Justice Manual § 1-19.250

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.