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Accountable Care Organizations and ESRD: The Time Has Come
World Kidney Forum Accountable Care Organizations and ESRD: The Time Has Come Allen R. Nissenson, MD,1 Franklin W. Maddux, MD,2 Ruben L. Velez, MD,3 Tracy J. Mayne, PhD,1 and Jess Parks, MBA1
WKF Advisory Board John T. Harrington, MD Boston, Massachusetts Rashad S. Barsoum, MD Cairo, Egypt Christopher R. Blagg, MD Mercer Island, Washington John Boletis, MD Athens, Greece Garabed Eknoyan, MD Houston, Texas Tazeen H. Jafar, MD, MPH Singapore Nestor Schor, MD, PhD São Paulo, Brazil
D
espite advances in kidney care processes and research, patients with end-stage renal disease (ESRD) receiving dialysis continue to experience high rates of morbidity and mortality and poor quality of life.1-5 Although mortality rates in dialysis patients have decreased over the past 20 years, they remain much higher From 1DaVita Inc, Denver, CO; 2Fresenius Medical Care North America, Waltham, MA; and 3Dallas Nephrology Associates, Dallas, TX. Received October 17, 2011. Accepted in revised form February 19, 2012. Originally published online March 29, 2012. Address correspondence to Allen R. Nissenson, MD, DaVita Inc, 601 Hawaii St, El Segundo, CA 90245. E-mail: allen. [email protected] © 2012 by the National Kidney Foundation, Inc. 0272-6386/$36.00 doi:10.1053/j.ajkd.2012.02.004 724
Accountable care organizations (ACOs) are a newly proposed vehicle for improving or maintaining high-quality patient care while controlling costs. They are meant to achieve the goals of the Medicare Shared Savings Program mandated by the Patient Protection and Affordable Care Act (PPACA) of 2010. ACOs are voluntary groups of hospitals, physicians, and health care teams that provide care for a defined group of Medicare beneficiaries and assume responsibility for providing high-quality care through defined quality measures at a cost below what would have been expected. If an ACO succeeds in achieving both the quality measures and reduced costs, the ACO will share in Medicare’s cost savings. Health care for patients with end-stage renal disease is complex due to multiple patient comorbid conditions, expensive, and often poorly coordinated. Due to the unique needs of patients with end-stage renal disease receiving dialysis, ACOs may be unable to provide the highly specialized quality care these patients require. We discuss the benefits and risks of a renal-focused ACO for dialysis patients, as well as the kidney community’s prior experience with an ACO-like demonstration project. Am J Kidney Dis. 59(5):724-733. © 2012 by the National Kidney Foundation, Inc.
than in the nondialysis population.2,3 The all-cause mortality rate for prevalent dialysis patients 65 years and older with Medicare was about 7 times higher than for nondialysis individuals in 2009.6 Dialysis patients continue to experience frequent, lengthy, and costly hospitalizations. In 1993-2009, the hospitalization rate remained steady at an average of 1.9 hospitalizations per year, totaling about 12 days per year.6 Such a poor outcome may be attributed in large part to high patient acuity and complexity and a fragmented care delivery system. One result of this fragmentation is that in 19951998, a total of 69% of patients required hospitalization to start dialysis therapy, leading to higher costs, additional stress on patients, and increased burden on the health care system.7 Although patients with ESRD make up ⬍1% of the Medicare population, they consume a disproportionate 6.7% of the total Medicare budget, excluding Medicare Part D.6 In 2009, the approximately 571,000 patients
with ESRD in the United States cost Medicare $29.1 billion. Despite these high costs to individuals and society, early referral to nephrologists and increasing the proportion of planned dialysis therapy starts can reduce emergency dialysis starts, catheter use, and mortality rates.8-10 In addition to early chronic kidney disease (CKD) referrals, care coordination for the ESRD population has been shown to improve outcomes and control costs in the ESRD demonstration projects.11-13 The Centers for Medicare & Medicaid Services (CMS) has recently established a new vehicle for improving outcomes and controlling costs: the accountable care organization (ACO).15,16 ACOs provide a potential to change the provision of health care, but the current structure will miss some of the most severe chronically ill patients, including patients with ESRD. Although the ACO concept generated significant interest, the details have left many disappointed and raised a number of questions. Am J Kidney Dis. 2012;59(5):724-733
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What is an ACO? What role do they play in health care reform? What about recent court challenges to the health care reform laws? How will an ACO work? What are the implications for renal patients? What about a renalfocused ACO? How will nephrologists and other dialysis providers fit into this new paradigm?
WHAT IS AN ACO? An ACO is a network of health care providers that assumes joint accountability for coordinating and delivering efficient and high-quality health care while slowing the growth of health care costs. The goal of ACOs is to integrate and align the quality of care with the payment system, thus inserting performance risk into the financial incentives of the payment methodology. One key aspect that differentiates the ACO model from others is that the ACO model, according to the American Hospital Association, “fosters accountability for care and costs by offering a joint payment to all providers involved with the provision of care.”16(p5) ACOs differ from health maintenance organizations (HMOs) in a number of important ways. ACO patients are free to choose their providers, do not have to change their insurance, and can stay in the Medicare program. HMOs receive capitated payments, whereas ACOs do not receive capitated payments. Instead, every provider is still paid through the fee-forservice Medicare program and costeffectiveness is incented by adding performance-based payments for desired clinical outcomes. The ACO concept has been included in national health care reform legislation (Patient Protection and Affordable Care Act [PPACA]),17 with certain organizational and operational modiAm J Kidney Dis. 2012;59(5):724-733
fications for Medicare. This discussion of ACOs will reflect the specific aspects of the Medicare ACO model.
WHAT ROLE DO ACOs PLAY IN HEALTH CARE REFORM? In 2009, a total of 46.3 million (15.4%) Americans were uninsured, 201.0 million (66.7%) were privately insured, and 87.4 million (29.0%) were covered by government health insurance.18 Of those covered by the government, 42.6 million (14.1%) were covered by Medicaid and 43.0 million (14.3%) were covered by Medicare. Medicare is available for Americans older than 65 years, and in 1972, a special entitlement was enacted covering people of all ages with ESRD.19 Medicare covers both dialysis treatments (with waiting periods for those younger than 65 years and/or covered by commercial insurance) and transplant procedures. Unfortunately, Medicare’s reimbursement system for dialysis has both gaps in coverage and payment-structure issues. For example, although the goal of the Fistula First Breakthrough Initiative, a project created in partnership with the CMS, is to increase arteriovenous fistula use in incident and prevalent hemodialysis patients, Medicare does not cover this procedure for patients younger than 65 years who have not yet started dialysis therapy. Therefore, patients younger than 65 years are not eligible to receive vascular access services from Medicare in preparation for transitioning to dialysis therapy.20,21 The result is a high prevalence of central venous catheters used at the start of dialysis therapy. The structure of the Medicare payment system is problematic.
Currently, most Medicare payments are based on a fee-forservice model, which may result in fragmentation of care. Under fee for service, each health care provider is paid for their services, and this may function as an economic disincentive for collaboration between providers (including hospitals) because fee-for-service pays providers for performing procedures, ordering tests, and prescribing drugs, but not for providing preventative or pre-emptive care. This may result in lower costs to the Medicare program for each disease episode, but also lower revenues to providers. In addition, the Medicare payment system is split into hospital-based care (Medicare Part A) and outpatient/physician care (Medicare Part B). This division inhibits innovation in preventative care (reimbursed under Part B) because it generally is not reimbursed, while the benefits are accrued to Part A in the form of lower hospitalizations. The irony is that the latter would be sufficient to fund the former, but this is not permitted in the fee-for-service Medicare paradigm. The potential disadvantages of the fee-for-service model, coupled with increasing costs, have led to the consideration of alternative models. Kidney disease has been on the forefront of these reform efforts through the CMS ESRD Demonstration and Medicare Care Management for High Cost Beneficiaries Demonstration programs and through federally mandated payment systems. Congress passed the Medicare Improvements for Patients and Providers Act of 2008, mandating that a prospective payment system for dialysis be implemented in phases beginning in 2011.22 The prospective payment system combines separately bill725
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with the first ACO agreements to start April 1 and July 1, 2012.
WHAT ABOUT THE CONSTITUTIONALITY OF THE PPACA? The existence of ACOs hinges on the constitutionality of the PPACA. More than half of the 50 states have filed a suit challenging the act. The primary focus of the challenges is the constitutionality of what is called the “individual mandate,” requiring that all citizens be covered by health insurance and allowing penalties for those who choose not to be covered. To date, 7 district courts have ruled on the PPACA (see Fig 1).29 The Supreme Court is expected to rule on the PPACA by June 2012. The Supreme Court can rule that any individual section or the entire PPACA is constitutional or unconstitutional. With the elections soon after, this decision has significant political ramifications. Middle District of Pennsylvania Individual mandate and pre-exisng condions unconstuonal Eastern District Court of Virginia Individual mandate unconstuonal Western District Court of Virginia Individual mandate constuonal
There is equipoise as to whether the Supreme Court will rule that the PPACA is constitutional or unconstitutional. If the latter, then the legislative mandate behindACOs will disappear. It is impossible to know how a new Congress would legislate this issue or how the CMS would grandfather ACOs that had already come into existence.
