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
- Co-author, “The Challenges Facing Trump's Drug Pricing Order,” Law360 (September 25, 2020)
- Co-author, “Surveying Drug Pricing Reform: The Latest Federal Activity,” Law360 (July 31, 2020)
- Co-author, “A Look At CMS' Proposed Medicaid Drug Rebate Changes,” Law360 (July 9, 2020)
- Co-author, “Drug Pricing: What Happened In 2019, What To Watch In 2020,” Law360 (January 14, 2020)
- Co-author, “Scrutiny Of Physician-Owned Distributors Is Far From Over,” Law360 (April 26, 2019)
- Co-author, “A First Look At New HHS Prescription Drug Safe Harbors,” Law360 (February 15, 2019)
- Co-author, “The Trump Administration's Latest Drug Pricing Initiatives,” Law360 (January 14, 2019)
- Co-author, “A Closer Look At CMS' Drug Price Disclosure Proposal,” Law360 (October 24, 2018)
- Co-author, “Building a Better Mousetrap: A Physician’s Guide to Commercializing a Medical Device Invention,” American Health Lawyers Journal of Health & Life Sciences Law (October 2018)
- Co-author, “A Look Inside Trump's 4-Point Plan For Curbing Drug Prices,” Law360 (May 17, 2018)
- Co-author, “How States, Federal Agencies Are Challenging Drug Prices,” Law360 (April 23, 2018)
- Author, “Repeal and Replace a Year Later: Attempted Murder on a Disoriented Express,” Bloomberg BNA’s Health Law Reporter (December 7, 2017)
- Author, “Executive Sweet: Does the President’s E.O. Offer a Treat or Tooth Decay for Health Care?” Bloomberg BNA’s Health Law Reporter (October 19, 2017)
- Co-author, “The Future of Value-Based Care After Repeal and Replace,” Law360 (October 4, 2017)
- Author, "Rogue Two: A Health Care Reform Story – Five Things to Watch in the Insurgent, Long-Shot Campaigns to Salvage Health Care Reform Efforts," Bloomberg BNA’s Health Law Reporter (September 21, 2017)
- Co-author, “Blurring the Line Between Health Care Provider and Payor,” Law360 (September 20, 2017)
- Co-author, “OIG’s Warranty Safe Harbor Opinion and Value-Based Care,” Law360 (September 14, 2017)
- Author, “Revisiting the Road Not Taken: Five Alternative Pathways to Regulatory Reform of Obamacare,” Bloomberg BNA’s Health Law Reporter (August 10, 2017)
- Author, “Legislative Jenga: Building a Bipartisan Bill to Repair Obamacare,” Bloomberg BNA’s Health Law Reporter (July 19, 2017)
- Author, “Searching for Goldilocks: Five Takeaways From the Senate’s Health-Care Reform Porridge-Making,” Bloomberg BNA’s Health Law Reporter (June 22, 2017)
- Co-author, “New Frontiers in AMC Funding: Mission Support Alternatives Post-Halifax,” Member Briefing, American Health Lawyers Association (AHLA) AMCs and Teaching Hospitals Practice Group (May 2017)
- Author, “Reports of the AHCA’s Revival: Will Giving the States Obamacare Waivers Thread the Needle? ” Bloomberg BNA’s Health Law Reporter (April 27, 2017)
- Author, “Failure to Launch the American Health Care Act: Portents for the Future of Health Care Reform?,” Bloomberg BNA’s Health Law Reporter (April 6, 2017)
- Co-author, “Senate report discourages dealings with physicianowned distributorships,”Compliance Today (March 2017)
- Author, “The Price of TrumpCare: Five Takeaways From the HHS Secretary and Other Republican Proposals,” Bloomberg BNA’s Health Law Reporter (February 23, 2017)
- Cited, “The New U.S. Department of Health and Human Services: Tom Price and Value-Based Health Care,” JD Supra Business Advisor (January 6, 2017)
- Cited, “The New FDA: Product Development, Pricing and Beyond,” JD Supra Business Advisor (January 6, 2017)
- Co-author, “Medicare “carve-out” arrangements: No safe haven for PODs,” Compliance Today (June 2015 issue)
- Co-author, “National Institutes of Health Issues a Notice of Proposed Rulemaking on Clinical Trials Registration and a Draft Policy on Registration and Reporting of Results for NIH-Funded Clinical Trials,” Bloomberg BNA’s Medical Law & Policy Research Report (December 17, 2014)
