MARK E. LUTES is the Chair of the firm’s Board of Directors and a Member of the firm’s Health Care and Life Sciences practice. Based in Washington, DC, he has practiced with the firm for more than three decades. Prior to that, he was a legislative adviser to the Federal Trade Commission. He also offers strategic counsel in health policy and on reimbursement strategy through the firm's affiliates EBG Advisors, Inc., and National Health Advisors, LLC.
Mr. Lutes is a leader in the firm's representation of private equity and financial services firms with health care companies in their portfolios. He routinely deploys multidisciplinary teams of attorneys, reimbursement specialists, engineers, and scientists to assess the reimbursement, FDA and other domestic and international regulatory approvals, fraud and abuse compliance, CMS and legislative landscapes and other issues impacting proposed client investments in health care companies. Mr. Lutes combines experience with the corporate aspects of transactions with his deep experience in health care compliance issues to provide clients with practical advice in the negotiation of warranty and indemnification issues and in assessing risk factors in health and life science deals. He has advised on the largest transactions in the health care market including services, pharmaceutical and device companies.
An experienced antitrust counselor to health care companies contemplating mergers or acquisitions, Mr. Lutes has facilitated the antitrust clearance of numerous significant hospital mergers. He has managed the defense of high profile health care antitrust actions by the FTC.
With a deep understanding of managed care markets and regulation, Mr. Lutes is consulted by a variety of providers and payors in structuring innovative payment arrangements. Additionally, he counsels on hospital and physician ventures and compliance issues and in the area of information privacy and security. Mr. Lutes has developed privacy and security audit tools which support client compliance needs.
Typical engagements include:
- Health regulatory diligence, deal document, offering document review for lenders and investors
- Antitrust counseling in structuring hospital mergers and obtaining Hart Scott Rodino clearance
- Practice before the FTC and DOJ defending health care organizations under antitrust investigation
- Advising early stage companies with new medical technologies with respect to coding and Medicare and commercial coverage and payment strategies
- Corporate and regulatory advice to hospital systems structuring traditional and non-traditional affiliation arrangements including not for profit "conversions" and physician collaborations
- Structuring managed care, DME, post-acute, and other health care company acquisitions and joint ventures
As part of a thought leadership initiative between the firm and academia, Mr. Lutes serves as an adjunct professor of law at Cornell Tech, co-teaching a fall 2018 course in digital health law.
In 2016, Mr. Lutes was named to the BTI Client Service All-Stars list, the gold standard used by law firms and corporate counsel alike to identify the attorneys delivering the absolute best client service. He has been selected to the Washington DC Super Lawyers list (2007 to 2010, 2013 to 2020) in the areas of Health Care and Antitrust Litigation and honored by Nightingales as a leading health care antitrust lawyer. He has been ranked among the "Leaders in Their Field" by Chambers USA: America's Leading Lawyers for Business (2010 to 2020), selected by his peers for inclusion in The Best Lawyers in America© (2017 to 2021), and recommended by The Legal 500 United States (2014 to 2020). Mr. Lutes has also been cited in Who's Who Legal: Healthcare (2020).
- Georgetown University Law Center (J.D., with honors, 1983)
- Rutgers University (M.P.A., 1979)
- Eagleton Institute of Politics, H.E.W. Public Service Fellow
- Georgetown University School of Foreign Service (B.S.F.S, with honors, 1978)
- District of Columbia
- American Bar Association, Antitrust and Insurance Sections
- American Health Lawyers Association
- District of Columbia Bar, Health Law Committee
- Maryland Bar Association, Health Law Committee
- Epstein Becker Green
- Health Insights
- Network for Excellence in Health Innovation (NEHI)