DOJ Revises Justice Manual on FCA Guidance and Dismissal Policy
In a client alert, Hall Render reports that the Department of Justice has revised its Justice Manual to reshape False Claims Act enforcement in two ways. First, the revision confirms that sub-regulatory guidance, such as CMS manuals, coverage policies, and local coverage determinations, cannot alone establish FCA liability; an enforcement action must rest on an actual violation of a statute, regulation, or other binding legal requirement, though such guidance can still show notice or scienter. Second, DOJ attorneys must now affirmatively consider seeking dismissal of declined qui tam actions, including meritless, parasitic, or resource-draining claims, and may revisit dismissal later in litigation. Health care providers facing FCA claims tied to agency guidance are most directly affected by these changes.