False Claims Act Working Group: A Leadership Guide

In July 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of a DOJ-HHS False Claims Act Working Group.
The announcement, available here, highlights a renewed federal push to combat healthcare fraud in federal healthcare programs.

The two agencies have long worked together on False Claims Act enforcement. Now, the new False Claims Act Working Group will provide a more formal, structured approach to tackling fraud in both traditional and emerging healthcare markets. For healthcare executives, compliance officers, and legal counsel, understanding this working group’s focus is essential to preparing for FCA enforcement.

What is the Federal False Claims Act, and What Has It Accomplished?

The False Claims Act (FCA) dates back to the American Civil War, when the Union Army was receiving defective material and sick mules. In 1986 and again in 2009, Congress strengthened provisions of the law, turning it into an essential weapon in the fight against healthcare fraud. 

The FCA makes it unlawful to knowingly submit or cause someone to submit false claims for payment of federal funds. Major types of false claims in healthcare include:

• Submitting claims for services that were never rendered or are inadequately documented.
• Failing to report defective medical devices after they have been initially approved.
• Billing for services tied to improper physician compensation under the Stark Law.

The DOJ states that the False Claims Act has enabled the US to obtain settlements and judgments totaling over $78 billion through Fiscal Year 2024. Amounts recovered vary from year to year. For instance, for Fiscal Year 2021, the DOJ announced recoveries of $5.9 billion. That reflected a settlement with Purdue Pharma of $2.8 billion. As with several other recent settlements, the amount is tempered by the fact that the company had filed for bankruptcy. Over 90% of recoveries are related to HHS False Claims Act recoveries.

Who are the Members of the False Claims Act Working Group?

The claims act working group is jointly led by:

• The HHS General Counsel
• The Chief Counsel to HHS-OIG
• The Deputy Assistant Attorney General of the Commercial Litigation Branch

Other members include representatives from:

• The HHS Office of General Counsel
• The CMS Center for Program Integrity
• The Office of Counsel to the HHS Office of Inspector General (HHS-OIG)
• The DOJ’s Civil Division
• Multiple U.S. Attorneys’ Offices.

This leadership mix blends legal, investigative, and program integrity expertise.
It also facilitates cross-agency collaboration to address potential FCA violations more efficiently.

What are the Enforcement Priorities of the DOJ and HHS in the False Claims Act Working Group?

HHS will make referrals to the DOJ of potential violations of the FCA that, in addition to priority FCA matters previously announced by the Assistant Attorney General of the Civil Division, reflect Working Group priorities, including:

• Medicare Advantage Programs.
• 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.
• Inappropriate use or manipulation of Electronic Health Records systems (EHR) to drive inappropriate utilization of Medicare-covered products and services.

The Working Group is also supposed to maximize new cross-agency collaboration to expedite ongoing investigations in these priority areas. It can also 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 discuss whether HHS should implement a payment suspension. It may also consider whether DOJ should dismiss a qui tam complaint.

Some of these enforcement initiatives have been prioritized previously. Medicare Advantage Programs have been targeted based on complaints about illegal kickbacks related to enrollment and fraud related to patient diagnoses of co-morbid conditions. And medical device manufacturers have been scrutinized for kickbacks related to the use or prescribing of their devices. Manipulation of EHR systems is new area of

What are the FCA Priorities of the Assistant Attorney General of the Civil Division?

The Civil Division enforcement priorities are a little outside the realm of traditional healthcare priority enforcement areas, but do reflect the priorities of the Trump Administration.

• Investigating potential FCA violations tied to civil rights laws.
• Addressing claims from entities that knowingly enable antisemitism.
• Enforcing the Food, Drug, and Cosmetic Act against deceptive claims about long-term risks of certain medical treatments.

While some of these fall outside core healthcare fraud areas, they may still involve healthcare providers who submit federal claims.

Why This Matters for Healthcare Leaders

The formation of the DOJ-HHS False Claims Act Working Group signals more aggressive and coordinated FCA enforcement. Expect expanded ongoing investigations and greater use of data-driven oversight.

Regardless of the outcome of FCA investigations, healthcare organizations must combat healthcare fraud, waste and abuse within their institutions. You can achieve this by establishing a clear message on ethical conduct, fostering a culture of compliance, and staying abreast of new trends in FCA investigations to combat healthcare fraud.

To that end, healthcare leaders should take proactive steps:

1. Conduct internal reviews focused on priority enforcement areas as well as the OIG Work Plan initiatives and the OIG reports to Congress.
2. Strengthen compliance programs to detect and prevent such violations before they occur.
3. Update documentation and billing practices to meet Medicare and federal healthcare program standards and requirements.
4. Monitor regulatory updates from the Department of Justice DOJ and HHS-OIG.

How The Fox Group Can Help You Combat Healthcare Fraud

An effective compliance program is the most reliable safeguard against costly enforcement actions.

At The Fox Group, we help organizations:

Partnering with experienced consultants enables you to find and address billing mistakes or even healthcare fraud internally before it escalates into a DOJ or HHS case. Contact us to prepare your organization for heightened FCA scrutiny as well as a robust compliance plan!