Feature

Health Policy for Dialysis Care in Canada and the United States

Marcello Tonelli, Raymond Vanholder and Jonathan Himmelfarb
CJASN November 2020, 15 (11) 1669-1677; DOI: https://doi.org/10.2215/CJN.14961219

Abstract

Contemporary dialysis treatment for chronic kidney failure is complex, is associated with poor clinical outcomes, and leads to high health costs, all of which pose substantial policy challenges. Despite similar policy goals and universal access for their kidney failure programs, the United States and Canada have taken very different approaches to dealing with these challenges. While US dialysis care is primarily government funded and delivered predominantly by private for-profit providers, Canadian dialysis care is also government funded but delivered almost exclusively in public facilities. Differences also exist for regulatory mechanisms and the policy incentives that may influence the behavior of providers and facilities. These differences in health policy are associated with significant variation in clinical outcomes: mortality among patients on dialysis is consistently lower in Canada than in the United States, although the gap has narrowed in recent years. The observed heterogeneity in policy and outcomes offers important potential opportunities for each health system to learn from the other. This article compares and contrasts transnational dialysis-related health policies, focusing on key levers including payment, finance, regulation, and organization. We also describe how policy levers can incentivize favorable practice patterns to support high-quality/high-value, person-centered care and to catalyze the emergence of transformative technologies for alternative kidney replacement strategies.

Introduction

Over the last 5 decades, dialysis has been transformed from a life-support treatment for a select few into a routine therapy for a chronic disease. There are now >3 million people worldwide treated with hemodialysis, and continued increases in prevalence are anticipated as the global population ages (1–3).

Contemporary dialysis is complex, is associated with poor outcomes (4), and leads to high health costs (5), all of which pose substantial policy challenges. Moreover, even in high-income countries where incidence recently stabilized, prevalence continues to rise due to improved patient survival (6–8). Despite similar policy goals for their kidney failure programs, Canada and the United States have taken very different approaches to these challenges. For example, Canadian dialysis care is funded by the state and delivered exclusively in public facilities, whereas US dialysis care (while also funded by the state) is delivered predominantly by private providers. Similar differences exist for financing mechanisms and the incentives to influence providers and facilities. In addition to between-country and regional variation, there is substantial within-country heterogeneity in policy. For example, the specifics of Canadian dialysis care vary between the 13 provinces and territories, whereas in the United States, the quality of delivered care may differ for patients treated in for-profit versus not-for-profit facilities or in the Veterans Administration. In parallel with these differences, clinical outcomes also differ between countries.

The observed heterogeneity offers important learning opportunities. This article contrasts dialysis-related health policy in Canada and the United States, with additional reflections on policies and practice in Europe, focusing on key levers including payment, finance, regulation, and organization that may incentivize favorable practice patterns, such as high-quality/high-value, person-centered care. The discussion focuses on two specific policy goals: high-quality dialysis care and ensuring appropriate modality selection.

Transnational Comparisons

Compared with those in the United States, patients with ESKD in Canada include a higher proportion aged >75 years, a higher proportion of men, and a markedly lower proportion of Black patients (Table 1). Although the presence of diabetes mellitus among patients on incident dialysis is similar in the United States and Canada (Table 2), the prevalence rates of heart disease, cerebrovascular disease, and peripheral vascular disease are higher in Canada than in the United States. The overall burden of comorbidity seems to be slightly higher in Canada than in the United States, likely due in part to the differences in age. The prevalence of ESKD treated with dialysis is markedly higher in the United States than in Canada (Figure 1A), although the mean eGFR at dialysis initiation is similar (Figure 1B).

View this table:
Table 1.

Characteristics of patients on kidney replacement for Canada versus the United States

View this table:
Table 2.

Characteristics of patients on incident dialysis for Canada versus the United States

Figure 1.
Figure 1.

