Federal agencies unite to strengthen False Claims Act enforcement 

WASHINGTON – The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) have formed a False Claims Act Working Group to strengthen their coordination and better advance priority enforcement areas. 

As part of their work: 

• HHS shall make referrals to DOJ of potential violations of the FCA that reflect Working Group priorities. In addition to priority FCA matters previously announced by the Assistant Attorney General of the Civil Division, the Working Group is announcing the following priority enforcement areas: 
  • Medicare Advantage 
  • 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 shall maximize cross-agency collaboration to expedite ongoing investigations in these priority 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 shall discuss considerations bearing on whether HHS should implement a payment suspension pursuant to 42 C.F.R. § 405.370 et seq. or whether DOJ shall move to dismiss a qui tam complaint under 31 U.S.C. § 3730(c)(2)(A), consistent with Justice Manual Section 4-4.111. 

Membership in the working group will include leadership from the HHS Office of General Counsel, the Centers for Medicare & Medicaid Services (CMS) 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 group will be jointly led by the HHS general counsel, chief counsel to HHS-OIG, and the deputy assistant attorney general of the Commercial Litigation Branch. 

“The DOJ-HHS False Claims Act Working Group encourages whistleblowers to identify and report violations of the federal False Claims Act involving priority enforcement areas,” the agencies stated. “Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to HHS at 800-HHS-TIPS (800-447-8477).  Similarly, the Working Group encourages healthcare companies to identify and report such violations consistent with Justice Manual Section 4-4.112.”