Anyone interested in off-label cases should review the retrospective analysis recently published by researchers funded by the Agency for Healthcare Research and Quality. In the study, “Off-Label Use of Recombinant Factor VIIa in U.S. Hospitals: Analysis of Hospital Records,” Aaron C. Logan et al., Ann Intern Med, April 19, 2011, 154:516-522;  investigators examined 12,644 discharge records of patients who received rFVIIa at U.S. hospitals from 2000-2008. Investigators concluded that off-label use of rFVIIa increased more than 140-fold during this time, whereas use for hemophilia increased less than 4-fold. Worse, in 2008, 97% of the in-hospital use of rFVIIa was for off-label indications, including cardiovascular surgery, trauma, and intracranial hemorrhage. This, despite the concern about the application of rFVIIa to conditions that lack strong supporting evidence. As costs for certain biologicals are sometimes baked into the inpatient DRG reimbursement system, this type of off-label use without appropriate supporting evidence can cost taxpayers hundreds of millions, and worse…

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