Selected characteristics related to dialysis treatment (all modalities) for Canada and the United States. Sources: (A) the United States Renal Data System (USRDS) (70). (B) The USRDS (70) and the Canadian Organ Replacement Register (CORR) (23). (A) Comparison of the prevalence of dialysis treatment in Canada and the United States per million population. It shows that the prevalence of ESKD has been consistently higher over time in the United States (P<0.001), with a slight widening of this difference in recent years. (B) Comparison of eGFR at initiation of dialysis in Canada versus the United States. It shows fluctuations in both countries over time, with eGFR at dialysis progressively increasing from 2005 to 2010 and then decreasing thereafter. eGFR at initiation of dialysis has been slightly higher in Canada than in the United States (P<0.001).

Utilization of home hemodialysis, peritoneal dialysis, and transplantation is higher in Canada (Table 1), although utilization of each has recently increased in the United States. National data are not available from either country on the incidence or prevalence of kidney failure treated without dialysis, including palliative care and hospice care.

Acknowledging the potential limitations of registry data, these demographic differences (older age, men, White race, and increased comorbidity at the time of dialysis initiation and more kidney transplantation in Canada) should favor higher mortality among patients on dialysis in Canada than in the United States (Table 1). Instead, mortality has been historically higher among US patients on dialysis than Canadian patients (Figure 2), similar to studies that report adjusted transnational comparisons (9), although the gap has substantially narrowed over time. The European patient mix, modality choice, and outcomes parallel the Canadian pattern.

Figure 2.
Figure 2.

Survival after initiation of dialysis (all modalities) differ for Canada and the United States. Sources: the USRDS (70) and the CORR (23). The figure compares unadjusted survival at various time points (3 months and 1, 3, and 5 years) after initiation of dialysis among patients treated in Canada versus the United States. The figure shows that mortality at 1, 3, and 5 years is consistently lower in Canada than in the United States (for 1 and 3 years; all P<0.001) but that these between-country differences have tended to narrow over time. For survival at 3 months, mortality was lower in the United States than in Canada during 2014–2016 (P<0.001), although the magnitude of the difference was very small.

Given the discrepancy between demographics of incident patients, treatment modality selection practices, and the less favorable mortality in the United States compared with Canada, we next examined the potential role that organization of care might play as contributing factors. We analyzed country-specific payment, finance, and regulatory policies, as well as health care structure.

Overview of Dialysis Care in the United States

Payment

Since October 1972, Medicare coverage, initially enacted for the elderly in 1965, was extended to all persons with ESKD requiring dialysis or transplantation under Medicare Parts A and B (10). ESKD and amyotrophic lateral sclerosis remain the only disease-specific conditions covered by Medicare independent of age. Since 1983, Medicare has reimbursed dialysis facilities through the prospective payment system, providing a bundled payment consisting of a composite rate (primarily encompassing capital costs, administrative services, and labor cost for direct care of patients), with additional payments for medications, some laboratory tests, and certain medical supplies (11). Over time, the proportion of these additional payments nearly eclipsed the bundled payments, eventually leading to changes in reimbursement policies enacted in 2011 through an expanded bundle (Supplemental Table 1). On the other hand, payments to physicians have always been separate from facility payments, and they are on the basis of frequency of patient contact and require provision of certain monthly services (Supplemental Table 2).

Finance

Medicare and Medicaid are the dominant dialysis payors, and payments have increased steadily. Today, Medicare costs for aggregate care of patients on dialysis are approximately $35 billion annually, which approaches 1% of the entire federal budget (12). The remainder of ESKD cost is borne by the Veterans Affairs, Medicaid, private insurers, and safety net systems. Dialysis providers are reimbursed by commercial insurers at markedly higher rates per treatment than by government payors (13).

