The failure to follow federal regulations has been a recurring feature of fraud enforcement actions by the U.S. Department of Justice (DOJ) under the False Claims Act (FCA), which imposes treble damages and onerous penalties on defendants who fraudulently receive federal monies. The imposition of such severe penalties for regulatory non-compliance can be especially onerous given the complexity of the regulatory regimes facing many government contractors.

In January 2018, health care entities and other government contractors saw the promise of some relief when the DOJ Regulatory Reform Task Force issued the “Brand Memo,” a new policy that prohibited DOJ civil attorneys from using noncompliance with regulatory guidance documents—which do not go through the notice-and-comment rulemaking process—to prove violations of law in affirmative civil enforcement actions, including FCA actions. The Brand Memo promised to curtail the frequency of regulatory violations being bootstrapped into punishing FCA cases.