On September 18, 2026, the Department of Justice (DOJ or the Department) announced two significant revisions to the Justice Manual that aim to reshape False Claims Act (FCA) enforcement. The first revision reinstates and expands the Department’s 2017 policy limiting the use of sub-regulatory guidance documents in enforcement actions by restricting the government’s ability to treat agency guidance as binding legal authority. The second revision strengthens the Department’s approach to dismissing qui tam actions filed by private relators, directing attorneys to assess whether dismissal is warranted in every declined case. Together, these changes signal a more disciplined enforcement posture, suggesting that the Department intends to pursue fraud cases grounded in clear legal obligations while more actively culling meritless whistleblower suits.
Associate Attorney General Stanley E. Woodward, Jr. framed the revisions in terms of regulatory restraint: “The Department of Justice should enforce the law, not make law through enforcement. These updates reflect the Department’s commitment to fair notice, transparent enforcement, and the rule of law.”
Link to I. Revisions to JM 1-19.000: Limits on Agency Guidance I. Revisions to JM 1-19.000: Limits on Agency Guidance
First, the revisions provide that DOJ will not bring an enforcement action solely predicated on alleged violations of agency guidance that purports to create new legal obligations. The revised section incorporates the Administration’s previously communicated prohibition on the department’s use of “guidance documents” as the basis for creating substantive rights and obligations (Reinstating the Prohibition on Improper Guidance Documents.pdf) and builds upon similar restrictions on the use of sub-regulatory guidance issued during the first Trump Administration (memo_re_agency_guidance_documents.pdf) that were rescinded by Attorney General Merrick Garland in 2021 (attorney_general_memorandum_-_issuance_and_use_of_guidance_documents_by_the_doj712021.pdf). The revision explains that DOJ guidance may not be a substitute for regulation or impose new requirements on entities outside the Executive Branch unless authorized by law or contract. The revision also provides that the Department shall not issue guidance that purports to create binding rights or obligations outside the Executive Branch or otherwise establish the standard by which DOJ will determine compliance with existing law. To reinforce that distinction, the new requirements call for clear labeling, including disclaimers that the document has no force of law or binding effect outside the Executive Branch and an express statement that voluntary standards will not, by themselves, trigger enforcement. DOJ guidance also must avoid coercive or mandatory language, including “shall,” “must,” and “required,” unless it is accurately restating a clear statutory, regulatory, or judicial mandate.
More significantly for government contractors, healthcare providers, and federal grant recipients, the revised section also replaces the ability for attorneys to cite or rely on guidance as the basis for enforcement action with a more defined framework for bringing such actions. Stated differently, civil and criminal enforcement actions must be based on violations of applicable legal requirements, not mere noncompliance with agency guidance, under the new regime, and the Department may not proceed solely on an allegation that a party failed to follow a guidance document.
That said, the revisions also indicate guidance may nonetheless still be relevant when it bears on scienter, notice, knowledge, or other mens rea standards; provides evidence of professional or industry standards, duties, customs, or practices; reflects generally accepted scientific or technical processes; bears on a party’s compliance when that compliance is itself part of the claim, such as a false certification or a contractual commitment; or supplies legal or factual context in a filing. Those uses do not give the guidance force of law, establish the applicable mental-state standard, or make the agency’s interpretation conclusive. The revised section illustrates these categories with examples from healthcare, government fraud, and technical fields, while leaving the underlying statutory, regulatory, or contractual requirement as the basis for liability. As a general matter, these carve outs from the broader policy may provide DOJ attorneys with ample grounds on which to rely on guidance documents, notwithstanding the broader policy statement.
Based on these changes, we would generally expect agencies attempting to change legal requirements or create new rights and obligations through an FAQ response, informal guidance documents, agency memoranda, directive, etc., may face reluctance (or at least questions) from the Department when attempting to bring enforcement actions predicated on violations of obligations ostensibly imposed by such guidance documents. That said, given the areas in which informal guidance may nonetheless be used, we would expect that the revisions do not necessarily mean that such guidance will be of no importance or play no role in the government’s evaluation of liability under the False Claims Act moving forward. Stated differently, notwithstanding these revisions, contractors, healthcare entities, and federal funding recipients remain well served to continue reviewing and considering agency guidance in connection with their broader compliance and operational activities to ensure that such guidance can continue to inform their actions in mitigating if not avoiding compliance risk.
Link to II. Revision to JM 4-4.111: DOJ Dismissal of Qui Tam Actions II. Revision to JM 4-4.111: DOJ Dismissal of Qui Tam Actions
In addition, the revisions require prosecutors to evaluate every declined qui tam case for dismissal using a broadened list of factors. Specifically, the prior version of this Justice Manual section directed prosecutors considering a declination to consider whether a motion to dismiss the qui tam complaint would serve the government’s interests. The revised language bolsters that consideration, mandating that the Department assess dismissal in every declined case. If dismissal is not warranted when the Department declines intervention, then the Department may reassess the issue as the litigation develops. The revised policy therefore requires a recurring evaluation without creating an automatic presumption that declined cases should be dismissed.
The Department also revised the list of factors for consideration when assessing whether to move to dismiss a qui tam complaint. The updated factors place greater emphasis on preventing parasitic or opportunistic actions that duplicate a pre-existing government investigation without adding useful information. That consideration now appears first, while the former (and previously more detailed) description of facially meritless claims has been condensed into a second factor addressing meritless qui tams, followed by factors concerning interference with agency policy or program administration, control of litigation brought on behalf of the United States, protection of classified information and national security, preservation of government resources, and egregious procedural errors that could frustrate a proper investigation.
These are positive developments for qui tam defendants, and we expect this Administration to continue to be more favorably disposed towards proactively moving to dismiss meritless whistleblower suits.
Link to III. Practical Implications for Government Contractors, Healthcare Entities, and Federal Funding Recipients III. Practical Implications for Government Contractors, Healthcare Entities, and Federal Funding Recipients
Federal contractors, healthcare entities, and federal funding recipients now have a clearer basis to challenge FCA theories that treat sub-regulatory guidance as an independent legal obligation. Agency guidance may still support scienter or proof of professional standards, and it remains relevant where a party falsely certifies compliance or a contract or provider agreement makes compliance part of the bargain. For example, compliance programs would be well served to distinguish between voluntary guidance and binding requirements, and contractors should ensure that certifications or other statements to government officials do not overstate adherence to guidance that the organization does not follow.
For defendants in declined qui tam cases, the Department’s mandatory assessment may produce more motions to dismiss, particularly where a relator’s allegations duplicate an existing audit or investigation and add little information. This presents defendants with a possible opportunity to influence prosecutors’ decisions at such time, particularly where the defendant has played an active role in responding to government inquires and transparently cooperated with the government investigation. The Department may also revisit dismissal later, so parties should not assume that its initial decision to decline intervention will remain its final position, particularly as litigation lasts for a protracted period of time or results in multiple amended complaints following dismissals or the facts (or substantive lack thereof) warrant further reconsideration.
For questions or counsel about these topics, contact the authors of this article listed below, or another member of the McGuireWoods Government Investigations & White Collar Litigation, Government Contracts, or False Claims Act Investigations & Litigation Practice Groups.