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Laurence J. Freedman

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[email protected]

+1.202.434.7372

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Larry has a deep understanding of what drives government enforcement actions, and how to defend against them, in the health care and life sciences industries. As a trial lawyer and then official in the Civil Fraud Section of the U.S. Department of Justice, he litigated and supervised hundreds of False Claims Act and qui tam cases nationally. In his litigation practice, Larry has successfully represented hospitals and health care systems, laboratories, pharmaceutical and device manufacturers, and health care executives against fraud and abuse allegations and investigations brought by federal and state agencies. He is consistently recognized among the nation’s leading health care defense attorneys.

Larry’s health care and life sciences litigation practice focuses on defending clients against allegations and investigations of fraud and abuse involving governmental programs. He is highly experienced in representing clients against actions brought by federal and state agencies including the US Department of Justice (DOJ), the Department of Health and Human Services Office of the Inspector General (HHS OIG), the United States Attorneys’ Offices, and state OIGs and Medicaid Fraud Control Units (MFCUs).

Larry’s practice is based on his 34-years of experience handling complex civil litigation, often in the context of parallel proceedings, and achieving global resolutions. In addition to enforcement defense, Larry counsels clients through internal investigations, corporate compliance, investor due diligence reviews, and health care bankruptcies involving governmental liabilities. His clients include hospitals and health systems, dialysis providers, clinical laboratories, medical equipment companies, pharmaceutical and device manufacturers, and health care executives.

Prior to private practice, Larry served as an Assistant Director with the Civil Fraud Section of the DOJ and focused solely on the False Claims Act and its qui tam provisions. At DOJ he supervised hundreds of qui tam cases filed in US district courts throughout the country, was part of the leadership team for the pharmaceutical enforcement initiative, and managed high-profile actions often involving multiple US Attorneys’ Offices and federal agencies.

Prior to his position as Assistant Director, Larry served with the Civil Fraud Section as a trial attorney focused on health care fraud and defense procurement. He co-led the notable investigation and prosecution of national independent clinical laboratories known as “Operation LABSCAM.” For his achievements, Larry was highly-recognized by the Attorney General with the Department’s highest and second highest awards, as well as multiple awards from the HHS OIG and the MFCUs.

Following law school, Larry served as a law clerk for the Honorable Richard Cardamone of the U.S. Court of Appeals for the Second Circuit.
 

Larry has a deep understanding of what drives government enforcement actions, and how to defend against them, in the health care and life sciences industries. As a trial lawyer and then official in the Civil Fraud Section of the U.S. Department of Justice, he litigated and supervised hundreds of False Claims Act and qui tam cases nationally. In his litigation practice, Larry has successfully represented hospitals and health care systems, laboratories, pharmaceutical and device manufacturers, and health care executives against fraud and abuse allegations and investigations brought by federal and state agencies. He is consistently recognized among the nation’s leading health care defense attorneys.

Experience

  • Represent a major national “Part D” Plan Sponsor in declined qui tam litigations in the Southern District of New York and the District of Rhode Island regarding alleged industry-wide fraud in “Direct and Indirect Remuneration” reporting to CMS.   
  • Represent a national testing laboratory in a False Claims Act investigation and qui tam matter regarding relationships with hospital-clients, and part of teams representing numerous genetic testing clinical laboratories in qui tam investigations and settlements. 
  • Represented a $1B urban health care system in a DOJ criminal and civil investigation involving allegations of violations of the Anti-Kickback Statute and Stark Laws with respect to physician compensation, and successfully reached a comprehensive civil settlement. 
  • Represented a CEO of major Medicaid managed care company with respect to alleged fraud involving Medicaid “medical loss ratio” reporting. 
  • Represented leading solar distributed power company in False Claims Act investigation involving alleged fraud in connection with U.S. Treasury “1603” program of grants in lieu of tax credits.
  • Represented as settlement counsel Tuomey Hospital in its False Claims Act and Stark Law litigation involving physician compensation, and successfully resolved all allegations against it after two trials and appeals.
  • Represented a health care system with respect to its only known administrative proceeding by CMS alleging Stark Law violations, and successfully resolved allegations without any liability.
  • Represented national dialysis company with respect to a qui tam matter and high-profile internal investigation and whistleblower matters. 
  • Represented the United States as a DOJ official with respect to hundreds of qui tam actions nationally alleging fraud by hospitals and health systems, clinical laboratories, post-acute providers, dialysis companies, and others with respect to allegations under the False Claims Act, Anti-Kickback Statute, Stark Law, and related criminal and civil enforcement laws.
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viewpoints

On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the U.S. District Court for the District of Columbia. The lawsuit relates to J&J’s proposal to require certain 340B covered entities – specifically, disproportionate share hospitals (DSH) – that purchase J&J’s drugs Stelara and Xarelto under the 340B Drug Pricing Program to do so under a rebate model. J&J is challenging HRSA’s threatened enforcement action against the drug maker.

