Mintz Health Care Enforcement Trends & Analysis | 2026 Outlook Mintz Health Care Enforcement Trends & Analysis

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

Health Care Enforcement Trends & Analysis

Washington, DC KSLovitch@mintz.com +1.202.434.7324

Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

Karen S. Lovitch

A Letter from the chair

EnforceMintz —

Mintz’s Health Care Enforcement & Investigations practice group reports on qui tam FCA cases, other government enforcement actions, and significant regulatory developments from the past year.

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Editors

Boston SPKingsbury@mintz.com +1.617.348.1829

Of Counsel

Samantha Kingsbury

Washington, DC EBarron@mintz.com +1.415.202.434.7336

Member / Chair, Crisis Management and Strategic Response Practice

Erek L. Barron

Boston GRCampion@mintz.com +1.617.348.1785

Associate

Grady R. Campion

Contributors

New York, NY LFCollins@mintz.com +1.212.692.6252

Member

LisaMarie Collins

Boston, MA NALaPalme@mintz.com +1.617.348.1706

Associate

Nick LaPalme

Boston, MA NTidwell@mintz.com +1.617.348.1684

Member

Natashia Tidwell

Boston JTHaviland@mintz.com +1.617.348.4473

Associate

Jane T. Haviland

Boston, MA EPBeirne@mintz.com +1.617.348.1707

Member / Co-chair, White Collar Defense and Government Investigations Practice

Eoin P. Beirne

Health Care Enforcement Trends & 2026 Outlook

Health Care Enforcement Trends & Analysis

EnforceMintz —

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Mintz’s Health Care Enforcement Defense Practice Group is proud to present the latest edition of EnforceMintz, our regular newsletter analyzing current events, highlighting trends, and predicting future developments related to health care enforcement. EnforceMintz reports on False Claims Act (FCA) investigations and litigation, other government enforcement actions, and significant regulatory developments and court decisions related to health care enforcement.

As in past years, this edition reflects on health care enforcement trends and predicts how health care enforcement may evolve and where enforcement authorities will focus their efforts and resources in years to come. It also offers practical guidance about what these trends and predictions mean for the health care and life sciences industries.

At her Senate confirmation hearing in January 2025, Pam Bondi stated that she would “defend the constitutionality” of the FCA if confirmed as attorney general, and she has kept that promise. Constitutional challenges to the FCA’s qui tam provisions — particularly in declined cases — are picking up steam, and DOJ has intervened when necessary to make its case. Both sides of the FCA bar are watching these cases closely, and this important constitutional question ultimately may reach the US Supreme Court.

In this edition, we discuss the most significant health care enforcement developments of 2025 and our predictions for 2026. Some of the 2025 developments we cover represent long-standing enforcement priorities, while others signal emerging trends. We also cover regulatory policy developments, including DOJ’s continued focus on cooperation and self-disclosure, and case law developments from 2025 that may come to a head in 2026.

Karen Lovitch Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

Consistent with our past predictions, the Trump administration prioritized the pursuit of health care fraud and abuse in both the criminal and civil contexts in 2025, which is not surprising given that the pursuit of health care fraud and abuse has always had bipartisan support. While we continued to see FCA settlements and litigation in now-familiar areas such as Medicare managed care fraud, Trump’s Department of Justice (DOJ) took the unprecedented step of using its enforcement authority to pursue the president’s political priorities. For example, in July DOJ announced that it had sent subpoenas to over 20 health care providers performing transgender medical procedures on children and pledged to hold them accountable for “mutilat[ing] children in the service of a warped ideology.”

