DOJ Revises Justice Manual, Explaining How to Apply Sub-Regulatory Guidance and Qui Tam Dismissals

Key Takeaways

• DOJ has narrowed how sub-regulatory guidance may support False Claims Act enforcement. Nonbinding guidance cannot independently establish a legal violation, but DOJ may still use it as evidence of scienter, notice, industry standards, compliance, or relevant factual context.
• DOJ attorneys must assess whether dismissal serves the government’s interests in every declined qui tam. That assessment may continue throughout litigation, potentially creating additional opportunities for defendants to advocate for dismissal.
• Companies facing FCA scrutiny should reassess both guidance-based enforcement theories and potential dismissal arguments. Defendants should identify whether DOJ’s case depends heavily on nonbinding guidance and evaluate the Justice Manual’s dismissal factors early in the litigation.

On September 18, 2026, the Department of Justice (“DOJ”) announced two revisions of the Justice Manual aimed at building, and seeking dismissals of, qui tam actions brought under the False Claims Act (“FCA”).

According to former Associate Deputy Attorney General Paul Perkins, “These revisions will help ensure the department uses its enforcement authority fairly and effectively — holding fraudsters accountable for violations of binding legal or contractual obligations while seeking dismissal of meritless qui tam actions that waste taxpayer resources and impose unjustified burdens on businesses.”

How DOJ May Use Sub-Regulatory Guidance in False Claims Act Cases

DOJ has formally reinstated the department’s 2017 policy, which was enacted during the first Trump administration, that sub-regulatory guidance cannot impose legal obligations beyond those established by statute or regulation. In other words, the DOJ will focus its FCA enforcement on violations of binding statutory, regulatory, and contractual obligations, while prohibiting enforcement actions based solely on non-compliance with sub-regulatory agency guidance documents.

With this revision, the department formalizes a policy previewed by former Attorney General Pam Bondi’s February 5, 2025, memorandum, which reinstated the prohibition on improper guidance documents from 2017 and rescinded the memorandum issued by Attorney General Merrick Garland entitled, “Issuance and Use of Guidance Documents by the Department of Justice.”

However, sub-regulatory agency guidance does still have a role to play in several aspects of the DOJ’s FCA enforcement, which are outlined in the updated Justice Manual provision. Specifically, DOJ may still rely on sub-regulatory guidance or the awareness of sub-regulatory guidance to serve as evidence of:

• scienter, notice, knowledge, or mens rea behind the submission of false claim;
• a party’s satisfaction of, or failure to satisfy, profession or industry standards relating to applicable statutory or regulatory requirements;
• scientific or technical processes in a particular field to support a claim that certain action is consistent or inconsistent with those practices;
• a party’s compliance (or lack of compliance) with agency guidance when it is relevant to the claims at issue; and
• relevant legal or factual context in briefs or other filings.

What DOJ’s Guidance Policy Means for FCA Defendants

While DOJ has limited the role of sub-agency guidance, the Justice Manual revisions also make clear that such guidance can still play an important role in FCA exposure and liability. As a result, companies should continue to monitor relevant guidance documents closely.

This revision is also worth considering as a potential inflection point in any ongoing litigation to the extent agency guidance documents serve a major role in the government’s case for FCA liability. This may create opportunities to engage with DOJ or provide support for shifts in legal strategies challenging enforcement theories.

DOJ Expands Review of Qui Tam Dismissals Under the False Claims Act

The second revision to the Justice Manual reinforces and updates the department’s position on seeking dismissals of qui tam suits. Previously, DOJ attorneys were instructed, when considering declination, to consider if a dismissal served the government’s interests. The updated Justice Manual now requires DOJ attorneys to “in each case assess” whether the government’s interests are served by seeking a dismissal. The Justice Manual also states that following declination, the department “may re-evaluate whether dismissal becomes appropriate as the litigation progresses.” Thus, the DOJ will now evaluate dismissal at the outset of cases and continue to weigh the government’s interests in a dismissal throughout the pendency of an action.

Should the DOJ believe dismissal is warranted, it must also consult with the affected agency prior to seeking a dismissal.

Finally, this revision includes a list of non-exhaustive factors that can serve as a basis for dismissal, codifying the framework outlined in the January 2018 Granston Memorandum. Pursuant to this framework, DOJ attorneys are instructed to consider if dismissal would:

1. curb meritless qui tams;
2. prevent parasitic or opportunistic qui tam actions that duplicate a pre-existing government investigation and add no useful information to the investigation;
3. prevent interference with an agency’s policies or the administration of its programs;
4. control litigation brought on behalf of the United States, in order to protect the department’s litigation prerogatives;
5. safeguard classified information and national security interests;
6. preserve government resources, particularly where the government’s costs, including the opportunity costs of expending resources on other matters, are likely to exceed any expected gain; or
7. address egregious procedural errors that could frustrate the government’s efforts to conduct a proper investigation

What the New Qui Tam Dismissal Policy Means for FCA Defendants

Historically, the government has exercised its dismissal authority under § 3730(c)(2)(A) sparingly, dismissing roughly 15-25 qui tam cases annually against a backdrop of 800 to nearly 1,300 new cases filed each year. However, this revision could mean that the department intends to take a more aggressive stance on seeking dismissals early on and during the pendency of FCA enforcement actions.

Defendants in qui tam actions should assess these seven factors and evaluate the affirmative case for dismissal to present to the DOJ. Given the department must consult with the relevant agency prior to seeking any dismissal, both DOJ attorneys and the relevant agency could play a critical role in the government’s determination if seeking a dismissal is warranted.