Q&A with Former US Attorney Erek L. Barron on Enforcement Trends, Qui Tam Risks, and Strategic Opportunities — EnforceMintz

The Department of Justice (DOJ) is pairing aggressive health care fraud enforcement with a mandate for restraint. Former US Attorney Erek L. Barron shares insights on False Claims Act (FCA) trends, AI-driven investigations, new risk areas, and strategies for mitigating exposure in 2026.

KEY POINTS:

• DOJ balances aggressive enforcement with restraint. A DOJ Criminal Division memo emphasizes continued focus on health care fraud and FCA cases while urging prosecutors to avoid overreach. This mandate could create opportunities for defense counsel in negotiations.
• Data-driven and AI-assisted investigations are expanding. DOJ increasingly uses data analytics and AI tools to identify fraud. Companies relying on automated coding or billing algorithms should ensure transparency and human oversight to avoid FCA exposure.
• New risk areas are emerging. Beyond traditional health care fraud, risks now include tariff evasion, involvement in gender-affirming care, and DEI-related certifications under federal grants. Among other things, companies should audit supply chain data and stress-test compliance with civil rights certifications.
• Policy shifts create strategic opportunities. DOJ’s openness to deferred and non-prosecution agreements, combined with incentives for self-disclosure and remediation, offers companies under investigation a chance to mitigate penalties and avoid criminal exposure.

This article is part of EnforceMintz: Healthcare Enforcement Trends in 2025 & 2026 Outlook, a series exploring key developments and practical strategies for health care organizations navigating enforcement risks. Read more articles from EnforceMintz to stay current on enforcement trends and compliance strategies.

While changes are afoot in the DOJ, the FCA remains one of the government’s primary tools for combating fraud on federal health care programs. Even so, recent developments are reshaping enforcement efforts in both local US Attorney’s Offices and Main Justice. In this Q&A, former US Attorney and current Mintz Member Erek L. Barron addresses some of the most pressing issues and questions related to FCA enforcement trends, and talks about what to watch for in the year ahead.

Erek L. Barron’s DOJ Leadership and FCA Enforcement Expertise

From 2021 to 2025, Erek L. Barron served as the US Attorney for the District of Maryland, leading one of the nation’s most active US Attorney’s Offices. As US Attorney, he oversaw major criminal and civil matters involving health care fraud, government procurement fraud, and cybersecurity and national security matters. In this capacity, he led numerous high-impact FCA investigations. He previously worked in private practice representing companies in various government investigations. Erek’s public service background includes serving as counsel to the US Senate Judiciary Committee and holding elected office as a Maryland state legislator, where he served as a member of the health care committee.

Grady R. Campion: You’ve seen all sides of health care enforcement from your time as a US Attorney, as a legislator, and in private practice. What’s your big-picture takeaway from 2025?

Erek L. Barron: What’s happening now is unique. I’ve never seen this combination of aggressive health care fraud enforcement paired with explicit restraint mandates from the administration.

DOJ Priorities and Policy Shifts

GRC: How have these initiatives been communicated?

ELB: First, the message has been clear: Health care fraud and federal program waste and abuse remain top DOJ priorities. As such, health care and life sciences companies remain subject to criminal and civil enforcement. DOJ Criminal Division Chief Matthew Galeotti’s May 2025 memorandum, “Focus, Fairness, and Efficiency in the Fight Against White-Collar Crime” (the Galeotti Memo), explicitly confirms the DOJ’s continued focus on health care fraud, which often involves FCA investigations and litigation. Additionally, violations of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act are also designated as areas of focus. The latter two enforcement areas are particularly relevant to anyone involved in the manufacture, distribution, supply, and marketing of opioids.

But the Galeotti Memo is remarkable in its restraint. In this administration’s view, US businesses and national interests are burdened by “overbroad and unchecked corporate and white-collar enforcement.” So, prosecutors are directed to “avoid overreach” that may punish legitimate enterprises or hinder innovation. Practically speaking, this “efficiency mandate” is a strategic lever for defense counsel — for example, if an investigation is dragging on, defense counsel should consider aggressively opposing serial seal extensions by citing the DOJ’s own directives to encourage the government to make an intervention decision sooner.

