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+1 202 637 8276
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+1 202 637 5910
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Thomas
N.
Bulleit, Jr.
Partner, Washington, D.C.
tom.bulleit@hoganlovells.com
Thomas 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, physicians, 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 healthcare fraud and abuse, with an emphasis on helping clients navigate the application of federal and state antikickback, self-referral, and false claim laws in ways that allow them to continue to engage 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 clients to engage him extensively for strategic analysis, development, and negotiation of business deals, including contracts for professional service and employment, product purchase and sale, discounts and rebates, and asset purchases, and regulatory "due diligence" in both the securities and private equity arenas. 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.
In the field of technology transfer, Tom was the principal drafter of one of the first cooperative research and development agreements (CRADAs) signed between a private company and the U.S. National Institutes of Health under the Federal Technology Transfer Act of 1986. He has since frequently advised and negotiated on behalf of clients involved in or seeking to enter into CRADAs or other research relationships with federal laboratories and in the process has gained a particular knowledge of the legal and business issues that attend public-private partnerships for research, including Bayh-Dole Act licensing and conflict-of-interest issues. He has also represented numerous clients from both industry and the research community concerning the implications of federal funding for their private sponsored research relationships.
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 and Academic Medicine. 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.
Prior to joining Hogan & Hartson, he was a law clerk to The Honorable Bailey Brown of the U.S. Court of Appeals for the Sixth Circuit.
Hogan Lovells Publications
24 February 2012
"CMS releases proposed rule on reporting and returning overpayments from the Medicare program." Health Alert, Hogan Lovells
10 February 2012
"Proposed rule for federal Sunshine Act requires public disclosure of research payments." Health Alert, Hogan Lovells
10 February 2012
"Update on California A.B. 378: Still Prohibiting PODs for California Workers’ Compensation; Some Important Exceptions." Health Alert, Hogan Lovells
19 January 2012
"New California law prohibits medical device physician-owned companies in workers' compensation program." Medical Device Alert, Hogan Lovells
16 December 2011
"CMS proposes rule to implement Federal Physician Payment Sunshine Act." Health Alert, Hogan Lovells
27 October 2011
"Insights and implications of CMS ACO final rule." Health Alert, Hogan Lovells
19 October 2011
"OIG Releases Advisory Opinion Demonstrating Continued Concern with Physician-Owned Companies." Health Alert, Hogan Lovells
10 June 2011
"Senate asks OIG to probe physician-owned distributors." Health Alert, Hogan Lovells
08 April 2011
"Implications of federal agencies' proposed guidance on accountable care organizations." Health Alert, Hogan Lovells
13 December 2010
"Agencies seek comments regarding medical device excise tax." Health Alert, Hogan Lovells
09 July 2010
"OIG Settles Kickback Case with Physician-Owned Company for Leveraging Patient Referrals to Obtain Contract Business from Hospitals." Health, Hospitals, and Medical Devices Alert, Hogan Lovells
June 2010
"False Claims Act Settlement Calls into Question Some Medical Product Rebate Practices." Health Alert, Hogan Lovells
June 2010
"CMS Announces Policy on Medicare Secondary Payer Insurer Reporting Requirements for Clinical Trial Sponsors and CMS also Addresses 'Risk Management Write-Offs'." Health Alert, Hogan Lovells
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