Announcement of the DOJ-HHS False Claims Act Working Group to combat healthcare fraud and abuse through enhanced collaboration between the Department of Justice and Department of Health and Human Services. The group includes leadership from HHS Office of General Counsel, Centers for Medicare & Medicaid Services Center for Program Integrity, Office of Counsel to the HHS Office of Inspector General, and DOJ’s Civil Division, with designees from U.S. Attorneys’ Offices. It is jointly led by the HHS General Counsel, Chief Counsel to HHS-OIG, and the Deputy Assistant Attorney General of the Commercial Litigation Branch.
The Working Group has identified specific priority enforcement areas:
- Medicare Advantage.
- Drug, device or biologics pricing, including arrangements for discounts, rebates, service fees, formulary placement and price reporting.
- Barriers to patient access to care, including violations of network adequacy requirements.
- Kickbacks related to drugs, medical devices, DME, 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:
- Process HHS referrals to DOJ of potential FCA violations in priority areas.
- Maximize cross-agency collaboration to expedite ongoing investigations and identify new leads through enhanced data mining and assessment of HHS and HHS OIG report findings.
- Discuss considerations regarding payment suspensions under 42 C.F.R. § 405.370 et seq. or dismissal of qui tam complaints under 31 U.S.C.S. § 3730(c)(2)(A).
The Working Group encourages whistleblowers to report FCA violations in priority areas. Tips about potential fraud, waste, abuse, and mismanagement can be reported to HHS at 800-HHS-TIPS (800-447-8477). Healthcare companies are also encouraged to self-report violations consistent with Justice Manual Section 4-4.112.
