General Counsel’s Decision Tree for Internal Investigations for the Healthcare Industry

Healthcare systems, physician practices, post-acute providers, pharmacies, laboratories and other healthcare providers regularly face challenges that may require an internal investigation to determine the root cause of an issue in order to evaluate how best to remediate and guard against future occurrences of a potentially harmful event. These range from industry-specific concerns, such as those related to federal and state healthcare program billing, False Claims Act (FCA), Stark Law and Antikickback Statute, Health Insurance Portability and Accountability (HIPAA) protections, payor reimbursement, quality of care and adverse patient outcomes– to more general concerns equally applicable to the healthcare industry, including compliance with bribery and corruption statutes such as the Foreign Corrupt Practices Act (FCPA), data breaches, environmental catastrophes, accounting concerns, whistleblower complaints, risks introduced by the use of third parties and human resources issues. While having a robust compliance program can help avoid many issues, not all issues can be foreseen or avoided. The GC Decision Tree has been designed to assist with the identification and remediation of issues and is an important complement to a well-designed and functioning compliance program. It also will facilitate the in-house team’s communications with outside counsel, who have a range of experience guiding companies through these precarious situations. In addition, adherence to a well-crafted playbook helps companies meet the expectations of enforcement authorities, such as the Department of Justice (DOJ), the Securities and Exchange Commission (SEC) and state attorneys general (as well as others), which can materially mitigate potential enforcement efforts and sanctions.