Justice Manual § 1-19.220

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.