Melissa (Lisa) Thompson

Partner

  • Overview

    Biography

    Lisa Thompson advises companies, senior management, and their boards of directors, with a focus on the health care, life sciences and technology industries. She is a member of the firm’s Health Law Group and Data Privacy + Cybersecurity Team. She is also an arbitrator on the Commercial, Life Sciences, and Health Care panels of the American Arbitration Association and for the American Health Lawyers Association.

    Health Care, Life Sciences and Technology Industries

    Lisa represents domestic and international clients in the health care, life sciences and technology industries, including pharmaceutical companies, medical device manufacturers, biotechnology companies, hospital systems, academic medical centers, health information exchanges (HIEs) and technology services providers.  In addition, she has represented third party administrators, pharmacy benefit managers, health plans, laboratories, physician practices, pharmacies and retail pharmacy chains, among others in these industries.

    Lisa handles a range of matters, including corporate law and contracting, government investigations and audits, clinical research law, and matters involving Institutional Review Boards (IRBs). She has extensive experience representing clients on matters involving privacy and security including HIPAA, reimbursement, Medicare and Medicaid, state and federal surveys and termination actions, managed care disputes, pharmacy and compounding laws, fraud and abuse, Stark Law, anti-kickback, and federal program exclusions.

    Lisa’s life sciences experience includes U.S. Food and Drug Administration (FDA) compliance and regulatory matters, product recalls and liability claims, FDA citizen petitions and appeals, labeling review, advertising and marketing compliance, drug and medical device reimbursement, clinical research agreements, Sunshine Act compliance, and commercial contracting. Her technology sector experience includes advising on privacy and security, software licensing, data use agreements, information exchange system agreements, and regulatory requirements.

    She formerly served in-house as chief counsel for an international medical device manufacturer, as general counsel for a pharmacy benefit management company, and as corporate, privacy, and research counsel for a major academic medical center. She is a co-editor and contributor for the firm’s blog, Health Law Diagnosis.

    Administrative and Federal Court Appeals

    In addition to corporate and regulatory matters, Lisa also serves as a litigator. In this capacity, she handles administrative and federal court appeals for clients in the health care, life sciences and technology sectors. Lisa has prevailed in consolidated reimbursement appeals cases before the U.S. Department of Health and Human Services administrative law judges. She has also obtained temporary restraining orders in U.S. District Court against CMS. She has successfully helped clients resolve matters through alternative dispute resolution, and negotiated settlements with the U.S. Department of Justice, the HHS Office of Inspector General (OIG), the Centers for Medicare & Medicaid Services (CMS), and the Food and Drug Administration (FDA) on behalf of clients. Lisa also has experience with complex commercial litigation, product liability lawsuits, toxic torts and environmental litigation, class actions, shareholder suits, managed care issues, and insurance coverage disputes.

    Arbitration and Mediation

    Lisa provides mediation and arbitration services, both as an advocate and as a neutral. She is an arbitrator and mediator with the American Arbitration Association, serving on its Commercial Panel and National Healthcare Panel. She has also provided arbitration services for consultants preparing clients for arbitration. Her matters have included:

    •    International arbitrations
    •    Life sciences and health law arbitrations
    •    Commercial contract disputes
    •    Federal and state government party mediations
    •    Class actions
    •    Intellectual property and technology
    •    Product liability claims
    •    Real estate and franchise matters
    •    Partnership, employment, non-compete, and recruitment agreements
    •    Insurance coverage disputes
    •    Managed care arbitration between plans and providers
    •    Physician practice and hospital contract disputes
    •    Wrongful death and torts
     

  • Experience
    • Experience

      Experience

      • Prevailed in individual and in consolidated reimbursement appeals cases before administrative law judges for the U.S. Department of Health and Human Services.

      • Filed Stark law and excluded individual self disclosures with CMS and the Office of Inspector General (OIG) on behalf of clients.

      • Negotiated settlements with the U.S. Department of Justice, the Centers for Medicare & Medicaid Services, and state Medicaid in termination and enrollment actions, and with the HHS Office of Inspector General (OIG) in matters involving exclusions.

      • Obtained temporary restraining orders in federal court in hospital Medicare termination actions on behalf of a company that operates over 350 hospitals and ambulatory centers.

      • Handled HIPAA investigations and provided advice regarding HIPAA breaches with the Office for Civil Rights (OCR) for hospitals, physician practices, and home care companies.

      • Negotiated a favorable settlement of a criminal and civil action with the U.S. Food and Drug Administration (FDA) on behalf of an international medical device manufacturer involving allegations of violations of Good Manufacturing Practices (GMP).

      • Served as arbitrator in numerous domestic and international arbitrations in life sciences and health care industries, including managed care arbitration with claims in excess of $200 million.

