DOJ and OIG Reannouncement of the False Claims Act Working Group
Key Points:
- Signaling a renewed and elevated commitment to health care fraud enforcement
- Tips to mitigate compliance risks
Last July, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) reannounced the False Claims Act (FCA) Working Group, which has raised many questions. The Working Group is now jointly led by the HHS General Counsel, Chief Counsel to the HHS Office of Inspector General (OIG), and the Deputy Assistant Attorney General of DOJ’s Commercial Litigation Branch. Membership also includes the CMS Center for Program Integrity. The renewed mandate emphasizes enhanced coordination and collaboration between DOJ prosecutors and OIG investigators and auditors. It aims to promote consistent enforcement policies, facilitate the sharing of best practices, and support the handling of qui tam (whistleblower) cases.
The initiative is intended to strengthen healthcare fraud recoveries, improve alignment between DOJ enforcement remedies (e.g., treble damages, penalties), and OIG administrative actions (e.g., exclusions, civil monetary penalties, and Corporate Integrity Agreements). Key priorities include: (a) increased scrutiny on fraud, upcoding, Medicare Advantage enrollment abuses; (b) inflated pricing of drugs, devices, and biologics; (c) kickbacks, especially those designed to induce flow of business; and (d) misuse of electronic health records (EHRs) to drive inappropriate utilization of Medicare-covered products and services.
Identifying fraud schemes is a stated priority of the Working Group and examples include kickbacks, medically unnecessary services, upcoding, and improper billing. Notably, the majority of FCA cases and resulting penalties stem from whistleblower complaints involving financial arrangements with referral sources. The Working Group also plans to develop specialized training and guidance for investigators and attorneys working on FCA healthcare cases. As an add-on comment, they state they will be using artificial intelligence in their data analytics. Given this increased enforcement, compliance officers should consider the following actions:
- Ensure there are no barriers to patient access (e.g., network adequacy).
- Guard against EHR manipulation and prevent the use of defective devices that may impact patient safety.
- Recognize DOJ Civil Division’s focus on unlawful DEI programs, gender transition care, and related programs.
- Establish an arrangements database and monitor compliance.
- Engage in ongoing monitoring and auditing of claims processing to verify accuracy.
- Stay informed on DOJ’s handling of qui tam cases.
- Be prepared to show evidence of a strong compliance program. Third-party assessments are best.
- Ensure prompt self-disclosure and remediation practices to mitigate risk and minimize penalties.
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