Dialysis Facility Profit Status and Compliance With a Black Box Warning

HHS Public Access Author manuscript Author Manuscript JAMA Intern Med. Author manuscript; available in PMC 2016 March 04. Published in final edited form as: JAMA Intern Med. 2013 June 24; 173(12): 1152–1153. doi:10.1001/jamainternmed.2013.979. Dialysis Facility Profit Status and Compliance With a Black Box Warning Author Manuscript Julie H. Ishida, MD, Charles E. McCulloch, PhD, R. Adams Dudley, MD, MBA, Barbara A. Grimes, PhD, MS, and Kirsten L. Johansen, MD Divisions of Nephrology (Drs Ishida and Johansen) and Pulmonary Diseases and Critical Care Medicine (Dr Dudley), Department of Medicine; Department of Epidemiology & Biostatistics (Drs McCulloch, Dudley, Grimes, and Johansen); and Philip R. Lee Institute for Health Policy Studies (Dr Dudley), University of California, San Francisco, California; and Division of Nephrology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco (Dr Johansen). Erythropoiesis-stimulating agents (ESAs) for treatment of anemia in dialysis patients are a substantial Medicare drug expenditure. 1 In 2011, the Centers for Medicare & Medicaid Services implemented a “bundled” reimbursement system that provides a single payment for all dialysis services, including ESA administration. 2 A major objective of the bundled system was to contain the cost of medications administered during dialysis, which were previously separately billed. 3 Author Manuscript The new reimbursement system will fundamentally reverse the incentives in dialysis from providing more to less care and creates the possibility of underutilization not only of ESAs but also of other services that are beneficial for patients receiving dialysis, such as administration of antibiotics during dialysis. However, these issues are important only if there is reason to believe that dialysis facilities might consider financial goals in clinical decision making. Dialysis facilities previously faced a tension between clinical and cost considerations when the US Food and Drug Administration (FDA) issued a black box warning in 2007 calling for use of the lowest possible ESA dose to avoid the need for blood transfusion and for Author Manuscript Correspondence: Dr Ishida, Division of Nephrology, Department of Medicine, University of California, San Francisco, 521 Parnassus Ave, Clinic Sci C443, Box 0532, San Francisco, CA 94143-0532 (julie.ishida@ucsf.edu).. Author Contributions: Drs Ishida and Grimes had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Ishida, McCulloch, Dudley, and Johansen. Acquisition of data: Johansen. Analysis and interpretation of data: All authors. Drafting of the manuscript: Ishida. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: Ishida, McCulloch, and Grimes. Obtained funding: Johansen. Administrative, technical, and material support: Johansen. Study supervision: McCulloch, Dudley, and Johansen. Conflict of Interest Disclosures: Dr Grimes has received research funding from Dialysis Clinic, Inc. Dr Johansen serves on the Amgen National Nephrology Advisory Board. Disclaimer: The data reported herein have been supplied by the US Renal Data System. The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official policy or interpretation of the US government. Previous Presentation: This study was presented in part as a poster at Kidney Week 2012 (annual meeting of the American Society of Nephrology); November 2, 2012; San Diego, California. Online-Only Material: The eMethods, eTable, eFigure, and eReferences are available at http://www.jamainternalmed.com.