Dialysis Bundling, ESA Labeling Changes Did Not Increase Mortality

Observed rates of all-cause and cardiovascular mortality and myocardial infarction were consistent with expected rates, study shows.
Observed rates of all-cause and cardiovascular mortality and myocardial infarction were consistent with expected rates, study shows.

Dialysis payment reform and regulatory changes aimed at mitigating risks associated with the use of erythropoiesis-stimulating agents (ESAs) have not resulted in a relative increase in death or major cardiovascular events among dialysis patients, new findings suggest.

On January 1, 2011, the Centers for Medicare & Medicaid Services (CMS) enacted a prospective payment system—often referred to as “bundling”—for dialysis and related care. On June 24, 2011, the FDA approved modified product labels for epoetin alfa and darbepoetin alfa, advising against the use of ESAs in patients with end-stage renal disease and hemoglobin levels of 11 g/dL or higher.

Glenn M. Chertow, MD, of Stanford University in Palo Alto, Calif., and colleagues examined the effect of these changes on mortality and major cardiovascular events in annual cohorts of dialysis patients during 2005–2012. An abrupt decline in ESA dosing and hemoglobin level began in late 2010, the researchers reported online ahead of print in the Journal of the American Society of Nephrology. Observed rates of all-cause mortality, cardiovascular mortality, and myocardial infarction in 2011 and 2012 were consistent with expected rates, according to the investigators.

Results showed lower-than-expected observed rates of stroke, venous thromboembolic disease, and heart failure in 2012.

The findings indicate that, during 2011 and 2012, changes in CMS payment policy and ESA labeling contributed to clinically meaningful declines in the proportion of patients receiving epoetin alfa (approximately 10%), epoetin alfa dose (approximately 40%), and hemoglobin level (approximately 1 g/dl), and a corresponding increase in blood transfusions (approximately 30%), Dr. Chertow and his colleagues reported.

“These changes in practice were not associated with changes in all-cause or cardiovascular mortality beyond what was expected due to secular trends, consistent with results of previous studies on the correction of anemia with ESAs and mortality,” the authors wrote.

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