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Utilizing Medicare claims data for real-time drug safety evaluations: is it feasible?,


  • Name of institutions at which the research was conducted: Acumen LLC
  • Disclaimer: The views expressed in this manuscript represent the opinions of the authors and do not necessarily represent the views of the United States Food and Drug Administration or the United States Department of Health and Human Services.

A. G. Hartzema, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, HPNP, Rm. 3339, 101 S Newell Drive, PO Box 100496, Gainesville, FL 32610–0496, USA. E-mail:



The Centers for Medicare & Medicaid Services claims comprise an administrative database of beneficiary-specific clinical information. This study evaluates the impacts of (i) claim information updates (claims adjudication) and (ii) delay in claim processing (claims delay) on real-time evaluation of health service and drug safety signals using the Medicare database.


Using Medicare claims data accumulated through May 2009 on health services rendered in 2006 and drugs dispensed in 2007, this study measures the frequency with which clinical information changes in the database as a result of (i) claims adjudication and (ii) claims delay.


Over 85% of health services claims were processed within 8 weeks after the date of service, and 72% of drug claims were processed within 3 months after the dispense date. Clinical information changed for no more than 3% of unique claim groups in inpatient hospital, outpatient institutional, physician's office, and prescription drug Medicare claim settings.


Claims delay is consistent across time and is minimal. Claims adjudication does not substantially impact the content of clinical information in the Medicare claims database. Therefore, the Medicare claims database provides consistent information regarding health services and prescription drugs in a manner that is prompt enough to facilitate medical product safety evaluations in real time. Copyright © 2011 John Wiley & Sons, Ltd.