In December 2018, the Department of Justice (DOJ) updated its Justice Manual to add Title 1-20.000 et seq., Limitation on Use of Guidance Documents in Litigation. This addition formalizes guidance provided in two previous internal DOJ memoranda—the Sessions Memo and the Brand Memo—each discussing limiting the use of guidance documents and advisory opinions in both criminal and civil enforcement actions.

The Sessions and Brand Memos

The Sessions Memo, authored by then-Attorney General Jeff Sessions in November 2017, prohibited the DOJ from promulgating guidance documents “that purport to create rights or obligations binding on persons or entities outside the Executive Branch[.]” It also prohibited the DOJ from creating binding standards that could then be used to determine a person or entity’s compliance with applicable federal statutes or regulations. Importantly, the memo noted that such guidance documents were not produced through a notice-and-comment rulemaking process and were not promulgated by the agency charged with the constitutional authority to do so.

The Brand Memo, authored by then-Associate Attorney General Rachel Brand in January 2018, built on the Sessions Memo by explaining that the mandate is applicable not only to the DOJ’s guidance documents but also to other agencies’ guidance documents as well.  The Brand Memo prohibited DOJ litigators from using any agency’s “guidance documents as a basis for proving violations of applicable law in [affirmative civil enforcement] matters,” with limited exceptions.

Title 1-20.000 – Limitation on Guidance Documents in Litigation

Formalizing these mandates in the DOJ’s Justice Manual, a new section, Title 1-20.000, requires that DOJ enforcement actions “must be based on violations of applicable legal requirements, not mere noncompliance with guidance documents issued by federal agencies[.]” In the past, it has not been uncommon for False Claims Act (FCA) complaints to allege violations not only of statutes and regulations but also of guidance documents such as Office of Inspector General (OIG) opinions or Coverage Determinations. After this update, DOJ litigators are prohibited from using a defendant’s noncompliance with these guidance documents to establish a violation of any applicable statute or regulation. Like the Brand Memo, however, the new Justice Manual section provides the following exceptions that constitute acceptable uses for guidance documents in litigation.

  1. Guidance documents may still be used to establish scienter, notice, knowledge, or mens rea. Thus, DOJ may still use guidance documents to show that a person or entity had knowledge of the relevant law or deliberately disregarded the guidance documents and their explanation of how the regulation or statute should be interpreted.
  2. Guidance documents may still be used to demonstrate professional and industry standards as well as DOJ practices, duties or customs. The Justice Manual offers the example of a physician writing opioid prescriptions in excess of the Centers for Disease Control Guideline for Prescribing Opioids for Chronic Pain. The DOJ may use that fact as evidence that the prescriptions did not have any “legitimate medical purpose” or were outside the usual course of conduct in violation of the Controlled Substances Act.
  3. The DOJ may “use a guidance document reflecting scientific or technical processes that are generally accepted in a particular field to support a claim that a certain action is, or that a factual or expert witness is rendering an opinion that is, consistent or inconsistent with those processes.”
  4. DOJ lawyers may reference guidance documents where a party’s compliance or noncompliance with the guidance is itself relevant to the claims at issue. For example, if an entity falsely certifies that it complied with certain guidance documents, and that certification is material to the government’s payment decision, or if a government contractor’s contract explicitly requires compliance with certain guidance documents, those documents may be referenced because the “deceit of the false certification” or breach of contract is probative of the claims at issue, not the binding or nonbinding nature of the guidance document.
  5. Guidance documents may be used to provide relevant legal or factual contexts, such as in a legal brief or other court filing. For example, the DOJ may cite a manual to explain how an agency processes payments.

For attorneys with experience representing parties charged with violations of federal regulations or statutes, such as the FCA, the addition of Title 1-20.000 to the Justice Manual is a welcome one. It helps clarify that the constitutionally promulgated regulations and statutes are the requirements to which individuals and entities must adhere.

However, the practical effect of this update remains to be seen. Rarely does litigation involve only the alleged violation of guidance documents or advisory opinions, and most litigation likely could be modified to allege violations of statutes or regulations but still utilize guidance documents in an acceptable way as identified by Title 1-20.000 et seq.  Moreover, qui tam relators may argue that the Justice Manual does not apply to them in non-intervened cases and continue to attempt to use guidance documents to establish FCA violations.

Nonetheless, clarification that the DOJ cannot base FCA lawsuits on violations of guidance documents is a welcome confirmation of the recent DOJ trend of recognizing certain limits on enforcement, and practitioners should keep this section of the DOJ Manual in mind when defending against such actions.

The full text of Title 1-20.000 et seq. can be found here.

For additional insight on the Sessions and Brand Memos, read Bass, Berry & Sims attorney Taylor Chenery’s article for Nashville Medical News here.

To stay apprised of future developments in government enforcement efforts, subscribe to this blog or contact a member of the Bass, Berry & Sims Healthcare Fraud Task Force.