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Boston, MA JFlaherty@mintz.com +1.617.348.1729

Project Analyst

Jordyn Flaherty

Boston, MA KAhuja@mintz.com +1.617.348.1813

Associate

Keshav Ahuja

Washington, DC TEDwyer@mintz.com +1.202.585.3504

Member

Tara E. Dwyer

Boston HSFoster@mintz.com +1.202.661.8758

Member

Hope S. Foster

Boston CAHill@mintz.com +1.617.348.1723

Member

Caitlin A. Hill

Boston, MA KLaRosa@mintz.com +1.617.348.1783

Associate

Kayla LaRosa

Boston, MA SLashway@mintz.com +1.617.348.1833

Member / Co-chair, Privacy & Cybersecurity Practice

Scott T. Lashway

Boston, MA CProber@mintz.com +1.617.348.4847

Associate

Clare Prober

Boston, MA MStein@mintz.com +1.617.348.1770

Special Counsel

Matthew MK Stein

Washington, DC MPMathewson@mintz.com +1.202.434.7319

Associate

Melody P. Mathewson

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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Mintz’s Health Care Enforcement Defense practice group reports on qui tam FCA cases, other government enforcement actions, and significant regulatory developments from the past year.

Health Care Enforcement Trends & Analysis

EnforceMintz —

Subscribe to Insights

Learn more

Contributors

Editors

A Letter from the Co-chairs

Read Our Report

In our annual report, we examine the data and explore health care enforcement trends and likely targets of government scrutiny for 2024 and beyond.

Health Care Enforcement Trends & 2024 Outlook

Health Care Enforcement Trends & Analysis

EnforceMintz —

Karen Lovitch Chair, Health Care Enforcement Defense Practice

On January 15, 2025, DOJ released its annual report of FCA enforcement activity. In the last fiscal year, FCA settlements and judgments exceeded $2.9 billion, $1.67 billion of which related to matters involving the health care industry. DOJ handled 1,402 new FCA matters and qui tam relators filed 979 of those cases, a record number for a single year.

Even if health care enforcement efforts slow under a second Trump administration, state-level enforcement may accelerate. Regardless, qui tam relators continue to drive the vast majority of FCA enforcement activities, and they show no signs of slowing down, so we anticipate that these matters will continue to reflect the trends and issues we have been following, as well as emerging theories of liability.

Pamela Bondi, President Trump’s nominee for attorney general, is no stranger to health care fraud enforcement. She is the former attorney general for the State of Florida, which is a hotbed of government health care program fraud, but neither she nor President-elect Trump has expressed whether health care fraud enforcement will be a DOJ priority this time around. At her Senate confirmation hearing, Bondi stated that she would “defend the constitutionality” of the FCA and committed to ensuring that DOJ had sufficient staffing and resources to “properly support and prosecute” FCA cases, including those brought by qui tam relators.

While the Trump administration redux is expected to pursue sweeping changes in various areas, one constant is likely to be health care fraud enforcement. As we observed in 2021, in President Trump’s first term, the total volume of FCA cases actually increased, which was the result of an increase in government-initiated enforcement actions. Similarly, overall FCA recoveries from 2017 to 2020 remained relatively constant, and, in each year, the health care industry was the main source of overall recoveries. Perhaps for that reason, health care fraud enforcement efforts generally have bipartisan support, and monetary recoveries help to fill the Medicare program’s coffers, which could in turn help President Trump fulfill his campaign promise to reduce government spending without cutting Medicare or Social Security.

As in past years, this installment reflects on health care enforcement trends and predicts how health care enforcement may evolve and where enforcement authorities will focus their efforts and resources in years to come. We also offer practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

Mintz’s Health Care Enforcement Defense practice group is proud to present the latest issue of EnforceMintz, our regular newsletter analyzing current events, highlighting trends, and predicting future developments related to health care fraud enforcement. EnforceMintz reports on qui tam cases brought under the False Claims Act (FCA), other government enforcement actions, and significant regulatory developments and court decisions.

Washington, DC KSLovitch@mintz.com +1.202.434.7324

Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

Karen S. Lovitch

Boston SPKingsbury@mintz.com +1.617.348.1829

Of Counsel

Samantha Kingsbury

Boston GRCampion@mintz.com +1.617.348.1785

Associate

Grady R. Campion

Click through to learn more.

Policy shifts create strategic opportunities.

New risk areas are emerging.

Data-driven and AI-assisted investigations are expanding.

DOJ balances aggressive enforcement with restraint.