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The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically violated the Stark Law from 2014-2021 and “knowingly” submitted claims for hospital procedures in violation of the False Claims Act. The lawsuit was initially brought as a qui tam (whistleblower) lawsuit filed by a former Chief Compliance Officer and a former Chief Financial Officer of Erlanger. While fair market value compensation is a key criterion for most Stark Law exceptions, this lawsuit is one of the few enforcement actions initiated by the DOJ focused on fair market value compensation paid to employed physicians. This blog post covers three key takeaways from the DOJ’s allegations against Erlanger.

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The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the relator, Adam Hart, a former McKesson employee, filed a petition for certiorari seeking Supreme Court review of a Second Circuit decision that upheld the dismissal of relator’s complaint asserting claims under the civil False Claims Act (FCA) premised on alleged violations of the AKS. U.S. ex rel. Hart v. McKesson Corp., 96 F.4th 145 (2d Cir. 2024). A violation of the AKS requires as the scienter element that the defendant "knowingly and willfully" offered or paid remuneration to induce the recipient of the renumeration to purchase goods or items for which payment may be made under a federal health care program. 42 U.S.C. § 1320a-7b(b)(2). The Second Circuit held that a defendant does not act “willfully” within the meaning of the AKS unless that defendant “act[s] knowing that his conduct is unlawful.” United States ex rel. Hart, 96 F.4th at 154.

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Several case dispositions from this past year, both criminal and civil, reaffirm DOJ’s policy of ensuring individual accountability in resolving allegations of wrongdoing and underscore the importance of considering that issue in the resolution of any FCA case.

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In 2023, the Supreme Court and the US Courts of Appeals published a number of significant decisions involving FCA issues with implications for health care and life science entities, including a deepening circuit split on the causation standard applicable to FCA cases based on theories under the Anti-Kickback Statute.

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Despite the DOJ Criminal Division’s January 2023 revisions to its Corporate Enforcement Policy defining the criteria for declining to prosecute a criminal case, based on the two case examples from this past year, it is unclear how often the DOJ will actually put that policy into practice and decline or defer prosecution.

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The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. In addition to civil False Claims Act settlements, there were a number of criminal enforcement matters, including some involving politicians, government employees, and those with connections to gangs and transnational crime networks.

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In the past year, DOJ obtained some of its largest recoveries in cases where violations of the Stark Law, which bars physicians from profiting from self-referrals for certain services payable by Medicare or Medicaid, served as a predicate offense for FCA claims. These included cases against Community Health Network, Covenant Healthcare System, Cardiac Imaging, and Steward Health entities.

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As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a false claim to the government for payment. On June 1, 2023, the Court issued its highly anticipated opinion in the consolidated cases U.S. ex rel. Schutte v. SuperValu, Inc. and U.S. ex rel. Proctor v. Safeway, Inc. (SuperValu) and addressed the question of whether a defendant is liable under the FCA if its conduct is consistent with an “objectively reasonable” interpretation of ambiguous statutory or regulatory language. Justice Thomas, writing for the Court, held that an “objectively reasonable” interpretation does not provide a complete legal defense to liability under the FCA. Rather, a defendant meets the FCA’s intent (scienter) requirement if the defendant’s subjective beliefs indicate it had knowledge that its submission of claims was “false or fraudulent,” regardless of whether the defendant’s conduct could be supported by a later “objectively reasonable” interpretation of the ambiguous legal or regulatory issue. Further, the Court articulated new standards for what might constitute “deliberate ignorance” or “reckless disregard” under the “knowledge” prong of the FCA.

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News & Press

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Members Scott Lashway, Laurence Freedman, and Special Counsel Matthew Stein published an article in Bloomberg Law about how recent False Claims Act (FCA) settlements show a focus on cybersecurity enforcement. In the article, they outline how organizations with government contracts can mitigate the risk of cybersecurity-related FCA investigations and litigation. 

