The Policy Changes Leading to Increases in Transfusions
"According to the United States Renal Data System, in each of the first 9 months of 2011, the share of dialysis patients covered by Medicare who received blood transfusions increased by 9 to 22 percent over the corresponding months in 2010. Last September, for instance, there were 10,041 transfusions for dialysis patients, compared with 8,259 for the same month in 2010. There had been virtually no change in transfusion rates between 2009 and 2010."
This excerpt from an article that appeared in the May 11, 2012, edition of the New York Times reports on the recent increase in transfusions. Many nephrologists have been concerned about the possibility of this increase because of 3 important recent policy changes.
First, on January 1, 2011, the Centers for Medicare & Medicaid Services (CMS) changed the end-stage renal disease (ESRD) bundled payment to incorporate injectables into the composite rate.
Second, in June 2011, the US Food and Drug Administration (FDA) changed the target goal hemoglobin in the product labeling for erythropoiesis-stimulating agents (ESAs) used by patients with ESRD. This change was in response to the results of the TREAT study, which found that the use of darbepoetin-alfa in patients with diabetes, chronic kidney disease (CKD), and moderate anemia who were not undergoing dialysis did not reduce the risk for death or a cardiovascular or renal event and was associated with an increased risk for stroke.
In the release, the FDA updated product labels for epoetin-alfa and darbepoetin, replacing the target hemoglobin range of 10-12 g/dL with the instructions to use just enough ESA to avoid transfusion and keep the hemoglobin level less than 12 g/dL. The FDA was concerned that no safe dosing strategy could be supported by trial data, so they believed that no minimum hemoglobin level could be endorsed.
Finally, in July 2011, after this change in the package insert, the CMS modified the Quality Incentive Program so that quality care in ESRD was defined for reimbursement purposes a maximum hemoglobin value of 12 g/dL but no minimum value. The former CMS definition was a hemoglobin level of 10-12 g/dL.