This article was originally published by the American Health Law Association. Reprinted with permission. Any opinions in this article are not those of Winston & Strawn or its clients. The opinions in this article are the authors' opinions only.
Over the past decade, there have been a myriad of changes in the regulatory and enforcement landscape for health care and life sciences organizations. Between shifting enforcement guidance coming out of the U.S. Department of Justice (DOJ) to significant judicial decisions, navigation of False Claims Act (FCA) cases today is quite different than it was 10 years ago. While regulatory changes have been less frequent during the same time period, save for substantial changes to Civil Monetary Penalties (CMP) in 2016, that changed with the U.S. Department of Health and Human Services' (HHS') "Regulatory Sprint to Coordinated Care" (Regulatory Sprint).
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