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187 Mintz attorneys have been recognized by Best Lawyers® in the 2025 edition of The Best Lawyers in America©. Notably, three Mintz attorneys received 2025 “Lawyer of the Year” awards, and 64 firm attorneys were included in the 2025 edition of Best Lawyers: Ones to Watch.

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Mintz announced today that 42 of its practices and 83 of its attorneys earned recognition in the 2024 edition of Chambers USA, a guide to the country’s leading law firms. Of those included in the guide, 18 attorneys and seven practice areas were awarded Chambers’ highest ranking, Band 1. The firm obtained new listings in three practice areas and 10 of its lawyers were recognized for the first time.

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Mintz is pleased to announce that 120 firm attorneys have been recognized as leaders by Best Lawyers® in the 2024 edition of The Best Lawyers in America©.

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BOSTON –Mintz announced today that 39 of its practices and 81 of its attorneys earned recognition in the 2023 edition of Chambers USA, a guide to the country’s leading law firms.

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Member Laurence J. Freedman spoke to Law360 about the growing challenges with the Anti-Kickback Statute.

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Mintz Member Laurence J. Freedman spoke to Law360 about the awaited brief from the U.S. Department of Health and Human Services on whether Anti-Kickback Statute cases should show whether health care "remuneration" intentionally impacted medical decision making.

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Mintz Member Laurence Freedman was quoted in a Law360 article exploring the U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies and how this is causing a divide in circuit courts.

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Best Lawyers® recognized 108 firm attorneys in the 2023 edition of The Best Lawyers in America©. Notably, two Mintz attorneys – Poonam Patidar and Scott M. Stanton – received 2023 “Lawyer of the Year” awards, and 28 firm attorneys were included in the inaugural edition of Best Lawyers: Ones to Watch.

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Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch, Member Laurence Freedman, Of Counsel Samantha Kingsbury, and Associates Grady Campion and Caitlin Hill co-authored the Global Overview and corresponding United States chapter of the seventh edition of Lexology’s Healthcare Enforcement & Litigation 2022. Together these pieces outlined federal enforcement priorities in 2020, including matters involving opioids, COVID-19-related fraud, Medicare, and more, and look ahead to how health care enforcement is expected to evolve in the coming year. 
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In a January 24 article published by Law360, Mintz Member Laurence J. Freedman commented on a reported plateau in filings and recoveries from cases involving the False Claims Act (FCA). In the article, he noted that “any decrease in [qui tam] filings will not affect recoveries down the road.” If the U.S. Department of Justice (DOJ)’s willingness to dismiss declined cases or the Escobar materiality standard has discouraged filings, these qui tams likely “would have been cases without fraud that would have wasted government resources to investigate."
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Mintz Members Brian Dunphy and Laurence Freedman, and Member and Co-Chair of the firm’s Health Law Practice Karen Lovitch co-authored this Law360 expert analysis article examining trends in U.S. Department of Justice health care enforcement in 2019, noting that the False Claims Act remains the government’s most powerful civil health care enforcement tool.
Member Laurence Freedman provides analysis on recent development, legal questions raised thus far, and what’s at stake in the Supreme Court's recent interest in the Intermountain Healthcare Inc. FCA case.
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This feature story discusses a False Claims Act case that has interested in Supreme Court which centers upon a hospital system’s challenging of the FCA’s constitutionality. The case further accuses the Tenth Circuit of improperly letting whistleblowers pursue cases with scant details. Mintz Member Larry Freedman is among the industry sources quoting providing commentary.

