, 15, 16 These studies report variable benefits with daily dialysis.14, 15, 16, 17 Consistently reported benefits include improved blood pressure control,14, 15, 17 reduced medication requirements, and improved solute clearance.15 Other outcome measures such as improvements in anemia,15 health-related quality of life,18 mineral metabolism, and patient survival19 have been noted in some studies but not in others. The costs of providing daily dialysis on a large scale are likely to be substantial. However, if there are significant improvements in the outcome measures outlined earlier as well as decreased hospitalization rates, daily dialysis may prove cost-effective or budget neutral from a global standpoint.

In the modern-day practice of evidence-based medicine, more than a pathophysiologic rationale is needed to support the introduction of a procedure or treatment such as daily dialysis; scientific studies documenting beneficial outcomes are necessary.20 A scientific basis is all the more important to justify changing the Medicare ESRD Program to fund daily dialysis because the Medicare ESRD Program is large (more than 300,000 patients per year on dialysis in the United States), costly (over 20 billion dollars per year in 2003), and consumes a disproportionate share of Medicare resources (6.7% of Medicare budget for 1.2% of Medicare covered patients in 2004).21 Decisions regarding the allocation of limited medical resources such as the Medicare budget should consider ethically appropriate criteria such as the likelihood of benefit, urgency of need, change in quality of life, duration of benefit, patient selection, the amount of resources required, and equitable distribution of those resources.22 In this article, daily dialysis will be considered in light of these ethical criteria to see if there is sufficient justification for the Medicare ESRD Program to fund daily dialysis.

Likelihood Benefit

This criterion is essential because the ethical principle of beneficence obliges physicians to promote the benefit of their patients. One aspect of beneficence is utility. Utility requires that nephrologists maximize benefits compared with burdens to produce the best overall results for their patients.23 In the case of conventional hemodialysis (CHD) versus short daily hemodialysis (SHD), Medicare needs to consider whether SHD produces benefits comparable with or greater than CHD in order to justify its expected greater cost. In their book Clinical Ethics: A Practical Approach to Ethical Decisions in Medicine (ed 6), Jonsen et al24 urge an approach to ethical analysis that considers first whether a treatment is “medically indicated.” A treatment is medically indicated if the potential benefits justify the risks. In the case of CHD versus SHD, the risks, benefits, and probable outcomes of SHD need to be considered to determine whether the probabilities of successful treatment with SHD are at least comparable with CHD and thereby justify its use. The ethical criteria of likelihood of benefit and duration of benefit are both factors that need to be evaluated to determine if a treatment such as SHD is medically indicated.

Clinical benefits of daily dialysis include cardiovascular benefits of better blood pressure control25, 26, 27, 28, 29, 30 and regression of left ventricular mass,31, 32 improved small solute clearance,32, 33 and better phosphorus control and B2 microglobulin clearance in patients on nocturnal hemodialysis (NHD).34, 35 The effects of quotidian dialysis on anemia and erythropoietin requirements are not entirely clear. Most studies have failed to show any significant change in erythropoietin utilization.26, 27, 31, 36, 37, 38, 39, 40 SHD has been shown to improve appetite and protein intake,26, 41 but effects of SHD on normalized protein equivalent nitrogen appearance and serum albumin are variable. Patients on NHD have fewer dietary restrictions than all other modalities.

The potential drawbacks of quotidian dialysis that may limit benefit include patient fatigue or burnout leading to problems with compliance and failure of the dialysis modality. Complications related to increased blood loss during dialysis via dialyzer losses, bleeding, and frequent blood draws remain a concern. Problems related to vascular access also remain an important consideration because of more frequent cannulation and infections.28, 42, 43, 44, 45, 46

In combination with an ethical assessment of likelihood of benefit of daily dialysis (beneficence), the ethical principle of justice also supports the ethical criteria we have identified to evaluate whether Medicare should pay for SHD. In settings of limited resources such as the Medicare ESRD Program budget, justice examines the distribution of burdens and benefits within the context of a society. One of the main principles of justice is utilitarianism, a principle that calls for promoting the greatest good for the greatest number. The greatest good is achieved when there is a high likelihood of benefit for a long duration.47 To date, the data on the net benefits of daily dialysis have only shown improved outcomes for some clinical endpoints like blood pressure control and quality of life, and these findings have only been in small clinical trials. There have not been any large-scale clinical trials attesting to the positive impact of daily dialysis on other clinical outcomes. The ethical criterion of likelihood of benefit compared to CHD has not yet been satisfied for daily dialysis.

