Many of the high-profile False Claims Act (FCA) cases against the health care industry have involved allegations that false claims for payment were submitted for items or services provided to Medicare or Medicaid beneficiaries. A recent case, however, highlights the fact that health care providers may face FCA liability based on other types of interaction with the federal government.
In U.S. ex rel. Jones v. Brigham and Women's Hospital, __ F.3d ___, 2012 WL 1571232 (1st Cir. May 7, 2012), a whistleblower alleged that the defendants submitted a false application for a research grant to the National Institute on Aging (NIA), a federal agency. Defendants sought the grant to continue their research regarding factors that would predict the onset of Alzheimer's Disease. That research involved the use of MRI scans to track "regions of interest" in the brains of study participants. In the course of their preliminary research conducted before the grant application, the defendants encountered "anatomical anomalies" in the data originally collected, which led them to gather additional data from some (but not all) of the study participants. The whistleblower, who was part of the defendants' research team, raised concerns that the additional data relied upon by defendants to show a causal relationship between certain changes in brain structure and the development of Alzheimer's was flawed because the additional data was not collected through a "blinded" study methodology, but rather, was allegedly "manipulated" and "cherry picked." In response to the whistleblower's concern, the defendants asked an expert to review the data. That expert concluded that the defendants' use of the additional data was appropriate.
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