- “Ominous Outlook for Physician-Owned Distributors,” Law360 (Sept. 22, 2014)
- “Physician-owned entity fraud alert: Hospital compliance officers take note,” Compliance Today (December 2013)
- “Why Physicians Should Not Be Permitted to Profit from Self-Referral to Physician-Owned Implant Distributors,” FDLI Policy Forum (Vol. 2, No. 17, September 12, 2012)
- Letter to editor in response to “The Risks of PODs” by Walter Eisner in Orthopedics This Week (May 10, 2011)
- “Kickbacks, Courtesies, or Cost-Effectiveness? Application of the Medicare Antikickback Law to the Marketing and Promotional Practices of Manufacturers of Drugs and Medical Devices,” Food & Drug Law Journal (Vol. 54, No. 3, 1999)
Quotations
- Quoted, “4 Key Areas As Biden Sets New Health Policy Path In 2021,” Law360 (January 3, 2021)
- Quoted, “Changes to Anti-Fraud Laws Spur ‘Paradigm Shift’ in Health Care,” Bloomberg Law (November 24, 2020)
- Quoted, “Trump's Latest Drug Pricing Executive Order Draws Doubts,” Law360 (September 14, 2020)
- Quoted, “Government Works to Match Health Rules to Rapid Virus Response,” Bloomberg Law (March 31, 2020)
- Quoted, “Drug Pricing Legislation In Doubt After COVID-19 Relief Bill,” Law360 (March 26, 2020)
- Quoted, “High Court ERISA Case Has States, Pharmacies On Edge” Law360 (January 17, 2020)
- Quoted, “Health And Life Sciences Policy To Watch In 2020,” Law360 (January 1, 2020)
- Quoted, “Ipsen Biopharmaceuticals May Dispute HHS’s Drug Rebate Letters,” Bloomberg Law (December 3, 2019)
- Quoted, “Stark Anti-Kickback Law Refined for Clarity,” Healthcare Risk Management (December 2019)
- Quoted, “Part-Time Documentation Eased Among Many Favorable Rule Changes,” Healthcare Risk Management (December 2019)
- Quoted, “Hospitals pledge to fight Trump admin price transparency plan in court,” Healthcare Dive (November 18, 2019)
- Quoted, “Hospitals’ Risk May Rise as Anti-Fraud Proposal Narrows Loophole,” Bloomberg Law (October 24, 2019)
- Quoted, “Some Say Stark, Anti-Kickback Rules Encouraging, Providers Want More,” Inside Health Policy (October 16, 2019)
- Quoted, “Key Health Care And Pharma Policy Debates To Track This Fall,” Law360 (August 30, 2019)
- Quoted, “CMS Wants to Force Hospitals to Reveal Negotiated Rates. Can It Do That?” Healthcare Dive (August 5, 2019)
- Quoted, “Trump’s International Drug Pricing Plan Faces Rocky Reception,” Bloomberg Law (July 15, 2019)
- Quoted, “3 Takeaways From Nixing Of Drug Pricing Rule,” Law360 (July 10, 2019)
- Quoted, “Biggest Health And Life Science Rulings Of 2019: Midyear Report,” Law360 (June 21, 2019)
- Quoted, “Drug-Pricing Measures On The Edge Left Out Of Senate Health Package,” Inside Health Policy (June 19, 2019)
- Quoted, “Drugmakers Must Police Each Other Over TV Ad Price Disclosures,” Bloomberg Law (May 9, 2019)
- Quoted, “Coming Soon to a TV Near You: List Prices for Pharmaceuticals,” Bloomberg Law (May 8, 2019)
- Quoted, “PBMs Want to Distribute New Rebate Payments, Pharmacists Disagree,” Inside Health Policy (April 12, 2019)
- Quoted, “Pay-for-Delay Drug Deals Could Jeopardize Medicare Payments,” Bloomberg Law (March 11, 2019)
- Quoted, “Expect legislative baby steps, not big leaps on drug prices,” Medical Marketing & Media (March 4, 2019)
- Quoted, “Azar Challenges Democrats to Propose Alternative to Axing Rebates,” Inside Health Policy (February 1, 2019)
- Quoted, “HHS Report Card: Attorneys Grade Health Secretary's 1st Year,” Law360 (January 29, 2019)
- Quoted, “Health Care Policy Moves To Watch In 2019,” Law360 (January 1, 2019)
- Quoted, “HHS’ Expected Rule On Rebates, Safe Harbor Could Draw Lawsuits,” Inside Health Policy (December 10, 2018)
