Compliance, Government Investigations, and False Claims Act Defense
Amid increasing scrutiny from regulatory agencies and whistleblowers, the margin for error in the healthcare and life sciences industries has never been smaller — and the risks never greater. Barnes & Thornburg’s cross-disciplinary healthcare compliance, government investigations, and False Claims Act (FCA) defense team will help you minimize risk and challenge accusations by providing practical compliance program advice, responding swiftly to government investigations, and defending against alleged False Claims Act violations.
We work with healthcare and life sciences clients to design, implement, and pressure test, real-world compliance programs. Our team advises on:
- Federal and state healthcare fraud and abuse laws (criminal and civil), including the Stark Law and Anti-Kickback Statute
- False Claims Act exposure and defense strategy
- Controlled Substances Act, Sunshine Act, and Food, Drug, and Cosmetic Act compliance
- Civil Monetary Penalties Law as well as CMH and HHS-OIG self-disclosure protocols
- Federal criminal, securities, and anti-corruption laws, including the Foreign Corrupt Practices Act (FCPA)
- Internal and government audits, training programs, and risk assessments
- Compliance planning and governance under Corporate Integrity Agreements (CIAs)
Focused FCA defense
Our FCA team is known for its experience handling FCA litigation, at the federal and state levels, across the country as well as the full spectrum of healthcare fraud and abuse matters — this includes litigation, internal and government investigations, criminal healthcare fraud defense, and compliance program guidance. We bring together nationally recognized attorneys, including many former U.S. Department of Justice prosecutors from our Healthcare Industry and White Collar practices to guide clients through every phase of FCA litigation.
We advise on:
- FCA investigations, parallel proceedings, and settlement negotiations
- Defense in qui tam litigation, both sealed and unsealed
- Criminal and civil healthcare fraud enforcement
- Internal investigations across clinical, compliance, and billing operations
- Responding to DOJ, HHS-OIG, CMS, and state AG inquiries
- Managing Civil Investigative Demands and subpoenas
- Self-disclosures, corrective actions, and regulatory reporting
We continually monitor FCA enforcement trends and share insights through our annual Healthcare Enforcement and Compliance Report — helping clients stay informed, proactive, and prepared for what’s next.