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Don't Set It & Forget It: The Importance of Evaluating & Evolving Healthcare Compliance Programs
On June 1, 2020, the Department of Justice (DOJ) released an updated version of its "Evaluation of Corporate Compliance Programs" guidelines for prosecutors to apply in assessing compliance program effectiveness in the context of resolving criminal investigations of companies (the DOJ Guidance). The latest revisions to the DOJ Guidance — originally published by the DOJ's Criminal Division in February 2017 and updated in April 2019 — are not voluminous. Nonetheless, the changes reflect a continued and concerted emphasis by DOJ on the robustness of a company's processes for reevaluation and, as necessary, evolution of the organization's compliance program to ensure it is not only in place, but working effectively. Parallels to the prominence of measuring and testing compliance programs found in the DOJ Guidance for criminal prosecutions can be found in the practice and policies of the Office of Counsel to the Inspector General for the U.S. Department of Health & Human Services (HHS-OIG), which investigates civil, criminal, and administrative violations of the healthcare laws, often in conjunction with the DOJ.
According to fiscal year (FY) 2019 data released in June 2020, the federal government won or negotiated over $2.6 billion in healthcare fraud judgments and settlements that year. The DOJ also opened 1,060 new criminal healthcare fraud investigations and 1,112 new civil healthcare fraud investigations in FY 2019. These trends have continued apace, as illustrated by the DOJ, HHS-OIG, and multiple other federal agencies coordination of a national healthcare fraud and opioid takedown on September 30, 2020 resulting in charges against 345 defendants responsible for more than $6 billion in alleged fraud losses, including more than $4.5 billion connected to schemes involving telemedicine. The federal government's investment of resources toward combatting fraud, waste and abuse in healthcare can be expected to continue in full force, irrespective of a change in political administration. Accordingly, it is important for healthcare companies to focus on maintaining flexible and effective compliance programs to not only avoid government scrutiny but also satisfy government expectations and mitigate costs in the event of an investigation.
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