Regulatory Changes

In the last week, several states are advancing changes to their certificate-of-need (CON) laws, with active proposals in Maryland seeking to streamline healthcare facility development and mitigate redundancy in services. This shift reflects a growing tension between the need for healthcare expansion and cost management, which is crucial for Value-Based Care (VBC) stakeholders navigating an evolving regulatory landscape. Meanwhile, the FDA's unexpected rejection of a potentially game-changing cancer therapy underscores the challenges drugmakers face in securing timely approvals, which could impact treatment options for patients with rare diseases as well as future VBC initiatives. For more on state-level CON law changes, visit Becker's ASC, and for insights on FDA challenges, see Stat News.