By: Eddie Suarez and Sara Mieczkowski (we are grateful for the assistance and contribution of our friend and colleague Michael Igel, a Florida Bar Certified Health Law practitioner. For more information visit: https://www.jpfirm.com/people/michael-a-igel/)
The Department of Justice’s (DOJ) latest enforcement activity—headlined by a large-scale healthcare fraud takedown and the formal relaunch of the False Claims Act (FCA) Working Group—marks an apparent shift in federal strategy. These developments reflect a more data-centric approach to enforcement, expansive civil liability theories, and targeted coordination across agencies.
For in-house counsel and compliance officers, especially in healthcare organizations, these announcements highlight areas of heightened risk and the need for renewed focus on proactive compliance strategies, early internal risk assessments, and careful consideration of DOJ’s policy frameworks.
Summary: Attorneys Need to Know
- The DOJ is deploying advanced data analytics to initiate investigations, making billing patterns and statistical anomalies potential triggers for scrutiny.
- The FCA Working Group has released six priority enforcement areas, indicating a more coordinated and thematic approach to civil enforcement. The 6 areas can be found here: DOJ-HHS False Claims Act Working Group | HHS.gov
- Traditional white-collar enforcement, including PPP and other COVID-related fraud and international financial crime, continues to receive significant DOJ and state-level attention.
- Regulatory shifts at the SEC and state agencies are creating new layers of exposure, especially for digital assets and fintech clients.
DOJ’s 2025 Healthcare Fraud Takedown: Implications for Defense Counsel
On June 30, 2025, DOJ announced charges against 324 defendants in what it described as the largest healthcare fraud takedown in U.S. history. The cases spanned 50 federal districts and involved alleged fraud schemes totaling over $14.6 billion in intended losses. Nearly 100 licensed professionals were charged, including doctors, nurse practitioners, and pharmacists.
Key Enforcement Features:
- Use of advanced data analytics using DOJ’s Health Care Fraud Data Fusion Center.
- Proactive identification of anomalies in billing and claims data, rather than reliance on whistleblower reports.
- Emphasis on individual criminal liability and high-dollar scheme aggregation.
Implications for in-house counsel, compliance officers and healthcare regulatory lawyers:
- Data analytics appears to be central to DOJ enforcement. In-house counsel, compliance officers and regulatory lawyers must consider their clients’ internal billing and claims data from a risk-management perspective.
- Compliance programs should be stress-tested to ensure they can detect potential outliers or patterns that might attract scrutiny.
- Medical professionals remain a key enforcement target, underscoring the importance of advising individuals—not just corporate entities—on exposure and rights during investigations.
FCA Working Group Relaunch: Civil Enforcement Blueprint
On July 2, 2025, the DOJ and HHS announced the reactivation of the False Claims Act Working Group, signaling long-term coordination on civil fraud investigations in the healthcare sector. The initiative reflects DOJ’s continued use of the FCA as its primary civil enforcement tool and expansion of FCA liability into areas not traditionally associated with fraud, including contractual disputes and regulatory noncompliance.
Key Focus Areas:
- Medicare Advantage upcoding: Investigating inflated diagnosis codes used to boost risk-adjusted payments.
- Drug and device pricing practices: Examining rebate structures, formulary agreements, and price reporting.
- Barriers to patient access: A newer theory targeting failures to meet network adequacy or contractually required patient access levels.
- Kickbacks: Continued focus on Anti-Kickback Statute (AKS) violations involving remuneration for referrals.
- Defective devices: Enforcement based on claims for services involving devices that may be materially defective.
- EHR manipulation: Scrutiny of software features that may promote upcoding or create conflicts of interest.
Takeaways for Defense Attorneys
- Use of analytics is now a foundational enforcement tool. Defense strategies should include review and audit of client data to identify potential red flags.
- FCA liability theories are expanding. Any failure to meet contractual or regulatory requirements tied to federal funds could serve as the basis for an FCA claim.
- State enforcement is more active. Clients must be counseled on risks from both federal and state regulators.
- Criminal cases still focus heavily on individual liability. Clients should be advised early and comprehensively—including family members or staff who may unintentionally interfere with investigations.
- Compliance infrastructure is not a luxury. A robust, well-documented compliance program can play a pivotal role in reducing liability and improving outcomes during negotiations.
If you’d like more in-depth insights on structuring internal investigations, managing qui tam risks, or preparing clients for DOJ scrutiny, feel free to connect.
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