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 of the False Claims Act (FCA) in the healthcare space. While the DOJ and HHS have long worked together to combat fraud, this Working Group marks a formalized, tightly coordinated effort focused on high-impact enforcement areas.
Why This Matters
The FCA is the government’s primary tool for policing fraud in federal programs—including Medicare and Medicaid—and it carries steep penalties. The creation of this Working Group signals a sharpened focus and enhanced capabilities for identifying and prosecuting fraud, particularly in certain hot-button areas.
For healthcare providers, payors, manufacturers, and technology vendors, this means more scrutiny, faster investigations, and a greater likelihood of FCA exposure in 2025 and beyond.
But this Working Group also means that new enforcement leaders could be thinking about ways to reform how FCA is utilized. Members of the Working Group have previously expressed skepticism about how declined qui tams can be abused by relator’s counsel, and so this Working Group could create reforms that both increase government-led enforcement and decrease whistleblower-led enforcement.
What’s New
The Working Group will be jointly led by DOJ’s Civil Division and top HHS legal and enforcement officials, including representatives from CMS, the HHS Office of Inspector General (OIG), and U.S. Attorneys’ Offices. Their mission: accelerate enforcement through increased data sharing, more efficient case referrals, and unified strategic priorities.
According to the press release, the Working Group will:
- Make high-priority FCA referrals from HHS to DOJ;
- Coordinate enforcement decisions, including DOJ’s use of its dismissal authority in qui tam cases;
- Leverage data mining and OIG reports to uncover new leads separate and apart from whistleblowers;
- Evaluate potential payment suspensions in parallel with FCA investigations;
- Encourage voluntary disclosures by companies and whistleblower complaints alike.
Priority Enforcement Areas
While DOJ and HHS have previously outlined FCA focus areas, this Working Group brings fresh emphasis and coordination in the following key sectors:
1. Medicare Advantage – especially risk adjustment fraud
2. Drug and device pricing – including rebates, discounts, and formulary placement
3. Barriers to patient care – such as failure to meet network adequacy requirements
4. Kickbacks – involving drugs, DME, and other federally reimbursed products
5. Defective medical devices – particularly those affecting patient safety
6. EHR manipulation – designed to inflate Medicare reimbursements
Each of these areas reflects ongoing concern from both regulators and whistleblowers—and now, a concerted federal push to address them.
What Does it Mean for the Future
These changes could operationalize changes in future enforcement as discussed on our podcast reviewing the new leadership. It also could enhance removing small and arguably frivolous shakedown cases and replacing them with broader data driven cases that materially matter to the bottom line: bringing large improper payment models to court for litigation and recovery. It adds items that are new in the industry focus of enforcement and are multi-billion-dollar issues like managed care plans and how they price and give access to care, manipulation of EMRs that affect payment on a grand scale, discounts and formulary recovery across platforms. These are three large buckets of potentially untapped recoveries and new industry risks for compliance that may be made possible for litigation and recovery under this combined effort.
What Healthcare Companies Should Do Now
If your organization touches federal healthcare dollars in any way—whether through billing, reimbursement, contracting, or data systems—you should take three immediate steps:
1. Review internal compliance programs in light of the Working Group’s enforcement priorities;
2. Reassess risk exposure in pricing strategies, referral arrangements, and EHR systems;
3. Consider voluntary disclosure of known or suspected issues, particularly in areas named above.
This new initiative isn’t just window dressing—it reflects a policy-level commitment to more aggressive FCA enforcement. Companies that wait until a subpoena arrives are likely to find themselves on the back foot. Indeed, the DOJ compliance guidance says if you have not incorporated these risks into your compliance plan you will not be scored highly or may not receive a downward departure.
The DOJ-HHS Working Group is also encouraging whistleblowers to come forward. That alone should prompt proactive risk assessments across the industry.
Bottom Line
The launch of the DOJ-HHS False Claims Act Working Group is a clear warning shot: healthcare enforcement is becoming more sophisticated, more targeted, and more collaborative. Healthcare companies need to act accordingly—by strengthening compliance, engaging in thoughtful internal reviews, and seeking legal counsel when needed.