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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 24-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

In our annual Health Care Enforcement Year in Review & Outlook report, we examine the data and explore health care enforcement trends and likely targets of government scrutiny for 2022 and beyond.
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False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021

February 2, 2022 | Blog | By Laurence Freedman, Jane Haviland

The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year ending September 30, 2021 (FY2021) – the second largest annual total recovery in False Claims Act (FCA) history.
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Senator Grassley and Others Propose Amendments to the False Claims Act

August 2, 2021 | Blog | By Samantha Kingsbury, Brian Dunphy, Laurence Freedman

Earlier this week, a bipartisan group of Senators led by Senator Chuck Grassley (R-Iowa) introduced two pieces of proposed legislation, one of which would amend the existing False Claims Act (FCA) and the other of which would amend the Program Fraud Civil Remedies Act of 1986 (the PFCRA) to create the Administrative False Claims Act of 2021 (AFCA). The AFCA would focus on smaller claims than does the FCA. Senator Grassley described the bills as being intended to “help recoup even more money by clarifying confusion after the Escobar case” and as being needed more than ever “to fight the significant amounts of fraud we are already seeing” related to the trillions of dollars Congress has appropriated for COVID relief.
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In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as “speaker programs.” The OIG’s Special Fraud Alert (Alert) highlights what it deems the “inherent fraud and abuse risks” associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs by pharmaceutical and medical device companies. The OIG expressed that is skeptical of the educational value of such programs, and thus the Alert sends a clear signal that such programs will undergo intense scrutiny under the federal Anti-Kickback Statute (AKS). OIG is using the pandemic as an opportunity to caution the pharmaceutical and medical device industry to limit or eliminate in-person speaker programs once such programs are able to resume.
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On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback Statute (AKS) and Stark Law. The settlement resolved False Claims Act allegations that were triggered by a qui tam lawsuit brought by a former vice president of Wheeling Hospital who oversaw hospital operations and physician engagements. According to the relator's complaint, Wheeling Hospital, under its former management, paid several physicians annual compensation in excess of a million dollars based on the volume or value of their referrals.
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Seventh Circuit Adds to Circuit Split Over Standard for DOJ Dismissals in FCA Cases

August 25, 2020 | Blog | By Laurence Freedman, Geoffrey Friedman, Caitie Hill

The Seventh Circuit Court of Appeals recently decided a case that created a new standard to assess requests by the Department of Justice (DOJ) to dismiss declined qui tam (whistleblower) suits under the False Claims Act (FCA). See U.S. ex rel. CIMZNHCA LLC V. UCB Inc. et al., No. 19-2273 (7th Cir. 2020). Prior to this decision, federal Courts of Appeals applied either the Sequoia Orange standard or the Swift standard, discussed below. In this decision, the Seventh Circuit opined that the standard should be informed by Federal Rule of Civil Procedure (FRCP) 41, and this standard “lies much nearer to Swift.” The Seventh Circuit also decided a key jurisdictional issue: whether the United States can appeal a denial of its motion to dismiss a declined qui tam action. Again, taking a new tack, the panel resolved this issue by construing the motion to dismiss also as a motion to intervene and construing the district court’s decision as a denial of that motion, thus obviating the need to invoke the collateral order doctrine.
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Landmark AseraCare Case Finally Ends in Settlement

March 2, 2020 | Blog | By Samantha Kingsbury, Brian Dunphy, Laurence Freedman

As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services lacking “medical necessity” violate the False Claims Act (FCA) as well as to efforts by providers to defend such cases. On Wednesday, we learned that the AseraCare case has reached its dramatic conclusion with an agreement to resolve $200 million in alleged damages for the agreed amount, as reported by AseraCare, of $1 million.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends

January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch, Nicole Henry, Clare Prober

As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care enforcement tool.  This post will give an overview of our article, which covers these issues and more in great detail.
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On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment.  Instead, there must be proof of an objective falsehood. More than three years have passed since the U.S. District Court for the Northern District of Alabama issued the series of rulings that gave rise to the Eleventh Circuit case. 
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Insys Bankruptcy Filing Immediately After Global Settlement Triggers Powerful Remedies

June 25, 2019 | Blog | By Samantha Kingsbury, Laurence Freedman

Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray.  Subsys is powerful and highly addictive fentanyl spray (administered under the tongue) that was approved by the FDA in 2012 for the treatment of persistent breakthrough pain in adult cancer patients who were already receiving, and tolerant to, regular opioid therapy.  On June 5, 2019, DOJ announced a global resolution with Insys, including criminal pleas, a Deferred Prosecution Agreement (DPA), a civil settlement agreement, and a Corporate Integrity Agreement (CIA).  Then, on June 10, 2019, Insys filed for bankruptcy protection, which triggered DOJ and HHS’s ability to upend these agreements and impose powerful criminal, civil, and exclusion remedies against Insys. While much of the coverage of this case over the last few years has focused on the high-profile prosecution and conviction of company executives (including Insys’s founder) and other employees who were accused of paying kickbacks to prescribers in exchange for increased prescriptions and increased doses of Subsys, the resolution of this case on the corporate side has proven to be equally fascinating. 
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News & Press

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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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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

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
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Panelist
Jun
15
2021
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Speaker
Panelist
Nov
7
2018

HCCA's Healthcare Enforcement Compliance Conference

False Claims Act Developments

Washington, DC

Speaker
Moderator
Speaker
Panelist
Jul
12
2017
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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 (2017-2024)

  • 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 (2019-2023)

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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

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