Dialysis Delivery in Canada and the United States: A View From the Trenches

Article Outline

• Abstract
• Market Forces
• Entry to Dialysis
• Quality of Care
• Modality Distribution
• Pre-ESRD Care
• Expensive New Drugs
• Mortality on Dialysis Therapy
  • Suggestions for the United States
  • Suggestions for Canada
• Conclusions
• Acknowledgements
• References
• Copyright

Although the general framework for health care delivery is vastly different in Canada and the United States, the framework for dialysis delivery is less divergent. However, the 2 systems have evolved very differently. Examined during the past 20 years, it is apparent that the dialysis system in the United States has undergone profound change, whereas the system in Canada is relatively stagnant. Most of the change in the United States has been positive, and this evolutionary change is expected to continue. In Canada, a system that historically has worked reasonably well is now showing severe signs of suboptimal performance that would be expected to get worse if no effort is made to improve it. This article, written from the perspective of 2 academic clinicians, tries to describe similarities and differences, identify strengths and weaknesses, and serve as a catalyst for discussions about improving both systems. Just as no dialysis treatment modality is perfect, the same can be said for dialysis delivery systems. Empirical methods to objectively evaluate the impact of change must be included in the design and implementation of new initiatives in the United States and Canada.

Comparing general aspects of health care delivery in Canada and the United States generates passionate discussion. For example, Michael Moore's recent film Sicko portrays only the worst aspects of the US system and presents the Canadian system as a shining example for the United States to emulate. However, critics of Canada's system often call for a parallel private stream, which inevitably leads to rhetoric about Americanization.

Canada has government-controlled universal health care coverage paid through taxation. Hospital care is publicly funded and not for profit. Physician services are provided by government-based insurance; however, drugs are not universally covered except for patients older than 65 years. Access to emergency care is excellent, but access to primary care and specialist care is constrained, and lengthy waiting lists for elective procedures have led to calls for a parallel private system for those who can afford it. A recent Supreme Court ruling states that if the public system is unable to provide adequate timely care, there can be no prohibition of privately funded care.¹

In the United States, health care is mostly private, for profit, and paid for by insurance provided through an employer or purchased by individuals. Government-funded health care is available for the elderly and the very poor (Medicare and Medicaid, respectively) and veterans of the armed forces. In the 1990s, managed care led to concerns about gatekeeping and denial of necessary care to even insured patients. However, it is the plight of the 46 million Americans with no health care insurance that generates the most negative publicity.² Nonetheless, the United States ranks first in the world in terms of overall health care spending per capita at $5,274 annually, whereas Canada is a distant second at $3,572. This represents 14.6% of the US gross domestic product and 9.3% of that of Canada.³, ⁴

Although the general framework for health care delivery is vastly different in Canada and the United States, the framework for dialysis delivery is less divergent. In 1972, the US Congress created an exceptional, universal, government-sponsored entitlement for end-stage renal disease (ESRD). This occurred at almost the exact time that universal medical coverage began in Canada. Despite the apparent similarities in government funding for ESRD care, the 2 systems have evolved very differently (Table 1). This article, written from the perspective of 2 academic clinicians, tries to describe those similarities and differences, identify strengths and weaknesses, and serve as a catalyst for discussions about improving both systems.

Table 1. Vital Statistics

Abbreviation: ESRD, end-stage renal disease.

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Market Forces 

Although medical care for patients with ESRD in the United States is primarily (80%) government funded, market forces, politics, and economics have had strong roles in shaping how that care is delivered. About two-thirds of dialysis care in the United States is provided by 2 large for-profit dialysis chains, which have emerged after 3½ decades of consolidation in the industry. Government spending for patients with ESRD in the United States was approximately $20 billion in 2003, or $60,337 per patient. This was before Medicare Part D came into effect, which includes prescription drugs. Because the composite rate for dialysis treatment had not increased for inflation in nearly 2 decades, the profit margin for many providers became negligible or negative, and many providers began to depend on the profit from separately billable injectable drugs and the greater reimbursement from commercial payers. The Medicare Payment Advisory Commission (MedPAC) conceded this reality in 2006 when it recommended an increase in the composite rate by 15.5%.⁵ Some providers decided to sell their businesses to the increasingly dominant chains, which had economies of scale that allowed for greater profitability.

