Several days ago, Biogen Inc. announced that it had reached a settlement to resolve a whistleblower lawsuit under the False Claims Act (FCA). Relator’s claims were based on allegations that Biogen’s speaker and consultant programs were a façade for a scheme to pay doctors in exchange for prescribing Biogen drugs in violation of the Anti-Kickback Statute (AKS). Claims submitted to the government resulting from a violation of the AKS are deemed fraudulent claims under certain provisions of the Affordable Care Act passed in 2010. This settlement is only the latest in high dollar FCA settlements related to speaker and consultant programs. Government scrutiny of these programs is increasing for both the companies that conduct the programs and the physicians that participate in them. Applying the lessons of recent enforcement efforts and government statements about speaker programs may be the key to mitigating the risks inherent in such programs.
Speaker and consultant programs are common in the pharmaceutical and medical device industries. Such programs facilitate the exchange of information between physicians that prescribe drugs or use devices, and the companies that develop and manufacture such products. Typically, physicians that utilize the drugs or products go through training programs, attend meetings with the company and provide feedback on clinical matters, and speak to practitioners at events organized by the company or a third-party...
CONCORD, N.H.- The head of the Division of Children, Youth and Families has addressed claims of abuse against the Sununu Youth Services Center. Appearing Monday before a Senate subcommittee Direct...