DOJ Announces Significant Changes to Justice Manual Concerning Dismissal of FCA Qui Tams and the Issuance and Use of Sub-Regulatory Guidance

On September 18, 2026, the Department of Justice ("DOJ") announced revisions to the Justice Manual regarding: (i) when and how DOJ decides whether to move to dismiss a whistleblower's False Claims Act ("FCA") qui tam suit; and (ii) DOJ's issuance and use of agency guidance documents in litigation.

The revisions to DOJ's dismissal process are significant for two reasons. First, they require DOJ attorneys to consider dismissing a qui tam complaint before declining to intervene. Second, they expand the universe of cases eligible for dismissal from those that are facially meritless to those that more broadly lack merit. The revisions to DOJ's permitted use of agency guidance further confine the use of such documents to a narrow set of circumstances, restoring, with only subtle changes, the guidance DOJ gave its attorneys from 2017 to 2021 and overturning the approach adopted under Attorney General Merrick Garland.

DOJ Broadens the Grounds for Dismissing Qui Tam Suits and Requires Department Attorneys to Consider Dismissal

The False Claims Act both allows a private relator to sue on the government's behalf and lets the government dismiss that suit over the relator's objection. For years, DOJ used the power sparingly. In January 2018, Michael Granston, then Director of the Commercial Litigation Branch's Fraud Section, circulated a memorandum surveying cases in which the government had sought dismissal and distilling seven recurring factors. That framework was later codified at Section 4-4.111 of the Justice Manual, including the seven factors DOJ attorneys should consider in determining whether to seek dismissal of a qui tam complaint (the "Seven Factors"). The September 2026 revision to Section 4-4.111 makes two significant changes.

First, DOJ attorneys are now required to consider dismissal in every case before declining to intervene.[i] The prior text said that Department attorneys evaluating a declination "should also consider" dismissal; the current text says they "will in each case assess" it.[ii] The following two sentences were also added to this section. One observes that dismissal "will not be warranted in every declined case," because the government often investigates only far enough to conclude that declination is warranted, "which may not equate to the conclusion that a qui tam is meritless." The other provides that the Department "may re-evaluate whether dismissal becomes appropriate as the litigation progresses," leaving the door open to reconsideration after, for instance, further briefing and discovery by the parties. Neither sentence appeared in the prior text of Section 4-4.111, but both echo observations in the Granston Memorandum and may not represent a significant change.

The second significant change to Section 4-4.111 is the removal of a critical qualifier from one of the Seven Factors. The factor formerly read that a basis for seeking dismissal is to "[c]urb[ ] meritless qui tams that facially lack merit (either because the relator's legal theory is inherently defective, or the relator's factual allegations are frivolous)"—language aimed at fringe cases that lacked any credibility. It now reads, in full, "[c]urbing meritless qui tams." The parenthetical and the limitation to facial deficiency are gone. The other six factors are untouched, but this change has the potential to broaden the scope of cases eligible for dismissal well beyond fringe qui tams, to include cases in which DOJ has been unable to substantiate a relator's allegations after an investigation.

Each of these changes is significant on its own, but together their effect is potentially greater still. Because Department attorneys are now required to consider dismissal at the time of declination, they will need to give their supervisors the basis not only for their declination recommendation but also for their dismissal recommendation. And while Section 4-4.111 acknowledges that cases are sometimes declined for reasons other than a lack of merit,[iii] many are undoubtedly declined after DOJ has investigated thoroughly and concluded that the allegations, even if not frivolous, otherwise lack merit. Under the new guidelines, such cases would satisfy one of the Seven Factors, potentially warranting dismissal.

