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.

Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry. In November 2008, Karen completed the Harvard Business School's seven-day program on Leading Professional Service Firms.

Representative Matters

· Represented an academic medical center in a Medicare reimbursement appeal that resulted in a $21 million settlement in favor of the provider.

· Served as lead counsel 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 in the now-unsealed qui tam case.

· Designed and drafted an independent laboratory'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 agencies.

Recognitions & Awards

· Nightingale's Healthcare News: Outstanding Young Healthcare Lawyer (2007)

· Phi Beta Kappa

Professional & Community Involvement

· 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, Suited for Change (2007 - 2010)