Regulation

Dialysis as an industry is subject to federal and state regulations, with a consistently increasing focus over the past decade on improving the quality of dialysis care while reducing costs through mandated reforms (Figure 3). These include implementation of fully bundled prospective payment systems (14) and the launch of the first nationally mandated Medicare pay-for-performance program (known as the ESRD Quality Incentive Program [15]). The Centers for Medicare and Medicaid Services (CMS) and the Veterans Administration have broadened services to patients through telehealth and advance care planning. The Medicare Access and CHIP Reauthorization Act, which includes a Merit-Based Incentive Payment System, allows for Advanced Alternative Payment Models designed to enhance person-centered dialysis care delivered by ESRD Seamless Care Organizations (ESCOs) (16). The ESCOs represent a model whereby dialysis clinics and nephrologists join together to coordinate care, with shared financial incentives. More recently, the CMS, in part through the Center for Medicare and Medicaid Innovation, has proposed new payment models designed to encourage the use of home dialysis and transplantation (in essence making in-center hemodialysis the “treatment option of last resort”). The Kidney Care Choices Model is voluntary and expands care to include stage 4 CKD, and it incentivizes delaying the onset of dialysis as well as kidney transplantation. The ESRD Treatment Choices Model proposes required participation for 50% of Medicare beneficiaries with ESKD; however, implementation (initially scheduled for January 2020) is delayed pending issuance of a final rule. Thus, the regulatory/reimbursement policy is increasingly moving in the direction toward more comprehensive holistic care.

Figure 3.
Figure 3.

Timeline of the regulatory landscape changes for ESKD in the United States, 2008–2016. The figure shows key changes in the regulatory landscape for ESKD in the United States since 2008. The Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 established the current expanded prospective payment system (PPS) for reimbursement for the care of patients with ESKD in the United States. There have been no substantive changes in the regulatory landscape for ESKD in Canada over this period. CMS, Centers for Medicare and Medicaid Services; ESCO, ESRD Seamless Care Organizations; HHS, US Department of Health and Human Services; MAT, Measure Assessment Tool; QIP, Quality Incentive Program. Image credit: Matt Rivara, M.D.

Organization

In the 1960s, at the inception of outpatient dialysis, care was entirely delivered by nonprofit providers. Perhaps the greatest difference between the United States and Canada is the extent to which dialysis in the United States is now provided by for-profit companies (>90% of patients and facilities). Furthermore, two companies effectively constitute an oligopoly that dominates the market through purchasing power, active lobbying efforts with government and payors, and extensive economic reserves (17).

Overview of Dialysis Care in Canada

Payment

The Canadian federal government contributes approximately 20%–30% of the total health care cost; the ten provinces (and three territories) contribute the remainder, administer the funds, and are responsible for ensuring delivery of care (18,19). Most nephrologists are independent contractors paid by the provinces. The vast majority of hospitals and dialysis clinics are publicly funded and not for profit. All Canadians are eligible for publicly funded medical services, including dialysis.

Payment for physician services is generally fee-for-service, with incomes directly linked to the volume of services provided, although a minority of physicians are paid through a salary-like arrangement, typically in academic centers. In some provinces, physicians are paid for dialysis care as a bundled weekly fee (similar to capitation), whereas others tie payments to specific activities, like visits during dialysis. In some provinces, fees for physicians are substantially higher for in-center hemodialysis than for home hemodialysis or peritoneal dialysis. None of the provinces remunerate physicians for meeting performance targets.

Most provinces provide organized kidney care delivered by programs that are administered at the provincial or regional level and support the management of people treated with kidney replacement and/or with incipient kidney failure. The precise basket of services provided by the kidney programs as opposed to the remainder of the provincial health system varies between provinces. Payment to such programs is generally made as a transfer from the provincial health care plan; the amount provided is often linked to historical levels of payment (with adjustments for inflation and program growth), whereas some provinces use activity-based funding (20).

Finance

Health care is financed largely through provincial taxation and supplemented by federal transfers; there are no user fees or other charges for insured services (21). Outpatient prescription medications are not covered. Parenteral medications administered during hemodialysis treatments (e.g., intravenous iron) are typically covered by provincial or regional dialysis programs, although erythropoiesis-stimulating agents are not, often necessitating out-of-pocket payments. All or nearly all Canadians with kidney failure hold supplementary public or private health insurance against such payments, which often involves a copayment. The annual cost of care for ESKD in Canada has been estimated at Canadian $1.8 billion (6).