According to data from MedPAC based on facility cost reports from 2003, the 4 largest chains had a profit margin of 5.4%, whereas nonchain providers had a profit margin of −0.7%.⁶ The role of nephrologists as dialysis facility owners has become less prominent as the publicly held chains grew and their fiscal leadership came from the corporate world, driven by accountability to shareholders. In the 1970s and 1980s, the majority of dialysis facilities were owned by nephrologists. Since the 1990s, most nephrologist ownership of facilities is in joint ventures with for-profit dialysis chains. Dialysis facilities and small chains owned solely by nephrologists are almost inevitably bought out by the chains in a cycle of dialysis arbitrage. Nephrologists continue to have a major role in the medical leadership as medical directors, but many financial decisions that may impact on patient care are influenced by administrators accountable for the viability of the business.⁶

Reimbursement for dialysis in the United States is a parallel system of public and private funding. Patients who have employer-paid group health insurance at the time they start dialysis therapy continue to derive benefits from that insurer for the first 33 months they are on dialysis therapy, with the insurer paying 80% and Medicare paying 20%. If the patient has no employer-paid group health insurance, Medicare pays 80% after a 3-month waiting period. If the patient does not qualify for Medicare and is indigent, Medicaid becomes the primary payer. Private insurance pays considerably more than Medicare, which pays more than Medicaid; thus, payer mix becomes an important determinant of profitability.

Market forces are generally not at play in the Canadian setting. Government funds public not-for-profit hospitals to deliver dialysis care. Nephrologists are not permitted to own dialysis facilities. On a per-year basis, Canada spends Can $55,466 (US $45,094) per patient with ESRD. Although there are mechanisms that operate to increase funding if unanticipated expansion occurs, these do not cover indirect costs. Hospitals perceive dialysis as a deficit generator.⁷ One perverse aspect of this arrangement is that hospitals may believe it is better to suppress results that indicate that they deliver a high quality of care to avoid excess referral of expensive patients. This perception of the patient as a source of costs is in direct contrast to the US model, in which the patient is a source of revenue in fee-for-service medical systems.

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Entry to Dialysis 

The United States is the most generous society in the world for access to dialysis therapy and annually starts treatment on 340 new patients per million population.⁸ In part, market forces in the dialysis industry would seem to have a major role in allowing the system to expand to cope with the epidemic of ESRD growth.

At first glance, it would seem that Canada's dialysis system would be as generous as the United States. The Canada Health Act enshrines the principle of access to care for all Canadians who require it, and there is no policy that promotes rationing of dialysis therapy. However, Canada's treatment rate is less than half the US rate at 158 per million population.⁹ In the early 1990s, it appeared that incident and prevalent patients in the United States were older and sicker than in Canada. Dialysis Outcomes and Practice Pattern Study (DOPPS) II and III data show clearly that the age distribution is now similar, and except for diabetes, the comorbidity profile is not different.¹⁰ It is unlikely that the greater prevalence of diabetes in the United States is sufficient to account for the increased treatment rate. Another possibility is that family physicians in Canada may not refer all patients who might benefit from dialysis treatment.¹¹ Other factors include real and perceived dialysis shortages that may limit referral, complete government control of expansion decisions, lack of central planning, lack of timely decisions, and lengthy secondary approval of expansions that are to be funded with public dollars. These factors all contribute to shortages of hemodialysis (HD) facilities that are worse in some regions than others.¹², ¹³, ¹⁴

It also is apparent that Canadian hospitals in the dialysis business have increasingly negative attitudes toward further dialysis expansion. This is especially true in Toronto, Ontario, where there are multiple regional centers. An ambivalent hospital might assume that dialysis care shortfalls can be picked up at some other center. Reasons for this increased reluctance to expand include the following factors: (1) hospitals must pay 50% of capital costs with money fund-raised from their community; (2) expansion has a large impact on the rest of the facility, including the emergency department, intensive care units, hospital laboratory, and diagnostic imaging services; (3) only direct operating costs are funded (eg, inpatient beds required to support dialysis growth are not funded); (4) the outdated funding formulas¹⁵ are insufficient to cover costs, especially for in-center HD⁷; and (5) hospitals have new accountability agreements that prohibit budget deficits. One emerging opportunity is that governments are interested in downsizing acute-care hospitals and shifting chronic disease management to community settings. It would seem timely and appropriate for non–hospital-based kidney care centers that provide comprehensive care of patients with all chronic kidney disease (CKD) stages to evolve.

