On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at strengthening the government's civil enforcement law (FCA) in the health sector. While DOJ and HHS have been working together for a long time to combat fraud, the working group marks a formal, rigorously coordinated effort focusing on shocking areas of enforcement.
Why is this important?
The FCA is the government's primary tool for police fraud in federal programs, including Medicare and Medicaid, and imposes sudden penalties. The creation of this working group demonstrates a keen focus and enhanced ability to identify and prosecute fraud, particularly in certain hot button areas.
For healthcare providers, payers, manufacturers and technology vendors, this means increasing the likelihood of more scrutiny, faster investigations and FCA exposures from 2025 onwards.
But this working group means that new executive leaders are thinking about ways to reform how FCAs are used. Members of the working group have previously expressed skepticism about how Qui Tam has declined by the attorneys involved, which could create reforms that will increase government-led enforcement and reduce whistleblower-led enforcement.
what's new
The working group will be jointly led by the civil division of DOJ and top HHS law and enforcement officers, including representatives of the CMS, the HHS Inspectors' Office (OIG), and representatives of the U.S. Attorney General. Their mission: to accelerate enforcement through increased data sharing, more efficient case introductions, and unified strategic priorities.
According to the press release, the working group is:
We will introduce priority FCAs from HHS to DOJ. Coordinating enforcement decisions, including the use of DOJs by the dismissal authorities in the Qui Tam case. Use data mining and OIG reports to separate new leads from whistleblowers. We encourage voluntary disclosures by businesses and whistleblower complaints as well.
Priority Enforcement Area
While DOJ and HHS have previously outlined the FCA focus area, this working group brings new emphasis and coordination in the next major sectors:
1. Medicare Benefits – Particularly Risk Adjustment Fraud
2. Drug and Device Pricing – Includes Rebates, Discounts, and Formation Placement
3. Patient care barriers – failing to meet network validity requirements, etc.
4. Kickback – Includes drugs, DME, and other federal refund products
5. Defective medical devices – especially those that affect patient safety
6. EHR Operations – Designed to inflate Medicare rebates
Each of these areas reflects ongoing concerns from both regulators and whistleblowers, and now reflects the federal government's coordinated driving force to address them.
What does that mean for the future:
These changes could operate future enforcement changes, as discussed in podcasts reviewing new leadership. You can also remove small and undoubtedly frivolous shakedown cases and replace them with a wider, ultimately important, data-driven case. Bring a major inappropriate payment model to court for litigation and recovery. It's a way to add new enforcement-focused items to the industry, and give them access to managed care plans and how they set prices and provide access to care, and EMR operations that affect large payments, discounts and formula recovery across platforms. These are three large buckets that are potentially undeveloped and potentially recoverable, and the new industry risks of compliance that could be made possible for litigation and recovery under this combined effort.
What should a medical company do now?
Three immediate actions must be taken if an organization in any way touches federal healthcare costs through billing, reimbursements, contracts and data systems.
1. Check the internal compliance program against the working group's enforcement priorities.
2. Reassessing pricing strategies, referral arrangements, and risk exposures in EHR systems.
3. Consider voluntary disclosure of known or suspicious issues, particularly in the above areas.
This new initiative reflects a policy-level commitment to more aggressive FCA enforcement than just window dressing. Companies that wait for the subpoena to arrive may find themselves on their backs. In fact, the DOJ Compliance Guidance states that if these risks are not incorporated into a compliance plan, they may not be highly graded or receive a downward departure.
The DOJ-HHS Working Group encourages whistleblowers to move forward. That alone should encourage aggressive risk assessments across the industry.
Conclusion
The launch of the DOJ-HHS False Claims Act Working Group is a clear warning shot. Healthcare enforcement is becoming more refined, more targeted and more supportive. Healthcare companies need to act accordingly by enhancing compliance, engage in thoughtful internal reviews and seeking lawyers when necessary.
(View source.)