HOW WILL AN ACO WORK? ACOs are collaborations between groups of health care professionals that are eligible to receive incentives from the government based on achievement of care quality standards and reductions in the total cost of care for the particular ACO’s patient population. According to McClellan et al,30 ACOs can be defined by 3 key principles: (1) Provider-led organizations with a strong base of primary care that are collectively accountable for quality and total per capita costs across the full continuum of care for a popula-
3rd Circuit Court No Decision
4th Circuit Court Lack of jurisdicon
District Court of DC Individual mandate constuonal
DC Circuit Court Individual mandate constuonal
Eastern District Court of Texas Prohibing expansion of physicianowned hospitals constuonal
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Eastern District Court of Michigan Individual mandate constuonal
6th Circuit Court Individual mandate is constuonal
Northern District Court of Florida Individual mandate unconstuonal Enre PPACA unconstuonal
11th Circuit Court Individual mandate unconstuonal Remaining PPACA constuonal
No Decision
Supreme Court
able services into a single adjusted base rate and provides a quality incentive adjustment, effectively creating Medicare’s first system of pay for performance.23-25 This quality incentive adjustment, the ESRD Quality Incentive Program, will be implemented in 2012 using claims-based quality metrics to withhold up to 2% of a clinic’s payment for not meeting a set of standards based on 2010 performance; quality metrics may be adjusted annually.26 Although this payment system addresses costs by tying payments to quality metrics, it does not address the disjointed structure of health care delivery. Economic model research has suggested that the integration of health care delivery could reduce costs and improve quality, and ACOs have been touted as models of integrated care programs.27 The ACO health care model will soon be tested on a national level. On March 23, 2010, the PPACA was signed into law and initiated a new phase of health care reform.17 Section 3022 of the PPACA created the Medicare Shared Savings Program to “promote accountability for a patient population and coordinate items and services under [Medicare] part A and B, and encourage investment in infrastructure and redesigned care processes for high quality and efficient service delivery.”17(p277) Specifically, the PPACA directs the Department of Health and Human Services to use ACOs to implement an integrated care delivery system. The Department of Health and Human Services updated the initial guidelines published in March 2011 after extensive public comment; final rules for establishment of ACOs were published in November 2011.14,28 The program was established on January 1, 2012,
Figure 1. Current and pending federal court decisions regarding the Patient Protection and Affordable Care Act (PPACA). Adapted from Cauchi.29 Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum tion of patients. (2) Payments linked to quality improvements that also reduce overall costs. (3) Reliable and progressively more sophisticated performance measurements, to support improvement and provide confidence that savings are achieved through improvements in care.30(p983)
Other important aspects of ACOs include the use of electronic health records and health information exchanges and promotion of evidence-based medicine and patient centeredness. Under the PPACA, the CMS will determine to which ACO patients are assigned based on a quarterly preliminary prospective assignment method. At the end of each performance year, the CMS will complete a final reconciliation based on the patients served by the ACO using claims data. Beneficiaries who received at least one primary care service from a physician will be assigned the physician with the plurality of primary care service code charges for the beneficiary; this is designated the patient’s “primary care physician.” For beneficiaries who have not received primary care physician services, the plurality of allowed charges for primary care services provided by any other ACO professional will be used in the assignment process. The goal is to provide an incentive for ACOs to enhance the quality of care for all patients served by its health care providers. Under the PPACA rules, if the total costs of the care are less than the target amounts set by the CMS for any given period, the ACO receives a portion of the savings generated, assuming prespecified quality metrics are met. If the total costs are greater than the target amount, the ACO pays back a portion of the excess costs.28 For each 3-year ACO agreement, the ACO Am J Kidney Dis. 2012;59(5):724-733
will be able to choose to participate in 1 of 2 payment options.31 In the more conservative “1-sided” risk option, ACOs would be eligible for only the shared savings in the 3 years. In the more aggressive “2-sided” risk option, ACOs would be accountable for repaying a portion of excess cost in the 3 years, but would also be eligible to receive a greater percentage of the shared savings (60% vs 50% in the 1-sided option). For both risk options, the ACOs will receive shared savings when the minimum savings rate has been achieved. Importantly, quality performance measures are linked to financial incentives. The CMS implemented 33 quality measures for making assessments, setting benchmarks, and rewarding quality performance. The quality measures include the following: (1) Patient/Caregiver Experience (7 measures), (2) Care Coordination/ Patient Safety (6 measures ⫹ double-weighted electronic health record measure), (3) Preventative Health (8 measures), and (4) AtRisk Population/Frail Elderly Health (12 measures). Benchmarks, based on the fee-for-service or Medicare Advantage rates, will be set before the start of each annual performance period. The eligibility of the ACO for shared savings and the percentage of shared savings the ACO receives will be based on overall ACO quality scores in relation to the benchmarks. In the first year, ACOs will be paid for reporting quality measures; in subsequent years, ACOs will be paid for reporting and their performance on quality measures. Quality measure improvements are based on institutions’ historic spending and quality data, which may penalize efficient providers and areas of the country. The performance
risk leading to shared savings will have to evolve into more bundled or capitated models of payment over time as rebasing occurs and limited shared savings are available. The Medicare Shared Savings Program approach highlights one of the key criticisms of HMOs. Although HMOs typically have capitated payments, they have been criticized for sacrificing quality of care for cost savings. Policymakers believe the ACO model addresses some of these issues.16 Although the evidence is limited, pilot programs testing the payment and health care delivery initiatives in the ACO model suggest that ACOs may succeed where HMOs have failed. The Physician Group Practice (PGP) Demonstration was a shared savings pilot program modeling an ACO. Although the providers continued to receive fee-for-service payments, they were held accountable for costs and quality measures. PGP participants performed well on the quality metrics, with increased quality scores in diabetes, heart failure, coronary artery disease, cancer screening, and hypertension.32 All providers during their fourth year showed improvements in 29 of the 32 measures. Unfortunately, cost savings were more difficult to achieve, with only 2 of 10 PGP participants exceeding the 2% savings threshold in the first year of the demonstration. By year 4 of the program, 5 of the 10 participating providers reduced costs enough to receive a shared savings payment. Although the number of PGP participants reaching the 2% savings threshold was disappointing, a total Medicare savings of $38.7 million was achieved in the first 4 years of the program.33 The quality results from the PGP participants are laudable, but the savings 727
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results are a cause for concern. The Brookings Institution/Dartmouth Institute for Health Policy & Clinical Practice, the Robert Wood Johnson Foundation, Baylor Health System, and Premier Health Care Alliance are currently piloting ACO programs that will provide more information on better ways to implement and execute ACOs. Questions remain about how the ACOs will be implemented, if patient assignment will work, if shared savings are realistic, and if this reform can improve quality of care for patients with special conditions. The PPACA suggests that physicians and providers instead of insurers or hospitals play a fundamental role in the management of ACOs; the CMS regulations further support this. The amount of money that will be saved also is unknown. The Congressional Budget Office predicted the ACO Medicare Shared Savings Program would reduce Medicare expenditures $4.9 billion from 2013 through 2019.34 Although the Congressional Budget Office predicted a hefty savings and the PGP Demonstration yielded a net savings for Medicare, only half the pilot programs received a shared savings payment and therefore it is unclear whether the savings and quality of care are sustainable nationwide. This is an inherent feature of layering the ACO on top of a fee-for-service model. One main distinction between the old capitation and gatekeeper model that failed is patient choice. An ACO will assume some risk of a patient choosing to go out of the ACO’s network. This may be a benefit to patients who have established relationships to a particular provider, but clearly decreases the ability of the ACO to 728
control unnecessary or inappropriate care. Fragmented health care and the continued increase in health care costs are problems that patients, physicians, hospitals, insurers, and the government hope to correct, but it will take large system-wide changes in fundamental assumptions of how we provide health care in America for this to happen. The current health care reforms at both the state and national levels are bold attempts to make these changes. In this setting, it is important to consider the complex needs of patients on dialysis therapy and the special skills of nephrologists and dialysis care teams.
WHAT ARE THE IMPLICATIONS FOR RENAL PATIENTS? Given the deficiencies in the feefor-service health care system, poor management of care transitions, and the required ongoing and highly specialized care this vulnerable population requires, dialysis patients will benefit greatly if ACOs are implemented in the right way and be harmed if they are not. Unfortunately, the low overall prevalence of dialysis patients and lack of expertise and experience in dialysis care in primary-care focused ACOs may lead to suboptimal care. Also, ACO rules may inhibit the nephrologist from continuing to be the primary care physician for dialysis patients. Most hospitals and primary care networks do not have sufficient knowledge and experience working with dialysis patients to provide the high-quality and innovative care dialysis patients require. Also, because patients with ESRD would likely represent ⬍1% of an ACO’s assigned population and these patients would be broadly dispersed across the ACO’s catch-
ment area, it is unlikely that each ACO would operate efficiently and have conveniently located dialysis centers exclusively for its patients. Instead, individual ACOs may try to transfer accountability to kidney care providers. A single dialysis facility could be partnering with multiple ACOs. This mixed population would require care providers to follow 2 systems of care and medical record keeping: those of the ACO and those of the kidney care providers. ACO-led initiatives might apply to only a few patients in the dialysis facility and conversely, kidney care provider– led initiatives may not be endorsed by ACO-authorized processes of care. Treating patients differently within a single dialysis facility could lead to confusions, inefficiencies, and inhibition of innovative processes of care by both the dialysis provider and the ACO. The prospective payment system recently was implemented for dialysis patients with payments tied to quality measures instead of the traditional fee-for-service model. If dialysis facilities served both typical Medicare beneficiaries and patients within an ACO, they would be responsible for reconciling payments under 2 structures that are each tied to 2 separate sets of quality metrics, resulting in an excessive bureaucratic burden.
