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Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.

ABSTRACT: Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer. We compared observed rates of death and major cardiovascular events in 2011 and 2012 with expected rates calculated on the basis of rates in 2005-2010, accounting for differences in patient characteristics and influenza virulence. An abrupt decline in erythropoietin dosing and hemoglobin concentration began in late 2010. Observed rates of all-cause mortality, cardiovascular mortality, and myocardial infarction in 2011 and 2012 were consistent with expected rates. During 2012, observed rates of stroke, venous thromboembolic disease (VTE), and heart failure were lower than expected (absolute deviation from trend per 100 patient-years [95% confidence interval]: -0.24 [-0.08 to -0.37] for stroke, -2.43 [-1.35 to -3.70] for VTE, and -0.77 [-0.28 to -1.27] for heart failure), although non-ESA-related changes in practice and Medicare payment penalties for rehospitalization may have confounded the results. This initial evidence suggests that action taken to mitigate risks associated with ESA use and changes in payment policy did not result in a relative increase in death or major cardiovascular events and may reflect improvements in stroke, VTE, and heart failure.

SUBMITTER: Chertow GM

PROVIDER: S-EPMC5042674 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.

Chertow Glenn M GM Liu Jiannong J Monda Keri L KL Gilbertson David T DT Brookhart M Alan MA Beaubrun Anne C AC Winkelmayer Wolfgang C WC Pollock Allan A Herzog Charles A CA Ashfaq Akhtar A Sturmer Til T Rothman Kenneth J KJ Bradbury Brian D BD Collins Allan J AJ

Journal of the American Society of Nephrology : JASN 20160225 10

Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, wit ...[more]

PMID: 26917691

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Project description:ImportanceThe dialysis industry is highly concentrated, with large dialysis organizations now providing dialysis for more than 85% of patients with kidney failure in the United States. In 2011, Medicare introduced a new Prospective Payment System (PPS) for end-stage kidney disease, which bundled payment for dialysis care into 1 payment per patient. Trends in dialysis facility consolidation after the PPS went into effect are unknown.ObjectiveTo determine whether the introduction of the PPS in 2011 was associated with an acceleration in acquisitions and closures of small dialysis chains (<20 facilities) and independently owned facilities.Design setting and participantsThis retrospective cohort study included all Medicare-certified independent or small chain-affiliated dialysis facilities in the continental US between 2006 and 2016. Data were obtained from Medicare and the US Renal Data System and were analyzed in 2020.ExposuresThe PPS.Main outcomes and measuresDiscrete time hazard models were used to estimate the odds of acquisition and closure before the PPS (2006-2010) vs after the PPS (2011-2016). Analyses controlled for facility, market, and regional demographic characteristics. The average predicted marginal probabilities of acquisition and closure over time were estimated.ResultsThe proportion of small chain-affiliated and independently owned facilities declined from 29% (1383 of 4750 facilities) in 2006 to 15% (1038 of 6738) in 2016. Among 13 481 facility-years, 6352 (47%) were for profit, and mean (SD) census was 68 (59) patients. Overall, 3286 (24%) facilities opened during the observation period. The proportion of acquisitions that occurred each year varied from 1.1% (12 of 1065 facilities in 2015) to 7.2% (86 of 1192 facilities in 2012), while closures varied from 0.8% (9 of 1065 facilities in 2015) to 2.2% (28 of 1286 facilities in 2010), making both fairly rare. There was a 3.48 higher odds of acquisition in the post-PPS period compared with the pre-PPS period (95% CI, 1.62-7.47; P = .001). The odds of closure before and after the PPS were not statistically significantly different (odds ratio, 2.03; 95% CI, 0.61-6.73; P = .25). Facilities that opened during the observation period had a 7.2% higher predicted probability of acquisition compared with older facilities (95% CI, 5.4%-9.0%; P < .001).Conclusions and relevanceIn this cohort study of continental US Medicare-certified dialysis facilities, small-chain and independently owned facilities retained a declining share of the dialysis market. Further research should evaluate the effect of continued dialysis market consolidation on patient access, health care utilization, and clinical outcomes.

