Life Science Compliance Update

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June 28, 2016

The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS"), has recently updated its guidance about its decisions to impose permissive exclusion and other integrity obligations to protect Federal health care programs ("FHP"). This article explores that new advice and the potential impact for life science compliance programs.

Recently, the Inspector General Daniel R. Levinson of the HHS announced the OIG's updated published guidance regarding how the office would be making "decisions about using its permissive exclusion authority and requiring integrity obligations when presented with False Claims Act (FCA) settlement.

From a regulatory and historical perspective, the permissive exclusion authority referenced in the OIG's new guidance stems from Section 1128(b)(7) of the Social Security Act, 42 U.S.C. 1320a-7(b)(7).113 That section grants the OIG the exclusive regulatory authority to bring an exclusion action for violative conduct under the FCA including fraudulent claims, anti-kick-back and Stark related legal claims. The 1997 guidance though lacks any significant, meaningful enforcement provisions, and is explicitly described by the agency as a "policy statement with non-binding criteria."

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