WHAT ABOUT A RENAL-FOCUSED ACO? Because of the high cost of dialysis and the complex comorbidities of ESRD, patients with ESRD may be undesirable to ACOs. A compelling alternative would be to form a renal-specific ACO based on the general ACO model to put nephrologists and dialysis centers at the hub of a redesigned kidney Am J Kidney Dis. 2012;59(5):724-733
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care delivery system. Initially, we suggest including only dialysis patients and then eventually expanding to include patients with latestage progressive CKD. In a renal care model of an ACO, the nephrologist would be a “principal” care provider coordinating the overall activities, but would not have the plurality of primary care service codes. The nephrologists’ role in a renal ACO would serve as the accountable “principal” care physician, who is responsible for coordinating care with the primary care physician and other subspecialists, providing preventative care, monitoring care, and overseeing quality measure reporting. It is possible that renal ACOs may operate with fewer than the specified 5,000 patients or be spread across a network of kidney care providers due to the relatively low incidence of kidney disease. Renal ACOs might have kidney-specific clinical performance measures that could replace some of the typical quality measures that are not necessary for a population with such a high mortality rate. The current renal care delivery systems within the United States provide a perfect opportunity to test a disease-based ACO given the vulnerability of the patients, low incidence rate of kidney disease, sheer size and cost of dialysis and kidney transplant, currently recognized gaps in the fee-forservice and now prospective payment systems, defined nature of renal replacement therapy, and experience with ACO-like programs in CMS demonstrations by the nephrology community. Potential concerns over cherry-picking patients and inappropriate control by large dialysis organizations would have to be addressed carefully in the plan. Experienced nephrologists understand the importance of distinAm J Kidney Dis. 2012;59(5):724-733
guishing key patient cohorts (CKD, incident ESRD, and prevalent ESRD) and the unique clinical and financial challenges of caring for patients with ESRD because of the complexity and common comorbid conditions. The needs of patients at different stages of their kidney disease vary, and there is a growing body of evidence to support the idea that identifying the patient who is at high risk of progression of kidney disease, appropriate nephrology referral, timely preparation for renal replacement therapies, and attention to the physiologic effects of the kidney disease lead to better end point outcomes when measuring processes of care and clinical results.35-37 Often, when patients begin dialysis therapy, they are in poor health and “crash” into dialysis with a catheter for vascular access and have little information or understanding of what lies ahead. Many dialysis provider–led programs and processes for incident patients with ESRD have been effective in improving health outcomes and quality of life as patients adjust to dialysis. For example, programs such as RightStart by Fresenius Medical Care and IMPACT (Incident Management of Patients, Actions Centered on Treatment) by DaVita have been shown to reduce morbidity and mortality in patients enrolled in the program.38,39 These programs are examples of how to improve coordination and care, but could be lost in a general ACO. However, these are examples of programs that a renal ACO could use and deploy throughout the ACO, improving outcomes and decreasing costs of care. Within a general ACO, there may be too few patients with ESRD in the ACO to make such renal-focused programs
fiscally sound. Thus, the most critical advantage of the renal ACO is the scale advantage of using the facility as the point of assignment. According to an internal DaVita analysis, there is sufficient scale to economically re-engineer care processes and improve patient outcomes with 70% or more of a facility’s patients participating. Patients with ESRD are a vulnerable population in need of continuous care coordination, including management of dietary and fluid intake, medication use, infection-risk mitigation, renal replacement therapies, and comorbid conditions. Patients have on average more than 3 comorbid conditions and about 8 drug prescriptions and are in frequent contact with health care providers.40 Despite continued improvements in ESRD care, mortality rates are about 7 times higher for dialysis patients than the general Medicare population.41 Patients with ESRD were hospitalized 1.9 times per patient year and averaged 11.8 hospital days per patient year in 2009.6 These issues could negatively affect the quality measures that ACOs must achieve to receive their maximum payments. Finally, kidney disease itself is different from other chronic disease states because it is a well-defined disease with no ambiguity about who has ESRD. When diagnosed, patients are staged within a continuum of kidney disease and those destined to progress toward ESRD will require dialysis, kidney transplant, or palliative therapy. The characteristics of CKD, with its well-defined path from CKD to ESRD, make it a natural fit for a renal-specific integrated-care model such as an ACO. Perhaps more importantly, large dialysis providers have successfully demonstrated ACO-like integrated patient-centered care delivery in 729
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CMS demonstration projects. The most recent demonstration project is discussed next.
THE ESRD DEMONSTRATION PROJECT In 2006, CMS initiated a 5-year ESRD Management Demonstration.42 The goal of the demonstration was to study the impact of delivering integrated care to dialysis patients on clinical outcomes and Medicare costs. In anticipation of the structure and processes of ACOs, the groups within the demonstration assumed the risk for the total cost of care for enrolled patients by receiving capitated risk-adjusted payments from CMS. Three Disease Management Organizations (DMOs) participated in the demonstration. DMOs are networks of health care providers administering a system of coordinated health care interventions with significant patient self-care efforts.43 All DMOs focused on a series of common elements and each DMO developed its own programs to deliver coordinated care while managing the dialysis-specific issues of anemia, bone and mineral disease metabolism, and vascular access management. They also integrated patient education and disease management programs for diabetes and cardiovascular disease. Each DMO also selected additional problems to target unique interventions. Arbor Research Collaborative for Health and the Lewin Group provided independent analyses of the results. The complete Arbor report11 and DMO commentary and comment by participating physicians have been published.12,13 The demonstration was evaluated on its ability to improve hospitalization and mortality outcomes, quality of life, and patient satisfaction in a cost-effective man730
ner. The DMOs designed interventions to achieve these common goals. These interventions included coordination of care between physicians and nurses, in-hospital follow-up and discharge planning, focus on optimizing vascular access, protocols for management of anemia and bone and mineral disease, patient education, advanced care directives, and management of diabetes and cardiovascular disease. The cost of expanding the care team by adding case managers, call centers, and additional upfront resources necessary for the interventions was balanced against the savings achieved from reducing expensive hospitalizations. The strategies used by all DMOs were compared with those unique to a single DMO to understand which components lead to improved processes of care. Each DMO was able to modify and enhance their care processes throughout the demonstrations to enhance the effectiveness and efficiency of the integrated care process and reduce fragmentation of health care delivery. According to the Arbor report (Box 1), survival rates were higher in 2 of the 3 DMOs in the first year of the demonstration compared with fee-for-service. One DMO had significantly fewer all-cause and cardiovascular-related hospitalizations compared with fee-forservice. The oral nutritional supplementation initiative by one DMO was associated with a significant reduction in mortality at 1 year. Vascular access improvements were noted in all DMOs; catheter rates in the DMOs were 8% compared with 18% reported by the US Renal Data System (USRDS) 2007 Annual Data Report.12 Immunization rates for influenza and pneumococcal vaccines far exceeded the USRDS average. Dia-
Box 1. Arbor Evaluation of the ESRD Disease Management Demonstration Project This ESRD Disease Management Demonstration represented a unique opportunity to identify improvement in clinical outcomes in a population that is ideally suited for Disease Management. We observed significant survival benefit in this notably fragile and complex patient population. Additionally, at least one DMO demonstrated improved metrics in evaluating hospitalization outcomes, including improved time to first all-cause and cardiovascular hospitalization, and hospital admission rate over time. In addition, utilization of other costly services including SNF stays and outpatient physician visits were consistently reduced in the DMOs as compared to FFS. These findings translated to cost savings which were considerable in at least one participating DMO. Although there was no clear impact of Disease Management on improving QoL, patients and providers expressed satisfaction with their experiences with the Disease Management Demonstration. We believe our findings merit consideration in the ongoing assessment of the value of Disease Management. Finally, one related approach, among others, that may have benefits for this population is the Accountable Care Organization (ACO). Note: Analysis based on the first 3 years of the 5-year ESRD demonstration project. Abbreviations: DMO, Disease Management Organization; ESRD, end-stage renal disease; FFS, fee-for-service; QoL, quality of life; SNF, skilled nursing facility. Reproduced from Arbor Research Collaborative for Health.11(p117)
betic care and medication adherence also improved (Table 1). Importantly, patients reported a high level of satisfaction with the ESRD program across all DMOs and at every time point. As Nissenson et al12 concluded, “The fact that patients reported a high degree of satisfaction with their healthcare delivery during this project is an important component of the program’s effectiveness.”44(p41) Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum Table 1. Dialysis Care Measures, Hospitalization, and Mortality by Demonstration Project Participants Versus US Norms Disease Management Organization Metric
A
B
C
Benchmark
Vascular access rates (%) Fistula Graft Catheter
56 36 8
48 42 10
55 39 6
55a 27a 18a
Immunization rate (%) Influenza Pneumococcal
90 60
—b —b
—b —b
57c 20c
Diabetes care (%) Retinal examination Podiatric examination
65 80
—b —b
—b —b
48d 70d
Hospitalization (/member/y) Hospital admission Hospital readmissions Emergency department visits
1.74 0.64 1.05
1.85 0.72 1.57
1.82 0.64 1.48
1.89c NAc NAc
Adjusted survival (%) 1y 2y
88.0 73.5
91.2 80.9
90.7 80.1
79c NAc
—b
—b
16.2
23.4f
—b —b —b
—b —b —b
0.83-0.86 0.55 0.82
—h —b —b
Annualized mortality of patients receiving oral nutritional supplementse Home weight monitoringg Clinically important IDWG All-cause mortality All-cause hospitalization
Abbreviations: NA, not applicable; USRDS, US Renal Data System; IDWG, interdialytic weight gain. Modified and reproduced with permission from Nephrology News & Issues.13 a Based on USRDS (www.usrds.org) data from 2007, the last year for which this information was available. b Not assessed. c Based on USRDS data from 2008. d Based on DOPPS (Dialysis Outcomes and Practice Patterns Study; www.dopps.org) data from 2008. e Patients with albumin level ⬍3.8 g/dL. f Based on 2006 End-Stage Renal Disease Clinical Performance Measures data (www.cms.gov/CPMProject). g Odds ratio, relative risk, or hazard ratio of indicated outcome in those who had home weight monitoring versus those who did not. h Data not available in USRDS 2010 Annual Data Report.
HOW WILL NEPHROLOGISTS AND OTHER DIALYSIS PROVIDERS FIT INTO THIS NEW PARADIGM? Nephrologists already treat patients in ways that fit with the Am J Kidney Dis. 2012;59(5):724-733
ACO model. Nephrologists treat kidney disease as well as multiple comorbid conditions in patients with ESRD; thus, many already serve as principal care physicians. The patient-centered medical
home, which defines and uses the concept of principal care physicians and the ability of specialty practices to serve as medical homes, is suggestive of a dialysis facility. The kidney community’s experience with “bundled payments” under the prospective payment system and the ESRD demonstration project has spurred innovations in processes of care. Preventive care in the form of immunizations, noncatheter vascular access, diabetic care, home weight monitoring, and oral nutritional supplements are key components currently being tested. Finally, nephrologists regularly work with varied members of the care team (eg, dietitians, social workers, nurses, and patient care technicians) and other physicians (eg, vascular surgeons, endocrinologists, cardiologists, and general practitioners) to coordinate the care of dialysis patients. Functioning as de facto principal care physicians, collaborating with other subspecialties, balancing multiple clinical opinions and competing comorbid conditions, directing care teams that have weekly direct contact with patients, leading interdisciplinary teams, and directing quality management efforts are key roles of the ACO primary care physician that nephrologists already perform. Unfortunately, PPACA and CMS regulations preclude renal-specific ACOs. Only the following providers are eligible to form ACOs: ACO professionals (eg, physicians, physician assistants, nurse practitioners, and clinical nurse specialists) in group practices, networks of individual practices of ACO professionals, partnerships or joint venture arrangements between hospitals and ACO professionals, hospitals employing ACO professionals, critical 731
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access hospitals that bill under method II, and recognized providers or suppliers. Nonphysician nonhospital providers (eg, dialysis providers) are not eligible to form an ACO. Although a renal-specific ACO is not defined in the current legislation, Congress created a system under the PPACA to flexibly evaluate and expand promising innovations from the health care community. The Center for Medicare & Medicaid Innovation was established by the PPACA to test innovative health care delivery and payment models, and it selects the most promising models from solicited ideas, tests and evaluates these models, and eventually promotes the spread of the most successful models. The pathway of the Center for Medicare & Medicaid Innovation is a viable mechanism by which renal-specific ACOs may be created and tested under support of the broad renal community.