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Mintz Member Larry Freedman is quoted in this Bloomberg BNA Health Care Daily Report article on Supreme Court Justices’ search for a decision on the limits of FCA liability “when a claim for payment is submitted to the government for a service that doesn’t comply with all applicable regulations.”
Mintz is pleased to announce that eight attorneys have been named Washington, D.C. Super Lawyers for 2018 and three others have been named Washington, D.C. Rising Stars. The annual publication identifies lawyers who have attained a high degree of peer recognition and professional achievement.
Mintz Member Larry Freedman was quoted in Bloomberg Law about a new policy from the Justice Department that prevents guidance documents from being used as a basis for bringing civil enforcement actions. It may lessen the risk of catastrophic punitive damages, particularly in False Claims Act cases.
Larry Freedman was quoted in a Law 360 article regarding a new Justice Department policy that prevents guidance documents from being used as a basis for bringing civil enforcement actions. The policy may lessen the risk of catastrophic punitive damages, particularly in False Claims Act cases.
Larry Freedman and Jordan Cohen, both health care attorneys at Mintz, authored an article that was the third part of four in a series on health care enforcement trends in 2017. The series was published by Law360.
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Best Lawyers named 85 Mintz attorneys to its 2018 list of The Best Lawyers in America. In addition, Mintz attorneys Matthew J. Gardella and Samuel M. Tony Starr were named “Lawyer of the Year” in their respective practice areas.
Larry Freedman, a health care and life sciences litigator and Member in the Mintz Washington, DC office, was quoted in this Law360 article on the impact of the U.S. Supreme Court’s Escobar decision one year earlier.
Eight Mintz attorneys have been named Washington, D.C. Super Lawyers for 2017 and four have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in The Washington Post Magazine and in a stand-alone magazine, Washington D.C. Super Lawyers Magazine.
This is the third installment of a four-part series recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
Three attorneys from Mintz author the second installment of a four-part series recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
Larry Freedman, a health care and life sciences litigator and Member in the Mintz Washington, DC office, was quoted in this Bloomberg BNA Health Care Blog piece on whether regulatory compliance matters in False Claims Act (FCA) cases.
Larry Freedman, a litigator and Mintz Member, is quoted in this Law360 article covering some of the most important False Claims Act (FCA) or government contracts-related court decisions in 2016.
Larry Freedman, a health care and life sciences litigator and Mintz Member, is quoted in a Bloomberg BNA Health Care Fraud Report article on how current fraud investigations being conducted by U.S. attorneys could be impacted as the start of a new presidential administration approaches.
Best Lawyers named 73 Mintz attorneys to its 2017 list of The Best Lawyers in America. Mintz attorneys selected for inclusion in this year’s list span 44 practice areas. 
Mintz Member Larry Freedman is quoted in this Modern Healthcare article discussing the mixed reactions to U.S. Supreme Court case outcomes related to the health care industry as their current term comes to a close.
Mintz Washington, D.C. Member and health care and life sciences litigator Larry Freedman is quoted in this Bloomberg BNA Health Care Daily Report article on the Senate Finance consideration to overhaul fraud law.
Mintz Member Larry Freedman is quoted in this Bloomberg BNA Health Care Daily Report article on the U.S. Supreme Court ruling’s impact on False Claims Act liability in the Escobar case.
Mintz Member Larry Freedman is quoted in this MedPage Today article discussing the U.S. Supreme Court’s decision in the Universal Health Services v. United States ex rel. Escobar case.
Mintz Member Larry Freedman is quoted in this Bloomberg BNA Health Care Daily Report article on the Department of Justice’s increased pressure behind their demands for corporate cooperation in False Claims Act cases.
Mintz Members Larry Freedman and Chuck Samuels are quoted in this Law360 article on how the jury verdict in favor of Abbott Laboratories in its False Claims Act trial involving off-label marketing puts the defense bar on an official winning streak in these types of cases.  
Mintz Member and health care litigator Larry Freedman is quoted in this Law360 article on the U.S. Department of Justice’s efforts to “avert an eagerly anticipated ruling” from the Fourth Circuit Court of Appeals on whether statistical sampling can be used to establish False Claims Act liability.  
Mintz Members Brian Dunphy and Larry Freedman authored this BNA’s Medicare Report article discussing the long-awaited final Medicare Overpayment Rule from the Centers for Medicare & Medicaid Services.
Larry Freedman, a Mintz Member, is quoted in this BNA’s Health Care Daily Report article on the final rule as it applies to Medicare overpayments, stating providers will “be responsible for reporting and returning all overpayments identified within six years of when the overpayment was received.”
Mintz Members Hope Foster and Larry Freedman authored this Law360 column providing an overview of “some of the most important joint criminal and civil matters” impacting health care fraud enforcement from 2015 into 2016.
Mintz Members Hope Foster and Larry Freedman authored this Law360 column, the second part in a three-part series, discussing some of the more notable cases and criminal prosecutions pertaining to health care enforcement in 2015.
This column kicks off a three-part series from the Mintz Health Law team. Members Hope Foster and Larry Freedman authored this Law360 piece that recaps policy developments impacting fraud enforcement in 2015.
In this Law360 feature article, Larry provides commentary on the new guidelines for viability of False Claims Act cases after the Supreme Court’s ruling in Universal Health Services v. Escobar.  
Seven Mintz attorneys have been named Washington, D.C. Super Lawyers for 2015 and five have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in Washington Post Magazine and in a stand-alone Washington D.C. Super Lawyers Magazine.
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Events & Speaking

