On September 18, 2026, the Department of Justice (DOJ) revised two sections of the Justice Manual bearing on False Claims Act (FCA) enforcement. The first memorializes limits on using agency guidance as the basis for enforcement, reversing prior DOJ policy established during the Biden Administration. The second directs DOJ lawyers to assess, in every declined qui tam matter, whether the government should seek dismissal under 31 U.S.C. § 3730(c)(2)(A).1
Neither development arose in a vacuum. The guidance revision carries forward the February 2025 Bondi Memorandum, the latest turn in a policy debate spanning the Sessions, Brand, and Garland tenures. The qui tam dismissal revision formalizes DOJ leadership’s renewed emphasis on exercising its statutory authority to dismiss qui tam actions over relators’ objections.2
The practical lesson is that both policies concern enforcement discretion—and that discretion can change with administrations. Agency guidance may not create a binding legal obligation, but how a company evaluates and responds to guidance may become evidence of what it understood about the governing law. And because the FCA’s limitations period can reach back 10 years, communications created under one administration may be scrutinized under another’s enforcement priorities.3
I. DOJ’s position swings, but the record a company creates endures
Justice Manual §§ 1-19.100–1-19.260
DOJ’s position on the impact of agency guidance has shifted with changes in administrations. In November 2017, then-Attorney General Jeff Sessions prohibited DOJ components from issuing guidance documents that purported to create binding rights or obligations beyond those established by statute, regulation, or binding judicial precedent. The Sessions Memorandum also directed that DOJ guidance could not be used to impose new requirements on regulated parties or to treat noncompliance with voluntary standards as an independent basis for enforcement. In January 2018, then-Associate Attorney General Rachel Brand extended that principle to affirmative civil enforcement. The Brand Memorandum prohibited DOJ from using enforcement actions to convert agency guidance into binding requirements, while permitting appropriate evidentiary uses of guidance, including as evidence of knowledge.4
In July 2021, Attorney General Merrick Garland rescinded the Sessions and Brand memoranda, which had the practical implications of permitting DOJ lawyers to cite or rely on relevant guidance in appropriate and lawful circumstances while reaffirming that guidance alone cannot create binding requirements or support enforcement. Then, in February 2025, then-Attorney General Pamela Jo Bondi reversed course, reinstating the prohibition on guidance documents that operate as substitutes for rulemaking. The 2026 revisions to the Justice Manual memorialize that policy and extend its limitations across civil and criminal enforcement.5
Given this history, the current Manual reflects DOJ policy as it stands today—not a permanent guarantee. A company evaluating agency guidance now cannot assume that DOJ will apply the same framework years from now.6
The central rule is straightforward: A plaintiff in an FCA action, whether DOJ or a relator in a declined qui tam, must prove a knowing violation of an applicable legal or contractual requirement that materially influenced the government’s decision to pay a claim. It may not establish liability merely by showing that a person or entity failed to comply with an agency manual, policy statement, interpretive document, or other guidance lacking the force and effect of law.7
That rule reflects a foundational distinction: Statutes and regulations bind the public; guidance does not. An agency may not bypass notice-and-comment rulemaking and then produce the same result through enforcement. Nor may DOJ supply the missing legal force by treating an agency’s interpretation as the underlying obligation.8
The revised Manual operationalizes that distinction. DOJ components must label guidance as such, explain that it lacks binding effect outside the Executive Branch, and avoid mandatory language unless restating a statutory, regulatory, or precedential requirement. Guidance may not coerce conduct beyond what law requires, and noncompliance with voluntary standards cannot, by itself, trigger enforcement.9
The revised definition of “guidance document” does not encompass every government statement. It excludes, among other things, certain adjudicatory decisions, statements of enforcement priorities, internal directives and training materials, litigation positions, legal advice, and documents shared with state, local, or tribal law-enforcement agencies. So whether a statement qualifies as guidance may matter. Its significance will turn not only on what it says, but also on the government action it represents.10
II. Noncompliance with subregulatory guidance may not establish liability, but it may be probative of knowing conduct under the FCA
Nonbinding does not mean irrelevant. Guidance may not furnish the rule of decision, but it may bear on notice, knowledge, scienter, professional or industry standards, and the factual significance of a party’s conduct.11
The key distinction is between falsity and scienter. DOJ must first identify a binding obligation and show that the claim was false under it—guidance cannot do that work. But once the governing requirement is identified, a party’s awareness of guidance addressing it may bear on whether it acted knowingly.12
That distinction has particular force after SuperValu, where the Supreme Court held that FCA scienter turns on the defendant’s “knowledge and subjective beliefs,” not on what a hypothetical reasonable person may have known. The question is what the defendant actually believed when presenting the claim, and “facial ambiguity alone is not sufficient to preclude a finding that respondents knew their claims were false.”13
A company’s response to agency guidance may speak directly to that inquiry. Evidence that employees received guidance, understood it to address a binding requirement, raised compliance concerns, or tried to avoid scrutiny can support an inference of actual knowledge or reckless disregard. In SuperValu, the relators offered evidence that the defendants understood the relevant billing standard and tried to conceal inconsistent practices. The Court made clear that the defendants’ subjective contemporaneous beliefs—not a later-developed legal theory—governed the scienter analysis.14
The converse may also be true. A contemporaneous, well-documented analysis of the governing statute, regulation, contract, and relevant guidance may support an inference that the company adopted its position in good faith.