CONCLUSIONS The PPACA or health care reform act will change the landscape of the delivery of kidney disease care by (1) increasing health care access to 22 million Americans by 2014; (2) adjusting reimbursement rates downward, except potentially in primary care; and (3) creating alternate pay structures, such as ACOs, to constrain costs. Some version of coordinated accountable care models are needed, even if ACOs as they are currently defined may not be the answer to the problems with dialysis care delivery. Because dialysis management is expensive and complex (or possibly despite that), the renal community is on the forefront of health care reform and has demonstrated its ability to deliver high-quality care using integrated care manage732
ment while constraining the total costs of care. Despite concerns that general ACOs may be ill suited to deliver promised benefits of reform to kidney patients, some have pointed out that a potential way to bridge the gap is with a renal-focused ACO. The renal community has experience doing this with its demonstration projects that were accountable for quality and total per-capita costs in the ESRD demonstration project and has implemented the concept of bundled payments tied to quality measures with the prospective payment system. The proposed ESRD Quality Incentive Program measurements will require dialysis organizations and nephrologist practices to continue to implement, test, and refine care processes focused on integrated care. All these factors make for an exciting and dynamic period of change for kidney care. It is our hope that the promise of ACOs, high-quality integrated, and patientcentered care that reigns in costs, is achieved within the dialysis community.
ACKNOWLEDGEMENTS We acknowledge Karen Spach, PhD, of DaVita Clinical Research for editorial contribution to this manuscript. Financial Disclosure: Dr Nissenson and Mr Mayne are employees of DaVita and each own stock in DaVita Inc. Mr Parks is a former employee of DaVita. Dr Maddux is an employee of Fresenius Medical Care and owns stock in Fresenius Medical Care. Dr Velez is president of the Renal Physicians Association and is employed by Dallas Nephrology Associates, Dallas, TX.
REFERENCES 1. Brown EA. Can quality of life be improved for the increasing numbers of older patients with end-stage kidney disease? Expert Rev Pharmacoecon Outcomes Res. 2010;10(6):661-666. 2. Fried LF, Shlipak MG, Crump C, et al. Renal insufficiency as a predictor of cardiovascular outcomes and mortality in
elderly individuals. J Am Coll Cardiol. 2003;41(8):1364-1372. 3. Rifkin DE, Shlipak MG, Katz R, et al. Rapid kidney function decline and mortality risk in older adults. Arch Intern Med. 2008;168(20):2212-2218. 4. Yarlas AS, White MK, Yang M, Saris-Baglama RN, Bech PG, Christensen T. Measuring the health status burden in hemodialysis patients using the SF-36(R) health survey. Qual Life Res. 2011;20(3): 383-389. 5. Chiu YW, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009;4(6): 1089-1096. 6. US Renal Data System. USRDS 2011 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Vol 2. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2011:e208, e282. 7. St Peter WL, Khan SS, Ebben JP, Pereira BJ, Collins AJ. Chronic kidney disease: the distribution of health care dollars. Kidney Int. 2004;66(1):313-321. 8. Astor BC, Eustace JA, Powe NR, et al. Timing of nephrologist referral and arteriovenous access use: the CHOICE Study. Am J Kidney Dis. 2001;38(3):494-501. 9. Stack AG. Impact of timing of nephrology referral and pre-ESRD care on mortality risk among new ESRD patients in the United States. Am J Kidney Dis. 2003;41(2):310-318. 10. Ortega T, Ortega F, Diaz-Corte C, Rebollo P, Ma Baltar J, Alvarez-Grande J. The timely construction of arteriovenous fistulae: a key to reducing morbidity and mortality and to improving cost management. Nephrol Dial Transplant. 2005;20(3):598603. 11. Arbor Research Collaborative for Health. End-Stage Renal Disease (ESRD) Disease Management Demonstration Evaluation Report: Findings From 20062008, the First Three Years of a Five-Year Demonstration, Prepared for The Centers for Medicare & Medicaid Services. 2010. 12. Nissenson AR, Deeb T, Franco E, Krishnan M, McMurray S, Mayne TJ. The ESRD Demonstration Project: what it accomplished. DaVita Inc. Nephrol News Issues. 2011;25(7):39-41. 13. Sauer PF, Farrell RE, Lazarus JM. The ESRD Demonstration Project: what it accomplished. Fresenius Medical Care Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum North America. Nephrol News Issues. 2011;25(7):32, 34-35, 37-38. 14. Berwick DM. Making good on ACOs’ promise—the final rule for the Medicare shared savings program. N Engl J Med. 2011;365(19):1753-1756. 15. HR 4872, Health Care and Education Affordability Reconciliation Act, enacted March 29, 2010:5. 16. American Hospital Association, 2010 Committee on Research. AHA Research Synthesis Report: Accountable Care Organizations. Chicago, IL: American Hospital Association; June 2010. 17. HR 3590, Patient Protection and Affordable Care Act. Enacted March 22, 2010. 18. US Census Bureau. Highlights: 2009. http://www.census.gov/hhes/www/ hlthins/data/incpovhlth/2009/highlights. html. Accessed July 27, 2011. 19. Compilation of the Social Security Laws. 1972. http://www.socialsecurity.gov/ OP_Home/ssact/title18/1881.htm. 20. Centers for Medicare & Medicaid Services. Fistula First Breakthrough 2011. http://www.cms.gov/ESRDQualityImprove Init/04_FistulaFirstBreakthrough.asp#Top OfPage. Accessed October 15, 2011. 21. Centers for Medicare & Medicaid Services. Medicare coverage of kidney dialysis and kidney transplant services. 2011; p 12. http://www.medicare.gov/ Publications/Pubs/pdf/10128.pdf. Accessed October 13, 2011. 22. HR 6331, The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008. 23. Centers for Medicare & Medicaid Services. End-stage renal disease prospective payment system. Fed Regist. 2010; 75(155):49029-49214. 24. Mayne TJ, Burgess M, Weldon J. Finding the case mix adjusters in the CMS proposed bundle. Nephrol News Issues. 2009;10:34-38. 25. Nissenson AR, Mayne TJ, Krishnan M. The 2009 proposed rule for prospective ESRD payment: perspectives from a large dialysis organization. Am J Kidney Dis. 2010;55(2):223-226.
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26. Centers for Medicare & Medicaid Services. End-Stage Renal Disease Prospective Payment System and Quality Incentive Program. Fed Regist. 2011;76(218): 70228-70318. http://www.gpo.gov/fdsys/ pkg/FR-2011-11-10/pdf/2011-28606.pdf. Accessed December 10, 2011. 27. Tollen LA. Physician Organization in Relation to Quality and Efficiency of Care: A Synthesis of Recent Literature. Commonwealth Fund pub. no. 1121. The Commonwealth Fund, New York, NY; April 2008. 28. Centers for Medicare & Medicaid Services Medicare Program. Medicare shared savings program: accountable care organizations. Fed Regist 2011;76(212): 67802-67990. 29. Cauchi R. State legislation opposing certain health reforms, 2009-2010, National Conference of State Legislatures. 2010. http://www.ncsl.org/?tabid⫽18906. Accessed October 10, 2011. 30. McClellan M, McKethan AN, Lewis JL, Roski J, Fisher ES. A national strategy to put accountable care into practice. Health Aff (Millwood). 2010;29(5):982-990. 31. Rosenthal MB, Cutler DM, Feder J. The ACO rules—striking the balance between participation and transformative potential. N Engl J Med. 2011;365(4):e6. 32. Wilensky GR. Lessons from the physician group practice demonstration—a sobering reflection. N Engl J Med. 2011; 365(18):1659-1661. 33. Centers for Medicare and Medicaid Services. Fact sheet: Medicare Physician Group Practice Demonstration: physicians groups continue to improve quality and generate savings under Medicare physician pay for performance demonstration; 2009. http://www.cms.gov/DemoProjects EvalRpts/downloads/PGP_Fact_Sheet.pdf. Accessed September 15, 2011. 34. Newman D. Accountable Care Organizations and the Medicare Shared Savings Program, Congressional Research Service, CRS Report for Congress 7-5700, R41474. 2010. 35. Lorenzo V, Martn M, Rufino M, Hernandez D, Torres A, Ayus JC. Predialysis nephrologic care and a functioning arterio-
venous fistula at entry are associated with better survival in incident hemodialysis patients: an observational cohort study. Am J Kidney Dis. 2004;43(6):999-1007. 36. Mendelssohn DC, Malmberg C, Hamandi B. An integrated review of “unplanned” dialysis initiation: reframing the terminology to “suboptimal” initiation. BMC Nephrol. 2009;10:22. 37. Wasse H, Kutner N, Zhang R, Huang Y. Association of initial hemodialysis vascular access with patient-reported health status and quality of life. Clin J Am Soc Nephrol. 2007;2(4):708-714. 38. Wingard RL, Pupim LB, Krishnan M, Shintani A, Ikizler TA, Hakim RM. Early intervention improves mortality and hospitalization rates in incident hemodialysis patients: RightStart program. Clin J Am Soc Nephrol. 2007;2(6):1170-1175. 39. Robertson J, Chen G, Goel P, Levine R, Benner D. Effect of IMPACT Program on Clinical Indicators of Incident Hemodialysis Patients. Munich, Germany: European Renal Association-European Dialysis and Transplant Association; 2010. 40. Manley HJ, Cannella CA, Bailie GR, St Peter WL. Medication-related problems in ambulatory hemodialysis patients: a pooled analysis. Am J Kidney Dis. 2005; 46(4):669-680. 41. US Renal Data System. USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Vol 2. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2010:s269-s280. 42. Centers for Medicare & Medicaid Services. [CMS 5003-N] RIN 0938-ZA39 Medicare Program; Demonstration: End-Stage Renal Disease-Disease Management. Fed Regist. 2003;68(107):notice 33495. 43. Coughlin J, Pope J, Leedle B. Old age, new technology and future innovations in disease management and home health care. Home Health Care Manage Pract. 2006;18(3):196-207. 44. Rastogi A, Linden A, Nissenson AR. Disease management in chronic kidney disease. Adv Chronic Kidney Dis. Jan 2008;15(1):19-28.
