Spencer Fane attorney Beth Siemer was recently quoted in a 340B Report article discussing analysis that found that 340B refunds have been concentrated among certain manufacturers and drugs. The article also featured Beth and Aurora Kammerer’s March 5 blog post, 340B Manufacturer Notices of Correction.
The article, Manufacturer Refunds to 340B Providers Have Steadily Increased Since 2019, Says Analysis, describes how the total number of manufacturer refunds issued has increased from less than 10 in 2019 to about 40 in 2023. The same analysis also found that many of the manufacturers repeatedly issue notices of correction for the same drug.
When asked what might explain the increased pace of manufacturer refunds, referencing 2019 changes in reporting requirements, Beth said, “When there’s not accountability, it’s very difficult to turn attention to compliance to that degree. When accountability starts it can shift how attention is paid. The data shows that pretty dramatically for some manufacturers and the accelerating pace of corrections can show that as well.”
At Spencer Fane, 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 that allow her clients to keep the focus on innovating and providing high-quality products and services.*
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