In The Press August 11, 2022

340B Entities Face Increased Challenges in a Shifting Regulatory and Enforcement Landscape (MedCity News)

On June 15, 2022, the Supreme Court issued an opinion in favor of 340B hospitals rejecting steep reductions in reimbursements for covered 340B drugs that the Centers for Medicare and Medicaid Services (“CMS”) had tried to implement in 2018. But even following this decision, all entities involved in the 340B Drug Pricing Program (“340B Program”) still face a significant amount of uncertainty in complying with its requirements. In addition to the reimbursement amount issue, the U.S. Department of Health and Human Services (“HHS”) and its sub-agencies have recently taken shifting and inconsistent positions that threaten to create a legal and practical quagmire for the 340B Program designed to provide healthcare to underserved and vulnerable patient populations. In this article, we look at three key areas of uncertainty for the 340B Program. Complex Litigation & Dispute Resolution counsel Katie Cheng and partner William Jackson of Goodwin explain more in this byline article. Read the MedCity News article here.