Laura F.Laemmle-Weidenfeld

Partner

Washington + 1.202.879.3496

Drawing on her extensive experience defending clients against health care fraud enforcement actions, Laura Laemmle-Weidenfeld also provides practical compliance advice on federal and state health care fraud and abuse issues. She has defended against numerous investigations and litigation brought by the Department of Justice (DOJ), various U.S. Attorneys offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), state attorneys general, and other state and federal agencies. Laura also helps clients navigate challenging compliance issues, including analyzing arrangements under the Stark Laws and Anti-Kickback Statute (AKS), conducting internal investigations, and preparing self-disclosures.

Laura has represented a broad spectrum of health care providers, including hospitals and health systems, home health care agencies, telehealth providers, physician practices, clinical laboratories, post-acute care providers, and pharmacies, as well as pharmaceutical and medical device manufacturers and electronic health record software developers.

Earlier in her career, Laura served as a trial attorney in the Frauds Section of DOJ's Civil Division, where she conducted health care fraud investigations and litigation matters brought under the False Claims Act (FCA) and its whistleblower (or qui tam) provisions. While at DOJ, she focused largely on FCA matters alleging violations of AKS, Stark Laws, and the Federal Food, Drug, and Cosmetic Act.

An active member of the American Health Lawyers Association (current member, editorial board, Journal of Health & Life Sciences Law; chair, Fraud and Abuse Practice Group, 2014-2017) and Law360's health editorial advisory board, Laura frequently speaks and writes on health care fraud issues.

Experience

  • MEDHOST obtains dismissal of qui tam action relating to alleged false claims under HITECH ActJones Day obtained a dismissal on behalf of MEDHOST, Inc. (a developer of electronic health record ("EHR") software) in a qui tam False Claims Act action.
  • National diagnostic clinician network expands telehealth programming in response to COVID-19 public health crisisJones Day represented a national diagnostic clinician network in their expansion of telehealth programming in response to the COVID-19 public health crisis.
  • Leading specialty telemedicine organization launches novel telemedicine-oriented revenue cycle management offeringJones Day provided health regulatory counsel to one of the Nation’s leading specialty telemedicine organizations for its innovative reimbursement, enrollment, contracting, compliance policies, data privacy, and billing arrangements regarding specialty telemedicine services across the U.S.
  • Former executive of medical device manufacturer obtains criminal and civil declination in federal investigationJones Day successfully represented a former executive who was criminally and civilly targeted in a parallel investigation conducted by the U.S. Attorney's Office for the District of Maryland, the Department of Justice Civil Frauds Section, and the Department of Justice Consumer Protection Branch.
  • Individual obtains declination in investigation without settlement paymentJones Day successfully represented a former executive of a rehabilitation hospital chain who was personally targeted in a civil False Claims Act case involving alleged violations of the Federal Anti-Kickback Statute and Stark Law by the hospital chain and its executives.
  • Pain practice obtains favorable resolution of civil investigationJones Day successfully represented a pain management practice in obtaining a favorable settlement and dismissal of a False Claims Act case by the U.S. Attorney's Office for the Eastern District of Virginia.
  • Medical device manufacturer secures declination and dismissal of FCA complaint without any settlement paymentJones Day represented a medical device manufacturer in a False Claims Act case involving whether the company violated the Federal Anti-Kickback Statute.
  • Emerging digital health company launches multi-state telehealth platformJones Day advised an emerging digital health company in launching its telehealth operations in multiple states throughout the U.S., with additional expansion to come.
  • Large digital health company grows operations across U.S.Jones Day advised a large digital health company in expanding operations throughout multiple states in the U.S. and in responding to several state regulator inquiries regarding its operations.
  • California hospital obtains dismissal of qui tam actionJones Day successfully defended a California healthcare district and hospital against an investigation conducted by the U.S. Attorney's Office for the Northern District of California, the Department of Justice Civil Frauds Section, the California Office of the Attorney General, and the Health and Human Services/Office of Inspector General.
  • Jefferies finances AMAG Pharmaceuticals' acquisition of Cord Blood Registry®Jones Day advised Jefferies Finance LLC, as administrative agent, collateral agent, joint lead arranger and joint bookrunner, and Jefferies LLC, as representative of the initial purchasers, in connection with the $850 million in financing provided to AMAG Pharmaceuticals, Inc., a specialty pharmaceutical company with a focus on maternal health, anemia, and cancer supportive care, to finance a portion of its acquisition of Cord Blood Registry® (CBR®), a large stem cell collection and storage company.
  • Jefferies and Barclays complete $231 million public offering of Common Stock by AMAG PharmaceuticalsJones Day advised Jefferies LLC and Barclays Capital Inc., as representatives of the underwriters, in connection with the $231 million public offering of Common Stock by AMAG Pharmaceuticals, Inc., a specialty pharmaceutical company with a focus on maternal health, anemia, and cancer supportive care.
  • Home healthcare provider successful in qui tam actionJones Day successfully represented a home healthcare provider in Indiana in defending against an investigation conducted by the U.S. Attorney's Office in the Northern District of Indiana, the Office of the Indiana Attorney General, and the Health and Human Services Office of Counsel to the Inspector General in connection with a qui tam action filed by a former employee of our client.
  • The following represents experience acquired prior to joining Jones Day.

