DOJ Revises Justice Manual on Non-Binding Guidance and Qui Tam Dismissals: Practical Considerations

On September 18, 2026, the U.S. Department of Justice (DOJ) announced revisions to two sections of the Justice Manual (JM) in an effort to strengthen the “fight against fraud” in False Claims Act (FCA) and other civil enforcement matters.

The revisions clarify and reinforce limits on the use of sub-regulatory guidance in DOJ litigation and on when DOJ will seek dismissal of qui tam actions.

First, revisions to JM 1-19.000 build upon DOJ’s 2017 policy that sub-regulatory guidance cannot impose legal obligations beyond those established by statute or regulation. The 2017 policy and a related January 2018 memorandum were rescinded in 2021 by then-Attorney General Merrick Garland and reinstated in February 2025 by then-Attorney General Pam Bondi.

Second, revisions to JM 4-4.111 emphasize that, when exercising its discretion to intervene in an FCA qui tam action, DOJ attorneys are required, in each case, to assess whether the government’s interests are served by seeking dismissal pursuant to 31 U.S.C. § 3730(c)(2)(A). This is a more forceful articulation than the prior version of 4-4.111 from October 2021, which states “attorneys should also consider” whether the government’s interests are served.

Why Now?

Sub-Regulatory guidance

The U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo,[1] overturning judicial deference to reasonable agency interpretations of ambiguous statutes, is making its presence known in FCA cases. As FCA litigation often depends on regulatory agency interpretations and sub-regulatory guidance, Loper Bright may impact FCA cases involving interpretations of the Stark Law or Anti-Kickback Statute and Centers for Medicare & Medicaid Services interpretations of Medicare and Medicaid statutes.

Dismissal Authority

As Epstein Becker Green noted in February, remarks at the Federal Bar Association’s Qui Tam Conference highlighted that, in 2025, DOJ moved to dismiss only 25 qui tam cases using its dismissal authority pursuant to 31 U.S.C. § 3730(c)(2)(A). Deputy Assistant Attorney General Brenna Jenny predicted that DOJ would increase use of its statutory authority to dismiss cases in the future, and would evaluate dismissal decisions at the declination stage for all cases, rather than making dismissal decisions on an ad hoc basis, as was the practice in prior administrations. Statistics for 2026 are not yet available.

Use of Sub-Regulatory Guidance in Civil Enforcement Actions

Previously, JM 1-19.000 was explicit that guidance documents don’t have the force and effect of law, yet the 2026 version is even more explicit: “Agency guidance documents may not be used as a substitute for regulation and may not be used to impose new requirements on persons outside the Executive Branch except as expressly authorized by law or contract.”

Guidance documents will not “create rights or obligations binding on persons or entities outside the Executive Branch” or “create binding standards by which [DOJ] will determine compliance with existing regulatory or statutory requirements.”

No appropriate circumstances. The revised JM 1-19.000 removes language indicating that DOJ attorneys may rely on guidance documents “in any appropriate and lawful circumstances,” including where the guidance is entitled to deference or otherwise carries persuasive weight. When issuing guidance documents, DOJ will:

• Identify the documents as guidance, disclaim any force or effect of law, and avoid language suggesting that the public has obligations that go beyond those set forth in the applicable statutes and regulations;
• Clearly state that the documents have no legally binding effect on persons or entities outside of the Executive Branch and may be rescinded or modified in [DOJ’s] complete discretion;
• Avoid using the documents for the purpose of coercing persons or entities outside of the federal government into taking any action or refraining from any action beyond what is required by the terms of the applicable statute or regulation;
• Avoid using mandatory language such as “shall,” “must,” “required,” or “requirement” to direct parties outside the Executive Branch to take or refrain from taking action except when restating—with citations to statutes, regulations, or binding judicial precedent—clear mandates contained in the statute, regulation, or binding judicial precedent; and
• Clearly state that noncompliance with voluntary standards will not, in itself, result in any enforcement action.

Revisions to JM 4-4.111

When determining whether to seek dismissal, DOJ’s non-exhaustive list of factors in JM 4-4.111 remains largely the same after the revisions. The September 2026 version adds two important clarifications:

• “Dismissal will not be warranted in every declined case, because to maximize its resources the government often will investigate a qui tam action only to the point where it concludes a declination is warranted, which may not equate to the conclusion that a qui tam is meritless”; and
• “For cases in which [DOJ] concludes at the time of declination that dismissal pursuant to § 3730(c)(2)(A) is not warranted, [DOJ] may re-evaluate whether dismissal becomes appropriate as the litigation progresses.”

Practical Implications

Sub-Regulatory Guidance

FCA defendants facing DOJ enforcement post-Loper Bright should keep in mind what sub-regulatory agency guidance can and cannot do. Defendants may have more arguments in their arsenal, including that the sub-regulatory guidance on which the government or relator relies exceeds statutory authority. An enforcement action has to rest on an actual binding obligation: a statute, regulation, contract term, or constitutional provision.

Under JM 1-19.230, DOJ may use a guidance document “as probative evidence that a party has satisfied, or failed to satisfy, professional or industry standards or practices relating to applicable statutory or regulatory requirements.” JM 1-19.250 states that DOJ may cite a guidance document when a party’s compliance, or failure to comply, is relevant to the claims at issue: “when a provider falsely certifies compliance with a guidance document, and the certification is material to an agency’s payment decision, the false certification to obtain a payment may be offered to establish the elements of falsity, materiality, and scienter.”

JM 1-19.220 further states that when a guidance document or its contents describe a statute or regulation, DOJ:

• may use awareness of the document or contents “as evidence that the party had the requisite scienter, notice, or knowledge of the law”; and
• may use the document or its contents to establish mens rea in some circumstances, including, for example, when “a party has submitted a false claim that is contrary to fact, but was crafted in a way that otherwise appears to be consistent with a guidance document, or when a party’s deliberate indifference to a guidance document is probative of deliberate indifference to the requirements imposed by statute, regulation, or other obligation (e.g., a contract or certification).” 

Under the same provision, a guidance document, in addition to not having the force of law, does not establish the relevant mens rea for a criminal offense, nor may DOJ treat awareness of a legal interpretation in a guidance document as an admission that the document is a correct interpretation of the statute or regulation.

Dismissal Authority

While DOJ advocates that it will voluntarily dismiss meritless cases, the actual number of cases it elects voluntarily to dismiss has not, so far, amounted to many. Given these changes in the JM, however, stakeholders should push DOJ not just to decline meritless cases, but to affirmatively dismiss them. When DOJ announced in May its intention to accelerate review of FCA cases, focusing on state programs and imposing time limits—announcing that all newly filed state-administered benefits program fraud qui tam actions will be reviewed in 60 to 120 days after filing, to determine if the government will continue its investigation—the agency included dismissing cases as one of the efforts it would pursue.

Also remember: the revisions specifically note DOJ may re-evaluate whether dismissal becomes appropriate as non-intervened qui tam litigation progresses. At the same time, the government continues to rely heavily on qui tam cases in its fight against health care fraud, and whistleblower cases are not going anywhere any time soon. The revisions were clearly meant to reverse former policies, yet it remains to be seen to what extent DOJ carries them out—particularly with respect to dismissals.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.

Endnotes

[1] 603 U.S. 369 (2024).

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The Health Law Advisor blog is currently edited by Emily Chi Fogler.