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RESEARCH OBJECTIVE: The Home Health Value‐Based Purchasing (HHVBP) Model provides financial incentives for quality improvement to home health agencies in nine states with the goal of improving quality and efficiency of care for Medicare beneficiaries. The maximum Medicare payment adjustment increases during each of the five years of the model, ranging from ±3% in 2018 to ±8% in 2022. Our goal is to understand the early impact of the HHVBP Model on quality, utilization, and Medicare spending during its first three years (2016–2018), which includes the first year in which payment adjustments to agencies took effect. STUDY DESIGN: CMS randomly selected nine states to participate in the HHVBP Model starting January 2016, with mandatory participation from all agencies. Agencies in these states received performance scores for 20 measures of quality of care used to determine their payment adjustment relative to other agencies within their state. To evaluate the effects of HHVBP, we used a difference‐in‐differences design and multivariate linear regression to compare differences in the changes in outcomes of the nine HHVBP states with those in the 41 comparison states for three years pre‐intervention (2013–2015) through the first three years of the model (2016–2018). We evaluated agency performance using Outcome and Assessment Information Set (OASIS)‐based quality measures and measures of claims‐based Medicare fee‐for‐service (FFS) health care utilization and spending. POPULATION STUDIED: Medicare and Medicaid patients receiving home health care in the nine HHVBP states and forty‐one comparison states. PRINCIPAL FINDINGS: We found evidence of slightly greater improvements in most measures of improved functional status used to determine payment adjustments in HHVBP states relative to non‐HHVBP states. Compared to non‐HHVBP states, Medicare FFS beneficiaries who received home health care in the nine HHVBP states had a relative decrease in unplanned hospitalization rate (−1.8%) and in skilled nursing facility (SNF) stays (−4.9%) from pre‐HHVBP implementation average levels. Conversely, we observed a 2.4% increase in emergency department (ED) visits relative to the average pre‐implementation rates for HHVBP states. Overall, we found evidence of a 1.2% reduction in Medicare spending due to HHVBP, corresponding to an average $141 million reduction in annual Medicare spending in HHVBP states over the first three years of the model. The reduction in spending among home health Medicare FFS patients was driven primarily by reductions in inpatient hospital spending (−2%) and SNF spending (−4%). We did not find an appreciable difference in savings between the third year—in which payment adjustments were applied—and the first two years of the model prior to HHVBP agencies receiving payment adjustments. CONCLUSIONS: Through the HHVBP Model's first three years—which includes the first year of payment adjustments to agencies—we found modest impacts of HHVBP: lower growth in Medicare spending, declines in unplanned hospitalizations and use of SNFs, somewhat greater increases in ED use, and somewhat greater improvements in many OASIS‐based quality measures among home health patients in the HHVBP states. IMPLICATIONS FOR POLICY OR PRACTICE: The findings from current and subsequent research will inform policymakers, home health care patients, and other stakeholders about potential benefits of expanding the model to include agencies in other states. PRIMARY FUNDING SOURCE: Centers for Medicare and Medicaid Services.

BACKGROUND The effects of Medicare payment reforms aiming to improve the efficiency and quality of care by establishing greater financial accountability for providers may vary based on the extent and types of other coverage for their patient populations. Providers who are more resource constrained due to a less favorable payer mix face greater financial risks under such reforms. The impact of the expanded Medicare dialysis prospective payment system (PPS) on quality of care in independent dialysis facilities may vary based on the extent of higher payments from private insurers available for managing increased risks. OBJECTIVES To evaluate whether anemia outcomes for dialysis patients in independent facilities differ under the Medicare PPS based on facility payer mix. DESIGN We examined changes in anemia outcomes for 122,641 Medicare dialysis patients in 921 independent facilities during 2009-2014 among facilities with differing levels of employer insurance (EI). We performed similar analyses of facilities affiliated with large dialysis organizations, whose practices were not expected to change based on facility-specific payer mix. RESULTS Among independent facilities, similar modeled trends in low hemoglobin for all 3 facility EI groups in 2009-2010 were followed by increased low hemoglobin during 2012-2014 for facilities with lower EI (P

Rationale & Objective Transitions between dialysis modalities can be disruptive to care. Our goals were to evaluate rates of transition from peritoneal dialysis (PD) to in-center hemodialysis (HD), mortality, and transplantation among incident PD patients in the US Renal Data System from 1996 to 2015 and identify factors associated with these outcomes. Study Design Observational registry-based retrospective cohort study. Setting & Participants Medicare patients incident to end-stage renal disease (ESRD) from January 1, 1996, through December 31, 2011 (for adjusted analyses; through December 31, 2014, for unadjusted analyses), and treated with PD 1 or more days within 180 days of ESRD incidence (n = 173,533 for adjusted analyses; n = 219,787 for unadjusted analyses). Exposure & Predictors Exposure: 1 or more days of PD. Predictors: patient- and facility-level characteristics obtained from Centers for Medicare & Medicaid Services Form 2728 and other data sources. Outcomes Patients were followed up for 3 years until transition to in-center HD, death, or transplantation. Analytical Approach Multivariable Cox regression was used to estimate hazards over time and associations with predictors. Results Compared with earlier cohorts, recent incident PD patient cohorts had lower rates of death (48% decline) and transition to in-center HD (13% decline). Among many other findings, we found that: (1) rates of transition to in-center HD and death were lowest in the 2008 to 2011 cohort, (2) longer time receiving PD was associated with higher mortality risk but lower risk for transition to in-center HD, and (3) larger PD programs (≥25 vs ≤6 patients) displayed lower risks for death and transition to in-center HD. Limitations Data collected on Form 2728 are only at the time of ESRD incidence and do not provide information at the time of transition to in-center HD, death, or transplantation. Conclusions Rates of transition from PD to in-center HD and death rates for PD patients decreased over time and were lowest in PD programs with 25 or more patients. Implications of the observed improved technique survival warrant further investigation, focusing on modifiable factors of center-level performance to create opportunities for improved patient outcomes., Visual abstract

