Clients turn to our healthcare team because it is a one-stop shop for advice on strategies to address the full range of regulatory concerns, from reimbursement challenges to fraud and abuse concerns, to patient privacy, the Sunshine Act and similar state laws, and compliance program development. Our clients regularly seek our counsel on:
- Pricing and price reporting issues
- Sales and marketing practices, including product launches
- Reimbursement strategies for new services, drugs and technologies
- Negotiating customer contracts
- Clinical trial implementation, real-world evidence development, and other research and development activities
- Digital health
- Patient assistance and reimbursement support programs
Our lawyers are deeply familiar with all aspects of the Medicare program, Medicaid, the 340B Drug Pricing Program, and other federal healthcare programs. Other areas of particular focus include: product distribution; discounting and rebating; group purchasing organization (GPO) and pharmacy benefit manager (PBM) administrative fees and price concessions; free goods; samples; educational and research grants; advisory boards and similar personal services relationships; gifts and business courtesies and joint ventures.
Our longstanding work in the healthcare regulatory space makes us uniquely attuned to the latest issues and business challenges. This deep understanding—informed by our work for manufacturers of pharmaceuticals and biologics and many other players in the healthcare industry – allows us quickly to recognize new and old problems alike. That, in turn, allows us to advise clients on how best to optimize their business models and implement those models while avoiding pitfalls.
