Policy & Regulatory Changes

In the last week, significant developments have emerged that will impact value-based care and payment models. HHS Secretary Robert F. Kennedy Jr. is navigating challenges within the agency amid ongoing scrutiny over the FDA's handling of rare disease drug denials, raising questions about the potential impact on access to innovative treatments for vulnerable populations. Concurrently, new legislative changes affecting noncompete agreements and certificate-of-need regulations are reshaping the operational landscape for ambulatory surgery centers (ASCs), prompting stakeholders to reassess their strategies in response to evolving state policies and regulatory frameworks. These dynamics highlight the need for ACO leaders and health system executives to stay vigilant and adaptable in a rapidly changing environment, particularly as they align their strategies with the shifting regulatory context in this administration. For more details, see coverage on noncompete agreements and CON updates and the FDA's investigation into rare disease drug rejections.