The Justice Department is now limiting the use of sub-regulatory guidance in False Claims Act enforcement and directing its attorneys to assess every dismissed lawsuit filed by a private citizen in qui tam cases.
The revisions to its justice manual, released Sept. 18, codify positions DOJ leadership has voiced over the past year and create new advocacy opportunities for FCA defendants. At the same time, they’re not a retreat from FCA enforcement.
The first revision retitles the section from “Principles for Issuance and Use of Guidance Documents” to “Limitations on Issuance and Use of Guidance Documents” — a change that captures the thrust of the new policy.
Enforcement actions now “must be based on violations of applicable legal requirements, not mere noncompliance with guidance documents.” The DOJ can’t bring an action based solely on alleged noncompliance with agency guidance or treat a departure from guidance as itself a violation of a statute or regulation.
A policy from the first Trump administration — reflected in a 2017 memo and a 2018 memo — that the Biden administration rescinded was revived in the revision and goes further by spelling out how guidance may and may not be used in litigation, a crucial distinction in healthcare cases.
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