The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic immunosuppressants using US Medicare Part D Prescription Drug Event (PDE) and Colorado pharmacy claims (including both Part D and non-Part D) data from 2008 to 2013. Data from 26 070 kidney, 15 548 liver, and 6685 heart recipients from Part D, and 1138 kidney and 389 liver recipients from Colorado were analyzed. The proportions of patients with PDEs or claims for generic and brand-name tacrolimus or mycophenolate mofetil were calculated over time by transplanted organ and drug. Among Part D kidney, liver, and heart beneficiaries, the proportion dispensed generic tacrolimus reached 50%−56% at 1 year after first generic approval and 78%−81% by December 2013. The proportion dispensed generic mycophenolate mofetil reached 70%−73% at 1 year after generic market entry and 88%−90% by December 2013. There was wide interstate variability in generic uptake, with faster uptake in Colorado compared with most other states. Overall, generic substitution for tacrolimus and mycophenolate mofetil for organ transplant recipients increased rapidly following first availability, and utilization of generic immunosuppressants exceeded that of brand-name products within a year of market entry.

RESEARCH OBJECTIVE: CMS launched the ESRD Quality Incentive Program (QIP) in 2010. The ESRD QIP adjusts Medicare payments to dialysis facilities based on their performance on a set of quality measures. The measures are revised in most years. We assessed whether the magnitude of ESRD QIP payment reductions was associated with several important patient outcomes that are not an intrinsic part of the QIP measure set. STUDY DESIGN: We compared mortality, utilization of health care services, and Medicare payments per patient‐year during 2015‐2017 for dialysis facilities in each ESRD QIP payment reduction category (0%, 0.5%, 1.0%, 1.5%, and 2.0%) corresponding to their QIP performance for the same year. The data sources include Medicare claims and enrollment files. Results were expressed as unadjusted averages and as modeled measures of association that adjusted for important patient factors (age, sex, race, ethnicity, diabetes, duration of ESRD, and dual eligibility). POPULATION STUDIED: The patient cohort consisted of Medicare fee‐for‐service beneficiaries receiving chronic dialysis for ESRD on the first day of each year. Patients were attributed to the first facility that provided treatment during the year. PRINCIPAL FINDINGS: Most patients were treated in facilities that did not receive an ESRD QIP payment reduction (Table). There was a stepwise increase in mortality, hospitalization, hospital days, and Medicare payments per year in facilities with successively larger payment reductions. The increase in Medicare payments was largely for inpatient services. All findings were statistically significant in adjusted regression models (shown in the Table for mortality and total payment). CONCLUSIONS: Mortality, utilization, and Medicare payments were substantially higher for patients treated in facilities whose contemporaneous performance on ESRD QIP measures resulted in a payment reduction. Moreover, these outcome measures increased stepwise with the magnitude of facility payment reductions. The findings are consistent with the hypothesis that the ESRD QIP measures and scoring system capture meaningful determinants of health care quality and value. IMPLICATIONS FOR POLICY OR PRACTICE: The findings support the validity of ESRD QIP. The findings offer an approach to ongoing monitoring and validation of QIP measures. PRIMARY FUNDING SOURCE: The study was funded by the Centers for Medicare and Medicaid Services.

BACKGROUND AND OBJECTIVES: Peritoneal dialysis (PD) use increased in the United States with the introduction of a new Medicare prospective payment system in January 2011 that likely reduced financial disincentives for facility use of this home therapy. The expansion of PD to a broader population and facilities having less PD experience may have implications for patient outcomes. We assessed the impact of PD expansion on PD discontinuation and patient mortality. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A prospective cohort study was conducted of patients treated with PD at 90 days of ESKD. Patients were grouped by study start date relative to the Medicare payment reform: prereform (July 1, 2008 to December 31, 2009; n=10,585), interim (January 1, 2010 to December 31, 2010; n=7832), and reform period (January 1, 2011 to December 31, 2012; n=18,742). Patient characteristics and facility PD experience were compared at baseline (day 91 of ESKD). Patients were followed for 3 years for the major outcomes of PD discontinuation and mortality using Cox proportional hazards models. RESULTS: Patient characteristics, including age, sex, race, ethnicity, rurality, cause of ESKD, and comorbidity, were similar or showed small changes across the three study periods. There was an increasing tendency for patients on PD to be treated in facilities with less PD experience (from 34% during the prereform period being treated in facilities averaging

Objective To evaluate the effect of the Medicare dialysis payment reform on potential disparities in the selection of peritoneal dialysis (PD) for the treatment of end-stage renal disease (ESRD). Data Sources Centers for Medicare & Medicaid Services (CMS) ESRD Medical Evidence Form, Medicare claims, and other CMS data for 2008–2013. Study Design We examined the association of patient age, race/ethnicity, urban/rural location, pre-ESRD care, comorbidities, insurance, and other factors with the selection of PD as initial dialysis modality across prereform (2008–2009), interim (2010), and postreform (2011–2013) time periods. Principal Findings Selection of PD increased among diverse patient subgroups following the payment reform. However, the lower PD selection observed with older age, black race, Hispanic ethnicity, less pre-ESRD care, and Medicaid insurance before the reform largely remained in the initial postreform years. Conclusions Despite recent growth in PD, there may be ongoing disparities in access to PD that have largely not been mitigated by the payment reform. There is potential for modifying provider financial incentives to achieve policy goals related to cost and quality of care. However, even with a substantial shift in financial incentives, separate initiatives to reduce existing disparities in care may be needed.

