Spencer Fane attorney Beth Siemer was recently quoted in the Law360 article HHS Bolsters 340B Rebate Plan After Legal Setbacks.
The article examines HHS’s revised 340B drug pricing rebate pilot and its effort to address concerns that previously led courts to block a similar program. Beth states that the expanded regulatory notice could actually strengthen hospitals’ legal challenges by providing more detail to contest the agency’s reasoning and by failing to adequately address the administrative and financial burdens on covered entities.
With respect to commentary indicating a shift from the presumption that 340B covered entities are entitled to 340B discounted pricing to a presumption that 340B covered entities must prove entitlement to the pricing up front for each unit purchased, Beth said, “That is a significant, substantive, fundamental shift for HRSA to hold out in a preamble and expect to withstand scrutiny.”
Beth is a pragmatic health care attorney who advises individuals and organizations navigating complex state and federal laws that govern transactions, compliance, and reimbursement. Working with various providers, payers, benefit managers, and vendors in the health care space, she offers practical tools, actionable advice, and customized solutions.
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