Laura F.Laemmle-Weidenfeld

Partner

Washington + 1.202.879.3496

For more than 25 years, Laura Laemmle-Weidenfeld has successfully defended a broad spectrum of health care providers, digital health entities, distributors, and pharmaceutical and medical device manufacturers against health care fraud enforcement actions brought by the U.S. Department of Justice (DOJ), U.S. Attorney's Offices, private whistleblowers, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and state attorneys general. Earlier in her career, she led health care False Claims Act (FCA) investigations and litigation, including those brought under the FCA's qui tam (whistleblower) provisions, at the DOJ's Civil Division.

Laura also draws on her enforcement experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Physician Self-Referral Law (Stark Law), Anti-Kickback Statute (AKS), and FCA, and their state analogs. In addition, Laura helps clients conduct internal investigations, prepare and negotiate self-disclosures to regulators including HHS-OIG and the Centers for Medicare and Medicaid Services (CMS), and obtain advisory opinions from HHS-OIG. She also helps clients negotiate corporate integrity agreements (CIAs) with HHS-OIG and counsels clients on creating and maintaining effective compliance programs.

Laura frequently writes and speaks on health care enforcement issues, is an active member of the American Health Law Association (AHLA) (chair, Fraud and Abuse Practice Group, 2014-2017; member, Planning Committee for the 2023 Fraud and Compliance Forum), and is the author of Legal Issues in Health Care Fraud and Abuse, Fifth Edition, and its annual supplements, published by the AHLA.

Experiencia

  • Hospital obtains favorable advisory opinion from HHS-OIG regarding use of nurse practitionersJones Day successfully advised a hospital in obtaining a favorable advisory opinion (Advisory Opinion 22-20) from the Department of Health and Human Services, Office of Inspector General, in connection with its utilization of its employed nurse practitioners to perform services that traditionally have been performed by attending physicians.
  • Home health agency manager avoids exclusion proceedingsJones Day successfully defended a mid-level home health agency manager at a Florida home health agency against the threat of exclusion proceedings by the Department of Health and Human Services Office of Inspector General (HHS-OIG), which alleged that she had participated in the payment of kickbacks to referring physicians.
  • Medical device manufacturer receives favorable advisory opinion from HHS-OIGJones Day advised a durable medical equipment device manufacturer in obtaining a favorable advisory opinion (Advisory Opinion 22-13) from the Department of Health and Human Services, Office of Inspector General, in connection with its offering of zero-interest financing to qualified customers.
  • Nurx merges with Thirty MadisonJones Day provided healthcare and data privacy counsel to Nurx in connection with its merger with Thirty Madison, a leading digital healthcare company operating across the U.S.
  • Hospice provider resolves criminal and civil DOJ investigationJones Day represented a Midwest based hospice provider in a multi-year, federal criminal and civil investigation of its Medicare billing practices.
  • Pharmaceutical distributor successfully resolves False Claims Act investigationJones Day advised a pharmaceutical distributor in obtaining a favorable settlement of two qui tam actions under the False Claims Act investigated by the U.S. Attorney's Office for the District of Massachusetts.
  • Genesis Healthcare Partners creates partnership with Triton Pacific Capital Partners to form Urology Partners of AmericaJones Day represented Genesis Healthcare Partners, P.C., a large San Diego-based physician group specializing in comprehensive urologic care, including radiation oncology and gastroenterology, in its sale to Urology Partners of America, LLC, a newly-formed national urology platform backed by Triton Pacific Capital Partners.
  • PWNHealth and Home Access Health Corporation sold to Everlywell, forming Everly HealthJones Day advised PWNHealth LLC and Home Access Health Corporation in its sale to Everlywell, a leading digital health company, and forming Everly Health.
  • Associated Urological Specialists sold to Solaris Health Holdings, LLCJones Day advised Associated Urological Specialists, LLC, a large Chicago-based physician group specializing in comprehensive urologic care, including radiation oncology, pathology, and pharmacy, in its sale to Solaris Health Holdings, LLC, a leading national urology platform backed by Lee Equity Partners.
  • Digital health companies, specialty hospitals, and health systems maintain compliance with multistate requirements through 50-state surveyJones Day is representing digital health companies, specialty hospitals, and health systems in maintaining compliance with multistate requirements through a regularly updated, extensive 50-state survey on state laws and regulations applicable to telehealth activities of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
  • Cleveland Clinic acquires Mercy Medical CenterJones Day advised Cleveland Clinic in its acquisition of Mercy Medical Center from the Sisters of Charity Health System.
  • Medical device manufacturer obtains successful resolution of multiple government investigationsJones Day successfully represented a medical device manufacturer in obtaining a combined settlement of qui tam False Claims Act cases filed in four federal districts, which alleged violations of the federal health care Anti-Kickback Statute.
  • Direct lender provides $84 million financing to healthcare companyJones Day advised a direct lender, as administrative agent and sole lead arranger, in connection with a $76.5 million senior secured term loan facility and $7.5 million senior secured revolving loan facility provided to a healthcare company.
  • 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.
  • 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.