    On behalf of multiple affiliated not-for-profit skilled nursing facilities, successfully resolved a False Claims Act quality-of-care investigation by negotiating a False Claims Act settlement with the Department of Justice on an ability-to-pay basis and negotiating a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General, in an investigation conducted by the U.S. Attorney's Office for the District of Maryland and the State of Maryland Office of the Attorney General.

    Successfully represented a hospital in an investigation by the U.S. Department of Health and Human Services Office of Inspector General, which resulted in that office's declination of the matter.

    Successfully represented a national home health care provider in a parallel civil False Claims Act and criminal investigation led by the U.S. Attorney's Office in Newark, New Jersey and negotiated a global resolution in which the company entered into a Deferred Prosecution Agreement and civil settlements with the United States and more than 30 states, as well as a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General.

    Filed successful motion in the Eastern District of Michigan to dismiss a complaint alleging False Claims Act violations by a dialysis provider in connection with the quality of care provided to Medicare and Medicaid patients.

    Filed successful motion in the Middle District of Florida to dismiss a complaint alleging False Claims Act violations in connection with marketing practices allegedly undertaken by a for-profit provider of higher education.

    Filed successful motion in federal district court in the District of Columbia to dismiss a complaint against small business subcontractor alleging False Claims Act violations relating to contract for provision of IT services to the United States Customs and Immigration Services.

    On behalf of individual dermatologist, assisted in successfully negotiating a False Claims Act resolution in a matter involving alleged violations of the Anti-Kickback Statute.

    Filed successful motions in the Western District of Wisconsin to dismiss a government complaint alleging False Claims Act violations by a pharmacy chain in connection with Medicaid billings for prescription drugs provided to consumers with primary private insurance coverage.

    Represented an individual consultant who provided FDA-related assistance to a start-up medical device manufacturer, in an investigation by the U.S. Attorney's Office in Boston, Massachusetts, under the False Claims Act and the Federal Food, Drug, and Cosmetic Act, which the U.S. Attorney's Office ultimately declined to pursue.

    On behalf of a well-known nationwide DME (durable medical equipment) provider, successfully resolved False Claims Act litigation relating to marketing practices by negotiating a civil settlement with the Department of Justice and a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General.

    Successfully defended a national home health care provider against a criminal investigation by a state attorney general's office, ultimately obtaining a formal declination of the matter, which related to Medicaid billing concerns.

