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Laurence J. Freedman

Member

[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.
 

Education

  • Yale University (JD)
  • Colgate University (BA, magna cum laude)

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. 
     

Recognition & Awards

  • Included on the Washington DC Super Lawyers: Health Care list (2014 - 2019)
  • Best Lawyers in America: Health Care Law (2017 - 2020)
  • 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 (Band 3) – Healthcare (2019)

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

Viewpoints

Viewpoint General
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. 
Viewpoint General

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. 
Viewpoint General
On June 3, 2019, the U.S. Supreme Court issued a decision in Azar v. Allina Health Services. The case involved a challenge by hospitals over whether the Department of Health and Human Services (“HHS”) was required to proceed through notice-and-comment rulemaking before promulgating a retroactive Medicare rate calculation methodology for Disproportionate Share (DSH) payments to hospitals. In a 7-1 decision by Justice Gorsuch, the Court ruled in favor of the hospitals, holding that the new rate calculation established a substantive legal standard, and therefore notice-and-comment was required under the Medicare Act.
Viewpoint General

DOJ Issues Guidance on Cooperation Credit in FCA Settlements

May 10, 2019 | Blog | By Jane Haviland, Laurence Freedman

The U.S. Department of Justice (DOJ) issued policy guidance on May 6, 2019, about providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation." DOJ has never previously issued guidance regarding credit in FCA matters. This guidance, coupled with the passage of the Tax Cuts and Jobs Act in 2017 (which requires DOJ to specify the amount of “restitution” or “remediation” at the time of settlement), provides meaningful specificity as to what conduct constitutes disclosure, cooperation, and remediation, as well as data for evaluating whether credit is actually reflected in negotiated FCA settlements. This policy guidance is contained in the Justice Manual, Section 4-4.112.
Viewpoint General
On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus must be issued through formal rulemaking. As discussed in our prior post, the Court is reviewing the U.S. Court of Appeals for the D.C. Circuit’s decision that threw out a Medicare rate calculation methodology for Disproportionate Share Payments (DSH) to hospitals adopted by the U.S. Department of Health and Human Services (HHS) for its failure to undergo notice and comment rulemaking. During oral arguments, the Court grappled with a broader question: what is the legal standard for when HHS must use formal rulemaking and not “interpretative” instructions to its contractors in the administration of the Medicare program?
Viewpoint General
On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus must be issued through formal rulemaking.  In Azar v. Allina Health Services, the Court will review the U.S. Court of Appeals for the D.C. Circuit’s decision that threw out a new Medicare rate calculation methodology for Disproportionate Share Payments (DSH) to hospitals adopted by the U.S. Department of Health and Human Services (HHS) because the agency promulgated it through “interpretative guidance” but failed to undergo notice-and-comment rulemaking. The Supreme Court is now tasked with answering a broader question: what is the legal standard for when HHS must use formal rulemaking and not “interpretative” instructions to its contractors in the administration of the Medicare program?
Viewpoint General

Health Care Enforcement Year in Review and 2019 Outlook: Civil Litigation Developments and Settlements

January 11, 2019 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch

As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators, including 645 new qui tam actions initiated in FY 2018.
Viewpoint General
Last year, as we previously discussed, there were two significant Department of Justice (DOJ) policy developments that are applicable to False Claims Act (FCA) litigation: (1) the “Granston Memo” (issued by DOJ Civil Fraud Director Michael Granston), which set forth direction for DOJ’s exercise of its authority to dismiss declined qui tam FCA cases; and (2) the “Brand Memo” (issued by Associate Attorney General Rachel Brand), which instructed DOJ’s FCA litigators not to use any sub-regulatory guidance to create legal obligations. 
Viewpoint General

DOJ Follows Through on a 2018 New Years’ Resolution: Rein In Qui Tam Actions

December 20, 2018 | Blog | By Laurence Freedman, Bridgette Keller

Along with most of us, last January DOJ set its own goals for 2018: new policies related to False Claims Act (“FCA”) enforcement. One such “resolution” for 2018 was the DOJ Civil Fraud section’s instruction to its attorneys and all AUSAs handling FCA cases to routinely consider whether declined qui tam actions should be dismissed under the Department’s authority in Section 3730(c)(2)(A) of the FCA, which it had rarely used from 1986 through 2017. Known as the “Granston Memo” (which we discuss here) and now codified in the Justice Manual, the central theme of the instruction is that seeking dismissal of qui tam actions may be in the government’s interest to “preserve limited resources and avoid adverse precedent.” We are now seeing the first evidence of DOJ following through on that resolution.

News & Press

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.
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.

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.
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.

Does Regulatory Compliance Matter in False Claims Act Cases?

December 29, 2016 | https://www.bna.com/regulatory-compliance-matter-b73014449144/ Bloomberg BNA Heath Care Blog

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.

U.S. Attorney Changes Mean Opportunities for Fraud Defendants

September 7, 2016 | http://healthlawrc.bna.com/hlrc/4231/split_display.adp?fedfid=96842311&vname=hfranotallissues&jd=a0k0x5n8x3&split=0 Bloomberg BNA Health Care Fraud Report

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 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 U.S. Supreme Court ruling’s impact on False Claims Act liability in the 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.

Events

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