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WKF Advisory Board John T. Harrington, MD Boston, Massachusetts Rashad S. Barsoum, MD Cairo, Egypt Christopher R. Blagg, MD Mercer Island, Washington John Boletis, MD Athens, Greece Garabed Eknoyan, MD Houston, Texas Tazeen H. Jafar, MD, MPH Singapore Nestor Schor, MD, PhD São Paulo, Brazil
D
espite advances in kidney care processes and research, patients with end-stage renal disease (ESRD) receiving dialysis continue to experience high rates of morbidity and mortality and poor quality of life.1-5 Although mortality rates in dialysis patients have decreased over the past 20 years, they remain much higher From 1DaVita Inc, Denver, CO; 2Fresenius Medical Care North America, Waltham, MA; and 3Dallas Nephrology Associates, Dallas, TX. Received October 17, 2011. Accepted in revised form February 19, 2012. Originally published online March 29, 2012. Address correspondence to Allen R. Nissenson, MD, DaVita Inc, 601 Hawaii St, El Segundo, CA 90245. E-mail: allen. [email protected] © 2012 by the National Kidney Foundation, Inc. 0272-6386/$36.00 doi:10.1053/j.ajkd.2012.02.004 724
Accountable care organizations (ACOs) are a newly proposed vehicle for improving or maintaining high-quality patient care while controlling costs. They are meant to achieve the goals of the Medicare Shared Savings Program mandated by the Patient Protection and Affordable Care Act (PPACA) of 2010. ACOs are voluntary groups of hospitals, physicians, and health care teams that provide care for a defined group of Medicare beneficiaries and assume responsibility for providing high-quality care through defined quality measures at a cost below what would have been expected. If an ACO succeeds in achieving both the quality measures and reduced costs, the ACO will share in Medicare’s cost savings. Health care for patients with end-stage renal disease is complex due to multiple patient comorbid conditions, expensive, and often poorly coordinated. Due to the unique needs of patients with end-stage renal disease receiving dialysis, ACOs may be unable to provide the highly specialized quality care these patients require. We discuss the benefits and risks of a renal-focused ACO for dialysis patients, as well as the kidney community’s prior experience with an ACO-like demonstration project. Am J Kidney Dis. 59(5):724-733. © 2012 by the National Kidney Foundation, Inc.
than in the nondialysis population.2,3 The all-cause mortality rate for prevalent dialysis patients 65 years and older with Medicare was about 7 times higher than for nondialysis individuals in 2009.6 Dialysis patients continue to experience frequent, lengthy, and costly hospitalizations. In 1993-2009, the hospitalization rate remained steady at an average of 1.9 hospitalizations per year, totaling about 12 days per year.6 Such a poor outcome may be attributed in large part to high patient acuity and complexity and a fragmented care delivery system. One result of this fragmentation is that in 19951998, a total of 69% of patients required hospitalization to start dialysis therapy, leading to higher costs, additional stress on patients, and increased burden on the health care system.7 Although patients with ESRD make up ⬍1% of the Medicare population, they consume a disproportionate 6.7% of the total Medicare budget, excluding Medicare Part D.6 In 2009, the approximately 571,000 patients
with ESRD in the United States cost Medicare $29.1 billion. Despite these high costs to individuals and society, early referral to nephrologists and increasing the proportion of planned dialysis therapy starts can reduce emergency dialysis starts, catheter use, and mortality rates.8-10 In addition to early chronic kidney disease (CKD) referrals, care coordination for the ESRD population has been shown to improve outcomes and control costs in the ESRD demonstration projects.11-13 The Centers for Medicare & Medicaid Services (CMS) has recently established a new vehicle for improving outcomes and controlling costs: the accountable care organization (ACO).15,16 ACOs provide a potential to change the provision of health care, but the current structure will miss some of the most severe chronically ill patients, including patients with ESRD. Although the ACO concept generated significant interest, the details have left many disappointed and raised a number of questions. Am J Kidney Dis. 2012;59(5):724-733
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What is an ACO? What role do they play in health care reform? What about recent court challenges to the health care reform laws? How will an ACO work? What are the implications for renal patients? What about a renalfocused ACO? How will nephrologists and other dialysis providers fit into this new paradigm?
WHAT IS AN ACO? An ACO is a network of health care providers that assumes joint accountability for coordinating and delivering efficient and high-quality health care while slowing the growth of health care costs. The goal of ACOs is to integrate and align the quality of care with the payment system, thus inserting performance risk into the financial incentives of the payment methodology. One key aspect that differentiates the ACO model from others is that the ACO model, according to the American Hospital Association, “fosters accountability for care and costs by offering a joint payment to all providers involved with the provision of care.”16(p5) ACOs differ from health maintenance organizations (HMOs) in a number of important ways. ACO patients are free to choose their providers, do not have to change their insurance, and can stay in the Medicare program. HMOs receive capitated payments, whereas ACOs do not receive capitated payments. Instead, every provider is still paid through the fee-forservice Medicare program and costeffectiveness is incented by adding performance-based payments for desired clinical outcomes. The ACO concept has been included in national health care reform legislation (Patient Protection and Affordable Care Act [PPACA]),17 with certain organizational and operational modiAm J Kidney Dis. 2012;59(5):724-733
fications for Medicare. This discussion of ACOs will reflect the specific aspects of the Medicare ACO model.
WHAT ROLE DO ACOs PLAY IN HEALTH CARE REFORM? In 2009, a total of 46.3 million (15.4%) Americans were uninsured, 201.0 million (66.7%) were privately insured, and 87.4 million (29.0%) were covered by government health insurance.18 Of those covered by the government, 42.6 million (14.1%) were covered by Medicaid and 43.0 million (14.3%) were covered by Medicare. Medicare is available for Americans older than 65 years, and in 1972, a special entitlement was enacted covering people of all ages with ESRD.19 Medicare covers both dialysis treatments (with waiting periods for those younger than 65 years and/or covered by commercial insurance) and transplant procedures. Unfortunately, Medicare’s reimbursement system for dialysis has both gaps in coverage and payment-structure issues. For example, although the goal of the Fistula First Breakthrough Initiative, a project created in partnership with the CMS, is to increase arteriovenous fistula use in incident and prevalent hemodialysis patients, Medicare does not cover this procedure for patients younger than 65 years who have not yet started dialysis therapy. Therefore, patients younger than 65 years are not eligible to receive vascular access services from Medicare in preparation for transitioning to dialysis therapy.20,21 The result is a high prevalence of central venous catheters used at the start of dialysis therapy. The structure of the Medicare payment system is problematic.
Currently, most Medicare payments are based on a fee-forservice model, which may result in fragmentation of care. Under fee for service, each health care provider is paid for their services, and this may function as an economic disincentive for collaboration between providers (including hospitals) because fee-for-service pays providers for performing procedures, ordering tests, and prescribing drugs, but not for providing preventative or pre-emptive care. This may result in lower costs to the Medicare program for each disease episode, but also lower revenues to providers. In addition, the Medicare payment system is split into hospital-based care (Medicare Part A) and outpatient/physician care (Medicare Part B). This division inhibits innovation in preventative care (reimbursed under Part B) because it generally is not reimbursed, while the benefits are accrued to Part A in the form of lower hospitalizations. The irony is that the latter would be sufficient to fund the former, but this is not permitted in the fee-for-service Medicare paradigm. The potential disadvantages of the fee-for-service model, coupled with increasing costs, have led to the consideration of alternative models. Kidney disease has been on the forefront of these reform efforts through the CMS ESRD Demonstration and Medicare Care Management for High Cost Beneficiaries Demonstration programs and through federally mandated payment systems. Congress passed the Medicare Improvements for Patients and Providers Act of 2008, mandating that a prospective payment system for dialysis be implemented in phases beginning in 2011.22 The prospective payment system combines separately bill725
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with the first ACO agreements to start April 1 and July 1, 2012.
WHAT ABOUT THE CONSTITUTIONALITY OF THE PPACA? The existence of ACOs hinges on the constitutionality of the PPACA. More than half of the 50 states have filed a suit challenging the act. The primary focus of the challenges is the constitutionality of what is called the “individual mandate,” requiring that all citizens be covered by health insurance and allowing penalties for those who choose not to be covered. To date, 7 district courts have ruled on the PPACA (see Fig 1).29 The Supreme Court is expected to rule on the PPACA by June 2012. The Supreme Court can rule that any individual section or the entire PPACA is constitutional or unconstitutional. With the elections soon after, this decision has significant political ramifications. Middle District of Pennsylvania Individual mandate and pre-exisng condions unconstuonal Eastern District Court of Virginia Individual mandate unconstuonal Western District Court of Virginia Individual mandate constuonal
There is equipoise as to whether the Supreme Court will rule that the PPACA is constitutional or unconstitutional. If the latter, then the legislative mandate behindACOs will disappear. It is impossible to know how a new Congress would legislate this issue or how the CMS would grandfather ACOs that had already come into existence.
