Anti-Kickback Statute Master Class: Trends in Enforcement and Regulatory Guidance - What Should Be On Your AKS Radar?

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.

Kate Stern is a senior associate in King & Spalding's Healthcare practice. Kate focuses on the representation of health systems, hospitals, physician organizations, academic medical centers, home health companies, retail pharmacy chains, large retailers with pharmacy operations, specialty pharmacies and management services organizations.

Kate has experience advising clients on a wide variety of healthcare regulatory matters, specifically including fraud and abuse laws such as the Stark law and the federal anti-kickback statute, Medicare and Medicaid regulation (including Medicare Advantage and audit and enforcement matters), EMTALA, HIPAA and various state laws and regulations that govern provider operations. She has experience with accountable care organizations, clinically integrated networks, shared savings and incentive payment compensation.

Kate also has experience creating and implementing compliance programs, implementing health information technology systems and electronic health records and drafting Medicare provider reimbursement appeals. In addition, Kate represents health industry clients in various transactional matters and government investigations.

Kate is an active member of the American Health Lawyers Association.

Joan Killgore provides value to her clients by bringing specialized clinical and technical knowledge to the table, which enables her to quickly assess urgent matters and provide practical and creative recommendations. Her background includes experience as a pediatric hospital nurse and an adjunct professor for the Center for Health Care Studies at Saint Louis University School of Law, which has been ranked by U.S. News & World Report as the No. 1 health law program in the nation.

On a daily basis, Joan counsels clients on an array of health care regulatory, operational, and transactional matters. Joan has significant experience assisting clients with regulatory compliance matters, such as utilizing various federal agency disclosure procedures, when clients identify potential compliance issues.