Objective To analyze variation in medical care use attributable to Medicare's decentralized claims adjudication process as exemplified in home hemodialysis (HHD) therapy. Data Sources/Study Setting Secondary data analysis using 2009–2012 paid Medicare claims for HHD and in-center hemodialysis (IHD). Study Design We compared variation across Medicare administrative contractors (MACs) in predicted paid treatments per standardized patient-month for HHD and IHD patients. We used ordinary least-squares regression to determine whether higher paid HHD treatment counts expanded HHD programs’ presence among dialysis facilities. Data Collection We identified HHD and IHD treatments using procedure, revenue center, and claim condition codes on type 72x claims. Principal Findings MACs varied persistently in predicted HHD treatments per patient-month, ranging from 14.3 to 21.9 treatments versus 10.9 to 12.4 IHD treatments. The presence of facilities’ HHD programs was uncorrelated with average HHD payment counts. Conclusions Medicare's claims adjudication process promotes variation in medical care use, as we observe among HHD patients. MACs’ discretionary decision making, while potentially facilitating innovation, may admit inefficiency in care practice as well as inequitable access to health care services. Regulators should weigh the benefits of flexibility in local coverage decisions against those of national standards for medical necessity.

In 2011, Medicare implemented a prospective payment system (PPS) covering an expanded bundle of services that excluded blood transfusions. This led to concern about inappropriate substitution of transfusions for other anemia management methods.Medicare claims were used to calculate transfusion rates among dialysis patients pre- and post-PPS. Linear probability regressions adjusted transfusion trends for patient characteristics.Dialysis patients for whom Medicare was the primary payer between 2008 and 2012.Pre-PPS (2008-2010) versus post-PPS (2011-2012).Monthly and annual probability of receiving one or more blood transfusions.Monthly rates of one or more transfusions varied from 3.8%-4.8% and tended to be lowest in 2010. Annual rates of transfusion events per patient were -10% higher in relative terms post-PPS, but the absolute magnitude of the increase was modest (-0.05 events/patient). A larger proportion received 4 or more transfusions (3.3% in 2011 and 2012 vs 2.7%-2.8% in prior years). Controlling for patient characteristics, the monthly probability of receiving a transfusion was significantly higher post-PPS (β = 0.0034; P0.001), representing an -7% relative increase. Transfusions were more likely for females and patients with more comorbid conditions and less likely for blacks both pre- and post-PPS.Possible underidentification of transfusions in the Medicare claims, particularly in the inpatient setting. Also, we do not observe which patients might be appropriate candidates for kidney transplantation.Transfusion rates increased post-PPS, but these increases were modest in both absolute and relative terms. The largest increase occurred for patients already receiving several transfusions. Although these findings may reduce concerns regarding the impact of Medicare's PPS on inappropriate transfusions that impair access to kidney transplantation or stress blood bank resources, transfusions should continue to be monitored.

Background Medicare implemented a new prospective payment system (PPS) on January 1, 2011. This PPS covers an expanded bundle of services, including services previously paid on a fee-for-service basis. The objectives of the new PPS include more efficient decisions about treatment service combinations and modality choice. Methods Primary data for this study are Medicare claims files for all dialysis patients for whom Medicare is the primary payer. We compare use of key injectable medications under the bundled PPS to use when those drugs were separately billable and examine variability across providers. We also compare each patient's dialysis modality before and after the PPS. Results Use of relatively expensive drugs, including erythropoiesis-stimulating agents, declined substantially after institution of the new PPS, whereas use of iron products, often therapeutic substitutes for erythropoiesis-stimulating agents, increased. Less expensive vitamin D products were substituted for more expensive types. Drug spending overall decreased by ∼$25 per session, or about 5 times the mandated reduction in the base payment rate of ∼$5. Use of peritoneal dialysis increased in 2011 after being nearly flat in the years prior to the PPS, with the increase concentrated in patients in their first or second year of dialysis. Home hemodialysis continued to increase as a percentage of total dialysis services, but at a rate similar to the pre-PPS trend. Conclusion The expanded bundle dialysis PPS provided incentives for the use of lower cost therapies. These incentives seem to have motivated dialysis providers to move toward lower cost methods of care in both their use of drugs and choice of modalities.

Background: Different types of providers often face differing financial incentives for providing similar types of care. This may have implications for payment systems that target improvements in care requiring multiple types of providers. Objectives: The objective of this study was to determine how hospitalization influences the anemia of Medicare patients with chronic renal failure, where anemia is treated under a prospective payment system during hospitalizations and under a fee-for-service system during outpatient renal dialysis. Methods: We examined the effects of time in hospital and reason for hospitalization on levels of anemia among 87,263 Medicare renal dialysis patients with a hospital stay of 3 days or more during 2004. Medicare claims were used to measure changes in hematocrit between the month before and the month after hospital discharge, and to classify admissions with a high risk of anemia. Multilevel models were used to study variation in outcomes across providers. Results: Longer time in the hospital was associated with worsening anemia. As expected, larger declines in hematocrit occurred following admissions for conditions or procedures with a high risk of anemia. However, we observed a similar effect of time in the hospital for admissions both with and without a high risk of anemia. There were relatively large differences in anemia outcomes across both individual hospitals and physicians. Conclusions: Hospitalization-related anemia increases the need for care by outpatient renal dialysis providers. Efforts to improve care through payment system design are more likely to be successful if financial incentives are aligned across care settings.