Regulation

Health facilities, including dialysis units, are chiefly regulated by national organizations, which administer standards related to technical aspects of dialysis. These regulatory bodies do not concern themselves with quality, cost, or delivery of care. There are national practice guidelines but no nationally agreed quality measures (22). The national dialysis registry reports a few performance metrics but not in a form that might identify individual providers or centers (23). There are no national audit and feedback programs aimed at nephrologists and no national initiatives to improve the quality of dialysis care. Some provincial renal agencies have implemented quality control measures (24,25), and most regional or local programs have protocols and/or quality targets for various aspects of dialysis care. However, in the absence of national programs, the need to produce standards at the local, regional, or provincial level leads to considerable duplication of work, and even when such standards exist, nephrologists generally have considerable autonomy regarding whether to participate or not.

Organization

In several provinces, agencies are responsible for central planning of kidney services (including dialysis), with considerable latitude to promote policy goals such as increased use of home dialysis and appropriate use of conservative care. In addition, nephrologists in Canada are supported by a universally funded primary care system, and primary care physicians increasingly partner with provincial or regional renal agencies to improve care of patients and in the prevention of kidney failure.

Utilization of Health Policy Levers to Improve Care

Policy Levers to Facilitate High-Quality Care

Using a Donabedian (26) construct (structure, process, and outcomes), the structural differences related to the dominant role for consolidated for-profit entities in the US market have likely contributed to the observed disparities in clinical outcomes. The data presented herein are consistent with this hypothesis, although they are on the basis of unadjusted comparisons. However, concerns that for-profit status leads to worse outcomes in the US hemodialysis population are not new: Relman and Rennie (27) raised this concern nearly 40 years ago. In addition to transnational comparisons, within the United States, many studies suggested that provider profit status is associated with differences in high-quality/high-value, person-centered care because survival, patient experience of care, use of home dialysis modalities, and access to transplantation are historically better in the Veterans Administration and in not-for-profit, smaller dialysis organizations (28–40). Moreover, US in-center hemodialysis has often focused primarily on treatment expediency and efficiency rather than on patient-centeredness (41).

A recent television report focused on historical dialysis practices at DaVita, Inc. (one of the two dominant dialysis providers in the United States), describing short treatment times/fast transition times, no attention to sterility procedures, under-referral to transplantation, and overuse of injectable medications (42) and detailing a number of large financial settlements made between DaVita, Inc. and the federal government over the past decade (43–45). When President Nixon signed the 1972 Social Security Amendments legislation enabling federal payments for ESKD, some form of universal health care was anticipated. We suggest that current policies should continue to emphasize incentivizing holistic and comprehensive care and that research should aim to identify quality indicators most closely tied to important patient outcomes. Consideration should also be given to selecting clinically relevant outcomes (e.g., infection rate and wait-listing for transplantation) as quality markers at the facility level, although this would require further study.

In contrast, despite appearing to deliver better outcomes at similar or lower cost compared with the United States, the Canadian health system consistently misses opportunities to capitalize on available policy levers benefiting patients on dialysis. In Europe, dialysis reimbursement is generally higher than in the United States or Canada (46,47), but this is often compensated for by active policies in favor of sustainable kidney replacement options (e.g., transplantation [Spain, France, and Belgium], peritoneal dialysis [Latvia and Denmark], or home therapies at large [Scandinavian countries]) (46,48). In Canada, mechanisms for finance and regulation often do not aim for key policy goals. Similarly, the considerable autonomy that Canadian practitioners enjoy makes it challenging for authorities to mandate change, and other mechanisms for encouraging provider behavior are also underused (49). The Canadian Society of Nephrology has formulated quality targets, but mechanisms enforcing or even measuring progress toward these goals are lacking. The federated structure of Canada’s health system makes coordinated innovation difficult (50)—the provinces and territories set their own health policy, without a mechanism for national regulation of dialysis care such as that in the United States. Although provincial renal agencies have made progress in certain areas of kidney care, these gains have not been universal, and lack of harmonization between the provinces seems to be a significant challenge for Canada. Canada has thus been aptly termed “a nation of pilot projects” (50), and effective policies or practices that are successfully deployed in one province are not necessarily used in any of the others. The innovative national policies related to kidney transplantation in Spain (which also must contend with the challenges of a federation) demonstrate that such challenges are not necessarily insurmountable (51,52).

