Overview
Private equity sponsors trust attorney Mark Lutes to help them understand the impact of regulatory compliance concerns on their health care industry investments. Mark draws on his nearly four decades of experience to analyze investments and distinguish temporary challenges from serious red flags.
Under his direction, the country’s largest team of health care compliance lawyers, reimbursement consultants, engineers, and scientists reviews the nuanced regulatory concerns of life sciences companies, health care service providers, and suppliers. Investors use his assessments to evaluate their potential exposure, quantify and limit their risk, and avoid future surprises.
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, and managed health care plans. His prior experience as a legislative adviser to the Federal Trade Commission informs his knowledge of federal antitrust enforcement. Based on his appreciation of the underlying economic, financial, and strategic possibilities of a transaction, Mark helps clients understand what they are buying and protect themselves against risk.
Through the firm's affiliates EBG Advisors, Inc., and 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, and technology.
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Focus Areas
Services
- Antitrust
- Corporate & Transactional
- Corporate Financing
- Corporate Governance
- Government and Commercial Coding, Coverage, and Payment
- Health Care
- Health Care and Life Sciences Investor Services
- Health Care Mergers and Acquisitions
- Health Policy and Legislation
- Interoperability
- Life Sciences Due Diligence
- Managed Care
- Mergers, Acquisitions & Divestitures
- Privacy, Cybersecurity & Data Asset Management
- Value-Based Purchasing and Accountable Care
Industries
Trending Issues
Experience
- Advised Summit Partners on the $1.4 billion acquisition of the largest health maintenance organization in Puerto Rico. Mark and his team handled the complex state and federal regulatory schemes, approvals in multiple jurisdictions, and compensation from the feds and state to the health plan and from the health plan to the provider network.
- Achieved a significant appellate victory for a longtime hospital system client in an antitrust case brought by a former competitor. Mark and his team convinced the U.S. Court of Appeals for the Fourth Circuit to affirm the judgment of the lower court, dismissing with prejudice all of the plaintiffs’ 11 antitrust claims under the Sherman and Clayton Acts against the hospital system.
- Managed diligence and health regulatory issues pertaining to a $4.4 billion SPAC acquisition of a Medicare Advantage risk-assuming physician group.
- Advised the sponsors in the merger of Great Lakes Caring, National Home Health Care, and Jordan Health Service, a deal that created one of the largest home-based care services in the United States.
- 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.
- 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.
- Served as regulatory counsel to Apax in the $6.3 billion acquisition of KCI, a life sciences wound management company (now Acelity).
- Managed regulatory support to Altaris in the carve-out of Kindeva, a global drug delivery business, from 3M for $650 million.
Recognition
- Chambers USA: America's Leading Lawyers for Business, District of Columbia—Healthcare (2010 to 2023)
- The Best Lawyers in America©, Health Care Law (2017 to 2023)
- 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 2023)
- Washington, DC, Super Lawyers, Health Care and Antitrust Litigation (2007 to 2010, 2013 to 2023)
- Who's Who Legal: Healthcare (2020)
- BTI Client Service All-Stars list, Recognized for superior client focus, innovative thought leadership, unmatched business understanding, legal skills, outsized value, and outstanding results (2016)
Credentials
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)
Bar Admissions
- District of Columbia
- Maryland
Board of Directors
- EBG Advisors
- Epstein Becker Green, Chair
- Health Insights, Chair
- Network for Excellence in Health Innovation (NEHI), Chair
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
Media
Events
Past Events
Insights
Insights
- Media Coverage
As Featured in Law360: Epstein Becker Promotions Inch Up with 12 Members Named
2 minute read - Firm Announcements
Epstein Becker Green Receives New York Law Journal’s 2023 Innovation Award
4 minute read - Firm Announcements
Epstein Becker Green Earns National Recognition and High Rankings in the 2023 Edition of Legal 500
3 minute read - PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
- Firm Announcements
Epstein Becker Green Recognized for Focused Excellence Across Core Practice Areas in Chambers USA 2023
5 minute read - Firm Announcements
Thirteen Epstein Becker Green Attorneys Named to the 2023 Washington, DC, Super Lawyers and Rising Stars Lists
4 minute read - PublicationsIs CMS Ignoring the Realities of Biopharmaceutical Costs?2 minute read
- BlogsIs CMS Ignoring the Realities of Biopharmaceutical Costs?6 minute read
- Media CoverageMark Lutes Discusses What’s in Store for 2023: “D.C.-Area Business Leaders Offer Their Takes — and Resolutions” ...2 minute read
- Firm AnnouncementsEpstein Becker Green Celebrates 50 Years of Focused Excellence3 minute read
- Firm AnnouncementsEpstein Becker Green Honored for Outstanding Leadership in Business by Northeast Business Group on HealthDecember 7, 20223 minute read
- Media CoverageNashville Boom, Health Care Fuel Epstein Becker Green Growth Bet3 minute read
- Media CoverageEpstein Becker Green Taps Former Waller Chairman John Tishler to Spur Growth4 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession
11 minute read - PublicationsFTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector23 minute read
- Firm AnnouncementsAttorney and Biopharma Strategist Richard Hughes Returns to Epstein Becker Green in Washington, DC4 minute read
- Firm Announcements
2022 Edition of The Legal 500 Recognizes Epstein Becker Green with High Rankings in Health Care and Workforce Management ...
