On September 18, 2026, the U.S. Department of Justice (DOJ) revised its Justice Manual to clarify enforcement standards under the False Claims Act (FCA), addressing the use of sub-regulatory guidance and the Department’s treatment of qui tam litigation. The revisions state that DOJ enforcement should be grounded in binding statutory, regulatory, or contractual obligations rather than guidance lacking the force of law.

 

The updated policy also directs the Department to consider dismissal of qui tam actions when it declines intervention, particularly when claims lack legal or factual merit or do not advance the interests of the United States. DOJ may reassess dismissal as litigation progresses.

 

For physicians, medical groups, and health systems, these revisions underscore the importance of regulatory precision, fair notice, and clearly defined compliance obligations. The distinction between enforceable requirements and sub-regulatory guidance may have practical implications for documentation, coding, billing, reimbursement, and participation in federal healthcare programs.

 

From a medical association perspective, predictable enforcement standards are important to maintaining compliance while limiting unnecessary administrative burden and allowing physicians to focus resources on patient care and sustainable practice operations.

 

“Regulatory clarity is fundamental to the practice of medicine. This matters because physicians should have clear, enforceable standards for compliance. Understanding the distinction between binding legal requirements and agency guidance is essential to protecting physician practices, reducing regulatory uncertainty, and allowing clinicians to focus on patient care.” - Desire’e Hardge, MBA, CEO & Executive Director

 

Please read the full DOJ press release and review the Justice Manual revisions for the complete policy changes and enforcement guidance.​