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Quality of Care 

In the 1980s and early 1990s, there was great concern in the United States that compromises were being made that sacrificed quality of care in favor of profit. High dialysis mortality rates in the United States were believed to be associated with poor quality of care.¹⁶ In the past 10 years, the United States has made great progress in addressing these concerns. The National Kidney Foundation began publishing clinical practice guidelines for dialysis in 1997, which have served as a basis for tracking quality of care.¹⁷, ¹⁸, ¹⁹, ²⁰ The US Renal Data System (USRDS) is an excellent national database, and its analyses are published in detailed national reports and scholarly publications.⁸ This is complemented by the ESRD Clinical Performance Measures Project, a data collection activity from a random sample of HD and peritoneal dialysis (PD) patients analyzed to show regional variations and temporal changes in outcomes.²¹

The United States is divided into 18 ESRD Networks, with a mandate to track and improve quality of care. The quality agenda of each regional Network is driven by its medical review board, which is a voluntary physician-driven peer-review body. Because of competition for patients and physicians, the large chains have a strong incentive to improve quality of care and increasingly are held publicly accountable by a Medicare-sponsored website, Dialysis Facility Compare, which shows outcome data for all facilities. There are no data to suggest that the quality of care provided by for-profit dialysis facilities differs significantly from that provided by nonprofit facilities in the United States.

In 1996, an initiative implemented by the Arbor Research Collaborative for Health led to the establishment of DOPPS, an ongoing, international, prospective, observational study.²² Its goal is to determine which practice patterns are associated with better or worse patient outcomes and to increase longevity and quality of life in HD patients. DOPPS has served to highlight US, Canadian, and international practice patterns and track trends over time (Table 2). More recently in the United States, a coalition of renal stakeholders implemented a successful initiative, Fistula First (www.fistulafirst.org), to improve vascular access practice patterns. Kidney Care Partners, a coalition of ESRD stakeholder organizations that includes dialysis chains (for profit and nonprofit), pharmaceutical companies, and professional organizations has been active in pressing for legislative and regulatory changes that will improve the processes by which long-term dialysis in the United States is financed, delivered, measured, and improved.

Table 2. Mean Achieved Levels for Selected Hemodialysis Practices in Canada and the United States

Note: Data based on prevalent cross-sections of patients from nationally representative samples of hemodialysis facilities participating in the Dialysis Outcomes and Practice Patterns Study II (2002-2004).

All these forces have had a profound and measurable impact on quality of dialysis care in the United States. Especially during the past 10 years, published data show improvements in dialysis dose,²¹ anemia management,⁸ and, to a lesser extent, management of abnormalities of mineral metabolism.²⁹ The past 5 years have seen a remarkable improvement in the use of arteriovenous fistulas and a decrease in use of arteriovenous grafts.⁸ All these factors have been associated with a modest improvement in survival over time. The annual adjusted mortality rate for dialysis patients in the United States has decreased from 22.5% in 1980 to 20.12% in 2006.³⁰ However, many of these outcomes, particularly fistula placement and mortality, lag behind most industrialized countries of the world. Furthermore, there is increasing evidence that greater public accountability of providers and the prospect of payment for performance is resulting in the involuntary discharge of patients with less-than-desirable outcomes, so-called “cherry picking.”³¹ This has resulted in an increased burden on hospital-based dialysis providers that are required to care for these patients.³²

The situation in Canada is far different. With the exception of British Columbia and Alberta, which have regional agencies that manage the renal budget, most of the 90 dialysis programs in the country function independently and cannot afford to invest in data management software that allows for proper continuous quality improvement activities. The national Canadian Organ Replacement Registry (CORR) is a part of the Canadian Institute of Health Informatics (CIHI). Its plans to implement prospective online reporting have not been realized, and as a result, it tracks only a limited number of outcomes.⁹ Fortunately, Canada has participated in DOPPS since 2002, allowing for detailed examination of practice patterns and outcomes in a representative national random sample.

Compared with other nations in DOPPS, Canada's quality of dialysis care is average. Dialysis dose and anemia management are good.²³ Mineral metabolism management shows modest improvement from DOPPS II to DOPPS III.²⁹ Of profound concern is that Canada relies heavily on central venous catheters for vascular access.¹⁰ This appears to be caused by shortages of vascular surgeons and operating room time. Both CORR and DOPPS III data show central venous catheter use continues to increase²³, ³³ Nonetheless, the adjusted Canadian mortality experience is better than in the United States and Europe, but not as good as in Japan (Fig 1).

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• Figure 1. 

  Relative risk of mortality, Canada versus the United States. Both adjusted models include age, race, sex, time on dialysis therapy, and 13 summary comorbid conditions and accounted for facility clustering effects. Dialysis Outcomes and Practice Patterns Study II, N = 4,110.

