Ann T.Hollenbeck

Partner

Detroit + 1.313.230.7960

Ann Hollenbeck is an experienced health care lawyer who advises health care industry clients on telehealth, reimbursement, pharmacy/340B, human subjects research, and fraud and abuse matters. She advises academic medical centers and health systems on clinical and research affiliations, faculty and physician compensation, and effort reporting. Ann also represents health care entities and telehealth platforms in transactional matters such as ancillary services and pharmacy arrangements, joint ventures, and physician-hospital relationships, such as co-management arrangements. She regularly advises health care entities regarding the negotiation of clinical trial-related agreements, including virtual clinical trials, and related regulatory matters, such as Medicare reimbursement and institutional review board responsibilities.

Ann's recent experience includes advising providers on threatened whistleblower claims, collaborating with in-house legal and compliance personnel to assess Medicare reimbursement irregularities in the clinical research arena, and disclosing facts and circumstances of compliance challenges to federal agencies.

Ann previously served as assistant general counsel at the University of Michigan. She is a Fellow of the Michigan State Bar Foundation and a member of the American Health Lawyers Association and of the State Bar of Michigan (former chair, Health Law Section). Ann is a member of the community board of Ele's Place in Ann Arbor and the board of directors of Ann Arbor Symphony Orchestra (former president).

Ann has been quoted in publications, such as MedPage Today and Crain's Detroit Business, and has published on various health care topics, including digital health and pharmacy services.

Experience

  • Large health care system investigates and voluntarily discloses clinical trial compliance concerns to federal agencyJones Day represented a large health care system in internal investigation, self-disclosure, and revision of company policies related to allegations of clinical trial noncompliance.
  • Nonprofit health system collaborates with research enterpriseJones Day is representing a nonprofit health system in its clinical research collaboration and support agreement in conjunction with a specialty research enterprise.
  • 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.
  • Emerging digital health company expands operations to new telehealth servicesJones Day advised an emerging digital health company in expanding its telehealth product offerings to patients across the United States and in responding to several state regulator inquiries regarding its operations.
  • Nonprofit hospital enters co-management agreement with physician group for oncology service lineJones Day represented a nonprofit health system in negotiating and drafting a co-management agreement with physician group for oncology services at one of its subsidiary hospital's inpatient facility and outpatient locations.
  • The following represents experience acquired prior to joining Jones Day:

    Prepared provider gain sharing structure for CMS Comprehensive Care for Joint Replacement Model.

    Structured clinical integrated network among physician groups and hospital in response to health care reform initiative.

    Negotiated acquisition transaction for specialty hospital.

    Structured collaborative human subjects research consortium among research institutions, hospitals and physicians.

    Counseled hospitals on compliance issues arising with non-fair market value transactions, fraud/abuse, research, and physician matters.

    Advised long-term care and home health provider on collaborative relationships with other providers in response to readmission penalties and related quality initiatives.

    Evaluated fraud/abuse and Stark issues to structure successful hospital and physician joint venture and other arrangements for radiology, physical therapy, and outpatient surgery services.

    Advised non-profit tax-exempt Board of Directors on TBOR2 (intermediate sanctions) protections offered by IRS for insider transactions and physician/executive compensation plans.

    Advised medical school in educational affiliation arrangements and faculty compensation.

    Led team in conducting audit of academic health care system’s physician compensation practice.

    Drafted research, licensing, and joint venture agreements among health care institutions, medical researchers, and pharmaceutical companies.

    Structured recruitment arrangement between hospital and physician group within confines of tax-exempt principles and fraud/abuse regulations.

    Provided counseling as to the impact of the Medicare reimbursement rules for routine patient care costs in clinical trials.

    Analyzed the application of federal and state fraud and abuse statutes to the financial relationships created by clinical trials.

    Obtained favorable private letter ruling from IRS regarding unique activities of health care trade association.

    Structured tailored physician incentive compensation plan at academic hospital.

    Provided overviews of the various regulatory and accreditation standards that are applicable to potential conflicts of interest in Board of Directors’ governance and clinical research contexts.

    Evaluated physician compensation relationships with drug company clinical trial sponsors in context of conflict of interest regulations.

    Counseled health plan on formation and Michigan regulatory matters.

    Additional Publications

    • May 6, 2019
      Legal and Regulatory Issues with Teledermatology, Current Dermatology Reports
    • March 5, 2019
      Health Care Compliance Legal Issues Manual, Co-Editor, American Health Lawyers Association
    • December 2018
      Institutional Review Boards, Co-author of Secondary Findings in Genomic Research, American Health Lawyers

    Publications Prior to Jones Day

    February 2017

    Advice for the Non-Healthcare Lawyer Representing Clients in Arrangements with Hospitals and Other Health Care Providers (February 2017) Michigan Bar Journal

    August 2016

    Representing Hospitals  and Health Systems Handbook (August 2016) Co-author American Health Lawyers Association (AHLA)

    April 2016

    Policy and Review:  The IRB's Imperative in Incidental Findings in Research (April 2016) Co-author American Health Lawyers Association (AHLA)

    2014

    Health Care Compliance Legal Issues Manual (2014) Co-author American Health Lawyers Association (AHLA)




    Speaking Engagements

    • December 3, 2019
      Artificial Intelligence, Machine Learning, and Big Data: What You and Your Organization Should Know
    • June 21, 2019
      Pharmaceutical Compliance & Legal Issues, Health Care Compliance Association Regional Conference
    • March 7, 2019
      Federal Regulatory Update, Health Law Institute, Institute of Continuing Legal Education/Michigan State Bar Association

    Speaking Engagements Prior to Jones Day

    March 2017

    Incidental Findings in Genomic Research: Ethics, Law and Practicality, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, AHLA co-sponsored with National Association of College and University Attorneys (NACUA) and Association of American Medical Colleges (AAMC),

    Baltimore, MD

    April 2016

    Hospital/Physician Relationships and the Law, Excellence in Governance Fellowship, Michigan Health and Hospital Association

    Grand Rapids, MI

    January 2015

    Clinical Research Update - How Will New Developments Impact Your Institution?, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, AHLA co-sponsored with National Association of College and University Attorneys (NACUA) and Association of American Medical Colleges (AAMC)

    Washington, D.C.

    October 2013

    Tax Issues in Clinical Research, Tax Issues for Health Care Organizations Conference, American Health Lawyers Association

    Washington, D.C.

    January 2013

    Research Collaborations between AMCs and Community Hospitals, Legal Issues Affecting Academic Health Centers and Other Teaching Institutions Conference, American Health Lawyers Association

    Washington, D.C.


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