That prospect is especially notable given DOJ's recent willingness to use this tool. Deputy Assistant Attorney General Brenna Jenny stated earlier this year that the Department "is not reluctant to exercise its authority to dismiss" and is "committed to doing so where cases are proven to be meritless or inconsistent with current law and where the allegedly defrauded agency does not support the case."[iv] And DOJ dismissed roughly 25 qui tam cases in 2025, against an average of approximately six per year under the prior administration.[1]

A Decade of Shifting Positions on the Issuance and Use of Guidance Documents

The second revision to the Justice Manual reinstates limitations on DOJ's use of sub-regulatory guidance that were in place during the first Trump administration.[v] Federal agencies issue an enormous volume of material that explains, interprets, or elaborates on statutes and regulations—Medicare coverage manuals, advisory opinions, and prescribing guidelines, among countless other materials. Over the past decade, DOJ has shifted its position with each administration on how far the government may rely on such guidance in litigation.

In November 2017, Attorney General Jeff Sessions issued a memorandum barring Department components from issuing guidance that purported to bind the public. Two months later, Associate Attorney General Rachel Brand extended the principle to litigation, instructing that Department lawyers "may not use noncompliance with guidance documents as a basis for proving violations of applicable law" in affirmative civil enforcement cases. The Brand Memo nevertheless recognized a limited evidentiary role for guidance documents—permitting their use to establish that a party knew of a particular legal requirement. In December 2018, the Department codified both memoranda into the Justice Manual, at Section 1-19.000 for issuance and Section 1-20.000 for litigation use.[vi]

In July 2021, Attorney General Merrick Garland rescinded the Sessions and Brand memoranda and directed that the Justice Manual be revised to match. As Jones Day previously discussed, in doing so, he removed the strict limitations on the issuance and use of guidance documents that those memoranda had imposed.

Specifically, the Justice Manual under Attorney General Garland defined a guidance document as "a statement of general applicability issued by an agency to inform the public of its policies or legal interpretations."[vii] Department attorneys were then instructed that although, under the Supreme Court's decision in Kisor v. Wilkie, a guidance document by itself "never forms 'the basis for an enforcement action,'" they could nevertheless rely on guidance "in any appropriate and lawful circumstances, including when a guidance document may be entitled to deference or otherwise carry persuasive weight."[viii] The Garland-era Manual also deleted the five enumerated examples of permissible use that the Sessions-era Manual had provided, removing the implicit limitation on the types of guidance materials Department attorneys could rely upon in litigation.[ix] On February 5, 2025, however, the current administration rescinded the Garland Memorandum but left the Manual provision standing, unreplaced, until now.

The revisions to these sections of the Justice Manual represent a significant departure from DOJ's position under the Biden administration and a return to its position during the first Trump administration. As DOJ explained, the changes are meant to "reinstate[] and build[] upon [the Department]'s 2017 policy that sub-regulatory guidance cannot impose legal obligations beyond those established by statute or regulation."

Limitations on the Issuance and Use of Guidance Documents (§ 1-19.100–1-19.260)

With respect to the issuance of guidance documents, the Justice Manual reverts, word for word, to its previous definition of "agency guidance document"—a definition borrowed from President Clinton's Executive Order 12866. DOJ has likewise reverted to its prior list of directives for issuing guidance documents; however, these directives are now mandatory, while they were only encouraged under the Sessions-era Manual.

With respect to the use of guidance documents in litigation, the general principles are largely unchanged in substance between the Sessions-era Manual and the current one; both set out nearly identical, nonexhaustive lists of permissible uses. Specifically, both provide that such documents may be used:

• As evidence that a party had the requisite scienter, notice, or knowledge of the law;
• As evidence that a party has satisfied, or failed to satisfy, professional or industry standards or practices relating to applicable statutory or regulatory requirements;
• To support a claim that a certain action is, or that a factual or expert witness is, rendering an opinion that is, consistent or inconsistent with processes described in a guidance document reflecting certain scientific or technical generally accepted processes;
• As evidence when a party's compliance, or failure to comply, with the agency guidance is itself relevant to the claims at issue (for instance, when a provider falsely certifies compliance with a guidance document and the certification is material to an agency's payment decision, the false certification may be offered to establish the elements of falsity, materiality, and scienter); and
• To provide relevant legal or factual context in briefs and other filings (for example, citing a manual in the background section of a brief to explain how an agency processes payments).