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Modality Distribution 

Several modalities are available for the treatment of patients with ESRD. Most experts agree that kidney transplantation is the modality of choice for suitable patients. However, lack of organ availability and the increasing age and burden of comorbid disease limit transplantation as an option for most patients with ESRD. Of the dialysis methods, there is a paucity of data available that compares these with each other in terms of survival, hospitalization rates, or quality of life. However, it seems clear that PD and home HD are significantly less expensive than in-center HD in both the United States and Canada. In the United States, total Medicare expenditures per year were $71,889 per HD patient and $53,227 per PD patient in 2006.³⁰

There is astonishing international variation in modality distribution. For example, PD use is 70.5% in Mexico, 18.7% in Canada, and only 7.4% in the United States.³⁰ Similarly, home HD use is 16.2% in New Zealand, 9.5% in Australia, 2.5% in Canada, and 0.76% in the United States.³⁰ Many explanations and concerns about home dialysis trends have been advanced, but no clear consensus on an optimal distribution has emerged.³⁴, ³⁵, ³⁶, ³⁷ Nonetheless, there is increasing recognition that many more patients are suitable for home-based dialysis modalities than are currently treated that way in North America.³⁸, ³⁹ Survey methodology has shown that both Canadian and US nephrologists believe that an optimal modality distribution would include 45% to 55% home dialysis.⁴⁰, ⁴¹ In terms of cost-effectiveness, it seems desirable to promote methods of home dialysis for suitable patients.⁴²

The modality mix in the United States has always been dominated by HD. PD use peaked in 1993 at 14.9% and has been in decline ever since. By 2006, it had decreased to 7.4%. Evidence suggests that US nephrologists believe that patient choice should guide modality decisions, but many HD patients were never presented with home dialysis as an option.⁴³, ⁴⁴ Furthermore, evidence also suggests that informed patients will choose home dialysis much more often.⁴⁵, ⁴⁶, ⁴⁷

Home HD in the United States has been stagnant over time. Enthusiasm about preliminary results from daily home HD is shown in a survey in which US nephrologists said this option should make up 12% to 16% of an optimal modality mix.⁴¹ However, efforts to convince Medicare to fund home HD more than 3 times weekly have failed. In contrast, such jurisdictions as The Netherlands, Australia, and parts of Canada have implemented funding for daily home dialysis.

It does not seem likely that there will be a surge of interest in PD therapy in the United States. Although new PD solutions represent an opportunity to extend patient and membrane survival, the US Food and Drug Administration treats PD solutions like a new drug. Because the PD market is small and shrinking, neither sufficient peer review nor industry research funding is available to perform the trials required to test the new solutions for safety and efficacy. This sets up a vicious cycle of PD therapy decline. This is compounded further because many nephrology trainees in the United States receive marginal training in PD.⁴⁸

Canada has always promoted PD and historically has been an international leader in PD use. In part, this has been caused by shortages in HD stations and delays in HD expansion. As in the United States, PD peaked in 1993 (at 37.4%), but has decreased to 18.8%.⁴⁹ In a country with more government control, directed attempts to increase PD use can be instituted, as is currently the case in Ontario, where an implementation committee is charged with increasing penetration to 30% by 2010.⁵⁰ Canada has been a jurisdiction in which clinical research in PD and study of new solutions is attractive. Canada does not categorize PD solutions as drugs and therefore had early access to icodextrin and biocompatible solutions. However, funding for PD solutions is not flexible, and as a result, there is little clinical use of expensive biocompatible solutions outside research settings.

For daily home HD, Canadian innovation and research has been at the forefront in introducing and extending these therapies.⁵¹, ⁵² Implementation is still limited. In regions with an agency-type model (British Columbia and Alberta), these programs are thriving. In Ontario, programs established through research funds continue, but cannot grow because routine funding is not available. Canadian nephrologists also believe that 9% to 12% of patients would be on home HD therapy in an optimal dialysis system.⁴⁰ Furthermore, since 1997, the Canadian Society of Nephrology (CSN) has a published public policy that states that suitable patients should be encouraged to choose home dialysis, but that it not be made mandatory.⁵³

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Pre-ESRD Care 

In the United States, there is no integration of care of patients with CKD stages 1 to 5 not yet on dialysis therapy with their subsequent dialysis care. In general, CKD care is provided by nephrologists in private office settings. Nephrologists are paid fee for service for consultations and follow-up care, but there is no funding arrangement to compensate the nephrologist or other caregivers for educating patients about kidney disease or treatment modalities. However, increasing attention is directed toward raising awareness of these problems. One recent initiative is the promotion of laboratory reporting of estimated glomerular filtration rate, which will lead to earlier identification of patients with serious and progressive kidney disease and perhaps to earlier referral of patients to nephrologists.⁵⁴, ⁵⁵ Although this goal is laudable, it seems unlikely that funding of new CKD care models will be augmented in the near future.