3 minute read - Firm AnnouncementsChambers USA 2022 Recognizes Epstein Becker Green's Focused Excellence in Core Practice Areas: Distinguished in ...4 minute read
- Firm Announcements
Thirteen Attorneys Named to the 2022 Washington, DC, Super Lawyers and Rising Stars Lists
5 minute read - Firm Announcements
Epstein Becker Green Finalist for Law Firm of the Year in Healthcare and Labor & Employment by Chambers USA 2022 ...
2 minute read - Firm Announcements
Corporate Counsel Name Epstein Becker Green as a Client Service Standout – BTI A-Team 2022 Report
2 minute read - Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as ...7 minute read
- Firm Announcements
Epstein Becker Green Recognized as “Unparalleled M&A Standout” by Clients and Corporate Counsel—BTI M&A Outlook ...
3 minute read - Firm Announcements
Epstein Becker Green Receives High Rankings for Health Care and Workforce Management Practices in 2021 Edition of The Legal ...
3 minute read - Firm Announcements
Ten Epstein Becker Green Attorneys Named to 2021 Washington, DC, Super Lawyers and Rising Stars Lists
5 minute read - Firm Announcements
Corporate Counsel Rank Epstein Becker Green’s Client Service in Top 10% of Law Firms – BTI A-Team 2021 Report ...
2 minute read - PublicationsMark Lutes Discusses Key Health Care Business Trends Concerning Stakeholder Preparedness in 2021, Beyond Continued ...2 minute read
- Firm AnnouncementsFifty-Five Epstein Becker Green Attorneys Recognized for Professional Excellence–Two Attorneys Distinguished as ...7 minute read
- Firm AnnouncementsThe Legal 500 United States Recognizes Epstein Becker Green as Top-Tier Law Firm in Health Care and Workforce Management ...4 minute read
- Firm Announcements
Epstein Becker Green’s Focused Excellence in Health Care and Workforce Management Recognized in 2020 Edition of Chambers ...
3 minute read - Firm Announcements
Sixteen Epstein Becker Green Attorneys Named to 2020 Washington, DC, Super Lawyers and Rising Stars Lists
5 minute read - Media CoverageEpstein Becker Green Leaders Discuss the Impact of COVID-19 on Clients and the Firm6 minute read
- Firm AnnouncementsLawyers of Color's 2020 Power List Names Adam Abrahms as Honoree and Mark Lutes as Diversity Ally3 minute read
- Media CoverageEpstein Becker Green Analysis Featured in "Healthcare Predictions for 2020: Health Systems Will Get Bigger, Demand for ...3 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read
- Media CoverageMark Lutes Quoted in "Health and Life Sciences Policy to Watch in 2020"2 minute read
- Firm Announcements
Forty-Seven Epstein Becker Green Attorneys Named by The Best Lawyers in America 2020, One Attorney Distinguished as "Lawyer ...
5 minute read - Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "Prominent Law Firm Loses Nashville Chief"2 minute read
- Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "National Firm Adds to Tennessee Health Care Team"2 minute read
- Firm Announcements
Epstein Becker Green Recognized as Top-Tier Law Firm by The Legal 500 United States, Receives Additional High Rankings ...
4 minute read - Firm Announcements
Epstein Becker Green Recognized Among Leading Law Firms and Attorneys in 2019 Edition of Chambers USA
4 minute read - Firm Announcements
Sixteen Epstein Becker Green Attorneys in Washington, DC, Named to 2019 Super Lawyers and Rising Stars Lists
6 minute read - Media CoverageVictoria Vaskov Sheridan Featured in "On the Move"1 minute read
- Publications
Mark Lutes Discusses Unexpected 2019 Healthcare Trends in MCOL ThoughtLeaders
2 minute read - Firm Announcements
Epstein Becker Green Recognized by BTI Legal Innovation and Technology Outlook 2019 as a "Mover & Shaker"
3 minute read - Media Coverage
Mark Lutes Discusses Employer Demand for Increased Member Cost Sharing in MCOL ThoughtLeaders
3 minute read - Firm AnnouncementsBehavioral Health Association of Providers, Epstein Becker Green, Nelson Hardiman Join Together to Address Legal and ...5 minute read
- Firm Announcements
Epstein Becker Green Attorneys Selected for The Best Lawyers in America 2019 and Four Attorneys Named "Lawyer of the Year ...
5 minute read - Media CoverageMark Lutes Quoted in "Healthcare Lawyers Tout Surge in Care Transactions as Transformational"2 minute read
- Firm AnnouncementsLegal 500 United States Recognizes Epstein Becker Green as Top-Tier Recommended Law Firm, Awards Additional High Rankings ...4 minute read