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.

Excess Deaths Attributable to Influenza-Like Illness in the ESRD Population

“…The variability in timing and severity of each influenza season (and resulting ILI incidence) can affect morbidity and mortality events, and investigators should consider accounting for ILI in their analyses. 49 This study should be evaluated in light of the following limitations. We used an ecologic study design owing to the sources of exposure (CDC ILINet) and death (ESRD) data included in the analysis.…”

Use of the Medicare database in epidemiologic and health services research: a valuable source of real-world evidence on the older and disabled populations in the US

“…Awareness of these reimbursement changes and their possible influence on provider practices are critical when conducting studies to address a specific clinical question. In fact, designing and conducting studies that take advantage of such policy changes can often provide compelling information regarding the effectiveness and/or safety of therapeutic interventions 22,23…”

Contemporary Trends in Clinical Outcomes among Dialysis Patients with Medicare Coverage

“…Fourth, dialysis providers consolidated to the point of 2 providers operating roughly 70% of dialysis facilities [22]; consolidation may have encouraged protocol standardization. However, it may be that none of these changes are relevant: infection-related hospital admissions began to decrease one decade after fistula use began to increase [1]; the efficacy of cardioprotective medications has not been proven in large trials of dialysis patients; falling rates of all-cause and cardiovascular mortality may have merely coincided with changes in anemia treatment [23]; and the association of dialysis facility profit status with clinical outcomes remains equivocal [24,25]. Process and intermediate outcomes in the dialysis population are mostly stagnant.…”