HOW WILL AN ACO WORK? ACOs are collaborations between groups of health care professionals that are eligible to receive incentives from the government based on achievement of care quality standards and reductions in the total cost of care for the particular ACO’s patient population. According to McClellan et al,30 ACOs can be defined by 3 key principles: (1) Provider-led organizations with a strong base of primary care that are collectively accountable for quality and total per capita costs across the full continuum of care for a popula-
3rd Circuit Court No Decision
4th Circuit Court Lack of jurisdicon
District Court of DC Individual mandate constuonal
DC Circuit Court Individual mandate constuonal
Eastern District Court of Texas Prohibing expansion of physicianowned hospitals constuonal
5th Circuit Court
Eastern District Court of Michigan Individual mandate constuonal
6th Circuit Court Individual mandate is constuonal
Northern District Court of Florida Individual mandate unconstuonal Enre PPACA unconstuonal
11th Circuit Court Individual mandate unconstuonal Remaining PPACA constuonal
No Decision
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able services into a single adjusted base rate and provides a quality incentive adjustment, effectively creating Medicare’s first system of pay for performance.23-25 This quality incentive adjustment, the ESRD Quality Incentive Program, will be implemented in 2012 using claims-based quality metrics to withhold up to 2% of a clinic’s payment for not meeting a set of standards based on 2010 performance; quality metrics may be adjusted annually.26 Although this payment system addresses costs by tying payments to quality metrics, it does not address the disjointed structure of health care delivery. Economic model research has suggested that the integration of health care delivery could reduce costs and improve quality, and ACOs have been touted as models of integrated care programs.27 The ACO health care model will soon be tested on a national level. On March 23, 2010, the PPACA was signed into law and initiated a new phase of health care reform.17 Section 3022 of the PPACA created the Medicare Shared Savings Program to “promote accountability for a patient population and coordinate items and services under [Medicare] part A and B, and encourage investment in infrastructure and redesigned care processes for high quality and efficient service delivery.”17(p277) Specifically, the PPACA directs the Department of Health and Human Services to use ACOs to implement an integrated care delivery system. The Department of Health and Human Services updated the initial guidelines published in March 2011 after extensive public comment; final rules for establishment of ACOs were published in November 2011.14,28 The program was established on January 1, 2012,
Figure 1. Current and pending federal court decisions regarding the Patient Protection and Affordable Care Act (PPACA). Adapted from Cauchi.29 Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum tion of patients. (2) Payments linked to quality improvements that also reduce overall costs. (3) Reliable and progressively more sophisticated performance measurements, to support improvement and provide confidence that savings are achieved through improvements in care.30(p983)
Other important aspects of ACOs include the use of electronic health records and health information exchanges and promotion of evidence-based medicine and patient centeredness. Under the PPACA, the CMS will determine to which ACO patients are assigned based on a quarterly preliminary prospective assignment method. At the end of each performance year, the CMS will complete a final reconciliation based on the patients served by the ACO using claims data. Beneficiaries who received at least one primary care service from a physician will be assigned the physician with the plurality of primary care service code charges for the beneficiary; this is designated the patient’s “primary care physician.” For beneficiaries who have not received primary care physician services, the plurality of allowed charges for primary care services provided by any other ACO professional will be used in the assignment process. The goal is to provide an incentive for ACOs to enhance the quality of care for all patients served by its health care providers. Under the PPACA rules, if the total costs of the care are less than the target amounts set by the CMS for any given period, the ACO receives a portion of the savings generated, assuming prespecified quality metrics are met. If the total costs are greater than the target amount, the ACO pays back a portion of the excess costs.28 For each 3-year ACO agreement, the ACO Am J Kidney Dis. 2012;59(5):724-733
will be able to choose to participate in 1 of 2 payment options.31 In the more conservative “1-sided” risk option, ACOs would be eligible for only the shared savings in the 3 years. In the more aggressive “2-sided” risk option, ACOs would be accountable for repaying a portion of excess cost in the 3 years, but would also be eligible to receive a greater percentage of the shared savings (60% vs 50% in the 1-sided option). For both risk options, the ACOs will receive shared savings when the minimum savings rate has been achieved. Importantly, quality performance measures are linked to financial incentives. The CMS implemented 33 quality measures for making assessments, setting benchmarks, and rewarding quality performance. The quality measures include the following: (1) Patient/Caregiver Experience (7 measures), (2) Care Coordination/ Patient Safety (6 measures ⫹ double-weighted electronic health record measure), (3) Preventative Health (8 measures), and (4) AtRisk Population/Frail Elderly Health (12 measures). Benchmarks, based on the fee-for-service or Medicare Advantage rates, will be set before the start of each annual performance period. The eligibility of the ACO for shared savings and the percentage of shared savings the ACO receives will be based on overall ACO quality scores in relation to the benchmarks. In the first year, ACOs will be paid for reporting quality measures; in subsequent years, ACOs will be paid for reporting and their performance on quality measures. Quality measure improvements are based on institutions’ historic spending and quality data, which may penalize efficient providers and areas of the country. The performance
risk leading to shared savings will have to evolve into more bundled or capitated models of payment over time as rebasing occurs and limited shared savings are available. The Medicare Shared Savings Program approach highlights one of the key criticisms of HMOs. Although HMOs typically have capitated payments, they have been criticized for sacrificing quality of care for cost savings. Policymakers believe the ACO model addresses some of these issues.16 Although the evidence is limited, pilot programs testing the payment and health care delivery initiatives in the ACO model suggest that ACOs may succeed where HMOs have failed. The Physician Group Practice (PGP) Demonstration was a shared savings pilot program modeling an ACO. Although the providers continued to receive fee-for-service payments, they were held accountable for costs and quality measures. PGP participants performed well on the quality metrics, with increased quality scores in diabetes, heart failure, coronary artery disease, cancer screening, and hypertension.32 All providers during their fourth year showed improvements in 29 of the 32 measures. Unfortunately, cost savings were more difficult to achieve, with only 2 of 10 PGP participants exceeding the 2% savings threshold in the first year of the demonstration. By year 4 of the program, 5 of the 10 participating providers reduced costs enough to receive a shared savings payment. Although the number of PGP participants reaching the 2% savings threshold was disappointing, a total Medicare savings of $38.7 million was achieved in the first 4 years of the program.33 The quality results from the PGP participants are laudable, but the savings 727
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results are a cause for concern. The Brookings Institution/Dartmouth Institute for Health Policy & Clinical Practice, the Robert Wood Johnson Foundation, Baylor Health System, and Premier Health Care Alliance are currently piloting ACO programs that will provide more information on better ways to implement and execute ACOs. Questions remain about how the ACOs will be implemented, if patient assignment will work, if shared savings are realistic, and if this reform can improve quality of care for patients with special conditions. The PPACA suggests that physicians and providers instead of insurers or hospitals play a fundamental role in the management of ACOs; the CMS regulations further support this. The amount of money that will be saved also is unknown. The Congressional Budget Office predicted the ACO Medicare Shared Savings Program would reduce Medicare expenditures $4.9 billion from 2013 through 2019.34 Although the Congressional Budget Office predicted a hefty savings and the PGP Demonstration yielded a net savings for Medicare, only half the pilot programs received a shared savings payment and therefore it is unclear whether the savings and quality of care are sustainable nationwide. This is an inherent feature of layering the ACO on top of a fee-for-service model. One main distinction between the old capitation and gatekeeper model that failed is patient choice. An ACO will assume some risk of a patient choosing to go out of the ACO’s network. This may be a benefit to patients who have established relationships to a particular provider, but clearly decreases the ability of the ACO to 728
control unnecessary or inappropriate care. Fragmented health care and the continued increase in health care costs are problems that patients, physicians, hospitals, insurers, and the government hope to correct, but it will take large system-wide changes in fundamental assumptions of how we provide health care in America for this to happen. The current health care reforms at both the state and national levels are bold attempts to make these changes. In this setting, it is important to consider the complex needs of patients on dialysis therapy and the special skills of nephrologists and dialysis care teams.
WHAT ARE THE IMPLICATIONS FOR RENAL PATIENTS? Given the deficiencies in the feefor-service health care system, poor management of care transitions, and the required ongoing and highly specialized care this vulnerable population requires, dialysis patients will benefit greatly if ACOs are implemented in the right way and be harmed if they are not. Unfortunately, the low overall prevalence of dialysis patients and lack of expertise and experience in dialysis care in primary-care focused ACOs may lead to suboptimal care. Also, ACO rules may inhibit the nephrologist from continuing to be the primary care physician for dialysis patients. Most hospitals and primary care networks do not have sufficient knowledge and experience working with dialysis patients to provide the high-quality and innovative care dialysis patients require. Also, because patients with ESRD would likely represent ⬍1% of an ACO’s assigned population and these patients would be broadly dispersed across the ACO’s catch-
ment area, it is unlikely that each ACO would operate efficiently and have conveniently located dialysis centers exclusively for its patients. Instead, individual ACOs may try to transfer accountability to kidney care providers. A single dialysis facility could be partnering with multiple ACOs. This mixed population would require care providers to follow 2 systems of care and medical record keeping: those of the ACO and those of the kidney care providers. ACO-led initiatives might apply to only a few patients in the dialysis facility and conversely, kidney care provider– led initiatives may not be endorsed by ACO-authorized processes of care. Treating patients differently within a single dialysis facility could lead to confusions, inefficiencies, and inhibition of innovative processes of care by both the dialysis provider and the ACO. The prospective payment system recently was implemented for dialysis patients with payments tied to quality measures instead of the traditional fee-for-service model. If dialysis facilities served both typical Medicare beneficiaries and patients within an ACO, they would be responsible for reconciling payments under 2 structures that are each tied to 2 separate sets of quality metrics, resulting in an excessive bureaucratic burden.
