Significant knowledge of life sciences regulatory enforcement trends, market access, market access strategy, payer and PBM-related issues, payer and PBM contracts, other market access contracts, contract operations, government pricing requirements (ideally for both medical and pharmacy benefit products), regulatory and compliance issues, the FDCA, the False Claims Act, federal and state fraud and abuse laws, and antitrust laws. The level of counseling requires a deep understanding of market access principles, market access strategy, payers, pharmacy benefit managers ("PBM"), payer and PBM contracts, pharmaceutical distribution channels, contract operations, government pricing, regulatory and compliance issues, the False Claims Act, the Anti-Kickback Statute, and OIG guidance, and other applicable state and federal healthcare laws.