New Mandated Centers for Medicare and Medicaid Services Requirements for Sepsis Reporting: Caution from the Field.

Background: The release of the Center for Medicare and Medicaid Service's (CMS) latest quality measure, Severe Sepsis/Septic Shock Early Management Bundle (SEP-1), has intensified the long-standing debate over optimal care for severe sepsis and septic shock. Although the last decade of research has demonstrated the importance of comprehensive bundled care in conjunction with compliance mechanisms to reduce patient mortality, it is not clear that SEP-1 achieves this aim. The heterogeneous and often cryptic presentation of severe sepsis and septic shock, along with the multifaceted criteria for the definition of this clinical syndrome, pose a particular challenge for fitting requirements to this disease, and implementation could have unintended consequences.