    Additional Publications

    September 2013

    How Not to Go Down in Flames with Your Client in Fraud Matters: Compliance with the Ethical Rules is Not Enough!, coauthor, American Health Lawyers Association/Health Care Compliance Association Fraud and Compliance Institute Course book

    2013

    Navigating the Complexities of Health Care Law Enforcement and Compliance, Inside the Minds: Health Care Law Enforcement and Compliance, 2013 ed., Aspoatore Books 

    Spring 2013

    The Intersection of the Stark Law and Medicaid Claims: Catching Providers in a Legal Quagmire, coauthor, AHLA Connections

    March 2013

    Coronia: The Anticipated Effect on Off-Label Cases, American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues coursebook

    February 20, 2013

    Negotiating a Criminal Settlement in a Health Care Case, coauthor, BNA Health Care Fraud Report

    December 2012

    Manufacturer Liability Under the False Claims Act Based on Violations of Other Statutes: No Relief in Sight, Practising Law Institute, Health Care and Life Sciences Law 2012 conference coursebook

    June 2012

    The Intersection Between the Civil False Claims Act and the 60-Day Overpayment Rule, coauthor, American Health Lawyers 2012 Annual Meeting coursebook

    May 2012

    Supreme Court Continues Status Quo on FCA ‘Implied Certification’ Theory, American Health Lawyers Association Fraud and Abuse Newsletter, Vol. I, Issue 2

    November 2009

    In-House Counsel Beware: The False Claims Act May Impact Your Business, coauthor, ACC Docket

    Speaking Engagements

    • March 20-22, 2019
      Institute on Medicare and Medicaid Payment Issues
    • 12/12/2018
      Hot Topics in Health Care Law 2018, Enforcement Trends in Health Care Law -- Overview and Lessons Learned in 2018
    • September 26-28, 2018
      Fraud and Compliance Forum
    • May 22-23, 2018
      American Conference Institute’s (ACI) Life Sciences & Healthcare Qui Tam and False Claims Summit
    • March 21-23, 2018
      Institute on Medicare and Medicard Payment Issues, AHLA
    • December 14, 2017
      PLI's Health Care Law Institute 2017
    • October 4-6, 2017
      Fraud and Compliance Forum, AHLA
    • June 26-28, 2017
      Modern Ethics Rules for Attorneys Managing Internal and Government Investigations and Litigation, panelist, AHLA Annual Meeting
    • April 4, 2017
      Fraud and Abuse Advanced Enforcement, Part I: Advanced Tactics and Strategies for Handling FCA Actions (Advanced)
    • March 29-31, 2017
      Hot Topics in Health Care Fraud and Abuse, panelist, AHLA Medicare and Medicaid Payment Institute
    • March 26, 2017
      Anatomy of a False Claims Act Case, panelist, Health Care Compliance Association's 21st Annual Compliance Institute
    • December 13, 2016
      PLI's Health Care Law Institute 2016: Emerging Challenges and Trends in Reimbursement, Enforcement, Compliance and other Hot Topics
    • November 2, 2016
      PLI's Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries
    • October 25, 2016
      Negotiating and Surviving a Corporate Integrity Agreement, panelist, Health Care Compliance Association's Healthcare Enforcement Compliance Institute
    • October 6-7, 2016
      The Lifecycle of a CIA: How to Get Started, Survive and Thrive, panelist, AHLA Fraud and Compliance Forum
    • September 29, 2016
      Successfully Mediating Healthcare False Claims Act Cases, panelist
    • May 4, 2016
      Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
    • April 17, 2016
      20th Annual Compliance Institute, Health Care Compliance Association
    • April 13-14, 2016
      Institute on Medicare and Medicaid Payment Issues, AHLA
    • January 21, 2016
      The Year in Review - What Recent Cases Reveal about Future False Claims Act Litigation, panelist, American Conference Institute's 3rd Annual Executive Forum on False Claims & Qui Tam Enforcement
    • November 11, 2015
      Compliance Programs and Investigations, panelist, Health Care Law Institute 2015: Emerging Challenges and Trends in Reimbursement, Enforcement and Other Hot Topics
    • October 28, 2015
      Effective Compliance Programs and Investigations: A Hypothetical, panelist, PLI's Life Sciences 2015: Navigating Legal Challenges in the Drug and Device Industries
    • October 25, 2015
      Anatomy of False Claims Act Case: Investigation, Negotiation, Resolution, panelist, Health Care Compliance Association's 2015 Healthcare Enforcement Compliance Institute
    • September 28-29, 2015
      Managed Care: Fraud and Abuse's New Frontier. panelist, American Health Lawyer's Association Fraud and Compliance Forum
    • May 15, 2015
      Anatomy of an Internal Investigation and its Aftermath, panelist, Health Care Compliance Association Regional Conference
    • May 13-15, 2015
      Litigating False Claims Act Cases, moderator, American Bar Association's 25th Annual National Institute on Health Care Fraud
    • March 25-27, 2015
      Recent Developments in Fraud and Abuse Enforcement, moderator, American Health Lawyers Association's Institute on Medicare and Medicaid Payment Issues
    • January 21-22, 2015
      Inside the Most Significant Legal Issues Arising from False Claims Act Litigation, panelist, American Conference Institute's 2nd Advanced Forum on False Claims Act and Qui Tam Enforcement
    • January 16, 2015
      Legal Perspectives Essential to Reimbursement, American Telemedicine Association
    • October 24, 2014
      Effective Compliance Programs and Investigations: A Hypothetical, Practising Law Institute's Health Care and Life Sciences Law 2014
    • October 6-7, 2014
      Tips on Negotiating and Then Living Under a CIA, panelist, American Health Lawyers Association Fraud and Compliance Forum

