Past, present, and future of chronic kidney disease anemia management in the United States.

The management of anemia in the United States during the past 2 decades and since the introduction of erythropoietin (EPO) has continuously evolved, shaped by the interplay of reimbursement, evidence, clinical performance measurement, and, most recently, risk management. A fee-for-service reimbursement system has driven average EPO doses higher than anywhere else in the world, despite opportunities to decrease such dosing through more effective iron management and subcutaneous administration. Calls by Congress for Medicare to constrain ESA costs and FDA relabeling of erythropoietic-stimulating agents (ESAs), in the wake of The Correction of Hemoglobin and Outcomes in Renal Insufficiency and The Cardiovascular risk Reduction by Early Anemia Treatment with Epoetin Beta trials, have in 2007 led to the first decrease in mean hemoglobin levels in US hemodialysis patients since EPO was introduced in 1989. The implementation of a case-mixed adjusted bundled payment system for ESRD services in 2011 will turn ESAs from a profit center to a cost center for dialysis providers. This is likely to have profound implications regarding anemia management directed at curtailing ESA dosing, including subcutaneous administration, more aggressive iron therapy, and decreased target hemoglobin levels. Medicare has developed a third generation of clinical performance measures (CPMs) for ESRD providers (facilities and physicians) to ensure that quality is maintained in the new fiscal environment. Unlike the previous generations, these new CPMs emphasize an upper limit of hemoglobin as well as a lower one. Payment for performance based on these CPMs will likely be a key driver of future practice patterns for anemia management.