Despite the call for restraint in the Galeotti Memo, enforcement actions have not slowed. Seemingly every summer, the Criminal Division’s Health Care Fraud Unit announces a historic year resulting in a long list of charges it has brought. This year was no different: The 2025 National Health Care Fraud Takedown detailed charges against 300 individuals, including nearly 100 medical professionals, involving alleged schemes resulting in $14.6 billion in claims targeting Medicare, Medicaid, and other government health care programs. The combination of restraint and record recoveries has thus resulted in some mixed messaging.

Key Enforcement Trends and Risk Areas

GRC: What enforcement trends from the past year stand out to you?

ELB: DOJ continues to highlight its data-driven approach and the use of cloud computing, AI-assisted technology, and data analytics to identify outliers and investigate potentially fraudulent schemes; this activity likely will continue, especially given the mandate that a shorter-staffed DOJ find ways to do more with less.

Regarding AI-assisted technology, based on conversations with current Assistant US Attorneys, I know the Department has “black box” billing algorithms on the radar. Companies using automated coding or clinical decision support algorithms could face new exposure. They should audit the explainability of these tools — if you can’t demonstrate a human-in-the-loop validation process for your AI’s coding or billing suggestions, prosecutors may view that opacity as “reckless disregard” under the FCA.

GRC: Are there any other specific enforcement areas you find noteworthy?

ELB: It’s early, but investigations and enforcement actions in areas including Medicare Advantage, the opioid supply chain, and Medicare/Medicaid billing practices remain common. But there are other areas outside of health care that are receiving less attention, such as trade and other broad administration priorities.

Historically, trade or tariffs may not be the first things that come to mind for health care and life sciences companies when considering FCA exposure, but it’s worth mentioning because it’s a priority area for the current administration. Tariff evasion may give rise to so-called “reverse false claims” liability. Reverse false claims liability arises when a person knowingly makes a false statement or conceals information to reduce or avoid an existing financial obligation to the government. Reducing or avoiding a tax or tariff would seem to fit that framework.

If, for example, you import medical devices or pharmaceuticals, you need to ensure your “Country of Origin” declarations at the border match what you are representing in government contracts. A mismatch here isn’t just a customs issue, it can trigger “reverse false claims” liability. A privilege-protected audit of import data to catch these discrepancies before the government does might be wise.

Policy Intersections and Corporate Enforcement

GRC: Are there any other areas where the administration’s priorities are intersecting with health care or life sciences?

ELB: FCA enforcement activity may be on the horizon in the context of gender-affirming care and health care entity diversity, equity, and inclusion (DEI) initiatives, reflecting the administration’s creativity in enforcing broader policy priorities beyond the traditional priority of financial harm.

On gender-affirming care, DOJ’s subpoena strategy has faced pushback in multiple jurisdictions, and, so far, providers have prevailed.

There has been a lot of press about FCA enforcement in the area of DEI — most notably the Civil Rights Fraud Initiative (CFRI) established by DOJ in May 2025. The CRFI states that the FCA will be used to investigate and pursue claims against federal funds recipients who knowingly violate federal civil rights laws.

While early commentary focused on risks to higher education, this initiative also creates a new “materiality” risk for any entity receiving federal grants, including health care and life science companies. Grant recipients should review the specific certifications in their grant applications regarding civil rights compliance. If your internal DEI policies don’t align with those certifications, a whistleblower could allege that you knowingly made a false statement to secure funding. You need to stress-test those certifications now, rather than waiting for a subpoena.

GRC: Shifting gears: On the criminal side, there has been a lot of recent discussion about deferred and non-prosecution agreements. Some of our colleagues wrote about that in this year’s edition of EnforceMintz. What’s your take on corporate criminal enforcement efforts under the current administration?

