On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance priority enforcement areas” in combatting healthcare fraud. The two agencies cited the long history of partnership between them in enforcing the False Claims Act (FCA) and their concern that healthcare fraud “depletes taxpayer funds, corrodes public health and safety, and undermines the integrity of the federal healthcare system.”
Members of the Working Group “will include leadership from the HHS Office of General Counsel, the Centers for Medicare & Medicaid Services Center for Program Integrity, the Office of Counsel to the HHS Office of Inspector General (HHS-OIG), and DOJ’s Civil Division, with designees representing U.S. Attorneys’ Offices.” The Working Group is being led by the HHS General Counsel, the Chief Counsel to HHS-OIG, and the Deputy Assistant Attorney General of the Commercial Litigation Branch. As part of the Working Group’s coordination efforts, HHS will refer matters to DOJ that represent potential violations of the FCA reflecting Working Group priorities. The press release announcing the Working Group listed the following healthcare enforcement priorities:
- Drug, device or biologics pricing, including arrangements for discounts, rebates, service fees, and formulary placement and price reporting
- Barriers to patient access to care, including violations of network adequacy requirements
- Kickbacks related to drugs, medical devices, durable medical equipment, and other products paid for by federal healthcare programs
- Materially defective medical devices that impact patient safety
- Manipulation of Electronic Health Records systems to drive inappropriate utilization of Medicare covered products and services
The Working Group will “maximize cross-agency collaboration to expedite ongoing investigations” in the listed areas and “identify new leads, including by leveraging HHS resources through enhanced data mining and assessment of HHS and HHS-OIG report findings.” The Working Group will also confer on whether “HHS should implement a payment suspension” or “DOJ shall move to dismiss a qui tam complaint” under the FCA.
