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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

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.
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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.
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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?
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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?
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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.
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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. 
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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.
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Tenth Circuit Rejects Request for Rehearing in Closely Watched FCA Medical Necessity Case

November 13, 2018 | Blog | By Samantha Kingsbury, Laurence Freedman

In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by submitting a claim for reimbursement and certifying the medical necessity of the charged service, providers also certify that the claim meets all of the standards set forth in the Medicare Program Integrity Manual (MPIM).
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All-Payor Kickback Statute Included in the Recently Passed Opioid Legislation Applies Broadly to Laboratories

November 12, 2018 | Blog | By Karen Lovitch, Laurence Freedman, Benjamin Zegarelli

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious effects of opioid abuse – contains an all-payor kickback prohibition that applies to laboratories, recovery homes, and clinical treatment facilities.   
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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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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

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Moderator
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Panelist
Jul
12
2017
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Dec
13
2016
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May
12
2016
Moderator
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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 (2014-2020)

  • 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 – 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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