Urgency of Need

Because of the high mortality and morbidity of ESRD patients, it can be said that there is an urgency of need for alternative dialysis modalities that achieve better outcomes. The urgency of need as a criterion can be supported by the ethical principle of beneficence that places a moral obligation on people to act for the benefit of others, especially in dire circumstances such as high morbidity and mortality.48 Cardiovascular disease, anemia, hypertension, bone disease, poor nutrition, and poor physical and cognitive function all contribute to the high mortality and morbidity of these patients.3, 4, 5 Observational studies have suggested that inadequate hemodialysis dose may contribute to these problems.10, 49 Improved hemodynamic stability, fewer volume-related events during dialysis, and decreased medication burden may lead to improvements in ESRD patient outcomes, but large-scale controlled studies attesting to this fact are lacking.

Successful kidney transplantation can be a life-saving procedure by reducing the mortality risk and improving the quality of life for most patients when compared with maintenance dialysis.50, 51, 52 However, a large percentage of patients on dialysis may not be candidates for kidney transplantation. The shortage of available donor kidneys also leads to long wait times, and mortality while on the transplant waiting list is about 6% to 10% per year.53, 54 Therefore, strategies to improve survival outcomes of patients with ESRD who cannot receive a transplant or are waiting for a transplant are urgently needed. Daily dialysis is possibly one of these strategies, but there is not sufficient evidence yet to conclude that the ethical criterion of urgency of need argues for funding of daily dialysis.

Change in Quality of Life

Fundamental to the ethics of medical practice is to institute treatments that maintain or improve the quality of life for patients for many years.55 In Jonsen et al’s Clinical Ethics: A Practical Approach to Ethical Decisions in Medicine, quality of life is 1 of 4 key factors to be considered.56 All the goals of medicine are aimed at changing the quality of life for the better. Beauchamp and Childress57 agree that “quality of life is an ethically essential concept” that focuses on the good of the individual. The importance of quality of life to the practice of medicine justifies its place as an ethical criterion to be considered in the evaluation of whether Medicare should pay for SHD.

A number of studies, most of which were observational in nature, have shown improvements in quality of life when patients change to daily dialysis.27, 58, 59, 60, 61, 62 Depression scores have also been shown to improve with daily dialysis.60 Sleep architecture is also improved in patients on NHD, and significant improvements in apneic spells and overnight oxygen tension have also been noted.63 Thus, the ethical criterion of improved quality of life seems to be satisfied by daily dialysis.

Duration of Benefit

Quality-adjusted life-years is an analytical concept commonly used to evaluate which treatments should be used in medicine, and it is based on the ethical criterion of duration of benefit. In essence, duration of benefit considers quantity of life as an important criterion much like ethicists have recognized quality of life to be one.

To date, there has been no conclusive evidence that survival is improved in patients on quotidian dialysis. Therefore, the duration of benefit of daily dialysis remains unclear. The National Institutes of Health and Centers for Medicare and Medicaid Services are in the process of conducting 2 randomized controlled trials comparing CHD with SHD and NHD.16 However, because of limited sample size, these trials will not address change in mortality as a primary endpoint. However, they will provide information about composite 1-year mortality rates, change in left ventricular mass index, and the Short-Form 36 Physical Health Composite Score. At this point, funding of daily dialysis by the Medicare ESRD Program is not supported by the ethical criterion of duration of benefit.

Resources Required for Successful Treatment

In their book, Jonsen et al64 also include contextual features as one of four key factors to be considered in ethical analysis. They note that “The possibilities and constraints of that context influence patient care, positively or negatively.”64 They include in their contextual analysis financial and economic factors as well as social and institutional features. The resources required for successful treatment are germane to an analysis of contextual features.

Economic Resources

The expenses associated with daily dialysis include initial equipment setup, consumables, medications, laboratory testing, physician time, and personnel. Cost savings may be realized with decreased requirement for medications, especially erythropoietin and phosphate binders, fewer hospital days, and an increased rate of employment or re-employment. In both NHD and SHD, cost of consumables is higher than that with CHD. Personnel costs with daily dialysis done at home are much lower than in center dialysis.65 Medication expenses such as antihypertensives, erythropoietin, and phosphate binders and cost of hospitalizations tend to be lower with NHD.58, 66 Therefore, overall treatment costs will depend on the supplies to labor cost ratio in different countries. However, the distribution of costs among the different players is intrinsically unequal as are economic benefits to each group. This presents a potential barrier to development and acceptance of home hemodialysis therapies.