Importantly, the numerous initiatives to assess and improve quality in the United States seem to be producing tangible benefits for mortality (Figure 1). Chief medical officers from both for-profit and not-for-profit US-based dialysis providers now meet to address modifiable and patient-oriented outcomes, such as assessment of extracellular volume and “dry weight,” which may lead to further reductions in mortality (53,54). Similarly, efforts to harmonize data-reporting elements for dialysis outcomes internationally will likely lead to further improvements in processes and outcomes. These data suggest an urgent need for cooperation among Canadian policy makers at all levels (national, provincial/territorial, and regional) to scale and spread effective policies between jurisdictions.

In both the United States and Canada, quality assessment and benchmarking tools for providing high-value care could be improved. Benchmarking has been instrumental for promoting transplantation in Spain and informing patients on all kidney replacement options in The Netherlands. Historically, many of the systematically collected quality indicators mandated in the United States by the CMS, such as urea clearance or blood hemoglobin, have marginal or complex nonlinear associations with outcomes. Moreover, evidence from well-designed and well-powered randomized clinical trials is unfortunately lacking (55). Finally, the patient experience, whether assessed as overall health–reported quality of life, overall patient satisfaction, or relief of symptom burden or via the development of validated instruments for patient-reported outcomes (56), has not been sufficiently emphasized or tied to payment, finance, or regulation in either country. Although there is limited evidence from kidney populations specifically that such benchmarking will improve outcomes, there is a large body of evidence indicating that “what gets measured, gets done,” which in turn suggests that efforts to develop, measure, and report appropriate metrics will lead to improvements in patient-important outcomes.

Policy Levers to Facilitate Appropriate Treatment Modality Selection

When feasible (often on the basis of available family and social support), home dialysis has intrinsic advantages for maintaining patient autonomy and sense of well-being. Because home therapies are usually less costly (6,57,58), Canadian and US dialysis programs have some incentive to offer and promote these modalities to patients. There are further opportunities to increase use of the most appropriate dialysis modality by implementing activity-based funding for home dialysis programs, enhancing patient education about options for dialysis modality, publicly reporting the proportion of patients receiving each modality by center, and increasing payments for home hemodialysis and peritoneal dialysis (59–62). However, the considerable autonomy of nephrologists in both countries, coupled with the lack of comfort among US nephrologists due to limited training and education in home dialysis management, reduces the potential to achieve this objective. A program that lacks a champion for home therapies and appropriate education is far less likely to have a high proportion of patients using home modalities. Therefore, there may be potential benefits of US-based programs that incentivize or require facilities to offer a blend of dialysis modalities and to provide educational support to enhance care provider comfort with managing home therapies. Finally, some evidence suggests that addressing the costs and inconvenience that home dialysis poses for patients and families may help to increase the use of home dialysis, and therefore, policies that address these barriers are worth considering, such as nursing support or small financial rebates to defray the costs of dialysis-related water and electricity (63,64).

Conservative management is an important option for patients with kidney failure that is likely underused (65). Supporting patients and families through this process is complex and time consuming, and it is not well reimbursed. To increase appropriate use of conservative care, payments for family meetings, prolonged consultations, and palliative and hospice care should be increased in both countries.

