The Big Picture On January 8, the U.S. Department of Health & Human Services (HHS) released a final rule that imposes a ten-year sunset date on most regulations that have ever been, or will ever be, issued by HHS and its component agencies, including the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA). 1 To preserve a rule past this automatic expiration date, HHS must assess whether the rule significantly affects “small entities”; if so, HHS must publish an analysis of whether the rule ought to be preserved, amended or rescinded, as described below. The so-called SUNSET rule—which stands for “Securing Updated and Necessary Statutory Evaluations Timely”—was finalized largely as proposed in November. The most significant difference pertains to the timeline for reviewing the backlog of rules that are already more than ten years old: HHS now has five years to complete these assessments, up from two years in the proposed rule. Other notable changes include a requirement for HHS to publish a monthly announcement of newly opened regulatory assessments, and an expanded list of current regulations that are exempt from the SUNSET rule’s requirements; this list includes certain key regulations related to Medicare payment, FDA product classifications, and healthcare fraud and abuse.