System/Capacity Requirements

To gain widespread acceptance of home dialysis, new technologies and user-friendly dialysis machines are essential along with resources for patient safety and monitoring.67, 68, 69, 70 Thus, the resources required for SHD versus CHD are unclear, and, at this time, the ethical criterion of resources required does not support Medicare funding for daily dialysis.

Patient Selection

Because of the ethical principle of justice and the need to be fair in the distribution of any beneficial treatment, patient selection is certainly an important consideration. Most patients can be considered candidates for daily dialysis unless there are contraindications to systemic anticoagulation71 or other serious medical problems such as poorly controlled seizures. Apart from incident dialysis patients, patients who may benefit most from daily dialysis include those who are not candidates for kidney transplantation or do not have a living donor. Patients who are unable to achieve adequate dialysis, such as those with large body habitus, and those with large interdialytic fluid gain and severe hypertension may also benefit most.

Candidates for daily dialysis at home need to be able to learn how to safely perform it and be compliant with the dialysis prescription. Patients should also be relatively stable so that the procedure can be performed in a setting without immediate medical supervision and also need to have a family member or friend willing to assist the patient with the procedure. Hence, not all dialysis patients are candidates for daily dialysis.

Equitable Distribution

There is an inherent tension in the ethical principle of justice between utility and equality. Utility seeks to maximize the benefits possible, whereas equality seeks to give each person an equal share.47 Equitable distribution as a criterion is grounded in the principle of equality. As noted earlier, not all patients are candidates for SHD. Consequently, equitable distribution can only be accomplished among those patients who are candidates for SHD. The need to make this distinction is similar to the one made regarding which ESRD patients are candidates for kidney transplantation. Not all ESRD patients are deemed medically suitable for transplantation. Consequently, the application of the ethical criterion of equitable distribution to the evaluation of CHD versus SHD needs to be qualified. This qualification does not detract from the ethical desirability of Medicare funding daily dialysis if and when the other ethical criteria proposed in this article are supported by medical evidence.

Conclusion

Each physician has a duty to promote the benefit of the individual patient. The American Medical Association Code of Medical Ethics states with regard to the allocation of limited medical resources, “Physicians have a responsibility to participate and contribute their professional expertise in order to safeguard the interests of patients in decisions made at a societal level regarding the allocation or rationing of health care resources.”22 The decision regarding the widespread institution of daily dialysis for dialysis patients is just that type of decision anticipated by the American Medical Association statement. It requires the exercise of responsibility by nephrologists. We have used the following ethical criteria: likelihood of benefit, urgency of need, change in quality of life, duration of benefit, the amount of resources required, patient selection, and equitable distribution to evaluate studies pertaining to daily dialysis.22 So far, the benefits of daily dialysis have only been shown in small studies, and they are limited to improvements in some outcomes such as blood pressure control, regression of left ventricular hypertrophy, fewer dietary restrictions, and better quality of life. There has been no clear improvement in patient survival with daily dialysis when compared with CHD. In this article, the application of ethical criteria for evaluating a limited resource like Medicare funding for dialysis indicates that there are not yet sufficient grounds to recommend daily dialysis. The National Institutes of Health and CMS randomized controlled trials comparing CHD to SHD and NHD are likely to provide additional evidence to allow a further analysis of daily dialysis using the ethical criteria proposed in this article. To be able to justify Medicare funding for daily dialysis, these large-scale controlled studies will need to show significant clinical benefits such as improved blood pressure control, regression of left ventricular hypertrophy, fewer adverse cardiac events, and improved quality of life compared with CHD. Ideally, these studies would also show improved patient survival when compared with CHD to satisfy the ethical criterion of duration of benefit and budget-neutral costs to satisfy the criterion of resources required. Until such time as there is conclusive evidence regarding the outcomes of daily dialysis, advocates of it will best serve their patients by conducting carefully controlled studies examining benefits and burdens, quality of life, and costs of daily dialysis compared to CHD.

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a Section of Nephrology, West Virginia University School of Medicine, Morgantown, WV

b Center for Health Ethics and Law, West Virginia University School of Medicine, Morgantown, WV.

Address correspondence to Priya Anantharaman, MD, Section of Nephrology, West Virginia University School of Medicine, PO Box 9165, Morgantown, WV 26506.

PII: S1548-5595(07)00045-6

doi:10.1053/j.ackd.2007.03.001

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