Blog Post

DOJ Revises Justice Manual to Strengthen False Claims Act Enforcement

Richard P. Kusserow | November 2026

On September 18, 2026, the Department of Justice (DOJ) revised its Justice Manual to clarify enforcement under the False Claims Act (FCA). The revisions address two issues: the use of agency guidance in enforcement actions and the dismissal of whistleblower, or qui tam, cases in which DOJ declines to intervene.

Agency manuals, contractor instructions, coverage policies, billing guidance, and similar materials generally do not have the force of law. DOJ should not base an enforcement action solely on noncompliance with such guidance unless the underlying obligation is established by statute, regulation, or a binding contract.

This distinction is especially important for healthcare providers that rely heavily on Centers for Medicare & Medicaid Services (CMS) manuals and contractor guidance. Although these materials may provide evidence of knowledge, intent, materiality, or reasonableness, they do not independently create FCA liability. Compliance teams should therefore connect key billing, coding, reporting, and repayment requirements to binding legal authority.

DOJ attorneys should consider seeking dismissal when the government declines to intervene in a qui tam action and should revisit that decision as the litigation develops. Dismissal may be appropriate when allegations lack legal or factual merit, duplicate a government investigation, interfere with agency programs, risk disclosure of sensitive information, impose excessive burdens, or otherwise conflict with federal interests.

A decision not to intervene does not necessarily mean a case lacks merit. However, the revised guidance may give defendants a clearer opportunity to present a focused, evidence-based case for dismissal.

For more information on this subject, please contact [email protected].

About the Author

Richard P. Kusserow established Strategic Management Services, LLC, after retiring from being the DHHS Inspector General, and has assisted over 3,000 health care organizations and entities in developing, implementing and assessing compliance programs.

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