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Abstract 2752 Introduction: Progressive multifocal leukoencephalopathy (PML) is a rare but fatal disease that is the result of activation of a highly prevalent dormant JC virus during immunosuppressed states such as advanced HIV, malignancy or immune-modulating medications. Rituximab, an immunomodulator, has been approved for both Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). We previously reported 57-non-HIV patients developed PML after rituximab (1). This report identified the need for epidemiological cohort studies to further evaluate incidence rates and risk factors for PML by comparing Rituximab treated patients with suitable non-treated patients. Of note, natilzumab-associated PML is now well-characterized, with a reported incidence of 21 PML cases per 10,000 natilizumab-treated persons (2). Methods: In this first such epidemiological study we identified from the national data of the Department of Veteran's Affairs (VA), 61,132 patients with a primary International Classification of Diseases version 9 (ICD-9) code for either HL or NHL between 1999 to 2011 and reported the use of Rituximab among patients with and without PML. This project was conducted inside the Veterans Affairs Informatics and Computing Infrastructure (VINCI) after obtaining approvals from the VA Institutional Review Board and other oversight groups. Results: We identified 62,642 with a primary diagnosis of HL or NHL and excluded 1,510 (2.4%) patients with VA lab confirmed HIV. Our final cohort had 61,132 patients, 10,459 (17.1%) received Rituximab. A total of 12 (0.020%) patients had developed PML, 5 (0.008%) belonged to the Rituximab group and 7 (0.011%) to non-rituximab group; which results in a statistically significant unadjusted relative risk of 3.46 (95% confidence interval 1.1, 10.9). Univariate analyses of outcomes other than rate-estimates are not statistically significant between PML patients who received rituximab and those that did not receive rituximab, primarily due to extremely small sample sizes (5 and 7 patients, respectively) (Table 1). Overall, compared to non-rituximab PML patients, rituximab PML patients were younger at PML diagnosis and age of death by more than 6-years; although they did appear to live slightly longer post PML diagnosis by about 4-months. Conclusions: These results show that among lymphoma patients, the use of Rituximab is associated with a statistically significant relative risk for documented PML of 3.46. We now report a baseline rate among Veterans of 4.78 PML cases per 10,000 rituximab treated Veterans with lymphoma (25% of the rate reported among natilizumab-treated multiple sclerosis patients). As with hepatitis B, measurement of JC virus might be considered prior to initiation of rituximab therapy. Acknowledgment: This project was supported through the resources of the Wiliam JB Dorn Veterans Affairs Medical Center. Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government. Disclosures: No relevant conflicts of interest to declare.

Abstract 4275 Introduction: Annually, $82 billion to $272 billion is reportedly lost to federal health care fraud. Between 1996 and 2005, 379 federal health care fraud cases initiated by qui tam relators (“whistle blowers”) concluded, resulting in $9.3 billion in recoveries. Of these, pharmaceutical companies accounted for 13 cases (False Claims Act (FCA) cases, the primary statute invoked in health care fraud and abuse), but $3.9 billion of recoveries (4% of the cases and 39% of the financial recoveries). We report concluded FCA cases involving pharmaceutical manufacturers between 2006 and 2011. Oncology accounts for the largest per cent of total pharmaceutical expenditures. Over 90% of all new cancer pharmaceuticals cost > $20,000 for 12-weeks of treatment. Methods: Websites for the Department of Justice (DOJ), Taxpayers Against Fraud, Health and Human Services Inspector General's Office, Health Care Fraud and Abuse Control Project, and Lexis/Nexis were queried for pharmaceutical FCA cases (2006 to 2011). Results: Between 2006 and 2011, the DOJ closed 54 cases with pharmaceutical FCA violations, 38 with and 16 without qui tam relators, accounting for recoveries of $11.3 billion (mean $296 million) and $2.6 billion (mean, $165 million), respectively. Illegal marketing is the most common fraud allegations invoked against pharmaceutical manufacturers (19 cases). Pharmaceutical manufacturers accounted for 31% of total FCA cases, and 71.5% of total FCA recoveries (Table 1). Conclusion: Since the DOJ's shift of focus to pharmaceutical corporations in 2001, the trend has intensified, with virtually every large pharmaceutical corporation settling at least one FCA case. Pharmaceutical cases now account for 31% of the federal fraud cases and 71% of the financial recoveries. Fraud and abuse may be an important component of the high costs of cancer care in the United States. Moreover, unless fundamental changes occur, the pharmaceutical industry will continue to be the main FCA investigative target as this sector has the deepest pockets and is the health care sector most resistant to deterrence. Disclosures: No relevant conflicts of interest to declare.