1-19.000 – Limitations on Issuance and Use of Guidance Documents

1-19.100 – Limitations on Issuance of Guidance Documents.

An agency guidance document is any agency statement of general applicability and future effect that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statute or regulation, other than a substantive action by an agency that promulgates or is expected to promulgate a regulation. See Exec. Order 12,866, Regulatory Planning and Review, § 3(e), 58 Fed. Reg. 51,735 (1993). [Footnote 1] 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. 

In accordance with this principle, Department components may not issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch (including state, local, and tribal governments). Likewise, Department components may not issue guidance documents that create binding standards by which the Department will determine compliance with existing regulatory or statutory requirements.

To ensure compliance with this policy, and to ensure that persons and entities outside the Executive Branch are aware that guidance documents are not binding, Department components, when issuing guidance documents, 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that the documents have no legally binding effect on persons or entities outside of the Executive Branch and may be rescinded or modified in the Department’s complete discretion;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.

Department components should continue posting any new or revised guidance documents to the Department’s Online Guidance Portal, https://www.justice.gov/guidance; guidance documents posted there should contain unique numbers and include issuance and revision dates. While the Guidance Portal is intended for guidance documents, Department components may submit to the portal other public-facing materials that are published elsewhere when the publication of those materials on the Guidance Portal would benefit the public.

1-19.200 – Limitations on Use of Guidance Documents in Litigation 

1-19.210 – General Principles

Criminal and civil enforcement actions brought by the Department must be based on violations of applicable legal requirements, not mere noncompliance with guidance documents issued by federal agencies, because guidance documents cannot by themselves create binding requirements that do not already exist by statute or regulation. The Department must establish a violation by reference to statutes and regulations. The Department may not bring actions based solely on allegations of noncompliance with guidance documents. Thus, the Department should not treat a party’s noncompliance with a guidance document as itself a violation of applicable statutes or regulations.

The Department may continue to rely on agency guidance documents for purposes that do not treat such documents as creating by themselves binding requirements that do not already exist by statute or regulation, including evidentiary purposes that are otherwise lawful and consistent with the Federal Rules of Evidence. 

The following sections provide examples that are intended to serve as specific, but not exhaustive, illustrations of appropriate uses of guidance documents. 

1-19.220 – Scienter, Notice, Knowledge, and Mens Rea

When a guidance document describes a relevant statute or regulation, the Department may use awareness of the guidance document (or its contents) as evidence that the party had the requisite scienter, notice, or knowledge of the law. Additionally, in some circumstances, the Department may use a guidance document (or its contents) to establish mens rea, when, for example, 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). 

The usages described above are subject to three important limiting principles. First, these usages do not give guidance documents the force of law. Second, a guidance document alone does not establish what the relevant mens rea standard is for a criminal offense.  Such standards are set by Congress through legislation. Third, the Department may not treat awareness of a legal interpretation in a guidance document as an admission that the guidance document is a correct interpretation of the binding legal requirements in a statute or regulation.

1-19.230 – Professional or Industry Standards or Practices and Duties, Customs, or Practices for Government Agencies

The Department 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. For instance, if a physician writes prescriptions in excess of the CDC Guideline for Prescribing Opioids for Chronic Pain, which contain medical recommendations for primary care physicians, that fact may be offered as evidence that the prescriptions were issued and opioids dispensed without a “legitimate medical purpose” and outside “the usual course of [] professional practice,” 21 C.F.R. § 1306.04(a), in violation of the Controlled Substances Act. 

This rationale applies more broadly in the healthcare arena, where 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.”  E.g., 42 U.S.C. § 1395y(a)(1)(A); 42 U.S.C. § 1396 et seq.; 42 C.F.R. § 410.50. Such usage does not give these documents the force of law but rather aids in demonstrating that the standards in the relevant statutory and regulatory requirements have been or have not been satisfied. Such usage should also not be conflated with a presumption that a guidance document correctly states the relevant professional or industry standard.  Like other forms of evidence, a guidance document’s articulation of the appropriate standard can be contested or rebutted through other forms of evidence.

Similarly, in certain types of government fraud and government insider trading cases, the government sometimes must establish the existence of a duty (such as a duty of confidentiality or a duty to disclose with respect to certain information) or a breach of that duty. To do so in such cases, it may rely on agency guidance documents as evidence of the existence of that duty. This rationale exists more broadly in cases in which the government must prove a duty, custom, or practice with respect to a government agency. Such reliance on guidance documents does not impart to those guidance documents the force of law any more than use of an internal corporate manual to prove a duty, custom, or practice with respect to a private corporation would impart to that manual the force of law.

1-19.240 – Scientific or Technical Processes

The Department may cite and use a guidance document reflecting scientific or technical processes that are generally accepted in a particular field 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 those processes.

1-19.250 – Party’s Compliance with Guidance

The Department may cite a guidance document when a party’s compliance, or failure to comply, with the agency guidance is itself relevant to the claims at issue. For example, 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. In this example the deceit of the false certification is probative, not the binding or nonbinding nature of the guidance. Similarly, when a company falsely represents to investors or auditors that it has complied with all relevant SEC guidance on a particular issue, the false representation properly may be offered to prove securities fraud. Additionally, when a government contract or provider agreement requires compliance with some agency guidance document, it is the contract—not the agency guidance itself—that makes the agency guidance pertinent and, in these cases, violations of that guidance undertaken with the requisite mental state may expose individuals to liability.

1-19.260 – Legal or Factual Context

The Department may also use agency guidance documents to provide relevant legal or factual context in briefs and other filings. For example, in the background section of a brief, the Department may cite a manual to explain how an agency processes payments.