Mark E. Lutes

“Smart health care transactions aren’t just about compliance—they’re about anticipating challenges and structuring for growth. My role is to help clients see around corners and move forward with clarity.” —Mark Lutes

When private equity sponsors, hospital systems, and health care companies face complex regulatory minefields, they turn to attorney and Epstein Becker Green Board Chair Mark Lutes.

With more than four decades of experience in health law, including antitrust enforcement perspectives from his time advising the Federal Trade Commission, Mark provides clients with not just advice—but strategic foresight, risk quantification, and confidence in the face of regulatory and antitrust scrutiny. His combination of deep legal knowledge, industry insight, and leadership experience helps clients distinguish fleeting compliance hurdles from deal-breaking issues, empowering clients to make informed decisions that protect investments and drive growth.

At Epstein Becker Green, Mark chairs the board, fostering a culture of innovation and collaboration while contributing to firm-wide initiatives on diversity and recruiting. He extends his impact through community involvement, serving on health policy advisory boards and volunteering with organizations supporting underserved medical access, reinforcing his commitment to broader industry advancement.

Landmark Legal Wins and Strategic Business Guidance

Mark inspires confidence through landmark achievements, like securing a pivotal appellate victory in a high-stakes antitrust case for a major hospital system, dismissing all claims under the Sherman and Clayton Acts. His guidance has shaped first-of-their-kind deals, such as the $1.4 billion acquisition of Puerto Rico's largest HMO, navigating multi-jurisdictional approvals to ensure seamless integration and sustained reimbursement flows. Clients value his approachable style, blending rigorous analysis with practical, forward-thinking strategies that resonate across industries from financial services to technology.

What Mark Delivers for Clients

• Clarity in Complex Transactions: Mark directs multidisciplinary teams that analyze regulatory concerns and quantify risk, giving clients a clear picture of exposure before they move forward.
• Stronger Negotiating Position: His counsel provides leverage in deal discussions, enabling him to identify key advantages and structure terms that maximize client outcomes.
• Confidence in Compliance: Whether navigating antitrust scrutiny, the Stark Law, or other legal or regulatory hurdles, Mark helps clients design strategies that withstand regulator review.
• Trusted Experience: Clients benefit from insights gained through representing sponsors, health systems, and providers in transactions totaling billions of dollars.

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Regulatory Compliance Assessment for Health Care Investments

Under Mark’s direction, a team of health care compliance lawyers from Epstein Becker Green and reimbursement consultants, engineers, and scientists from the firm’s affiliate, EBG Advisors, Inc., reviews the regulatory concerns of life sciences companies, health care service providers, and suppliers.

Investors use Mark's assessments to:

• Identify regulatory compliance gaps and evaluate their potential exposure
• Remediate issues and implement controls to limit risk
• Plan post-close compliance and ongoing monitoring

Guiding Hospital Systems Through M&A, Joint Ventures, and Strategic Alliances

Mark also advises large hospital systems in their mergers, acquisitions, and joint ventures. Clients rely on his insight into evolving state and federal health care finance and policy trends to structure transactions with:

• Other hospital systems
• Physician groups
• Managed health care plans

Antitrust Enforcement Insight and Transaction Review

Mark’s prior experience as a legislative adviser to the Federal Trade Commission informs his knowledge of federal antitrust enforcement. He evaluates transactions from an economic, financial, and strategic perspective, helping clients understand risks and protect their interests.

Health Policy, Reimbursement Strategy, and Workforce Management Consulting

Through EBG Advisors, Inc., and its affiliate, National Health Advisors, LLC, Mark offers strategic counsel in health policy and on health care reimbursement changes. He also provides workforce management consulting to a wide range of industry stakeholders across:

• Financial services
• Health care
• Life sciences
• Hospitality
• Retail
• Technology

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Health Regulatory Compliance and Enforcement

• Led a team in successfully reversing a Centers for Medicare & Medicaid Services action to exclude a private equity-backed post-acute company from Medicare participation.
• Managed diligence and health regulatory issues pertaining to a $4.4 billion SPAC acquisition of a Medicare Advantage risk-assuming physician group.
• Advised multiple private equity sponsors on their acquisition of an electronic medical record and claims management software platform. EBG provided health regulatory counsel throughout the duration of the deal.
• Provided health regulatory and employment law support for a private equity sponsor’s acquisition of a comprehensive clinical site platform and operator of clinical research sites.
• Supported a private equity company’s acquisition of a global manufacturer of cardiovascular devices. Mark assembled and led a global team of health regulatory advisors for the transaction.

