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
Increased focus on telehealth-related fraud, scrutiny of AI-driven healthcare systems, and attention to data privacy breaches within the healthcare sector could be notable trends in investigations and litigation for 2024. Rapid technological advancements may bring forth unique legal challenges. Keep an eye on industry updates for the latest developments.
A Letter from the chair
EnforceMintz —
© 2025 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo. P.C.
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.
Subscribe to Insights
Learn more
Policy Developments
Editors
Boston
SPKingsbury@mintz.com
+1.617.348.1829
Of Counsel
Samantha Kingsbury
Washington, DC
LJFreedman@mintz.com
+1.202.434.7372
Member
Laurence J. Freedman
Boston, MA
JBKoss@mintz.com
+1.617.210.6855
Managing Director, E-Data Consulting Group
John Koss
San Francisco, CA
DCody@mintz.com
+1.415.432.6114
Member
Daniel A. Cody
Boston
GRCampion@mintz.com
+1.617.348.1785
Associate
Grady R. Campion
Contributors
Boston, MA
CSFlashner@mintz.com
+1.617.348.1605
Member
Cory S. Flashner
Boston, MA
NALaPalme@mintz.com
+1.617.348.1706
Associate
Nick LaPalme
Washington, DC
REYount@mintz.com
+1.202.434.7427
Of Counsel
Rachel E. Yount
Boston
JTHaviland@mintz.com
+1.617.348.4473
Associate
Jane T. Haviland
Washington, DC
TDKupupika@mintz.com
+1.202.434.7431
Associate
Trust D. Kupupika
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 & 2025 Outlook
DOJ Policy Developments in 2024 Seek to Motivate More Voluntary Self-Disclosures
Health Care Enforcement Trends & Analysis
EnforceMintz —
Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024
Read HERE
Read HERE
Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025
Read HERE
Long Tail of Pandemic Fraud Schemes Will Likely Result in Continued Enforcement for Years to Come
Read HERE
Don’t Forget Your Other Regulators: Consumer Protection Enforcement in Health Care Markets
Read HERE
FCA Enforcement in Value-Based Care Arrangements Heated Up in 2024 and Likely to Remain a Priority in 2025
Read HERE
Telemedicine Enforcement: Trends in 2024 Suggest More Sophisticated Enforcement to Come in 2025
Read HERE
Could the Supreme Court’s Decision in Jarkesy Mean the End to HHS Civil Monetary Penalty Authorities as We Know Them?
Read HERE
Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues
Read HERE
Regulatory and
Areas of
Enforcement Focus
Developments
Case Law
Share to Social:
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.
For the first time, we also examine trends and predictions in enforcement related to the fast-moving utilization of artificial intelligence (AI). The use of AI in health care — and related enforcement activities — may evolve as quickly as AI itself. Demonstrating the pace of change, since our annual predictions last year, AI has exploded into the public consciousness and quickly materialized into practical use in many industries, including health care. The pace of AI’s progress is astonishing to observe.
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.
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.
Relators may raise concerns about AI in healthcare, particularly if there are issues related to data privacy, biased algorithms, or unethical practices. False Claims Act lawsuits could emerge if there are allegations of fraudulent activities, but it’s speculative at this point. Monitoring developments in AI healthcare ethics is crucial.
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.
We at least agree with ChatGPT that everyone should keep an eye on industry developments. Hopefully, you will find our take on industry trends and developments discussed in this issue both practical and informative.
Karen Lovitch
Chair, Health Care Enforcement Defense Practice
We appreciate your questions and feedback on these trends and predictions, and we would be glad to discuss this issue of EnforceMintz. Please feel free to contact us at KSLovitch@mintz.com or BDunphy@mintz.com. We look forward to hearing from you.
The next edition of EnforceMintz — our annual False Claims Act Statistical Year In Review — will analyze trends in FCA cases using data compiled by Mintz in its Qui Tam Database and dive into the data from DOJ’s annual report.
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.
Read Our Report
Boston, MA
NEHenry@mintz.com
+1.617.348.1867
Associate
Nicole E. Henry
The next edition of EnforceMintz — our annual False Claims Act Statistical Year In Review — will analyze trends in FCA cases using data compiled by Mintz in its Qui Tam Database and DOJ’s annual report of FCA enforcement activity, which is typically released in the first quarter of each year. View the statistical edition here.
Healing Healthcare? DOJ’s Cybersecurity Enforcement Trained Up for 2025
Read HERE
2024’s Key False Claims Act Settlements Involving Hospitals and Health Systems: Continued Focus on Stark Law and Anti-Kickback Statute Violations
Read HERE
Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024
Read HERE
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
Washington, DC
RGKidwell@mintz.com
+1.202.661.8752
Member
Robert G. Kidwell
Boston
SLashway@mintz.com
+1.617.348.1833
Member / Co-Chair, Privacy & Cybersecurity Practice
Scott T. Lashway
Washington, DC
PTThornton@mintz.com
+1.202.434.7435
Associate
Payton T. Thornton
Boston, MA
MStein@mintz.com
+1.617.348.1770
Special Counsel
Matthew MK Stein
Boston, MA
KMcGinty@mintz.com
+1.617.348.1688
Co-Chair, Class Action Practice & Member, Health Care Enforcement Defense Practice
Kevin M. McGinty
In this issue, we discuss 2024’s areas of enforcement focus and our predictions for 2025. Some of the 2024 developments we analyze 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 2024 that are expected to come to a head in 2025.
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.
