Samuel Bernstein Bio

Sam focuses his practice on representing life sciences companies and healthcare providers and suppliers, including medical device and pharmaceutical manufacturers, hospitals, physician practices, laboratories, IDTFs, dialysis facilities, and ambulatory surgery centers, regarding a wide range of regulatory, compliance, commercial, transactional, and corporate matters. Sam regularly provides guidance to medical device and other life sciences companies regarding compliance and regulatory matters, including developing compliant sales models and value-based arrangements, addressing marketing, off-label promotion, MDR, and other FDA-regulated matters, complying with the Physician Payments Sunshine Act and similar State laws, negotiating clinical trial agreements and purchase agreements, establishing and updating compliance programs, and addressing privacy-related matters. Over the past 15 years, he has helped life sciences companies navigate fraud and abuse issues, including in connection with governmental investigations, and served as a key resource for compliance and legal departments. Sam also assists healthcare providers and suppliers with compliance, commercial, transactional, and corporate governance matters, including addressing fraud and abuse concerns under anti-kickback laws, the Stark Law, and the False Claims Act, responding to governmental investigations, appealing overpayment determinations with Medicare, Medicaid, and commercial payors, challenging the termination of Medicare billing privileges and other adverse Medicare enrollment decisions, addressing HIPAA and data privacy issues, negotiating payor, supplier, electronic health record system, and other commercial agreements, and advising on corporate restructuring, transactions, and conflicts matters. Sam has significant experience in value-based care and frequently assists healthcare providers and suppliers, including IPAs, health systems, ACOs, and physician practices develop, structure, and negotiate compliant value-based care models, including outcomes-based, risk-based, capitated, and other models. Sam formerly held Series 6, 63, and 26 securities licenses, was an Illinois licensed insurance producer and mortgage broker, and is an Illinois licensed real estate broker. Sam is also a regular speaker at industry conferences and corporate seminars.