As we reported here and here, the DOJ has been keen on limiting the use of guidance documents to govern its prosecution decisions. That concept has been enshrined in the first chapter of the DOJ's Justice Manual. New Section 1-20.000 sets forth the Department's view. It begins, "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 DOJ will no longer consider a party's failure to comply with guidance documents as a violation of a statute or regulation, but will "continue to rely on agency guidance documents for purposes, including evidentiary purposes that are otherwise lawful and consistent with the Federal Rules of Evidence." So, for example, "[w]here 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." The DOJ might also "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." It specifically notes the usefulness of guidance from the Centers for Medicare and Medicaid Services, which issues its own policy manual. The usage of such materials "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." Consistent with its aversion to guidance documents and " [m]anagement-by-memo," the new section "fully implements, clarifies, and supersedes prior Department memoranda on this topic."

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