ELB: One theme that emerges from recent DOJ statements is the balance between individual accountability and corporate responsibility. As the Galeotti Memo notes, “[n]ot all corporate misconduct warrants federal criminal prosecution.” The emphasis is thus on prosecuting individual wrongdoers first, while narrowly tailoring corporate resolutions, with corporate incentives for self-disclosure, cooperation, and proactive remediation. While the investigation and prosecution of health care fraud remains a top DOJ priority, the Galeotti Memo explains how entities can avail themselves of favorable outcomes in appropriate cases.

The consequences of this policy shift appear to be twofold: increased use of non-prosecution and deferred prosecution agreements and decreased use of corporate monitorships. These changes present opportunities for companies to avoid criminal exposure and mitigate monetary damages. With this administration in particular, entities under investigation need to know where to look and what levers to pull in seeking favorable outcomes.

Looking Ahead: Structural Changes and Takeaways

GRC: There have been a number of recent structural changes at DOJ. For health care and life sciences entities, what is significant about those changes?

ELB: The new DOJ-HHS FCA Working Group is one seemingly important structural change. In July 2025, DOJ and HHS announced the reestablishment and reinvigoration of the FCA Working Group, which was originally constituted by the Biden administration. The full impact of the FCA Working Group remains to be seen, but a few aspects of the partnership are noteworthy. As an initial matter, the Working Group makes clear that health care enforcement remains a government priority. It is also interesting that the membership of the Working Group appears to be predominantly or entirely comprised of civil, rather than criminal, lawyers. Finally, the announcement of the Working Group hints at potential new trends, including increased use of “enhanced data mining” in investigative matters.

The government is looking at your data more closely than ever before. In response, health care companies should consider conducting their own data audits, using similar data mining techniques to identify billing outliers internally. You want to spot and explain those anomalies before the Working Group flags them.

Other emerging trends include the government’s increased use of regulatory payment suspension under the Medicare program and policy pronouncements reflecting DOJ’s potential willingness to dismiss qui tam FCA lawsuits after declining to intervene.

GRC: What about recent personnel changes at DOJ? Anything significant?

ELB: I’ve spoken with former colleagues at DOJ’s Civil Fraud Section and elsewhere who confirm that recent departures have created a backlog in intervention decisions. These departures include several longtime leaders of the Civil Division. For ongoing investigations, turnover at DOJ may result in slower-moving investigations as incoming staff get up to speed. Tight staffing at DOJ may also create a larger role for relator’s counsel in cases where the government has intervened. Similarly, recent personnel changes may in some cases present an opportunity for defendants to persuade DOJ to decline or dismiss.

GRC: Thanks so much for sharing your insights and perspective, Erek. Any final thoughts for entities and individuals in the health care and life sciences industries as we look ahead to 2026?

ELB: I’d highlight four main takeaways:

• Review compliance programs. Companies should consider proactively assessing compliance frameworks to determine how they align with DOJ’s emphasis on efficiency and fairness under the Galeotti Memo; also, turnover at DOJ may slow investigations. Use this time to strengthen internal defenses.
• Prepare for data-driven enforcement. Enhanced data mining and AI-assisted investigations mean health care companies must ensure billing and reporting accuracy to avoid FCA exposure. This is particularly important for entities in value-based care arrangements or other alternative payment models.
• Audit supply chain data. Health care and life sciences companies importing devices or pharmaceuticals should audit tariff practices to mitigate potential FCA exposure.
• Leverage DOJ policy shifts. Entities under investigation can benefit from incentives for self-disclosure and remediation. In appropriate circumstances, there may be opportunities to seek declination or dismissal consistent with the current administration’s recent policy pronouncements.

Get early access to Part 2 of EnforceMintz

The next edition of EnforceMintz — our annual False Claims Act Statistical Year In Review — will analyze trends in FCA cases using data from DOJ’s recently released annual report on FCA settlements and judgments.

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