    • Professional Associations

      Professional Associations

      Boston Bar Association
      Co-chair, Health Law Section (2019)
      Steering Committee, Health Law Section

      American Arbitration Association
      Commercial Arbitration Panel
      National Health Care Arbitration Panel and Life Sciences Panel
      Life Sciences Advisory Committee Member
      AAA Mediator Panel

      Boston International Arbitration Council
      Advisory Board Member

      American Health Lawyers Association
      Life Sciences Section
      Fraud and Abuse Section
      Hospitals and Health Systems Section
    • Community Involvement

      Community Involvement

      Boston Bar Foundation Society of Fellows
      Member

      American Arbitration Association / International Centre for Dispute Resolution (AAA-ICDR) Foundation
      Chair's Circle and Founding Donor

      Go Red for Women, American Heart Association, Southern New England
      Executive Leadership Team (2016 - 2018)
  • NEWS + PRESS
    • Publications

      Publications

      "CMS Revises Process for Reporting Stark Law Violations," blog post from Health Law Diagnosis (4/4/2017)

      "21st Century Cures Act – Implications for Investigators and Research Sites," blog post from Health Law Diagnosis (2/15/2017)

      "Clearing Up Confusion Over the Modified HIPAA Privacy Rule," published in Information Counts (February 2016)

      "HIPAA and Text Messaging," published in Information Counts (November 2015)

      "Update on Fraud and Abuse, chapter in the Health Law Handbook," co-authored with C. Martin and published by Thomson Reuters (2011 and 2012)

      "Medicare Termination: How to Get out of the Frying Pan and Avoid the Fire," co-authored with Louise Joy, AHLA white paper (2011)

      "Recovery Audit Contractor (RAC) Appeal Strategies," published in the American Health Lawyers Association (AHLA) Regulation, Accreditation and Payment Practice Group RAP Sheet (June 2010)

      "Accreditation, Licensure, Certification, and Surveying Bodies, chapter in the Risk Management Handbook for Health Care Organizations," co-authored with R. Robinson and published by the American Society for Healthcare Risk Management (2010)

      "Medicare Termination: It Could Happen to You," co-authored with Dan Peterson, AHLA Connections (August 2009)

    • Presentations

      Presentations

      "Data Sharing Across the Health Care Industry," presented as a panelist at the Boston Bar Association's Health Care Conference. (5/30/2019)
      • » more info

      "The Complexities of International & Domestic Life Sciences Disputes," (May 1, 2019)
      • » more info

      "Health Care Provider-Payor Dispute Resolution—Techniques and Strategies," faculty for Massachusetts Bar Association program in Boston, Massachusetts (9/25/2018)
      • » more info

      "Data Governance: Essential Practices for Data Governance in Healthcare," Global Cyber Institute Webinar (6/11/2018)

      "Managing Dispute Risk in Business Agreements," presentation at the Massachusetts Bar Association (5/22/2018)

      "Arbitration: Important Things You Didn't Know You Didn't Know," Robinson+Cole Webinar (11/1/2017)
      • » more info

      "Oversight of HIPAA Business Associates," webinar (9/7/2017)
      • » more info

      "Cybersecurity for Medical Devices," panel presentation co-sponsored by Robinson+Cole, the Biomedical Engineering Alliance and Consortium (BEACON), and Court Square Group (CSG). (6/1/2017)
      • » more info

      "Self Disclosures: Navigating the OIG and CMS/Stark Law Self Disclosure Protocols," Annual Health Law Symposium, Massachusetts Bar Association (04/13/2017)

      "Navigating Voluntary Self-Disclosure Protocols," Robinson+Cole Webinar (4/19/2017)
      • » more info

      "Arbitration in Long Term Care, the CMS Regs and their Aftermath," at the Massachusetts Bar Association (11/2016)

      "HIPAA Policies and Procedures for Business Associates," presented at the NNRC Meeting (June 2016)

      "HIPAA for Court Reporters," presented at the NNRC Meeting (June 2016)

      "Security Risk Analysis," presented to Medical Mutual physician insureds (June 2015 and October 2015)

      "Payment and Reimbursement," presented to the American Bar Association, Health Law Section (February 2014)

      "HIPAA Compliance Audits: Are you Prepared?" presented at the HIM Conference, HealthPort (July 2012)

      "Medicare and Medicaid Enrollment Under Heightened CMS Scrutiny, Best Practices to Obtain and Maintain Enrollment," presented via teleconference for Strafford Publications (April 2011)

      "Accountable Care Organizations," presented at Emerging Programs and Models for Medicare Care Management, Financial Research Associates in Orlando, Florida (February 2011)

    • News

      R+C in the News

      • May 31, 2019

        Lisa Thompson Addresses Boston Bar Association's Health Care Conference

        • » more info
      • May 15, 2019

        Lisa Thompson Presents on "The Complexities of International & Domestic Life Sciences Disputes," American Arbitration Association (May 1, 2019)

        • » more info
      • February 8, 2019

        Boston Office Attends Annual John & Abigail Adams Benefit Ball

      • September 26, 2018

        Lisa Thompson Presents MassBar Program on Health Care Provider-Payor Dispute Resolution

        • » more info
      • September 15, 2017

        Lisa Thompson and Pam Del Negro Present Webinar on HIPAA

        • » more info
      • June 7, 2017

        Robinson+Cole Sponsors Panel Discussion on Cybersecurity for Medical Devices

        • » more info
      • May 5, 2017

        Health Law Group Lawyer Presents on Voluntary Self-Disclosure Protocols

        • » more info