Healthcare Providers and Voluntary Disclosures: Evaluating If, When, and How to Report to CMS, DOJ, or OIG

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.

Ms. Tamulis focuses her practice on counseling a diverse range of clients on complex healthcare regulatory issues affecting operations and compliance matters. She advises pediatric hospital systems on compliance issues, including daily operations matters and internal compliance audits and reviews. She also provides guidance on healthcare regulatory compliance for pharmaceutical and medical device manufacturers and distributors and health plans. Drawing on her healthcare regulatory experience, Ms. Tamulis assists with internal compliance reviews and responding to government investigations, including defending companies facing government scrutiny in False Claims Act (FCA) matters. She has represented clients in the medical device, pharmaceutical, long-term care, and imaging sectors, as well as senior healthcare executives, before U.S. Attorneys’ Offices and the Department of Health and Human Services (HHS) Office of Inspector General in FCA, Stark Law, and Anti-Kickback Statute enforcement actions.

Mr. Oppenheim’s practice includes all aspects of transactional, operational and regulatory healthcare law, including mergers & acquisitions, affiliations, joint ventures and the formation of integrated delivery systems. Among his clients are many of the largest healthcare companies and hospital systems in the U.S. A nationally-recognized expert on anti-kickback and Stark Law issues, Mr. Oppenheim wrote the 2014 American Health Lawyers Association Monograph on Stark. He has served as an expert on anti-kickback and Stark Law issues in arbitration and litigation, in both civil and criminal proceedings. In addition, he creates and implements compliance programs, investigates compliance issues, responds to government enforcement actions, and negotiates settlements for many types of healthcare providers.