Federal False Claims Act (FCA) enforcement continues to be a top
risk for healthcare and life sciences organizations, with
settlements reaching a record high in 2025. In this environment, an
effective compliance governance program is not static—it must
evolve, taking into consideration enforcement trends, Corporate
Integrity Agreements (CIAs) requirements, published guidance, and
organizational growth.
To help reduce the risk of FCA violations, compliance
departments should consider implementing the following five
governance essentials into their overall Compliance Program.
1. Stay informed on enforcement actions and
settlements
Recent enforcement actions provide some of the clearest insight
into how regulators interpret and apply the FCA. Organizations
should routinely review public settlements to understand the
underlying conduct that triggered enforcement and the compliance
breakdowns regulators identified.
