On September 18, 2026, the Department of Justice announced two significant revisions to the Justice Manual governing how DOJ pursues False Claims Act (FCA) cases. For healthcare providers, health systems, and other entities that bill federal healthcare programs, these changes signal a shift toward narrower, more predictable enforcement. Simultaneously, these changes underscore DOJ’s continued reliance on qui tam relators as an enforcement tool.
What Changed
1. Sub-regulatory guidance can no longer create new liability.
DOJ reinstated and expanded its 2017 policy prohibiting the use of sub-regulatory guidance, such as agency memos, FAQs, bulletins, and similar materials that lack the force of law, to establish legal obligations beyond what is set out in a statute or regulation. In practical terms, this means the government cannot premise an FCA case on a provider’s failure to follow informal guidance (such as a CMS FAQ or program manual provision) unless that guidance merely interprets an existing binding requirement. DOJ framed this as a fair notice principle: providers should be liable for violating binding law, not for departing from non-binding agency commentary.
2. DOJ will more actively consider dismissing qui tam suits it declines to join.
The second revision directs DOJ attorneys to affirmatively evaluate whether to seek dismissal of whistleblower (qui tam) suits when the government declines to intervene, and to revisit that assessment as litigation progresses if circumstances change. DOJ says it will focus this dismissal authority on actions that lack legal or factual merit, waste government resources, or impose unjustified burdens on defendants.
Why It Matters for Healthcare Clients
- Stronger defenses against “guidance-based” theories. Providers facing FCA allegations rooted in alleged departures from CMS transmittals, sub-regulatory billing guidance, or informal agency interpretations now have a clearer basis to argue that no actionable legal obligation was violated.
- A potential check on non-intervened qui tam litigation. Because the large majority of FCA cases against healthcare entities proceed without DOJ intervention, this policy could give defendants a new avenue to seek, or press DOJ to seek, dismissal of weak relator-driven suits, particularly those built on regulatory ambiguity rather than clear-cut fraud.
- Enforcement is narrowing, not disappearing. DOJ leadership was explicit that it intends to keep pursuing violations of binding legal and contractual obligations. Providers should not read these revisions as a retreat from FCA enforcement generally.
Practical Takeaways
- Audit compliance programs to distinguish between binding regulatory requirements and informal sub-regulatory guidance your organization currently treats as mandatory.
- Revisit pending qui tam exposure. If your organization is defending a non-intervened relator suit, consider whether the revised Justice Manual provisions support a renewed request that DOJ exercise its dismissal authority.
- Document good-faith reliance on regulatory text and binding guidance when designing billing, coding, and coverage policies, since this distinction is now more consequential to liability analysis.
- Monitor DOJ’s implementation of these standards, as their real-world impact will depend on how U.S. Attorney’s Offices and the Civil Division apply them case by case.
