Elizabeth Hardcastle

BETH HARDCASTLE is a life sciences lawyer who provides strategic regulatory counseling to a wide range of pre-commercial and established healthcare companies. She focuses her practice on healthcare regulatory and compliance matters, bringing deep experience across federal healthcare program coverage, coding, and reimbursement; government price reporting; healthcare compliance programs; market access and healthcare contracting; and healthcare fraud and abuse.

Coverage, Coding, and Reimbursement. Beth has extensive experience in federal healthcare program coverage, coding, and reimbursement issues across drugs, biologics, devices, durable medical equipment (DME), and laboratory tests. She has a strong track record of successfully launching innovative products and obtaining favorable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) for clients. She advises on coverage and coding strategy from early in the product development cycle — often well before regulatory approval. Her work has ranged from helping pharmaceutical manufacturers bring to market therapies with favorable coverage, coding, and reimbursement, to navigating complex reimbursement pathways for digital health technologies, AI-enabled diagnostics, and radiopharmaceuticals.

Government Price Reporting and 340B. Beth advises on complex government price reporting obligations under the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, the Medicare Part B Program, and the Federal Supply Schedule. She has particular depth in the 340B program, where she counsels manufacturers on a broad range of matters including the design and implementation of limited distribution networks, compliance with program policies and manufacturer obligations, audits of covered entities, and litigation efforts related to 340B disputes. She helps clients navigate the evolving regulatory and enforcement landscape of the 340B program, including guidance issued by HRSA and developments arising from judicial decisions reshaping program requirements.

Healthcare Fraud and Abuse and Compliance. Beth has managed defense matters, including helping pharmaceutical manufacturers respond to government inquiries and subpoenas relating to fraud and abuse allegations associated with their distribution arrangements and patient assistance programs. She has also led internal compliance investigations and advised clients on the design and implementation of effective healthcare compliance programs.

Market Access and Healthcare Contracting. Beth advises clients on market access strategy and healthcare contracting, helping them navigate the full array of regulatory and commercial considerations critical to successful product launches and ongoing operations, including payer engagement, formulary strategy, and value-based contracting arrangements.

Digital Health, Artificial Intelligence, and Radiopharmaceuticals. Beth has particular experience advising clients in emerging and highly regulated product categories, including digital health technologies, AI-powered medical products, and radiopharmaceuticals. She understands the coverage, coding, reimbursement, and regulatory challenges these products present and works with clients to develop tailored strategies to achieve and maintain market access in a rapidly evolving landscape.