In Canada, in general, the centralization of dialysis and other renal services in acute-care hospitals allows for complete integration of CKD clinics with home-based and in-center dialysis. Canadian nephrologists have easy access to multidisciplinary team–based CKD care, which includes professional services provided by nurse educators, social workers, dieticians, and pharmacists.⁵⁶ It has been suggested (but not proved) that 1 reason for lower ESRD incidence rates in Canada than the United States relates to easier access to primary care, nephrologist care, and multidisciplinary predialysis care. The CSN recently joined the international call for estimated glomerular filtration rate reporting.⁵⁷ It has been implemented province wide in British Columbia, Alberta, and Ontario. Coordinated efforts to extend this to other provinces are ongoing.

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Expensive New Drugs 

Given that ESRD care is already very expensive, as costly new treatments are developed, they will be scrutinized before a government payer or insurance company agrees to cover them. Increasingly, evidence of both survival advantages and cost-effectiveness are required, especially in Canada. This is problematic given the complex interactions of factors associated with mortality rates in patients with ESRD and the difficulties securing funding for large-scale randomized controlled clinical trials in ESRD.⁵⁸

A case study of this issue in the United States is the public policy regarding the use of erythropoiesis-stimulating agents, which has come under increased Congressional scrutiny following publication of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)⁵⁹ and Cardiovascular Risk Reduction by Early Anemia Treatment With Epoetin Beta (CREATE)⁶⁰ studies, as well as demonstration of significant variability in their use and in hemoglobin targets among dialysis providers.⁶¹ Based on both political (safeguarding the public) and economic (cost saving) grounds, it appears that hemoglobin targets will be lowered on a national basis through erythropoiesis-stimulating agent package insert relabeling, reimbursement policy changes, and provider public accountability.⁶² For other new expensive medications, such as cinacalcet, rationing can take a more insidious form. Health plans do not put these medications on their formularies, meaning that providers need to submit extensive paperwork to procure payment or that patients are denied access to these drugs altogether by individual payer reimbursement policies.

One Canadian example surrounds treatments for mineral metabolism abnormalities with such new drugs as sevelamer, lanthanum, and cinacalcet, which cost $4,000 to $5,000 per patient per year. Although current clinical evidence for the 3 drugs differs in important ways, all lack definitive hard-end-point and cost-effectiveness studies. Although they may increase rates of achievement of guideline targets and may reduce cardiovascular calcification and improve hard outcomes, these agents are not publicly funded in most provinces. Unless the current paradigm for approving public funding for new drugs is modified, patient access to promising, but expensive, new drugs will be markedly constrained.

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Mortality on Dialysis Therapy 

Crude mortality rates in the United States show modest improvements over time. In 2002 to 2004, the crude death rate for HD patients was 19.0 deaths/100 patient-years.³ DOPPS data show that adjustment for demographic and comorbid conditions reduces, but does not eliminate, the greater death rate in the United States compared with Europe.⁶³ However, additional adjustments that include differences in vascular access make this difference small and statistically not significant.⁶³

The crude death rate for HD patients in Canada is 16.1 deaths/100 patient-years.⁴ CORR reports improved survival in 5-year cohorts of dialysis patients over time. Compared with European countries in DOPPS II and with the adjustments noted (including facility vascular access use), the death rate in Canada is a statistically significantly 24% lower (R.L. Pisoni, personal communication, May 2009). Given that the crude death rate in Japan for HD patients is 5.2 deaths/100 patient-years,⁶⁴ it would seem that there are opportunities to increase patient survival in both Canada and the United States.

Based on these comparisons between the United States and Canada, the authors of this article offer the following recommendations to improve the funding, delivery, assessment, and outcomes of services for patients with CKD and ESRD.

Suggestions for the United States 

Suggestions for Canada 

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Conclusions 

Dialysis delivery systems will impact on patient quality of life and survival with ESRD and deserve the same continuous quality improvement effort and accountability framework that direct medical care already receives. When examined during the past 20 years, it is apparent that the dialysis system in the United States has undergone profound change, whereas the system in Canada is relatively stagnant. Most of the change in the United States has been positive, and this evolutionary change is expected to continue. In Canada, a system that historically has worked reasonably well is now showing severe signs of suboptimal performance that would be expected to get worse if no effort is made to improve it. There are bilateral lessons to be learned, and we have tried to set out constructive recommendations that should be considered. Just as no dialysis treatment modality is perfect, the same can be said for dialysis delivery systems. Similar empirical methods to objectively evaluate the impact of change must be included in the design and implementation of new initiatives in the United States and Canada.

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Acknowledgements 

The authors thank Susan Stark, BA, for significant contribution to the preparation of this article.

Financial Disclosure: None.

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