The healthcare enforcement landscape is shifting quickly. This issue of McDermott’s Healthcare Enforcement Quarterly examines emerging trends and key issues for organizations that may become subject to enforcement scrutiny, and offers practical strategies for ensuring compliance and minimizing risk.

For example, healthcare organizations facing the prospect of False Claims Act (FCA) investigations and qui tam suits have a strengthened defense tool in their arsenal, thanks to the US Court of Appeals for the Fourth Circuit’s recent ruling in Allergan. Companies that can demonstrate objectively reasonable interpretations of ambiguous laws should emphasize this argument in discussions with the Department of Justice and, if the case moves into litigation, seek early dismissal. The importance of this decision will likely become more pronounced since the federal government has repeatedly signaled its intention to increase pandemic-related enforcement activity, which we expect will implicate programs with complex, ambiguous, and frequently changing program rules.

Relatedly, in this issue we also examine recent cases that seek to distinguish what Medicare guidance is enforceable and what is not, and review the CDC’s much-anticipated draft revision of its Clinical Practice Guideline for Prescribing Opioids. These timely updates should help healthcare organizations continue to develop their compliance programs and internal controls.