Nor does awareness of agency guidance concede that the agency’s interpretation is correct. A company may conclude that agency guidance reflects a misreading of the statute, exceeds the regulation, conflicts with a contract, or inaccurately describes the relevant professional standard. If a company departs from the agency’s guidance and interpretation, it should identify the binding text, document its reasoning, address contrary authority, and preserve the contemporaneous analysis.
III. DOJ formalizes renewed scrutiny of declined qui tam actions
Justice Manual § 4-4.111
The revised Manual also formalizes DOJ leadership’s renewed emphasis on using 31 U.S.C. § 3730(c)(2)(A) to dismiss qui tam actions over relators’ objections.15 When recommending declination, DOJ lawyers “will in each case assess” whether dismissal would serve the government’s interests.16 Every declination recommendation must now address not only whether DOJ should take over the case, but also whether the case should proceed at all.
The shift from “should also consider” to “will in each case assess” is more than stylistic. The former recommended consideration; the latter requires it. The Manual continues to identify familiar grounds for dismissal, including meritless or parasitic claims, interference with agency policy, threats to DOJ’s litigation prerogatives, risks to classified information or national security, demands on government resources, and serious procedural defects.17
Intervention and dismissal remain distinct inquiries. Declination does not necessarily mean a case lacks merit—the government often investigates only to the point where it concludes intervention is unwarranted. But a decision against dismissal at declination does not permanently resolve the issue; DOJ may reconsider as discovery, expert analysis, or the responsible agency’s position reveals new concerns.18
The revised Manual reinforces that continuing review by broadening one of the grounds for dismissal. The prior version referred to qui tam actions that “facially lack merit.” The revised provision refers simply to “meritless qui tams.” Removing “facially” recognizes that a case’s deficiencies may emerge only after the investigation, pleadings, or discovery have developed.19
For defendants, these revisions create two natural advocacy opportunities: at the intervention stage and as a declined case proceeds through litigation. The most effective presentation will address the government’s interests—not merely the burdens on the defendant—and should show how continued litigation would impair a federal program, consume disproportionate resources, conflict with the responsible agency’s position, or threaten unfavorable precedent.
In some cases, the two revisions will converge. A declined action that treats nonbinding guidance as the source of liability may implicate both the Manual’s limits on guidance-based enforcement and its grounds for dismissal. The absence of a binding legal predicate may bear not only on the merits, but on government resources, agency policy, and the risk of adverse precedent.
Practical guidance for companies
- Keep abreast of new agency guidance and revisions to existing agency guidance. When evaluating agency guidance or responding to an FCA inquiry, determine whether the asserted obligation arises from a statute, regulation, or contract. The government or relator should be required to identify that source as well.
- Treat internal communications as lasting evidence. The FCA’s statute of limitations can reach back 10 years. Communications created under one administration may be reviewed under another’s enforcement priorities. Refresh employee training on responsible use of internal communication tools, and ensure that correspondence regarding agency guidance is handled with awareness that its tone and content may be scrutinized by FCA plaintiffs.
- Frame dismissal requests around the government’s interests. When a company first becomes aware of an FCA investigation that likely originates from a sealed qui tam complaint, assess whether persuasive arguments exist for DOJ to decline intervention and seek dismissal. Raise the topic of proactive dismissal at each opportunity with assigned DOJ lawyers, and upon securing a declination, determine whether a formal presentation advocating dismissal is warranted.
Footnotes
1. Press Release, U.S. Dep’t of Just., DOJ Revises Justice Manual to Strengthen False Claims Act Enforcement (Sept. 18, 2026) [hereinafter DOJ September 2026 Press Release.; U.S. Dep’t of Just., Justice Manual §§ 1-19.000, 4-4.111 (2026).
