DOJ Revises Justice Manual on FCA Guidance Use, Qui Tam Dismissals
In a client alert, Bass, Berry & Sims reports that the Department of Justice has revised its Justice Manual to limit reliance on sub-regulatory guidance to establish legal duties in False Claims Act cases and to expand DOJ's use of dismissal authority over qui tam suits. The firm notes that guidance documents such as CMS manuals and Local Coverage Determinations remain usable as evidence of scienter, notice, industry standards, and medical necessity, even though they cannot themselves create the underlying legal obligation. Healthcare providers and Medicaid managed care organizations facing FCA exposure are most affected, since many billing and coverage disputes turn on sub-regulatory guidance. The firm does not specify an effective date for the revisions in the excerpt provided.