Justice Manual § 1-19.230

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.