Health Care Mergers and Acquisitions

• Advised Summit Partners on the $1.4 billion acquisition of the largest health maintenance organization in Puerto Rico, handling complex state and federal regulatory schemes and approvals.
• Advised the sponsors in the merger of Great Lakes Caring, National Home Health Care, and Jordan Health Service, creating one of the largest home-based care services in the United States.
• Served as regulatory counsel to Apax in the $6.3 billion acquisition of KCI, a life sciences wound management company.
• Assisted an investment capital firm in the acquisition of a behavioral health provider with residential facilities operating across multiple states. Mark and his team advised on federal and state health care licensing, reimbursement, and compliance issues. The platform investment closed at a value of approximately $1.3 billion.
• Guided a private equity company through the acquisition of a mental health residential treatment program for children and young adults. The target company included over 350 beds in 50 residential facilities operating across several states.
• Deployed a cross-disciplinary team to support several private equity sponsors in a deal to acquire a manufacturer of medical equipment and supplies used in hospitals, surgery centers, and acute care and other medical facilities across the globe.

Health Care Antitrust and Competition Matters

• Achieved a significant appellate victory for a longtime hospital system client in an antitrust case, convincing the U.S. Court of Appeals for the Fourth Circuit to affirm dismissal of all 11 claims under the Sherman and Clayton Acts.
• Served as deal counsel to a health care company in a merger joining together a dialysis products and services provider, a physician organization, and a health care technology platform. Mark and his team provided health regulatory and antitrust counseling.

Health Care Divestitures and Sales

• Led a team that advised Apax on regulatory matters in all phases of the acquisition, growth, and successful $1 billion sale of a generic drug company.
• Conducted pre-sell diligence and aided the pharmaceutical company client in addressing health regulatory matters involving the Food and Drug Administration, the Drug Enforcement Agency, state-controlled substances laws, and the Consumer Product Safety Commission.
• Managed regulatory support to Altaris in the carve-out of Kindeva, a global drug delivery business, from 3M for $650 million.
• Provided transactional and regulatory counseling to an academic medical center in the sale of its outreach laboratory business to a national laboratory company.

• Chambers USA: America's Leading Lawyers for Business: District of Columbia—Healthcare, "Leader in Their Field" (2010 to 2025)
• The Best Lawyers in America^©: Health Care Law (2017 to 2023, 2025 to 2026); "Lawyer of the Year," Health Care Law, Washington, DC (2025)
• Hope for a Healthier Humanity 2024 Humanitarian Award
• The Legal 500 United States: Healthcare: Advice to Health Insurers, Healthcare: Advice to Service Providers, and M&A: Middle Market (Sub $500 Million) (2014 to 2025)
• Washington, DC, Super Lawyers: Health Care and Antitrust Litigation (2007 to 2010, 2013 to 2025)
• Who's Who Legal: Healthcare (2020)
• BTI Client Service All-Stars: Recognized for superior client focus, innovative thought leadership, unmatched business understanding, legal skills, outsized value, and outstanding results (2016)

Education

• 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)

Board of Directors

• EBG Advisors
• Epstein Becker Green, Chair
• Health Insights, Immediate Past Chair
• Hope for a Healthier Humanity
• Network for Excellence in Health Innovation (NEHI), Chairman (2002 to 2024)

Professional & Community Involvement

• American Bar Association, Antitrust and Insurance Sections
• American Health Lawyers Association
• District of Columbia Bar, Health Law Committee
• Maryland Bar Association, Health Law Committee