Recombinant human erythropoietin (rHuEPO) was approved for use in the treatment of anemia in ESRD in 1989. Over the course of almost a quarter of a century, there have been several revisions in product recommendations, labels and reimbursement for ESAs. Most of these changes were a result of studies showing an increased risk for thromboembolic phenomena in patients exposed to ESAs. Specifically, in 2010, an article in the New England Journal of Medicine brought attention to the issue of possible adverse cardiovascular events and the use of ESAs in patients with ESRD1. The CHOIR, CREATE, and TREAT studies all, in various ways, pointed to adverse events associated with ESA use in this patient population. 2-4 Thus, the subsequent “snowball” effect of the FDA revision of clinical indications coupled with the Medicare bundling of reimbursement proved to effectively limit use of these agents. 5,6 In particular, the current reimbursement bundle from Medicare began phasing in in January 2011. Along with these issues, there is also a requirement for outpatients with ESRD to maintain a target Hgb greater than 10g/dL. or an additional 1-2% decrease in reimbursement occurs (personal communication). Given the current reimbursement constraints for ESA use, many nephrologists are choosing to transfuse to maintain this Hgb, viewing the cost associated with transfusion to be less in the long-term than what they might lose with ESAs.
So, if indeed we are beginning to see an increase in transfusion in patients with ESRD, this may be a reflection of the regulatory and reimbursement changes as noted. Unfortunately, the medical community, as well as the FDA and Medicare, have likely not taken into account the true “costs” associated with chronic transfusion therapy. These costs are NOT limited to merely the direct acquisition cost but include the indirect dollars accumulated in donation, testing, processing, issuing and administering RBCs. The cost of adverse events associated with transfusion must also be considered, especially in this somewhat precarious patient population. These include, but are not limited to: transfusion-related immune modulation, transfusion-related iron overload, transfusion-related circulatory overload, transfusion-related acute lung injury, potential for hemolytic transfusion reactions and possible transfusion-transmitted diseases. Overall dollars attributed to transfusion may actually be close to $1200/unit and outpatient reimbursement for transfusion represents only a fraction of this. 7,8
I certainly understand the physicians’ hands seem often to be tied. However, the “costs” in terms of dollars or poor clinical outcomes associated with transfusion should clearly be considered in the decision-making process for this group of chronically-ill anemic patients. Another significant population to be considered in the same light is the Hematology/Oncology patients with chemotherapy or radiation therapy-induced anemia. If reimbursement has not affected this group, it likely will in the foreseeable future.
This appears to me to be another example of the cavalier attitude that surrounds transfusion therapy and unfortunately our government agencies are feeding the frenzy!
- Unger EF. Erythropoiesis-stimulating agents-time for a reevaluation. N Engl J Med, 2020;362:189.
- Szczech LA et al. A secondary analysis of the CHOIR trial shows that comorbid conditions differentially affect outcomes during anemia treatment. Kidny Int, 2010;77:239
- Druecke TB et al. Normalization of hemoglobin levels in patients with chronic kidney disease and anemia. N Engl J Med, 2006; 355:2071
- Pfeffer MA et al. A trial of darbapoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med, 2009; 361:2019
- Speigel DM et al. Changes in hemoglobin level distribution in US dialysis patients from June 2006 to November 2008. Am J Kidney Dis, 2010; 55:113
- Weiner DE, Watnick SG The 2009 proposed rule for prospective ESRD payment: Historical perspectives and public policies- bundle up! Am J Kidney Dis, 2010; 55:217
- Shander A et al. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion, 2010; 50:753
- CMS Publishes 2012 Hospital Outpatient Prospective Payment System Rule, http://www.aabb.org/programs/reimbursementinitiatives/Pages/12hoppsrule.aspx