Private and public payers are focusing on measuring and rewarding quality and efficiency in health care (Milgate and Cheng 2006; Rosenthal et al. 2006;). Such efforts include “pay-for-performance” (P4P) systems that reward measured performance, capitation systems that put providers at financial risk for high utilization, and tiered networks in which insurers use measured performance to assign providers to “preferred” status levels. A key component of the design of such systems is the determination of whose performance to measure and reward. Typically, patients have contact with multiple physicians and institutions (Pham et al. 2007). For example, surgical outcomes could be affected by the surgeon, the surgical team (surgeons, nurses, and anesthetists), and the institution where the surgery was performed. Therefore, determining rules regarding attribution of outcomes to providers creates major challenges in payment system design. Failure to accurately identify the provider or providers with the greatest influence on outcomes could adversely affect the credibility and impact of the payment system, and it could make providers accountable for decisions outside their control. Similarly, the validity of provider profiles, which are being developed for quality assessment and improvement (Bodenheimer 1999) using more rigorous methods (Huang et al. 2005; Shahian et al. 2005; Zheng et al. 2006;), also depends on whether they identify the providers with the greatest ability to affect the outcome the policy maker is trying to influence. In principle, outcomes could be measured and rewarded for any or all of the providers or types of providers involved in a patient's care. However, doing so would present a variety of challenges. Data may not be available across all providers and only limited case mix adjusters may be available to control for differences in the patient populations. Even when data are available, statistical power to differentiate outcome variations associated with different physicians and facilities is often limited by sample size. Likewise, providers treating atypical patient populations could face substantial financial risks under a prospective payment system (PPS). Owing in part to these difficulties, decisions about whom to measure and reward have generally not been based on empirical analyses of the relative impact of particular providers (or of different types of providers) on outcomes. Rather, decisions about which provider (or type of provider) to attribute responsibility have been based on factors such as convenience (e.g., measurement at the institutional level due to easier availability of data or large sample sizes), prospective assignment of patients to a designated “gatekeeper” physician (Rosenthal et al. 2006), or arbitrary retrospective rules such as attributing responsibility to all providers with a minimum level of patient contact or to the single provider with the most patient contact during the year (Dudley and Rosenthal 2006; Milgate and Cheng 2006;). The Medicare Payment Advisory Commission (MedPAC) as well as physicians and their professional societies have expressed concern regarding the attribution methods in use today (American College of Cardiology 2006; Milgate and Cheng 2006; Sinsky 2007; American Academy of Family Physicians 2008;). This paper uses renal dialysis services to demonstrate a method for identifying the extent to which different types of providers influence variation in resource use and patient outcomes. Dialysis provides an excellent context for this study. Patients have ongoing relationships with both an institutional provider (the dialysis facility) and a physician (the nephrologist who manages dialysis-related services). Multiple nephrologists practice within most dialysis facilities, and most nephrologists practice in multiple facilities. This double “cross-over” facilitates the statistical identification of physician and facility effects on outcomes. Because the vast majority of dialysis patients are insured by Medicare, available data include a large number of patients. Further, detailed clinical data are available to adjust for case mix. Finally, several clinical performance measures are well established and relatively well accepted. Dialysis facilities have a financial incentive to increase the use of the services, primarily injectable medications, which are paid on a fee-for-service basis by Medicare. However, physicians, who generally do not profit from these services, are ultimately responsible for prescribing care. Given the recent controversy about appropriate anemia management in dialysis facilities, these issues are particularly salient. Researchers have presumed that the organization is the decision making locus (e.g., Thamer et al. 2007), while others have argued that institutional protocols are physician driven and modified by individual physicians in response to patient condition (Lazarus and Hakim 2007). Although outcomes and resource utilization may depend on both the dialysis facility and the nephrologist, public reporting of performance measures (Dialysis Facility Compare; http://www.cms.hhs.gov/DialysisFacilityCompare/), quality improvement initiatives (e.g., http://www.esrdnetworks.org), P4P proposals (Milgate and Cheng 2006), and the development of an expanded case mix–adjusted dialysis PPS as required by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173) all use the dialysis facility as the locus of measurement and/or reward. Not only does this implicitly attribute responsibility to the facility for the practices of nonemployee physicians but also failure to report at the physician level provides no guidance to patients regarding choice of physician, and failure to provide physician incentives may forego opportunities to improve care. Two prior studies are particularly relevant. Krein et al. (2002) developed an empirical basis for deciding which provider level to profile (facility, professional group, or physician) in the context of diabetes care in the Veterans Administration (VA) system. They found that for outcome and resource use measures, variation at the facility level is dramatically higher than that at the physician level. Physician variation was substantial only for narrow process measures (ordering of specific laboratory tests), and the provider group explained relatively little variation in any measure. However, their study was limited to 13 facilities in one VA region. A second prior study investigated the relative variation of resource use in U.S. dialysis facilities across four levels: facilities, nephrologists, patients, and time (different months for a given patient) (Turenne et al. 2008). The analysis of four levels of variation created computational limitations which required a sampling strategy that limited the analysis to a 4 percent random sample of facilities and distinguished provider-level effects only through multiple physicians practicing within a facility (and not from physicians practicing in multiple facilities). Although this study also found that the variation across facilities exceeded across physicians, the physician-level variation was relatively more important than that found by Krein, with financially significant variation in resource use across both facilities and physicians. The current study extends this previous research in several significant ways. First, by aggregating data across multiple months for each patient, this study uses data from almost all physician-facility pairs and both types of “cross-over” between physicians and facilities. Second, the prior dialysis study only examined resource utilization (costs per dialysis session for a set of services, primarily injectable medications and laboratory tests). The current study uses the same utilization measure but adds two outcome measures (achieving treatment targets for dose of dialysis and anemia management). Third, this study uses slightly more recent data (2004) than the prior dialysis study (2003).