© 2024 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo. P.C.
Share to Social:
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
Karen Lovitch and Brian Dunphy
Co-Chairs, Health Care Enforcement Defense Practice
The next edition of EnforceMintz — False Claims Act Statistical Year In Review — will analyze trends in FCA cases using data compiled by Mintz in its Qui Tam Database and DOJ’s annual report of FCA enforcement activity, which is typically released in the first quarter of each year. View it here.
We appreciate your questions and feedback on these trends and predictions, and we would be glad to discuss this issue of EnforceMintz. Please feel free to contact us at KSLovitch@mintz.com or BDunphy@mintz.com. We look forward to hearing from you.
We at least agree with ChatGPT that everyone should keep an eye on industry developments. Hopefully, you will find our take on industry trends and developments discussed in this issue both practical and informative.
Increased focus on telehealth-related fraud, scrutiny of AI-driven healthcare systems, and attention to data privacy breaches within the healthcare sector could be notable trends in investigations and litigation for 2024. Rapid technological advancements may bring forth unique legal challenges. Keep an eye on industry updates for the latest developments.
While we are closely watching AI trends, and we predict AI enforcement trends in this issue, we opted to also go to the source: we asked ChatGPT for its predictions related to AI-related health care enforcement in 2024 and beyond. ChatGPT predicts the following:
For the first time, we also examine trends and predictions in enforcement related to the fast-moving utilization of artificial intelligence (AI). The use of AI in health care — and related enforcement activities — may evolve as quickly as AI itself. Demonstrating the pace of change, since our annual predictions last year, AI has exploded into the public consciousness and quickly materialized into practical use in many industries, including health care. The pace of AI’s progress is astonishing to observe.
In this issue, we survey important enforcement agency policies and guidance covering compliance, self-disclosure, and individual accountability; discuss key areas of enforcement focus, including Medicare Advantage, cybersecurity, private equity investors in health care, and tele-fraud; and examine developments in FCA investigations, settlements, and case law.
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.
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
The next edition of EnforceMintz — our annual False Claims Act Statistical Year In Review — will analyze trends in FCA cases using data compiled by Mintz in its Qui Tam Database and dive into the data from DOJ’s annual report.
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.
In this issue, we discuss 2024’s areas of enforcement focus and our predictions for 2025. Some of the 2024 developments we analyze 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 2024 that are expected to come to a head in 2025.
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.
Could the Supreme Court’s Decision in Jarkesy Mean the End to HHS Civil Monetary Penalty Authorities as We Know Them?
Read HERE
Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues
Read HERE
Developments
Case Law
Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024
Read HERE
DOJ Policy Developments in 2024 Seek to Motivate More Voluntary Self-Disclosures
Read HERE
Policy Developments
Regulatory and
Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024
Read HERE
2024’s Key False Claims Act Settlements Involving Hospitals and Health Systems: Continued Focus on Stark Law and Anti-Kickback Statute Violations
Read HERE
Healing Healthcare? DOJ’s Cybersecurity Enforcement Trained Up for 2025
Read HERE
Telemedicine Enforcement: Trends in 2024 Suggest More Sophisticated Enforcement to Come in 2025
Read HERE
Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025
Read HERE
Long Tail of Pandemic Fraud Schemes Will Likely Result in Continued Enforcement for Years to Come
Read HERE
Don’t Forget Your Other Regulators: Consumer Protection Enforcement in Health Care Markets
Read HERE
FCA Enforcement in Value-Based Care Arrangements Heated Up in 2024 and Likely to Remain a Priority in 2025
Read HERE
Enforcement Focus
Areas of
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
Washington, DC
REYount@mintz.com
+1.202.434.7427
Of Counsel
Rachel E. Yount
Boston, MA
MStein@mintz.com
+1.617.348.1770
Special Counsel
Matthew MK Stein
Washington, DC
PTThornton@mintz.com
+1.202.434.7435
Associate
Payton T. Thornton
Boston, MA
KMcGinty@mintz.com
+1.617.348.1688
Co-Chair, Class Action Practice & Member, Health Care Enforcement Defense Practice
Kevin M. McGinty
Boston
SLashway@mintz.com
+1.617.348.1833
Member / Co-Chair, Privacy & Cybersecurity Practice
Scott T. Lashway
Boston, MA
NALaPalme@mintz.com
+1.617.348.1706
Associate
Nick LaPalme
Washington, DC
RGKidwell@mintz.com
+1.202.661.8752
Member
Robert G. Kidwell
Boston
CAHill@mintz.com
+1.617.348.1723
Member
Caitlin A. Hill
Boston, MA
NEHenry@mintz.com
+1.617.348.1867
Associate
Nicole E. Henry
Boston
JTHaviland@mintz.com
+1.617.348.4473
Associate
Jane T. Haviland
Boston
HSFoster@mintz.com
+1.202.661.8758
Member
Hope S. Foster
Washington, DC
LJFreedman@mintz.com
+1.202.434.7372
Member
Laurence J. Freedman
Washington, DC
TEDwyer@mintz.com
+1.202.585.3504
Member
Tara E. Dwyer
San Francisco, CA
DCody@mintz.com
+1.415.432.6114
Member
Daniel A. Cody
Boston, MA
EPBeirne@mintz.com
+1.617.348.1707
Member / Co-chair, White Collar Defense and Government Investigations Practice
Eoin P. Beirne
Boston, MA
KAhuja@mintz.com
+1.617.348.1813
Associate
Keshav Ahuja