WHAT ABOUT A RENAL-FOCUSED ACO? Because of the high cost of dialysis and the complex comorbidities of ESRD, patients with ESRD may be undesirable to ACOs. A compelling alternative would be to form a renal-specific ACO based on the general ACO model to put nephrologists and dialysis centers at the hub of a redesigned kidney Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum
care delivery system. Initially, we suggest including only dialysis patients and then eventually expanding to include patients with latestage progressive CKD. In a renal care model of an ACO, the nephrologist would be a “principal” care provider coordinating the overall activities, but would not have the plurality of primary care service codes. The nephrologists’ role in a renal ACO would serve as the accountable “principal” care physician, who is responsible for coordinating care with the primary care physician and other subspecialists, providing preventative care, monitoring care, and overseeing quality measure reporting. It is possible that renal ACOs may operate with fewer than the specified 5,000 patients or be spread across a network of kidney care providers due to the relatively low incidence of kidney disease. Renal ACOs might have kidney-specific clinical performance measures that could replace some of the typical quality measures that are not necessary for a population with such a high mortality rate. The current renal care delivery systems within the United States provide a perfect opportunity to test a disease-based ACO given the vulnerability of the patients, low incidence rate of kidney disease, sheer size and cost of dialysis and kidney transplant, currently recognized gaps in the fee-forservice and now prospective payment systems, defined nature of renal replacement therapy, and experience with ACO-like programs in CMS demonstrations by the nephrology community. Potential concerns over cherry-picking patients and inappropriate control by large dialysis organizations would have to be addressed carefully in the plan. Experienced nephrologists understand the importance of distinAm J Kidney Dis. 2012;59(5):724-733
guishing key patient cohorts (CKD, incident ESRD, and prevalent ESRD) and the unique clinical and financial challenges of caring for patients with ESRD because of the complexity and common comorbid conditions. The needs of patients at different stages of their kidney disease vary, and there is a growing body of evidence to support the idea that identifying the patient who is at high risk of progression of kidney disease, appropriate nephrology referral, timely preparation for renal replacement therapies, and attention to the physiologic effects of the kidney disease lead to better end point outcomes when measuring processes of care and clinical results.35-37 Often, when patients begin dialysis therapy, they are in poor health and “crash” into dialysis with a catheter for vascular access and have little information or understanding of what lies ahead. Many dialysis provider–led programs and processes for incident patients with ESRD have been effective in improving health outcomes and quality of life as patients adjust to dialysis. For example, programs such as RightStart by Fresenius Medical Care and IMPACT (Incident Management of Patients, Actions Centered on Treatment) by DaVita have been shown to reduce morbidity and mortality in patients enrolled in the program.38,39 These programs are examples of how to improve coordination and care, but could be lost in a general ACO. However, these are examples of programs that a renal ACO could use and deploy throughout the ACO, improving outcomes and decreasing costs of care. Within a general ACO, there may be too few patients with ESRD in the ACO to make such renal-focused programs
fiscally sound. Thus, the most critical advantage of the renal ACO is the scale advantage of using the facility as the point of assignment. According to an internal DaVita analysis, there is sufficient scale to economically re-engineer care processes and improve patient outcomes with 70% or more of a facility’s patients participating. Patients with ESRD are a vulnerable population in need of continuous care coordination, including management of dietary and fluid intake, medication use, infection-risk mitigation, renal replacement therapies, and comorbid conditions. Patients have on average more than 3 comorbid conditions and about 8 drug prescriptions and are in frequent contact with health care providers.40 Despite continued improvements in ESRD care, mortality rates are about 7 times higher for dialysis patients than the general Medicare population.41 Patients with ESRD were hospitalized 1.9 times per patient year and averaged 11.8 hospital days per patient year in 2009.6 These issues could negatively affect the quality measures that ACOs must achieve to receive their maximum payments. Finally, kidney disease itself is different from other chronic disease states because it is a well-defined disease with no ambiguity about who has ESRD. When diagnosed, patients are staged within a continuum of kidney disease and those destined to progress toward ESRD will require dialysis, kidney transplant, or palliative therapy. The characteristics of CKD, with its well-defined path from CKD to ESRD, make it a natural fit for a renal-specific integrated-care model such as an ACO. Perhaps more importantly, large dialysis providers have successfully demonstrated ACO-like integrated patient-centered care delivery in 729
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CMS demonstration projects. The most recent demonstration project is discussed next.
THE ESRD DEMONSTRATION PROJECT In 2006, CMS initiated a 5-year ESRD Management Demonstration.42 The goal of the demonstration was to study the impact of delivering integrated care to dialysis patients on clinical outcomes and Medicare costs. In anticipation of the structure and processes of ACOs, the groups within the demonstration assumed the risk for the total cost of care for enrolled patients by receiving capitated risk-adjusted payments from CMS. Three Disease Management Organizations (DMOs) participated in the demonstration. DMOs are networks of health care providers administering a system of coordinated health care interventions with significant patient self-care efforts.43 All DMOs focused on a series of common elements and each DMO developed its own programs to deliver coordinated care while managing the dialysis-specific issues of anemia, bone and mineral disease metabolism, and vascular access management. They also integrated patient education and disease management programs for diabetes and cardiovascular disease. Each DMO also selected additional problems to target unique interventions. Arbor Research Collaborative for Health and the Lewin Group provided independent analyses of the results. The complete Arbor report11 and DMO commentary and comment by participating physicians have been published.12,13 The demonstration was evaluated on its ability to improve hospitalization and mortality outcomes, quality of life, and patient satisfaction in a cost-effective man730
ner. The DMOs designed interventions to achieve these common goals. These interventions included coordination of care between physicians and nurses, in-hospital follow-up and discharge planning, focus on optimizing vascular access, protocols for management of anemia and bone and mineral disease, patient education, advanced care directives, and management of diabetes and cardiovascular disease. The cost of expanding the care team by adding case managers, call centers, and additional upfront resources necessary for the interventions was balanced against the savings achieved from reducing expensive hospitalizations. The strategies used by all DMOs were compared with those unique to a single DMO to understand which components lead to improved processes of care. Each DMO was able to modify and enhance their care processes throughout the demonstrations to enhance the effectiveness and efficiency of the integrated care process and reduce fragmentation of health care delivery. According to the Arbor report (Box 1), survival rates were higher in 2 of the 3 DMOs in the first year of the demonstration compared with fee-for-service. One DMO had significantly fewer all-cause and cardiovascular-related hospitalizations compared with fee-forservice. The oral nutritional supplementation initiative by one DMO was associated with a significant reduction in mortality at 1 year. Vascular access improvements were noted in all DMOs; catheter rates in the DMOs were 8% compared with 18% reported by the US Renal Data System (USRDS) 2007 Annual Data Report.12 Immunization rates for influenza and pneumococcal vaccines far exceeded the USRDS average. Dia-
Box 1. Arbor Evaluation of the ESRD Disease Management Demonstration Project This ESRD Disease Management Demonstration represented a unique opportunity to identify improvement in clinical outcomes in a population that is ideally suited for Disease Management. We observed significant survival benefit in this notably fragile and complex patient population. Additionally, at least one DMO demonstrated improved metrics in evaluating hospitalization outcomes, including improved time to first all-cause and cardiovascular hospitalization, and hospital admission rate over time. In addition, utilization of other costly services including SNF stays and outpatient physician visits were consistently reduced in the DMOs as compared to FFS. These findings translated to cost savings which were considerable in at least one participating DMO. Although there was no clear impact of Disease Management on improving QoL, patients and providers expressed satisfaction with their experiences with the Disease Management Demonstration. We believe our findings merit consideration in the ongoing assessment of the value of Disease Management. Finally, one related approach, among others, that may have benefits for this population is the Accountable Care Organization (ACO). Note: Analysis based on the first 3 years of the 5-year ESRD demonstration project. Abbreviations: DMO, Disease Management Organization; ESRD, end-stage renal disease; FFS, fee-for-service; QoL, quality of life; SNF, skilled nursing facility. Reproduced from Arbor Research Collaborative for Health.11(p117)
betic care and medication adherence also improved (Table 1). Importantly, patients reported a high level of satisfaction with the ESRD program across all DMOs and at every time point. As Nissenson et al12 concluded, “The fact that patients reported a high degree of satisfaction with their healthcare delivery during this project is an important component of the program’s effectiveness.”44(p41) Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum Table 1. Dialysis Care Measures, Hospitalization, and Mortality by Demonstration Project Participants Versus US Norms Disease Management Organization Metric
A
B
C
Benchmark
Vascular access rates (%) Fistula Graft Catheter
56 36 8
48 42 10
55 39 6
55a 27a 18a
Immunization rate (%) Influenza Pneumococcal
90 60
—b —b
—b —b
57c 20c
Diabetes care (%) Retinal examination Podiatric examination
65 80
—b —b
—b —b
48d 70d
Hospitalization (/member/y) Hospital admission Hospital readmissions Emergency department visits
1.74 0.64 1.05
1.85 0.72 1.57
1.82 0.64 1.48
1.89c NAc NAc
Adjusted survival (%) 1y 2y
88.0 73.5
91.2 80.9
90.7 80.1
79c NAc
—b
—b
16.2
23.4f
—b —b —b
—b —b —b
0.83-0.86 0.55 0.82
—h —b —b
Annualized mortality of patients receiving oral nutritional supplementse Home weight monitoringg Clinically important IDWG All-cause mortality All-cause hospitalization
Abbreviations: NA, not applicable; USRDS, US Renal Data System; IDWG, interdialytic weight gain. Modified and reproduced with permission from Nephrology News & Issues.13 a Based on USRDS (www.usrds.org) data from 2007, the last year for which this information was available. b Not assessed. c Based on USRDS data from 2008. d Based on DOPPS (Dialysis Outcomes and Practice Patterns Study; www.dopps.org) data from 2008. e Patients with albumin level ⬍3.8 g/dL. f Based on 2006 End-Stage Renal Disease Clinical Performance Measures data (www.cms.gov/CPMProject). g Odds ratio, relative risk, or hazard ratio of indicated outcome in those who had home weight monitoring versus those who did not. h Data not available in USRDS 2010 Annual Data Report.
HOW WILL NEPHROLOGISTS AND OTHER DIALYSIS PROVIDERS FIT INTO THIS NEW PARADIGM? Nephrologists already treat patients in ways that fit with the Am J Kidney Dis. 2012;59(5):724-733
ACO model. Nephrologists treat kidney disease as well as multiple comorbid conditions in patients with ESRD; thus, many already serve as principal care physicians. The patient-centered medical
home, which defines and uses the concept of principal care physicians and the ability of specialty practices to serve as medical homes, is suggestive of a dialysis facility. The kidney community’s experience with “bundled payments” under the prospective payment system and the ESRD demonstration project has spurred innovations in processes of care. Preventive care in the form of immunizations, noncatheter vascular access, diabetic care, home weight monitoring, and oral nutritional supplements are key components currently being tested. Finally, nephrologists regularly work with varied members of the care team (eg, dietitians, social workers, nurses, and patient care technicians) and other physicians (eg, vascular surgeons, endocrinologists, cardiologists, and general practitioners) to coordinate the care of dialysis patients. Functioning as de facto principal care physicians, collaborating with other subspecialties, balancing multiple clinical opinions and competing comorbid conditions, directing care teams that have weekly direct contact with patients, leading interdisciplinary teams, and directing quality management efforts are key roles of the ACO primary care physician that nephrologists already perform. Unfortunately, PPACA and CMS regulations preclude renal-specific ACOs. Only the following providers are eligible to form ACOs: ACO professionals (eg, physicians, physician assistants, nurse practitioners, and clinical nurse specialists) in group practices, networks of individual practices of ACO professionals, partnerships or joint venture arrangements between hospitals and ACO professionals, hospitals employing ACO professionals, critical 731
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access hospitals that bill under method II, and recognized providers or suppliers. Nonphysician nonhospital providers (eg, dialysis providers) are not eligible to form an ACO. Although a renal-specific ACO is not defined in the current legislation, Congress created a system under the PPACA to flexibly evaluate and expand promising innovations from the health care community. The Center for Medicare & Medicaid Innovation was established by the PPACA to test innovative health care delivery and payment models, and it selects the most promising models from solicited ideas, tests and evaluates these models, and eventually promotes the spread of the most successful models. The pathway of the Center for Medicare & Medicaid Innovation is a viable mechanism by which renal-specific ACOs may be created and tested under support of the broad renal community.
