On September 18, the US Department of Justice (DOJ) announced revisions to the Justice Manual aimed at strengthening False Claims Act (FCA) enforcement through what it described as “clearer standards that promote fair and effective enforcement.”
The revisions address two areas. First, the DOJ reinstated and expanded upon its previous policy that sub-regulatory guidance documents cannot impose legal obligations beyond those established by statute or regulation. DOJ components may not issue guidance documents that purport to create rights or obligations binding on parties outside the executive branch, nor issue guidance documents that create binding standards by which the DOJ will determine compliance with existing regulatory or statutory requirements. Accordingly, the DOJ “may not bring actions based solely on allegations of noncompliance with guidance documents” and “must establish a violation by reference to statutes and regulations.” Previously, the DOJ policies regarding agency guidance likewise provided that an enforcement action could not be based exclusively on a guidance document. The revision permits the continued use of guidance documents for evidentiary purposes, including as scienter, professional or industry standards, and context.
Second, the DOJ revised the Justice Manual to clarify that it should consider exercising its dismissal authority when it declines to intervene in qui tam actions and should revisit that assessment as appropriate during litigation....
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