Thomas N. Bulleit

Partner

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  • JD, University of Michigan Law School, 1985
  • AB, cum laude, Yale University, 1979

Qualifications

  • District of Columbia, 1988
  • Maryland, 1987

Court Admissions

  • District of Columbia Court of Appeals
  • Maryland Court of Appeals
  • Supreme Court of the United States
  • Member, American Health Lawyers’ Association
  • Member, National Association of College and University Attorneys
  • Washington, D.C. Super Lawyers, Health Care (2007-2016)
  • Chambers USA, Health Care (2006-2018); Health Care: Regulatory & Litigation (2011-2018)
  • The Best Lawyers in America, Health Care Law (2007-2016, 2018-2019)
  • Legal 500 US, Healthcare and Life Sciences (2011-2018)
  • Guide to Leading U.S. Health Care Lawyers (2006)
  • Who's Who in American Law (2006)
  • Nightingale's Healthcare News, Outstanding Fraud and Compliance Lawyer (2006)
  • National Registry of Who's Who (2001)
  • Louis Honigman Award, Greatest Contribution to University of Michigan Journal of Law Reform (1985)

Thomas N. Bulleit

Partner

Tom Bulleit represents a wide range of clients in all sectors of the healthcare industry, from academic medical centers and companies engaged in biomedical research and development, to large and small manufacturers of medical devices and pharmaceuticals, to HMOs and other healthcare payors, to hospitals, hospices, physicians, physician practice management companies, physical therapists, and other hands-on providers of healthcare, to niche companies offering unconventional services such as e-health connectivity. Tom's practice focuses on legal and regulatory compliance, coverage, and reimbursement, especially under Medicare and other federal healthcare programs but also under state licensing and regulatory regimes, as a counselor, a business lawyer, and an advocate.

A primary focus of Tom's practice has been compliance with health regulatory requirements, especially the healthcare fraud and abuse laws. He strives to provide counseling that allows clients to meet legal requirements while still engaging in competitive business arrangements. His counseling practice includes internal client audits and the development of compliance plans, policies, and standard operating procedures. Because the fraud and abuse rules often dictate or heavily influence the permissibility of financial relationships in the healthcare industry, Tom’s regulatory experience has led his healthcare and investor clients to engage him extensively for strategic analysis, development and negotiation of business deals, including academic affiliation agreements between medical schools and their teaching hospitals, and between academic medical centers and community healthcare providers, contracts for healthcare professional services and employment, medical product purchase and sale, discounts and rebates,asset purchases, and regulatory “due diligence” in both the public and private company arenas. Tom also advises in other key areas of health regulation, including coverage and reimbursement, provider payment sunshine laws, digital health and information privacy, and clinical research. He also represents clients who are under investigation by the U.S. Department of Health and Human Services Office of Inspector General, the U.S. Department of Justice, and state Attorneys General, including the negotiation and implementation of Corporate Integrity Agreements and Deferred Prosecution Agreements.

Tom is a graduate of the National Health Lawyers Association's Masters Program in healthcare fraud and abuse. He has often spoken and authored numerous articles in the areas of technology transfer and healthcare fraud and abuse, including publications in the Food and Drug Law Journal, Academic Medicine and Compliance Today. He was elected to three terms as Chair of the Health Law Section of the District of Columbia Bar, and to a total of six years as a member of that organization's steering committee.

Experience

  • Negotiating academic affiliation agreements between medical schools and teaching hospitals, and between academic medical centers and community healthcare providers.
  • Representing coalitions in legislative and regulatory advocacy on Capitol Hill and at regulatory agencies, including HHS Office of Inspector General and Centers for Medicare and Medicaid Services.
  • Counseling numerous provider and drug/device manufacturer clients on financial relationships among healthcare providers, including: Stark, Antikickback, and False Claims laws; and physician-owned distribution of medical devices.
  • Developing and assisting in implementation of compliance policies and procedures for providers, drug and medical device manufacturers.
  • Drafting and negotiating agreements that meet compliance and commercial standards, including contracts for physician consulting services; purchase, sale and marketing of drugs and medical devices; health insurer participating provider networks; physician practice management.
  • Supporting healthcare transactions: regulatory diligence, opinions, terms and conditions.
  • Negotiating and implementing OIG Corporate Integrity Agreements and DOJ Deferred Prosecution Agreements.
  • Technology Transfer including: the Federal Technology Transfer Act, the Bayh-Dole Act, CRADAs, and sponsored research agreements.

Publications

Publications

Quotations

Presentations

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