- Quoted, “Democratic Skeptics Stepping Up Against Trump’s Drug Change,” Bloomberg Law’s Pharmaceutical and Life Sciences News (October 25, 2018)
- Quoted, “5 Takeaways As Trump Eyes Cut To Medicare Drug Payments,” Law360 (October 25, 2018)
- Quoted, “HHS Eyes Changes to Anti-Kickback Statute: 4 things to Know,” Becker’s Hospital Review (August 27, 2018)
- Quoted, “Trump Administration Eyes Lifting Health Kickback Curbs,” Bloomberg Law Health Law Reporter (August 24, 2018)
- Quoted, “Drug Rebates’ Legal Protections are on the Chopping Block,” Modern Healthcare (July 19, 2018)
- Quoted, “The Health 202: The FDA's bid to lower some drug costs will help. But it won't solve the problem.,” The Washington Post (July 18, 2018)
- Quoted, “The FDA's Bid to Lower Some Drug Costs Will Help. But it Won't Solve the Problem,“ The Washington Post and reprinted in San Francisco Chronicle and Connecticut Post (July 18, 2018)
- Quoted, “The Health 202: States are targeting a key middleman in the drug-pricing chain,” The Washington Post (May 21, 2018)
- Quoted, “Trump Vows (Again) To Lower Drug Prices But Skeptics Doubt Much Will Change,” Kaiser Health News (republished in The Washington Post and MedCity News) (May 11, 2018)
- Quoted, “Trump Vows Cheaper Drugs 'Very Soon,' But That's Unlikely,” Law360 (May 11, 2018)
- Quoted, “What to Expect From Trump's Friday Drug Pricing Speech,” BioPharma Dive (May 9, 2018)
- Quoted, “Trump's Drug Price Speech Moved to May 11,” Bloomberg BNA’s Health Care Daily Report (May 8, 2018)
- Quoted, “Pharma Charity's Suit Tests OIG's Kickback Oversight,” Law360 (January 10, 2018)
- Quoted, “Deadline Looms for Obamacare Open Enrollment,” CBS MoneyWatch (December 11, 2017)
- Quoted, “6 Must-Dos for the Toughest Open Enrollment Yet,” CBS MoneyWatch (October 30, 2017)
- Quoted, “States’ Lawsuit to Continue Cost-Sharing Payments Faces a Challenging Road,” Modern Healthcare (October 16, 2017)
- Quoted, “Latest ACA Repeal Failure Only a Pause, Not a Full Stop,” Law360 (September 26, 2017)
- Quoted, “Attys Predict Next Steps After ACA Repeal Failure,” Law360 (July 28, 2017)
- Quoted, “Will ACA Repeal Pass? Here’s What 11 Experts Think,” Law360 (July 10, 2017)
- Quoted, “MacArthur Amendment and Pre-Existing Health Conditions,” WCBS-AM New York (June 23, 2017) (90 seconds)
- Quoted, “American Health Care Reform Podcast,” WCBS-AM New York (June 23, 2017) (8 minutes)
- Quoted, “Pundits and pols question whether the BCRA can pass in its entirety,” Modern Healthcare (June 23, 2017)
- Quoted, “Health Bill Would Stabilize Individual Markets in Short Run,” Bloomberg BNA’s Health Care Daily Report (June 22, 2017)
- Quoted, “Guess Who Else Doesn’t Love the American Health Care Act?” CBS MoneyWatch (May 26, 2017)
- Quoted, “4 Key Takeaways As CBO Scores Revised ACA Repeal Bill,” Law360 (May 24, 2017)
- Quoted, “Health Care Lawyers Offer Guidance on How to Ride Out the AHCA Storm,” National Law Journal (May 4, 2017)
- Quoted, “Medicare Advisors Consider Tighter Rules on Doctor-Owned Medical Distributors,” The Hill (April 18, 2017)
- Quoted, “Medicare Advisors Decry Physician-Owned Distributorships,” Bloomberg BNA’s Health Care Daily Report (April 11, 2017)
- Quoted, “4 ACA change paths that just got more popular,” Life Health Pro (March 27, 2017)
- Quoted, “Most Obamacare Exchanges Would Likely Die Under GOP Health Plan,” Bloomberg BNA Health Care Daily Report (March 8, 2017)
- Quoted, “Feds Propose Rule to Stabilize Marketplaces During ACA Repeal,” National Law Journal (February 15, 2017)
- Quoted, “Trump's '2-for-1' regulation order seems straightforward, but it isn't,” The Business Journals (January 31, 2017)
- Quoted, “Trump order targeting business rules leaves key regulations untouched,” Reuters (January 30, 2017)
- Quoted, “Trump’s latest executive order targets and caps new regulations,” FierceHealthcare (January 30, 2017)
