Health Law Daily New DOJ policy prohibits use of guidance documents to establish violations
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Friday, January 26, 2018

New DOJ policy prohibits use of guidance documents to establish violations

By Sheila Lynch-Afryl, J.D., M.A.

The Office of the Associate Attorney General established a new policy prohibiting Department of Justice (DOJ) litigators from using guidance documents (or noncompliance with guidance documents) to establish violations of law in affirmative civil enforcement (ACE) actions. This rule applies to ACE cases seeking to recover funds for violations of federal health laws, including enforcement of the False Claims Act (FCA) (31 U.S.C. §3729 et seq.) (Associate Attorney General Memorandum, January 25, 2018).

Sessions memo. The DOJ’s new policy was in response to a memo issued by Attorney General Jeff Sessions on November 26, 2017, which noted that the DOJ has published guidance documents that "effectively bind private parties without undergoing the rulemaking process" required by the Administrative Procedure Act. He said that the DOJ and other agencies have "blurred the distinction between regulations and guidance document" and vowed to end "longstanding abuse of issuing rules by simply publishing a letter or posting a web page." Accordingly, he prohibited DOJ components from issuing guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch. He later rescinded 25 guidance documents.

Guidance documents. Sessions established the following requirements for guidance documents:

  • identify themselves as guidance and disclaim any force of law;
  • clearly state that they are not final agency actions and have no legally binding effect on persons/entities outside the government;
  • should not be used for coercing people/entities outside the federal government from taking or refraining from taking any action beyond what is required by the applicable law or regulation;
  • should not use mandatory language such as "must" or "shall" to direct parties outside the federal government except when restating clear mandates in law or regulation; and
  • if the guidance sets out a voluntary standard, it should state that compliance is voluntary and noncompliance, in itself, will not result in enforcement actions.

According to the Associate Attorney General memo, the DOJ may continue to use agency guidance documents for "proper purposes"—for example, the DOJ can use evidence that a party read a guidance document that explained or paraphrased the law to help prove requisite knowledge of the mandate.

Memo on dismissing FCA cases. As reported by the National Law Reviews, another recent DOJ memo discussed factors DOJ attorneys should consider when deciding whether to seek dismissal of an FCA qui tam action pursuant to 31 U.S.C. §3730(c)(2)(A). The memo noted that while the agency has historically used Sec. 3730(c)(2)(A) "sparingly," it "remains an important tool to advance the government’s interests, preserve limited resources, and avoid adverse precedent." The following factors can be used in the determination of whether to seek dismissal: (1) curbing meritless qui tam actions; (2) preventing opportunistic actions; (3) preventing interference with agency policies and programs; (4) controlling litigation brought on behalf of the U.S.; (5) safeguarding classified information and national security interests; (6) preserving government resources; and (7) addressing egregious procedural errors.

MainStory: TopStory AgencyDocuments CMSNews FCANews FraudNews QuiTamNews EnforcementNews GCNNews FedTracker HealthCare LifeSciences

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