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 and has extensive experience in federal healthcare program coverage, coding, and reimbursement issues; government price reporting; healthcare compliance programs; market access and healthcare contracting; and healthcare fraud and abuse.
Beth’s work has ranged from helping pharmaceutical manufacturers successfully launch unique therapies with favorable coverage, coding, and reimbursement to advising on complex government price reporting obligations under the Medicaid Drug Rebate Program, the 340B Program, the Medicare Part B Program, and the Federal Supply Schedule. She has also 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, and led compliance investigations.
Beth has worked to help numerous clients, including large and small pharmaceutical, biologics, and medical device manufacturers, durable medical equipment suppliers, patient advocate organizations, and health information technology companies, among others. For these clients, she covers the full array of healthcare regulatory matters that are of critical importance to these companies, including drug pricing, government reporting, compliance programs, market access, and government affairs.
She is also committed to disability rights issues and has represented a number of disability rights organizations and individuals with disabilities on a pro bono basis in matters challenging Medicaid coverage denials, appealing disability benefits denials, and advocating on healthcare public policy issues.
Prior to law school, Beth competed on the U.S. Paralympic Swim Team in the 2008 Beijing Paralympics.
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