Background: In developing “pay-for-performance” and capitation systems that provide incentives for improving the quality and efficiency of care, policymakers need to determine which healthcare providers to evaluate and reward. Objectives: This study demonstrates methods for determining and understanding the relative contributions of facilities and physicians to the quality and cost of care. Specifically, this study distinguishes levels of variation in resource utilization (RU), based on research to support the development of an expanded Medicare dialysis prospective payment system. Research Design: Mixed models were used to estimate the variation in RU across institutional providers, physicians, patients, and months (within patients), after adjusting for case-mix. Subjects: The study includes 10,367 Medicare hemodialysis patients treated in a 4.2% stratified random sample of dialysis facilities in 2003. Measures: Monthly RU was measured by the average Medicare allowable charge per dialysis session for separately billable dialysis-related services (mainly injectable medications and laboratory tests) from Medicare claims. Results: There was financially significant variation in RU across institutional providers and to a lesser degree across physicians, after adjusting for differences in case-mix. The remaining variation in RU reflects unexplained differences across patients that persist over time and transitory fluctuations for individual patients. Conclusions: The greater variation in RU occurring across dialysis facilities than across physicians is consistent with targeting payments to facilities, but alignment of incentives between facilities and physicians remains an important goal. Similar analytic methods may be useful in designing payment policies that reward providers for improving the quality of care.

and also met with several Minntech executives. During this period, the authors ex- plained their analytical methods and results to Minntech, provided statistical output to Minntech, and considered Minntech’s disagreements with the research. As part of a prepublication review pro- cess, a draft version of the study manuscript

Medicare is considering an expansion of the bundle of dialysis-related services to be paid on a prospective basis. Exploratory models were developed to assess the potential limitations of case-mix adjustment for such an expansion. A broad set of patient characteristics explained 11.8% of the variation in Medicare allowable charges per dialysis session. Although adding recent hematocrit values or prior health care utilization to the model did increase explanatory power, it could also create adverse incentives. Projected gains or losses relative to prevailing fee-for-service payments, assuming no change in practice patterns, were significant for some individual providers. However, systematic gains or losses for different classes of providers were modest.

The Medicare program reimburses dialysis providers a flat rate for a bundle of services that comprise the basic dialysis treatment. This payment system is being modified to incorporate case-mix adjustment for age and body size, which have been shown to influence dialysis costs. This study simulated the economic impact of the recently issued Medicare rule on case-mix adjustment by estimating the variation in payments across patients, facilities, and broad classes of facilities. Case-mix adjustment results in considerable patient-level variation in payments (dollar 12.99 SD in case-mix adjusted payments). The variation across dialysis facilities is smaller but still economically significant (dollar 3.77 SD). However, there was little evidence that particular classes of facilities (e.g., ownership, chain membership, size) will be substantially advantaged or disadvantaged by case-mix adjustment. There do seem to be modest changes in the regional distribution of payments.

Choices with respect to labor force participation and medical treatment are increasingly intertwined. Technological advances present patients with new choices and may facilitate continued employment for the growing number of chronically ill individuals. We examine joint work/treatment decisions of end stage renal disease patients, a group for whom these tradeoffs are particularly salient. Using a simultaneous equations probit model, we find that treatment choice is a significant predictor of employment status. However, the effect size is considerably smaller than in models that do not consider the joint nature of these choices.

Implementation of the Medicare ESRD prospective payment system (PPS) and changes to dosing guidelines for erythropoiesis-stimulating agents (ESAs) in 2011 appear to have influenced use of injectable medications among dialysis patients. Given historically higher ESA and vitamin D use among black patients, we assessed the effect of these policy changes on racial disparities in the management of anemia and mineral metabolism. Analyses used cross-sectional monthly cohorts for a period-prevalent sample of 7384 maintenance hemodialysis patients at 132 facilities from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor. Linear splines with knots at each policy change were used in survey-weighted regressions to estimate time trends in hemoglobin (Hgb), erythropoietin (EPO) dose, intravenous (IV) iron dose, ferritin, transferrin saturation (TSAT) concentration, parathyroid hormone (PTH), IV vitamin D dose, cinacalcet use, and phosphate binder use. From August 2010 to December 2011, mean Hgb declined from 11.5 to 11.0 g/dl (P0.21). Mean EPO and vitamin D dose and serum PTH levels remained higher in blacks. Despite evidence that anemia and mineral metabolism management practices have changed significantly over time, there was no immediate indication of racial disparities resulting from implementation of the PPS or ESA label change. Further studies are needed to examine effects among patient and facility subgroups.

