The drug Epogen (EPO) has been widely used to treat and manage anemia in patients with End Stage Renal Disease. Findings from several recent randomized clinical trials suggest that unfettered use of the drug in these patients can lead to adverse health outcomes such as mortality. Two related strategies have been pursued to reign in the use of EPO. First, the Food and Drug Administration (FDA) tried to curb the use of EPO with the use of several "black-box" warning labels issued in 2007 that highlight possible adverse health effects. Second, the Centers for Medicare and Medicaid Services (CMS) has restricted reimbursement, and authorized other financial disincentives when EPO is used outside of the typical hemoglobin ranges advised by the FDA. The Medicare Improvement for Patients and Providers Act (MIPPA 2008) passed in July 2008 called for a quality incentive program that will monetarily penalize providers when they "are not compliant with the labeling approved by the Food and Drug Administration for anemia management and measures on dialysis adequacy". The MIPAA also authorized a switch from the "EPO" Fee-For- Service (FFS) reimbursement to a bundled payment beginning in January 2011 that would cover most dialysis services including EPO. The rapidly increasing expenditure on health care has resulted in calls for integrating the findings of Comparative Effectiveness Research (CER) into clinical practice. A change in behavior of health care providers (and consumers) is absolutely critical to the success of the aforementioned call for "evidence-based" clinical practice. Both FDA warnings and/or financial incentives are viable strategies to stimulate changes in behavior. However, relatively little is known as to whether the warnings and the incentives have had a causal impact on the use of EPO in these patients. In this proposal, we seek to understand which policy initiatives may be useful in curbing the use of EPO. The central hypothesis is that FDA warnings are not effective in curbing the use of EPO when there is still some uncertainty on the CER findings. On the other hand, we conjecture that financial incentives or disincentives may be more powerful in altering EPO use even in the presence of some uncertainty on CER findings. There are two specific aims of our proposal: 1. Estimate the effect of FDA warning labels on EPO use for ESRD patients. This issue becomes extremely relevant since FDA mandated warning labels on drugs have become quite ubiquitous. 2. Estimate the impact of financial incentives on EPO use. There are two strands in this aim: a. Anemia related "pay for performance" policy implemented in MIPPA 2008 b. Bundling of Medicare's ESRD payments that also includes any expenditures on EPO

Public Health Relevance

In this project, we evaluate the impact of two policies that have been used to curb the use of the drug Epoetin (EPO) - a drug used to treat anemia- among all individuals with End Stage Renal Disease (ESRD). The first policy considered are mandatory warnings (on the label) required by the Food and Drug Administration (FDA) detailing the potential health risks arising from unfettered use of the drug. The second policy evaluated is the role of financial incentives including: (1) A move to penalize providers of services to ESRD patients when FDA guidelines on anemia management are not met, and (2) the bundling of payments in Medicare's End Stage Renal Disease Program.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Exploratory/Developmental Grants (R21)
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Special Emphasis Panel (ZRG1-HDM-G (50))
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Narva, Andrew
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Brown University
Public Health & Prev Medicine
Schools of Public Health
United States
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