Key Points

READ HERE

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

community outreach

San Francisco, CA DCody@mintz.com +1.415.432.6114

Member

Daniel A. Cody

Boston, MA MConnolly@mintz.com +1.617.348.1810

Associate

Molly Connolly

Boston, MA AVGreco@mintz.com +1.617.348.4866

Associate

Alexa Greco

New York, NY DRGilboa@mintz.com +1.212.692.6736

Associate

David R. Gilboa

New York, NY LGalloCook@mintz.com +1.212.692.6259

Member

Alexandra Gallo-Cook

Boston, MA AAMarkson@mintz.com +1.617.348.1681

Associate

Ashley A. Markson

Privilege should be managed carefully.

A strong compliance culture is important.

Proper documentation is critical.

FCA retaliation claims are easy to bring and hard to defend.

Key Points

READ HERE

Preventing False Claims Act Retaliation Claims: What Every Company Should Know

community outreach

Unpredictability is expected in 2026.

Traditional fraud enforcement remains strong.

Enforcement priorities are becoming politicized.

Leadership turnover is reshaping enforcement.

Key Points

READ HERE

Health Care Enforcement Under Trump 2.0: Leadership Shakeups and Shifting Priorities

community outreach

New FCA and regulatory challenges are emerging.

Aggressive risk adjustment enforcement and litigation.

Medicare Advantage oversight remains a top priority.

Key Points

READ HERE

Medicare Advantage Under the Microscope: Enforcement Priorities and Legal Battles

community outreach

High-stakes appeals could reshape FCA enforcement.

Excessive Fines Clause limits are being tested.

The government’s defense of the qui tam provisions is changing.

Constitutional challenges to the FCA’s qui tam provisions are gaining momentum.

Key Points

READ HERE

Qui Tam Quandaries: False Claims Act at a Constitutional Crossroads

community outreach

Strong compliance programs are critical.

Health care industry is seeing early resolutions.

NPAs and DPAs are increasingly accessible.

Expanded voluntary self-disclosure policy creates opportunities.

Key Points

READ HERE

Streamlined DOJ Resolutions: Declinations, NPAs, and DPAs Explained

community outreach

Pricing transparency under the microscope.

AI oversight expands at the state level.

GLP-1 enforcement heats up. State AG and FTC crack downs.

Key Points

READ HERE

The Old, the New, and the Unknown: Consumer Protection Enforcement Activity in Health Care

community outreach

Compliance requires proactive governance and transparency.

Government agencies are using AI to detect fraud.

Enforcement risks are growing.

States are driving AI regulation amid federal uncertainty.

Key Points

READ HERE

From Innovation to Regulation: Health Care Enforcement Related to AI

community outreach

New Jersey expands state-level kickback law.

Supreme Court review possible.

DOJ EKRA guidance still absent. Compensation structures unclear.

Ninth Circuit clarifies EKRA’s scope in Schena.

Key Points

READ HERE

The Eliminating Kickbacks in Recovery Act in 2025: New Developments and New Questions for Laboratory Sales Compensation

community outreach

Criminal exposure and heightened penalties are emerging.

Successor liability and investor risk are real.

Self-disclosure and cooperation reduce penalties.

Cybersecurity enforcement remains a priority.

Key Points

READ HERE

Cybersecurity-Related Enforcement Under the False Claims Act in 2025: New Settlements, Same Lessons

community outreach

What’s ahead for 2026. State-led enforcement on GLP-1s, AI, and pricing.

Feature Articles

A Letter from the chair

Boston, MA JFlaherty@mintz.com +1.617.348.1729

Project Analyst

Jordyn Flaherty

Preventing False Claims Act Retaliation Claims: What Every Company Should Know

Q&A with Former US Attorney Erek L. Barron: DOJ Enforcement Trends & FCA Risks

Health Care Enforcement Under Trump 2.0: Leadership Shakeups and Shifting Priorities

From Innovation to Regulation: Enforcement of AI in Health Care

The Old, the New, and the Unknown: How Consumer Protection Regulators Are Applying Existing Frameworks and Creating New Rules for the Health Care Industry

Streamlined DOJ Resolutions: Declinations, NPAs, and DPAs Explained

Qui Tam Quandaries: False Claims Act at a Constitutional Crossroads

Medicare Advantage Under the Microscope: Enforcement Priorities and Legal Battles

Cybersecurity-Related Enforcement Under the False Claims Act in 2025: New Settlements, Same Lessons

EKRA Update — NJ State–Level Law / Schena

READ HERE

Part 2 of EnforceMintz — our annual False Claims Act Statistical Year in Review — will analyze trends in FCA cases using data from the Department of Justice’s annual report on FCA settlements and judgments.