Despite DOJ's stated limitations on the use of guidance documents, they will still prove pivotal in many FCA cases. The Justice Manual continues to state that "guidance documents such as CMS's Medicare Benefit Policy Manual or Local Coverage Determinations are relevant evidence of, inter alia, violations of the principal requirement that procedures billed to Medicare or Medicaid be medically 'reasonable and necessary,'" even if such documents do not have "the force of law" but instead "aid[] in demonstrating that the standards in the relevant statutory and regulatory requirements have been or have not been satisfied."[x]

DOJ may also introduce evidence that a party read an agency guidance document to establish that the party knew of a legal requirement, so long as it does not treat noncompliance with the guidance as proof of the violation itself.[xi] That is the line the Brand Memo drew: guidance could not establish liability, but it could establish knowledge. And because the FCA requires scienter, and the Justice Manual expressly permits the use of guidance documents to prove it, nonbinding agency guidance is likely to continue playing a significant role in FCA litigation notwithstanding these revisions.

Key Points

• DOJ attorneys must now affirmatively assess dismissal in every qui tam case before declining to intervene, which means declination recommendations to supervisors will need to address dismissal as well.
• By deleting the requirement that a qui tam "facially lack merit," DOJ has expanded the grounds for dismissal to reach cases that may assert plausible claims but that DOJ concludes lack sufficient merit after an investigation. Combined with the mandate for DOJ attorneys to consider dismissal pre-declination and DOJ's stated commitment to dismissing meritless cases, this change gives defendants greater reason to press DOJ for dismissal before the government makes an intervention decision.
• The restored limits on sub-regulatory guidance mean that DOJ cannot use such guidance in FCA cases to impose obligations beyond statute or regulation or to establish liability on its own. Nevertheless, sub-regulatory guidance remains admissible to show scienter, notice, industry standards, and relevant context; accordingly, nonbinding guidance will continue to play a significant role in FCA litigation.

[1] Brenna Jenny, Deputy Assistant Att’y Gen., Commercial Litig. Branch, Civ. Div., U.S. Dep’t of Just., Keynote Remarks at the American Conference Institute’s 13th Annual Advanced Forum on False Claims and Qui Tam Enforcement (Jan. 28, 2026); see also Letter from Charles E. Grassley, Chairman, S. Comm. on the Judiciary, to Brett A. Shumate, Assistant Att’y Gen., Civ. Div., U.S. Dep't of Just. 2 (Apr. 2, 2026), https://www.grassley.senate.gov/imo/media/doc/grassley_to_doj_-_qui_tam_dismissals.pdf.

[i] U.S. Dep't of Just., Just. Manual § 4-4.111 (2026).

[ii] U.S. Dep't of Just., Just. Manual § 4-4.111 (2021); U.S. Dep't of Just., Just. Manual § 4-4.111 (2026).

[iii] Id. ("… the government will often investigate a qui tam only to the point where it concludes a declination is warranted, which may not equate to the conclusion that a qui tam action is meritless.").

[iv] Brenna Jenny, Deputy Assistant Attorney General, Department of Justice, Commercial Litigation Branch, Keynote Address at the Federal Bar Association's Qui Tam Conference (Feb. 19, 2026).

[v] U.S. Dep't of Just., Just. Manual §§ 1-19.000, 1-20.000 et seq (2026).

[vi] U.S. Dep't of Just., Just. Manual §§ 1-19.000, 1-20.000 (2018).

[vii] U.S. Dep't of Just., Just. Manual § 1-19.000 (2021); Garland Memo, § 1.

[viii] U.S. Dep't of Just., Just. Manual § 1-19.000 ¶ 3 (2021).

[ix] Id.

[x] U.S. Dep't of Just., Just. Manual § 1-19.230 (2026).

[xi] Id.