Effects of the ESRD medicare bundling rule on anemia management in private dialysis units

Purpose: Reform of the CMS ESRD payment policy in January 2011 required bundled payments for previously separated billable drugs.  Given the cost difference between erythropoiesis stimulating agents & IV iron, this study evaluated implications of the new bundling rule on anemia management.

Methods: This was a retrospective cohort study of in-center hemodialysis (IHD), home hemodialysis (HHD) & peritoneal dialysis (PD) patients at 2 private, nonprofit dialysis centers in Upstate New York.  Medical record & laboratory data were pooled and evaluated for time periods Jan 2010—April 2010 (pre-bundle) and from Jan 2011—April 2011 (post-bundle). All patients with available anemia medication use data were included.  Monthly epoetin alfa (EPO) and IV iron sucrose (IVFe) doses were analyzed pre- and post-bundling. All available monthly [hemoglobin] for study patients were collected.

Results: A total of 1470 patient-months were evaluated, IHD=1061 mo, HHD=288 mo, PD=121 mo.  Among IHD patients receiving EPO, mean(SD) monthly doses significantly decreased after the bundle was imposed, 62,758 (69,034) vs 44,140 (45,454) units, respectively (p<0.001).  For those on IVFe, mean monthly doses significantly increased from 306 (221) to 453 (290) mg (p<0.001). Mean hemoglobin concentrations were significantly lower after implementation of the bundle 11.1 (1.4) compared to 11.6 (1.4) g/dL pre-bundle (p<0.001). Similar drug use shifts were observed in both the HHD and PD patients.  Both the HHD and PD groups had a 0.5 g/dL reduction in Hb concentrations in the post-bundle observation period (p<0.001 in both groups). 

Conclusions: Since the revision of the ESRD Conditions for Coverage, we observed significant decreases in EPO and increases in IVFe doses.  Hemoglobin concentrations were significantly reduced, but remained within target range.  Given long-term safety concerns with EPO and IV iron, practice pattern changes related to the bundled drug coverage policy should continue to be closely evaluated with regard to patient outcomes.