Read Our Report

Boston JTHaviland@mintz.com +1.617.348.4473

Associate

Jane T. Haviland

READ HERE

Read here

Enforcement Trends and Practical Guidance

Areas of Focus

Enforcement Trends and Practical Guidance

Case Law Developments

New Jersey expands state-level kickback law.

Supreme Court review possible.

DOJ EKRA guidance still absent. Compensation structures unclear.

Ninth Circuit clarifies EKRA’s scope in Schena.

Key Points

READ HERE

The Eliminating Kickbacks in Recovery Act in 2025: New Developments and New Questions for Laboratory Sales Compensation

community outreach

High-stakes appeals could reshape FCA enforcement.

Excessive Fines Clause limits are being tested.

The government’s defense of the qui tam provisions is changing.

Constitutional challenges to the FCA’s qui tam provisions are gaining momentum.

Key Points

READ HERE

Qui Tam Quandaries: False Claims Act at a Constitutional Crossroads

community outreach

Enforcement Trends and Practical Guidance

Case Law Developments

What’s ahead for 2026. State-led enforcement on GLP-1s, AI, and pricing.

Pricing transparency under the microscope.

AI oversight expands at the state level.

GLP-1 enforcement heats up. State AG and FTC crack downs.

Key Points

READ HERE

The Old, the New, and the Unknown: Consumer Protection Enforcement Activity in Health Care

community outreach

New FCA and regulatory challenges are emerging.

Aggressive risk adjustment enforcement and litigation.

Medicare Advantage oversight remains a top priority.

Key Points

READ HERE

Medicare Advantage Under the Microscope: Enforcement Priorities and Legal Battles

community outreach

Criminal exposure and heightened penalties are emerging.

Successor liability and investor risk are real.

Self-disclosure and cooperation reduce penalties.

Cybersecurity enforcement remains a priority.

Key Points

READ HERE

Cybersecurity-Related Enforcement Under the False Claims Act in 2025: New Settlements, Same Lessons

community outreach

Compliance requires proactive governance and transparency.

Government agencies are using AI to detect fraud.

Enforcement risks are growing. AI use in health care...

States are driving AI regulation amid federal uncertainty.

Key Points

READ HERE

From Innovation to Regulation: Health Care Enforcement Related to AI

community outreach

Enforcement Trends and Practical Guidance

Areas of Focus

Privilege should be managed carefully.

A strong compliance culture is important.

Proper documentation is critical.

FCA retaliation claims are easy to bring and hard to defend.

Key Points

READ HERE

Preventing False Claims Act Retaliation Claims: What Every Company Should Know

community outreach

Strong compliance programs are critical.

Health care industry is seeing early resolutions.

NPAs and DPAs are increasingly accessible.

Expanded voluntary self-disclosure policy creates opportunities.

Key Points

READ HERE

Streamlined DOJ Resolutions: Declinations, NPAs, and DPAs Explained

community outreach

Policy shifts create strategic opportunities.

New risk areas are emerging.

Data-driven and AI-assisted investigations are expanding.

DOJ balances aggressive enforcement with restraint.

Key Points

READ HERE

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

community outreach

Unpredictability is expected in 2026.

Traditional fraud enforcement remains strong.

Enforcement priorities are becoming politicized.

Leadership turnover is reshaping enforcement.

Key Points

READ HERE

Health Care Enforcement Under Trump 2.0: Leadership Shakeups and Shifting Priorities

community outreach

Enforcement Trends and Practical Guidance

Click through to learn more.

Feature Articles