CONCLUSIONS The PPACA or health care reform act will change the landscape of the delivery of kidney disease care by (1) increasing health care access to 22 million Americans by 2014; (2) adjusting reimbursement rates downward, except potentially in primary care; and (3) creating alternate pay structures, such as ACOs, to constrain costs. Some version of coordinated accountable care models are needed, even if ACOs as they are currently defined may not be the answer to the problems with dialysis care delivery. Because dialysis management is expensive and complex (or possibly despite that), the renal community is on the forefront of health care reform and has demonstrated its ability to deliver high-quality care using integrated care manage732
ment while constraining the total costs of care. Despite concerns that general ACOs may be ill suited to deliver promised benefits of reform to kidney patients, some have pointed out that a potential way to bridge the gap is with a renal-focused ACO. The renal community has experience doing this with its demonstration projects that were accountable for quality and total per-capita costs in the ESRD demonstration project and has implemented the concept of bundled payments tied to quality measures with the prospective payment system. The proposed ESRD Quality Incentive Program measurements will require dialysis organizations and nephrologist practices to continue to implement, test, and refine care processes focused on integrated care. All these factors make for an exciting and dynamic period of change for kidney care. It is our hope that the promise of ACOs, high-quality integrated, and patientcentered care that reigns in costs, is achieved within the dialysis community.
ACKNOWLEDGEMENTS We acknowledge Karen Spach, PhD, of DaVita Clinical Research for editorial contribution to this manuscript. Financial Disclosure: Dr Nissenson and Mr Mayne are employees of DaVita and each own stock in DaVita Inc. Mr Parks is a former employee of DaVita. Dr Maddux is an employee of Fresenius Medical Care and owns stock in Fresenius Medical Care. Dr Velez is president of the Renal Physicians Association and is employed by Dallas Nephrology Associates, Dallas, TX.
REFERENCES 1. Brown EA. Can quality of life be improved for the increasing numbers of older patients with end-stage kidney disease? Expert Rev Pharmacoecon Outcomes Res. 2010;10(6):661-666. 2. Fried LF, Shlipak MG, Crump C, et al. Renal insufficiency as a predictor of cardiovascular outcomes and mortality in
elderly individuals. J Am Coll Cardiol. 2003;41(8):1364-1372. 3. Rifkin DE, Shlipak MG, Katz R, et al. Rapid kidney function decline and mortality risk in older adults. Arch Intern Med. 2008;168(20):2212-2218. 4. Yarlas AS, White MK, Yang M, Saris-Baglama RN, Bech PG, Christensen T. Measuring the health status burden in hemodialysis patients using the SF-36(R) health survey. Qual Life Res. 2011;20(3): 383-389. 5. Chiu YW, Teitelbaum I, Misra M, de Leon EM, Adzize T, Mehrotra R. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009;4(6): 1089-1096. 6. US Renal Data System. USRDS 2011 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Vol 2. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2011:e208, e282. 7. St Peter WL, Khan SS, Ebben JP, Pereira BJ, Collins AJ. Chronic kidney disease: the distribution of health care dollars. Kidney Int. 2004;66(1):313-321. 8. Astor BC, Eustace JA, Powe NR, et al. Timing of nephrologist referral and arteriovenous access use: the CHOICE Study. Am J Kidney Dis. 2001;38(3):494-501. 9. Stack AG. Impact of timing of nephrology referral and pre-ESRD care on mortality risk among new ESRD patients in the United States. Am J Kidney Dis. 2003;41(2):310-318. 10. Ortega T, Ortega F, Diaz-Corte C, Rebollo P, Ma Baltar J, Alvarez-Grande J. The timely construction of arteriovenous fistulae: a key to reducing morbidity and mortality and to improving cost management. Nephrol Dial Transplant. 2005;20(3):598603. 11. Arbor Research Collaborative for Health. End-Stage Renal Disease (ESRD) Disease Management Demonstration Evaluation Report: Findings From 20062008, the First Three Years of a Five-Year Demonstration, Prepared for The Centers for Medicare & Medicaid Services. 2010. 12. Nissenson AR, Deeb T, Franco E, Krishnan M, McMurray S, Mayne TJ. The ESRD Demonstration Project: what it accomplished. DaVita Inc. Nephrol News Issues. 2011;25(7):39-41. 13. Sauer PF, Farrell RE, Lazarus JM. The ESRD Demonstration Project: what it accomplished. Fresenius Medical Care Am J Kidney Dis. 2012;59(5):724-733
World Kidney Forum North America. Nephrol News Issues. 2011;25(7):32, 34-35, 37-38. 14. Berwick DM. Making good on ACOs’ promise—the final rule for the Medicare shared savings program. N Engl J Med. 2011;365(19):1753-1756. 15. HR 4872, Health Care and Education Affordability Reconciliation Act, enacted March 29, 2010:5. 16. American Hospital Association, 2010 Committee on Research. AHA Research Synthesis Report: Accountable Care Organizations. Chicago, IL: American Hospital Association; June 2010. 17. HR 3590, Patient Protection and Affordable Care Act. Enacted March 22, 2010. 18. US Census Bureau. Highlights: 2009. http://www.census.gov/hhes/www/ hlthins/data/incpovhlth/2009/highlights. html. Accessed July 27, 2011. 19. Compilation of the Social Security Laws. 1972. http://www.socialsecurity.gov/ OP_Home/ssact/title18/1881.htm. 20. Centers for Medicare & Medicaid Services. Fistula First Breakthrough 2011. http://www.cms.gov/ESRDQualityImprove Init/04_FistulaFirstBreakthrough.asp#Top OfPage. Accessed October 15, 2011. 21. Centers for Medicare & Medicaid Services. Medicare coverage of kidney dialysis and kidney transplant services. 2011; p 12. http://www.medicare.gov/ Publications/Pubs/pdf/10128.pdf. Accessed October 13, 2011. 22. HR 6331, The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008. 23. Centers for Medicare & Medicaid Services. End-stage renal disease prospective payment system. Fed Regist. 2010; 75(155):49029-49214. 24. Mayne TJ, Burgess M, Weldon J. Finding the case mix adjusters in the CMS proposed bundle. Nephrol News Issues. 2009;10:34-38. 25. Nissenson AR, Mayne TJ, Krishnan M. The 2009 proposed rule for prospective ESRD payment: perspectives from a large dialysis organization. Am J Kidney Dis. 2010;55(2):223-226.
Am J Kidney Dis. 2012;59(5):724-733
26. Centers for Medicare & Medicaid Services. End-Stage Renal Disease Prospective Payment System and Quality Incentive Program. Fed Regist. 2011;76(218): 70228-70318. http://www.gpo.gov/fdsys/ pkg/FR-2011-11-10/pdf/2011-28606.pdf. Accessed December 10, 2011. 27. Tollen LA. Physician Organization in Relation to Quality and Efficiency of Care: A Synthesis of Recent Literature. Commonwealth Fund pub. no. 1121. The Commonwealth Fund, New York, NY; April 2008. 28. Centers for Medicare & Medicaid Services Medicare Program. Medicare shared savings program: accountable care organizations. Fed Regist 2011;76(212): 67802-67990. 29. Cauchi R. State legislation opposing certain health reforms, 2009-2010, National Conference of State Legislatures. 2010. http://www.ncsl.org/?tabid⫽18906. Accessed October 10, 2011. 30. McClellan M, McKethan AN, Lewis JL, Roski J, Fisher ES. A national strategy to put accountable care into practice. Health Aff (Millwood). 2010;29(5):982-990. 31. Rosenthal MB, Cutler DM, Feder J. The ACO rules—striking the balance between participation and transformative potential. N Engl J Med. 2011;365(4):e6. 32. Wilensky GR. Lessons from the physician group practice demonstration—a sobering reflection. N Engl J Med. 2011; 365(18):1659-1661. 33. Centers for Medicare and Medicaid Services. Fact sheet: Medicare Physician Group Practice Demonstration: physicians groups continue to improve quality and generate savings under Medicare physician pay for performance demonstration; 2009. http://www.cms.gov/DemoProjects EvalRpts/downloads/PGP_Fact_Sheet.pdf. Accessed September 15, 2011. 34. Newman D. Accountable Care Organizations and the Medicare Shared Savings Program, Congressional Research Service, CRS Report for Congress 7-5700, R41474. 2010. 35. Lorenzo V, Martn M, Rufino M, Hernandez D, Torres A, Ayus JC. Predialysis nephrologic care and a functioning arterio-
venous fistula at entry are associated with better survival in incident hemodialysis patients: an observational cohort study. Am J Kidney Dis. 2004;43(6):999-1007. 36. Mendelssohn DC, Malmberg C, Hamandi B. An integrated review of “unplanned” dialysis initiation: reframing the terminology to “suboptimal” initiation. BMC Nephrol. 2009;10:22. 37. Wasse H, Kutner N, Zhang R, Huang Y. Association of initial hemodialysis vascular access with patient-reported health status and quality of life. Clin J Am Soc Nephrol. 2007;2(4):708-714. 38. Wingard RL, Pupim LB, Krishnan M, Shintani A, Ikizler TA, Hakim RM. Early intervention improves mortality and hospitalization rates in incident hemodialysis patients: RightStart program. Clin J Am Soc Nephrol. 2007;2(6):1170-1175. 39. Robertson J, Chen G, Goel P, Levine R, Benner D. Effect of IMPACT Program on Clinical Indicators of Incident Hemodialysis Patients. Munich, Germany: European Renal Association-European Dialysis and Transplant Association; 2010. 40. Manley HJ, Cannella CA, Bailie GR, St Peter WL. Medication-related problems in ambulatory hemodialysis patients: a pooled analysis. Am J Kidney Dis. 2005; 46(4):669-680. 41. US Renal Data System. USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Vol 2. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2010:s269-s280. 42. Centers for Medicare & Medicaid Services. [CMS 5003-N] RIN 0938-ZA39 Medicare Program; Demonstration: End-Stage Renal Disease-Disease Management. Fed Regist. 2003;68(107):notice 33495. 43. Coughlin J, Pope J, Leedle B. Old age, new technology and future innovations in disease management and home health care. Home Health Care Manage Pract. 2006;18(3):196-207. 44. Rastogi A, Linden A, Nissenson AR. Disease management in chronic kidney disease. Adv Chronic Kidney Dis. Jan 2008;15(1):19-28.
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