Hemoglobin Down After ESA Pay

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WASHINGTON—Hemoglobin levels in dialysis patients have fallen in concert with Medicare's bundling system of reimbursement and label changes on erythropoiesis stimulating agents (ESAs), researchers said.

Data from two monitoring systems revealed about a 0.4 g/dL drop in hemoglobin levels in 2011 over previous stable years, with corresponding declines in ESA doses and an uptick in blood transfusions that had some clinicians at the National Kidney Foundation (NKF) meeting concerned.

"What's bad about blood transfusion is that it reduces access to subsequent kidney transplantation" because of increased problems with organ matching, said Joseph Vassalotti, MD, chief medical officer of the NKF. He noted, however, that it's too early for data to show whether kidney transplants— or other patient care outcomes such as quality of life —have been affected.

The changes in hemoglobin levels have been prompted by two events. First, Medicare implemented the 'bundle' system of reimbursement for dialysis treatment in January 2011, which pays a flat rate of $230 per dialysis treatment, including lab work and intravenous medications such as ESAs, vitamin D, and iron. (The cost of oral medications will be added into the bundle in January 2014.)

In June of 2011, the FDA changed labeling on ESAs that specified a target hemoglobin range of 10 to 12 g/dL for dialysis patients. Instead, the agency said, ESA therapy should be started only if levels fall below 10 g/dL and the dose should be reduced or interrupted once levels hit 11 g/dL.

The agency had cited concerns about an increased risk of cardiovascular events as the reason for the label change, but clinicians have noted that the bundling measures were intended to curb the overuse of the costly ESAs, the second most expensive component of dialysis, aside from the procedure itself.

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