The Department of Justice has created a new Enforcement & Affirmative Litigation branch within the department’s civil division in an effort to escalate civil fraud enforcement and government lawsuits, JD Supra reported Oct. 27.
Here are five things to know about the new enforcement unit:
1. Related to healthcare fraud enforcement specifically, the formation of this new enforcement arm marks a more “integrated, data-driven and swift” approach to enforcement actions that will expand beyond the False Claims Act. Life sciences, managed care, private equity, fintech-enabled health services, government contracting and other regulated sectors that interact with federal funds will be more included in the EAL branch’s enforcement efforts.
2. The EAL branch formation also suggests that the DOJ intends to “centralize high-impact affirmative litigation capabilities” while streamlining case selection and pursue leads in a more accelerated and coordinated manner.
3. The EAL branch will focus its attention on scienter standards and causation frameworks in the Anti-Kickback Statute, as well as emphasizing inducement evidence and remuneration valuation, typing marketing practices, consulting agreements, free goods or services, and “value-add” perks to claim submissions. The new branch will also focus on “medical necessity” and “upcoding” disputes in peer-comparison data and physician-level outlier analysis.
4. Medicare Advantage risk-adjustment enforcement will also remain a priority for the new branch. It will utilize advanced analytics to evaluate chart reviews, diagnosis coding and interact with data that can support cases targeting inflated risk scores, unsupported hierarchical condition categories and retrospective coding initiatives.
5. Quality-of-care and patient safety theories may also see renewed enforcement activity under the EAL branch, especially in post-acute settings, behavioral health and telehealth-enabled models.
