Charitable Patient Assistance Programs: Ensuring Compliance

Ms. Fethke provides regulatory advice on a wide range of issues, including healthcare and FDA regulatory matters and compliance program development and support. She regularly advises medical device and pharmaceutical companies on legal issues related to sales, marketing, medical and research activities, including federal and state laws and industry codes regulating manufacturer interactions with providers, payors and patients. In addition, Ms. Fethke provides advice with respect to FDA requirements related to the testing, sales and promotion of prescription drugs and medical devices. She works with healthcare institutions and life sciences companies to implement and enhance comprehensive compliance programs both domestically and globally, including structural design, operational support, and external assessments of program effectiveness.

Mr. Mathias represents clients across the U.S. in all areas of the health care industry, with a particular emphasis on fraud and abuse, internal and government investigations, and corporate compliance matters. His practice focuses on advising clients on compliance with the federal antikickback law, the Stark physician self-referral statute and the federal civil monetary penalty provisions. He also advises health systems and GPOs on compliance with the discount and GPO safe harbors as well as strategies for reducing legal risks associated with cutting edge supply chain management and purchasing programs. He is a former vice chair of the American Health Lawyers Association’s Fraud & Abuse Practice Group.

Ms. Michael’s practice focuses on fraud and abuse and federal and state regulatory compliance. Before joining the firm, Ms. Michael served as Chief of the Industry Guidance Branch at the U.S. Department of Health & Human Services, Office of Counsel to the Inspector General. In that role, she led a team of attorneys responsible for interpreting and applying federal fraud and abuse statutes to a wide variety of arrangements across all segments of the health care industry. Under her leadership, the Industry Guidance Branch issued dozens of advisory opinions, the first-ever rescission of an advisory opinion, Special Fraud Alerts, policy statements, and various other guidance documents. In addition, Ms. Michael supervised rulemakings involving the federal anti-kickback statute and the federal civil monetary penalty law prohibiting inducements to beneficiaries. Her duties also included advising the Chief Counsel and other senior leaders at the Office of Inspector General (OIG) regarding the application of federal fraud and abuse laws to healthcare arrangements. As the leading source of knowledge on federal fraud and abuse statutes, she provided and supervised technical assistance to government officials at the Department of Justice (DOJ), the Centers for Medicare & Medicaid Services, and other state and federal agencies.