- Quoted, “Obamacare Executive Order Has Little Effect on Litigation Testing Health-Reform Law,” Bloomberg BNA Health Law Reporter (January 26, 2017)
- Quoted, “GOP Repeal-And-Delay Plans Spell Uncertainty For Insurers,” HealthcareDive (December 14, 2016)
- Quoted, “Trump Administration Could End Need for ACA Appeal, House Republicans Say,” Health Law Reporter (December 1, 2016)
- Quoted, “Obamacare Cases in Limbo Following Republican Wins in White House, Congress,” Health Law Reporter (November 17, 2016)
- Quoted, “Republicans face divisions over ObamaCare repeal,” The Hill (November 13, 2016)
- Quoted, “How GCs Should Prepare for Trump's ACA Repeal,” Corporate Counsel (November 11, 2016)
- Quoted, “BigLaw Reacts To Trump's Election To The White House,” Law360 (November 9, 2016)
- Quoted, “Upcoming Hearing on Physician-Owned Distributorships Development,” Health Care Daily Report (November 17, 2015)
- Quoted, “OIG struggles to ID owners of physician-owned device distributorships,” Modern Healthcare (August 14, 2015)
- Quoted, “Health Care Legislation and regulation to Watch in 2015,” Law360 (January 2, 2015)
- Quoted, “Michigan doctor charged in alleged surgery scam,” Modern Healthcare (November 26, 2014)
- Quoted, “Federal probe of doc-owned distributorship yields False Claims suit,” Modern Healthcare (September 8, 2014)
Presentations
- Speaker, “Outlook 2020 Teleconference: Washington, D.C. Updates and Insights on Life Sciences and Health Care,” (January 30, 2020)
- Speaker, “What’s Happening (And Likely to Happen) With Prescription Drug Pricing?,” (December 11, 2019)
- Speaker, “The New AdvaMed Code,” Ropes & Gray Webinar (February 14, 2019)
- Speaker, “Outlook 2019 Teleconference: Washington, D.C. Updates and Insights on Life Sciences and Health Care,” (January 23, 2019)
- Moderator, “Vertical Integration in Movement to Value-Based Health Care,” Yale Healthcare Conference 2018 (April 13, 2018)
- Panelist, “Is the Current Regulatory Framework Stifling Value-based Health Care?” Will Value-based Care Save the Health Care System? Conference at Harvard Law School Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (March 2, 2018)
- Speaker, “Outlook 2018 Teleconference: The Trump Administration’s Impact on Life Sciences and Health Care—the First Year,” Ropes & Gray Teleconference (January 23, 2018)
- Speaker, "The Transition to Value-Based Health Care: A View from Washington of President Trump’s First 60 Days," Ropes & Gray Teleconference (March 15, 2017)
- Presenter, "It Takes a Village: AMC Outreach to Community Physicians in the Age of Value-Based Health Care," Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions (March 9-10, 2017)
- Speaker, “Outlook 2017: The New Administration and Its Impact on Life Sciences and Health Care,” Ropes & Gray Teleconference (January, 2017)
- Presenter, “New Frontiers in AMC Funding: Mission Support Alternatives Post-Halifax,” Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions (March 14-16, 2016)
- Presenter, “Physician-Owned Distributors: A Real Roll of the Dice,” Oppenheimer 23rd Annual Healthcare Conference, New York, NY (December 13, 2012)
- Presenter, “Physician-Owned Distributors: To Be or Not to Be?,” American Health Lawyers Association Webinar (September 2012)
Education
- JD, University of Michigan Law School, 1985
- AB, cum laude, Yale University, 1979
Admissions / Qualifications
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
Awards
- Washington, D.C. Super Lawyers, Health Care (2007-2016)
- Chambers USA, Health Care (2006-2020); Health Care: Regulatory & Litigation (2011-2020)
- The Best Lawyers in America, Health Care Law (2007-2016, 2018-2021)
- The Best Lawyers in America - Lawyer of the Year (2021)
- Legal 500 (2011-2020)
- 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)