Utilization of Transformative Policy Levers

Advances in dialysis technologies that characterized the 1960s and early 1970s were followed by stagnation, perhaps related to the expansion of fixed “brick-and-mortar” facilities and payment entitlements for “doing the same thing the same way” in both countries. As a consequence, the US Food and Drug Administration, the Kidney Health Initiative (66), the US Department of Health and Human Services, and strategic philanthropic organizations (67) have recognized that important potential policy levers exist to facilitate transformative/disruptive technologic advancements (Figure 3). In 2018, the US Department of Health and Human Services and the American Society of Nephrology formed the Kidney Innovation Accelerator (KidneyX) as a partnership to accelerate innovation in the prevention, diagnosis, and treatment of kidney disease. In April 2019, KidneyX announced winning solutions to a Redesign Dialysis Phase 1 design competition for prototype solutions to technical dialysis challenges. In July 2019, the Trump administration released a report (68) and signed an Executive Order on Advancing American Kidney Health (69). This initiative lays out a blueprint and timelines that include specified targets for increasing access to kidney transplantation and home dialysis and steps to promote the development of new forms of wearable or implantable artificial kidneys in lieu of conventional dialysis. The latter efforts represent a dramatic attempt to catalyze new types of vascular access, miniaturized and wearable or implantable dialysis devices, and hybrid devices that contain human kidney cells. Given the high costs and relatively poor clinical outcomes using contemporary technology, these remarkable efforts should similarly be catalyzed in all countries through supportive public policies, including the development of precompetitive public-private partnerships with medical device and biotechnology accelerators. To foster dynamic breakthroughs in dialysis and other treatments for kidney disease, these initiatives can follow the recently described Technology Roadmap for Innovative Alternatives to Renal Replacement Therapy, created by the Kidney Health Initiative (66), or the Dutch Beating Kidney Disease program. Such innovative efforts should be similarly catalyzed in as many countries as possible. These might include but should not be limited to prevention, regenerative and personalized medicine, and patient quality of life.

Summary

In Donabedian (26) terms, the structure of consolidated for-profit dialysis care in the United States seems to have historically contributed to worse outcomes at higher costs compared with dialysis in Canada, although between-country differences in access to predialysis care, the quality of primary care, or the social determinants of health could also have played a role. However, in recent years, care delivery in the United States has been increasingly influenced by regulatory reforms and incentives to improve comprehensive care that have relatively advantaged patients in the United States—and the CMS is moving rapidly away from fee-for-service (volume-based) care toward value-based purchasing. As a result of payor pressures coupled with increasingly collaborative activities among physician leaders in dialysis organizations, disparities in transnational outcomes (as well as between for-profit and not-for-profit providers within the United States) have progressively narrowed over the past decade.

Moving forward, patients in Canada could benefit from less regulatory parsimony and a national effort to adopt and scale effective policies from other jurisdictions—including the United States. Patients in the United States should benefit from supporting ongoing initiatives to improve current care paradigms through continued health services innovation, particularly as the plans for the Advancing American Kidney Health initiative are implemented. Patients in both countries would benefit from changes to payment and regulation that incent appropriate modality selection and conservative care for patients with incipient kidney failure, from continued efforts to reduce the burden of kidney failure by effective upstream preventive strategies, and from implementation of policies that facilitate disruptive technologic innovation in dialysis care while also promoting appropriate use of home therapies and kidney transplantation.

Disclosures

J. Himmelfarb is a founder and holds equity in AKTIV-X Technologies. The Kidney Research Institute and the Center for Dialysis Innovation at the University of Washington, directed by J. Himmelfarb, have received gift and grant support from the Northwest Kidney Centers, a not-for-profit dialysis provider. The Center for Dialysis Innovation has received a Phase 1 prize from KidneyX and a grant from the Veterans Administration. M. Tonelli received a lecture fee from B. Braun, which was donated to charity. R. Vanholder has been a consultant to Baxter Healthcare, B. Braun, and Neokidney, a Dutch Kidney Foundation initiative.

Funding

M. Tonelli is funded by Canadian Institutes of Health Research Foundation Award and Canada Foundation for Innovation Leaders Opportunity Fund.

Supplemental Material

This article contains the following supplemental material online at http://cjasn.asnjournals.org/lookup/suppl/doi:10.2215/CJN.14961219/-/DCSupplemental.

Supplemental Table 1. Items included in the Centers for Medicare and Medicaid Services ESKD prospective payment system (expanded bundle).

Supplemental Table 2. Physician monthly capitated payment requirements for the Centers for Medicare and Medicaid Services in the United States.

Footnotes

  • Published online ahead of print. Publication date available at www.cjasn.org.

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Health Policy for Dialysis Care in Canada and the United States
Marcello Tonelli, Raymond Vanholder, Jonathan Himmelfarb
CJASN Nov 2020, 15 (11) 1669-1677; DOI: 10.2215/CJN.14961219
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