DOJ and HHS New False Claims Act Working Group Targeting Healthcare Fraud: A Discussion with Knicole Emanuel, Partner at Nelson Mullins

Episode Date: July 16, 2025

In this episode of Stark Integrity, Knicole Emanuel, Partner at Nelson Mullins, joins Bob Wade (Captain Integrity) to break down a significant new development in healthcare enforcement:

The DOJ and HHS False Claims Act (FCA) Working Group—and what it means for healthcare organizations.

The episode highlights a clear warning:

Healthcare providers should be concerned.

A New Level of Enforcement Coordination

The DOJ and HHS have formalized a deeper level of collaboration through this Working Group, designed to:

• Align enforcement priorities
• Share data and resources
• Accelerate investigations
• Target high-risk areas more effectively

This initiative reflects a broader trend:

Government agencies are working more closely than ever to identify and pursue healthcare fraud.

Purpose of the Working Group

The Working Group strengthens the long-standing partnership between DOJ and HHS in enforcing the False Claims Act, which remains:

One of the government’s most powerful tools to combat healthcare fraud.

The collaboration includes leadership from:

• HHS Office of General Counsel
• CMS Center for Program Integrity
• HHS Office of Inspector General (OIG)
• DOJ Civil Division and U.S. Attorneys’ Offices

The takeaway:

This is a coordinated, multi-agency enforcement effort with significant reach.

Key Enforcement Priorities

The Working Group has identified several priority areas for investigation, including:

• Medicare Advantage practices
• Drug, device, and biologics pricing arrangements
• Barriers to patient access to care
• Kickbacks involving healthcare products and services
• Defective medical devices impacting patient safety
• Manipulation of electronic health records (EHRs)

These areas represent:

High-impact risks where enforcement activity is expected to increase.

Data-Driven Enforcement

A major feature of the Working Group is its use of:

Enhanced data sharing and analytics.

HHS will:

• Refer potential violations to DOJ
• Leverage data mining and internal findings
• Identify trends and outliers

The takeaway:

Your data is being actively analyzed across agencies—not just within one.

Faster Investigations and Referrals

The collaboration is designed to:

• Expedite investigations
• Increase referrals from HHS to DOJ
• Streamline enforcement actions

This means:

Issues may be identified and escalated more quickly than in the past.

Implications for Healthcare Organizations

Knicole Emanuel emphasizes that organizations should:

• Reevaluate their compliance programs
• Assess exposure in high-risk areas
• Ensure documentation and billing practices are defensible

Because:

The enforcement environment is becoming more aggressive and coordinated.

The Role of Voluntary Disclosure

The episode highlights the importance of:

Proactive self-assessment and disclosure.

Organizations that:

• Identify issues internally
• Address them early
• Consider voluntary disclosure

May be better positioned when facing enforcement scrutiny.

The takeaway:

Waiting for the government to find an issue is no longer a viable strategy.

A Paradigm Shift in Enforcement

Knicole Emanuel describes the Working Group as:

A paradigm shift in how healthcare fraud enforcement is conducted.

Key changes include:

• Greater interagency coordination
• Increased reliance on data analytics
• Faster and more targeted investigations

The result:

A more efficient—and more formidable—enforcement environment.

Compliance Program Expectations

Healthcare organizations should ensure their compliance programs are:

• Proactive rather than reactive
• Data-informed
• Regularly updated and tested
• Integrated across departments

Because:

Compliance programs will be judged by their ability to prevent and detect issues in real time.

Key Takeaways

• The DOJ-HHS FCA Working Group represents increased enforcement coordination
• The False Claims Act remains a central enforcement tool
• Specific high-risk areas have been targeted for investigation
• Data analytics and interagency collaboration are driving enforcement
• Investigations and referrals are likely to move faster
• Healthcare organizations must reassess compliance strategies
• Voluntary disclosure is an important consideration
• This initiative represents a shift toward more aggressive enforcement

Final Thoughts

This episode sends a strong message:

The enforcement landscape for healthcare fraud is intensifying.

With insights from Knicole Emanuel, it is clear that:

• Government agencies are aligned
• Tools and data are more advanced
• Expectations for compliance are higher

Ultimately:

Organizations must be proactive, vigilant, and prepared.

Because in today’s environment:

Effective compliance is not just about avoiding risk—it is about staying ahead of coordinated enforcement efforts.

Click here to listen to this Stark Integrity Podcast Episode:
https://podcasts.apple.com/us/podcast/doj-and-hhs-new-false-claims-act-working-group/id1588939373?i=1000717454890&l=fr-FR