Vascular access failure causes substantial morbidity to hemodialysis patients. We sought to identify factors determining survival of the permanent vascular access in use at the start of end-stage renal disease during 1990 in a national sample of 784 incident hemodialysis patients insured by Medicare. Medicare claims records were used to identify access failures or revisions among patients with an arteriovenous (AV) fistula (n = 245) and an AV vascular graft (n = 539). A proportional hazards analysis of time to first failure or revision, controlled by stratification for sex, race, and cause of end-stage renal disease, was used to determine the effect of age, access type, and peripheral vascular disease on vascular access survival. Patients with an AV fistula and who were older than 65 years had a risk of access failure that was 24% lower than similar patients with an AV graft (P < 0.02). The relative risk of access failure for an AV fistula, but not an AV graft, varied significantly with age for patients younger than 65 years (P < 0.01). The relative risk of access failure for a patient with an AV fistula, compared with a patient of the same age with an AV graft, was 67% lower at the age of 40 years, 54% lower at the age of 50 years, and 24% lower at the age of 65 years. A history of peripheral vascular disease was associated with a 24% higher risk of AV graft or fistula failure (P = 0.05). Measures to decrease vascular access-related morbidity among hemodialysis patients should include reversing the current trend toward increasing use of AV grafts, particularly in patients younger than 65 years.

We have examined trends in hemodialysis practice from August 2010 to August 2011, a time frame spanning the implementation of the bundled PPS, a major ESA label change by the FDA, and announcements from CMS on the proposed and final rules for the first year of the Quality Incentive Program (QIP) plus the proposed rules for the second and third years of the QIP. Although many hemodialysis practices have remained stable during this 1-year time period, substantial changes have been seen. These include a decline in epoetin dose and hemoglobin levels, an increase in IV iron use and serum ferritin levels, and an increase in PTH levels. The rates of decline in hemoglobin and epoetin dosing levels were greatest in the 2 months after the ESA label change in June 2011. Trends in anemia care in ensuing months, with more follow-up time after the label change, will be of great interest. In view of declining hemoglobin levels, a mechanism for comprehensive monitoring of transfusion rates is warranted to understand this important aspect of care for hemodialysis patients. Regarding clinical outcomes, no trend in all-cause mortality has been evident during this 1-year time period. Additional follow-up is warranted to understand if findings reported here persist over time, and require confirmation with national data as these become available. Trends in clinical care may not necessarily affect patient outcomes, and careful evaluation is required to understand effects on patient outcomes.

A new initiative of the United States (U.S.) Dialysis Outcomes and Practice Patterns Study (DOPPS), the DOPPS Practice Monitor (DPM) provides up-to-date data and analyses to monitor trends in dialysis practice during implementation of the new Centers for Medicare and Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS; 2011–2014). We review DPM rationale, design, sampling approach, analytic methods, and facility sample characteristics. Using stratified random sampling, the sample of ~145 U.S. facilities provides results representative nationally and by facility type (dialysis organization size, rural/urban, free-standing/hospital-based), achieving coverage similar to the CMS sample frame at average values and tails of the distributions for key measures and patient characteristics. A publicly available Web report (www.dopps.org/DPM) provides detailed trends including demographic, comorbidity, and dialysis data, medications, vascular access, and quality of life. Findings are updated every 4 months and lagged only 3–4 months. Baseline data are from mid-2010, prior to the new PPS. In sum, the DPM provides timely, representative data to monitor the effects of the expanded PPS on dialysis practice. Findings can serve as an early warning system for possible adverse effects on clinical care and as a basis for community outreach, editorial comment, and informed advocacy.

Because of adverse survival effects, anemia management and financial incentives to increase doses of erythropoiesis-stimulating agents (ESAs) have been controversial. Prior studies showed more aggressive anemia management in dialysis facilities owned by for-profit chains, but have been criticized for not accounting for practices of individual physicians and facilities.To improve understanding of how dialysis practices and resource utilization are influenced by physicians, facilities, and chains.Mixed models with chain fixed effects and facility and physician random effects.Medicare hemodialysis patients in 2004.A total of 234,158 patients, 3995 facilities, 4838 physicians, and 7 chain classifications were included.Spending per session for dialysis-related services billed separately from the dialysis treatment and for ESAs. Achievement of hematocrit (HCT) and urea reduction ratio (URR) targets.Of the 4 largest for-profit chains, 3 had higher resource use than independents, with differences up to $17.92 higher ESA/session. Utilization was positively associated with achieving target HCT. Despite incurring lower costs, patients treated by a large nonprofit chain were as likely as patients of independents to achieve the HCT target. The largest chains were more likely than independents to achieve the URR target. Substantial variation occurred across physicians and facilities, and adjustment for chain only modestly decreased this variation.Chains' methods of influencing practices were not directly observed.Chains appear to have the ability to implement protocols that shift practices, but not the ability to substantially reduce local variation. Assertions that chain effects found by earlier studies were spurious are not supported.