Speaker
Nov
18
2024

Litigating FCA Matters

Healthcare Enforcement Compliance Conference

Baltimore, MD

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Jun
15
2023

Handling Whistleblower Claims 2022 - Rights of Private Sector Employees

DC Bar Continuing Legal Education

D.C. Bar, Washington, DC

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Speaker
Nov
7
2022

Enforcement Liability and Insolvency and Bankruptcy

Health Care Compliance Association

Online Event

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Jun
22
2022

Enforcement Liability & Bankruptcy/Insolvency

ABA 32nd Annual National Institute on Health Care Fraud

Caesars Palace

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Speaker
Oct
28
2021
Webinar Reference Image
Panelist
Jun
15
2021
Webinar Reference Image
Speaker
Panelist
Nov
7
2018

HCCA's Healthcare Enforcement Compliance Conference

False Claims Act Developments

Washington, DC

Speaker
Moderator
Speaker
Panelist
Jul
12
2017
Speaker
Dec
13
2016
Speaker
May
12
2016
Moderator
Speaker
Oct
25
2015

P3 Litigating a False Claims Act Case

Healthcare Enforcement Compliance Institute

Washington, DC

Mar
13
2015

ACI's 15th Advanced Forum on Fraud & Abuse in the Sales and Marketing of Drugs

American Conference Institute

Omni Parker House, Boston, MA

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Larry has a deep understanding of what drives government enforcement actions, and how to defend against them, in the health care and life sciences industries. As a trial lawyer and then official in the Civil Fraud Section of the U.S. Department of Justice, he litigated and supervised hundreds of False Claims Act and qui tam cases nationally. In his litigation practice, Larry has successfully represented hospitals and health care systems, laboratories, pharmaceutical and device manufacturers, and health care executives against fraud and abuse allegations and investigations brought by federal and state agencies. He is consistently recognized among the nation’s leading health care defense attorneys.

Recognition & Awards

  • Best Lawyers in America: Health Care Law (2017-2025)

  • Included on the Washington DC Super Lawyers: Health Care list (2014-202, 2024)

  • Recognized by the The Legal 500 United States for Healthcare: Service Providers (2015)

  • US Attorney General’s Award for Exceptional Service (2000)

  • US Attorney General’s Award for Distinguished Service (1997)

  • DOJ Special Commendation for Outstanding Service (2003)

  • DOJ Special Achievement Awards (1997, 2000)

  • DOJ Meritorious Award (1996)

  • HHS Inspector General’s Exceptional Achievement Award (1997)

  • HHS Inspector General’s Integrity Award (1995)

  • National Association of Medicaid Fraud Control Units Award (1997, 2003)

  • Phi Beta Kappa

  • Chambers USA: District of Columbia – Healthcare (2019-2024)

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Larry has a deep understanding of what drives government enforcement actions, and how to defend against them, in the health care and life sciences industries. As a trial lawyer and then official in the Civil Fraud Section of the U.S. Department of Justice, he litigated and supervised hundreds of False Claims Act and qui tam cases nationally. In his litigation practice, Larry has successfully represented hospitals and health care systems, laboratories, pharmaceutical and device manufacturers, and health care executives against fraud and abuse allegations and investigations brought by federal and state agencies. He is consistently recognized among the nation’s leading health care defense attorneys.

Involvement

  • Officer, Board of Trustees, Temple Sinai (DC) 2021-2025
  • Member, Board of Trustees, Temple Sinai (DC) 2018 - 2025
  • Member, American Bar Association
  • Member, American Health Lawyers Association
  • BNA Health Care Fraud Report, Editorial Board Member
  • Rx Compliance Report, Advisory Board Member
  • Sinai Assisted Housing Foundation, Board Member
  • Member, Program Committee, AdvaMed 2013
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