In December 2018, the Department of Justice (DOJ) formalized its position on limiting the use of guidance documents issued by federal agencies to govern its prosecution decisions. See The DOJ codified this position by adding new Section 1-20.000 to the DOJ Manual which says, "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." While this was heralded as good news, health care providers should remain cautious as the DOJ specifically notes the usefulness of guidance from the Centers for Medicare and Medicaid Services (CMS), which issues its own policy manual, and notes that its 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." Thus, health care providers need to remain vigilant to CMS policy changes and ensure compliance.
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