Background: Racial disparities in health care are widespread in the United States. Identifying contributing factors may improve care for underserved minorities. To the extent that differential utilization of services, based on need or biological effect, contributes to outcome disparities, prospective payment systems may require inclusion of race to minimize these adverse effects. This research determines whether costs associated with end-stage renal disease (ESRD) care varied by race and whether this variance affected payments to dialysis facilities. Study Design: We compared the classification of race across Medicare databases and investigated differences in cost of care for long-term dialysis patients by race. Setting & Participants: Medicare ESRD database including 890,776 patient-years in 2004-2006. Predictors: Patient race and ethnicity. Outcomes: Costs associated with ESRD care and estimated payments to dialysis facilities under a prospective payment system. Results: There were inconsistencies in race and ethnicity classification; however, there was significant agreement for classification of black and nonblack race across databases. In predictive models evaluating the cost of outpatient dialysis care for Medicare patients, race is a significant predictor of cost, particularly for cost of separately billed injectable medications used in dialysis. Overall, black patients had 9% higher costs than nonblack patients. In a model that did not adjust for race, other patient characteristics accounted for only 31% of this difference. Limitations: Lack of information about biological causes of the link between race and cost. Conclusions: There is a significant racial difference in the cost of providing dialysis care that is not accounted for by other factors that may be used to adjust payments. This difference has the potential to affect the delivery of care to certain populations. Of note, inclusion of race into a prospective payment system will require better understanding of biological differences in bone and anemia outcomes, as well as effects of inclusion on self-reported race. Am J Kidney Dis 56:928-936. © 2010 by the National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Background Recent publications suggest that increased mortality is associated with high hematocrit targets in erythropoietin-stimulating agent–treated patients with chronic kidney disease. We aim to further inform the debate about optimal hematocrit targets, advancing the hypothesis that the current hematocrit target may not optimize the survival of patients with end-stage renal disease. Study Design Cross-sectional observational study. Setting & Participants Medicare dialysis patients from 2002 to 2004 (n = 393,967). Factors Quarterly average hematocrit and erythropoietin alfa (EPO) dose. Outcomes Mortality hazard ratios from time-dependent Cox proportional hazard models, adjusting for comorbidities. Results N = 2,712,197 patient-facility quarters. During the study, 100,086 deaths were identified. Percentages of patient quarters within each hematocrit category: hematocrit less than 27% (2.0%), 27% to 28.49% (1.7%), 28.5% to 29.9% (2.9%), 30% to 31.49% (5.2%), 31.5% to 32.99% (9.0%), 33% to 34.49% (14.9%), 34.5% to 35.99% (19.2%), 36% to 37.49% (18.0%), 37.5% to 38.99% (12.0%), 39% to 40.49% (6.4%), 40.5% to 41.99% (3.0%), and 42% or greater (3.1%). Mortality hazard ratios from the fully adjusted model: hematocrit less than 27% (3.11), 27% to 28.49% (2.60), 28.5% to 29.9% (2.14), 30% to 31.49% (1.80), 31.5% to 32.99% (1.44), 33% to 34.49% (1.17), 34.5% to 35.99% (reference), 36% to 37.49% (0.98), 37.5% to 38.99% (1.01), 39% to 40.49% (1.13), 40.5% to 41.99% (1.32), and 42% or greater (1.57). Limitations First, potential confounding by indication related to associations between underlying illness and mortality, anemia, and EPO responsiveness. Second, Medicare claims data reflect a range of conditions and degrees of severity not easily translated into the clinical context. Third, for Medicare claims, EPO reporting is not required if EPO is not billed. Greater than 95% of "missing hematocrit" quarters are "EPO = 0" patient quarters. Interpretation of results for the missing hematocrit and EPO=0 use categories is complicated by data source limitations. Conclusions We show an association between mortality and low hematocrit in dialysis patients, in part reflecting the presence of comorbidities. We also show an association between increased mortality and high hematocrit. Additional interventional trials should be undertaken to better define the optimal target for anemia management in patients with end-stage renal disease, with careful prospective identification of underlying comorbidities and clinical factors contributing to high erythropoietin-stimulating agent requirement.

Patient survival is a very basic but important outcome of any therapeutic intervention. In the case of end stage renal disease (ESRD), outcome studies have included several other outcomes such as quality of life indicators, morbidity measures (e.g., hospitalizations), length of time on a treatment modality (‘technique survival’) and survival with a functioning kidney allograft (graft survival). The establishment of regional and national registries has markedly facilitated the evaluation of these outcomes in actual practice rather than in the referral practice or related multicenter environment. This chapter will focus primarily on population-based patient survival studies using information from the United States Renal Data System (USRDS) and the Michigan Kidney Registry

In April 2005, Medicare began adjusting payments to dialysis providers for composite-rate services for a limited set of patient characteristics, including age, body surface area, and low body mass index. We present analyses intended to help the end-stage renal disease community understand the empirical reasons behind the new composite-rate basic case-mix adjustment. The U-shaped relationship between age and composite-rate cost that is reflected in the basic case-mix adjustment has generated significant discussion within the end-stage renal disease community. Whereas greater costs among older patients are consistent with conventional wisdom, greater costs among younger patients are caused in part by more skipped sessions and a greater incidence of certain costly comorbidities. Longer treatment times for patients with a greater body surface area combined with the largely fixed cost structure of dialysis facilities explains much of the greater cost for larger patients. The basic case-mix adjustment reflects an initial and partial adjustment for the cost of providing composite-rate services.

Inferior outcome of two-haplotype matched (2-HM) renal transplants in blacks: Role of early rejection. Acute rejection in the early post-transplant period is a major determinant of long-term outcome. A cohort analysis was performed to evaluate the race-specific incidence rates of early acute rejection episodes (AR) and delayed graft function (DGF) in Americans of African (blacks) and European (whites) descent (N = 2565) who received a 2-HM living-related donor (LRD) first kidney transplant between 1984 and 1992. After adjusting for center and recipient characteristics, blacks had a higher incidence of AR during the initial transplant hospitalization (blacks 13.2% vs. whites 7.4%, OR = 1.64, P = 0.02). DGF also occurred more frequently in blacks (unadjusted OR = 1.58, P = 0.07). Blacks with AR had significantly worse Cox-adjusted five year graft survival than similarly affected whites (blacks 50% vs. whites 76%, P < 0.01). We conclude that failure to take immunosuppressive medications cannot be implicated as a cause of the higher incidence of AR during the initial transplant hospitalization in black kidney transplant recipients. The excess risk of AR in blacks may reflect previously reported intrinsic differences in immune responsiveness and/or pharmacokinetics of immunosuppressive agents. The profound deleterious effect of AR appears to be largely responsible for the accelerated rate of late graft loss in African Americans.

