Karen focuses her practice on representing health care companies in regulatory, transactional, and operational matters. She has a substantial health care regulatory background and advises clients on matters pertaining to the federal anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, the Clinical Laboratory Improvement Amendments of 1988, and the federal Physician Payments Sunshine Act. Karen often applies her strategic insight on these matters to counsel companies on regulatory issues arising in connection with mergers and acquisitions and other transactions. She also defends companies in high-stakes state and federal investigations. Karen regularly speaks and writes on challenges facing laboratories, diagnostic companies, and other health care companies.
Karen is the Practice Leader of the firm’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Her experience includes matters related to the anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, and the federal Physician Payments Sunshine Act.
Karen applies her compliance and regulatory experience in transactional as well as litigation contexts. In addition to counseling health care entities on regulatory matters arising in connection with mergers and acquisitions, she has successfully defended clients subject to state and federal surveys, Medicare and Medicaid overpayment and reimbursement appeals, and state licensure proceedings. Karen also represents clients subject to state and federal investigations alleging violation of the anti-kickback statute, the federal False Claims Act, and other state and federal laws.
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.
Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry. She is the co-author of What Is…the Anti-Kickback Statute?, a book recently published by the American Bar Association.
- American University (JD, magna cum laude)
- West Virginia University (BA, summa cum laude)
- Served as lead counsel to two national independent laboratories in a federal investigation of violations of the federal False Claims Act based on billing and sales/marketing practices as well as quality of care allegations. The government filed a notice of non-intervention, and the parties reached a settlement favorable to the laboratories.
- Designed and drafted a diagnostics company’s compliance program policies and conducted general and specialized compliance training programs for employees and board members.
- Advised a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with the division of the company and oversaw the preparation of hundreds of filings to be submitted to all licensure and accreditation agencies, the Medicare program, and state Medicaid programs nationwide.
- Counseled a specialty laboratory regarding whether and how to make a self-disclosure related to a Medicare overpayment and met with the U.S. Attorney’s Office regarding the self-disclosure, which did not lead to further investigation or enforcement action.
- Counseled a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with its acquisition by an international diagnostics and laboratory services company, and prepared over one hundred filings to be submitted to a variety of agencies.
Recognition & Awards
- Chambers USA: District of Columbia – Healthcare (2014 – 2019)
- Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2019)
- Included on the Washington DC Super Lawyers: Health Care list (2017, 2019)
- Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyer (2007)
- Phi Beta Kappa
- Member, BNA Bloomberg Medicare Report Editorial Board
- Member, Law360 Healthcare Editorial Advisory Board
- Associate, The Women Business Leaders of the U.S. Health Care Industry Foundation
- Board member, DC SCORES
- Board member, Suited for Change (2007 – 2010)