Project description:Background and objectivesBecause of the limited capacity of its own dialysis facilities, the Department of Veterans Affairs (VA) Veterans Health Administration routinely outsources dialysis care to community providers. Prior to 2011-when the VA implemented a process of standardizing payments and establishing national contracts for community-based dialysis care-payments to community providers were largely unregulated. This study examined the association of changes in the Department of Veterans Affairs payment policy for community dialysis with temporal trends in VA spending and veterans' access to dialysis care and mortality.Design, setting, participants, & measurementsAn interrupted time series design and VA, Medicare, and US Renal Data System data were used to identify veterans who received VA-financed dialysis in community-based dialysis facilities before (2006-2008), during (2009-2010), and after the enactment of VA policies to standardize dialysis payments (2011-2016). We used multivariable, differential trend/intercept shift regression models to examine trends in average reimbursement for community-based dialysis, access to quality care (veterans' distance to community dialysis, number of community dialysis providers, and dialysis facility quality indicators), and 1-year mortality over this time period.ResultsBefore payment reform, the unadjusted average per-treatment reimbursement for non-VA dialysis care varied widely ($47-$1575). After payment reform, there was a 44% reduction ($44-$250) in the adjusted price per dialysis session (P<0.001) and less variation in payments for dialysis ($73-$663). Over the same time period, there was an increase in the number of community dialysis facilities contracting with VA to deliver care to veterans with ESKD from 19 to 37 facilities (per VA hospital), and there were no changes in either the quality of community dialysis facilities or crude 1-year mortality rate of veterans (12% versus 11%).ConclusionsVA policies to standardize payment and establish national dialysis contracts increased the value of VA-financed community dialysis care by reducing reimbursement without compromising access to care or survival.

Project description:BACKGROUND AND OBJECTIVES:This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx. Dosing was adjusted according to the epoetin alfa prescribing information. The coprimary efficacy end points were the least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment. RESULTS:The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin was -0.12 g/dl and the 95% confidence interval (-0.25 to 0.01) was contained within the prespecified equivalence margin (-0.5 to 0.5 g/dl). The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week, and the 95% confidence interval (-10.40 to 11.13) was contained within the prespecified equivalence margin (-45 to 45 U/kg per week). Incidences of adverse events (77.1% versus 75.3%), serious adverse events (24.9% versus 27.0%), and deaths (n=5 versus 6) were similar between the epoetin alfa-epbx and epoetin alfa groups, respectively. Five patients tested positive for anti-recombinant human erythropoietin antibodies at baseline, and two additional patients (n=1 per group) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of pure red cell aplasia. CONCLUSIONS:This 24-week, comparative, clinical trial in patients on hemodialysis with ESKD and anemia demonstrated there is no clinically meaningful difference in efficacy or safety between epoetin alfa-epbx and epoetin alfa.

Project description:Background and objectivesPeritoneal 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, & measurementsA 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.ResultsPatient 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 <14 patients on PD per year to 44% in the reform period). Patients treated in facilities with less PD experience had a higher rate of PD discontinuation than patients treated in facilities with the most experience (hazard ratio [HR], 1.16; 95% confidence interval [95% CI], 1.10 to 1.23 for the first versus fifth quintile of PD experience). Nevertheless, the risk of PD discontinuation fell during the late interim period (HR, 0.88; 95% CI, 0.82 to 0.95) and most of the reform period (from HR, 0.85; 95% CI, 0.79 to 0.91 to HR, 0.94; 95% CI, 0.87 to 1.01). Mortality risk was stable across the three study periods.ConclusionsIn the context of expanding PD use and declining facility PD experience, the risk of PD discontinuation fell, and there was no adverse effect on mortality.PodcastThis article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2019_09_12_CJN01610219.mp3.

Dataset Information

Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.

Publications

Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.

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