There is an ongoing discussion in the renal community about how to monitor the treatment of hemodialysis patients in the United States. Comparison of the US patient experience to that of other countries with populations of similar heath status is one way to assess treatment. Another technique involves examining the level of dialysis therapy US patients receive. This paper reviews recent studies which found that the United States has higher mortality than both Japan and Europe and provides additional information as to why those comparisons might be underestimating the mortality differences. We also examine the data on the level of dialysis US patients receive, both as a prescription and as delivered care. We conclude that US patients receive less hemodialysis therapy than their European and Japanese counterparts, and that in general US patients are not receiving the level of dialysis they were prescribed. These factors are correlated with an increased mortality among US hemodialysis patients.

Continuous ambulatory peritoneal dialysis and hemodialysis: Comparison of patient mortality with adjustment for comorbid conditions. A historical prospective national sample of 1,725 diabetic and 2,411 non-diabetic Medicare end-stage renal disease (ESRD) patients incident from 1986 to 1987 was analyzed for the mortality of patients selected to receive continuous ambulatory peritoneal dialysis (CAPD) or hemodialysis (HD) with adjustment for patient characteristics, including the presence of comorbid conditions at onset of ESRD. Cox proportional hazards analyses were used to compare the mortality of CAPD and HD patients. Patients were followed from 30 days following onset of ESRD until two to four years post-onset. No statistically significant difference in relative mortality risk (RR) was found among non-diabetic patients selected for CAPD compared to HD (RR = 0.84 for CAPD versus HD, P = 0.25), while evidence of higher adjusted mortality for CAPD compared to HD was found among diabetic patients (RR = 1.26, P = 0.03). Mortality analyses adjusted for pre-treatment risk factors suggest that CAPD and HD provide incident non-diabetic ESRD patients with similar expected survival outcomes. Evidence that increased mortality was associated with CAPD among diabetic patients, particularly among elderly patients, suggests the need for further controlled studies of mortality among CAPD patients with diabetes.

Previous comparisons of the survival of end-stage renal disease (ESRD) patients in the US with Europe and Japan indicated worse survival outcomes for the US, with adjustment for differences in age and diabetes [1]. A similar set of survival comparisons between Japan and the US was presented at a recent conference in New York [2] (April 26, 1993) for a newer cohort of incident patients treated with continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). This report summarizes the results of those across-country comparisons, with added consideration given to the expected survival of dialysis patients compared to the expected survival of the general population in both societies.

Risk of peritonitis and technique failure by CAPD connection technique: A national study. Peritonitis has been a leading complication of long-term therapy with continuous ambulatory peritoneal dialysis (CAPD). This study was designed to evaluate the risk of peritonitis and technique failure according to the initial CAPD connection technique. Patients from all U.S. facilities starting CAPD therapy at home between January 1 and June 30, 1989 were followed for up to 21 months on the initial CAPD connection technique to change in technique or dialytic modality, to transplantation, death or loss to follow-up. Patients were grouped into standard connection techniques (SCT) (N = 1,133), Y-set (N = 1,067), standard UV set (N = 916) and O-set (N = 167). The time to first peritonitis episode was analyzed actuarially and by using the Cox proportional hazards model which adjusted for age, sex, race, cause of ESRD, CAPD program size and ESRD therapy prior to CAPD. Peritonitis occurred on average at 9.0 month intervals with SCT, 15.0 months with Y-set, 13.4 with standard UV and 9.4 with O-set. The relative risk (RR by Cox analysis) of first peritonitis compared to SCT was 0.60 (40% lower) for the Y-set (P < 0.01), 0.75 for standard UV (P < 0.01), and similar to SCT (RR = 0.96) for the O-set (NS), all else being equal. Analysis time to second (N = 1,271) peritonitis episode gave similar results as did analysis of time to CAPD technique failure. Significantly higher RR of peritonitis and technique failure was observed for younger and black patients. These findings suggest the utilization of connection techniques with superior results.

Objective. —Complications from vascular access account for 15% of hospital admissions among US hemodialysis patients. Complications are less frequent with arteriovenous fistulas than with synthetic grafts. We assessed clinical and nonclinical predictors of whether patients with end-stage renal disease (ESRD) starting hemodialysis receive a fistula or graft. We also investigated changes in practice between 1986-1987 and 1990. Design. —Cross-sectional study. Setting. —United States hemodialysis population. Patients. —Random, national samples of ESRD patients who started hemodialysis in 1986-1987 (n=2741) or 1990 (n=1409) from United States Renal Data System Special Studies. Main Outcome Measure. —Type of permanent vascular access (arteriovenous fistula vs synthetic graft), analyzed using multivariate logistic regression. Results. —Clinical and demographic factors as well as socioeconomic status, region of residence, and year starting hemodialysis predicted the type of vascular access. Overall, 56% of patients had grafts 30 days after starting dialysis, but graft use increased from 51% in 1986-1987 to 65% in 1990 (adjusted odds ratio [AOR], 1.67for 1990 vs 1986-1987; 95% confidence interval [CI], 1.43-1.95; P P P Concclusions. —This national study documents large variations in the relative use of fistulas and grafts and a trend away from fistulas. The prevalence of comorbid conditions fails to explain these findings. Presentation and referral of patients early in the process of their ESRD, teaching surgeons to place fistulas, and training dialysis nurses to access fistulas may increase their use.