    Speaking Engagements Prior to Jones Day

    March 26-27, 2014

    Recent Developments in Fraud and Abuse Enforcement, panelist, American Health Lawyers Association’s Institute on Medicare and Medicaid Payment Issues

    Baltimore, MD

    January 28, 2014

    FCA and Qui Tam Settlement Strategy Session: The Finer Points for Determining When to Engage in Settlement Discussions, and How to Negotiate with Federal and State Authorities, panelist, ACI Executive Forum on False Claims and Qui Tam Enforcement

    New York, New York

    October 4, 2013

    Enforcement Trends, panelist, Practising Law Institute’s Health Care and Life Sciences Law 2013

    New York, NY

    September 30-October 1, 2013

    Legal Ethics: How Not to Go Down in Flames with Your Client, panelist, American Health Lawyers Association/Health Care Compliance Association’s Fraud and Compliance Forum

    Baltimore, MD

    July 1-3, 2013

    Fraud and Abuse: Hot Topics, panelist, American Health Lawyers Association’s Annual Meeting

    San Diego, CA

    April 21-24, 2013

    Navigating the OIG’s Self-Disclosure Protocol, panelist, Health Care Compliance Association’s 17th Annual Compliance Institute

    National Harbor, MD

    April 18-19, 2013

    Litigating Under the False Claims Act, panelist, CLE International’s False Claims Act and Qui Tam Conference

    San Francisco, CA

    March 20-22, 2013

    Evolving Fraud and Abuse Issues, panelist, American Health Lawyers Association’s Institute on Medicare and Medicaid Payment Issues

    Baltimore, MD

    June 26-27, 2012

    Fraud and Abuse Year in Review: Hot Topics, panelist, American Health Lawyers Association’s Annual Meeting

    Chicago, IL

    June 6-8, 2012

    Investigation of a False Claims Act Case, panelist, American Bar Association’s Ninth National Institute on the Civil False Claims Act and Qui Tam Enforcement

    Washington, DC

    September 27, 2011

    Settling False Claims Act Cases in the Healthcare Fraud and Enforcement World: Tips and Traps for Providers and Payors, panelist, American Health Lawyers Association’s Fraud and Compliance Forum

    Baltimore, MD

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