2. Memorandum from Pamela Jo Bondi, Att’y Gen., Reinstating the Prohibition on Improper Guidance Documents 1 (Feb. 5, 2025) [hereinafter Bondi Memorandum.; DOJ September 2026 Press Release, supra note 1; Justice Manual § 4-4.111.
3. 31 U.S.C. § 3731(b)(2).
4. Memorandum from Jefferson B. Sessions III, Att’y Gen., Prohibition on Improper Guidance Documents 1–2 (Nov. 16, 2017) [hereinafter Sessions Memorandum.; Memorandum from Rachel Brand, Assoc. Att’y Gen., Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases 1–2 (Jan. 25, 2018) [hereinafter Brand Memorandum..
5. Memorandum from Merrick B. Garland, Att’y Gen., Issuance and Use of Guidance Documents by the Department of Justice 1–2 (July 1, 2021) [hereinafter Garland Memorandum.; Bondi Memorandum, supra note 2, at 1; DOJ September 2026 Press Release, supra note 1.
6. See Sessions Memorandum, supra note 4, at 1–2; Brand Memorandum, supra note 4, at 1–2; Garland Memorandum, supra note 5, at 1–2; Bondi Memorandum, supra note 2, at 1.
7. U.S. Dep’t of Just., Justice Manual §§ 1-19.200–1-19.260; DOJ September 2026 Press Release, supra note 1 (stating that enforcement should address violations of “binding legal or contractual obligations,” rather than noncompliance with guidance lacking the force and effect of law).
8. Perez v. Mortg. Bankers Ass’n, 575 U.S. 92, 97 (2015) (quoting Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 99 (1995)); see also Kisor v. Wilkie, 588 U.S. 558, 584 (2019) (plurality opinion) (explaining that guidance may advise the public how an agency understands and is likely to apply binding legal requirements).
9. Justice Manual § 1-19.100.
10. Id.; Brand Memorandum, supra note 4, at 1 n.1.
11. Justice Manual §§ 1-19.220–1-19.260; see also Kisor, 588 U.S. at 584 (plurality opinion) (recognizing that guidance may serve the valuable function of advising the public how an agency understands and is likely to apply its binding law).
12. See United States ex rel. Schutte v. SuperValu Inc., 598 U.S. 739, 749–54, 757–58 (2023) (holding that FCA scienter turns on the defendant’s “knowledge and subjective beliefs,” rather than what an objectively reasonable person may have understood, and explaining that facial ambiguity does not preclude a finding that the defendant knew its claims were false); United States ex rel. Brooks v. Stevens-Henager Coll., Inc., 2024 WL 2857885, at 6–9 (D. Utah Mar. 29, 2024) (denying the government summary judgment on scienter because the evidence permitted a reasonable jury to find that the defendant did not subjectively believe its compensation plan violated the governing requirement, but also denying the defendant summary judgment because competing evidence could support a finding of reckless disregard); United States v. McComber, 2024 WL 1243851, at 33–36 (D. Md. Mar. 22, 2024) (holding that extensive circumstantial evidence permitted the jury to find that the defendant knew she had billed the government for hours she did not work and explaining that subjective scienter does not permit a defendant to rely on uncertainty that may have confused others when the defendant understood what the governing requirement demanded), aff’d, 2026 WL 266808 (4th Cir. Feb. 2, 2026); Justice Manual §§ 1-19.220–1-19.260.
13. SuperValu, 598 U.S. at 749–52.
14. Id. at 746–54, 757–58; Justice Manual § 1-19.220.
15. 31 U.S.C. § 3730(c)(2)(A); Karen L. Stevenson & James E. Fitzgerald, Federal Civil Procedure Before Trial ¶ 16:324.5 (Cal. & 9th Cir. ed., Apr. 2026 update) (explaining that the government may intervene after initially declining to do so and, upon intervention, seek dismissal of a qui tam action).
16. DOJ September 2026 Press Release, supra note 1; Justice Manual § 4-4.111.
17. Memorandum from Michael D. Granston, Dir., Com. Litig. Branch, Fraud Section, Factors for Evaluating Dismissal Pursuant to 31 U.S.C. § 3730(c)(2)(A) 3–8 (Jan. 10, 2018) [hereinafter Granston Memorandum.; Justice Manual § 4-4.111.
18. Justice Manual § 4-4.111; DOJ September 2026 Press Release, supra note 1.
19. Justice Manual § 4-4.111; DOJ September 2026 Press Release, supra note 1.
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