Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Karen draws from her deep health care regulatory knowledge to provide legal and practical business counsel to clients across the health care and life sciences industries. Recognized by a client in Chambers USA as an “absolute star attorney in the area of health care compliance,” Karen applies this foundation when representing clients in state and federal government investigations, transactions, and day to day regulatory and operational matters. She is highly regarded for her commitment to exceptional client service and her unique ability to guide clients through the complex maze of regulatory and business issues, providing holistic guidance on both to in-house counsel. Karen is Chair of the firm’s Health Law Practice and Health Care Enforcement Defense Practice. She is a member of the firm’s Executive Committee

Karen’s substantial health care regulatory and compliance background includes advising clients on matters pertaining to the federal anti-kickback statute, the Stark law, the Eliminating Kickbacks in Recovery Act (EKRA), state statutes prohibiting kickbacks and self-referrals, Medicare and Medicaid program an reimbursement requirements, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the federal Physician Payments Sunshine Act, and state licensure laws. She also has experience advising clients operating in the value-based care arena. Karen routinely works with clients to develop and implement health care compliance programs to avoid the government spotlight, oversees internal investigations, and advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices.

In addition to counseling health care and life sciences entities on regulatory matters, Karen represents clients subject to federal False Claims Act investigations and qui tam litigation, state investigations involving false claims/insurance fraud, state and federal surveys and inspections, and state licensure proceedings. She has negotiated and structured high stakes settlement agreements with the US Department of Justice and its US Attorneys’ Offices and state Attorneys General Offices, as well as corporate integrity agreements with the Department of Health and Human Services Office of Inspector General. In the negotiation of a recent significant settlement on behalf of a client with several US Attorneys’ Offices and the Department of Justice, Karen successfully negotiated no admission of liability and no corporate integrity agreement.

Karen draws upon her regulatory counseling and health care enforcement experience to provide practical advice on health care regulatory transactions, including the assessment of risk, appropriately tailored reps and warranties, and the negotiation of R&W insurance exclusions.  Karen serves as regulatory counsel to private equity firms, other investors, and health care companies in mergers, acquisitions, and other transactional matters. She leads complex due diligence projects for these entities across a vast array of industry areas, including behavioral health, laboratories, diagnostic companies, hospice and home health providers, and benefit management companies.

Karen also specializes in the representation of laboratories and diagnostics companies. She regularly counsels on compliance with CLIA and state laboratory licensure laws, federal and state limitations on billing for diagnostic services, and legal restrictions on sales and marketing activities. Karen has served as regulatory counsel in a number of mergers and acquisitions involving laboratories and diagnostics companies and has represented numerous laboratories and diagnostics companies in state and federal government investigations.

She is a frequent author and speaker on regulatory and compliance issues confronting the industry and editor of the firm’s Health Care Viewpoints.

Karen has two German Shepherds, and she has served as a foster parent for the Mid-Atlantic German Shepherd Rescue for many years.  She and her family have helped nearly 30 dogs find their forever homes.

The Women Business Leaders of the U.S. Health Care Industry Foundation Board Member (2019 - 2022), Advisory Board Member (2022 - Present), DC KinCare Alliance Council Member, American University Washington College of Law - Health Law and Policy Program Alumni Advisory Council Board Member, DC SCORES (2013 – 2016) Board Member, Suited for Change (2007 – 2010) Foster Parent, Mid-Atlantic German Shepherd Rescue

American University (JD, magna cum laude) West Virginia University (BA, summa cum laude)