On July 2, 2024, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the formation of a new False Claims Act (FCA) Working Group.  The creation of the group, especially in the wake of record-breaking FCA recoveries in 2024, underscores the government’s ongoing commitment to combating health care fraud and makes clear that FCA enforcement is here to stay.

Overview and Structure of the FCA Working Group

The group is a joint venture between the DOJ and HHS.  The group will be jointly led by the HHS General Counsel (Sean Keveney, acting General Counsel), the Chief Counsel to HHS-OIG (Susan Edwards, acting Chief Counsel), and the Deputy Assistant Attorney General of the DOJ’s Commercial Litigation Branch (Brenna Jenny).  The divisions of DOJ and HHS represented in the group include:

  • HHS-OIG (Office of Inspector General)
  • HHS OGC (Office of General Counsel)
  • CMS CPI (Center for Program Integrity)
  • DOJ Civil Division
  • Various U.S. Attorney’s Offices

Notably, this renewed collaboration between DOJ and HHS breaks down the traditional siloed approach to FCA enforcement, which would permit more streamlined decision-making and enforcement.  The group’s coordination of efforts may ultimately lead to expedited timelines for investigations and a greater ability to pursue more FCA leads.

Key Enforcement Priorities

The group will focus on the agencies’ previously identified enforcement priorities, including:

  • Medicare Advantage: Investigating allegations of improper reporting of risk factors and incorrect diagnostic coding, given the program’s significant share of Medicare funds and millions of participants.
  • Drug, device or biologics pricing: Scrutinizing arrangements involving discounts, rebates, service fees, formulary placement, and price reporting.
  • Barriers to patient access to care: Focusing on violations of network adequacy requirements and other practices that may impede patient care.
  • Kickbacks: Investigating potential improper remuneration related to drugs, medical devices, durable medical equipment, and other federally reimbursed products.
  • Defective medical devices: Targeting devices that may be materially defective and impact patient safety.
  • Electronic Health Records (EHR) Manipulation: Addressing the use of EHR systems that could drive inappropriate utilization of Medicare-covered products and services.

A Shift Toward Proactive, Data-Driven Enforcement

A defining feature of the new FCA Working Group is its commitment to leveraging HHS’s vast data resources to proactively identify fraud.  Brenna Jenny, the Deputy Assistant Attorney General of the General Commercial Litigation Branch at DOJ, spoke on this topic at the American Health Law Association Annual Meeting on July 2, 2025.  During the government regulators session that included Jenny and officials from HHS, Jenny shared that while the DOJ will continue to welcome and review qui tam (whistleblower) complaints, the agencies will not rely solely on these filings.  Instead, the agencies will pursue its own case, such as by using advanced data mining and analysis to detect patterns of fraud, waste, and abuse. 

Additionally, Jenny shared that the group would focus on, early in the matter, whether novel legal theories are viable and should be pursued, and whether the DOJ should invoke its authority to dismiss qui tam complaints pursuant to 31 U.S.C. § 3730(c)(2)(A).

Looking Ahead: Practical Implications and Recommendations

The launch of the FCA Working Group signals a new era of coordinated, data-driven enforcement in the health care sector.  As the government sharpens its focus on priority areas and leverages sophisticated data analytics, healthcare organizations, providers, and industry stakeholders should take proactive steps to mitigate risk and ensure compliance.

Reed Smith will continue to follow developments related to FCA enforcement and the new working group. If you have any questions about this or any other FCA enforcement development, please do not hesitate to reach out to the authors of this or to the health care lawyers at Reed Smith.