    Publicaciones adicionales

    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

    Ponencias

    • September 28, 2023
      Speaker, "Joint Ventures Guidance Going on 30 Years - Where Do We Go From Here?" American Health Law Association, Fraud and Compliance Forum 2023
    • September 14, 2023
      Speaker, "Effective Life Sciences Compliance Programs and Investigations," Practising Law Institute, Life Sciences 2023: Navigating Legal Challenges in Drug and Device Industries
    • March 22, 2023
      Speaker, "Fraud and Abuse Hot Topics," American Health Law Association, Institute on Medicare and Medicaid Payment Issues 2023
    • December 8, 2022
      Speaker, "Enforcement Trends in Health Care Law - Lessons Learned in 2022," Practising Law Institute, Hot Topics in Health Care Law 2022
    • November 7-9, 2022
      Panelist, "Anatomy of a False Claims Act Case," Health Care Compliance Association, Healthcare Enforcement Compliance Conference
    • September 28, 2022
      Speaker, "Effective Compliance Programs and Investigations: A Hypothetical," Practising Law Institute, Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries
    • September 28-30, 2022
      Speaker, "Current State of Telehealth Enforcement," American Health Law Association, Fraud and Compliance Forum
    • September 13, 2022
      Speaker, "Ethical Issues in Qui Tam Investigations," American Bar Association, 2022 Virtual Civil False Claims Act and Qui Tam Enforcement Institute
    • June 27-29, 2022
      Speaker, "Telemedicine Post-COVID: Where Are We and What's Next?" American Health Law Association, Annual Meeting 2022
    • June 22-24, 2022
      Panelist, "False Claims Act Developments," American Bar Association, Health Care Fraud 2022
    • March 23-25, 2022
      Speaker, "Hot Topics in Fraud and Abuse," American Health Law Association, Institute on Medicare and Medicaid Payment Issues 2022
    • December 9, 2021
      Speaker, "Enforcement Trends in Health Care Law - Lessons Learned in 2021," Practising Law Institute, Hot Topics in Health Care Law 2021
    • December 7-9, 2021
      Panelist, "Dispelling Myths in Telehealth," American Telemedicine Association, EDGE2021
    • October 5, 2021
      Speaker, "Effective Compliance Programs and Investigations," Practising Law Institute, Life Sciences 2021: Navigating Legal Challenges in Drug and Device Industries
    • September 21-22, 2021
      Speaker, "EKRA: Enforcement Trends and Future Projections," American Health Law Association, Fraud and Compliance Forum Program 2021
    • March 24-26, 2021
      Speaker, "Hot Topics in Fraud and Abuse," American Health Law Association, Institute on Medicare and Medicaid Payment Issues 2021
    • October 13, 2020
      Speaker, "Effective Compliance Programs and Investigations," Practising Law Institute, Life Sciences 2020: Navigating Legal Challenges in Drug and Device Industries
    • September 30-October 2, 2020
      Speaker, "Managing Fraud and Abuse Challenges in Telehealth," American Health Lawyers Association, Fraud and Compliance Forum
    • December 11, 2019
      Speaker, "Enforcement Trends in Health care Law - Lessons Learned in 2019," Practising Law Institute Hot Topics in Health Care Law 2019
    • October 10, 2019
      Speaker, "Effective Compliance Programs and Investigations: a Hypothetical," Practising Law Institute, Life Sciences: Navigating Legal Challenges in Drug and Device Industries 2019
    • September 25-27, 2019
      Speaker, "Fraud and Abuse in Telehealth," American Health Lawyers Association, Fraud and Compliance Forum 2019
    • March 20-22, 2019
      Panelist, "Hot Topics in Fraud and Abuse," American Health Lawyers Association, Institute on Medicare and Medicaid Payment Issues 2019
    • 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
      Speaker, "Fraud and Abuse Issues in Telehealth," American Health Lawyers Association, Fraud and Compliance Forum 2018
    • May 22-23, 2018
      Panelist, "Settling False Claims Act Cases and Considerations for Potential Follow-on Litigation," American Conference Institute, 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
    • 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